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The Official Publication of the American Society for Artificial Internal Organs
ASAIO Promotes the Development, Application, and Awareness of Organ Technologies
that Enhance Quality and Duration of Life

ASAIO 65th Annual Conference


San Francisco, CA
June 26-29, 2019

ASAIO 2019 Annual Conference Abstracts

Published for the Society by


May/June 2019 Volume 65  •  Supplement 1
ISSN 1058-2916

Bioengineering Abstracts........................................................................................................................................................................................... Pages 1-45

Cardiac Abstracts.................................................................................................................................................................................................... Pages 46-101

Critical Care / Anesthesiology / Pathology (CAP)................................................................................................................................................. Pages 102-104

Nursing Circ-Support ........................................................................................................................................................................................... Pages 105-118

Pediatric Abstracts ............................................................................................................................................................................................... Pages 119-125

Pulmonary Abstracts ........................................................................................................................................................................................... Pages 126-128

Renal Abstracts .................................................................................................................................................................................................... Pages 129-136

Author Index......................................................................................................................................................................................................... Pages 137-145


ASAIO BIOENGINEERING ABSTRACTS
9 21
Fabrication and Evaluation of Chitosan-based Nanofibrous Membrane as Designing a Visual Analogue Scale Questionnaire to Determine the
an Effective Tissue Adhesion Barrier Emotional Impact of Wearable Components of Ventricular Assist Devices
O. Kwon; Kumoh National Institute of Technology, Gumi, KOREA, (VADs)
REPUBLIC OF. J. Dunn1, K. Ko1, E. Nusem1, K. Straker1, C. Wrigley1, S.
Study: Post-operative peritoneal adhesions are common and give seri- Gregory2; 1Architecture, Design and Planning, University of Sydney,
ous complications for surgeons. They can cause pelvic pain, infertility, Sydney, AUSTRALIA, 2Department of Mechanical and Aerospace
and potentially lethal bowel obstruction. Chitosan is the deacetylated Engineering, Monash University, Melbourne, AUSTRALIA.
derivative of chitin, which is the second most abundant polysaccharide Study: Visual Analogue Scales (VAS) have been proven to be reliable
found on earth next to cellulose. It comprises copolymers of glucosamine when used to objectively determine a measurement of patient quality of
and N-acetyl glucosamine has a combination of many unique properties life. They have also been successfully used since the 1970s in the field of
such as nontoxicity, biocompatibility and biodegradability. This study was environmental psychology to determine the emotional impact and affec-
designed to evaluate the effect of chitosan/PVP nanofibrous membrane tive quality attributed to environments. It follows that if the influence of a
on the prevention of post-surgical tissue adhesion. human-made environment on one’s spatial experience can be measured
Methods: Nanofibrous membranes composed of chitosan and poly(vinyl by VAS, then the influence and experience of an artificial artefact interfac-
pyrrolidone)(PVP) were fabricated by electrospinning method. Mor- ing with the body could similarly be measured. The aim was to develop
phological structures of electrospun nanofibers were observed using a VAS questionnaire based upon VAD literature, to be used to determine
SEM and image analyzer. ATR-FTIR was used to characterize electrospun the occurrence and intensity of emotional impact and affective user expe-
nanofibers. Biodegradation study was also carried out. In vitro NIH3T3 cell rience attributed to the wearable components of VADs.
culture was conducted in Dulbecco’s modified Eagle’s medium (DMEM). Methods: A systematic literature review on human factors and user
Outbred Sprague-Dawley rats were used to evaluate the effects of nano- experience of the wearable components of VADs returned 338 titles, with
fibrous sheet as physical barrier for the prevention of intra-abdominal 35 studies included for cross-study analysis and synthesis. Data from the
adhesion. selected studies generated a comprehensive list of user-defined keywords
Results: Addition of PVP into chitosan solution considerably improved describing emotional impact and affect attributed to the wearable
the spinnability of the solution. The average diameter of nanofibrous components of VADs. These keywords were categorised thematically and
chitosan/PVP membrane was about 390 nm determined by SEM and used as data input for the development of adjective pairs to create a VAS
image analyzer. Chitosan/PVP nanofiber was gradually degraded in PBS questionnaire using established methods.
buffer. Chitosan/PVP nanofiber lost its nanofibrous structure within 4 Results: A novel VAS questionnaire was developed, which requires testing
weeks of incubation. Chitosan/PVP nanofiber showed a good in vitro cell and refinement with VAD users i.e. patients, caregivers and healthcare
proliferation behaviour compared to the control group. The in vivo animal practitioners. To date, research surrounding the emotional impact and
test demonstrated that significant decrease of postoperative tissue adhe- user experience of the wearable components of VADs has rarely been
sion by applying the Chitosan/PVP nanofiber sheet. From these results, it directly translated into readily available insights for use as input to future
is concluded that the Chitosan/PVP nanofiber sheets could be a promising product development. The VAS questionnaire could become a suitable
material to prevent post-operative tissue adhesion. research tool to generate these much-needed user insights, enabling
strategic design decision makers and VAD manufacturers to prioritise
which user experience issues more urgently require attention due to the
intensity of affect.

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<zdoi;>Unauthorized reproduction of this article is prohibited.
ASAIO BIOENGINEERING ABSTRACTS

22
Clot Detection in Membrane Oxygenators using Micro-Computed-
Tomography - A Feasibility Measurement
C. Birkenmaier1, C. Dornia2, K. Lehle3, L. Krenkel1; 1Biofluid Mechanics,
Technical University of Applied Sciences Regensburg, Regensburg,
GERMANY, 2Dept. of Radiology, University Hospital Regensburg,
Regensburg, GERMANY, 3Dept. of Cardiothoracic Surgery, University
Hospital Regensburg, Regensburg, GERMANY.
Study: Notwithstanding advances made, coagulation disorders and clot-
ting are still a considerable complication in extra corporeal life support.
Direct visualisation and analysis of thrombotic deposits inside membrane
oxygenators (MO) is an important issue.These measurements are so far
performed with clinical multidetector computed tomography (MDCT).
The drawbacks of this method, such as limited spatial resolution, can be
circumvented by using high-resolution micro tomography (µCT). Here
we show the feasibility of µCT for clot detection and analysis in MOs and
compare it to the established MDCT method.
Methods: Three clinically used Quadrox PLS MOs were included in this
study, which were analysed in terms of clot volume and distribution.
µCT analysis was performed with VGStudioMax 3 based on a combina-
tion of a threshold criterion with a dynamic region growing method. The
thresholds were determined from histograms, based on Otsu’s method.
µCT-results are compared to the standard medical MDCT results.
Results: Using MDCT, clot volumes are systematically underestimated,
compared to µCT results. Standard MDCT gives occluded volumes of 13%,
0%, and 1%, whereas technical µCT gives 50%, 21%, and 24%, respectively
(fig.1). The high-res µCT is able to resolve the individual geometrical
features inside the MO. This avoids the issue of integrating attenuation
properties of air, fibre material and clot, which MDCT does. Thus, small
individual clot structures can be measured much more precise. Using µCT,
much more occluded volume is detected in the outlet membrane package
than in MDCT (fig.2). This can be explained by the presence of the heat
exchanger in zones I and II, which changes the integrative attenuation
properties.

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ASAIO BIOENGINEERING ABSTRACTS

32 33
Design Domain Identification of a Beating Left Ventricular Simulator
Tissue-Inducing Characteristics of Titanium Fiber Mesh with One Side
with Finite Element Modelling
Sealed with Non-Porous Material for Its Application to Artificial Heart
U. Gulbulak, T. Baturalp, A. Ertas; Mechanical Engineering, Texas Tech
E. Okamoto1, K. Arimura2, Y. Mitamura2; 1Sapporo Liberal Arts Center,
University, Lubbock, TX. Tokai University, Sapporo, JAPAN, 2Graduate School of Engineering and
Study: This study aims to identify the design domain of a beating left Science, Tokai University, Sapporo, JAPAN.
ventricular (LV) simulator made of latex rubber and McKibben actuators. Study: Titanium fiber mesh is the only artificial extracellular matrix made
A parametric study is formed in order to investigate the effect of design from metal, and salient features of titanium fiber mesh suitable for an
parameters, such as wall thickness of latex rubber, number of actuators, artificial heart are its mechanical strength maintaining 3D geometry and
and helical orientation of actuators. Using these design parameters, 150 its good electrical conductivity. In the application of titanium fiber mesh
nonlinear finite element (FE) models are prepared to construct the design to an artificial heart system, one side of the titanium fiber mesh is sealed
domain. The main objective of this study is to investigate parameters with a metal or polymer material. In this study, we investigated tissue-
within the design domain which will result in better ejection fraction. inducing characteristics of a titanium fiber mesh with one surface sealed
Methods: The geometry of the LV cavity was generated according to diastole with non-porous material for its application to an artificial heart system.
mean length and inner diameter of the cavity. Actuators were considered as Methods: One side of the sintered titanium fiber mesh (Hi-Lex Co.,Zellez,
solid cylinders to simplify FE models. Simulator geometries were generated Japan) which is disk-shaped with a diameter of 5 mm and a thickness of
with Inventor (Figure 1a). Nonlinear FE models were prepared with ANSYS 1.5 mm having a titanium fiber diameter of 50 <&#181;>m and volumetric
R19.1. Mechanical properties of the latex rubber were determined ASTM porosity of 87% with an average pore size of 200 <&#181;>m, was sealed
D412-16 (Figure 1b). Deformation behavior of the actuators was mimicked with a thin film of no venomousness silicone rubber adhesive(Shin-Etsu
with thermal deformation by replicating experimental strains with thermal Co, KE-42-T,Japan).Two sets of the sealed and the non-sealed titanium
strains. Directional deformation and rotation probes were placed on the apex. fiber mesh disk were implanted in two rats under the skin of the dorsal
FE modelling methodology was validated in the previous study (Figure 1c). region, and they were extracted in the 12th postoperative week. The
fixed titanium fiber meshes with 10% buffered formalin solution were
sectioned after staining with hematoxylin-eosin and they were examined
by light microscopy.
Results: The distribution of capillaries was mainly confined to the area
around the sealed titanium fiber mesh disk and connective tissue inside
the sealed titanium fiber mesh disk seemed to be in a poor condition.
From estimation of the extent of the spread of oxygen from capillaries
using the diffusion equation, an area in which oxygen was poorly supplied
may exist in the center of the sealed titanium fiber mesh disk. For applica-
tion of the sealed titanium fiber mesh to an artificial heart system, the
thickness of the titanium fiber mesh is an important factor for keeping the
inside tissue in a healthy condition.

Results: The design domain was built with the directional deformation of
the apex and the rotation of the apex. As shown in Figure 2, the design
domain is discretized into six subdomains with respect to helical orienta-
tions of actuators. As helical orientation angles increase, subdomains
exhibit rotation of the apex dominant behavior. As known from previous
research studies, rotation of the apex plays an important role in ejection
fraction. Experimental simulation results revealed that 4 mm wall thick-
ness of a simulator with 90 degrees helical orientation and 8 actuators is
the preferred combination for the manufacturing of beating LV simulator.

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ASAIO BIOENGINEERING ABSTRACTS

39 40
A Perfusion Device to Preserve Liver Function in an Ex Vivo Environment Rotary Blood Pump Control Strategy for Physiologic Perfusion, Suction
for Multiple Days Prevention, and Augmentation of Vascular Pulsatility
D. Becker1, D. Eshmuminov2, M. Hefti3, M. Schuler3, L. Bautista Borrego2, Y. Wang1, M. Meki2, X. Xu1, P. Sethu3, A. S. El-Baz2, G. A.
C. Hagedorn2, X. Muller2, R. Graf2, P. Dutkowski2, M. Tibbitt1, C. Onder1, Giridharan2; 1School of Optoelectronic Engineering and Instrumentation
P. Clavien2, P. Rudolf von Rohr1; 1ETH Zurich, Zurich, SWITZERLAND, Science, Dalian University of Technology, Dalian, CHINA, 2Bioengineering,
2
University Hospital Zurich, Zurich, SWITZERLAND, 3Wyss Zurich, Zurich, University of Louisville, Louisville, KY, 3Medicine and Biomedical
SWITZERLAND. Engineering, University of Alabama at Birmingham, Birmingham, AL.
Study: Donor liver graft shortage is among the greatest crisis faced by Study: Rotary blood pumps (RBP) are currently operated at a fixed pump
the transplant society. Alternative strategies and novel technologies to speed which does not provide physiologic perfusion, diminishes vascular
increase the available donor pool are urgently required. Ex vivo normo- pulsatility, and is susceptible to ventricular suction. We report a control
thermic liver perfusion provides the mean to allow for assessment and strategy for RBP that meets the objectives of physiologic perfusion and
treatment of marginal donor grafts, or even regeneration of split grafts ex suction prevention, while simultaneously augmenting vascular pulsatil-
vivo. However, treatments such as liver regeneration are limited by the ity. Furthermore, the control algorithm does not require pressure, flow,
duration of ex vivo viability. or volume sensors that are prone to failure and baseline drift over the
Methods: Here, we present a novel perfusion technology to keep a long-term.
liver viable and functional outside of the body for one week. Perfusion Methods: The proposed algorithm uses the intrinsic pump parameter
experiments were conducted with porcine livers, keeping livers viable of pump speed to calculate the variation in RBP speed over a 2-second
for multiple days outside of the body. The technology was developed by time window (ΔRPM). A gain-scheduled, proportional-integral controller
a multidisciplinary team in a close collaboration of surgeons, biologists maintains the ΔRPM at a low ΔRPM setpoint (ΔRPMLr), leading to high
and engineers. The perfusion machine acts as an artificial body, closely RBP flow. When the ΔRPM reduces as the native ventricle is unloaded,
mirroring its main functions, thereby ensuring physiological blood condi- the controller automatically switches to a high ΔRPM setpoint (ΔRPMHr)
tions. An integrated dialysis unit replaces the kidneys’ function, ensuring that reduces RBP flow and generates pulsatility. Efficacy and robustness
physiological electrolyte balance, removing metabolic waste products and of the proposed algorithm were evaluated in-silico during simulated rest
controlling hematocrit. An artificial pancreas controls blood glucose con- and exercise test conditions, transition from exercise to rest, a rapid (<
centration, injecting insulin or glucagon based on continuous measure- 20 s) five-fold increase in pulmonary vascular resistance (PVR), and noisy
ment of glucose levels. Infusion of vasoactive substances allows keeping pump speed.
the liver’s hemodynamics at desired levels. Results: The proposed control algorithm maintained adequate physi-
Results: The livers constantly produced bile during the course of perfu- ologic perfusion while avoiding ventricular suction for all test conditions,
sion and cleared bilirubin into the bile. Initial rise of cell damage marker including measurement noise and a rapid increase in PVR (Figure 1). The
AST reduced during perfusion, similarly, lactate was constantly cleared. proposed algorithm augmented vascular pulsatility by generating aortic
Histologically, tissue integrity was preserved as can be seen in H&E pressure variation of about 40 mmHg at rest and 30 mmHg during exer-
staining. Summarizing, porcine livers were kept in a close to physiologic cise at a frequency of 3–10 cycles per minute.
environment during several days of perfusion, illustrating maintained Conclusion: The computer simulation findings demonstrated feasibility
metabolic function and cell integrity. This technology may open new and robustness of the proposed sensorless RBP control algorithm, and
doors for the application of therapeutic measures and ex vivo treatment successfully predicted its function and efficacy over the wide range of
of livers, whose scope will be revealed by future applications. expected clinical test conditions. In-vitro and in-vivo tests will be con-
ducted to validate these results.

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ASAIO BIOENGINEERING ABSTRACTS

41 62
Effect of PEG Chain Length and Solvent Composition on Antifouling Evaluation of Plasma Leakage in Extracorporeal Membrane Oxygenators
Capacity of Silane-PEG Coatings Based on the Gas Inlet Pressure
A. J. Patil1, Z. Iqbal1, W. H. Fissell2, S. Roy1; 1Department of Bioengineering Y. Nakamura1, T. Nakakita2, K. Yamamoto2, A. Kamada2, S. Iguchi2, K.
and Therapeutic Sciences, University of California San Francisco (UCSF), Umimoto1; 1Osaka Electro-Communication University Graduate School,
San Francisco, CA, 2Nephrology and Hypertension, Vanderbilt University Osaka, JAPAN, 2Osaka Electro-Communication University, Osaka, JAPAN.
Medical Center, Nashville, TN. Study: During long-term use of oxygenators, reduction of the oxygenation
Study: Silicon nanopore membranes (SNMs) are used in the development capacity due to plasma leakage can be problematic. At present, the occur-
of hemofilters for renal replacement and immunoprotective encapsula- rence of plasma leakage is judged from the viscosity or color of moisture
tion barriers for islet transplant. Silane-PEG (SPEG) coatings have previ- discharged from the gas outlet of the oxygenator and a more precise
ously shown to be effective in reducing protein adsorption on SNMs. This method of evaluation has not been established. An indirect method for
work investigates the effect of chain length of PEG in the SPEG molecule evaluating plasma leakage was investigated by using an asymmetric mem-
and solvent water content on coating thickness and protein adsorption. brane oxygenator (BIOCUBE6000).
Methods: Plasma treated silicon substrates were exposed to three SPEG Methods: To simulate plasma leakage, four different solutions were
solutions with varying PEG chain length for 2 hours at 60 degree Celsius prepared with sodium dodecyl sulfate (SDS) and pure water (1%, 0.1%,
(Fig. 1 A). SPEG1, SPEG2, and SPEG3 solutions were prepared by dissolving 0.01%, and 0%). SDS was added to reduce the surface tension in the
663 mg, 614 mg, and 200 mg, respectively of the corresponding materials oxygenator. These solutions were circulated through the BIOCUBE 6000,
in 50 ml of toluene. Selected samples of SPEG solutions were hydrolyzed while the gas inlet pressure and the amount of moisture leaking from the
by adding 60 µl of 1 M HCl to the 50 ml of toluene. Coating thickness was membrane into the gas flow path were measured over time.
measured using ellipsometry while coating performance was evaluated Results: After 120 min of circulating pure water, the gas inlet pressure
by an ELISA assay to determine the relative adsorption of human serum showed a slight increase to 0.56 ± 0.11 mmHg (n = 3, mean ± S.D.), and
albumin (HSA) compared to non-coated silicon substrates, which served the gas moisture content was 16.67ml ± 0.94 ml. When SDS solutions
as the control. were circulated instead of pure water, the gas inlet pressure increased
Results: Ellipsometry data indicated that SPEG coatings ranged from moderately to 0.98 ± 0.11 mmHg (n = 3, mean ± S.D.) after circulation
0.70–2.04 nm in thickness. For the same PEG chain length, the coating of the 0.01% SDS solution for 120 min, while it increased to 1.64 ± 0.21
thickness was non-significantly (p greater than 0.075) greater for hydro- mmHg with the 0.1% SDS solution and was markedly elevated to 16.5
lyzed compared to non-hydrolyzed conditions (Fig 1 B). The solvent water ± 0.22 mmHg with the 1% SDS solution. In addition, the gas moisture
content (non-hydrolyzed vs hydrolyzed) had a significant effect on HSA content was 23.3 ± 1.33 ml with the 0.01%SDS solution, 29.0 ± 2.33 ml
adsorption (p less than 0.008), but there was no significant effect of PEG with the 0.1% SDS solution, and 36.7 ± 0.47 ml with the 1% SDS solution,
chain length on HSA adsorption (p greater than 0.37) (Fig 1 B). Hydrolyzed increasing along with the SDS concentration. Thus, reduction of mem-
SPEG1 exhibited a coating thickness of 1 nm with relative protein adsorp- brane hydrophobicity during long-term oxygenator use with consequent
tion of less than 1.5% compared to control. Future studies will focus on leakage of plasma components from the blood into the gas flow path was
further characterization of SPEG1 to determine its suitability for SNM reproduced by using these SDS solutions. It was found that the gas inlet
applications in vivo. pressure and leakage of moisture both increased in proportion to the SDS
concentration. These results indicate that the gas inlet pressure of the
oxygenator reflects the extent of plasma leakage.

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ASAIO BIOENGINEERING ABSTRACTS

65 69
A Growing Database for Viscosity Profiles of Bovine Blood with Varying The Effect of Shear Rate and Exposure Time on the Size of Platelet
Hematocrits Across Shear Rates Aggregations
S. G. Boucher, A. A. Ruiz, J. B. Loayza, F. Casas; MCS R&D, Medtronic, C. Chan1, M. Inoue2, K. Ki3, T. Murashige4, J. Fraser3, M. Simmonds5, N.
Miami Lakes, FL. Watanabe2, G. Tansley1; 1School of Engineering and Built Environment,
Study: Centrifugal ventricular assist devices are the most commonly used Griffith University, Gold Coast, AUSTRALIA, 2Department of Life Sciences,
mechanical circulatory support devices providing treatment for patients Systems Engineering and Science, Shibaura Institute of Technology,
with end-stage heart failure. In these pumps blood is exposed to high Saitama, JAPAN, 3Faculty of Medicine, University of Queensland, Brisbane,
shear rates, potentially changing the dynamics these cells normally expe- AUSTRALIA, 4School of Engineering, Tokyo Institute of Technology, Tokyo,
rience when hemodynamic performance is crucial to improving patient JAPAN, 5Menzies Health Institute, Queensland, Griffith University, Gold
outcomes. This study aimed to establish a growing database of shear rate Coast, AUSTRALIA.
versus viscosity data for bovine blood at varying hematocrits. The goal for Study: Clinical outcomes from Left Ventricular Assist Devices (LVADs) have
this database is to collect a large sample size of viscosity profiles against improved significantly in recent decades. Common complications of long-
shear rates for advancing current understanding of non-Newtonian blood term LVAD use include bleeding events, plausibly due to the supraphysi-
dynamics under shear forces inside a blood pump. ological shear environment of these pumps. Greater understanding of the
Methods: This study used 0.5 mL samples of bovine blood that was impact of shear rate on the formation size of platelet aggregation, which
diluted to three hematocrits (20%, 25%, and 30%) for each shear ramp. is influenced by the functional activity of high molecular weight von Wil-
The shear ramp test ran each sample on an LVDV2T+ viscometer using the lebrand factor (vWF), could provide insight into these bleeding complica-
RheoCalcT software from a low shear rate of 0 seconds-1 to a high shear tions. The purpose of this study was to investigate the effect of shear
rate of 800 seconds-1 in 25 seconds-1 increments (Ametek-Brookfield, MA). rate and exposure time on the platelet aggregation size, vWF activity and
Results: The average viscosity at 450 seconds-1 (60 RPM) for each hema- molecular weight of vWF multimers.
tocrit group are as follows: 2.84 ± 0.07 cP for 25% hematocrit, 2.92 ± 0.30 Methods: human platelet-poor plasma and fluorochrome-labelled
cP for 27% and 3.09 ± 0.20 cP for 30%. Readings were variable amongst platelets (n=5) were subjected to discrete shear rates (0 to 15,000 s-1)
different samples of the same hematocrit group and overlapped across for specific exposure times (0, 5, 10, 15 minutes) using a custom blood-
distributions. Particularly for the 27% hematocrit group, the spread shearing device equipped with a combination of high-speed camera and
overlapped into both the 25% and 30% hematocrit region. A higher fluorescent microscope. In addition, vWF activity was determined by the
sample size is needed to better define the distributions of viscosity and capacity of platelets to aggregate in the presence of ristocetin using flow
distribution overlap for each hematocrit. This understanding could lead to cytometry. Molecular weight of vWF multimers were measured using gel
improvement of future algorithms with better flow estimations and more electrophoresis and immunoblotting.
physiologically accurate mock loop testing environments which could Results: Larger platelet aggregations of between 200 - 300 μm formed
improve pump performance, and in turn, patient outcome and care. gradually in response to increasing duration of exposure to shears in
the physiological range of 360 - 3,000/s. The size of platelet aggregates
decreased to 50 -100 μm following exposure to higher shear rates in
excess of 6,000 s-1. Under these non-physiological regimes, the decrease
in platelet aggregation size was due to the loss of high molecular weight
vWF multimers and lowered functional activity of vWF for platelet aggre-
gation. In conclusion: shear-mediated changes in platelet aggregation size
may be a cause of bleeding in patients implanted with LVADs.

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ASAIO BIOENGINEERING ABSTRACTS

70 72
CFD Analysis of Segmented MicroCT Data of Ventricular Assist Devices: Apico Aortic Blood Pump: Short Term In Vivo Experiments
A Comparative Study B. Utiyama, J. Fonseca, E. Drigo, E. Leal, A. Andrade, F. Pimenta; Instituto
E. Agrafiotis1, M. A. Geith2, I. Anders3, G. A. Holzapfel4, V. Hergesell1, Dante Pazzanese de Cardiologia, São Paulo, BRAZIL.
O. E. Dapunt1, S. Spiliopoulos1; 1Research Unit Mechanical Circulatory Study: Purpose of study: Apico Aortic Blood Pump (AABP) is a centrifugal
Support and Heart Replacement, Department of Cardiac Surgery, Medical intrathoracic LVAD. AAPB’s In Vitro studies have demonstrated that the
University, Graz, AUSTRIA, 2Biomedical Engineering Department, King’s device have an adequate hydrodynamic performance for use in Bridge to
College London, London, UNITED KINGDOM, 3Division of Biomedical Transplantation therapy, a low hemolysis index and that the device has
Research, Medical University, Graz, AUSTRIA, 4Institute of Biomechanics, an adequate size for it to be fixed at left ventricle apex when implanted.
Graz University of Technology, Graz, AUSTRIA. In this study, AAPB’s short term In Vivo experiments report is presented.
Study: Blood constituents alter their behavior when they penetrate a Besides the further device analysis this study also allows the improve-
foreign environment such as a ventricular assist device (VAD). Eryth- ment of surgical procedures for AAPB’s implant.
rocyte deformation and platelet activation are triggered by the blood- Methods: AABP was implanted in seven pigs (female, +-140 lb). AABP’s
device interaction due to shear stresses and surface contacts. Common inlet cannula was inserted and fixed directly in the left ventricle, and
computer-aided design (CAD) strategies are insufficient to map precise outlet cannula was connected to the ascending aorta. After surgery, the
dimensions and material surfaces on the in silico model. Micro-computed animal was maintained for 6h, AAPB’s rotation speed, flow, current con-
tomography (CT) scanning can provide accurate internal and external sumption and temperature where monitored during the tests for analysis.
dimensions of 3D models nondestructively. This study aims to determine The animals were maintained under anesthesia but with the thoracic cav-
the high shear stress areas of continuous flow VADs in computational fluid ity opened for temperature and device outlet flow measurement.
dynamics (CFD) analysis by comparing the structural influence between Results: Summary of Results: AAPB’s monitored parameters indicated no
the MicroCT-generated models and the classic CAD models. device failure during the experiments, average rotational speed during
Methods: MicroCT-generated 3D models were extracted in high-quality the experiments was 2000 rpm for an outlet flow of 2 l/min, average
by capturing the structural details and the different cavities of the VAD current consumption was 0,2 A and average temperature at motor was
that in manual CAD designs are probably disregarded. In CFD (ANSYS- 30ᵒC. There where none significant clinical or anatomical alteration in the
Fluent), the shear stress transport k-ω model was chosen for turbulence animal’s during or after the experiments. Through the experiments surgi-
investigation with a fluid viscosity of 3.5 x 10–3 Pas and a density of cal time for AABP implant was from 2 hours to 30 minutes.
1050 kg/m3.
Results: MicroCT-generated data displayed very accurate internal
dimensions of the VAD without disregarding surface characteristics. The
qualitative difference between the two design strategies is depicted in
Figure 1. An inflow cannula is chosen as an example. Figure 1A highlights
the detailed inner surface of a MicroCT-generated 3D model. In contrast,
the less accurate result of a 3D CAD geometry is illustrated in Figure 1B.
Consequently, the numerical analysis of high shear stress predictions in
the MicroCT models is better resolved and therefore more realistic.

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ASAIO BIOENGINEERING ABSTRACTS

75 77
Development of the 2nd Generation DermaPort Ported Vascular Access In Vivo Performance of an Advanced Ventricular Assist Device with Pulse
System (PVAS)TM Augmentation and Regurgitant Flow Shutoff
A. D. Janis1, T. J. Lobl2, B. Moran3; 1DermaPort, Inc. (Former), Grayslake, N. Byram1, T. Miyamoto1, Y. Kado1, J. Adams1, A. R. Polakowski1,
IL, 2DermaPort, Inc.; Alfred Mann Institute, Univ. Southern California, Los R. Dessoffy1, D. J. Horvath2, B. D. Kuban1, J. H. Karimov1, K.
Angeles, CA, 3DermaPort, Inc.; Moran Medical Device Consulting, Santa Fukamachi1; 1Biomedical Engineering, Cleveland Clinic, Cleveland, OH, 2R1
Barbara, CA. Engineering LCC, Euclid, OH.
Study: The DermaPort™ Ported Vascular Access System (PVAS) was devel- Study: We have developed a ventricular assist device (VAD) under NHLBI
oped to improve central line access and reduce infections in hemodialysis. funding (Grant 5R21HL133871) that automatically couples with the ven-
The port is comprised of a percutaneous Ti conduit with a subcutaneous tricle. Previous reports disclosed that model AV020 RC showed improved
Ti mesh ingrowth cuff. After placement, the 14.5F dual lumen catheter is pulsatility and functionality of the shutoff feature over the AV010 and was
anchored to the conduit by a silicone brake. The brake can be released ready to move into in vivo studies. This study evaluated the pulsatility and
and re-anchored, permitting repositioning or replacement of the cath- functionality of the shutoff feature as a left (n=2) or right (n=1) VAD dur-
eter. Reports describing the design, in vitro/in vivo testing and clinical ing three acute studies in calves.
performance of the PVAS Gen1 have recently been published (Rajan D Methods: The Advanced VAD was implanted into three healthy calves
et al 2018. Cardiovasc Intervent Radiol; Lobl T et al 2019. ASAIO J. In (weight, 71.4 kg - 91.2 kg) through a median sternotomy. The inflow
press). Human factors feedback from the clinical trial revealed that the cannula was placed in the left ventricular apex (LVAD) or ventricular free
performance of the peel away sheath used during implantation was user- wall (RVAD), the outflow graft was anastomosed to the ascending aorta
dependent. Therefore a 2ndgeneration design (Gen2), was developed and (LVAD) or pulmonary trunk (RVAD), and the pump was run at 3000 RPM
validated in vivo. (LVAD) or 2500 RPM (RVAD) to evaluate pulse augmentation before being
Methods: Three candidate designs and cuff positions for the Gen2 dilat- stopped to assess regurgitant flow through the pump. The outflow graft
ing housing were compared to Gen1 with sheath in an acute porcine was then clamped to demonstrate the feasibility of a clinical pump-off
insertion model. The selected design and 3 potential mesh cuff posi- test. Other hemodynamic parameters were evaluated, including pulse
tions were tested in 6w and 4w chronic rabbit studies, respectively. Both amplification and general performance, and the resulting data were com-
chronic studies histologically characterized mesh ingrowth and marsupial- pared to our in vitro results.
ization in comparison to Gen1 and Dacron-cuffed catheter controls. Results: When the pump was stopped in both the LVAD and RVAD con-
Results: Insertion of Gen2’s new housing with a 10deg dilating distal end figurations, we noted no remarkable regurgitant flow, with -0.3 ± 0.2 L/
was determined to be the most similar to Gen1 in the porcine model. The min and -0.5 ± 0.1 L/min, respectively (See Figure for representative LVAD
4w rabbit implant study showed a trend towards greater downgrowth for trace). No significant changes in the arterial pressure waveform occurred
the deeper mesh designs and no observation of marsupialization. There when the outflow conduit was clamped, indicating that the pump-off test
were no significant differences in connective tissue ingrowth between could be performed without clamping the outflow conduit. In conclusion,
the two PVAS housing designs, which trended higher, more mature and the in vivo performance of the AV020 RC matched the data predicted by
less inflammatory than Dacron cuffed controls in the 6w study. These in vitro studies.
data provide support for the further development of the Gen2 PVAS in
response to clinical feedback on the Gen1 design.

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ASAIO BIOENGINEERING ABSTRACTS

83
Development of a Soft Robotic Organosynthetic Left Ventricle
C. Park1, E. T. Roche2; 1Department of Mechanical Engineering,
Massachusetts Institute of Technology, Cambridge, MA, 2Department of
Mechanical Engineering, Institute of Medical Engineering & Sciences,
Massachusetts Institute of Technology, Cambridge, MA.
Study: The objective of this study is to develop a physiological and
anatomically accurate in vitro cardiac simulator using a combination
of organic tissue with soft robotic synthetic muscle. Existing simulators
typically use intracardiac fluid pressurization to drive ventricular motion,
but this causes unnatural curvature in the ventricular walls and paradoxi-
cal pressure waves. We previously reported a simplified soft robotic left
ventricular simulator. Here, we use similar techniques, greatly enhanced
with a custom ex vivo molding process to recreate an anthropomorphic
active myocardium to drive the motion of the ventricular walls, recapitu-
late natural motion of the left ventricle (LV) and recreate physiological
hemodynamics. Furthermore, we combine this synthetic myocardium
with organic tissue to accurately represent the internal cardiac structures
for high fidelity device testing.
Methods: A whole porcine heart was dissected by removing the LV and
interventricular septal myocardium, leaving the endocardium intact. The
myocardial tissue was substituted with a soft robotic myocardial shell
made out of a silicone matrix and 8 pneumatic artificial muscle actuators
by a multi-part casting process. Actuators were placed equidistant from
one another and oriented in a left-handed helix (-60° to the basal plane)
simulating the LV outer myocardial fiber direction. Individual actua-
tors were precisely controlled using an electropneumatic system that
allowed fine-tuned motion during each cardiac cycle. The motion was
characterized by measuring the degree of rotation using image analysis
of screenshots from video recording. The hemodynamics were evaluated
by measuring the LV pressure waveform using a pressure transducer and
intraventricular catheter.
Results: The LV model replicated physiological twisting motion of 8.25° as
well as LV pressure waves. This LV model will have great utility for testing
intracardiac devices in which motion, hemodynamics and endocardial
anatomical properties are important.

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ASAIO BIOENGINEERING ABSTRACTS

89 98
Development of Multiple Point Bowel-sound Analysis System (MPBAS) Drag Reducing Polymers Improve Oxygen Transfer Rate In Miniature
for the Optimization of the Bowel Sound Measurement Position Hollow Fiber Membrane Oxygenators
J. Nishioka1, N. Igata2, Y. Takaoka3, T. Sueuchi3, M. Kagawa3, S. Kitamura3, D. Crompton, R. A. Orizondo, M. V. Kameneva; Bioengineering, University
T. Takayama3, M. Oono4, M. Fuketa4, M. Shishibori4, K. Terada4, M. of Pittsburgh, Pittsburgh, PA.
Sogabe5, T. Okahisa5; 1Graduate School of Medical, Tokushima University
Graduate School, Tokushima City, JAPAN, 2Faculty of Medicine, Student Study: Hollow fiber membrane oxygenators (HFMOs) are designed such
Lab, Tokushima University, Tokushima City, JAPAN, 3Gastroenterology and that gas transfer is maximized while minimizing device surface area. This
Oncology, Tokushima University Graduate School, Tokushima City, JAPAN, is often achieved through a combination of active and passive mixing
4
Intelligent Systems, Tokushima University Graduate School, Tokushima techniques aimed towards creating blood flow paths where the diffu-
City, JAPAN, 5General Medicine and Community Health Science, Tokushima sional boundary layer is reduced in order to increase gas permeance and
University Graduate School, Tokushima City, JAPAN. overall transfer efficiency. Previously, non-toxic blood additives known as
drag reducing polymers (DRPs) have shown in vitro and in vivo to reduce
Study: For medical management of functional bowel disorders, such the size of stagnant zones at bifurcation regions, eliminate regions of
as irritable bowel syndrome and chronic constipation, an evaluation of recirculation following microchannel expansions, and reduce of the size of
the intestinal motility is important. However, a noninvasive, simple, and the near-wall “cell-free” layer within the microvasculature and microchan-
easy rating system for evaluating the intestinal motility has not been nels. This study aims to test our hypothesis that the addition of DRPs will
developed so far. Bowel sounds result from the mixing intestinal contents reduce small areas of flow separation and/or recirculation within the fiber
due to intestinal motility. The possibility that intestinal motility can be bundle and increase gas transfer efficiency.
evaluated by performing computer-based analysis of the recorded bowel Methods: Washed bovine blood suspended in PBS at 30% hematocrit
sounds by an electro-stethoscope has been reported. However, the posi- was deoxygenated to venous conditions where half of the blood pool
tion for optimal bowel sound measurement has not yet been examined. received the addition of 5 ppm of the DRP poly(ethylene oxide). Blood
In this study, we developed a system (Multiple Point Bowel-sound was pumped through custom polymethylpentene miniature HFMOs at
Analysis System, MPBAS) that can be used to measure bowel sounds at a rate of 45 mL/min with an oxygen sweep gas flow rate of 300 mL/min.
20 places simultaneously and attempted to optimize the bowel sound Blood samples taken from the inlet and outlet of the oxygenator device
measurement position. were used to calculate oxygen gas transfer rates.
Methods: The bowel sounds of five subjects were measured in a silent Results: Nanomolar concentration of DRPs significantly increased the
environment during a resting period of 5 minutes and one hour after gas transfer rate of oxygen within the devices tested by 20% from 1.50 to
drinking carbonated water. The bowel sound recorded using MPBAS 1.80 mL/min (p=0.013). This pilot study serves as a proof of concept for
was analyzed using a software developed. Bowel sound was extracted our hypothesis, where further experiments will be employed to verify the
using the short-time energy method, and the sound-sound interval (SSI), ability of DRP to increase the oxygen gas transfer rate in clinically relevant
sound time (ST), sound per-minute (SPM), percent sound (%S), and sound oxygenators under established standards. If confirmed to increase the
energy (SE) were calculated. efficiency of HFMOs, the addition of DRP may enable the use of devices
Results: Between-subject differences were small for SPM and %S at rest, with much smaller membrane surface areas and reduce common device
and the maximum values were recorded at 9 cm on the right side of the complications such as thrombosis.
navel (the anatomical position of the ileocecal valve). Five minutes after
drinking carbonated water, a decrease in SPM and increase of SE were
noted at 9 cm on the right side of the navel and at the right hypochon-
drium (the anatomical position of the pylorus ring of the stomach). These
results indicate that 9 cm on the right side of the navel is an optimal site
to evaluate the bowel sound.

10
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ASAIO BIOENGINEERING ABSTRACTS

107 113
Optimization of Artificial Vascular Tissue Bioreactor for Use with Flow Distribution Analysis in Peripheral VA ECMO By Interposition Graft
Peristaltic LVAD G. Fragomeni1, M. Rossi2, P. Fratto2, A. Cuda1, A. Covino2, G.
Z. Frankman, R. Smolenski; Medical University of Gdansk, Gdansk, Catapano3; 1Magna Graecia University, Catanzaro, ITALY, 2Grande
POLAND. Ospedale Metropolitano “Bianchi-Melacrino-Morelli”, Reggio Calabria,
Study: Cardiovascular disease is the largest source of mortality in the ITALY, 3Università della Calabria, Cosenza, ITALY.
world, and has been projected to reach an annual death toll of 20 million Study: The most common sites for establishing peripheral ECMO are
by the year 2030. A substantial demand exists for a source of tissue engi- femoral artery and vein. The main goal of ECMO cannulation is to provide
neered vascular tissue for the replacement of vessels. Traditional sources the least traumatic and most durable and simplified method for delivering
of tissue engineered vascular tissue are low-throughput and require the blood to and from the circuit. During peripheral VA ECMO, one of the
several weeks to prepare. This makes tissue engineered vascular grafts complications of retrograde flow into femoral artery is lower limb isch-
infeasible for emergency situations where surgery must take place in a emia. One method to avoid this is to anastomose end-to-side a Dacron
short time span. In this study, our team investigates a method for optimiz- graft to the common femoral artery. However, its upward and downward
ing 3D endothelial cell culture to remove unnecessary culture time, and flow distributionIs is not clear.
to allow for the accurate projection of time to confluence and implanta- Methods: A computational approach was employed to carry out the
tion viability. In addition, this is a preliminary study for a novel LVAD investigation on a 3D patient-specific femoral artery model by means
developed by our team that utilizes a robust vascular graft for peristaltic of Computational Fluid Dynamics (CFD) simulations. In our model we
pumping, which requires a continuous stream of uniform vascular tissue compared the blood flow distribution of the interposition graft for AV
for experimentation. ECMO simulating different grade of Superficial Femoral Artery (SFA) and
Methods: We characterize free ICAM concentration using ELISA. We Profound Femoral Artery (PFA) caliber reduction.The pump output was
further measure metabolism of ATP, ADP, and AMP per unit mass of cells set at 2.5 L/m2/min and the anastomosis site was at the common femoral
under variable growth conditions using HPLC and Bradford assay, under artery with 10 mm diameter straight dacron tube in all cases.
both continuous flow and static growth conditions. Time to confluence Results: With no caliber reduction of SFA and PFA, we had only 78% of the
projections are confirmed using image processing and whole cell stains. blood flow towards the Common Femoral Artery (CFA) (tab. 1). Interest-
Two variable conditions are examined, achieved by 3D printing cell ingly, closure of the SFA and progressive reduction of caliber in the PFA,
growth environments using an inert polymer. The first is angled planar obtained with external snare provided the best flow distribution. Actually,
growth of cells on 0, 5, 10, 20, 30, and 40 degree slopes with separate total occlusion of SFA and 50% to 70% caliber reduction of PFA, achieved
metabolic analyses performed at three increasing topographical eleva- up to 91% forward flow without the need of excessive augmentation of
tions. The second variable condition is cylindrical section growth of the pump output. The use of interposition graft allows limb perfusion but
cells at 1, 2, and 3 cm diameter, with three separate metabolic analyses with significant blood loss central perfusion (22%). A better central blood
performed on the valley and sloped walls. Measurements performed at flow support can be achieved by external manipulation of peripheral
1–4 day incubation time. vascular resistances rather than by escalating the pump output.
Results: We demonstrate cell growth and variable metabolism at all vari-
able growth conditions. Our data can be used to project time to conflu- Flow distribution for different degree of SFA and PFA stenosis
ence for all growth conditions investigated.
SFA PFA
Stenosis Stenosis CFA flow SFA flow PFA flow
[%] [%] [%] [%] [%]

Case1 0 0 78 15 7
Case2 50 50 80 14 6
Case3 70 70 83 11 6
Case4 100 50 87 0 13
Case5 100 80 91 0 9

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ASAIO BIOENGINEERING ABSTRACTS

114 115
Centrifugal Blood Pump as Ventricular Assist Device evaluation in the Induced Spiral Flow and Helical Washout Mechanics
Hybrid Cardiovascular Simulator P. Huang Zhang1, R. Newman2, W. Grimme3, Z. Alali4, C. Tkatch1, D.
J. Fonseca1, B. Utiyama1, E. Silva1, J. Cardoso2, D. Filho2, A. Andrade1, J. Vainchtein5, J. Y. Kresh1; 1Cardiothoracic Surgery, Drexel University
Lucchi3; 1Bioengineering, Institute Dante Pazzanese of Cardiology, Sao College of Medicine, Philadelphia, PA, 2Physics, Drexel University,
Paulo, BRAZIL, 2Electrical Enginneering, University of Sao Paulo, Sao Paulo, Philadelphia, PA, 3Mechanical Engineering, Drexel University, Philadelphia,
BRAZIL, 3Electrical Enginneering, Maua Institute of Technology, Sao Paulo, PA, 4Materials Science, Drexel University, Philadelphia, PA, 5C. & J. Nyheim
BRAZIL. Plasma Institute, Drexel University, Philadelphia, PA.
Study: Evaluate centrifugal blood pump (CBP) assistance in a Hybrid Study: Spiral forms of blood flow, observed throughout the cardiovascular
(numeric and physical) Cardiovascular Simulator (HCS) and its speed system, are thought to impact hemorheological properties and confer
control. hemodynamic benefits. Spiral flow has been postulated to reduce ath-
Methods: HCS model is a tool composed by two sections (figure): 1) a erosclerosis risk and limit stenosis progression in large vessels. This study
physical section composed by: a reservoir, mimicking a passive left atrium; aimed to understand the washout potential of spiral flow using several
a pumping chamber with two bilealeft valves, as left ventricle; an air tight idealized vascular conduits. It is expected that the reported outcome will
compliance chamber; a proportional valve as systemic vascular resistance help inform future designs of circulatory devices (grafts, stents, vascular
and a set of tygon tubes. The electromagnetic actuator of pumping cham- access-ports, pumps).
ber, the air volume inside the compliance chamber and the proportional Methods: Washout potential was analyzed using angled (45°, 90°, 135°)
valve are controlled by a real time platform through the numeric section. and stenotic (axis-symmetric, asymmetric) conduits with predictable flow
2) The numeric section is composed by: vena cava; right heart; pulmonary recirculation regions. Numerical simulations were used to evaluate the
artery; lungs and pulmonary vein. All compartments of numeric section impact of induced spiral flow, with straight flow serving as control. Wash-
have been programmed in LabVIEW® RT. Interaction between both out was quantified by measuring the volume of low-velocity (<5cm/s) and
sections is made through pressure and flow signals which are acquired area of low wall shear stress (WSS<3dyn/cm2). Benchtop experiments,
at physical section by sensors. CBP has been used as ventricular assist incorporating 3D-printed models, were conducted to validate the simula-
device by researchers around the world due to its blood pump efficiency. tions. Fluid (viscosity=1cP, density=1000kg/m3) flow was set to 2L/min
However, during controller development, a special attention has to be and the models considered stiff, with no-slip wall boundary condition.
applied to CBP speed control adjustment. CBP performance evaluation Results: Spiral flow reduced the total volume of low-velocity by up to
was performed in four steps: firstly, the HCS was adjusted to simulate 86.7% and the area of low-WSS by up to 84.6%, compared to straight
a human healthy condition; after that, a congestive heart failure (CHF) flow. The reattachment length of the post-stenosis recirculation region
condition was simulated changing left ventricle contractility; the third was reduced by up to 43.4% with spiral flow. Principally, increased spiral
condition simulated was CHF with CBP assistance; finally, CPB was turned flow reduced recirculation in problem areas, but concomitantly increased
off while connected and pressure signals were collected. regions of high-WSS (>100dyn/cm2).
Results: HCS allows us to observe the impact of CBP assistance under In conclusion, spiral flow contributes significantly to improving washout
pump speed changes for several heart conditions. From results was characteristics and near-wall mixing. Optimizing the helical properties of
possible to observe that when the pump runs at high speed, aortic valve blood recirculating devices to match the target vasculature is expected to
remains closed. On the other hand, at lower pump speeds, the blood attenuate undesirable vascular remodeling and atheroma formation.
returns from aorta to left ventricle impairing cardiac assistance. Also,
through Pressure x Volume loop was possible to analyze specific charac-
teristics of CBP assistance.

12
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ASAIO BIOENGINEERING ABSTRACTS

119 120
Red Blood Cell Damage in a Magnetically Levitated Shearing Device A Virtual Reality Feedback System for High Quality CPR Training
J. Krisher1, R. Malinauskas2, S. W. Day1; 1Biomedical Engineering, G. Gonzalez1, M. S. Pena1, B. J. Hudson2, J. Tran3, J. T. Gilmer3, H. E.
Rochester Institute of Tehcnology, Rochester, NY, 2US Food & Drug Bergeron1, M. J. Slepian4; 1Biomedical Engineering, The University of
Administration, Silver Spring, MD. Arizona, Tucson, AZ, 2Biosystems Engineering, The University of Arizona,
Study: Rotary blood pumps may cause shear-induced hemolysis leading Tucson, AZ, 3Electrical and Computer Engineering, The University of
to adverse effects in patients. To evaluate blood damage caused by these Arizona, Tucson, AZ, 4Sarver Heart Center, The University of Arizona,
devices during development, in vitro testing has been performed using Tucson, AZ.
blood from different animal species. It is important to understand the Study: In the United States, more than 350,000 out-of-hospital car-
fragility of these species’ red blood cells (RBCs) relative to each other and diac arrests occur annually. CPR, while life saving, must be performed
to the applied fluid shear. The literature presents conflicting information accurately to be effective. We have previously identified that wearable
regarding these relationships, partially due to differences in the flow sensors can quantify the acceleration of CPR compressions. This study
fields and in how the applied shear is quantified. Here, we assess RBC aims to implement virtual reality (VR) with wearable sensors to measure
fragility in human, porcine, and ovine blood and evaluate characterizing compression acceleration, frequency, and depth while providing real time
the damage in terms of the viscosity-independent shear rate, rather than feedback to the user for more immersive and effective CPR training.
the commonly used parameter “shear stress”. Methods: VR scenarios were customized by BioflightVR and integrated
Methods: The test device was a modified axial flow blood pump with a into Unity programming software. An HTC Vive headset was used to
magnetically levitated, blade-less rotor. The rotor applied a Couette shear to immerse the user into a real world CPR scenario while an HTC Vive tracker
the blood while the “exposure time” was controlled using a syringe pump to tracked the position of a CPR mannequin in VR. An MPU6050 accelerom-
adjust the axial blood flow rate. The index of hemolysis (IH%) was calculated eter was programmed with an Arduino Micro to detect and analyze com-
for venipuncture-obtained human, porcine, and ovine blood (36% hematocrit) pression data. Leap motion hand tracking technology was utilized to track
exposed to known shear rates and exposure times. To determine how changes the user’s hand position in relation to American Heart Association guide-
in viscosity affect hemolysis at a given shear rate, two series of tests were lines. Speech recognition was implemented to recognize key phrases,
performed with porcine blood: (1) varying hematocrit over the range of 19% - such as “call 911,” spoken by the user to a non-playable character (NPC) in
41%, and (2) varying plasma viscosity with Dextran at a set hematocrit (23%). the VR scenario. Feedback was provided to the user in the form of visual
Results: Over shear rates of 20k-100k s-1 and exposure times from and auditory cues to correct CPR compressions.
200–1200 ms, human blood was found to be the most fragile, followed Results: The system was able to immerse the user into a real world VR
by porcine, then ovine (Fig. 1). Hemolysis (IH%) at a given shear rate was CPR scenario while tracking the user’s hand movements and CPR man-
independent of hematocrit and thus bulk viscosity. IH% at a set hema- nequin location at a frequency rate of 90 frames per second. The system
tocrit was found to increase with both shear rate and plasma viscosity. was able to detect key phrases spoken by the user with a minimum
However, when the same data are plotted against shear stress, which is of 85% accuracy. Current efforts involve implementing a NPC that will
the product of shear rate and bulk viscosity, it does not form a continuous provide responses to these phrases and feedback to the user in the VR
function (Fig. 2). This suggests that shear rate may be a better metric than scenario. CPR compression depth is predicted to be accurate within
shear stress for blood damage characterization. +/- 0.1 inches and CPR frequency is predicted to be accurate within +/- 5
compressions per minute.

13
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ASAIO BIOENGINEERING ABSTRACTS

127 131
Patient Hacks and User-Designed Problem Solutions for the Wearable Non-Homogeneous Haematocrit Distribution into VAD Modelling
Components of Ventricular Assist Devices (VADs): A Content Analysis of Practice to Improve Blood Damage Prediction
Online Sources S. Gurung1, K. W. Low2, H. Yousef2, S. Rolland2, A. Molteni1; 1Engineering,
J. Dunn1, K. Ko1, E. Nusem1, K. Straker1, C. Wrigley1, S. Calon Cardio-Technology, Swansea, UNITED KINGDOM, 2College of
Gregory2; 1Architecture, Design and Planning, University of Sydney, Engineering, ASTUTE 2020, Swansea, UNITED KINGDOM.
Sydney, AUSTRALIA, 2Department of Mechanical and Aerospace Study: To investigate device-related haemolysis, computational fluid
Engineering, Monash University, Melbourne, AUSTRALIA. dynamics (CFD) is used to provide insights and aid in the design iteration
Study: VAD users have devised many creative ways to manage their process. However, predicting mechanical haemolysis in medical devices
external VAD equipment. This research catalogues and categorises the using blood damage models is extremely challenging. This study proposes
various ways that patients and users overcome the daily obstacles of the novel method by CFD for better predictions of blood damage in VADs
wearing their equipment, in order to understand gaps and opportunities with an introduction of non-uniform haematocrit model.
for design innovation. Methods: For more accurate computed description of blood flow, a hae-
Methods: A number of digital channels were investigated to extract matocrit transport model domain is implemented. First, the non-uniform
evidence of patient, caregiver, or practitioner hacks, off-label use, modifi- haematocrit distribution and the shear thinning properties of blood is
cations, ‘helper products’, add-on products, auxiliary products, work- studied in a tube where the conditions are similar to small arteries. The
arounds, non-VAD-manufacturer assistive/supplementary products and model is then applied to ventricular assist device geometry where the
user-designed solutions for issues attributed to the wearable components flow is more complex. Haemolysis calculation by power law function of
of VADs. Digital channels surveyed included social platforms (e.g. Face- shear stress and exposure time is then implemented to the model to
book pages and groups, Instagram, Twitter); custom patient platforms/ locate more accurate RBC damage sites.
forums (e.g. MyLVAD.com); marketplace platforms (e.g. Amazon, Ebay, Results: The qualitative results of haematocrit distribution reproduced
Etsy); image database platforms (e.g. Flickr, Pinterest, Google Images); the observed rheology of blood in literature. The changing local dynamic
and video sharing platforms (e.g. YouTube, Vimeo). Data were analyzed viscosity impacts the scalar shear stresses and blood residence time. A
thematically, with 5 categories emerging. Competitor Positioning Matrix comparison between the results of benchmark model and the present
diagrams were created to visually represent the landscape of user solu- model showed clear distinction to the haemolysis prediction due to the
tions revealing gaps and opportunities for future product development non-uniform haematocrit distribution. Comparing with experimental
and innovation. data for VAD, the current model shows closer prediction of haemolysis
Results: A set of user-designed problem solutions emerged from the than benchmark model. Beside the application, the work highlighted
study i.e. Custom VAD Carry Systems (e.g. backpack, shoulder bag, t-shirt, gaps in published experimental data to correlate blood velocity and local
messenger bag, controller ‘pack’, vests); Repurposed Carry Systems (e.g. haematocrit. Shortcomings of the current implementation are identified,
holster, military/hunting/fishing vest, camera bag, purse, cargo shorts whereby its good performance is over-reliant on the boundary conditions.
pockets, waist bag); Activity-Based Products (e.g. sleeping belt, swim-
ming suit); Driveline Management (e.g. dressing/driveline cleaning kit);
and Hacks (e.g. modifying a dress with Velcro slot, modifying bag zipper
to cover teeth for a driveline outlet). Opportunities for design innova- 134
tion include convertible products, products allowing personalisation, and Control Algorithm for Pulsatile Flow in the Realheart Total Artificial
activity-specific products. Heart
N. Brynedal Ignell, F. Pahlm, I. Pieper; R&D, Scandinavian Real Heart AB,
Vasteras, SWEDEN.
Study: Controlling the cardiac output is important in a Total Artificial
Heart (TAH).
The Realheart TAH consists of two halves, each having an atrium and
a ventricle, just as the human heart. Blood is pumped by moving the
atrioventricular (AV) plane back and forth. Each half is powered by BLDC
motor. The Realheart’s heart rate and stroke volume can be controlled.
Heart rate is kept the same for both the systemic and pulmonary blood
flows. Stroke volume can be set differently to take the right/left balance
into account.
The purpose of this study was to assess the suitability of the control
algorithm of the Realheart.
Methods: The control algorithm had the desired heart rate and stroke
volume as inputs and calculated the desired position of the AV plane as
a function of time. Field-oriented control was then used to control the
motor to ensure proper motion of the AV plane. The control algorithm
was developed in the Ada and SPARK programming languages (AdaCore)
to foster high software quality. The algorithm was tested in several test
rigs that mimicked the resistance of human body, and in vivo (pigs and
calves). Heart rates in the range of 40 to 140 bpm and stroke volumes
from 20 to 65 ml were tested. Pressure, blood flow and power consump-
tion were recorded.
Results: The control algorithm maintained the actual heart rate precisely
equal to the desired heart rate. The actual stroke volume was maintained
within reasonable error margins of the desired values in all tests per-
formed. Power consumption varied depending on flow resistance, heart
rate and stroke volume, showing that the control algorithm adapts its
power consumption as needed.

14
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ASAIO BIOENGINEERING ABSTRACTS

138 143
Experimental Investigation of the Flow Inside the Rotor Passage of an Parametric Studies of a Centrifugal Heart Pump for Total Artificial Heart
Axial Ventricular Assist Device (TAH) Using Genetic Algorithms
H. Chen1, P. Drešar2, P. Sharma3, C. Williams1, J. Katz1; 1Mechanical G. K. Gampa, IV1, V. M. Kotturru, IV2, E. K. K, IV1; 1Medical Engineering,
Engineering, The Johns Hopkins University, Baltimore, MD, 2Faculty of Kakatiya Institute of Technology and Science, Warangal, INDIA,
Mechanical Engineering, University of Ljubljana, Ljubljana, SLOVENIA, 2
Electronics and Instrumentation Engineering, Kakatiya Institute of
3
Biomedical Engineering, The Johns Hopkins University, Baltimore, MD. Technology and Science, Warangal, INDIA.
Study: While not pulsatile, the advantages of continuous axial flow Study: In this research study it is proposed to perform a Genetic Algo-
Ventricular Assist Devices (VAD) include compact size and low mechani- rithm (GA) based parametric studies on Total Artificial Heart (TAH) to
cal failure rate. However, being compact, they operate at high speed, find optimal process parameters and their effect on the performance of
resulting in adverse effects including hemolysis caused by high flow shear a bearing-less continuous flow centrifugal heart pump with magnetic
and thrombosis formation in stagnant regions. While computational fluid levitation. Exhaustive studies were being performed to know the effect of
dynamics (CFD) is widely used in designing these devices, detailed high- different parameters on TAH using GA.
resolution experimental measurements of the flow within them are not Methods: Rapid study was performed to obtain data from Computational
readily available in the literature. Such data is crucial for understanding fluid dynamics (CFD) analysis. A mathematical equation was developed
the flow inside the VAD and its interaction with blood cells as well as for showing relationship among the parameters. This study was performed
validating the CFD predictions. The present study investigates the flow to design and develop a bearing-less continuous flow centrifugal heart
inside a 1:1 exact replica of a VAD - Reliant Heart HeartAssist5®. pump with magnetic levitation for TAH. It includes use of Navier Stokes
Methods: This model consists of an inlet guide vane (IGV), a rotor and Equations of fluid flow viz,. Continuity, Momentum and Energy equations.
a stator. Refractive index-matching is used to facilitate optical measure- Experimental model was prepared by ABS plastic using SLA 3D printer.
ments. Hence, all the blades and housing of the pump are made of trans- CFD model was generated to predict head-discharge curves. A paramet-
parent acrylic. The working fluid is a mixture of water, sodium iodide, and ric study was performed in detail for fluid flow by different boundary
glycerin, which matches the refractive index of acrylic, and the kinematic conditions. The effect of various flow parameters like velocity, exposure
viscosity of blood. Performance tests have been carried out to character- time to shear stress, strain rate, fluid forces on impeller were studied.
ize the flow rate vs. head rise curves at varying RPMs. High-resolution 2D Experimentation Experiments are conducted on prototype centrifugal
PIV measurements have been conducted at the inlet plenum upstream of pump developed as small as 0.4kg. The following operating parameters
the pump, as well as in meridional planes of the rotor passage at several are selected as per standards, the flow rate ranges from 4-9L/min, while
blade orientations. With a velocity vector spacing of 30μm, the measure- the speed of the pump is 3000–5500 rpm. The study was performed with
ment domain covers the rotor blade tip gap and provides 110 vectors fluid density of 1060kg/m3. Designed impeller has four blades with the
across the rotor blade span. optimal blade angle. The inlet diameter of casing and outlet diameter of
Results: In some aspects, the flow in the model shares similar features volute were taken as 10 mm. An In-Vitro-Vivo set up was installed to test
with common axial turbomachines, such as the inherent presence of tip hemo-compatibility. LAB-VIEW software was written to capture paramet-
leakage flows and development of tip leakage vortices. However, there ric data. Different sensors were used to measure pressure and discharge.
are some significant differences, such as secondary flows and local flow Results: Figure shows H-Q curve obtained from CFD analysis made for
separation associated with rotor-stator interactions. Future work will the above model. It can be seen that as the flow-rate increases, the head
compare the results to CFD simulations of the same flow. decreases and reaches minimum.

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ASAIO BIOENGINEERING ABSTRACTS

144 148
Computational Comparison of Ventricular Assist Device Implantation An In-vitro Human Endothelial Cell-Smooth Muscle Cell Co-culture
Sites Within Single Ventricle Hearts Model to Study the Effects of Pulsatility
A. Ginn-Hedman1, S. L. Jessen2, F. J. Clubb, Jr2, B. R. Weeks2; 1Biomedical M. H. Meki1, P. K. Patibandla1, A. S. El-Baz1, P. Sethu2, G. A.
Engineering, Texas A&M University, College Station, TX, 2Veterinary Giridharan1; 1Bioengineering, University of Louisville, Louisville,
Pathobiology, Texas A&M University, College Station, TX. KY, 2Medicine and Biomedical Engineering, University of Louisville,
Study: Patients with single-ventricle physiology such as hypoplastic left Birmingham, AL.
heart syndrome (HLHS) must undergo staged palliative care to sustain Study: Flow modulation strategies for continuous flow left ventricular
life. After surgical correction, ventricular assist devices (VADs) may be assist devices (CFLVAD) have been proposed to mitigate the adverse
implanted to improve cardiac output. However, device malposition can lead events associated with diminished pulsatility. However, the frequency and
to thrombotic complications. Limited data exist concerning the ideal inflow amplitude of flow modulation to achieve this is unknown.
cannula position to reduce thrombotic events within single ventricle hearts. Methods: A microfluidic co-culture model with human aortic endothelial
Computational fluid dynamic (CFD) analysis of alternate VAD locations was (HAEC) and smooth muscle cells (SMC) that can replicate physiologic
undertaken to provide data for pre-surgical planning for VAD placement. pressures, flows, shear stresses, and cyclic stretch was developed. The
Methods: A ventricular cannula was virtually implanted within a single effects of pulsatility and pulse frequency were evaluated during (1)
ventricle and CFD was employed to evaluate the hemodynamic effect of Normal pulsatile flow (120/80 mmHg, 60 BPM), (2) diminished pulsatility
device position. Cannula locations (Fig. 1) were chosen based on configu- (98/92 mmHg, 60 BPM), and (3) CFLVAD flow modulation at a reduced
rations described in medical literature. Virtual geometry was extracted pulse frequency (120/80 mmHg, 30 BPM). Cell size was assessed after 24
from a 4D cardiac MRI of a post-Fontan HLHS patient and heart motion hours under each flow condition using cell tracker (Invitrogen, CA). Shear
was derived from registration. Blood was modeled as an incompress- stresses were estimated using computational fluid dynamics (CFD) simula-
ible non-Newtonian fluid and flow varied from laminar to turbulent tions (ANSYS, PA).
throughout the cardiac cycle. High thrombotic potential (TP) was defined Results: While average shear stresses (4.2 dyne/cm2) and flows (10.1 ml/
by low-velocity vortex regions. min) were similar, the peak shear stresses for normal pulsatile flow (16.9
Results: Preliminary results indicate a higher TP with cannulas oriented dyne/cm2) and CFLVAD flow modulation (19.5 dyne/cm2) were higher
toward the neo-aortic valve (Fig. 2). Further investigation is needed compared to diminished pulsatility (6.45 dyne/cm2). HAEC and SMC
to evaluate TP in apical vs. diaphragmatic configurations. Future work demonstrated a statistically significant (p<0.05) cell size difference at
with this model includes improving dynamic mesh motion and validat- diminished pulsatility compared to normal pulsatile flow. CFLVAD flow
ing results with particle imaging velocimetry (PIV). Results of this work modulation resulted in normalization of HAEC cell size but not SMC,
will provide surgeons with insight into the hemodynamic impact of VAD Figure 1.
implantation within single ventricle hearts. Conclusion: Augmenting pressure amplitude may have a greater effect in
normalizing HAEC while both pressure amplitude and frequency may be
required to normalize SMC morphology. The co-culture model may be an
ideal platform to study flow modulation strategies.

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ASAIO BIOENGINEERING ABSTRACTS

152 153
A Long-term Cavopulmonary Assist Device to Reverse the Fontan: In- Alterations to Cardiac Decellularized Extracellular Matrix Hydrogel
silico and In-vitro Studies Processing Affects Material Strength and Cell Viability
G. A. Giridharan1, T. Beyerle1, M. H. Meki1, M. Neary2, T. Jonas3, M. D. N. A. Mehta1, N. P. Edenhoffer2, L. J. Taite3, F. J. Clubb, Jr.1, D. A.
Rodefeld4; 1Bioengineering, University of Louisville, Louisville, KY, 2RBTS, Taylor4; 1Veterinary Pathobiology, Texas A&M University, College Station,
inc, Phoenixville, PA, 3Mechanical Solutions, Inc, Whippany, NJ, 4Surgery, TX, 2Veterinary Integrative Biosciences, Texas A&M University, College
Indiana University, Bloomington, IN. Station, TX, 3Veterinary Physiology and Pharmacology, Texas A&M
Study: Despite medical and surgical advances, Fontan palliation remains University, College Station, TX, 4Regenerative Medicine Research, Texas
problematic, leading to Fontan failure. Currently, there are no long-term Heart Institute, Houston, TX.
mechanical circulatory support options to reverse the Fontan. In this Study: Cardiac patches have been explored as a treatment for cardiovas-
study, hydraulic and hemodynamic performance of a long-term Fontan cular disease, and ideally would serve as a contractile aid when applied
pump to power the Fontan circulation is assessed. to damaged myocardium. Different materials have been used, but none
Methods: Computer simulation studies were conducted to assess the per- recapitulate the cardiac extracellular matrix (ECM) fully. One method to
formance requirements for a Fontan pump to reverse the Fontan. A Fon- directly provide ECM as a therapy is via the use of decellularized ECM
tan pump based on the outrunner motor concept was fabricated along (dECM) hydrogels. However, their mechanical strength is low, rendering
with three different impellers (vane heights of 0.3 mm, 0.7 mm, 1.1 mm), them suboptimal as cardiac repair tools. Furthermore, to generate such
Figure 1. Mock circulation studies were conducted with the prototypes to gels, dECM must be digested to form soluble peptides, which may affect
assess the hydraulic performance and acute hemodynamic response to the final gel composition and influence cell behavior. Our objective was
different levels of Fontan pump support. to evaluate the effects of dECM digestion time on crosslinked hydrogel
Results: Computer simulation demonstrated that a modest cavopulmo- mechanical strength and on viability of added cells.
nary pressure head augmentation of 6 mmHg can reverse the Fontan. Methods: Porcine left ventricles were cut into 1–2 mm2 pieces, decellular-
In-vitro study demonstrated that the impeller with 1.1 mm vane height ized, and digested in pepsin/HCl for either 24, 48, or 72 hours, brought to
provided the best hydraulic performance by generating 7.1 L/min of flow pH 7.4, and kept on ice. A crosslinker (Genipin; 5 mM, 7.5 mM, or 10 mM)
against 10 mmHg at 5000 RPM. In a simulated Fontan mock flow loop, the was added to the solution and crosslinked at 37°C. Crosslinking comple-
Fontan pump augmented 4-way cavopulmonary flow by up to 15% and tion and mechanical strength were measured via fluorescence intensity
restored systemic pressures and flows (Table 1). The Fontan pump did not and a dynamic frequency sweep. Human cardiomyocyte viability was
cause venous flow obstruction even at zero RPM. measured 2 days after being seeded onto dECM gels.
Conclusion: A single Fontan pump stabilized and augmented cavopulmo- Results: Increasing the enzymatic digestion time of dECM solutions prior
nary flow in 4 directions, in the desired pressure range, without venous to crosslinking alters both the mechanical properties of the resulting gels
pathway obstruction. The Fontan pump is being developed for long-term and viability of cells seeded on gels, suggesting that specific environ-
implant and may be suitable as a temporary bridge-to-recovery or -trans- mental cues are lost as the ECM is digested into smaller pieces. Gels
plant or as a destination therapy in patients with Fontan. made from dECM digested for 48 hrs were mechanically stiffest when
crosslinked with 7.5 and 10 mM genipin (p<0.0001 vs 24 and 72 hours).
Cardiomyocyte viability was equally high (~97%) on gels formed from
solutions digested for both 24 and 48 hours (p<0.05 vs 72 hours) when
gels were crosslinked with 7.5 and 10 mM genipin. Studies on whether
these cues affect cell differentiation are underway to determine if the
changes observed are significant to cell behavior.

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ASAIO BIOENGINEERING ABSTRACTS

158 159
The Effect of Preserving Mitral Valve Function by Left Atrial Assist Extracorporeal Support Without Systemic Anticoagulation: Nitric Oxide
Device: In Vitro Mock Circulation Loop Model (NO) Releasing Circuits Combined with NO Sweep in Sheep
Y. Kado1, J. Adams1, N. Byram1, A. R. Polakowski1, T. Miyamoto1, J. H. M. M. Jeakle1, J. C. Kading1, G. Lautner2, O. I. Lautner-Csorba2, B. A.
Karimov1, R. C. Starling2, K. Fukamachi1; 1Biomedical Engineering, Schneider1, J. H. Jung1, T. C. Major1, M. E. Meyerhoff2, R. H. Bartlett1,
Cleveland Clinic, Cleveland, OH, 2Cardiovascular Medicine, Cleveland R. B. Hirschl3, G. B. Mychaliska3, A. Rojas-Pena4; 1Surgery, University of
Clinic, Cleveland, OH. Michigan, Ann Arbor, MI, 2Chemistry, University of Michigan, Ann Arbor,
Study: We are developing a left atrial assist device (LAAD) to treat heart MI, 3Surgery- Pediatric Surgery Section, University of Michigan, Ann Arbor,
failure with preserved ejection fraction (HFpEF). The device is intended MI, 4Surgery -Transplantation Section, University of Michigan, Ann Arbor,
to deliver blood from the left atrium to the left ventricle, thus reducing MI.
left atrial pressure and increasing cardiac output (CO). This pump can be Study: Nitric oxide (NO) releasing extracorporeal circuits (ECC) fixed with
implanted either at the mitral valve (MV) level (replacing the MV) or the Argatroban and dibutylhexanediamine without systemic anticoagulation,
supravalvular level (preserving MV function). This study aimed to examine prevent clotting, platelet (PLT) and white blood cell (WBC) activation. ECC
the effect of preserving MV function with LAAD using an in vitro mock oxygenators are thrombogenic; their fibers cannot be coated without
loop model. affecting gas exchange. NO releasing ECC and NO gas mixed in the sweep
Methods: Normal heart (NH), mild diastolic heart failure (DHF; DHF- line of the oxygenator were evaluated as an alternative to systemic
1), moderate DHF (DHF-2), and severe DHF (DHF-3) conditions were anticoagulation.
simulated by adjusting diastolic drive pressures to -44, +15, +25, and +40 Methods: Eight sheep (55±5Kg) were placed on venovenous ECC. The ECC
mmHg, respectively. The LAAD was set as three different speeds (2,600, consisted of: ¼” ID:82” Tygon PVC tubing, PVC connectors, a Hilite 800LT
3,200 rpm, and 3,800 rpm). To simulate implantation at the MV level, we oxygenator, a M-Pump and two biomedicus cannulae. Control circuits
held the inflow valve of a pneumatic mock ventricle pump open (without (n=5)-CC group, uncoated ECCs. Experimental circuits (n=3)-ANO group,
MV). CO and mean aortic pressure (AoP) were compared for each heart NO releasing ECC+100ppm of NO gas in the oxygenator sweep line. In all
and MV condition. groups, target ECC blood flow = 300mL/min without systemic antico-
Results: Without LAAD support, CO was 3.7, 2.2, 1.7, and 1.1 L/min and agulation for 22h. Sweep gas = 1L/min (100% O2) with/without NO gas.
mean AoP was 100, 53, 42, and 33 mmHg for NH, DHF-1, DHF-2, and Hemodynamics and ECC values were monitored continuously. Samples
DHF-3, respectively, showing deterioration of hemodynamics with DHF for PLT/WBC count and function, activated clotting time (ACT) were taken
(Figure). With LAAD support at low speed, CO with MV was higher than at baseline (BL) then Q6h or at experimental end-point. Mean values are
without MV (with MV: 3.6, 3.4, 3.2, and 2.9 L/min and without MV: 3.5, presented with standard deviation. Data was analyzed using Tukey HSD.
3.1, 3.0, and 2.8 L/min for NH, DHF-1, DHF-2, and DHF-3, respectively). Results: ECC in the ANO group had no occlusive clots and ran for
With LAAD at high speed, CO with and without MV were comparable 20.7±5.8h vs 12.5±9.5h in the CC group. Less clot area (0.9±0.1cm2) was
(with MR: 4.0, 4.0, 4.0, and 3.9 L/min and without MV: 4.1, 3.9, 3.9, and formed in the ANO group circuits vs CC group (3.52±0.1cm2), p<0.001.
3.9 L/min for NH, DHF-1, DHF-2, and DHF-3, respectively). Mean AoP PLT count (75±17.2K/uL) and aggregation function (64.7±9.1% activ-
showed a similar trend to CO (Figure). In conclusion, the LAAD pump ity) were significantly higher (p<0.05) in the ANO group vs CC group
implanted at the supravalvular level may provide higher CO and mean (46.5±9.4K/uL and 17±1%). Percentage of BL values for: PLT P-Selectin,
AoP than at the MV level at low speed, although values were comparable CD11b expression in monocytes and granulocyte trended closer to
at high speed. Additionally, CO and mean AoP under all DHF conditions baseline values in the ANO group vs CC group. ACT’s were 145±25s in
were increased by raising pump speed independent of pump position. both groups indicating no systemic anticoagulation effects of NO releas-
ing ECC or NO gas. These data indicate that NO releasing systems with
the addition of NO gas in the sweep is a potential alternative to systemic
anticoagulation.

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ASAIO BIOENGINEERING ABSTRACTS

161 165
Comparative Analysis of 3D Printed Mock Ventricular Assist Devices Advanced Graphical User Interface for Control and Testing of Mechanical
Using Computational Fluid Dynamics and In-Vitro Benchtop Testing Circulatory Support Devices
L. C. Polikaitis1, S. L. Jessen2, A. Ginn-Hedman1, F. J. Clubb, Jr2, B. R. B. D. Kuban1, D. W. Horvath2, D. J. Horvath2, N. Byram1, J. H. Karimov1, T.
Weeks2; 1Biomedical Engineering, Texas A&M University, College Station, Miyamoto1, Y. Kado1, K. Fukamachi1; 1Biomedical Engineering, Cleveland
TX, 2Veterinary Pathobiology, Texas A&M University, College Station, TX. Clinic, Cleveland, OH, 2R1 Engineering, Euclid, OH.
Study: New and modified Ventricular Assist Device (VAD) designs are Study: To test the advanced features of the mechanical circulatory sup-
tested using a variety of benchtop methods. 3D printing for prototyping port devices in development at Cleveland Clinic, it became necessary to
and benchtop testing of VAD designs allows reliable data accumulation develop user interface software that would allow the research team to
for evaluating and predicting VAD performance. However, 3D prototyping monitor key operating parameters, and efficiently alter operating modes,
and benchtop testing can be a lengthy process. Computational modeling governing equations and motor specifications. The Advanced Pump Con-
of VAD flow using fluid dynamics is possible, but the overall predictive trol Interface (APCI) was developed for this purpose.
accuracy of these computational models is unknown. The goal of this Methods: The APCI, developed using the Qt environment, runs on a
study is to compare data collected using an in-vitro mock flow loop test Windows computer communicating with the pump motor controller hard-
setup for 3D printed VADs to data collected from the same VAD models ware via USB. It receives continuous real-time data from the controller
using ANSYS Fluent computational fluid dynamics (CFD) software. The hardware, and allows the operator to choose the operating mode as well
comparison should assist in determining the accuracy and validity of as desired pump speed modulation parameters. The APCI was designed to
computational models for VAD performance. be used both for experimentation in the mock loop laboratory and during
Methods: Hypothetical VADs of various impeller and housing designs in-vivo testing.
were generated using SolidWorks software, printed using a FormLabs Results: Figure 1 shows the main screen of the APCI. Basic functions are
stereolithography 3D printer, and connected to a mock flow loop for fully operational and more advanced functions are in the process of being
physical flow rate and RPM data analysis. These same 3D models were implemented and tested. The current version implements sinusoidally
then modeled using ANSYS Fluent CFD software. This was completed by varying pump speed modulation which enables the advanced features
importing the VAD models from SolidWorks into SpaceClaim, applying an of the system by analysis of the dynamic motor response. The user can
accurate mesh to discretize the fluid domain, and implementing various choose the mean speed, percent pulsatility and beats per minute. The
boundary conditions and fluid characteristics similar to the benchtop APCI uses reconfigurable deep neural networks or regression equations
testing method in ANSYS to determine the velocity of the fluid leaving the to estimate pump flow, vascular resistances and imminent suction condi-
pumps after convergence was reached. tions, and provides scope readouts of important parameters. When flow
Results: Comparing trends in the ANSYS Fluent data to the benchtop test- and pressure data are available from external instrumentation, these
ing data made it possible to determine differences between the computa- values can be displayed as well. The ACPI also includes automatic speed
tional fluid dynamics simulation and the benchtop testing method. Future control modes, one which varies pump flow based on calculated esti-
studies will compare other virtual VAD testing models with other physical mates of systemic vascular resistance, and another which automatically
test methods already used for medical devices. reduces pump flow in the case of imminent inlet suction conditions and
then slowly increases flow when the condition resolves.

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ASAIO BIOENGINEERING ABSTRACTS

166 167
Staying Connected in the Loop: Shear Stress Errors Induced by Design and Experimental Evaluation of a Right Ventricular Assist Device
Connector Elements within Pre-Clinical Testing of Ventricular Assist F. De Gaetano1, D. Boccon2, S. Covelli2, S. Vandenberghe3, M. L.
Device Thrombogenicity Costantino1, S. Demertizis3; 1Chemistry, Material and Chemical
M. Li1, R. Walk2, Y. Roka-Moiia2, E. J. Barth1, M. J. Slepian2; 1Mechanical Engineering “G. Natta”, Politecnico di Milano, Milan, ITALY, 2Chemistry,
Engineering, Vanderbilt University, Nashville, TN, 2Biomedical Engineering, Material and Chemical Engineering, Politecnico di Milano, Milan, ITALY,
University of Arizona, Tucson, AZ. 3
Surgery, Cardiocentro Ticino, Lugano, SWITZERLAND.
Study: Adverse thromboembolic events due to shear stresses continue to Study: Heart failure is a condition that affects worldwide 26 million
hamper the efficacy of Ventricular Assist Devices (VADs). VAD-operated people, and different treatment options are available. This pathological
loops serve as a method to test shear forces prior to device implementa- state affects mainly the left ventricle since it has to work at a higher pres-
tion. Physical characteristics of test loops may contribute to inadvertent sure level. Most of the implantable blood pumps can support the function
platelet activation through imparted shear stress, causing additional error of the failing left ventricle, but they often also cause secondary right heart
when VAD thrombogenicity is tested. In this study, the effect of loop failure. In this project, we prototyped a ventricular assist device specific
components on additive shear stress via in-silico and in-vitro models was for the right ventricle.
tested. Methods: Based on classical pump theory, five impellers and volutes
Methods: Eight testing circulatory loops differing by connector geometry were designed and manufactured using a 3D printer. Experimental and
were established in silico: loops with 0~5 luer connectors, a loop with a computational methods were used to evaluate the performance of the
T-connector to create 90° angulation, and a loop with an ideal 90° angula- prototypes and to identify the area requiring improvement, respectively.
tion. Computational fluid dynamics (CFD) simulations were performed CFD simulations were performed only on the prototype showing the best
using k-omega turbulence model to calculate the scalar shear stress (sss). performance in order to analyse the fluid field better. Finally, the device
VAD-operated loops replicating in-silico designs were assembled, where was inserted in a hybrid simulator able to mimic pathological conditions
gel-filtered human platelets were recirculated for 1 hour. A chromogenic (e.g. pulmonary hypertension, right heart failure, etc.) in order to evalu-
platelet activity state assay measuring thrombin generation was used to ate its performance. The prototype was then tested in three different con-
quantify shear-mediated platelet activation. figurations: A) continuous flow, B) pulsatile flow in phase with the heart
Results: CFD simulations show high shear regions introduced at non- (copulsation) and C) pulsatile flow in counter phase (counterpulsation).
smooth regions such as edge-connector boundaries, tubing, and luer Results: Experimental pump performance curves are close to the stan-
hole. Blood flow patterns are disrupted at those locations, inducing high dard theoretical ones. They are different from typical LVADs and more
shear regions. Noticeable peaks’ shifts of sss distributions towards high suitable for right heart support due to the lower pressure generation at
shear-region exist. Platelet activation increased over shear exposure similar flow rates. The CFD simulations allow identifying some critical
time and was statistically higher when platelets exposed to connector- geometrical zone. According to the experimental results obtained from
employed loop designs. The extent of platelet activation in-vitro could the hybrid simulator (cardiac output, mean pulmonary pressure and
be successfully predicted by CFD simulations. Loops employing addi- pulse pressure), our prototype shows to provide adequate support in
tional components (non-physiologically friendly flow pattern connec- all the three tested configurations. We successfully designed a working
tors) resulted in higher shear stress and thus higher cumulative platelet prototype of a right ventricular assist device and demonstrated that it can
activation. deliver hemodynamic support for a failing right heart.

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ASAIO BIOENGINEERING ABSTRACTS

168
Development of a Pediatric Paracorporeal Centrifugal Blood Pump
M. Hernandes, Sr., E. Drigo, M. Barboza, B. Santos, T. Leao, E. Bock; Carol
Coracoes Artificiais, Arujá, BRAZIL.
Study: A company called Carol Artificial Heart was found in 2018 with
the purpose of delivering solutions for heart transplant in children. In
Brazil, 93 children were in waiting list for heart donation in 2017, and
38 children had transplants performed. The use of a Ventricular Assist
Devices in children is still a challenge in all countries. In United States,
54 devices were implanted in children with 6 to 10 years old during 2012
to march 2017. In 2004, the National Heart, Lung, and Blood Insti-
tute (NHLBI) started Pediatric Circulatory Support Program which was
remolded in 2010 to PumpKIN (Pump for Kids, Infants, and Neonates). In
2018, the FAPESP agency selected the Carol Artificial Heart Co. to develop
pediatric Ventricular Assist Devices. The first project is Hana, a Pediatric
Paracorporeal Ventricular Assist Device for patients with 6 to 10 years old,
with medium bsa of 0.9. This device is a centrifugal pump with coaxial
magnetic transmission which stabilizes rotor inside the device without
bearings.
Methods: First it was made 15 prototypes using Solid Works 2016, and
the hydrodynamics analysis was made with Solid Works 2018. After the
computational analyze was select the three best prototypes and the proj-
ect was prototyped and the Mock Loop was made with a similar viscosity
fluid.
Results: The Device works with 4000 RPM, and ideal flow of 2.5 L/min
with pressure head of 200 mmHg and 12 cc of prime volume. The results
of hydrodynamic performance tests with mock loop circuit were similar to
the results found in numerical computational analysis. The results allow
the use of this device in children, but it should be conducted hemolysis
test of the device before the animal’s tests. The differential of this project
was the little prime that allows more mobility of the implanted children.v

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ASAIO BIOENGINEERING ABSTRACTS

179 187
Observation of Thrombus Formation around TAVI models including Scripting an Anatomical Study Protocol
Leakage Flows by Optical Systems and the Evaluation by CFD Analysis C. Doose1, M. F. Menne1, M. Becker2, T. Schmitz-Rode3, U.
M. Tamagawa; Kyushu Institue of Technology, Kitakyushu, JAPAN. Steinseifer4; 1Department of Cardiovascular Engineering, Institute
Study: To avoid the thrombus formation on the wall is one of the most of Applied Medical Engineering, RWTH Aachen University, Aachen,
important and serious issue in developing the medical fluidics. On the GERMANY, 2Department of Cardiology and Nephrology, Rhein-Maas-
other hand, there are possibilities to have thrombosis near the leakage Klinikum, Würselen, GERMANY, 3Institute of Applied Medical Engineering,
flow (PVL: Paravalvular Leak) on TAVI (Transcatheter Aortic Valve Implan- RWTH Aachen University, Aachen, GERMANY, 4Monash Institute of
tation). Then it is necessary to elucidate the mechanism of the thrombus Medical Engineering and Department of Mechanical and Aerospace
formation for these phenomenon. In our previous studies, effects of the Engineering, Monash University, Melbourne, AUSTRALIA and Department
shear rate on the thrombus formation rate at wall were examined by of Cardiovascular Engineering, Institute of Applied Medical Engineering,
observation of thrombus formation, and found that the thrombus forma- RWTH Aachen University, Aachen, GERMANY.
tion rates increases with shear rates. In this study, thrombus formation Study: The consistent treatment of all datasets is crucial when imple-
around the leakage flow is visualized by optical systems, and the analysis menting an anatomical study. We performed a retrospective study of 125
is done by image processing. And the computational fluid dynamics (CFD) patient’s left atrial appendages as a basis for further automated analysis.
analysis is also used to compare with the experimental results. In order to ensure a consistent dataset for the automated analysis, the
Methods: In this investigation, the special PVL models with leakage (0.5 study protocol was implemented in a script that guides the user through
and 1.0mm) are used for the visualization. In addition to these, the orifice the individual steps.
pipe already used in the previous studies is used as control geometry. As Methods: For the retrospective study, a study protocol was defined. The
for the visualization, the image on the cross section along the center axis study protocol covers the processes of importing DICOM data, applying
of pipe and the image on the surface are obtained by optical laser sheet inclusion criteria, selecting a DICOM dataset for each included patient,
and illumination light. From the image processing, the thrombus forma- segmenting the left atrium, and identifying and analyzing the left atrial
tion rate is obtained. By using the CFD model, three kinds of orifice pipe appendage. The study protocol was implemented in a Python script
flows are analyzed, and the stream line and shear stress profile can be (Python 3.5, Python Software Foundation, Beaverton, OR). This Python
obtained in every geometry. script ran in the Mimics Innovation Suite (Mimics 20 & 3-matic 12, Materi-
Results: As for the thrombus visualization, it was found that the thrombus alise, Leuven, Belgium) providing the suite’s tools for working with DICOM
formation rate in case of 1mm leakage is larger than that in case of data and CAD features to the user via a graphical user interface. The
0.5mm leakage. It was also found that the thrombus formation rate in Python script was programmed to create and name all files and objects.
case of control orifice is much less than above two cases with leakages. In addition, the script exported measurement data and information from
Concerning about CFD analysis, it was found that the flow separation the DICOM tags. All operations ran with the same settings on each data-
induced high shear rate in the leakage in case of 1.0 mm leakage. And set, if the variability of the input did not necessitate a variable user input.
there is other possibilities of thrombus formation by a wake and recircula- Results: 189 DICOM datasets for 125 patients were imported while scouts
tion behind leakage. scans were automatically dropped. To date, the datasets of 55 patients
have been successfully segmented and analyzed with the scripted
protocol. The scripting of the anatomical study protocol required a lot of
up-front effort, but it ensured compliance with the protocol while at the
184 same time allowing the user to focus on the main tasks and speeding up
Platelet Margination Affects Thrombogenicity in LVAD Therapy the processing of each individual dataset.
R. Osuna-Orozco1, V. Chivukula1, J. Beckman2, C. Mahr2, A.
Aliseda1; 1Mechanical Engineering, University of Washington, Seattle,
WA, 2Division of Cardiology, University of Washington, Seattle, WA.
Study: We investigate platelet margination in the aortic arch and great
vessels. Our hypothesis is that platelets are more likely to be near the
arterial wall than near the center of the vessel (due to margination by red
blood cells). These higher concentrations of platelets are subject to higher
shear stresses and longer residence times as they flow in the ascending
aorta, and then are preferentially directed to the great vessels of the
brain, rather than to the descending aorta.
Methods: We use a model of platelet margination combined with
Lagrangian tracking and computational fluid dynamics to simulate the
hemodynamics in 3D patient-specific reconstructions of the aortic arch
and great vessels. A multiphase computational model tracks changes in
the hematocrit and platelet concentration, accounting for the interactions
between platelets and red blood cells to predict platelet margination. We
assess the impact of platelet margination on LVAD thrombogenicity using
platelet concentration, residence time (RT), and shear history (SH). Com-
parison of platelet thrombogenic metrics with and without margination
in the hemodynamics were conducted for different patient anatomies,
extent of aortic valve opening, and outflow graft anastomoses angles.
Results: Platelet margination increases concentration in low velocity, high
shear regions, particularly in the LVAD outflow graft. This effect results in
an increase in the shear stress history and residence time for the outliers
in the platelet population, extending the tail of the distribution with the
highest thrombogenic potential. These results confirm the importance in
understanding hemodynamics post LVAD implantation on thrombogenic-
ity and assists with predicting thrombosis risk.

22
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ASAIO BIOENGINEERING ABSTRACTS

189 190
Concept of Safety Embedded Systems Control applied to a 4.0 Controlling the Variance of In Vitro Hemolysis Test per ASTM Standards:
Ventricular Assist Device Experience and Recommendations
A. Cavalheiro1, D. Santos Filho2, M. Silva2, P. Miyagi2, A. L. Zhang, Y. Zhu, P. Hsu, C. Chen; Soochow University, Suzhou, CHINA.
Andrade3; 1Mechatronics, Fundacao Santo Andre, Santo Andre, Study: In vitro hemolysis tests per ASTM standards have been a standard
BRAZIL, 2Mechatronics, Universidade de São Paulo, São Paulo, BRAZIL, testing for rotary blood pumps. However, biological and manipulating fac-
3
Bioengineer, Instituto Dante Pazzanesse de Cardiologia, São Paulo, tors have made side-by-side or direct comparison almost impossible. Even
BRAZIL. though having a “predicate” device as FDA recommended may solve the
Study: The cyber-physical systems connect areas like informatics, manu- question of clinical relevance, it is not realistic for research community to
facture and health. Health 4.0 is a new way to improve medical care for always having a “relative” comparison for an innovative device. Here we
patients, business for hospitals and creating insights for researches and would like to give a detailed justification on the perspectives that influ-
medical device suppliers. But a Ventricular Assist Device (VAD), like any ence the variance of measurements with our practice.
smart electromechanical equipment, need to interact with other equip- Methods: Two maglev centrifugal blood pumps (CH-VAD, CH Biomedical,
ment. Collaboration between smart devices may generate fail which may Suzhou, China) were tested in circulation loops at the nominal work point
be caused by a hardware problem or by VAD interaction. Parts of these (5 L/min at 100 mmHg). Heparinized fresh porcine blood (500±25 ml) was
failures can be avoided by a VAD 4.0 intelligent control, able to learn- circulated in the loop, maintained at 37ºC, for 6 hours. Blood samples
ing and making decisions to anticipate actions, before a real medical were collected every 60 min conforming to the ASTM standards. Plasma
intervention. free hemoglobin (pfHb) was then measured to calculate the normalized
Methods: This work proposes a safe patient-oriented control architecture hemolysis index (NIH).
using Artificial Intelligence (AI) techniques combined with Discrete Event Results: We found the factors that could influence the variance of NIH
Systems (DES) modeling techniques, which provide autonomy and intel- include blood source, blood withdrawal, blood manipulation, anticoagu-
ligence for the VAD 4.0 control to prevent and mitigate failures. In addi- lant selection, circulating loop set-up, and pfHb Measurement. Among all,
tion, due to the embedded computing system, it is possible to create a the initiate blood condition and blood manipulation have greatest influ-
maintenance system that can manage routines and a global database (Big ence. The few fiber-like tissue that almost invisible in blood will dramati-
Data) in order to provide diagnostic information to the doctor about the cally increase both the average and deviation of NIH (Fig.1(a)). Besides,
system conditions and the VAD control actions. To suport the proposed for our test devices, there is no significant difference between arterial and
architecture, techniques of Machine Learning is applied and improve VAD venous blood in NIH statistic (Fig.1(b)). Thus, if the pre-test blood dam-
control, avoiding the recurrence of failures and improving the system age proved not to be an issue, whichever fastest and most convenient
performance. method should be used to minimize the risk of blood clot. Additionally,
Results: Simulations with the proposed architecture were performed that to avoid flow dead zones or extra blood damage, some optimization of
provided a reactive and colaborative control, allowing the performance blood regulation, loop geometries and set-up may be suggested. In sum-
adaptation to the patient conditions. Thus, the applied control techniques mary, even in the absence of “predict” device, we can still minimize the
are in agreement with the trends of a device adapted to new reality of variance of measurements by controlling the related parameters.
the concepts of Health 4.0 within a Hospital 4.0, providing to the VADs
the connectivity and adaptability of smart networked devices (IoT) in
order to meet the needs of patients using this type of device, providing a
fault tolerant control system that provides interoperability and connectiv-
ity with other devices while being autonomous and secure.

23
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ASAIO BIOENGINEERING ABSTRACTS

198 Results: Fig 1 shows CFD results with shear rate ranging between 0.1
to 600 s-1. NO in the sweep gas resulted in significantly decreased flow
Assessing Hemocompatibility of a Small-Scale Microfluidic Artificial Lung
resistance compared to the control N2 devices in vitro (not shown). The
A. Thompson1, L. J. Ma1, M. Jeakle2, T. C. Major2, A. H. Rojas-Peña2, R. H.
rabbit AV circuit and average time to failure for each µAL group is shown
Bartlett2, J. A. Potkay1; 1VA Ann Arbor Healthcare System, Ann Arbor, MI,
in Fig 2. PEG+NO devices (n=6) maintained blood flow significantly longer
2
Department of Surgery, University of Michigan, Ann Arbor, MI.
than UC+N2 (n=5), UC+NO (n=4), and PEG+N2 (n=4) devices. Fig 2 shows
Study: Microfluidic artificial lungs (µALs) have been demonstrated with clot area in µALs (differences ns).
record gas exchange efficiency, biomimetic blood flow networks, and
surface coatings to improve blood compatibility. Techniques to scale µALs
toward clinical applications have been demonstrated. However, studies on
µAL biocompatibility are lacking. Here, we present a single layer µAL with
a rated blood flow of 20 mL/min and a biomimetic blood flow network.
Computational fluid dynamics (CFD) software was used to model flow and
shear throughout the device. Two strategies to improve hemocompat-
ibility, a hydrophilic coating and the addition of nitric oxide (NO) to the
sweep gas, were studied in vitro and in vivo.
Methods: µALs were constructed using soft lithography as described
previously. 3D CAD and CFD were performed using Solidworks Flow
Simulation. For in vitro studies, platelet-rich plasma (PRP, Lampire; ACT
300–400 s) was flowed at a fixed rate through a µAL for up to 2 hr with
either pure N2 or NO (500 or 2000 ppm in N2) sweep gas. Device resistance
(pressure/flow) was monitored as an indicator of clotting.For in vivo tests,
µALs were attached between the left carotid artery and jugular vein
(arteriovenous, AV shunt) in anesthetized and anticoagulated rabbits (ACT
between 250–350 s) for 4 hr or until device failure by clotting. Device
resistance, ACT, and cell counts were recorded. µALs were either uncoated
(UC) or polyethylene glycol (PEG)-coated with sweep gas of pure N2 or 1000
ppm NO (balance N2). Devices were flushed and clot areas were analyzed
using ImageJ.

24
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ASAIO BIOENGINEERING ABSTRACTS

202
On FHIR: Clinical Data Automation and the ELSO Registry
L. D. Pihera1, A. Morgan1, L. M. Lima2, M. L. Paden2; 1Georgia Tech
Research Institute, Atlanta, GA, 2Pediatric Critical Care, Emory University,
Atlanta, GA.
Study: The Extracorporeal Life Support Organization (ELSO) registry col-
lects outcome data on >100,000 extracorporeal membrane oxygenation
(ECMO) patients and is the principle resource for ECMO research and
quality improvement. In its current state, data is hand entered at each
center and thus limits the amount of collected data. We sought to prove
the feasibility of automating direct transfer of data from the electronic
medical record (EMR) into the ELSO registry.
Methods: A multidisciplinary team of systems engineers, ECMO special-
ists, and clinicians used standard systems engineering techniques to
define the problem (Figure 1), determine the project scope, prioritize
the components, determine use cases, and arrive at a final design.
Fast Healthcare Interoperability Resources (FHIR) is a new standard of
exchanging electronic health information that defines a protocol for data
transfer between EMRs using standard web development methodologies.
MATLAB was used for the EMR Access Point (EMRAP) prototype and EPIC
for a model EMR. Publicly available EMR dummy data sets were used for
development/validation.
Results: Utilization of the EPIC FHIR interface successfully allows the
EMRAP client to request data from the EMR, with each value requested
having a unique resource number and definition. (Figure 2) The requested
data returns to the EMRAP client as a javascript object notation (JSON)
payload, which is sent to the correct field in the ELSO registry. We devel-
oped and validated a FHIR compliant data transfer agent providing proof
of concept for direct transfer of data from EMRs to the ELSO registry.

25
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ASAIO BIOENGINEERING ABSTRACTS

205
Underlying Mechanism of Right Heart Failure Induced by LVAD: A
Simulation Study
Y. Zhu, H. Lin, P. Hsu, T. Wu, Z. Chen; Mechanical and Electrical
Engineering, Artificial Organ Technology Lab, Suzhou, CHINA.
Study: Left ventricular assist device (LVAD) induced right heart failure
(RHF) has a mortality higher than 40% with poor prognosis. Risk factors
include the impaired cardiac function before LVAD implantation while
the direct cause is the increased right ventricular (RV) preload under high
LVAD support, which reverses the RV preload to a supra-healthy level.
Previous simulations have suggested a monotonous recovery of pulmo-
nary circulation with increased level of LVAD support (pump flow). The
results therefore left the mechanism of preload reversal for RHF unex-
plained. In this study, a new mathematical model with inter-ventricular
septum (SPT) and baroreflex (BR) mechanism was developed and a series
of simulations of LVAD-supported HF were conducted to investigate the
underlying mechanism of post-LVAD RHF.
Methods: The mathematical models of the cardiovascular system were
implemented in Simulink (MATLAB R2016a, MathWorks, Natick, MA). To
investigate the underlying mechanism of the reversal RV preload, four
model configurations - original (without SPT and BR), SPT only, BR only,
with both SPT and BR - were employed to simulate the healthy, LHF and
LHF with different level of LVAD support (pump flow = 1, 3, 5 l/min) condi-
tions. Healthy and LHF conditions were made the same for four configura-
tions as an agreeable baseline.
Results: Figure 1&2 summarize the simulation results of hemodynam-
ics of healthy, LHF, and LVAD support. For original configuration, end
diastolic RV volume (RVEDV, i.e. RV preload) declined monotonously with
the increase of flow. While for all the remaining configurations, RVEDV
presented an upward trend with the increase of flow, and BR mechanism
plays a keep role on the reversal of RVEDV. The results indicate that the
neural regulation intrinsic in human circulatory system is an important
underlying mechanism causing LVAD-induced RHF. Furthermore, this
study explains the insufficiency of applying standard mathematical mod-
els for such pathological simulation.

26
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ASAIO BIOENGINEERING ABSTRACTS

207 212
Left Atrial Assist Device Function at Variable Beat Rates Using a Mock Development of a Sutureless LVAD Outflow Graft Anastomotic Quick-
Circulatory Loop Platform connect System
J. Adams, Y. Kado, N. Byram, A. R. Polakowski, T. Miyamoto, R. Dessoffy, L. H. Tompkins1, S. C. Koenig1, M. A. Sobieski2, G. B. Koenig3, T. Adams2,
J. H. Karimov, R. C. Starling, K. Fukamachi; Biomedical Engineering, B. Gellman4, P. Petit4, K. A. Dasse4, M. S. Slaughter2; 1Department of
Cleveland Clinic, Cleveland, OH. Bioengineering, Cardiovascular Innovation Institute, Louisville, KY,
Study: We are developing a novel left atrial assist device (LAAD) designed 2
Department of Cardiovascular and Thoracic Surgery, Cardiovascular
for heart failure with preserved ejection fraction (HFpEF). This pump is Innovation Institute, Louisville, KY, 3MAST LLC, Louisville, KY, 4Inspired
intended to reduce left atrial (LA) pressure and increase cardiac output Therapeutics LLC, Merritt Island, FL.
(CO) by assisting flow across the mitral valve, easing symptoms associated Study: LVAD outflow grafts are sewn end-to-side to the ascending aorta
with diastolic heart failure (DHF). Here, we report initial results of LAAD requiring a large surgical window and partial cross-clamping of the aorta
function at different beat rates using a mock circulatory loop. with clinician variability in anastomotic angle and technique. To reduce
Methods: A continuous-flow pump was placed between the LA reservoir surgeon variability and operative time, we have developed a novel surgi-
and a pneumatic ventricle on a pulsatile mock loop. A bypass was routed cal tool (Uniti Connect) to perform a sutureless graft to aorta end-to-side
around the pump to avoid resistance during pump-off conditions. Data anastomosis. The Uniti Connect system is designed to enable a consistent,
were collected at 60, 80, and 120 bpm of the pneumatic ventricle, with repeatable, and efficient anastomotic connection from the LVAD outflow
the LAAD running at 3200 rpm at normal heart (170/-44 mmHg) and graft to the aorta.
three DHF conditions by adjusting the diastolic drive pressure of the Methods: The Uniti system consists of: (1) a super-elastic nitinol securing
pneumatic ventricle to +15 (DHF-1), +25 (DHF-2), and +40 mmHg (DHF-3). anchor that attaches to the leading edge of a beveled (50°) Dacron graft,
CO and mean atrial pressure (AoP) were recorded, and conditions were (2) an external locking ring, and (3) an aortotomy delivery tool (Figure 1).
analyzed. The delivery tool is designed to core the aorta under partial balloon occlu-
Results: The LAAD pump resulted in increased CO across all conditions sion and to seamlessly deliver the anchor (with attached graft) to provide
(Figure). At DHF-1, we observed an average increase of 1.5 L/min with the a strong connection and hemostatic seal. The prototype Uniti anchor was
pump across all beat rates. At DHF-2 and DHF-3, the increases were 1.9 tested using pressurized bovine aortas (diameter 2.1±0.6 cm, wall thick-
and 2.3 L/min, respectively. There was a 5.4% difference in CO between ness 3±1 mm) and blood analog solution (3 cP glycerol-saline) in a mock
60 and 80 bpm and 80 and 120 bpm at DHF-1 and a 2.9% difference flow loop model (n=4).
between 60 and 80 bpm and 80 and 120 bpm at DHF-3. Differences in Results: Proof-of-concept for the Uniti anchor was demonstrated as
mean AoP were found to be similarly minimal. The LAAD device concept evidenced by achievement of hemostatic seal (< 20 ml/min blood loss)
provides adequate CO and maintains its performance at various beat and pull-out forces (> 50 N) at flow rates of 4.2±0.6 L/min flow rate and
rates adjustments. maximum aortic pressures of 200 mmHg. The Uniti system was re-
designed with: (1) an outflow-graft-to-anchor coupler, (2) an integrated
coring and delivery tool, and (3) two sizes (10, 15 mm) to create the
anastomosis. Early bench testing of Uniti produced anastomoses with
physical characteristics similar to a sutured anastomosis. The Uniti
Connect system has the potential to facilitate LVAD outflow graft
anastomosis, reduce current risk factors, and to support other clinical
applications (dialysis, subclavian introducer).

Figure 1. Uniti Connect system consisting of nitinol anchor, locking ring,


and Dacron graft (left), and Uniti anchor and locking ring in cored aorta.

27
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ASAIO BIOENGINEERING ABSTRACTS

214 215
CFD Study on the Effect of Central versus Peripheral VA ECMO Support Dissolution of Nitinol Wire within Tissue - Expanding the Use of Paraffin
F. Nezami1, E. Edelman1, S. Keller2; 1Institute for Medical Engineering Histology for Medical Device Evaluation
and Science, Massachusetts Institute of Technology, Cambridge, MA, C. B. Robinson1, C. N. Kaulfus1, A. Ginn-Hedman2, S. Hong2, B. J.
2
Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital, Kroslowitz2, H. Lyon2, F. J. Clubb, Jr.1, B. R. Weeks1; 1Veterinary
Boston, MA. Pathobiology, Texas A&M University, College Station, TX, 2Biomedical
Study: ECMO is rapidly emerging as a means of mechanical circulatory Engineering, Texas A&M University, College Station, TX.
support for cardiogenic shock patients despite limited understanding of Study: During pathologic evaluation, metallic implants in tissue interfere
its effect on circulation and end-organ perfusion. ECMO profoundly alters with or prevent routine paraffin histology. The alternative—plastic
normal aortic blood flow as blood is shunted from the venous system and embedded microground histology—is hindered by extended process-
returned to the circulation via either a cannula inserted into the aortic ing times, limited staining options, and comparatively poor histological
arch (Central) or femoral artery (Peripheral). The resultant circulation resolution. As such, a technique wherein metallic implants could undergo
combines pulsatile blood flow from the failing heart and continuous routine paraffin histology would drastically improve tissue histology. As
perfusion provided by the EMCO circuit. low concentrations of HCl have reportedly shown to dissolve nitinol (e.g.,
Methods: An idealized CAD geometry of aorta was extracted from litera- gastric implants), and is commonly used to rapidly decalcify tissue for par-
ture including major aortic bifurcations, where the outlet diameters and affin histology, we postulate that HCl could be used to corrosively remove
aortic arch geometrical features were averaged amongst several in vivo small metallic implants from tissue prior to routine paraffin histology,
images and post-mortem measurements. The computational mesh was without sacrificing tissue integrity.
generated using ANSYS ICEM CFD to divide the lumen into unstructured Methods: 2.5 cm lengths of 0.127mm diameter nitinol wire were inserted
tetrahedral elements. The Navier-Stokes equations for incompressible into uniform pieces of formalin-fixed bovine heart. The heart specimens
Newtonian blood flow were solved using a fully-coupled finite volume were placed in 10% HCl solution, and radiographs were acquired at regu-
ANSYS CFX. For both Central and Peripheral cases, degree of support by lar intervals during incubation to monitor dissolution of the nitinol wire.
ECMO cannula was set to 90%, 75%, and 50% of ultimate constant flow Once dissolution of the nitinol was established radiographically, tissues
rate (heart + ECMO) of 5 L/min. Dynamic boundary conditions at the were submitted for routine histology preparation.
outlets were set using a 3-element Windkessel model. Parameters were Results: Resulting histological sections, as compared to control cardiac
analyzed using ANSYS CFD-Post and in-house codes. tissues, exhibited good retention of tissue architecture and good tissue
Results: We compared hemodynamic patterns between heart-only and staining with hematoxylin and eosin (H&E). This indicates small nitinol
Central and Peripheral ECMO cases with varying levels of cardiac support. devices implanted in tissue can be efficiently dissolved by 10% HCl, with
Perfusion to vital organs and extremities was quantitatively assessed. good preservation of tissue architecture and staining. Radiographic
Blood flow velocities at the cannulation site were two times that of physi- monitoring of the HCl dissolution process allows for minimal yet adequate
ological flow rates. Both forms of ECMO cannulation markedly increased acid treatment. Further work will optimize study procedures, including
blood flow to the aortic arch and superior anatomical structures com- HCl concentration, tissue size, and time, for corrosive removal of small
pared with the control and significantly altered blood flow patterns in the metallic implants prior to processing for histology.
aorta. This CFD study provides insights into the disruption in blood flow
induced by ECMO and supports the need for more study of this support
modality to better guide its clinical use.

28
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ASAIO BIOENGINEERING ABSTRACTS

216 217
Sensing Algorithm Code in Arduino Microcontroller for Autonomous In Vitro Antifouling Assessment of Diethylene Glycol Dimethyl Ether
Function of a Total Artificial Heart Model Coating on Silicon Substrates
W. C. Orejola1, C. A. Orejola1, C. T. Atillo2; 1Industry, Pompton Plains, NJ, A. J. Patil1, C. Blaha1, K. Sahagian2, W. H. Fissell3, S. Roy1; 1Department
2
Private Company, Pompton Plains, NJ. of Bioengineering and Therapeutic Sciences, University of California San
Study: To design or write an algorithm code or sketch for the Arduino Uno Francisco (UCSF), San Francisco, CA, 2Plasmatreat USA Inc, Hayward, CA,
microcontroller using a sensor to regulate autonomous function of an
3
Nephrology and Hypertension, Vanderbilt University Medical Center,
artificial heart model. Nashville, TN.
Methods: Arduino Uno MicrochipATmega328P microcontroller, bread- Study: Silicon nanopore membranes (SNMs) are under investigation for
board, LEDs, sensor, laptop computer blood filtration in the implantable bioartificial kidney, immunoprotec-
Results: The study is based on the concept that an Autonomous Total tion of beta-cells in the bioartificial pancreas, and membrane blood
Artificial Heart model could be designed based on the following Algo- oxygenation applications. The surface of SNMs need to be antifouling and
rithm: (see Figures 1 and 2) antithrombogenic. Diethylene glycol dimethyl ether (Diglyme) coating has
When the algorithm code was programmed into the Arduino Uno micro- demonstrated excellent antifouling and hemocompatibility properties on
controller using a series of LED switches shown in the following electronic plastic tubing. In this study, we examined the protein resistance of thin
diagram, the program was able to light on and off the LED switches in a Diglyme coatings applied to silicon substrates.
loop continuously until the power was shut off to the microcontroller. Methods: Diglyme coatings (MW: 134.17 g/mol) were deposited on
In the next sequence applying the required variable to the sensor, the plasma treated 1x1 cm silicon substrates via plasma enhanced chemical
microcontroller was able to slow down or speed up the LED switches in vapor deposition (PECVD) technique (Plasmatreat USA Inc). The coatings
the loop as programmed algorithm. (see Figure 3) were characterized by ellipsometry for coating thickness. Coating perfor-
Conclusion:The sensing function of an Autonomous Artificial Heart could mance was evaluated by an ELISA assay to determine the relative adsorp-
be programmed as a code or sketch into the Arduino Uno microcontroller. tion of human serum albumin (HSA) compared to non-coated silicon
The microcontroller could regulate the serial LED switches in response to substrates and tissue culture polystyrene (TCP) as the control.
the algorithm coded into the sensor. Results: Ellipsometry data confirm successful deposition of Diglyme coat-
ing on the silicon substrates. The coating thickness of the Diglyme coating
varied between 5–30 nm as a function of PECVD process parameters,
such as power and gas flow-rate (Fig.1. A). There is a significant decrease
in HSA adsorption on the 15 nm (2.33%) and 30 nm (7.66%) thin Diglyme
coated substrates as compared to the non-coated silicon substrate, which
exhibited 43.25% adsorption relative to the TCP control. Also, significant
protein fouling is observed on 5 nm coatings (32.24%). This data sug-
gests that that 15–30 nm thin Diglyme coatings will exhibit antifouling
characteristics. Future studies will focus on coating SNM with 15–30 nm
thin Diglyme coatings and examine platelet adhesion and activation of the
intrinsic coagulation cascade.

29
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ASAIO BIOENGINEERING ABSTRACTS

218 220
Development of a Pumpless Artificial Lung for Pediatric End Stage Lung Functional Aminosilane Based Coatings for Improved Gas Exchange in
Failure PDMS Oxygenators
A. Thompson1, S. Buchan1, W. Weir1, B. Carr1, C. Poling1, U. Fernando1, A. E. Abada, C. Yee, S. Hetts, S. Roy; University of California, San Francisco,
Kaesler2, P. Schlanstein2, F. Hesselmann2, J. Arens2, J. A. Potkay1, A. Rojas- San Francisco, CA.
Peña1, R. H. Bartlett1, R. B. Hirschl1; 1Department of Surgery, University Study: Research into new ECMO/ECCO2R devices has centered on PDMS
of Michigan, Ann Arbor, MI, 2Department of Cardiovascular Engineering, microfluidic devices, including our silicon-PDMS oxygenator. To improve
Helmholtz Institute, RWTH Aachen University, Aachen, GERMANY. hemocompatibility, we developed functional coatings on PDMS that also
Study: We recently demonstrated an artificial lung (the MLung) design facilitate O2 and CO2 exchange. Local acidification of blood enhances CO2
based on concentric gating to induce secondary flows to improve local removal by converting bicarbonate into dissolved CO2. We hypothesize
mixing, resulting in improved gas exchange efficiency. Here, we tailor the that acidic coatings, hyaluronic acid (HA), and poly(acrylic acid)-amino
design for pumpless pediatric applications, in which the MLung is intended acid conjugates (PAA) can modulate the blood interface environment to
to be attached between the pulmonary artery (PA) and left atrium (LA). facilitate increased gas exchange in vivo.
Based on the oxygen demand of a 1 year old (about 45 mL O2/min for 9 kg Methods: Silicon-PDMS membranes were modified with N1-(3-Tri-
child and O2 demand of 5 mL/min/kg) and typical PA pressures, a rated methoxysilylpropyl)diethylenetriamine (DETA) to introduce functional
blood flow ≥ 0.75 L/min and pressure drop ≤ 5 mmHg are required. Proto- groups. HA, PAA-lysine (Lys), and PAA-histidine (His) were covalently
type devices were fabricated and characterized in vitro and in vivo. attached by EDC/NHS condensation of amine and carboxylic groups. Coat-
Methods: The Carman-Kozeny equation and flow simulations (Solidworks) ings were characterized through contact angle and colorimetric assays.
were used to estimate pressure drop (∆P). The fiber bundles were Impact on water O2 transport was measured using an optical probe. A
modeled as an isotropic porous media. A custom fiber mat (Membrana) small subclinical prototype device was exposed to healthy in vivo porcine
with low density (6 fibers/cm) and a two-inlet design were used to reduce blood (20 mL/min, 2 h). Gas exchange and hemocompatibility were exam-
∆P (Fig 1). Benchtop testing used slaughterhouse bovine blood and O2 ined through ABG readings, gross exam, and SEM.
sweep gas and in vivo testing used PA-LA attachment in healthy, Results: Grafting density [nmol/cm2] of amine and carboxyl groups on the
anesthetized sheep (n=4, 22-31kg). Cannulation was performed through PDMS surface was determined using Coomassie stain (PDMS: 0.4, DETA:
an end to side anastomosis with either Dacron or PTFE graft. Occlusion of 38.3±5.8) and Toluidine blue O assays (DETA: 1.1±0.2, HA: 28.3±1.1, Lys:
the right pulmonary artery (rPA) was used as previously described as a 20.5±2.9, and His: 18.7±1.4). Contact angle was: PDMS: 110°, HA: 30–40°,
disease model for end stage lung failure. Lys and His: 80–100°. Unmodified PDMS and coatings showed similar
transport in water, around 130 mL/min/m2. In vivo, all substrates showed
no clots in gross exam or SEM. Blood O2 flux [mL/min/m2] was inconsis-
tent (PDMS: 63.7, Lys: 21.7, HA: 177, His: -108). The coatings strongly
increased CO2 removal at 8 L/min/m2 - 6 times PDMS alone at 1.3 L/min/
m2. ABG analysis showed no pH change despite lower pCO2 and HCO3-,
and a strong decrease in base excess. Ultimately, the coatings could
increase CO2 removal through local acidification, and such coatings may
be used in a PDMS CO2 removal device.

Results: Six pediatric MLungs were fabricated (Table 1). The fabricated
devices met the gas exchange requirement but have a higher than desired
resistance, likely due to the close spacing of fibers in the radial direc-
tion (Fig 2). After connection to the MLung and acute cinching of the
rPa, mean arterial pressures (MAP) decreased from 65.9 to 53.4 mmHg.
With cinching of the rPA, flow through the prototype lung increased as
designed (Fig 2). Ongoing work is focused on achieving the desired bundle
porosity to meet the pressure drop requirement.

30
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ASAIO BIOENGINEERING ABSTRACTS

221 226
Who is My Neighbor? Assisting Medical-Decision Making of LVAD Hemocompatibility of Biodegradable Polymers for Endovascular Devices
Recipients by Finding Similar Patients K. R. Ammann1, S. Hossainy2, M. J. Slepian3; 1Biomedical Engineering,
C. Khoo, J. Antaki; Biomedical Engineering, Cornell University, Ithaca, NY. University of Arizona, Tucson, AZ, 2Bioengineering, University of California
Study: High-dimensional clinical data sets, such as the Interagency Regis- Berkeley, Berkeley, CA, 3Medicine, University of Arizona, Tucson, AZ.
try for Mechanically Assisted Circulatory Support (INTERMACS), makes it Study: Endovascular polymers may function as structural supports, bar-
very difficult to locate “similar” patients. We propose the use of methods riers or provide a means for local drug delivery. Previous work from our
that identify patients with similar characteristics. group has examined the feasibility of such function via the process of
Methods: We implemented a complete-case analysis using Multiple Cor- “polymeric endovascular paving” [1,2]. However, multiple biodegradable
respondence Analysis (MCA) on 10 demographic and functional variables drug delivery polymers are potential candidates for endovascular applica-
on the training set of INTERMACS data (n=9,254). Additionally, hierarchi- tions. A criterion for material selection is the intrinsic hemocompatibility
cal clustering of variables was run to investigate the grouping of the input of the baseline polymer. As an initial screening approach for selection
variables. The stability of the outcome was tested with 50 bootstrap of polymers for in vivo use, thin films of 1) polyesters: poly-caprolactone
samples. (PCL), poly-lactic acid (PLA), poly-lactic acid:poly-glycolic acid (PLA:PGA),
Results: Based on the plot of stability of variable cluster partitions, the 2) polyanhydrides: FAD:SA, CPP:SA, and 3) PEG-ylated polyesters:
input patient characteristics were partitioned in 6–7 groups of variables. PLA:PEG, PCL:PEG and PCL:PLA:PEG were investigated. Specifically, we
The groups are (1) INTERMACS Patient Profile and NYHA (2) age group evaluated the hemocompatibility of these thin films, using an in vitro flow
and device strategy (3) gender (4) blood type and race (5) ethnicity (6) system and epifluorescence video microscopy.
working status, and (7) income level. Methods: Polymer films were formed via spin-casting on glass cover slips.
MCA analysis divides the patients into four quadrants. For example, the Films were then placed in an in vitro flow system, exposing them to over-
first quadrant was characterized as {age between 40–59, education: flowing whole blood with fluorescently-labelled platelets, as detailed in
college+, INTERMACS: Profile Level 1, non-Hispanic/Latino, blood type: previous work [3]. Platelet adherence, aggregate formation and thrombus
A, and treatment strategy: bridge-to-transplant.} The second quadrant area were assessed following 5 minutes of flow. PET, PEG, and polyure-
was found to be {age: 30–39, education: high school+, INTERMACS thane were used as references.
Profile: Levels 2 and 3, non-Caucasian, female, and blood types: O and Results: After 5 minutes of flow, the rank order in terms of least to most
B.} Ongoing refinements are investigating alternate sets of characteristics thrombogenic of baseline material was: PCL < FAD:SA < CPP:SA < PLA:PGA
to improve the versatility, stability and interpretability of these “similar” < PLA (Fig 1). PEGylated materials in general had less thrombus formation
patients. The outcomes of this project will contribute to a decision-sup- than baseline unmodified materials. Of the baseline polyesters, PCL was
port application (CORA) to provide physicians with recommendations of less platelet adherent than PLA or PLA:PGA. Of the polyanhydrides, there
similar patients to the one being evaluated. was little difference seen between FAD versus CPP:SA. Similarly, there was
little difference between polyanhydrides and PCL, though the polyanhy-
drides were less platelet adherent than PLA or PLA:PGA. These results
emphasize the importance of polymer selection and processing decisions
for use in blood-contacting devices.

31
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ASAIO BIOENGINEERING ABSTRACTS

235 241
Optimization of the Permanent Magnetic Bearings Construction Study of the Effect of Turbulence on Red Blood Cell Damage and Platelet
Providing Force Balance in Religa Heart® ROT Centrifugal Blood Pump Activation In Vitro
P. Kurtyka, J. Zalewski, M. Gawlikowski, A. Kapis, R. Kustosz, M. S. Rajesh1, G. Menallo2, J. F. Antaki3, W. R. Wagner4, M. V.
Gonsior; Artificial Heart Laboratory, Foundation of Cardiac Surgery Kameneva4; 1Bioengineering, University of Pittsburgh, PIttsburgh, PA,
Development, Zabrze, POLAND. 2
Bioengineering, University of Pittsburgh, Pittsburgh, PA, 3Bioengineering,
Study: The aim of the study was to develop the method for permanent Cornell University, Ithaca, NY, 4Department of Surgery, University of
magnetic bearing (PMB) optimization used in ReligaHeart® ROT (RH-ROT) Pittsburgh, Pittsburgh, PA.
centrifugal blood pomp. The mechanism of the central positioning rotor Study: Left ventricular assist devices (LVADs) are a viable option for the
system in the pump housing is based on the phenomenon of the balance survival of many patients with end-stage heart failure, but this technol-
of forces. The suspension system requires accurate synchronization of ogy is often associated with complications such as mechanical damage to
forces generated by two opposite direction active bearing types: PMBs blood cells leading to hemolysis and thrombosis. Unlike the natural flow
and hydrodynamic bearings (HB). The PMBs are responsible for radial of blood in the vascular system, which is generally laminar, blood flow in
stabilization of the rotor. However the balance of the forces generated assisted circulation systems is known to introduce regions of non-phys-
by PMBs and HBs is crucial for axial stabilization of the rotor. Therefore, it iologically high turbulence which has been proven to cause mechani-
was necessary to develop a PMB optimization method to design new con- cal trauma to erythrocytes and other blood cells. Still, the influence of
struction providing the increase of radial forces (RF) stabilization, while turbulence on damage to blood cells including RBC trauma, hemolysis and
maintaining axial forces (AF) in the balance of HB. platelet activation has yet to be completely characterized.
Methods: The study consisted of two main phases, which allowed to Methods: A modified in-vitro blood flow system, previously reported by
develop new PMBs construction. First phase was carried out to obtain Kameneva et al. (2004), was employed ovine blood which was driven
the data validation using finite element method (FEM) and experimental through a small diameter capillary tube over a range of shear stresses
analyses of the simplified PMB construction. The physical studies were from 100 to 300 Pa and Reynolds numbers ranging from 2,000 to 6,000.
performed using developed tester equipped with RF and AF sensors. The Ovine blood was obtained from donor-sheep via venipuncture and
validation process allowed to define material properties used for next adjusted to a hematocrit of 25 ± 1%. In some experiments, part of the
simulations. FEM calculations were performed for many PMB construc- plasma was replaced with dextrose solution (Dextran-40) to increase
tions differed in magnets quantity, sizes and positions. Then the construc- viscosity of blood without increasing hematocrit. This enabled experi-
tion characterized by the highest RF was selected for experimental tests. ments to be conducted with gradually reduce levels of turbulence, yet
The axial balance was obtained by thermal treatment of one of the rotor without changing the shear stress. Hemolysis (plasma free hemoglobin)
magnets used in PMB system. is determined at 1-hour intervals. Platelet activation is measured at
Results: The calculated and measured results were qualitatively con- 1-hour intervals using flow cytometric quantification of P-selectin (CD62)
vergent and quantitatively differed by ~5%. As final result the threefold expression.
increase in RF was obtained. The weakening of a single magnet in PMB Results: Early findings have recorded hemolysis and increased platelet
construction allowed to decrease the AFs generated by PMBs, balancing activation in turbulent setting produced at shear stresses of 100 to 300
with the lower HB forces. Verification of the obtained results for final RH- Pa. If future tests confirm significance of these results, it will provide
ROT device construction was confirmed in experimental in vitro tests. evidence that the small regions of turbulence in assisted circulation will
promote a higher risk of thrombosis.

32
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ASAIO BIOENGINEERING ABSTRACTS

244
Co-development of Regulatory-compliant and Commercializable Clinical
Diagnostics and Medical Devices Solutions
T. Li, Y. Poh; DxD Hub, Diagnostics Development Hub, Agency for Science,
Technology and Research (A*STAR), Singapore, SINGAPORE.
Study: Singapore’s Diagnostics Development (DxD) Hub is a Singapore
government initiative that performs co-productization and co-funding
of technologies into clinically implementable and commercializable
diagnostics solutions. DxD Hub sits within Singapore’s Agency for Science,
Technology and Research (A*STAR), a national Science and Technology
Organisation. DxD Hub is interested to partner with institutions with
research assays. Areas include oncology, metabolic diseases and cardiol-
ogy, with an interest towards the Asian phenotype.
Methods: The DxD Hub’s focus will be diagnostics and devices with high
growth potential addressing strategic global indications dealing with the
Asian phenotype. In the development of its products, the Hub will work
closely with SG’s clinical community to tap on its strengths, and also to
address pertinent clinical unmet needs. Our Expertise includes Regulatory
navigation and dossier preparation, ISO13485 product design and devel-
opment, Design optimisation and verification and Clinical validation.
Results: Recent collaborations to co-develop diagnostic solutions include:
Biocartis Group NV today announced that it has extended its partnership
with DxD Hub with a new five-year strategic partnership. The Laennec®
digital pathology imaging system has achieved IVD product status under
the Health Sciences Authority of Singapore as a Class A device. Johnson &
Johnson Metabolic Disease Quickfire Challenge: Advanced Glycation End
Products,
DxD Hub is equipped for medical device design and development, with
a multi-functional team, productization resources and is well-connected
with ecosystem players along the value chain of medical product
development. We hope to offer our assay development capabilities and
resources, to co-develop clinical diagnostics and medical devices, and also
serve as a gateway for enterprises to enter the ASEAN and Asia markets.

33
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ASAIO BIOENGINEERING ABSTRACTS

245
Evaluation of Decellularized Porcine Artery as Vascular Grafts with
Sustained Endothelial Formation
N. A. Suárez1, M. Cuellar1, M. A. Rodriguez1, M. L. Medina1, C. Muñoz-
Camargo1, J. C. Cruz1, N. F. Sandoval2, J. C. Briceño1; 1Deparment
of Biomedical Engineering, Universidad de los Andes, Bogotá D.C,
COLOMBIA, 2Department of Congenital Heart Disease and Cardiovascular
Surgery, Fundación Cardioinfantil Instituto de Cardiología, Bogotá D.C,
COLOMBIA.
Study: The success of a vascular graft is related to its capacity to support
endothelium regeneration. The formation of this cell layer depends on
the microstructure of the substrate over which cells grow (Fig1). We
suppose that after decellularization, a porcine artery would be an
exceptional substrate for endothelialization. This is contingent to avoiding
major structural damage on the substrate surface. We aim to evaluate the
capacity of decellularized porcine arteries to sustain HUVEC proliferation.

Figure 2: Decellularized aorta at high SDS concentration

Figure 1: Microstructure of an aortic porcine artery

Methods: Arteries were obtained from local market, cleaned and dis-
sected. Decellularization comprised a combination of physical (perfusion Figure 3: Presence of microgrooves after treatment at low SDS
and sonication) and chemical treatments (SDS and Triton 100X). H&E concentration
staining was conducted on arteries to evaluate tissue integrity and cell
presence. DAPI was used to observe remaining nuclei. DNA concentration
was estimated via absorbance upon extraction. Arteries were imaged via
SEM for topography study. 2500–5000 HUVEC cells per cm2 were seeded
on the graft. Cell viability was assessed using LDH at 24, 48 and 72h. A
smooth collagen surface served as control. HUVEC cell adhesion over the
lumen of the graft was imaged via SEM.
Results: Preliminary results proved that highly concentrated SDS effec-
tively decellularized aortic tissue by contact with the surface for 12 hours
(Fig 2). The proposed protocol aims to reduce the SDS concentration by
incorporating physical treatments. This approach allowed to maintain
the microstructure of the lumen of the artery as evidenced in Fig 3 after
surface treatment at low SDS concentration. Furthermore, we observed
HUVEC adhesion on collagen-based flat surfaces (Fig 4), which is in turn
expected in the decellularized arteries.

Figure 4: HUVEC cell adhesion to smooth collagen surface

34
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ASAIO BIOENGINEERING ABSTRACTS

249 250
Thoughts on FDA Benchmark Blood Pump - Insights from Physics-based “Hey ELSO”: Natural Language Processing (NLP) for ELSO Registry
Approach Queries
C. Jhun, C. Scheib, R. K. Newswanger, J. P. Cysyk, B. Lukic, E. Yeager, J. D. L. D. Pihera1, A. Morgan1, L. M. Lima2, M. L. Paden2; 1Georgia Tech
Reibson, P. Leibich, B. Doxtater, K. Bletcher, C. A. Siedlecki, W. J. Weiss, G. Research Institute, Atlanta, GA, 2Pediatric Critical Care, Emory University,
Rosenberg; Surgery, Penn State College of Medicine, Hershey, PA. Atlanta, GA.
Study: An international endeavor to validate computational fluid dynam- Study: The Extracorporeal Life Support Organization (ELSO) registry
ics (CFD) in blood-contacting devices was initiated by U.S. Food & Drug collects outcome data on >100,000 extracorporeal membrane oxygen-
Administration (FDA) involving multiple laboratories characterizing a ation (ECMO) patients and is the principle resource for ECMO research
centrifugal blood pump. While understanding their standard error in and quality improvement. A clinician’s ability to rapidly query the ELSO
hemolysis benchtop testing reaches beyond 100% of the mean at times, registry is limited by the need to know database structure/language and
this study is to provide thoughts based on our physics-based hemolysis access to the single individual who can perform the query. As ECMO use
approach (PBA) on feasibility of the benchtop results for CFD validation has scaled (cases/year, geographic diversity), the current state is not ade-
on the FDA pump. quate. We explored NLP options that would be highly available, appropri-
Methods: 3D model of the FDA pump was prepared for computations. ate for clinicians, and do not require SQL/database specific knowledge.
A physics-based energy dissipation hemolysis model developed by our Methods: A multidisciplinary group of systems engineers, ECMO special-
group was implemented as a user-defined function to Converge CFD, a ists, and clinicians used standard systems engineering techniques to
commercial CFD solver. All six flow-speed conditions were solved using define the problem, determine the project scope, prioritize techniques,
large eddy simulation on modified cut-cell grids. Relative and absolute determine use case, and arrive at a final design. Trade analysis was per-
scale of hemolysis acquired from the PBA were compared to the bench- formed between quality of results and the time taken to implement and
top results. train models. A text analytics based method was chosen over machine
Results: The PBA was able to provide comparable results in relative learning due to lack of a large training dataset. (Figure 1) Anonymised
hemolysis index within their in-vitro standard errors (Fig 1). Accuracy in ELSO registry data from 1,235 patients from a single center were used for
predicting absolute scale of hemolysis was not satisfactory as there was the analysis. NLP queries outcomes were validated against standard SQL
approximately an order of magnitude difference between in-vitro and queries for the same question. MATLAB was used for prototype design.
PBA. Nonetheless, narrowing these two within an order of magnitude is Results: Text analytics provides a successful mechanism to promote NLP
encouraging given that there is only one single universal constant in our based queries of the ELSO registry. (Figure 2) No queries tested produced
model and it is flow-independent, i.e., no need to calibrate constants SQL that differed from the traditional method. This work provides a proof
based on devices or flows generally employed in stress-based approaches of concept that could inform a highly available, web based, rapid method
potentially causing discrepancy up to three orders of magnitude. While to query the ELSO database using NLP. Future examination of other
the ultimate goal of our PBA is to predict the hemolysis in absolute scale machine learning approaches should be entertained to further enhance
within the experimental error, given substantial experimental errors the accuracy of results.
propagated in in-vitro possibly due to differences in cell fragility, loop
variation, contribution solely from the pump and/or peripherals such as
resistor, and sampling/processing techniques, a model that provides a
reasonable predictability even in relative scale should be considered use-
ful as a design tool.

35
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ASAIO BIOENGINEERING ABSTRACTS

253
LVAD Redesign: Pump Variation for Minimizing Thrombus Susceptibility
Potential
C. M. Scheib, R. K. Newswanger, J. P. Cysyk, J. D. Reibson, B. Lukic, B.
Doxtater, E. Yeager, P. Leibich, K. Bletcher, C. A. Siedlecki, W. J. Weiss, G.
Rosenberg, C. Jhun; Surgery, Penn State College of Medicine, Hershey, PA.
Study: Due to the complex geometries and fluid flow in current continu-
ous flow left ventricular assist devices (cf-LVADs), regions of low shear can
persist which can lead to thrombus formation. Driven by a parametric 3D
design optimization tool (CAESES) coupled with a CFD solver (Converge),
the study explored the dependent relationships between varying cf-LVAD
designs, regions of low-shear flow, and the overall potential for thrombus
formation.
Methods: Parametric cf-LVAD (Figure 1A) variation was conducted for
the cross-sectional scroll profiles (Figure 1B) and the end-cap spike
(Figure 1C). A starting scroll profile is smoothly swept into an end profile
(diamond, circular, or square), and the end-cap spike height and base
width are variable. The metric for design comparison was an Eulerian
user-defined function called thrombus susceptibility potential (TSP). TSP,
based on in-vitro studies defining the strain-rates that platelet adhesion
occurs, predicts a 0 to 100% potential on the model surface elements. For
each design iteration (n=40), TSP contour plots on the scroll and end-cap
were integrated across each contour length to associate values of TSP
with specific surface areas.
Results: Varying spike height and width at a given scroll shows stron-
ger TSP correlation with the width (R2= 0.554) than the height (R2=
0.140). The spike width TSP correlations were stronger on the end-cap
(R2= 0.808) than the scroll (R2= 0.299), showing spike width is inversely
related to end-cap TSP. Varying scroll profiles at a given end-cap shows
the strongest end-cap TSP correlation with the start profile (R2= 0.418)
and the strongest scroll TSP correlation with the end profile (R2= 0.484).
Scroll and end-cap TSP were minimized with square-like start and end
profiles, while diamond-like profiles yielded the highest TSP. These results
will drive more comprehensive in-silico design exploitation studies and a
first iteration optimized pump will be manufactured and tested in-vitro
for validation.

36
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ASAIO BIOENGINEERING ABSTRACTS

256
A Bioreactor Containing Primary Human Renal Epithelial Cells Supported
In Vivo without Immunosuppression
R. C. Gologorsky1, E. Kim1, J. Moyer1, A. Santandreu1, C. Blaha1, J. Ly1,
R. Shaheen1, D. Sarode1, N. Wright1, W. Fissell2, S. Roy1; 1Surgery/
Bioengineering, University of California, San Francisco, San Francisco, CA,
2
Nephrology, Vanderbilt University, Nashville, TN.
Study: The bioartificial kidney is intended to contain human cells in an
immunologic sanctuary and provide total renal replacement. In vitro
experiments have demonstrated the efficacy of silicon nanopore mem-
branes (SNM) as an immunologic barrier to inflammatory cytokines with
selective permeability that supports human renal epithelial cell (HREC)
viability. Here, we test an SNM-based bioreactor in vivo to demonstrate
HREC viability and functionality without immunosuppression or antico-
agulation in a swine model.
Methods: HREC were grown to confluence on semipermeable polycarbon-
ate membranes coated with type IV collagen and separated from blood flow
by SNM with 10 nm pores, allowing passage of nutrients but not immu-
noglobulins or immunocytes. The bioreactor was implanted in the neck of
a healthy Yucatan pig for three days and perfused via anastomoses to the
external jugular vein and carotid artery. A static control was comprised of
HRECs grown on identical membranes in cell culture media at 37°C.
Results: HREC were evaluated for viability and biomarkers of function-
ality upon device explantation. Cell viability was over 90% as shown
by fluorescence imaging after staining with calcein AM and ethidium
homodimer-1. Cells remained confluent with tight junctions expressed
by Zona Occludens (ZO1) protein comparable to that of the control.
γGlutamyltransferase (γ-GT) activity, which is a renal tubule cell (RTC)-
specific marker, and qPCR evaluating expression of RTC surface markers
including AQP1, γ-GT, and NHE3 were consistent with healthy static
control RTCs. NAGactivity, a biomarker of RTC damage, was low. We show
immunoprotection protection of primary human renal cells and preserva-
tion of renal tubule cell functional markers in a bioreactor after three-day
implantation in a swine. This is a promising model for bioartificial kidney
development in humans that may lead to total renal replacement.

37
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ASAIO BIOENGINEERING ABSTRACTS

261 266
Shear-Mediated Activation of Platelets is Associated with Global Destruction of von Willebrand Factor Occurs Despite the Absence of
and Regional Changes in Biomechanical Properties: Implications for Hemolysis: In-Vitro Study
Mechanism and Therapy C. Jhun, R. K. Newswanger, C. Scheib, E. Yeager, J. P. Cysyk, C. A. Siedlecki,
A. L. Sweedo1, Y. Roka-Moiia1, J. Sheriff2, D. Bluestein2, F. T. Arce1, M. J. J. D. Reibson, P. Leibich, K. Bletcher, W. J. Weiss, G. Rosenberg; Surgery,
Slepian1; 1University of Arizona, Tucson, AZ, 2Stony Brook University, Stony Penn State College of Medicine, Hershey, PA.
Brook, NY.
Study: It is known that supraphysiologic shear stresses in continuous
Study: Ventricular Assist Devices, while lifesaving, are plagued by throm- flow left ventricular assist devices (cf-LVADs) cause not only hemolysis
boembolic adverse events despite antithrombotic medication. Transduc- elevating plasma free hemoglobin (PlfHb) but also degrade high molecu-
tion of VAD-induced supraphysiologic shear stress is a primary mechanism lar weight multimers (HMWM) of von Willebrand factor (vWF) result-
for shear-mediated platelet activation (SMPA). Our prior work on quies- ing in bleeding complication in patients with cf-LVADs. As a part of our
cent platelets showed that overall platelet stiffness is a determinant of continued effort to design better cf-LVADs, a hemolysis free cf-LVAD was
shear-stress mechanotransduction. Still unknown is the effect of platelet developed and degradation of HMWM of vWF was evaluated.
activation on overall platelet stiffness and its distribution. Determining Methods: A centrifugal cf-LVAD having a rotor with three blades and
these parameters is important in enhancing multi-scale models of platelet hydrodynamic bearing was designed and built. Hemolysis and degrada-
activation as well in developing “mechanoceuticals,” to limited SMPA. tion of HMWM of vWF were tested using a fully controlled small volume
Here we examine the effect of SMPA on platelet shape, height and overall (450 ml) loop, filled with heparinized, freshly drawn ovine blood under
and regional stiffness utilizing atomic force microscopy (AFM). three sets of operating conditions: (4800 RPM, 5 LPM, 80 mmHg),
Methods: Gel-filtered platelets (20,000 plts/uL) from consenting volun- (5200RPM, 6 LPM, 90 mmHg), and (5500RPM, 8 LPM, 90 mmHg). Samples
teer blood were sheared (10 min. x 70 dynes/cm2) in a hemodynamic for hemolysis and vWF degradation were take every 30 min and 60 min,
shearing device. Sheared platelets or unsheared controls were adhered respectively, during 5-hour loop testing. The rate of PlfHb increase was
to a mica surface in PBS and examined via AFM (Bruker Multimode, Force used to calculate the normalized index of hemolysis (NIH). Multimer
Volume mode). Analysis fit to a Hertzian model determined images, analysis were performed at the Blood Center of Wisconsin.
height, regional stiffness distribution and overall modulus. Results: The increase in PlfHb was negligible during the testing (NIHmean
Results: Shear-activation increased global stiffness with an elastic = 0.000±0.002 mg/dl) (Fig 1A), Degradation of HMWM of vWF, however,
modulus of 20 ± 10 kPa relative to unactivated controls (8 ± 5 kPa), and was observed despite the absence of hemolysis (Fig 1B). While suggested
was associated with a heterogeneous distribution of elevated stiffness vs. that the thresholds of shear stress, energy dissipation, and exposure time
unactivated controls with a more uniform stiffness distribution. Shear- on red blood cells and vWF multimers are not equivalent, further studies
activation increased average height (800 ± 300 nm vs 400 ± 200 nm) and are warranted on differentiating the effect of loop peripherals from the
maximum height (1419 nm vs 691 nm). Correlation of observed height entire system. Defining the relationships between the metrics mentioned
and stiffness changes with known intra-platelet cytoskeletal rearrange- above is also needed for design of next generation cf-LVADs.
ments affords further understanding of platelet activation dynamics,
refinement of our evolving multiscale platelet model, and guides selec-
tion of candidate mechanoceutical agents modulating regional stiffness
changes.

38
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ASAIO BIOENGINEERING ABSTRACTS

272
Cardiac Assist Device Design Guided by Computational Modeling
D. Ivers1, G. Giridharan2, J. Woolley1, S. Patel-Raman1, R.
Smith1; 1NuPulseCV, Raleigh, NC, 2Department of Bioengineering,
University of Louisville, Louisville, KY.
Study: An implantable Intravascular Ventricular Assist System (iVAS,
NuPulseCV, Raleigh) has been demonstrated to provide long-term
mechanical circulatory support in over 50 patients in an FDA approved
clinical trial. The iVAS is a counterpulsation device that is driven by a
pneumatic drive unit (NDU). We report the development and validation
of a computer simulation model using Matlab and Simulink (MathWorks,
MA) that models the NDU and predicts acute hemodynamic efficacy to
guide the development of the next-generation NDU.
Methods: A lumped parameter dynamic model of the NDU was derived
using Bond Graph analysis. The model incorporates electrical, mechanical
(rotary and linear), and pneumatic domains, including the compressibility
and inertia of air (Figure 1). A Simulink model was then built based on
the Bond Graph model. The Simulink model was validated against bench
and in-vitro NDU data. The NDU performance results were input into a
computer simulation model of the circulatory system to predict acute
hemodynamic responses during heart failure.
Results: The NDU model predicted inflation and deflation times within
17 ms of the actual values. Figure 2 shows a comparison between the
model (above) and bench test data (below). The circulatory system model
predicted that the iVAS system augments cardiac output (14%), coronary
flow (38%), and reduced left ventricular external work (22%). These
computer simulation models are currently being used in the development
of the next-generation NDU by enabling rapid assessment of multiple
designs iterations, guiding specifications, and evaluating tradeoffs
between hemodynamic augmentation, power consumption, size, and
weight.

39
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ASAIO BIOENGINEERING ABSTRACTS

275 276
Portable Driver Optimization for NuPulseCV iVAS Chronic Humans and Pigs: Are We That Different? The Effect of Shear Stress and
Counterpulsation Cardiac Support Biochemical Activation on Porcine Platelets
J. Allen, D. Ivers, A. Chinta, A. Meyers, R. Smith; NuPulseCV, Raleigh, NC. Y. Roka Moiia1, A. Harhash2, K. Kern3, J. Sheriff4, D. Bluestein4, M.
Study: The NuPulseCV (Raleigh, NC) Intravascular Ventricular Assist Sys- J. Slepian1; 1Department of Medicine and Biomedical Engineering,
tem (iVAS) is a minimally-invasive, long-term, portable counterpulsation University of Arizona, Tucson, AZ, 2Sarver Heart Center, University of
device for the treatment of heart failure. An FDA-approved Feasibility Trial Arizona, Tucson, AZ, 3Department of Medicine, University of Arizona,
in 50 patients demonstrated that the first-generation pneumatic driver Tucson, AZ, 4Biomedical Engineering, Stony Brook University, Stony
(Gen1 NDU) provides effective counterpulsation while promoting reha- Brook, NY.
bilitation and patient discharge (15 patients discharged). The Gen1 NDU Study: The porcine animal model is widely used for preclinical assessment
was rated for only 90-days of use, expensive to build, needed refinement of hemocompatibility of implantable cardiovascular devices. Yet, limited
in end-user experience, and required predictive pumping algorithms con- data exists as to the response of porcine platelets to supraphysiologic
traindicating implants in patients with cardiac dysrhythmia. NuPulseCV is shear stress experienced with disordered flows through these devices.
developing a smaller, lighter, cheaper, and ergonomic second-generation Here we evaluate the effect of shear stress vs. biochemical agonists on
driver (Gen2 NDU) for introduction in the upcoming Pivotal Trial. porcine platelet activation.
Methods: Gen2 NDU target specifications include: (1) 100 cm3 volume Methods: Gel-filtered porcine platelets were subjected to continuous
reduction, (2) >1.5 lbs weight reduction, (3) 30% reduction in manufactur- shear stress (30, 50 and 70 dyn/cm2 x10’) in a hemodynamic shearing
ing costs, and (4) improved durability, and (5) reduced inflation/deflation device. Surface expression of P-selectin, phosphatidylserine exposure and
times to enable real-time 1:1 support for heart rates of up to 150 bpm. microparticle generation were visualized by multi-color flow cytometry.
To improve user experience, iVAS end users (n=19, 2 patients, 1 surgeon, Platelet aggregation induced by biochemical agonists, ADP, calcium
4 VAD coordinators, 5 nurses, 4 hospital engineers, 1 clinical specialist) ionophore, TRAP-6, and thrombin, was assessed by light-transmission
were surveyed about Gen1 NDU ergonomics and function. aggregometry.
Results: Improved geometry reduced bellows travel from 33 mm to Results: Shear-mediated platelet activation induced notable phospha-
14 mm, inflation time by 50% (against 140 mmHg), and deflation time by tidylserine exposure as indicated by an increase in annexin V positive
60% (against 50 mmHg) to provide 1:1 support for up to 150 bpm. A more platelet number in parallel with the magnitude of shear stress (Fig. 1A).
efficient electromechanical design is anticipated to reduce manufacturing Ejection of platelet microparticles was also detected, reaching 20% of
costs by 50%, volume by 106 cm3, weight by 2 lbs, and improve durability the platelet population exposed to 70 dyn/cm2 shear. Yet, P-selectin
to > 1 year. Human factor improvements in the Gen2 NDU include louder expression was barely elevated. In contrast, porcine platelet sensitivity
alarms, lighter batteries, and simplified alarm resolutions. Gen2 NDU to biochemical activation was significantly diminished, as shown by low
improvements will result in enhanced hemodynamic support and patient reversible aggregation induced by the universal agonists, ADP and calcium
experience, while expanding the patient population that could benefit ionophore, and the lack of TRAP-6-mediated aggregation (Fig. 1B). Only
from iVAS therapy. thrombin promoted high-amplitude non-reversible platelet aggregation
in pigs. To resume, porcine platelets show differing extent of response to
shear stress vs. biochemical activation. In comparison with human plate-
lets, porcine platelets demonstrate higher shear sensitivity while express-
ing a similar pattern of molecular markers. This elevated sensitivity of pig
platelets to shear stress must be considered when employing the porcine
model for preclinical testing of blood contacting devices.

40
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ASAIO BIOENGINEERING ABSTRACTS

284
Design of a Magnetic Bearing Couette Flow Shearing Device for Testing
Blood Fragility
J. Krisher, S. W. Day; Biomedical Engineering, Rochester Institute of
Tehcnology, Rochester, NY.
Study: Rotary blood pumps exert fluid shear on blood that exceeds physi-
ological levels. This shear is experienced by all blood components, such as
red blood cells or platelets, and can contribute to hemolysis, thrombosis
or bleeding for an implanted patient. The accurate prediction of how a
flow field will damage blood components is important during the design,
development, and approval of any device. Reported values of fluid shear
that can damage blood components are highly variable and are the result
of a range of flow types. To conduct rigorously controlled investigations of
shear-induced blood damage, we built a device that uses a magnetically
levitated rotor to apply known Couette shear with a simplified flow path,
avoiding any uncharacterized shear from bearings or seals.
Methods: An existing mag-lev VAD was modified to construct this device.
Rotor blades were replaced with a tapered concentric ring creating a
narrow (130um) gap at the center (Fig 1). The magnitude of applied shear
in this gap region is controlled by rotor speed. Duration of exposure is
controlled by the flow rate from a syringe pump (60ml). Radial rotor
position is measured via Hall Effect sensors and effective fluid viscosity is
monitored via a calibration of motor torque. These parameters are con-
tinuously logged into a single data file, where they are synchronized with
the blood collection intervals.
Results: Levitation is stable (<25um movement over the operating range).
At a constant exposure time, ranging from 200-1200ms, a single experi-
mental sweep applies increasing shear rates from 20k-100k s-1 (0–350
Pa), allowing approximately 20 (2ml) samples to define a shear damage
profile. Extremely low levels of damage relative to studies in the literature
were observed below 60k s-1 (~200Pa) in porcine and ovine blood,
indicating very little damage from secondary flows and bearings within
this device. Results are very repeatable with a trial to trial variability being
~10% and inter animal variation <30%, as shown in Fig 2.

41
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ASAIO BIOENGINEERING ABSTRACTS

287
CFD Modeling of the FDA Benchmark Centrifugal Pump Using a Cut-
Cell Method with Automatic Mesh Generation and Adaptive Mesh
Refinement
Y. Li, D. H. Rowinski; Convergent Science Inc., Madison, WI.
Study: The U.S. Food and Drug Administration (FDA)’s benchmark
centrifugal pump model provided experimental data for Computational
Fluid Dynamics (CFD) validation. A commercial CFD solver equipped with
innovative automatic mesh generation, CONVERGE, is used to study the
pump’s hydraulic performance at the measured conditions. Local flow
details are also investigated through comparisons to the measured par-
ticle image velocimetry (PIV) data.
Methods: For the employed method, the Cartesian mesh is created on-
the-fly and strictly conserves the volume. Automatic Mesh Refinement
(AMR) is employed to refine adaptively based on local velocity gradients.
Turbulence is modelled with the Shear Stress Transport (SST) k-ω model.
The multiple Reference Frame (MRF) approach with a frozen impeller is
compared to that with a transient moving impeller, and the MRF method
yields comparable results at much less runtime. All six conditions at 3500
and 2500 rpm are investigated, and condition 5 (Q=6L/min, 3500 rpm) is
selected for velocity contour comparison with PIV data.
Results: The hydraulic performance predictions are generally within 10%
error of the test data (Figure 1a) with runtime less than ten hours for a
three million cells grid. A grid convergence study was performed for con-
dition 5 (Figure 1b). The skew directions of the diffuser jet for conditions Figure 3: Velocity contour and 2-D velocity profile for condition 5
1, 2, 4, 5 and 6 are consistent with the experimental result (Figure 2). For
condition 5, the velocity contour at the upper-blade plane (Figure 3a)and
2-D velocity distribution at the centerline and across the diffuser com-
pares reasonably well to the PIV data (Figure 3b,c,d), correctly predicting
the peak velocity locations. Overall high cost-effectiveness is achieved
with the proposed approach.

Figure 1: Performance Curve and grid convergence for condition 5.

Figure 2: Skewness of the diffuser jet for conditions 1, 2, 4, 5 and 6.

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ASAIO BIOENGINEERING ABSTRACTS

297 298
Endovascular Cavo-Pulmonary Right Ventricular Assist Device Trans Catheter, Durable, Bio-Mimetic, Wireless-less Left Ventricular
J. Park, A. Geirsson, P. Bonde; Yale University School of Medicine, New Assist Device for End Stage Heart Failure
Haven, CT. J. Park, A. Geirsson, P. Bonde; Yale University School of Medicine, New
Study: Right ventricular (RV) dysfunction following LVAD placement can Haven, CT.
limit the benefits of LVAD therapy. Distinct anatomical and hemodynamic Study: LVAD therapy has changed the natural history of end stage heart
characteristics of RV limits the use of current LVAD as an RVAD, signifying failure patients. However, adverse related to strokes, infection and clots
the clinical need for dedicated RVAD technology. still plague the current generation of devices. Invasiveness and tethered
Methods: RVAD delivery system is designed to deploy through percutane- operation still preclude usage in less severe heart failure patients. A trans-
ous access to SVC and direct puncture of RPA. The design includes three catheter, tether-free device can minimize procedural morbidity and allow
separate self-expandable open stents linked in series, top stent anchored expansion to a less sick population of patients.
to the direct puncture from SVC to RPA, middle cage stent freely located Methods: A Co-Rhythmic, Isolable, Self-maintenance assist device is
at right atrium to prevent right atrial wall suction, and the bottom stent inserted via trans-septal puncture for inflow and intentional trans-right
fixed to IVC to assure RVAD positional stability. The top stent incorporates atrial appendage to ascending aortic for outflow. Two valves located at
a pump and isolation/maintenance system connected to a pacemaker-size inflow and outflow allow control based on decompensated and recovery
controller that is wirelessly powered. state. When the system is isolated with valves closed, a proteolytic
Results: 2D cross-sectional CT image shows the proximity between SVC solution is used to dissolve debris within the pump. By incorporating a
and RPA. Based on this structural relationship, RVAD that pumps blood wireless power delivery system, no tethered power cords exist to operate
from SVC to RPA was designed and performance for each component was the system.
tested in the mock circulatory system. Prototypes were created using 3D Results: Prototypes for each component were created using a 3D printer
printers with either Polylactic Acid (PLA) or watertight material, resin. and integrated into a single catheter device with a wireless power delivery
Both simulation and benchtop experiment study showed excellent perfor- system. The stent that has flared configurations at both ends is designed
mance particularly for RVAD use by providing high-volume/low-pressure to connect two hollow punctures, one at fossa ovalis and the other at
(5L/min at 30 mmHg). Gear driven valve having holding torque of 15 ascending aorta. Pump deployed inside the stent has AAA battery size and
N·mm could successfully isolate the system by making zero flowrates. its performance was optimized through computational fluid dynamics to
Both the pump and isolation/maintenance system were synchronously deliver 2–4 L/min. An iris-type valve with the linear motion of retractable
controlled by a wireless power delivery system with total power con- ballpoint pen locking /unlocking mechanism has been employed as a
sumption less than 5W. circumferential motion to open/close the valve within a twisting/untwist-
Our proposed delivery system exploits the unique relations of blood ves- ing manner by electromagnetic forces. Each component has been tested
sels around the heart to allow endovascularly implantable RVAD device. in-vitro for feasibility and repeatability with excellent performance.

43
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ASAIO BIOENGINEERING ABSTRACTS

299 300
Trans-catheter Septal Myectomy for Hypertrophic Cardiomyopathy: Endovascular Reconstitution of Aortic Sinotubular (eRAS) Junction for
Results from an Innovative Design and Testing Type A Dissection
J. Park, A. Geirsson, P. Bonde; Yale University School of Medicine, New J. Park, A. Geirsson, P. Bonde; Yale University School of Medicine, New
Haven, CT. Haven, CT.
Study: Surgical myectomy is highly invasive and sometimes a residual Study: Type A dissection repair requires highly invasive surgery with
gradient means doing a re-do sternotomy with added morbidity and circulatory arrest, mortality and morbidity following surgery remain high
mortality. A trans catheter septal myectomy can greatly improve the man- and poor risk patients are often not considered surgical candidates. Endo-
agement of the patients with ability to perform customized myectomy vascular repair of Type A dissection is hampered due to problems with
with simultaneous measurement of gradient and hemodynamics. And an fixation, migration and obliteration of the false lumen. We present our
ability for re-invention at little risk of comorbidity. innovative design which tackles all these issues with ease and reliability.
Methods: A specially designed trans-catheter construct involves three Methods: Critical anatomical relationships were exploited in the design
telescoping curved- cylinders that are axially aligned, a protective valve and development of this stent construct (Fig 1A). Graft delivery system
sheath, shielded cutting knife, and a core capture mechanism. Protec- was designed to have three anchors, the first one at non-coronary cusp,
tive sheath is introduced into aortic valve to protect aortic leaflets with a the second one at right brachiocephalic artery, and the third one extend-
retractable shielded semilunar knife. Core capture, the innermost part of ing to descending aorta (Fig 1B). Graft delivered into the true lumen is
the device, incorporates suction cup arrays to vacuum a portion of tissue composed of a specially manufactured and constructed magnetized mesh
toward the aperture. Once the core is captured cutting edge transect the with a fibril-covered surface for fixation.
core which is then transported out through the catheter. Series of cores Results: Critical anatomical relationships were analyzed in Type A dis-
can be sliced on demand to yield a gram of cylindrical tissue core for each section (n=140), demonstrating external opposing magnetic polarized
pass. material delivered to RAA, SVC, RPA, and MAP can surround more than 90
Results: Simulation showing different cut shapes by different angula- % of aorta circumference. For feasibility testing, magnetic flux was evalu-
tion of the device relative to the center point at aortic valve was built ated using six different magnets and the measurements were all under
assuming that initial hypertrophied myocardium is in a spherical shape. To muscle injury threshold (Fig. 1C). The static mock system mimics blood
validate the simulation, a silicone spherical lump was created using plati- filled false lumen to measure distraction forces (Fig. 1D). Signals from
num-cure silicone rubber. Three components, protective sheath, shielded a pressure sensor inside the anatomical phantom and a digital caliper
knife, and core capture were designed with computer-aided design soft- were collected synchronously to measure distraction/attraction pressure.
ware and prototypes were created using the 3D printer (Objet 30) with Circulating mock system mimics ascending aorta with type A dissection to
polyurethane. Core capture having arrays of holes inside the aperture is evaluate graft fixation under different pressure and flow conditions (Fig.
integrated with 100 mL syringe to provide negative pressure. Curved core 1E). Polytetrafluoroethylene (PTFE) Teflon sheet placed (intimal flap) was
capture was designed with 30 degrees operating arc. Benchtop simula- occluded with a pressure tolerance of 120 mmHg (mean).
tion created a series of reproducible measured cuts within the silicone
phantom mounted on a mock circulatory loop driven by a pulsatile driver
to mimic cardiac contractions.

44
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ASAIO BIOENGINEERING ABSTRACTS

301
Development of Novel Artificial Pericardium with Biodegradable Poly-
lactide Sheet
K. Ishibashi, M. Motokawa; Cardiovascular Surgery, Yonemori Hospital,
Kagoshima, JAPAN.
Study: It is often difficult to detach adhesions between for the re-opera-
tion in cardiovascular surgery. E-PTFE sheets are widely used as artificial
pericardium, but they are non-absorbable sheets and may cause inflam-
matory reactions. In this study, we have developed a new biodegradable
artificial pericardium with surface treatment.
Methods: (Experiment I) A film having a thickness of about 30 μm was
produced using a polylactic acid copolymer. Honeycomb-shaped hydroph-
ilization treatment was performed on the surface of the film using sodium
hydroxide. Wall side peritoneum on both sides of rat (n = 6) was ligated
with 2 points with silk thread and fixed on the right ligature so as to cover
with the prepared thin film. Rats were sacrificed at 1 week and 6 weeks
after transplantation.(Experiment II) Using a similar material, a fibrous
sheet with a thickness of 50 μm was prepared. The pericardium of the
rat (n = 8) was excised, and the same site was divided into a group fixed
so as to be filled with the prepared fibrous sheet and a control group not
supplemented, Sacrificed 6 weeks after transplantation.
Results: (Experiment I) At 1 week of transplantation, the film remained
on the abdominal wall. On the control side, strong adherence was
observed at the silk thread and the surrounding tissue. At 6 weeks, the
film remained and adhesion at the surrounding tissue was not observed.
Histologically, at 6 weeks, no cell invasion into the film was observed.
(Experiment II) At 6 weeks of transplantation, the sheet remained and
adhesion between the epicardium and the lung was not observed. How-
ever, the invasion of fibroblasts was recognized in the sheet, and a part of
the sheet was in the process of degradation in vivo. In the control group,
epicardium and lung adhered.
Conclusion: We have developed a new biodegradable artificial pericar-
dium. This film and sheet prevent adhesion in the early postoperative
period. The fibrous sheet had high permeability and formed a scaffold
that facilitated cell migration as compared with the film.

45
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ASAIO CARDIAC ABSTRACTS

18 19
Risk of Adverse Events in Patients undergoing Left Ventricular Assist Video Assisted Thoracoscopic Surgery with Sympathectomy for
Device Implantation in Cardiogenic Shock Refractory Ventricular Tachycardia in Patient with Left Ventricular Assist
C. Louis1, I. Gosev1, S. McNitt2, S. Prasad1, H. Vidula3, J. Alexis4, V. Device
Kutyifa4; 1Cardiothoracic Surgery, URMC, Rochester, NY, 2Heart Research C. Louis1, C. Jones2; 1Cardiothoracic Surgery, URMC, Rochester, NY,
Follow-up Program, URMC, Rochester, NY, 3Division of Cardiology, URMC, 2
Thoracic Surgery, URMC, Rochester, NY.
Rochester, NY, 4Cardiology Division, URMC, Rochester, NY.
Study: Video-Assisted Thoracoscopic Surgery (VATS) with sympathectomy
Study: The aim of this single-center, a retrospective study was to evaluate is an end-stage therapeutic to treat recurrent syncope, seizures or sud-
early and long-term adverse events in advanced heart failure patients den cardiac death associated with Long-QT Syndrome (LQTS). Use of this
with cardiogenic shock who underwent ventricular assist device (VAD) modality to treat refractory VT in patient’s status-post Left Ventricular
implantation. We hypothesize that outcomes in patients implanted with Assist Device (LVAD) is not well described. We hypothesize that patients
LVAD with INTERMACS 1 have increased the risk of perioperative bleeding who undergo VATS sympathectomy Our study will attempt to assess 1)
and infection. use VATS sympathectomy on patients with LVAD 2) Our institution-specific
Methods: We evaluated outcomes in 191 patients with a HeartMate outcomes in this cohort.
II LVAD implanted between May 2008 and June 2014 at the University Methods: This is a retrospective analysis from January 2013 to December
of Rochester Medical Center, enrolled in the Interagency Registry for 2018 with patients who underwent VATS sympathectomy in patients who
Mechanically Assisted Circulatory Support (INTERMACS) Registry. Patients previously underwent LVAD implantation. Data for this database will be
were divided into two groups: A) INTERMACS level 1 (cardiogenic shock) collected from the Electronic Health Records system and departmental
or B) INTERMACS level>1 (noncardiogenic shock). Preoperative character- database.
istics, as well as post-surgical bleeding, infection and all-cause mortality, Results: There were 4 patients who underwent VATS sympathectomy who
were assessed. The original LVAD database has received exempt status previously underwent LVAD implantation at University Medical Center
from the RSRB (RSRB00043111). between 2013 and 2018. Out of the 10 patients who underwent VATS
Results: From 191 patients, there were 59 patients with INTERMACS sympathectomy, 4 patients were LVAD patients. Intraoperatively these
level 1, and 132 with INTERMACS level greater than 1. Patients with patients did trend higher for perioperative blood transfusion and IVF
INTERMACS level 1 at LVAD implantation were younger. Following LVAD resuscitation.
implantation, INTERMACS level 1 patients had a trend towards bleeding
and infection.

46
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ASAIO CARDIAC ABSTRACTS

23 24
Impact of Delayed Systemic Heparinisation on Bleeding and Testing the Obesity Paradox in Patients on Long-term Milrinone Infusion
Thromboembolism During Post-cardiotomy Extracorporeal Membrane for End Stage Heart Failure
Oxygenation in Neonates M. M. Benjamin, S. Sundarajan, E. Garacci, A. Mohammed; Internal
M. von Stumm, I. Subbotina, D. Biermann, U. Gottschalk, G. Müller, R. Medicine, Medical College of Wisconsin, Milwaukee, WI.
Kozlik-Feldmann, H. Reichenspurner, A. Riso, J. Sachweh; University Heart Study: Obesity is a risk factor for heart failure (HF) but is associated with
Center Hamburg, Hamburg, GERMANY. longer survival once patients have an established diagnosis i.e. obesity
Study: Objective: Veno-arterial extracorporeal membrane oxygenation paradox. We investigated the relationship between the body-mass index
(ECMO) is well-established in paediatric patients with post-cardiotomy (BMI) and survival in stage D inotrope-dependent HF patients.
heart failure. However, ECMO is associated with major complications, i.e. Methods: This was a retrospectively review of electronic medical records.
haemorrhage and thromboembolism. Currently, standards for anticoagu- We included all adults with ACC/AHA stage D HF patients who were
lation on ECMO vary considerably. Thus, we seek to report our experience admitted to our institution between 01/ 2010 and 07/2018 and were initi-
with delayed systemic heparinisation in neonates on post-cardiotomy ated on continuous milrinone infusion. Patients (n=233) were divided into
ECMO and its impact on bleeding and thromboembolism. 3 groups based on their BMI; non obese (NOb):BMI <30 (n=154), obese
Methods: From our institutional database, we retrospectively identi- (Ob):30≤BMI<35 (n=39), markedly obese (MOb):BMI≥35 (n=40). The
fied 15 neonatal patients who were placed on ECMO after congenital primary endpoint was overall survival. Cox proportional hazard models
heart surgery during a period of three years (2015–2017). All patients were used to estimate risk ratios for survival. A multivariate proportional
underwent our standard anticoagulation scheme, consisting of full rever- hazards model for was also used.
sal of heparin by protamine after switching from CBP to ECMO (target Results: There was no significant differences between groups as far as
ACT120±20sec). In addition, administration of systemic heparinisation baseline demographics and comorbidities. After an average of 21.8 +/-
was delayed until postoperative drainage volume declined to <1ml/kg/h. 20.04 months of follow up, overall survival was 64.6 % (53.3–66.5) and
Primary endpoints of our study were thromboembolism, bleeding and 55.4% (47.4–62.7) at 1 and 5 years respectively. 23(14.9%), 8(20.5%) and
requirement of blood products on ECMO. 3(7.7%) patients in the Nob, Ob and Mob groups respectively received a
Results: In our cohort, mean duration of ECMO support was 4.5±2.2days. heart transplant, P value= 0.2737 while 49(31.8%), 13(33.3%), 15(38.5%)
Administration of heparin was delayed for 18.1±9.3 hours. No thrombo- of the patients received a left ventricular assist device, P value=0.2866.
embolic events were observed on ECMO or after weaning. Surgical site . Compared to NOb group, relative survival of patients in Ob group was
bleedings occurred in two patients (13.3%) requiring re-thoracotomy 0.68 (0.37 - 1.27) while that of MOb group was 1.21(0.72 - 2.02); P
on the first postoperative day. Analysis of transfusion volumes revealed value=0.30. In the multivariate model, relative survival was 0.85(0.44 -
mean packed red blood cells 24.5±21.9 ml/kg/d, mean fresh frozen 1.64) in the Ob group and 1.77(1.00 - 3.14) in the MOb groups; p=0.0837.
plasma 9.6±7.1 ml/kg/d, and mean platelets 7.5±5.7ml/kg/d. In-hospital In this retrospective study of ACC/AHA stage D inotrope dependent HF
survival was 93.4% (n=14). patients, there was no significant difference in survival between BMI
Conclusion: Delayed systemic heparinisation in neonatal post-cardiotomy groups. Ob patients had a tendency towards longer survival than NOb
ECMO revealed to be a safe and favourable strategy with no risk-increase- patients while MOb patients had the worst survival.
ment for thrombosis, low incidence of postoperative haemorrhage and
minimal utilization of blood products. We assume that initial heparin
reduction is a major advantage for neonatal ECMO.

47
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ASAIO CARDIAC ABSTRACTS

25 30
Comparison of Syncardia Total Artificial Heart and Heartware HVAD Left Ventricular Assist Device Caregiver Health Outcomes: A Systematic
Biventricular Support for Management of Biventricular Heart Failure: A Review of Qualitative and Quantitative Studies
Systematic Review and Meta-analysis M. M. Streur1, J. P. Auld1, A. S. Liberato1, J. A. Beckman2, C. Mahr2,
J. G. Luc1, M. P. Weber2, E. J. Maynes2, D. P. Horan2, J. H. Choi2, S. P. Patel2, E. A. Thompson1, C. M. Dougherty1; 1Biobehavioral Nursing and
S. A. Rizvi2, R. J. Morris2, J. W. Entwistle2, H. T. Massey2; 1Cardiovascular Health Informatics, University of Washington, Seattle, WA, 2Division of
Surgery, University of British Columbia, Vancouver, BC, CANADA, 2Cardiac Cardiology, University of Washington, Seattle, WA.
Surgery, Thomas Jefferson University, Philadelphia, PA. Study: This systematic review summarizes health outcomes for caregivers
Study: The aim of this study was to compare the outcomes of patients of adult patients living with a continuous flow left ventricular assist device
undergoing SynCardia total artificial heart (TAH) and biventricular Heart- (CF-LVAD).
Ware HVAD (BiVAD) support. Methods: Multiple databases were systematically queried for studies of
Methods: An electronic search was performed to identify all relevant health outcomes for caregivers of adult CF-LVAD recipients. Search dates
studies published. After assessment for inclusion and exclusion criteria, were constrained to articles published between 2004 and August of 2018
12 original studies from four countries were pooled for meta-analysis. as CF-LVADs were not implanted prior to 2004. Of 683 articles indepen-
Results: 512 patients were supported with TAH and 38 with BiVAD, dently screened by 2 authors, 15 met pre-determined inclusion criteria;
respectively. Ischemic cardiac etiology was present in 32% (95%CI 24–42) data were extracted by 3 authors.
of TAH vs 15% (95%CI 4–44) of BiVAD patients (p=0.21). Postoperative Results: Eligible articles reported results from 13 separate observational
bleeding was present in 42% (95%CI, 28–58) of TAH vs. 23% (95%CI, 8–52) studies. Of those, 8 used either qualitative or mixed-methods and 5 used
of BiVAD (p=0.22). There was a comparable incidence of stroke [TAH 11% quantitative methods. Caregivers were primarily female (83%) and mean
(95%CI 7–16) vs BiVAD 13% (95%CI 2–51), p=0.86] and acute kidney injury age was 59 years. Qualitative studies were all cross-sectional, conducted
[TAH 28% (95%CI 2–89) vs BiVAD 27% (95%CI 9–59), p=0.98]. Overall between 3 months and 5 years post-implant. For quantitative stud-
infection rate was 67% (95%CI 47–82) in TAH and 36% (95%CI 10–74) in ies, 4 were prospective and 1 retrospective and outcome assessments
BiVAD (p=0.16). Driveline infections were comparable between the two ranged from pre- to 34.6 months post-implant; only 2 studies obtained
groups [TAH 11% (95%CI 6–19) vs BiVAD 8% (95%CI 1–39), p=0.73] with a pre-implant outcome evaluations for comparison. Qualitative studies
trend towards higher incidence of mediastinitis in BiVAD [TAH 4% (95%CI revealed contending effects of gratitude for time with the loved one vs.
2–7) vs BiVAD 15% (95%CI 4–45), p=0.07]. Patients in the TAH group had burden related to the emotional, social, and physical caregiving demands.
shorter duration of support [TAH 71 days (95%CI 15–127) vs BiVAD 167 Caregivers experienced increased responsibilities coupled with loss of
days (95%CI 116–217), p=0.01] with similar overall mortality on device personal time, felt overwhelmed, persistently worried, and doubtful in
support [TAH 34% (95%CI 27–43) vs BiVAD 36% (95%CI 20–55), p=0.91]. their abilities as caregivers. Quantitative studies revealed that caregiver
Discharge home on support was achieved in 5% (95%CI 2–14%) of TAH strain peaked between 1 to 3 months post-implant, anxiety and depres-
patients vs 73% (95%CI 48–89%) of BiVAD (p<0.01), and 69% (95%CI sion were relatively stable over time, mental health status improved over
54–80) of TAH patients were transplanted vs 47% (95%CI 24–71) in the time, and physical health status was mildly reduced from pre- to post-
BiVAD group (p=0.14). implant. In conclusion, caregivers of patients with a CF-LVAD experience
Conclusions: Patients on BiVAD support were more likely to be able to significant, sustained strain for 3 months following implantation, report-
be discharged home on support and had similar overall mortality to TAH, ing considerable stress in meeting their own personal needs and those of
albeit a much longer duration of support. their loved one.

48
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ASAIO CARDIAC ABSTRACTS

31
Renal Replacement Therapy in Patients with Continuous Flow Left
Ventricular Assist Devices
U. Parikh, M. Ajmal, H. Lamba, C. Walther, S. Chatterjee, A. Shafii, W.
Etheridge, A. Nair, A. Civitello, J. Morgan; Baylor College of Medicine,
Houston, TX.
Study: Renal replacement therapy (RRT) after continuous-flow left ven-
tricular assist device (CF-LVAD) implantation considerably impacts quality
of life and survival of patients. There are no guidelines in place to manage
CF-LVAD candidates who have poor renal function. The purpose of this
study was to identify pre-operative prognostic markers in patients requir-
ing RRT after CF-LVAD implantation, as well as assess for possible markers
of renal function recovery.
Methods: Three hundred and thirty-three patients underwent CF-LVAD
implantation at our institution from 2012 to 2017. Patients who required
RRT pre-operatively were excluded. Baseline characteristics, comorbidi-
ties, clinical risk scores, renal function and recovery by discharge were
assessed in patients using multivariate logistic regression.
Results: 75 patients (22.5%) required RRT during index hospitalization. Of
those, 18 patients (5.4%) were discharged home on RRT. Patients needing
post-op RRT were more likely to be on mechanical circulatory support
(61.8%, p=<0.001), have an estimated glomerular filtration rate (eGFR)
less than 40 mL/min/1.73 m^3 (24.6%, p=0.001), hemoglobin less than
10 g/dL (43.3%, p=<0.001), albumin less than 3.5 g/dL (51.4%, p=<0.001)
and urine proteinuria (61.1%, p=0.001). Low hemoglobin (p=0.019), urine
proteinuria (p=0.002), eGFR less than 40 mL/min/1.73 m^3 (p=0.047),
mean right atrial pressure to pulmonary capillary wedge pressure ratio
(p=0.003) and white blood cell count (p=0.002) were significant predic-
tors of RRT after CF-LVAD implantation on regression. 1-year mortality
rate was significantly increased in patients requiring in-hospital RRT,
11% vs 56% (p=<0.001). We did not find any significant predictors of
renal function recovery. We conclude that urine proteinuria, right heart
dysfunction and anemia are significant predictors of renal failure after CF-
LVAD implantation and should be carefully assessed in candidates being
considered for destination therapy.

49
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ASAIO CARDIAC ABSTRACTS

34
Promising Parameters for Predicting Right Heart Failure After LVAD
Therapy
F. Gumus, M. S. Durdu, M. Cakici, M. B. Inan, M. Sirlak, A. R. Akar; Ankara
University Department of Cardiovascular Surgery, Ankara, TURKEY.
Study: Right heart failure (RHF) is an important prognostic factor in
continuous-flow left ventricular assist device (LVAD) therapy. We aimed to
assess the clinical variables associated with RHF after LVAD implantation
and to compare their performance against currently available RHF predic-
tive scoring systems.
Methods: The study cohort comprised 57 patients who underwent LVAD
therapy between January 2012 and May 2018 in our center. The mean
age of the patients was 39.9±18.3years, and 43 (81.1%) of them were
men. Thirty-eight patients (66.6%) were in the Interagency Registry for
Mechanically Assisted Circulatory Support (INTERMACS) profile I or II. The
study cohort was divided into the patients with RHF postoperatively (n =
20, 35.1%) and without RHF (n = 37, 64.9%).
Results: Independent predictors for RHF were preoperative RF-EF% <25%
[odds ratio (OR) 4.68, 95% confidence interval (CI) 1.41–15.5; P = 0.01],
RVSWI <400 mmHg ml-1 (OR 3.73, 95% CI 1.01–13.7; P = 0.04), RVOT-SE
<7 mm (OR 1.55, 95% CI 0.31–0.84; P = 0.002), RVOT FS<15% (OR 1.62,
95% CI 0.34–0.78; P = 0.02), right ventricular free wall longitudinal strain
<_19% (OR 3.13, 95% CI 1.01–2.43; P = 0.003), RV-FAC <27% (OR 3.71,
95% CI 1.15–11.9; P = 0.02) and prealbumin <14 mg/dl (OR 3.45, 95%
CI 1.07–11.03;P = 0.03). Modest diagnostic performance for RHF was
detected in 4 of 7 validated scoring systems with resulting area under the
curve values of 0.70 (95% CI 0.55–0.84; P = 0.001) for the Seattle Heart
Failure Model; 0.68 (95% CI 0.49–0.81, P = 0.03) for the Fitzpatrick’s; 0.68
(95% CI 0.53–0.83, P = 0.028) for APACHE II; and 0.66 (95% CI 0.50–0.82,
P = 0.04) for MELD scoring systems. However, we found best discrimi-
nation performance of the score with a resulting area under the curve
value of 0.94 (95% CI 0.55–0.89, P = 0.03) for right ventricular free wall
longitudinal strain >_-15.5% and 0.82 for RVSWI <400 mmHg ml-1 m-2 in
predicting RHF.

50
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ASAIO CARDIAC ABSTRACTS

36 37
Left Ventricular Assist Devices as Destination Therapy Outcomes of Non-Ischemic Patients in Cardiogenic Shock
A. Medressova1, Y. Pya2, S. Bekbossynov1, S. Andossova3, S. A. P. Do, C. Hughes, K. Curran, R. Solomon, C. Williams; Internal
Dzhetybayeva3, M. Bekbossynova2, K. Shaimerden4; 1Cardiac surgery Medicine, Henry Ford Hospital, Detroit, MI.
#2, National Research Center for Cardiac Surgery, Astana, KAZAKHSTAN,
2
National Research Center for Cardiac Surgery, Astana, KAZAKHSTAN, Study: Cardiogenic shock (CS) is a life-threatening condition that requires
3
Cardiology, National Research Center for Cardiac Surgery, Astana, temporary mechanical circulatory support (MCS). Data demonstrating
KAZAKHSTAN, 4VAD, National Research Center for Cardiac Surgery, Astana, improved outcomes with temporary MCS is lacking. We sought to identify
KAZAKHSTAN. clinical characteristics associated with poor outcomes amongst non-isch-
emic (NI) patients presenting in CS requiring temporary MCS.
Study: The purpose of this study was to analyse the results of implanta- Methods: A retrospective chart review of NI patients presenting in CS
tion of left ventricular assist devices (LVAD) as destination therapy (DT) in from June 2013 to July 2018 was conducted at a tertiary referral center.
end-stage heart failure patients. Student’s t-test for continuous and chi-square tests for categorical data
Methods: From 2011 to 2018, 293 VAD were implanted in 280 patients were used. Univariate analysis was included in the multivariate regression
with advanced heart failure in our Center. We analysed 207 patients with models to analyze outcomes.
HeartMate II, HeartWare HVAD, HeartMate 3 LVADs for DT and those who Results: 71.4% male, mean age of 57 ± 15, 47.9% Caucasians, 43.2%
received assist devices for bridge to transplantation (BTT) but in fact they African Americans. 55.2% hypertension (HTN), 16.7% prior dialysis. 8.9%
are in DT group because of the long waiting time for donor heart in our IABP, 12.5% Impella, 4.2% ECMO. 24.5% length of stay (LOS) (≥ 20 days),
country. All these patients were discharged from the hospital to home. 18.2% expired in hospital, 72.9% renal failure. Temporary MCS patients
60 patients live in Astana or were discharged to the city that is under 499 had higher risk of prolonged LOS (≥ 20 days). Age and IABP use were asso-
km from Astana, 21 patients - 500–999 km, 126 patients - more 1000 km ciated with death during hospitalization. Age, HTN and dialysis required
(more than 2000 km in some cases). Statistical analysis was performed during hospitalization were associated with renal failure. Table 1.
using IBM SPSS Statistics version 22.
Results: The most patients were males (n=188, 88%). Mean age was 49 ±
13 years. The average duration of VAD support was 787 ± 503 days, and
the maximum period is 2248 days. Kaplan-Meier survival estimates for
patients with LVADs as DT were 87.3%, 68.8%, 60.6%, 47.2% after 1, 2, 3,
4 years accordingly. After 4 years from the operation the survival rate of
patients who live under 499 km is 50.6%, 500–999 km - 65.7%, more 1000
km - 42.5%. Predictors of mortality were age of patients (p=0.049), LVAD
type (p=0.000), hemorrhagic stroke (p=0.000), pocket infection/medias-
tinitis (0.011). Body mass index has some impact on the mortality of the
patients (p=0.127). The distance from our Center to the city of residence
of patients did not have a statistically significant impact on the rate of
major adverse events. In conclusion, the results of LVAD as DT are satis-
factory and comparable with data from other reports. The major adverse
events and survival rates don’t depend on the distance of from the VAD
Center to the city of residence of patients. We hope that systematic train-
ing with patients, their relatives, regional VAD coordinators can improve
the results of VAD program.

51
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ASAIO CARDIAC ABSTRACTS

38 42
The Influence of Hemodynamics on Cerebral Perfusion and Clinical Experience With Pressure Sensor based Autoregulation of Blood
Thromboembolic Risk of LVAD Therapy Flow in an Artificial Heart
A. Straccia1, V. Chivukula1, M. Miramontes1, F. Chassagne1, J. A. I. Netuka1, Y. Pya2, C. Latrémouille3, J. Perlès4, B. Poitier5, P.
Beckman2, S. Li2, K. Koomalsingh3, C. Masri2, T. Dardas2, R. Cheng2, S. Jansen4; 1Cardiovascular Surgery, Institute for Clinical and Experimental
Lin2, E. Minami2, G. Wood2, S. Farris2, J. Kirkpatrick2, F. Sheehan2, C. Medicine, Prague 4, CZECH REPUBLIC, 2Cardiovascular Surgery, National
Mahr2, A. Aliseda1; 1Department of Mechanical Engineering, University Research Cardiac Surgery Center, Astana, KAZAKHSTAN, 3Cardiovascular
of Washington, Seattle, WA, 2Division of Cardiology, University of Surgery, European Hospital Georges Pompidou, Paris, FRANCE, 4Carmat
Washington, Seattle, WA, 3Division of Cardiothoracic Surgery, University of SA, Velizy, FRANCE, 5Biosurgical Research Laboratory, European Hospital
Washington, Seattle, WA. Georges Pompidou, Paris, FRANCE.
Study: In VAD patients, mean arterial pressure (MAP) has important impli- Study: The CARMAT Total Artificial Heart (TAH) is designed to provide a
cations on cerebral perfusion (CP). This work investigates the relation- therapy for patients with end-stage biventricular heart failure. This report
ship between MAP, patient anatomy of the vasculature from the aortic details the efficacy of the device Autoregulation mechanism, designed to
arch to the Circle of Willis, and thrombus properties on cerebral embolic mimic normal physiological responses to changing patient needs.
thrombus transfer. Methods: This TAH uses integrated pressure sensors to regulate the pump
Methods: Using 3D time-resolved computational fluid dynamics simula- output according to input pressures. Right and left ventricular outputs are
tions on patient-specific models, we investigate the hemodynamics in the automatically balanced. The operator sets target values and the inbuilt
aortic arch, great vessels and cerebral vasculature, including the Circle algorithm adjusts the beat rate, and hence output, automatically. The
of Willis. The transport of thrombi from the aortic arch into the brain is system collects data at 10-minute intervals. Hemodynamic data from 10
analyzed via Lagrangian particle tracking. Thrombi of different sizes and patients, representing 1319 days, was analyzed with respect to circadian
densities are released into the aortic root and tracked throughout their physiological needs. The Autoregulation Mode is activated shortly after
trajectories. With a very large distribution of thrombi properties and the implantation once initial hemodynamic stabilization is accomplished.
initial locations, we achieve a statistical description of the likelihood of Results: Ten patients (with a median support time of 142 days) exhibited
thrombi being transported towards the cerebral circulation. The influence a range of device-input pressures between 5 and 20 mmHg during their
of VAD flow, MAP, and patient anatomy on the probability of thrombus daily activities. This resulted in cardiac output responses of between 4.5
of different size, density and origin to lodge on a certain cerebrovascular to 7.2 l/min with beat rate changes of between 84 and 128 beats/min
territory is analyzed. (Fig. 1). Operator adjustments were required at only 20 occasions. Most
Results: Optimal cerebral perfusion strategies in VAD patients with of them occurred in ICU, while there was no need to adjust settings when
embolic stroke have not previously been defined. Cerebral blood flow the patients were at home (Fig. 2).
rates and patterns of thrombus transport are strongly influenced by This report demonstrates that the CARMAT TAH Autoregulation feature
vascular anatomy and physical properties of embolic material. Increasing effectively produces a physiological response to the changing daily patient
thrombus size and density favor embolic trajectories into the cerebral needs, and represents one of the unique characteristics of this device in
circulation, as opposed to the descending aorta. Thus, there exists a providing a physiological heart replacement therapy.
complex interplay between MAP, CP and cerebral embolization. This has
implications for optimizing CP in VAD patients to minimize stroke risk.

52
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ASAIO CARDIAC ABSTRACTS

43 48
A New Hemodynamic Index to Identify Different Profiles in Patients Implanting Durable MCS in Non-Compliant Patients: Do the Outcomes
Implanted with Last Generation Centrifugal Pump Outweigh the Risks?
A. Montalto, V. Piazza, M. Comisso, F. Nicolo, F. Musumeci; SAN CAMILLO H. Barone1, C. Runyan1, J. Hajj1, N. Huie1, M. Lindsay1, E. Passano1, M.
HOSPITAL - ROME, ROME, ITALY. Olman2, A. Fishman2, L. Olanisa2, J. A. Kobashigawa1, J. Moriguchi1, R.
Study: Introduction LVAD (Left Ventricle Assist Device) represents a valid Cole1, F. Esmailian1, J. Chung1, D. Ramzy1; 1Smidt Heart Institute at Cedars-
alternative to heart transplantation in patients who suffer from end Sinai, Los Angeles, CA, 2Cedars-Sinai Medical Center, Los Angeles, CA.
stage heart failure. The ventricular devices show a different performance Study: Patient non-compliance (NC) is known to be detrimental to the
related to preload, afterload and the fixed set revolutions per minute success of durable mechanical circulatory support (DMCS). However, the
(RPM). Our main intention was to introduce a new hemodynamic index definition or threshold to identify NC with DMCS has not been well estab-
that accounting for the RPM set, can easily identify different hemody- lished. For this study, we proposed NC as exhibiting one of the following:
namic profile occurring during LVAD support. Missed > 3 clinic appointments or 3 lab draws, documentation of not tak-
Methods: Methods From november 2015 to march 2018, 19 patients ing medications correctly or not following MD instructions > 3 occasions,
implanted with HM 3 underwent ramp tests during right heart cath- and active substance abuse (drug/alcohol).
eterization. Basal data were collected and Hemodynamic Index (HI) was Methods: Between 2007 and 2018, we reviewed 255 DMCS patients for
calculated according to the following formula: HI= PAM x (PCWP/ CVP) x NC while on support as defined above. The patients were divided into
(RPM set/RPM max) Compliant (n=219) vs Non-Compliant (n=36) and compared by overall
Results: Results Three main profile could be identified. Profile 1 HI less survival, number of unplanned readmissions, and adverse events (stroke,
than 60 and higher risk of right failure. Profile 2: HI between 65–90, gastrointestinal bleeding, pump thrombosis, infection requiring IV antibi-
requiring speed optimization, Profile 3 HI > 90 requiring afterload optimi- otics, severe respiratory and renal failure).
zation. A ROC curve analysis identified an HI value of 60 as highly predic- Results: Non-compliant patients compared to compliant patients had
tive of late right ventricular failure. similar survival but significantly more overall readmissions, readmissions
Conclusion: RPM should be set balancing an optimal unloading with per year and adverse events. (see table). NC as defined above in the
adequate afterload and preload and accounting for the right ventricular DMCS population does not impact overall survival, but does result in a
function. We proposed a new hemodynamic index that integrating differ- significant increase in readmissions and adverse events. DMCS patients
ent variables can stratify patients in three main profile according to which demonstrating these characteristics should receive more intense counsel-
the best treatment can be provided. ing and more frequent follow-up.

Compliant Non-Compliant
Endpoints (N=219) (N=36) P-value

Survival, % 91.7 80.8 0.115


Readmissions, mean ± SD 2.4 ± 2.9 5.7 ± 4.3 <.0001
Average Readmissions per 1.8 ± 1.9 4.0 ± 2.7 <.0001
Year, mean ± SD
Adverse Events, mean ± SD 4.1 ± 4.1 6.7 ± 4.5 0.001

53
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ASAIO CARDIAC ABSTRACTS

51 60
Hemodilution Enhances the Mechanical Fragility of Blood During In A Hybrid Experimental-Computational Modeling Framework for
Vitro Hemolysis Testing Cardiovascular Device Testing
C. R. Robinson1, I. L. Pieper2, V. Kanamarlapudi2, S. Ali3; 1Calon Cardio- E. O. Kung1, M. Farahmand2, A. Gupta2; 1Mechanical Engineering
Technology Ltd, Swansea University, Swansea, UNITED KINGDOM, & Bioengineering, Clemson University, Clemson, SC, 2Mechanical
2
Swansea University, Swansea, UNITED KINGDOM, 3Calon Cardio- Engineering, Clemson University, Clemson, SC.
Technology Ltd, Swansea, UNITED KINGDOM. Study: Significant advances in biomedical science often leverage power-
Study: The American Society for Testing and Materials (ASTM) standards ful computational and experimental modeling platforms. We present a
recommend using bovine blood for in vitro hemolysis testing of medical framework named “PSCOPE” that can capitalize on the strengths of both
devices. Hemodilution of the blood is used to standardize hematocrit types of platforms by combining them in a single hybrid model.
(HCT) to 30 ± 2% with phosphate buffered saline (PBS). Research has Methods: PSCOPE uses an iterative method to couple an in-vitro mock
shown that dilution of blood with PBS increases red blood cell mechanical circuit to a lumped-parameter numerical simulation of cardiovascular
fragility and significantly increases hemolysis. Thus, the purpose of this physiology, obtaining closed-loop feedback between the two. We first
study was to investigate the impact of multiple diluents and concentra- compared results of Fontan graft obstruction scenarios modeled using
tions during in vitro hemolysis testing, which may require future consider- both PSCOPE and an established multiscale computational fluid dynamics
ation for ASTM standards. method; next, we demonstrate an example application of PSCOPE to
Methods: Whole bovine blood was diluted with either PBS, PBS + 4 g% model a scenario beyond the current capabilities of multiscale compu-
BSA (bovine serum albumin) or FBS (fetal bovine serum) and pumped tational methods-- the implantation of a Jarvik 2000 blood pump for
with the CentriMag® (Thoratech Corp., USA) device under hemodynamic cavopulmonary support in the single-ventricle circulation.
conditions for 6 hours in vitro (n=3). Blood was diluted to a high (70%) or Results: Verification results show that the normalized root-mean-square
low (90%) dilution, or to a HCT of 30 ± 2%. Plasma free hemoglobin levels error values of important physiologic parameters were between 0.1% ~
were measured to calculate the normalized index of hemolysis (NIH). 2.1%, confirming the fidelity of the PSCOPE framework. The example clini-
Protein concentrations were measured pre- and post-dilution. cal application of PSCOPE revealed that the commercial Jarvik 2000 con-
Results: At a 70% dilution the CentriMag® caused significantly higher troller can be modified to produce a suitable rotor speed for augmenting
hemolysis with PBS than PBS + 4 g% BSA. However, blood diluted to 90% cardiac output by approximately 20% while maintaining blood pressures
with PBS + 4 g% increased hemolysis compared to PBS alone. When blood within safe ranges. In conclusion, PSCOPE is a unified hybrid modeling
was diluted to a 30 ± 2% HCT, PBS + 4 g% BSA and FBS both significantly framework that enables a testing environment which simultaneously
reduced NIH compared to PBS. Protein concentrations were significantly operates a medical device and performs computational simulations of the
reduced with PBS, however, dilution with PBS + 4 g% BSA or FBS main- resulting physiology, providing a tool for physically testing medical devices
tained protein levels. These results suggest that PBS introduces a bias with simulated physiologic feedback in a closed-loop.Figure. Computa-
by reducing oncotic pressure and enhancing the mechanical fragility of tional physiology simulation (circuit on right) fully-coupled to a physical
blood. Thus, the use of BSA may provide a true NIH reading. This study flow experiment (left) forms the PSCOPE hybrid model.
has further implications at clinical settings where hemodilution is carried
out with saline, which increases haemolysis and may worsen potential
clinical outcomes.

54
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ASAIO CARDIAC ABSTRACTS

63
Epicardial Pressure Analysis for Soft Robotic Direct Cardiac Compression
Sleeve
J. Han, D. R. Trumble; Biomedical Engineering, Carnegie Mellon
University, Pittsburgh, PA.
Study: While current ventricular assist devices continue to be problematic
due to thrombotic events associated with blood-contacting surfaces, we
propose a non-blood-contacting soft-robotic biventricular compression
sleeve that boosts cardiac output by applying epicardial pressure to both
left and right ventricles (LV and RV). The range and relationship between
the epicardial pressure (EP) and stroke volume (SV) and ejection fraction
(EF) in a passive biventricular model were studied.
Methods: A biventricular model with a prolate LV and crescent-shaped
RV with wall thicknesses of 1.6 cm and 0.9 cm, respectively, were drawn
on SolidWorks (Fig 1A). The end-diastolic volumes (before compression)
were set to 135 mL for LV and 150 mL for RV. Known hyperelastic material
properties of passive heart tissue and a variety of boundary conditions
were applied to the model prior to running static-structural finite element
analyses using ANSYS Workbench. The top surface of the model was
set as a fixed support to mimic the natural restricted movement of the
base of the heart. A range of EPs was uniformly applied to the epicardial
surface (Figs 1B-D) to examine the SV and EF of the model with zero after-
loads (AoP = 0 mmHg, PAP = 0 mmHg) and end-systolic afterloads (AoP =
100 mmHg, PAP = 30 mmHg).
Results: Applied pressure of 25 mmHg induced SVs of 28.9 mL and
101.9 mL (Fig 2A) and EFs of 21.3% and 67.7% (Fig 2B) for LV and RV,
respectively, at zero afterload. While an applied pressure of 60 mmHg
induced SV of 106.3 mL and EF of 70.6% for the RV at end-systolic
afterloads, the LV bulged outward instead of leading to increased cardiac
output due to its high initial afterload (Figs 2C-D). These results indicate
the need for separate cardiac compression pressures for the left and right
ventricles. The LV requires much higher EP to induce levels of cardiac
output similar to the RV due to its greater wall thickness and higher end-
systolic left ventricular pressure.

55
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ASAIO CARDIAC ABSTRACTS

66
Use of Intraoperative Extracorporeal Membrane Oxygenation (ECMO)
Bypass During Open-Thoracoabdominal Aortic Aneurysm Repair (TAAA)
M. S. Jorgensen1, H. Farres1, W. S. Sorrells1, Y. Erben1, A. K. Martin2, S. M.
Pham1, A. G. Hakaim1; 1Department of Surgery, Mayo Clinic, Jacksonville,
FL, 2Department of Anesthesia, Mayo Clinic, Jacksonville, FL.
Study: Ischemia is associated with open TAAA repairs due to aortic cross-
clamping and the quality of the clamped aorta. Therefore, the use of a
mechanical bypass support system is recommended. Here we present the
use of intraoperative venoarterial (VA) ECMO during an open TAAA repair.
Methods: The aneurysm was exposed and VA ECMO was initiated via
the left common femoral artery and vein. The patient received 12.5 g
mannitol and 40 mg Lasix prior to aortic clamping. The proximal aortic
graft anastomosis was created in the chest cavity in standard fashion
while maintaining perfusion to the viscera, kidneys, and lower extremities
through the ECMO machine. Visceral and renal anastomoses were cre-
ated in a sequential fashion without interruption of the ECMO circulation
(Fig1). The infrarenal aorta was clamped and ECMO discontinued. The
aneurysm sac was entered and the origin of the right renal artery was
anastomosed in an end-to-end fashion. An irrigating occluding catheter
was utilized to infuse renal preservation solution. The distal anastomo-
sis to the aortic bifurcation was created in an end-to-end fashion. Total
ECMO time was approximately 3 hours with an average flow of 5 liters
(L) per minute. The activated clotting time (ACT) was kept at 180 to 250
second (much lower than conventional cardiopulmonary bypass system)
throughout the case. The balance between both systems was accom-
plished using preload and pulsatility assessments while maintaining
end-tidal CO2>20.
Results: The patient was discharged on postoperative day 11 with normal
renal function throughout the hospital course. Postoperative CTA is
illustrated in Fig2 (A=pre-, B=postop). Compared with left atrium-femoral
artery shunt and conventional cardiopulmonary bypass, VA ECMO is
associated with less risk and provides a more stable hemodynamic report.
Therefore, the use of VA ECMO during open TAAA repair is safe and
should be considered as an alternative support system for this operation.

56
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ASAIO CARDIAC ABSTRACTS

67 85
Evaluation of Cytokine Expression in Regional Principal Organ During Efficacy of Therapeutic Modalities to Address Aortic Valve Insufficiency
Cardiopulmonary Bypass in the Setting of Left Ventricular Assist Device Support
Y. Fujii1, H. Hanawa2; 1Department of Clinical Engineering and Medical N. Sarsour1, P. C. Tang2, J. Haft3, A. Bitar4, M. Colvin4, T. Koeling4, K.
Technology, Niigata University of Health and Welfare, Niigata, JAPAN, Aaronson4, F. Pagani5; 1Cardiothoracic surgery, University of Michigan
2
Department of Health and Sports, Niigata University of Health and Medical School, Ann Arbor, MI, 2Cardiothoracic surgery, Michigan
Welfare, Niigata, JAPAN. Medicine, Ann Arbor, MI, 3University of Michigan Medical School, Ann
Study: Multiple organ failure, such as acute lung injury, acute kidney Arbor, MI, 4Cardiology, University of Michigan Medical School, Ann Arbor,
injury and inflammatory cardiac injury after cardiopulmonary bypass MI, 5Thoracic Surgery, University of Michigan Medical School, Ann Arbor,
(CPB) still is a major problem in patients undergoing cardiovascular MI.
surgery. Our current study showed that CPB lead to cytokine release and Study: Background: Aortic valve (AV) procedures are often performed
organ damage in the rat CPB model.This study aimed to investigate cyto- concurrent with or following LVAD implant to address AV insufficiency
kine expression of each organ during cardiopulmonary bypass. (AI). We investigated the outcomes of these various modalities.
Methods: The CPB system consisted of a membranous oxygenator Methods: Materials and Methods: Retrospective data was collected on
(polypropylene, 0.03 m2), tubing line (polyvinyl chloride, φ2.0 mm) and 56 patients from 2007 through 2018 who underwent an aortic valve pro-
roller pump. Priming volume of this system is only 8 ml. The left com- cedure in the presence of a durable LVAD or concomitant with a durable
mon carotid artery was cannulated with the arterial return cannula. The LVAD implantation. Paired Wilcoxon rank sum test was use to compare
venous uptake cannula was advanced through the right external jugular echocardiographic findings. Mantel-Cox statistics were used to analyze
vein into the right atrium. CPB flow was initiated and maintained at survival data
70 ml/kg/min. Male SD rats (450-500g) were divided into three groups: Results: Results: AV repair (“Park stitch”) was performed in 40 patients,
Control (n = 3), SHAM (received surgical preparation only without CPB) AV replacement with a bioprosthesis was performed in 6 patients,
group (n = 4) and CPB (120min) group (n = 3). Three heart, lung, kidney transcatheter aortic valve replacement (TAVR) was used in 8 patients and
and liver samples from a rat and examined gene expression of Monocyte 2 patients had a patch of the AV annulus (table). For AV repair, central
Chemotactic Protein (MCP)-1 and Interleukin (IL)-6 by real-time PCR. coaptation effectively improved AV competence to less than moderate AI
Results: Gene expression of MCP-1 and IL-6 in hearts and lungs of CPB at 2 months (P<0.001) and at the last available echocardiographic follow
group significantly increased compared with control and SHAM groups. up (P<0.001). Three patients (7.5%) had recurrence of at least moderate
Suspicions are raised about the effects of unphysiological blood flow AI. The AV replacement group had one patient with mild AI at last echo-
distribution during CPB. Expression of MCP-1 and IL-6 in heart and lung cardiographic follow up. For the TAVR group, there was one intraoperative
during CPB increased. mortality. The other 7 TAVR patients had no AI on last echocardiographic
follow up. At a median patient follow up of 16.0 (IQR=31.8) months
there was no difference in combined LVAD survival and survival to heart
transplant between patients who underwent AV repair, AV replacement,
and TAVR (P=0.324).

Follow Up Data

AV
AV procedures + LVAD AV repair replacement TAVR
(n =56) (n =40) (n=6) (n=8)

Median 3.0 3.3 (IQR=5.3) 2.3 (IQR=3.4)


echocardiographic (IQR=2.9)
follow up(months)
Moderate or greater 3 (7.5%) 0 (0%) 0 (0%)
AI on follow up
Combined Survival 85.0% 100% 75%
at 1 year

57
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ASAIO CARDIAC ABSTRACTS

87 88
Biliary Pathology and Cholecystectomy in Mechanical Circulatory Self Management of Anticoagulant Therapy in Continuous Flow Left
Support Patients Ventricular Assist Device Patients
A. Akhmerov1, D. Emerson2, D. Ramzy2, D. Megna2, Q. Chen3, M. Burch3, M. Akiyama, I. Yoshioka, K. Sasaki, Y. Suzuki, T. Suzuki, G. Takahashi, K.
R. Cole1, J. Moriguchi1, J. Chung2; 1Smidt Heart Institute, Cedars-Sinai Kumagai, Y. Saiki; Division of Cardiovascular Surgery, Tohoku University
Medical Center, Los Angeles, CA, 2Cardiac Surgery, Cedars-Sinai Medical Hospital, Sendai, JAPAN.
Center, Los Angeles, CA, 3Surgery, Cedars-Sinai Medical Center, Los Study: Anticoagulation control is critical in continuous flow left ventricular
Angeles, CA. assist device (CF-LVAD) patient due to increased incidences of throm-
Study: Biliary complications are common among pre-transplant patients boembolic and bleeding events. Patient self-management (PSM) of oral
temporized with mechanical circulatory support (MCS). Data on biliary anticoagulant therapy (OAT) is a concept empowering trained patients to
complications and cholecystectomy in this patient population has been monitor and adjust their treatment in home settings. However, there is
limited to single-case reports. Thus, there is a growing need for a more little information whether PSM of OAT improve anticoagulation control in
robust analysis of gallbladder pathology in MCS patients. CF-LVAD patient. The aim of this study was to evaluate the effectiveness
Methods: Our institutional MCS database was queried to identify patients of PSM of OAT in CF-LVAD patient.
who underwent cholecystectomy from 2011 to 2017. Baseline charac- Methods: Between June 2014 and October 2018, 31 CF-LVAD patients
teristics, cardiac pathology, gallbladder pathology, and outcomes were received care as outpatients after discharge. The therapeutic international
retrospectively analyzed. normalized ratio target range was dependent on each device (HeartMate
Results: Thirty two patients (54.1 ± 13.7 years old) with assist devices II, Jarvik 2000, EVAHEART, DuraHeart, and HVAD). All patients used the
underwent cholecystectomy. The majority of patients were white (43.8%), portable coagulometer CoaguChek equipped with CoaguChek PT-test
male (90.6%), and afflicted with ischemic (34.4%) and idiopathic (53.1%) strips.
cardiomyopathies. Predominant devices were total artificial heart Results: The total observation period of 31 CF-LVAD patients (mean age
(53.1%), HeartWare HVAD (21.9%), and HeartMate II (15.6%). Patients 44±14 years; 68% male) was 16,985 days (mean duration 530 days). Time
developed gallbladder disease at a median of 17.5 days following device in therapeutic range (TTR) was 81.0±8.8%, Time in below therapeutic
implantation. Acute and gangrenous cholecystitis comprised only 6.3% range (TBTR) was 7.3±5.6%, and Time in above therapeutic range (TATR)
and 12.5% of all cases, respectively, while chronic, and chronic with was 11.4±7.1%. During this period, 5 thromboembolic events (0.0035
focally acute cholecystitis comprised 40.6% and 31.3% of all cases. Pres- events/patient/year (4 pump thrombosis, and 1 hemolysis)) and 11 bleed-
ence of calculi, wall thickening, and positive HIDA imaging were noted ing events (0.0097 events/patient/year (11 gastrointestinal bleeding, 1
in 43.8%, 28.1%, and 71.4% of cases, respectively. Although white blood hemorrhagic stroke, 1 menorrhagia, and 1 epistaxis)) occurred. PSM of
cell counts increased significantly after device implantation (10.1 to OAT may potentially improve the standard of care for CF-LVAD patients.
13.1, p<0.05), cholecystectomy provided little improvement after 1 week
(12.1). Similarly, there were elevations in total bilirubin and transaminase
levels following device implantation, which did not improve appreciably
following cholecystectomy (p=ns, Figure 1). Thirty-day survival and 1-year
survival following cholecystectomy were 68.8% and 54.8%, respectively.

58
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ASAIO CARDIAC ABSTRACTS

94 99
Successful Cardiac and Renal Transplant in a Highly Sensitized Patient Development of an Extracorporeal Ventricular Assist Device with a
Bridged from Left Ventricular Assist Device Novel Centrifugal Pump with a Hydrodynamically Levitated Impeller
T. J. Trobiano, L. Dees, M. R. Oldsman, V. Ton; Cardiovascular Medicine, T. Tsukiya, T. Mizuno, Y. Takewa, E. Tatsumi; Artificial Organs, The
University of Maryland Medical Center, Baltimore, MD. National Cerebral and Cardiovascular Center, Suita, Osaka, JAPAN.
Study: Production of antibodies against human leukocyte antigen (HLA), a Study: Extracorporeal centrifugal blood pumps are increasingly used for
process called sensitization, is a well-known adverse consequence of left temporary ventricular assist device (VAD). We developed a novel centrifu-
ventricular assist device (LVAD) therapy. Highly sensitized patients have gal blood pump with a hydrodynamically levitated impeller to enhance
poor outcomes post heart transplant. Desensitization strategies are not endurance and antithrombogenicity in mechanical circulatory support
always effective and carry many risks. (MCS), and established an temporary VAD system including this pump,
Methods: We report a case of successful heart-kidney transplant in a patient inflow/outflow cannulas, and metallic tube connectors.
who developed high levels of anti-HLA antibodies post-LVAD implant. Methods: We performed chronic animal studies to demonstrate
Results: Outcome: A 59-year-old man with non-ischemic cardiomyopa- effectiveness and safety of the temporary VAD system. Chronic animal
thy received LVAD implant in 2015 for end-stage heart failure. Post-op experiments were conducted using nine male Holstein calves to evaluate
course was complicated by sternal dehiscence and renal failure. He later biocompatibility of the VAD system up to 30 days.
developed refractory right ventricular failure and waited inpatient for The experiment were performed in the following three phases;1) 30-day
heart-kidney transplant. His calculated panel reactive antibody (PRA) rose performance of LVAD system (N=3)2) 30-day performance of RVAD system
from 0% pre-LVAD to 67% at 6 months post-LVAD, with predominant class (N=3)3) performance in extended use as LVAD (up to 90 days) (N=3)
I anti-HLA antibodies. At the time of transplant in 2017, he received 3 In all the experiments the blood pump was fixed on the harness designed
rounds of intra-op plasmapheresis (PLEX) and high dose steroid, followed for the calves and kept in the cage. In the LVAD experiments, the inflow
by 3 more rounds of PLEX, anti-rabbit thymoglobulin (ATG, total 5mg/kg), cannula was inserted into the apex of the left ventricle and the outflow
and IVIG (total 0.5 mg/kg). He was maintained on traditional immunosup- graft (14 mm) was anastomosed to the descending aorta of the animal.
pressants and is doing well 2 years later without rejection. In the RVAD experiments, the inflow cannula was inserted into the right
Conclusion: Intra-op desensitization with PLEX, ATG and IVIG is a viable atrium and the outflow graft (7 mm) was anastomosed to the pulmonary
option for highly sensitized patients on LVAD support. Long-term out- artery. Anticoagulant and antiplatelet agents were administered orally
comes are needed regarding survival, graft function and rejection risks. to keep prothrombin time (PT) 3 to 4 times as long as the preoperative
values.
Results: The average flow rate (L/min) and motor speed (rpm) was 1)
97 4.1 & 3500, 2)4.3 & 3900, and 3)4.1 & 3400, respectively. All the animals
Successful Kidney Transplant on Veno-arterial Support After Heart were sacrificed after the scheduled periods except for one case in 3),
Transplant terminated at 55 POD due to inflow cannula occlusion by massive intimal
S. M. Pham1, P. Patel2, A. Pham1, K. Landolfo1, J. Burns2, D. Yip2, J. tissues. The blood contacting surfaces of thy pumps were all free of
Leoni-Moreno2, R. Goswami1, S. Jacob1, M. El-Sayed Ahmed1, I. Makey1, thrombus formation and signs of mechanical scratches. The results so far
M. Thomas1, R. Agnew1, B. Taner2; 1Cardiothoracic Surgery, Mayo were promising and we all hope this device will be approved to rescue the
Clinic Florida, Jacksonville, FL, 2Transplantation, Mayo Clinic Florida, patients requiring acute circulatory supports.
Jacksonville, FL.
Study: In combined heart-kidney transplant recipient there is a reluctance
from the transplant team to perform the kidney transplant when the
transplanted heart suffers primary graft dysfunction (PGD) that needs
mechanical support. We report two patients who received kidney trans-
plant while on VA ECMO support for PGD after heart transplant.
Methods: Patient # 1: A 55 year-old man with ischemic cardiomyopathy
and chronic kidney disease (CKD) who was on a Heartware left ventricular
assist device (LVAD) waiting for heart and kidney transplants. He under-
went a heart transplant but suffered PGD, requiring central V-A ECMO.
He received a kidney transplant from the same donor 24 hours later. He
was weaned off ECMO after 5 days of support. His immunosuppression
consisted of alemtuzumab induction and tacrolimus-based regimen. He
needed dialysis for 90 days. He was discharged on postoperative day
(POD) 95. Patient # 2: A 60 year-old man with non-ischemic cardiomyopa-
thy and CKD who was on the heart transplant waitlist and deteriorated,
requiring urgent insertion of an Impella LVAD. He was transitioned to
Heartware LVAD and CentriMag pump for right side support. His renal
function failed to recover therefore, he was listed for heart-kidney trans-
plant. Thirty-five days after biventricular support the patient had a heart
transplant but suffered PGD and needed central VA-ECMO. He received
a kidney from the same donor 24 hours later while on ECMO, which was
removed 6 days later. His transplanted kidney functioned well and did not
need dialysis postoperatively. He was discharged on POD 28.
Results: Both patient #1 and #2 are currently alive at 1.5 and 1 years after
transplant with good cardiac and renal function. At 1 year the LVEF = 63%
and 62%; creatinine = 1.61 and 2.05 mg/dl, respectively. No patient has
cardiac or kidney rejection.
Conclusion: Kidney transplantation on VA ECMO support after heart
transplant is safe. It allows the patient to receive a kidney from the same
donor with both immunological and survival advantage.

59
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ASAIO CARDIAC ABSTRACTS

100 108
Evaluation of tNIRS-1 Combined with Bis Monitor for Cardiac Surgery HVAD Parameters Risk Score
Patients V. Ramos, M. C. Brown, N. Voskoboynikov, D. Tamez; Medtronic, Miami
A. Sugiura1, K. Torii2, H. Tsutsumi2, T. Someya2, D. Yasuoka2, K. Nishikiori2, Lakes, FL.
D. Kitahara2, H. Tanaka2, H. Kakinuma2; 1Clinical Engineering, Showa Study: Visual representation of log files stored in the HVAD pioneer
University Northern Yokohama Hospital, Yokohama, JAPAN, 2Clinical controller are used by physicians to supplement a patient’s clinical
Engineer, Showa University Northern Yokohama Hospital, Yokohama, presentation. Experience from log file reviews suggest that deviations in
JAPAN. VAD parameters may be a leading indicator of adverse events, sometimes
Study: There are some reports that the combined use of BIS with NIRS days before controller alarms or representation of patient symptoms.
can be applied to detect of cerebral hypoxia. BIS and NIRS could be inde- HVAD Parameters Risk Score is a single upfront indicator to independent
pendently compared by the relative values, but there is little information algorithms that quantify deviations from patient’s baseline parameters
about the absolute values in the previous reports. Hemoglobin values and it may provide a helpful output to the log file report recipient with
could only be measured intermittently in the operation, but it was dif- additional warnings to the onset or presence of abnormal hemodynamics
ficult to evaluate cerebral oxygen saturation and hemoglobin concentra- or homeostasis.
tion continuously. In this study, we compared BIS with tNIRS-1 measured Methods: Two datasets were created: confirmed adverse event and
noninvasively and continuously the absolute values of cerebral oxygen control dataset. The event dataset was created by taking log files from
saturation(StO2). We also compared and analyzed between estimated the complaint database which indicated a clinical suspicion of said event,
hemoglobin concentration(estHb) measured by tNIRS-1 and the hemoglo- such as Thrombus, GI Bleeding. The intrinsic VAD parameters (pump
bin concentration(gasHb) measured by the blood gas analyzer. Moreover, power, estimated flow, current, speed) are used as inputs in threshold-
we also examined the relationship with the cerebral hypoxia by compar- based algorithms that may be indicative of homeostatic or hemodynamic
ing BIS and gasHb. changes/deviations, such as circadian rhythm, power and flow pulsatility
Methods: 10 adult patients who operated cardiac surgery were subject trackers. The VAD Parameters Risk Score is a cumulative weighted score,
to study excluding thoracic aorta surgery. The sensors of BIS and tNIRS-1 calculated considering the contribution of each input pump parameter’s
were placed on forehead and the values were monitored simultane- clinical relevance.
ously. In order to compare the variation of estHb with that of gasHb, we Results: Risk Score computation distinguished confirmed adverse events
sampled the blood during the periods of pre operation, every 30minutes, from the control dataset with 89% sensitivity and 2.02% False Positive
post operation, and we analyzed blood gas and compared the value of BIS PPY rate. Medtronic MCS has developed a HVAD Parameters Risk Score
with that of gasHb. that may provide the user with additional information utilizing analytics
Results: In comparison of BIS and StO2(r1), estHb and gasHb(r2), it was which could serve as a risk factor generator. These analytics may lead to
clearly showed the correlation of maximum r1=0.617, r2=0.946. In the earlier detection and prevention of major complications within our VAD
correlationship between BIS and gasHb(r3), there was a strong correla- population.
tion with maximum r3=0.969. There was a correlation between BIS and
StO2 continuously in cardiac surgery patients using tNIRS-1. In addition,
there was a strong correlation between estHb and gasHb, and a strong
correlation was also found between BIS and gasHb. As a result, it was
suggested that the combined use of BIS and tNIRS-1 was useful as an
index to evaluate the cerebral hypoxia, and it was possible to respond 109
quickly to cerebral hypoxia and decrease in hemoglobin concentration in Streamlining and Audio Analysis Device for Doctor Patient Encounters
the operation. S. P. Moore, B. M. Cassidy, S. A. Herbert, J. W. Winkelman, D. M. Spencer-
Bearham, M. J. Slepian; Biomedical Engineering, University of Arizona,
Tucson, AZ.
Study: Sounds associated with health and illness are vital for both health-
care diagnosis and therapy. This project focuses on developing a system
capable of processing and extracting additional features from sound and
speech associated with a healthcare encounter. Specifically, this project
captures a patient’s speech and breathing patterns, and extracts data
from them to provide new information that will ultimately assist in the
understanding and treatment of a variety of diseases which influence
breathing and speech patterns (such as some cardiac diseases).
Methods: The sound capture system uses high fidelity microphones
positioned around the room to record, store, analyze, and display sound
components of speech and other sound-generating aspects associated
with the physical examination, e.g. breath sounds. The system also
includes speech-to-text analysis to produce a written documentation of
the encounter. Additionally, the system incorporates Natural Language
Processing (NLP) for conversation analysis to organize useful information.
Results: The final product provides the user with valuable data which
may be incorporated into the electronic medical record system within the
context of a digital “Wired Room,”. The system is capable of capturing and
extracting otherwise missed sources of information during healthcare
encounters. Additionally, the product will use the speech-to-text conver-
sion and NLP to make a script of the encounter and also make a patient
data sheet write up containing data from the encounter (e.g. name, DOB,
pre-existing conditions, etc.). This system can improve efficiency medical
care, improve diagnoses, and reduce the time needed for a physician to
spend with each patient.

60
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ASAIO CARDIAC ABSTRACTS

111 117
Characteristics and Outcomes of Gastrointestinal Bleeding in Patients Ingested versus De Novo Thrombus Formation of HVADs
with Continuous-flow Left Ventricular Assist Devices: A Systematic S. L. Jessen1, C. N. Kaulfus1, K. Chorpenning2, A. Ginn-Hedman3, D. Tamez2,
Review B. R. Weeks1; 1Veterinary Pathobiology, Texas A&M University, College
L. A. Carlson1, J. Choi1, E. J. Maynes1, D. P. Horan1, A. K. Deb2, S. Station, TX, 2Medtronic, Miami Lakes, FL, 3Biomedical Engineering, Texas
Patel1, L. E. Samuels1, R. J. Morris1, J. W. Entwistle1, H. T. Massey1, V. A&M University, College Station, TX.
Tchantchaleishvili1; 1Division of Cardiac Surgery, Thomas Jefferson Study: Intra-device thrombotic material is a concern in the clinical man-
University, Philadelphia, PA, 2Philadelphia College of Osteopathic agement of Ventricular Assist Devices (VADs). While thrombi may form
Medicine, Philadelphia, PA. de novo within VADs, the alternative of material entering and lodging
Study: Gastrointestinal bleeding (GIB) is a common complication after within the device from “upstream” must be considered. While evaluat-
continuous-flow left ventricular assist device (CF-LVAD). We sought to ing explanted HVADs, our lab noticed histology patterns that led us to
evaluate patterns of GIB development and related outcomes in CF-LVAD theorize the observed thrombotic material may be ingested material from
patients. an upstream origin.
Methods: An electronic search was performed to identify all articles Methods: The location, size, and histology of thrombotic material were
related to GIB associated with CF-LVAD implantation, and a total of 34 analyzed in 59 HVADs and the presence of mechanical abrasion marks
studies consisting of 1,087 patients with GIB after CF-LVAD placement inside the pumps were noted. It was postulated that ingested material
were pooled for a systematic review. would exhibit histologic features suggestive of displacement from the site
Results: Mean patient age was 60 years (95%CI 57–64) and 24% (95%CI of origin and evidence of cellular infiltration from a vascularized tissue
21–28%) were female. History of GIB prior to CF-LVAD implantation was substrate. Alternatively, thrombi formed de novo within the HVAD would
present in 12% (95%CI 7–18%). The mean time from CF-LVAD implanta- be expected to exhibit orderly layering and less cellular infiltration.
tion to the first GIB was 54 days (95%CI 24–84), with 40% (95%CI 34–45%) Results: Of the 59 HVADs examined, no materials were classified as
of patients having multiple episodes of GIB. Anemia was present in 75% forming de novo within the device. All materials were classified as either
(95%CI 41–93%), and the most common bleeding source were arterio- possibly ingested, or histologically undeterminable (insufficient for histo-
venous malformations (36%, 95%CI 24–50%) (Table). The mean duration logical evaluation). Seven pumps contained presumed ingested material
of follow-up was 14.6 months (95%CI 6.9–22.3), during which the overall fully occluding the inflow and no internal abrasions. In five HVADs, the
mortality rate was 21% (95%CI 12–36%) and the mortality rate from GIB presumed ingested material was occluding the impeller flow channel/
was 4% (95%CI 2–9%). Overall thromboembolic events occurred in 32% centerpost with internal abrasions noted. Thirty-eight of the evaluated
(95%CI 22–44%) of the patients, with a specific stroke rate of 16% (95%CI HVADs exhibited much smaller presumed ingested materials on superior/
3–51%) and a pump thrombosis rate of 8% (95%CI 3–22%). Heart trans- inferior impeller surfaces with internal abrasions. Five HVADs exhibited
plantation was performed in 31% (95%CI 18–47%) of the patients, after presumed ingested material in the outflow tract or impeller but did not
which 0% (95%CI 0–10%) experienced recurrent GIB. exhibit internal abrasions. Four of the examined HVADs exhibited internal
Conclusion: Morbidity and mortality in patients with GIB is not directly abrasions, but the thrombotic materials were not usable for histological
related to the bleeding event and could be secondary to the associated evaluation. Overall, these results support our hypothesis that thrombotic
events such sequelae of thromboembolic complications. Heart transplant material found within the HVAD appears to arise from ingested material
in these patients appears to reliably resolve GIB. within the pump versus de novo thrombus formation within the device.

61
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ASAIO CARDIAC ABSTRACTS

118
Development of Malignancies and Their Outcomes in Patients
Supported on Continuous-flow Left Ventricular Assist Devices
E. J. Maynes1, J. S. Gordon1, M. P. Weber1, J. Choi1, T. Bauer1, G. R.
Reeves2, R. J. Morris1, L. E. Samuels1, J. W. Entwistle1, H. T. Massey1,
V. Tchantchaleishvili1; 1Division of Cardiac Surgery, Thomas Jefferson
University, Philadelphia, PA, 2Division of Cardiology, Thomas Jefferson
University, Philadelphia, PA.
Study: With increased use of continuous-flow left ventricular assist
devices (CF-LVAD) and improved survival of patients with advanced
heart failure, development of malignant tumors in this population is not
uncommon. There is, however, a significant data shortage in the litera-
ture. We sought to evaluate patterns of malignancies in CF-LVAD patients
and evaluate the outcomes of its treatment strategies.
Methods: After performing an electronic search, a total of 17 studies
consisting of 27 patients were identified who developed malignancies
after CF-LVAD placement. Patient-level data was extracted for systematic
review.
Results: Median patient age was 60 years (IQR 58 - 66) and 24 (89%)
were male. CF-LVAD was placed as bridge to transplant in 14 (60.9%)
patients. Malignancy types and frequency distribution is shown (table).
Median time from CF-LVAD implant to the diagnosis of malignancy was
6.4 months (IQR 2.9 - 87.4). Metastatic disease occurred in five patients
(18.5%) over the median time of 5.0 months (IQR 1.0 - 82.0) from the
diagnosis. Surgical resection of the malignancy was performed in 13
(48.1%) patients. Survival analysis from the diagnosis of the malignancy
is shown (figure) and was superior in surgical candidates. Three patients
were eventually relisted after successful surgical treatment, and two of
them were transplanted.
Conclusion: Surgical management of cancer in patients on CF-LVADs may
improve survival and transplant eligibility status; therefore, placement of
a CF-LVAD should not always preclude surgical treatment.

62
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ASAIO CARDIAC ABSTRACTS

125 126
Dual Antiplatelet Therapy is Not Associated with Increased Bleeding Pre-operative Serum Lactate Predicts Mortality in Patients Implanted
in Patients Implanted with Veno-arterial Extracorporeal Membrane with Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO)
Oxygenation N. Tashtish1, E. Zanath2, M. Karnib1, S. Al-Kindi1, S. Mitchel3, Y. Elgudin4, B.
E. Zanath1, N. Tashtish2, M. Karnib2, S. Al-Kindi2, S. Mitchel3, Y. Elgudin1, B. Medalion4, S. Deo5, B. Sareyyupoglu4, M. Zacharias1, G. Oliveira1, F. Lytle2,
Medalion4, S. Deo5, C. ElAmm2, F. Lytle1, B. Sareyyupoglu1; 1Department C. ElAmm1; 1Cardiovascular Medicine, University Hospitals Cleveland
of Anesthesia, University Hospitals Cleveland Medical Center, Cleveland, Medical Center, Cleveland, OH, 2Department of Anesthesia, University
OH, 2Cardiovascular Medicine, University Hospitals Cleveland Medical Hospitals Cleveland Medical Center, Cleveland, OH, 3Case Western Reserve
Center, Cleveland, OH, 3Case Western Reserve University, Cleveland, OH, University, Cleveland, OH, 4Cardiovascular Surgery, University Hospitals
4
Cardiovascular Surgery, University Hospitals Cleveland Medical Center, Cleveland Medical Center, Cleveland, OH, 5Cardiovascular Surgery,
Cleveland, OH, 5Cardiovascular Surgery, Cleveland VA Medical Center, Cleveland VA Medical Center, Cleveland, OH.
Cleveland, OH.
Study: Extracorporeal membrane oxygenation (ECMO) is increasingly
Study: Dual antiplatelet therapy (DAPT) is commonly used in patients used in the United States. There is a need to identify biomarkers to pre-
who undergo Veno-Arterial Extracorporeal Membrane Oxygenation (VA- dict ECMO outcomes.
ECMO), especially after myocardial infarction and percutaneous coronary Methods: We retrospectively reviewed consecutive patients who received
intervention. Whether DAPT increases the risk of bleeding during ECMO ECMO for either refractory cardiogenic shock or failure to wean from
support is unknown. cardiopulmonary bypass 2014–2018 at our hospital. We investigated the
Methods: We reviewed consecutive patients who received VA-ECMO for association between maximum pre-operative arterial lactate with short
either refractory cardiogenic shock (CS) or failure to wean from cardio- and long-term mortality.
pulmonary bypass between 2014 and 2018 at a single tertiary hospital. Results: A total of 105 patients were included: median age 59 [50–67]
Patients were divided into DAPT vs aspirin (ASA) vs no antiplatelet therapy years, 67% caucasian, 66% males, 46% resulted from failure to wean
(No-AP). All patients received parenteral anticoagulation during ECMO from bypass. Median pre ECMO Lactate level was 7.6 [4.3–13.4] mmol/L,
support. The primary endpoint was bleeding during VA-ECMO (vascular median SAVE score was -9 [-14 to -5]. Pre-ECMO lactate level correlated
access site, gastrointestinal, intrathoracic, intracranial) and blood transfu- with SAVE score (Spearman’s Rho=0.33, P<0.001). Median Lactate level
sion products. Chi-square test and ANOVA were used to compare bleed- decreased to 1.7 [1.2–3.5] mmol/L on day 1 post-ECMO. Pre ECMO-
ing outcomes between DAPT, ASA, No-AP groups. lactate level was higher in patients who died during index hospitaliza-
Results: Out of 105 patients who were included in the study, 25 (24%) tion versus patients who were discharged alive (10.5 ± 5.7 vs 6.5 ± 3.8
received DAPT, and 43 (41%) received aspirin only. A total of 62 (59%) mmol/L, P<0.001). Pre-ECMO lactate level was associated with inpatient
patients had bleeding complications. There was no difference in bleed- mortality (OR 1.15 per 1 mmol/L, 95% CI: 1.05–1.27), six-month (HR 1.08
ing complications between DAPT vs ASA vs No-AP (60% vs 61% vs 60%, per 1 mmol/L, 95% CI: 1.04–1.13) and one-year mortality (HR 1.08 per 1
P>0.99). With the exception of intracranial bleeding (8% vs 0 vs 0, mmol/L, 95% CI: 1.04–1.13), after adjusting for SAVE score. Pre ECMO-lac-
P=0.04), there was no difference in gastrointestinal (20% vs 7% vs 14%, tate level predicted inpatient mortality (AUC= 0.70 [0.60–0.80]) compared
P=0.28), access (28% vs 28% vs 13.5%, P=0.24), intrathoracic (4% vs 14% with SAVE score AUC 0.34 [0.23–0.45]. Lactate level of >4.4 mmol/L had
vs 24%, P=0.09). There was also no difference in the number of units 80% sensitivity, while >9.2 mmol/L had 80% specificity for prediction of
of blood products transfused: packed red blood cell (7.3 vs 7.5 vs 8.0, inpatient mortality. In conclusion, pre ECMO- arterial lactate level is a use-
P=0.53), platelets (4.4 vs 5.0 vs 4.6, P=0.32), fresh frozen plasma (2.0 vs ful marker to predict inpatient, six months and one-year mortality inde-
2.5 vs 2.4, P=0.17), or the percentage of patients who received mas- pendently of SAVE score. Lactate level of >9.2 mmol/L had 80% specificity
sive transfusion protocol (2.7% vs 7% vs 0, P=0.32). In this retrospective to predict inpatient death. Hence, the initiation of VA-ECMO in patients
study, DAPT is not associated with an increased risk of overall bleeding or with lactate levels >9.2 mmol/L should be considered carefully.
increased need for blood products. There was a signal of increased intra-
cranial hemorrhage with DAPT but the number of events was small.

63
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ASAIO CARDIAC ABSTRACTS

129 130
Impact of Intensive Blood Pressure Control in Patients with Centrifugal Comparison of Neurological Event Rates among HeartMate II,
Left Ventricular Assist Devices on Reducing Neurologic Events HeartMate 3, and HVAD
S. Li1, C. Ibeh2, C. J. Creutzfeldt2, J. Bjelkengren1, J. Herrington2, C. Masri1, S. Li1, C. Ibeh2, C. J. Creutzfeldt2, J. Bjelkengren1, J. Herrington2, C. Masri1,
E. Minami1, A. Stempien-Otero1, R. Cheng1, G. Wood1, T. Dardas1, S. Lin1, E. Minami1, A. Stempien-Otero1, R. Cheng1, G. Wood1, T. Dardas1, S. Lin1,
W. C. Levy1, K. Koomalsingh3, F. Chassagne4, A. Aliseda4, D. L. Tirschwell2, W. C. Levy1, K. J. Koomalsingh3, F. Chassagne4, A. Aliseda4, D. Tirschwell2,
C. Mahr1, J. A. Beckman1; 1Cardiology, University of Washington, Seattle, C. Mahr1, J. A. Beckman1; 1Cardiology, University of Washington, Seattle,
WA, 2Neurology, University of Washington, Seattle, WA, 3Cardiothoracic WA, 2Neurology, University of Washington, Seattle, WA, 3Cardiothoracic
Surgery, University of Washington, Seattle, WA, 4Mechanical Engineering, Surgery, University of Washington, Seattle, WA, 4Mechanical Engineering,
University of Washington, Seattle, WA. University of Washington, Seattle, WA.
Study: Stroke has become the leading cause of morbidity and mortality Study: Adverse neurological events remain a leading cause of morbidity
in continuous flow left ventricular assist device (LVAD) patients. Recent and mortality in patients with ventricular assist devices (VAD). Varying
evidence from the ENDURANCE Supplemental trial showed that a more definitions and reporting methods of these events make direct compari-
intensive blood pressure (BP) management protocol significantly reduced sons across clinical trials and registries challenging. We aimed to calculate
stroke risk. We aimed to estimate the impact of more intensive BP control standardized rates for strokes and other neurological events.
on mortality among centrifugal LVAD patients in the United States. Methods: We systematically identified key international clinical trials
Methods: The number of patients implanted with continuous flow LVADs and registries of HeartMate II, HeartMate 3, and HVAD devices from
in the last three years of available data (2014–2016) and the baseline PubMed. Reported neurological events were nonexclusively categorized
cumulative death rate caused by stroke were obtained from the INTER- into ischemic stroke, hemorrhagic stroke, disabling stroke, fatal stroke,
MACS registry. Reduction in stroke risk from intensive BP control was transient ischemic attack, and other neurological events per the studies’
extrapolated from data of the ENDURANCE Supplemental trial assuming a definitions. Event rates were standardized to event per patient-year when
linear relationship between stroke risk and mean arterial pressure (MAP). feasible and percentage of patients otherwise.
Results: On average, 2708 patients per year are implanted with a continu- Results: Six key clinical trials and registries were included in our analysis.
ous flow LVAD in the U.S. The cumulative risk of death from stroke from Various reporting methods were used for stroke event rates (event per
implantation to 72 months is 20%. The intensive BP control protocol in patient-year vs percentage of patients) and different types of neurologic
the ENDURANCE Supplemental trial compared to the original ENDUR- events were grouped and reported together with few reporting severity
ANCE trial lowered MAP by 6 mmHg (from 87.4 to 81.4 mmHg) on aver- of stroke (Table 1). There was no reduction in fatal and disabling strokes
age at 3, 6, and 12 months, and reduced overall risk of stroke by 24.2% between the Heartmate II and HeartMate 3. Overall, the three studied
and importantly hemorrhagic stroke by 50.5%. Methodically applying a VADs had similar neurological event rates (Table 1).
more intensive BP management strategy to control MAP in continuous
flow LVAD patients in the U.S. is estimated to prevent 162 deaths from
strokes per year. Assuming Doppler BP to be systolic BP rather than MAP
could undertreat MAP by 5 mmHg, which results in an excess of 109
additional deaths from stroke per year.

64
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ASAIO CARDIAC ABSTRACTS

136 141
Shear Stress-Induced Exosome Production: A Potential Biomarker of Mechanical Circulatory Support Hemodynamics for Biventricular Heart
VAD Complications? Failure Using Continuous Flow Total Artificial Heart
R. L. James1, C. R. Robinson1, S. Ali1, V. Kanamarlapudi2; 1Swansea J. H. Karimov1, D. J. Horvath2, T. Miyamoto1, Y. Kado1, N. Byram1, A. R.
University Medical School, Calon Cardio-Technology Ltd., Swansea, Polakowski1, J. Adams1, B. D. Kuban1, K. Fukamachi1; 1The Cleveland Clinic,
UNITED KINGDOM, 2Swansea University Medical School, Swansea, Cleveland, OH, 2R1 Engineering, Euclid, OH.
UNITED KINGDOM. Study: Biventricular assist device (BIVAD) implantation is the treatment
Study: Extracellular vesicles (EVs) are known to have roles in cellular of choice in patients with severe biventricular heart failure and cardio-
communication and implications in diseases. It is documented that blood genic shock. We previously developed a miniaturized continuous-flow,
derived EVs, specifically microparticles (MPs), increase following shear double-ended centrifugal pump intended for total artificial heart implant
stress. However, questions still arise regarding MP role, impact and bio- (CFTAH). The purpose of this initial in vivo study was to demonstrate that
genesis. Advancements in technology have shown that MPs are plasma the scaled-down CFTAH (P-CFTAH) can be appropriate for BIVAD support.
membrane derived. Additionally, there are smaller, cytoplasmic derived Methods: The P-CFTAH was implanted in 4 acute lambs (average weight,
vesicles, containing DNA, RNA and protein: Exosomes. As such, exosomes 41.5 ± 2.8 kg) through a median sternotomy. The cannulation was
should be considered when assessing effects of Ventricular Assist Device performed through the left and right atria and cannulae length adjust-
(VAD)-induced shear, to evaluate vesicle sub-sets and associated roles in ment was performed for atrial (A) and ventricular cannulation (V) (Fig1
VAD complications. A, B). The BIVAD system was tested at 3 pump speeds (3000, 4500 and
Methods: Whole human blood was subjected to VAD-like shear for 6 6000 rpm).
hours. Flow cytometry determined an EV population, markers were used Results: The BIVAD performance was maintained very well for both atrial
to identify leukocyte EVs, having eliminated cellular debris. Platelet-poor and ventricular cannulation within the 3000 - 6000 rpm range (Fig1 C,D).
plasma (PPP) was tested for vesicle size and quantity using Nanoparticle A stable hemodynamics were maintained after implantation. The device
Tracking Analysis. EV extraction was conducted on PPP, with the resulting self-regulating performance was demonstrated with the left (LAP) and
supernatant tested for remaining vesicle content. Exosome markers were right (RAP) pressure difference (LAP-RAP) falling predominantly within
used in immunoblotting to determined exosome presence. the range of - 5 to 10 mm Hg in left and right heart failure conditions.
Results: Immunoblot showed significant increases in exosome markers Left and right pump flows and total flow increased as the BIVAD speed
following shear stress, demonstrating that EV increase is not MP specific. was increased. This initial in vivo testing of BIVAD system demonstrated
EVs can be significantly depleted from PPP through modification of the adequate device performance and self-regulation for biventricular heart
differential centrifugation protocol for EV extraction, showing a method failure support over a wide range of conditions. The BIVAD system keeps
of EV isolation. Flow cytometry characterised EVs, displaying significant the atrial pressure difference within bounds and maintains acceptable
increases in monocyte and granulocyte EVs following shear stress. This cardiac output over a wide range of hemodynamic conditions. Figure.
study provides preliminary data that VAD-like shear induces significant Experimental set up (A) and intraoperative view (B). The BIVAD system
increases in human leukocyte EVs, namely exosomes. This, accompanied in vivo performance in comparison with in vitro BIVAD system validation
with understandings of known implications of EVs in inflammation, infec- data used for comparison (C, D).
tion and disease, suggests that exosomes may be associated with adverse
events in clinical settings. The effect of which should be further examined
to elucidate any role of exosomes as biomarkers of disease.

65
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ASAIO CARDIAC ABSTRACTS

145 147
Feasibility of Ambulating a Patient with End Stage Heart Failure Hemocompatibility Adverse Event Results From the NuPulseCV iVAS
Awaiting Heart Transplant on a Femoral Intra-Aortic Balloon Pump Feasibility Study
M. Gushurst1, C. Morreale2, S. Hussain2, G. Macaluso3, S. Pauwaa3, P. D. Severyn1, J. Woolley1, G. Giridharan1, S. Patel-Ramen1, J. Grinstein2,
Pappas4, A. Tatooles4, A. Andrade3, W. Cotts3; 1Physical Therapy, Advocate V. Jeevanandam3; 1NuPulseCV, Inc, Raleigh, NC, 2MedStar Washington
Christ Medical Center, Oak Lawn, IL, 2Internal Medicine, UIC/Advocate Hospital Center, Washington DC, DC, 3University of Chicago Medical
Christ Medical Center, Oak Lawn, IL, 3Cardiology, Advocate Christ Medical Center, Chicago, IL.
Center, Oak Lawn, IL, 4Cardiovascular and Thoracic Surgery, Advocate Study: Despite recent technological advances, mechanical circulatory
Christ Medical Center, Oak Lawn, IL. support (MCS) devices still have a high risk of hemocompatibility adverse
Study: Decreased gait speed has been shown to correlate with death and events (AE) (bleeding, thromboembolism, and pump thrombosis),
decreased quality of life in patients with advanced heart failure and heart resulting in increased mortality rates and treatment costs. Consequently,
transplantation. To date, no published literature describes this outcome MCS devices are often reserved only for advanced heart failure patients.
measure in patients ambulating with femoral intra-aortic balloon pump NuPulseCV is developing a long-term, portable, minimally invasive
(IABP). We review the feasibility of ambulation on femoral IABP and sub- Intravascular Assist System (iVAS) that is designed to have a low AE risk
sequent effects on gait speed using high intensity interval training (HIIT). to treat heart failure patients. We report the hemocompatibility AE for
Methods: A 24 year old male with familial hypertrophic cardiomyopathy the iVAS which has been implanted in NYHA Class III and IV heart failure
with beta myosin genetic defect presented to our center in acute cardio- patients as part of an ongoing FDA-approved all comers Feasibility Trial.
genic shock after a witnessed cardiac arrest. He was hemodynamically Methods: Hemocompatibility AE from the clinical trial were collected
optimized with inotropes and an IABP, and listed status 1A for primary and analyzed for all patients implanted with the iVAS (n=48, 88% male,
heart transplant. With use of a standing bed, the patient progressed to age=59.8+/-7.5 years). Review and adjudication by an independent medi-
ambulate after 21 days with an indwelling femoral IABP. Patient’s initial cal monitor of site-reported AE were categorized as device-related and
gait speed was 0.23 m/sec. He underwent 44 physical therapy sessions procedure-related. All AE adjudicated as serious and possibly or probably
over 114 days, using a combination of gait training, lower extremity device-related were analyzed. AE specific to hemocompatibility were
strengthening, and HIIT. The patient improved his comfortable gait speed identified and grouped into bleeding, thromboembolism, device throm-
to 1.21 m/sec and to 1.67 m/sec during interval training prior to heart bosis and stroke categories.
transplant. The patient had the femoral IABP in place for 135 days. Dur- Results: Mean support duration was 9.5 weeks (range: 0.3–51.4 weeks).
ing IABP support, there were no bleeding or thrombotic events, or IABP 89.6% (n=43) met the primary endpoint of survival to transplant or
malfunction. The patient remained well supported hemodynamically and stroke-free survival at 30 days. There were 2 bleeding events (0.23
has done well post-heart transplant. Upon discharge from the hospital, 37 events/patient year; 1 surgical, 1 anemia), 2 thromboembolic events
days after heart transplant, the patient’s gait speed increased to 1.40 m/ (0.23 events/patient year; limb ischemia, both resolved with medical
sec. The average gait speed of a healthy 24 year old male is 1.39 m/sec. intervention), 3 strokes (0.34 events/patient year; 2 transient ischemic
(Image 1) attack events that resolved without intervention and no sequelae, and 1
Results: This case demonstrates the feasibility of ambulation on a femoral hemorrhagic stroke resulting in death), and no gastrointestinal/peripheral
IABP and the use of gait speed as an appropriate outcome measure. Fur- bleeding events. These results demonstrate the low hemocompatibility
ther investigations with a larger sample size are needed to demonstrate AE rate of the iVAS. An FDA pivotal trial will be undertaken to further
safety and efficacy of ambulation on a femoral IABP in patients awaiting validate the safety of the iVAS.
heart transplant.

66
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ASAIO CARDIAC ABSTRACTS

151
Antiplatelet Therapy Monitoring for Durable Mechanical Circulatory
Support Utilizing TEG-Platelet Mapping
H. Mazur, A. Hadi, B. Stanton; Allegheny General Hospital, Pittsburgh, PA.
Study: Left ventricular assist device (LVAD) use is often complicated by
both thrombotic and bleeding events. Thromboelastography platelet
mapping (TEG-PM) provides an individual assessment of the arachadonic
acid (AA) and adenosine diphosphate (ADP) pathways of platelet activity
as well as an assessment of pharmacologic inhibition of platelet function.
This study evaluated the safety and effectiveness of a new protocol devel-
oped to titrate antiplatelet medications proactively based on TEG-PM
results in order to reduce incidence of thrombotic and bleeding (major,
non-major or minor) outcomes.
Methods: This observational, cohort study was completed both retro-
spectively and prospectively. Patients were matched and compared to
historical data based on type of LVAD implanted (HeartMate 3 [HM3]
versus HeartWare [HVAD]) in addition to pathway (destination therapy
[DT] versus bridge-to-transplant [BTT]) and etiology of cardiomyopathy
(ischemic [ICM] versus non-ischemic [NICM]). The platelet titration
protocol was implemented on August 1, 2018. Data collection is on-going;
the prospective cohort includes patients implanted post-protocol. Primary
objective is a composite of bleeding and thrombotic events at 90 days.
Results: Preliminary 30 day results include a total of 22 patients (TEG-PM
[n=11], control [n=11]). Of those included, 18 patients received a HM3
and 4 received an HVAD. A total of four bleeding events occurred: two
in each group. The TEG-PM had one non-major and one minor bleeding
episode of epistaxis that easily resolved without medication adjustments.
The control group had two major bleeding events: a subdural hematoma
with continued expansion resulting in discontinuation of aspirin therapy
and lowering of INR goal and another patient with gastrointestinal bleed
that resolved spontaneously without intervention. Long term data, includ-
ing 90 day results, is required to continue to assess safety and effective-
ness of newly implemented protocol.

67
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ASAIO CARDIAC ABSTRACTS

156
In Vivo Evaluation of the CH Biomedical Left Ventricular Assist System in
Bovine Model for 60 Days
Y. Wang1, P. A. Smith1, K. Handy1, J. Conger1, K. Dasse2, F. Lin3, C. Chen4, O.
H. Frazier1, L. C. Sampaio1; 1Texas Heart Institute, Houston, TX, 2Inspired
Therapeutics LLC., Merritt island, FL, 3CH Biomedical (USA), Inc., Torrance,
CA, 4CH Biomedical, Inc., Suzhou, CHINA.
Study: Left ventricular assist devices (LVADs) are increasingly used for
treating heart failure (HF) patients as an alternative to heart transplanta-
tion or destination therapy. The CH-VAD, developed by CH Biomedical
Inc, is a fully magnetically levitated (maglev) centrifugal LVAD to be used
to treat end stage HF patients. The CH-VAD pump is implanted in chest
cavity with inflow cannula inserted into the apex of left ventricle and the
outflow graft anastomosed to aorta. It is designed to accommodate a
smaller body size than other maglev LVADs and its maglev system offers
a larger suspension gap than the hydrodynamic suspension to enhance
hemocompatibility. The pump, controller, connections and peripherals
were assessed in the study.
Methods: The CH-VAD was implanted in two calves, and the hemody-
namic and hemocompatibility characteristics were evaluated over a
60-day period. The pump performance, hemodynamic characteristics,
controller function and blood work results were recorded throughout the
study. Complete necropsies were performed and tissue specimens from
major end-organs were fixed and embedded into paraffin wax blocks
for microscopic histopathology. The propensity for thrombus formation,
bleeding and infection was monitored.
Results: The study confirmed the CH-VAD is well tolerated in animals for
up to 60 days after implant, with no evidence of significant thrombus
formation or thromboembolic lesions in distal end organs. The pump
components, including the inflow cannula and outflow graft, were well
positioned and found to elicit a normal healing response without signifi-
cant complications or deleterious sequela. The plasma free hemoglobin
levels demonstrated minimal hemolysis. Normal fibrous pannus on the
textured surface of the inflow cannula afforded a smooth endocardial
transition onto the cannula without overgrowth or obstruction of the
inflow ostium. No thrombus was observed in the pump and the overall
performance of the system found to meet the design criteria.

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ASAIO CARDIAC ABSTRACTS

157 160
Generating Different Heart Failure Conditions on the Bench to Predict Multi-Scale, Multi-Resolution Simulation of Thrombosis in the HVAD
VAD Performance M. Zhussupbekov1, G. W. Burgreen2, W. Wu3, J. F. Antaki1; 1Biomedical
G. A. D’Souza1, J. E. Rinaldi1, S. M. Retta1, S. Shin2, J. Hahn2, L. H. Engineering, Cornell University, Ithaca, NY, 2CAVS, Mississippi State
Herbertson1; 1Center for Devices and Radiological Health, U.S. Food University, Starkville, MS, 3Department of Aerospace Science and
and Drug Administration, Silver Spring, MD, 2Department of Mechanical Technology, Nanjing University of Science and Technology, Nanjing,
Engineering, University of Maryland, College Park, MD. CHINA.
Study: Ventricular assist devices (VADs) are often used to provide short- Study: The HVAD is one of the most frequently implanted assist devices,
and long-term therapy for heart failure (HF) patients. Cardiac indices yet it has an increased stroke rate compared to the HeartMate II.
derived from intra-cardiac pressure, volume, and flow are used to moni- Thrombus is commonly observed within the thin blood-lubricated bearing
tor device performance and patient outcomes post-implant. Different HF regions of the HVAD. Unfortunately, the utility of CFD to investigate this
conditions among patients lead to a large variability in the cardiac indices. phenomenon is impeded by the need to adequately resolve blood flow
This presents challenges in predicting a priori the complex patient-VAD in these critical regions. This wide disparity of length scales in the HVAD
interaction during clinical use. Accounting for different HF conditions in precludes a high-resolution thrombosis simulation.
the early-stage development of VADs can reduce the risk of in vivo device Methods: Our novel approach to this multi-scale challenge is to segre-
failure and mitigate adverse events. Here, we pre-clinically evaluate gate the blood-lubricated bearing regions from the main flow path and
different HF conditions using a mock circulatory loop (MCL) to develop simulate the biophysics of thrombosis inside isolated high-resolution
comprehensive and standardized in vitro performance tests for VADs that computational subdomains. For each subdomain, blood velocity and pres-
cannot be conducted in vivo. sure boundary conditions are interpolated from a coarse-resolution CFD
Methods: Based on observations from past clinical studies and on prior simulation of the entire pump. Our multi-constituent numerical model of
experience with VAD testing, critical cardiac indices along with their range platelet deposition and thrombus growth is applied to reproduce patterns
of values are proposed for evaluating VAD performance. Different HF con- of thrombosis observed clinically in explanted devices.
ditions have been simulated using an MCL comprised of atrioventricular Results: The figure illustrates a segregated multi-scale simulation of the
chambers, heart valves, compliance chambers, resistances, pressure-flow HVAD with coarse-resolution (0.5M cell mesh) pressure contours (A),
sensors, and a data acquisition system. exploded CAD view of isolated upper and lower bearing regions (B), and
Results: The critical cardiac indices were determined to be: heart rate high-resolution (2M cell mesh) shear stresses in an upper blood bearing
(HR), cardiac output (CO), left ventricular systolic pressure (LVPs), left region (C). The advantage is reduced computational demands without
ventricular diastolic pressure (LVPd), left ventricular end diastolic volume loss of simulation fidelity in small-scale “hot spots”, enabling practical,
(LVEDV), left ventricular end systolic volume (LVESV), aortic systolic pres- systematic investigation of thresholds or combinations of shear stress,
sure (AoPs), aortic diastolic pressure (AoPd), and mean left atrial pressure initial platelet activation, agonists, and antagonists for initiation and
(LAP). The cardiac index ranges obtained from literature, along with unstable thrombus growth. Ongoing work is applying this technique to
representative cardiac pressure waveforms for different HF conditions study the influence of the pump operating conditions and pro-thrombotic
obtained using the MCL, are shown in Figure 1. VAD performance tests, states of blood on the severity of thrombosis in the HVAD.
conducted pre-clinically under different HF conditions, help to inform
standard methods, such as those in ISO 14708-5, allowing device manu-
facturers to develop safer and more effective VADs.

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ASAIO CARDIAC ABSTRACTS

163 169
Device Differences in LVAD Pump Thrombosis: A Systematic Review Does a Tighter International Normalized Ratio (INR) Target Range
G. Raitz, J. Maning, G. Macedo, V. Blume, S. Chaparro; Advanced Heart Decrease Adverse Events (AEs) in Left Ventricular Assist Device (LVAD)
Failure, University of Miami, Miami, FL. Patients?
Study: Guidelines recommend use of ventricular assist device (VAD) in E. L. Stauder, R. Alharethi, J. Nelson, A. G. Kfoury, K. Graham, W. T. Caine,
patients with advanced heart failure with reduced ejection fraction and B. B. Reid, V. Hebl, K. Afshar, B. Rasmusson, M. McCulloch, H. Smith, K.
refractory symptoms despite optimal pharmacologic treatment. Patients Stroth; Mechanical Circulatory Support, Intermountain Medical Center,
in use of a long-term mechanical circulatory support are in risk of devel- Murray, UT.
oping pump thrombosis in second (HeartMate II) and third generation Study: Tight INR control in LVAD patients is critical to decrease post-
(HeartMate 3 and HeartWare) devices. The purpose of this study is con- implant complications. In February 2018, the Intermountain Artificial
duct a systematic review and meta-analysis of device differences in pump Heart Program narrowed its standard INR goal range from 2.5–3.5 to
thrombosis in adults with advanced heart failure. 2.5–3.0 in the hopes of reducing AEs such as bleeding, pump thrombus,
Methods: We searched PubMed, Embase, and the Cochrane Database of and neurological events. This study evaluated the effect of the tightened
Systematic Reviews for English-language RCT or non randomized clinical INR range on the amount of AEs encountered by our patients.
studies published until January, 2019, that evaluated pump thrombosis Methods: The Artificial Heart Program’s database at Intermountain
in different types of VADs. Two investigators individually screened each Medical Center was queried for continuous-flow LVAD patients implanted
abstract and full-text article for inclusion; abstracted data; and rated qual- between January 2013 and December 2018. Patients were stratified
ity, and strength of evidence. into two groups: those with an INR goal of 2.5–3.5 (Group 1) and those
Results: Of a total 183 studies, we included 2 fair-quality non random- with an INR goal of 2.5–3.0 (Group 2). Patients were allowed to overlap
ized clinical trial that compared pump thrombosis in HeartMate II vs. between the cohorts if they were on support during both periods. AEs
HeartWare in a total of 789 patients. In one of the studies, the rate of were collected for each patient and normalized to account for total
pump thrombosis patient-year in the HeartMate II was 0.1 versus 0.2 in days on support. Time in therapeutic range (TTR) was calculated by the
the HeartWare (p=0.09). In the other study, the rate of pump thrombosis Rosendaal linear interpolation method, and unpaired t-tests were used to
in HeartMate II was 5% versus 28.6% in the HeartWare (p=0.043). We also determine significance.
included a good-quality randomized clinical trial with two publications Results: A total of 56 patients met the study criteria; 45 in Group 1 and 23
that compared HeartMate II vs. HeartMate 3 in a total of 366 patients. in Group 2, with 12 patients overlapping. Of the AEs, the percentages of
The second analysis was within 2 years of follow up showed the rate bleeding, pump thrombus, and neurological events between the cohorts
of pump thrombosis in the HeartMate 3 was 1.1%, versus 15.7% in the were as follows: 74.5% vs. 90.0%, 8.5% vs. 5.0%, and 17.0% vs. 5.0%. The
HeartMate II with a hazard ratio of 0.06 (CI 95%,0.01–0.26, p<.0001). average number of AEs per patient days was not significantly different
Conclusions: Discrepancies between studies that evaluate pump throm- between the groups (0.0076 vs. 0.0072, p=0.93). Measured parameters
bosis in HeartMate II, 3 and Heartware reinforce the idea that we need are summarized below.
more clinical trials assessing the correlation of different types of VADs and While tight INR control is imperative in LVAD patients, narrowing the goal
pump thrombosis. It could impact the decision-making plans about health from 2.5–3.5 to 2.5–3.0 did not decrease the amount of AEs. However,
care cost of implant a second or third generation device. increased efforts to improve TTR could prove to lower complications to
the point of significance.

164
Management Strategies of Invasive Mechanical Unloading in High Risk
Redo-open Heart Surgeries with Heart Failure
S. Lashin, M. Abdullah, A. Sabry, H. Hasn, M. Adia, M. Abdltawab, A.
Shawky; Cardiothoracic Surgery, Air Force Specialized Hospital, New
Cairo, EGYPT.
Study: Our experience of Egyptian Army Forces for the surgical redo-
complexity and invasiveness limits the application of mechanical
circulatory support to heart failure patients. Minimizing the invasiveness
of surgical strategies and surgical risk will expand the applicability of
mechanical circulatory support to earlier stage heart failure patients. Our
study reports end organ recovery and survival of patients on Veno-Arte-
rial (VA) ECMO with management protocols at our institution.
Methods: All four challenging patients were diagnosed with dilated car-
diomyopathy and worsening heart failure with liver and renal dysfunction,
Symptoms with NYHA Class IV and need for Redo-open heart surgery. They
had been sustained with pharmacological support and/or IABP for 7–14 days
prior to surgery. Through beating minimally invasive with / without hybrid
technique was done with Induction of total Cardio-Pulmonary Bypass (CPB)
using angioplastic catheter Balloon. Veno-Arterial (VA) ECMO was connected
and replaced Cardio-Pulmonary Bypass (CPB). Monitoring the patients with
Swan Ganz catheter and Heparin-bridged anti-coagulation scheme.
Results: The health condition of the patients improved significantly with
the support of Veno-Arterial (VA) ECMO. Within 3–8 days after implanta-
tion and continued on pharmacological support for 10 -13 days, all four
patients’ activities increased substantially and their NYHA classification
was recovered to I or II. One of the patients was developed chest infec-
tion and GIT bleeding with 2nd degree esophageal varices recovered with
medical treatment after diagnosed of upper GI endoscopy. They showed
no mechanical failure, no thrombosis, no stroke and no hemolysis.

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ASAIO CARDIAC ABSTRACTS

170 Methods: We retrospectively reviewed all patients with prior mechanical


A Retrospective Look at Mechanical Heart Valves in Left Ventricular mitral and/or aortic valves undergoing LVAD implantation at our center
Assist Device Patients between 2012 and 2017. Echocardiograms were read by a single cardiolo-
T. Al Saadi, K. Chickerillo, A. Andrade, T. Aicher, L. Kukla, N. Graney, S. gist to assess for mechanical valve dysfunction (thrombosis, stenosis,
Pauwaa, G. Macaluso, A. Joshi, C. Sciamanna, A. Tatooles, P. Pappas, W. pannus formation, valve dehiscence, or regurgitation).
Cotts; Advocate Christ Medical Center, Oak Lawn, IL. Results: Fifteen patients were identified. The implanted LVAD was
Study: Mechanical heart valves left in situ at the time of left ventricular HeartMate II in 13 patients and HeartWare HVAD in two patients. Median
assist device (LVAD) implantation are thought to potentially increase survival time was 58.8 months after LVAD implantation with a 1-year sur-
the risk of thromboembolic events. Current consensus is to replace vival rate of 93%. Complications and outcomes are summarized in Table
dysfunctional mechanical mitral valves and any mechanical aortic 1. At our center there was a low rate of complications in patients with
valves at the time of LVAD implantation. Due to potential increases in mechanical valves undergoing LVAD implantation that was comparable to
cardiopulmonary bypass time and associated comorbidities, our prac- those in the general LVAD population. We conclude that leaving a func-
tice has been to leave normally functioning mechanical valves in place tional mechanical valve in place at the time of LVAD implantation could be
at the time of LVAD implantation. We intend to examine outcomes in a reasonable alternative to valve replacement. More data are required to
these patients. further guide patient care in these individuals.

Table 1. Complications and outcomes among mechanical valve patients supported with LVADs.

Mechanical
Mechanical Mechanical Mitral and
Mitral Valve Aortic Valve Aortic Valve All
Complications (N) (N=8) (N=6) (N=1) (N=15)

Compli­cations (N) Major bleeding requiring transfusion 1 3 1 5


Major bleeding requiring re-operation 0 3 1 4
Hemorrhagic stroke 2 0 0 2
Transient ischemic attack/ischemic stroke 0 2 0 2
LVAD thrombosis/malfunction 2 2 0 4
Mechanical valve complications 1 1 0 2
Outcomes (N) Orthotopic heart transplant 1 0 1 2
LVAD exchange 2 1 0 3
Death 2 3 0 5

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ASAIO CARDIAC ABSTRACTS

171 172
Safety of Early Anticoagulation After Stroke in LVAD Patients Surgical Unroofing of an Anomalous Left Coronary Artery on VA-ECMO
C. Ibeh1, D. Tirschwell1, J. Herrington1, J. Bjelkengren2, S. C. Masri2, E. M. A. Khan1, F. M. Kazi1, D. Mehta2, S. Adhikari1, S. Hussain1, A. Andrade2,
Minami2, A. Stempien-Otero2, R. Cheng2, T. Dardas2, S. Lin2, W. Levy2, K. W. Cotts2, S. Pauwaa2, A. Joshi2, G. Macaluso2, C. Sciamanna2, P. S.
Koomalsingh3, F. Chassagne4, K. Venkat4, A. Aliseda4, J. A. Beckman2, C. Pappas3, A. J. Tatooles3; 1Internal Medicine, Advocate Christ Medical
Mahr2, C. J. Creutzfeldt1; 1Neurology, University of Washington, Seattle, Center, Oak Lawn, IL, 2Advanced Heart Failure & Transplant Cardiology,
WA, 2Cardiology, University of Washington, Seattle, WA, 3Cardiothoracic Advocate Christ Medical Center, Oak Lawn, IL, 3Cardiovascular Surgery,
Surgery, University of Washington, Seattle, WA, 4Mechanical Engineering, Advocate Christ Medical Center, Oak Lawn, IL.
University of Washington, Seattle, WA.
Study: Anomalous origin of the left coronary artery (AOLCA) from the
Study: Despite overall improvement in major adverse events with the opposite sinus of Valsalva is associated with myocardial infarction,
latest generation of left ventricular assist devices (LVADs), the incidence arrhythmias, syncope and sudden cardiac death (SCD). We present the
of neurologic complications remains excessively high. The timing of second reported case of successful surgical unroofing of AOLCA with com-
anticoagulation (AC) resumption after an ischemic stroke is controversial plete recovery in an adolescent who presented in cardiogenic shock and
and data limited. We aim to explore practices of anticoagulation manage- required veno-arterial extracorporeal membrane oxygenation (VA-ECMO)
ment following acute ischemic stroke in LVAD patients to identify optimal for hemodynamic support.
strategies. Methods: A 14 year old male presented after a syncopal episode while
Methods: We performed a comprehensive analysis of our institutional playing basketball. He reported symptoms of chest pain, palpitations and
LVAD database between 11/2012 and 5/2018. Patients were categorized dyspnea on exertion for the past several months. He was found to be in
into 3 groups based on the timing of AC post-stroke: (A) AC immediately cardiogenic shock with EKG showing ST depressions in lateral leads and
resumed, (B) AC held for 1–4 days, (C) AC held > 4 days. Primary outcome multiple premature ventricular contractions. Initial troponin was 0.13 ng/
events included recurrent ischemic stroke or TIA, device thrombosis, sys- ml, which peaked at 87.00 ng/ml. Transthoracic echocardiogram revealed
temic thrombosis, and intracranial bleeding or other major bleeding at 90 severe left ventricular (LV) systolic dysfunction and a possible AOLCA
days. Descriptive and nonparametric survival analyses were performed. arising from the right coronary sinus. Due to worsening cardiogenic shock
Results: Of the 38 patients identified as having an ischemic stroke, 22 and ventricular tachycardia, he was placed on peripheral VA-ECMO. CT
experienced a total of 37 primary outcome events including 5 recurrent coronary angiogram confirmed the AOLCA with a short proximal intramu-
ischemic strokes/TIAs, 3 device thromboses, 15 systemic embolic events, ral course prior to bifurcation of the left descending and left circumflex
9 intracranial and 5 systemic hemorrhages. Fifteen deaths occurred arteries (Fig 1). Cardiac catheterization demonstrated significant LV
within 90 days. Early AC resumption did not appear to reduce the rate dysfunction and lateral wall dyskinesia. Patient underwent successful
of recurrent ischemic events but was associated with the lowest rate of unroofing of the LCA along with ECMO decannulation. Subsequent serial
subsequent intracranial bleeding. Kaplan-Meier survival free of a primary echocardiograms revealed improvement in LV systolic function. He was
outcome was 65%, 56% and 50% at 7, 14 and 30 days post ischemic started on guideline directed medical therapy and had an uncomplicated
stroke, respectively. There was no association between survival and tim- postoperative course with complete clinical recovery.
ing of AC, age > 60, sex, or LVAD placement before vs after 2014. Overall, Results: Patients with an AOLCA are at an increased risk of myocardial
we found a high rate of early outcome events after ischemic stroke in ischemia and SCD. Therefore, a high clinical suspicion is warranted to
LVAD patients, but without excess risk with early AC resumption. Our detect and treat these anomalies. Our patient was diagnosed with AOLCA
results suggest that AC may not need to be held acutely to prevent subse- in setting of ischemia and cardiogenic shock. A fatal outcome was avoided
quent intracranial bleeding, systemic bleeding, or unfavorable outcomes with prompt detection, mechanical circulatory support via ECMO and
at 90 days. Further research is needed to identify best practices to reduce surgical correction with complete recovery.
these secondary complications.

72
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ASAIO CARDIAC ABSTRACTS

173 175
Characterization of Compliance Chamber Performance for Pre-Clinical Menorrhagia and Menstrual Bleeding in Patients Supported with
VAD Testing Ventricular Assist Devices
B. E. Richardson1, G. A. D’Souza2, L. H. Herbertson2; 1Centreville High C. Heith1, K. McHugh2, A. Phimister3, M. Clipp4, M. Steiner5, R.
School, Clifton, VA, 2U.S. Food & Drug Administration, Silver Spring, MD. Ameduri2; 1Cardiology, Boston Children’s Hospital, Boston, MA,
Study: Accurately reproducing complex in vivo conditions on the bench
2
Cardiology, University of Minnesota, Minneapolis, MN, 3Pediatrics,
for testing ventricular assist devices (VADs) can be very challenging. The University of Minnesota, Minneapolis, MN, 4Pediatric Cardiac Critical
compliance chamber is a key component of benchtop test systems, in Care, University of Minnesota, Minneapolis, MN, 5Pediatric Critical Care,
which ventricular-vascular compliance is simulated to produce physi- University of Minnesota, Minneapolis, MN.
ologic pressure-flow waveforms. The ability of a compliance chamber Study: Anti-coagulation and complications thereof continue to be a major
to produce a range of physiologic and pathophysiologic conditions is clinical challenge and source of morbidity and mortality in patients on
dependent on certain variables, which are identified here to characterize supported with ventricular assist devices (VADs). Menstruation further
the performance of different types of compliance chambers. complicates the anti-coagulation balance. This retrospective single-center
Methods: A literature review (years: 1999–2017) of compliance chambers study investigates the incidence, risk factors, management and outcomes
used in mock circulatory loops was first conducted. Based on the review, of patients with menstrual bleeding and menorrhagia in patients sup-
the following key variables were identified: operational mechanism, ported with VADs.
material, fluid volume, compliance type, input/output monitoring, feed- Methods: This was a single-center, retrospective chart review of female
back loop, active/passive control, chamber volume, type of working fluid, patients supported with VADs between the age of 11–50 between
fluid viscosity, size of tubing, achievable pressure waveforms, achiev- 1995–2018 at the University of Minnesota.
able flow rate range, and clinical validation. These variables were then Results: Menstrual bleeding occurred in 84% of eligible patients (27/32).
adjusted across their operating ranges to characterize and compare the Of those, 41% (11 patients) experienced menorrhagia. Menorrhagia
performance and robustness of different existing compliance chambers to was not associated with periods of supratherapeutic anticoagulation
inform the medical device community. or increases of or initiation of a new anticoagulant. Oral contraceptives
Results: Applying the above-mentioned variables, we were able to quali- did not prevent or effectively treat menorrhagia, however, hormonal
tatively compare the functionality of current compliance chambers. These intrauterine devices were often successful at controlling menorrhagia.
results may be beneficial for developing new mock circulatory loops for Thrombotic complications were not associated with starting contracep-
the pre-clinical testing of VADs. Compliance chambers with enhanced tion. Most episodes of menorrhagia required multiple interventions
designs and added functionality, such as those shown in Figure 1, will including transfusion, dilation and curettage and >50% of patients
enable robust and standardized pre-clinical VAD testing under variable required hospitalization to control bleeding. Menorrhagia is a significant
physiologic conditions when properly incorporated into mock circulatory and unrecognized source of morbidity for many females supported with
loops. VADs and could be preventable with the use of prophylactic IUDs. More
clinical attention and research is needed to determine the incidence and
optimal management of menorrhagia in patients with VADs.

73
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ASAIO CARDIAC ABSTRACTS

177 180
Shorter Duration of Pulsatility During Left Ventricular Assist Device Inflow Cannula Depth of Insertion Influences LVAD Thrombogenic Risk
(LVAD) Therapy is Associated with Vasoplegia at the Time of Heart V. Chivukula1, J. Beckman2, S. Li2, K. Koomalsingh3, C. Masri2, T. Dardas2,
Transplantation R. Cheng2, S. Lin2, E. Minami2, G. Wood2, S. Farris2, J. Kirkpatrick2, F.
M. Aras, N. Dikinov, C. Partida, L. Levin, M. Kassemos, V. Selby, T. De Sheehan2, C. Mahr2; 1Mechanical Engineering, University of Washington,
Marco, G. Wieselthaler, L. Klein; Cardiology, University of California, San Seattle, WA, 2Cardiology, University of Washington, Seattle, WA,
Francisco, San Francisco, CA. 3
Cardiothoracic Surgery, University of Washington, Seattle, WA.
Study: Vasoplegia (VP), arterial hypotension and low systemic vascular Study: This work investigates the influence of LVAD inflow cannula inser-
resistance with preserved cardiac output, can occur in the immediate tion depth on intraventricular hemodynamics and thrombogenicity.
post transplant period. The presence of continuous flow (CF) LVAD prior Methods: Intraventricular hemodynamics are investigated using 3D
to transplant has been identified as an independent predictor of post unsteady computational fluid dynamics simulation of an apical LVAD
transplant VP. We hypothesize that shorter duration of pulsatility over configuration. Two depths of insertion for the LVAD inflow cannula are
the course of LVAD therapy increases the risk of VP at the time of heart analyzed: a conventional depth of 27 mm and a reduced depth of 12 mm.
transplant. Physiologically realistic mitral valve inflow is applied as a boundary condi-
Methods: We performed a retrospective review of LVAD patients with tion to the model. Hemodynamics are simulated over 15 cardiac cycles to
home blood pressure (BP) monitoring data, who subsequently underwent compare the influence of the two insertion depths. Lagrangian tracking
heart transplant surgery at our institution from 2015–2018. Ambulatory of hundreds of thousands of platelets inside the LV provides biomechan-
BP data for each patient over the duration of LVAD therapy was obtained ics markers for platelet activation and aggregation. Platelet Shear Stress
and analyzed. Pulsatility was defined as a pulse pressure greater than History (SH) and Residence Times (RT), as well as endocardial Wall Shear
20mmHg during a single recording. VP after transplant was defined as Stress are combined into thrombogenic risk.
need for IV vasopressors for greater than 24 hours to maintain mean arte- Results: For patients with small LV dimensions, an inflow cannula depth
rial pressure > 70 mmHg despite normal cardiac function. of 27 mm into the LV is associated with higher platelet SH compared to an
Results: A total of 34 LVAD patients (mean age 55years, 76% men, 58% inflow cannula inserted to 12 mm. This is consistent with markedly
non-white, 97% centrifugal pump, average LVAD duration 437days) were abnormal intraventricular hemodynamics, characterized with recircula-
identified. VP was identified in 8 (24%) patients; of these, 6 had moderate tion regions in the apical pocket formed between the cannula outer wall
to severe VP. LVAD patients who developed VP following heart transplant and the apical myocardium. Comparatively, a more shallow 12 mm
had shorter duration of pulsatility when compared to those patients insertion depth achieved lower residence times in the LV and reduced
who did not develop VP (19% vs. 34%; p = 0.004). Similarly, patients who thrombogenicity. Increases in both SH and RT associated with the 27 mm
developed moderate to severe vasoplegia were pulsatile 20% of the time insertion show there is a clear impact of inflow cannula depth on platelet
(vs 34% in non-VP; p = 0.013). Average systolic BP (92mmHg in VP and activation, potentially leading to an increased risk of stroke in patients.
non-VP), diastolic BP (74mmHg in VP and 73mmHg in non-VP), and pulse Decreasing the depth of inflow cannula insertion, particularly in patients
pressure (18mmHg in VP and 19mmHg in non-VP) did not differ. Mean with small LV size, should be considered to improve outcomes in LVAD
post-transplant hospital length of stay (16 days in VP vs 19 days in non-VP, therapy through optimized surgical configuration of future devices.
p= 0.46) and 1 year patient survival (88% in VP vs 87% in non-VP) was
similar. Thus, patients who are mostly non-pulsatile over the duration of
LVAD therapy may be at risk of vasoplegia following heart transplant.

Figure 1: (a) Representative platelet trajectories indicating heterogeneous


shear stress exposure (b) Statistical analysis indicating a significantly
higher thrombogenic risk of platelets for the 27 mm insertion depth

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ASAIO CARDIAC ABSTRACTS

185 186
Ultrasound Strain Imaging of LVAD-Supported Ex vivo Beating Hearts ECLS Studies in a Mock Circulatory System
L. Fixsen, N. Petterson, F. van de Vosse, R. Lopata, M. Rutten; Biomedical M. Rutten1, K. Peeters1, J. Sels2, R. Lorusso2, F. van de Vosse1; 1TU
Engineering, Eindhoven University of Technology, Eindhoven, Eindhoven, Eindhoven, NETHERLANDS, 2MUMC, Maastricht,
NETHERLANDS. NETHERLANDS.
Study: A non-invasive method is needed for the assessment of the Study: Veno-arterial extracorporeal life support (ECLS) is an important
remaining cardiac function in continuous-flow left ventricular assist device therapy in cardiogenic shock. Tuning ECLS is tedious, because of the large
(LVAD) patients. Current non-invasive measurements, such as estimation number of patient-specific monitoring data involved. Models can give
of end-diastolic and end-systolic volumes, determined using ultrasound a physiology-based interpretation of this complex information. For this
(US), only make use of static imagery. US strain imaging (also known as purpose, we evaluated the effects ECLS in a mock circulatory system.
speckle-tracking) could enable the assessment of the dynamic behavior Methods: The system comprises the human circulation, and venous and
of the LV. In this study, 2-D US strain imaging was used to investigate arterial cannulae can be inserted, thus mimicking ECLS with a real support
changes in heart mechanics in LVAD-supported hearts, with an isolated device. Besides the Frank-Starling mechanism, models for blood volume
beating porcine heart platform. control, heart rate, etc. have been implemented.
Methods: Four ex vivo porcine hearts were implanted with MicroMed The model mimicked patients in cardiogenic shock, having a cardiac
Debakey (n=2) and Thoratec HeartMate II (n=2) LVADs. The hearts were output (CO) of 1–3 L/min, supported with a Maquet Cardiohelp, and a
connected to a mock circulatory loop (Figure 1A), re-perfused with Maquet IABP. Support levels were set to 0–4 L/min, with or without IABP
oxygenated blood and resuscitated (PhysioHeart, LifeTec Group). US support, in central and peripheral cannulations. PV-loops were mea-
and hemodynamic (pressure and flow) data were acquired as the hearts sured, the effects on coronary flow were assessed, as well as aortic valve
degraded from baseline condition, determined using cardiac output. The opening.
LV wall was segmented within the short-axis images and regional radial Results: Left ventricular (LV) stroke volume decreased with higher ECLS
and circumferential strains were estimated over each heart cycle. For flow levels, end diastolic volume increased. Mean arterial pressure (MAP)
each ‘heart condition’, the unloaded 0 krpm geometry was used as an returned to acceptable physiological levels, even in the cases with low CO.
initial geometry for each subsequent pump speed. In all cases, coronory flow rises with rising support levels. The effects of
Results: Good reproducibility was found in estimated regional radial and IABP support are lowered LV pressure, higher MAP and pulsatility. Also,
circumferential strain over multiple heart cycles (mean intra-class correc- LV stroke volume increases, at a lower end diastolic LV volume. In central
tion coefficient of 0.851). Median change in LV pressure and circumfer- cannulation vs. peripheral, the aortic valve closes at a lower support rate.
ential between 0 and 10.5 krpm was -21.6 mmHg and -7.24% in the first The model allows the testing of various cannulation methods and sup-
condition, in the final condition this was -33.4 mmHg and -19.2% (Figure port regimes in a wide range of patient features, with the actual clinical
1B). A change in LV contraction was observed through spatio-temporal devices attached to the model patient. Results indicate moderate differ-
plots of time-to-peak circumferential, as the pump speed was increased ences in hemodynamic parameters in peripheral vs. central cannulation
and the hearts degraded. These results demonstrate a novel method and important differences between ECLS with or without IABP support.
toward determining the effect of LVAD unloading on the remaining func-
tion of the failing heart.

75
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ASAIO CARDIAC ABSTRACTS

188 191
Flow Field Visualization in the Assisted Isolated Heart During Predictors of Poor Outcome in Acute Cardiogenic Shock Supported By
Mechanical Circulatory Support Percutaneous Ventricular Assist Device (Impella)
P. Aigner1, M. Schweiger2, K. Fraser3, F. Lemme4, N. Cesarovic5, H. T. Nakajima, Y. Tanaka, I. Fisher, K. Kotkar, R. Damiano, M. Moon, M.
Schima1, M. Huebler2, M. Granegger6; 1Medical University of Vienna, Masood, A. Itoh; Washington University in St. Louis, Saint Louis, MO.
Ludwig Boltzmann Cluster for Cardiovascular Research, Vienna, AUSTRIA, Study: For severe cardiogenic shock (CS), percutaneous ventricular assist
2
Pediatric Cardiovascular Surgery, Pediatric Heart Center, Department device (PVAD) is the fastest way to reestablish collapsed systemic circula-
of Surgery, University Children’s Hospital Zurich, Zurich, SWITZERLAND, tion. Patients with CS had poor prognosis as many articles mentioned. In
3
Department of Mechanical Engineering, University of Bath, UK, Bath, this study, we investigated what factors were correlated with the PVAD
UNITED KINGDOM, 4Pediatric Cardiovascular Surgery, Pediatric Heart patients outcomes.
Center, Department of Surgery, University Children’s Hospital Zurich, Methods: In this retrospective study, 252 patients were enrolled from
Vienna, SWITZERLAND, 5Division of Surgical Research, Department of 2/2010 to 4/2018. 149 patients underwent PVAD support for cardiogenic
Surgery, University Hospital Zurich, University of Zurich, Switzerland, shock. 103 patients were excluded because of prophylactic use for elec-
Zurich, SWITZERLAND, 6Pediatric Cardiovascular Surgery, Pediatric Heart tive PCI. Baseline characteristics, hemodynamic data, vasoactive-inotropic
Center, Department of Surgery, University Children’s Hospital Zurich; score(weight-based dose of norepinephrine ×100, vasopressin ×10,000,
Laboratory for Biofluidmechanics, Institute for Imaging Science and epinephrine ×100, milrinone ×10 and dobutamine ×1), laboratory data,
Computational Modeling in Cardiovascular Medicine, Charité Berlin, and outcomes were collected at the following timepoints: immediately
Berlin, GERMANY. preceding support initiation, 48 hours, and 30 days.
Study: Intraventricular flow patterns during mechanical circulatory Results: After 48 hours PVAD support, pulmonary artery systolic and
support (MCS) cannot be accessed by clinical imaging and therefore diastolic pressure, pulmonary artery mean pressure, and central venous
either computational or in-vitro models are used. However, the complex pressure were significantly improved (TABLE). The primary end point,
anatomy of the heart cannot be replicated and simulations inherently rely 48 hours survival was 89% and 30 days survival was 39%. Patients were
on assumptions and simplifications. In an isolated porcine heart setup significantly older in dead group (alive vs. dead, 51 vs 60, p <0.01).
the feasibility of flow measurements by Echocardiographic Particle Image Moreover, before PVAD support serum creatine (alive vs. dead, 1.9 vs 2.4,
Velocimetry (E-PIV) was evaluated. p =0.04), after 24hr support VIS (15vs 24, p <0.01) and after 48hr support
Methods: Similar to cardiac transplantation porcine hearts (n=8, animal VIS (15vs 29, p p=0.04) were significantly higher in dead group. High age
weight: 80–106 kg) were excised and connected to the isolated heart was an independent predictor of in-hospital mortality (Hazard ratio 1.05,
setup. After resuscitation using blood as perfusate, a rotary blood pump 95% confidence interval: 1.02–1.08, P<0.01) in multivariate analysis. In
was implanted Microbubbles were injected via the left atrium at differ- conclusion, high age patients with renal dysfunction were more likely to
ent support situations and echocardiographic 3-chamber-view B-mode be dead if PVAD support didn’t reduce inotropic support 48 hours later.
images were recorded with the highest possible frame rate of up to 141
Hz (Philips iE33, X5-1 xMatrix probe). By iterative PIV algorithms using
correlation domain averaging and beam sweep correction, flow fields
were evaluated for the different hemodynamic situations.
Results: All hearts were successfully resuscitated in the isolated heart
setup and different hemodynamic situations were adjusted. In the
unsupported heart physiologic flow patterns with a large clockwise vortex
structure that warrants washout of the whole cardiac chamber were
found. With increasing MCS (2200–2700 rpm) the formation of this flow
feature is diminished caused by the additional flow sink at the apex. In full
support without aortic valve opening in the left ventricular outflow tract a
stagnant structure was identified, that might be connected to thrombo-
embolic events. For the first time, the contribution of the mitral valve
apparatus to blood flow patterns especially in the LVOT, which may be
linked to energy loss, thrombus formation and valve deterioration during
MCS was investigated under realistic conditions.

76
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ASAIO CARDIAC ABSTRACTS

193 197
Medication Regimens and Adherence in VAD Patients Mild Aortic Insufficiency at the Time of Left Ventricular Assist Device
S. Zhou1, A. Damato2, P. Ting1, K. Seetharam3, A. Lala2; 1Icahn School of Implantation: Should It Be Repaired?
Medicine at Mount Sinai, New York, NY, 2Cardiovascular Institute, Icahn Y. Tanaka, A. Itoh, T. Nakajima, I. Fischer, M. R. Moon, R. J. Damiano, Jr,
School of Medicine at Mount Sinai, New York, NY, 3Mount Sinai Hospital, M. F. Masood; Division of Cardiothoracic Surgery, Department of Surgery,
New York, NY. Washington University School of Medicine, St. Louis, MO.
Study: Good blood pressure control after LVAD implantation is essential Study: The effect of concomitant aortic valve central suture (AVCS, “Park
to avoid complications. However, there is currently no standard approach stitch”) for patients with mild aortic valve insufficiency (AI) at the time
to optimal medication regimen and no single metric to measure medica- of left ventricular assist device (LVAD) implantation has not been well
tion adherence. We aimed to identify the medications prescribed at investigated.
our institution, determine adherence levels to these medications, and Methods: We reviewed 694 consecutive patients who underwent
validate a tool to assess adherence in VAD patients. continuous-flow LVAD implantation between 1/2006 and 3/2018. Patients
Methods: 41 LVAD patients from the Advanced Heart Failure Clinic were with pre-LVAD AI ≥ moderate, pre-LVAD AI ≤ trace and previous aortic
recruited and administered the Self-Efficacy for Appropriate Medica- valve procedure were excluded. 121 patients with mild AI identified by
tion Use Scale (SEAMS) survey. Medications and mean arterial pressures transthoracic echocardiogram before LVAD implantation were divided
(MAPs) were recorded that visit. The last three fill dates for each medica- into two groups: 27 patients with concomitant AVCS (AVCS group) and 94
tion were obtained from the pharmacy to calculate the continuous single- patients without any aortic valve intervention (no-AVCS group).
interval availability (CSA, supply obtained at fill divided by the number of Results: Follow-up period in both groups was 1.7 ± 1.2 years. There
days before the next refill). A CSA>0.8 was considered adherent. was no significant difference in 30 day mortality between the AVCS and
Results: Beta blockers were most commonly prescribed (63.4%), followed no-AVCS groups (14.8 vs. 10.6 %, p = 0.80). Overall the AVCS group had
by diuretics (58.5%) and ACE inhibitors (46.3%). Nitrates (7.3%) and significantly lower rates of AI ≥ moderate (18.5 vs. 41.5 %, p = 0.029),
hydralazine (2.4%) were rarely prescribed. Of the commonly prescribed mitral regurgitation ≥ moderate (14.8 vs. 42.6 %, p = 0.016) and also
medications, ACE inhibitors (84.2%), calcium channel blockers (77.8%), lower brain natriuretic peptide value (455 ± 405 vs. 834 ± 921 pg/ml, p =
and ARBs (75.0%) had the highest adherence, while aldosterone 0.046) compared to the no-AVCS group. Kaplan-Meier analysis indicated
antagonists (61.5%) had the lowest. Beta blockers, the most commonly that the AVCS group had a higher rate of freedom from AI ≥ moderate
prescribed medications, had an adherence of 61.5%. A higher SEAMS (p = 0.033). Readmission rates caused by heart failure were lower in the
score correlated with a lower MAP (p=0.02). However, SEAMS scores did AVCS group than the no-AVCS group (11.1 vs. 35.1 %, p = 0.033). There
not correlate with any individual medication’s adherence at a statistically was no significant difference in survival between the AVCS group and
significant level (p>0.5 for all). This data suggests that there is great vari- the no-AVCS group (p = 0.55), but post-LVAD NYHA functional class was
ability in antihypertensive medications and adherence in VAD patients, significantly different (1.4 ± 0.8 vs. 2.1 ± 0.9, p < 0.001). In summary,
and that the SEAMS survey may provide valuable clinical information. concomitant AVCS for mild AI at the time of LVAD contributes to the pre-
vention of post-LVAD AI progression and also improvement of post-LVAD
functional status. Surgeons are encouraged to consider placing AVCS for
mild AI during LVAD surgery.

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ASAIO CARDIAC ABSTRACTS

199 200
Simulated Performance of the Cleveland Clinic Continuous-Flow Total High-Speed Visualization of Ingested and Ejected Red Thrombus from
Artificial Heart Using the Virtual Mock Loop: Comparison with an In Vivo the HeartMate II Left Ventricular Assist Device
Study G. W. Rowlands1, F. D. Pagani2, J. F. Antaki1; 1Meinig School of Biomedical
T. Miyamoto1, D. J. Horvath2, D. W. Horvath2, J. H. Karimov1, J. Adams1, N. Engineering, Cornell University, Ithaca, NY, 2Michigan Medicine, University
Byram1, B. D. Kuban3, K. Fukamachi1; 1Biomedical Engineering, Cleveland of Michigan, Ann Arbor, MI.
Clinic, Cleveland, OH, 2R1 Engineering, Euclid, OH, 3Medical Device Study: Ischemic stroke remains a significant adverse event associated
Solutions (Erectronics Core), Cleveland Clinic, Cleveland, OH. with continuous flow ventricular assist devices (cfVADs) such as the HVAD
Study: The virtual mock loop (VML) is a mathematical model designed to and HeartMate II (HMII). Stroke may be the result of pump thrombosis,
simulate the human cardiovascular system interacting with mechanical resulting in emboli ejected from the cfVAD. The genesis of emboli could
circulatory support devices. Here, we aimed to mimic the hemodynamic be in-loco, due to deposition within the cfVAD, or upstream such as the
performance of Cleveland Clinic’s self-regulating continuous-flow total left atrial appendage or within the left ventricle. This study was con-
artificial heart (CFTAH) via VML and evaluate the accuracy of the VML ducted to visualize the trajectory of ingested thrombi, and specifically the
compared to an in vivo acute animal study. degree of mechanical disruption of the resulting ejected emboli.
Methods: The VML reproduced 124 hemodynamic conditions from three Methods: Explanted HMII clinical reports showing deposition patterns
acute in vivo studies in calves. Systemic/pulmonary vascular resistances, were classified by their frequency, composition, and severity in five areas
pump rotational speed, pulsatility, and pulse rate were set for the VML of the blood flow pathway in the pump (Fore Connector, Inflow Straight-
from in vivo data. We compared outputs (pump flow, left/right pump ener, Fore Bearing, Blade-Blade Region, and Outlet Bearing/Stator). Red
pressure rise, and atrial pressure difference) of the two methods. thrombi of varying sizes (0.5 cm3, 1.0 cm3, and 2.0 cm3) were introduced
Results: The pump performance curves all fell in the designed range. into a mock flow loop with a transparent replica of the HMII operating at
There was a strong correlation between the VML and the in vivo study physiological conditions. High-speed videography was used to visualize
in left pump flow and left pressure rise (Figure A, y = 0.9407x + 0.6503, the ingestion, disruption, and ejection of thrombus through the cfVAD.
R2 = 0.8482, p<0.01; Figure B, y = 0.8351x + 19.973, R2 = 0.7963, p<0.01) Results: Red, unlaminated thrombi were observed adhering to the
and a moderate correlation between the VML and the in vivo study in inflow straightener of the HMII, which was consistent with the explant
right pressure rise and atrial pressure differences (Figure C, y = 0.6029x + images examined from our clinical collaborator. This gives credence to
13.995, R2 = 0.5157, p<0.01; Figure D, y = 0.9147x + 1.4992, R2 = 0.5939, the hypothesis that some adherent clots witnessed post-mortem may be
p<0.01). Although there is room for improvement in simulating right- from ingested thrombi. Thrombi that entered the impeller region were
sided pump performance, the VML acceptably simulated the hemody- disrupted by mechanical forces and quantified by the size distribution of
namics observed in an in vivo study. These results indicate that we can fragments ejected by the HMII. Ingested thrombi of 0.5 cm3, 1.0 cm3, and
estimate pump flow and pressure rise from vascular resistances and 2.0 cm3 produced emboli of 0.06 cm2, 0.07 cm2, and 0.07 cm2, respec-
pump settings. tively; this distribution was found to be independent of the size of the
ingested thrombus. Therefore we conclude that thrombi ingested, dis-
rupted, and ejected by the HMII may generate emboli capable of causing
an ischemic stroke.

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ASAIO CARDIAC ABSTRACTS

203 208
Assessment of Left Ventricular Contractility During LVAD Support: First Acute In Vivo Study of the Advanced Ventricular Assist Device as a
Modeling and Validation Left and Right Ventricular Assist Device
E. Chen, M. Rutten, P. Bovendeerd, F. van de Vosse; Eindhoven University T. Miyamoto1, Y. Kado1, J. Adams1, N. Byram1, A. R. Polakowski1,
of Technology, Eindhoven, NETHERLANDS. R. Dessoffy1, D. J. Horvath2, B. D. Kuban1, J. H. Karimov1, K.
Study: Assessment of left ventricular contractility may act as a proxy for Fukamachi1; 1Biomedical Engineering, Cleveland Clinic, Cleveland, OH,
estimating the health of the heart. Observable quantities such as dp/dt
2
Biomedical Engineering, Cleveland Clinic, Euclid, OH.
max may be used for healthy populations, but not for mechanically sup- Study: The Advanced ventricular assist device (VAD) is a next-generation
ported patients as dp/dt max is dependent on load. For these patients, a VAD intended to prevent backflow in the event of pump stoppage, to
load-independent quantity is needed. We propose a numerical model for maintain physiological pulse pressure, and to reduce the risk of pump
this and validate it with ex-vivo studies. thrombosis or hemolysis with continued refinement. The purpose of this
Methods: Hearts harvested from Dutch landrace pigs were prepared and study was to evaluate the performance of the Advanced VAD as both a
placed into an ex-vivo circulation platform. The LV was connected to an left and right VAD in an acute in vivo study in calves.
afterload module representing systemic circulation, with a constant pres- Methods: The Advanced VAD was implanted through median sternotomy
sure preload module supplying blood to the left atrium. Furthermore, a in three healthy calves (weight, 71.4 kg - 91.2 kg) as a left VAD (n=2) or
HeartMate II LVAD was attached to the LV via the apex and connected to a right VAD (n=1). The outflow graft was anastomosed to the ascending
the aorta module. aorta or pulmonary trunk and an inflow cannula to the left ventricular
After resuscitation, a speed ramp protocol was performed where the apex or right ventricular free wall without cardiopulmonary bypass (CPB).
pump speed was incremented from 0 kRPM to a maximum speed of After implantation, several hemodynamic parameters were evaluated
around 10 kRPM. Pressures, flow rates, and dp/dt max were measured at including general performance, pump stoppage, cannula malposition,
each speed over several heartbeats. Each heart was then degraded and high contractility, low and high vascular resistances, increased heart rate,
the speed ramp protocol repeated several times. and ventricular fibrillation.
A numerical model of the experimental platform was designed with left Results: The Advanced VAD was successfully implanted as a left and
ventricular mechanics modeled with a non-dimensional contractility right VAD without CPB (Figure A: left VAD, B: right VAD). The Advanced
parameter (clv). Model parameters were estimated and fitted to the cases VAD successfully maintained hemodynamics during pump support. The
where the LVAD outlet was clamped shut, and the speed ramp protocol speed range of the Advanced VAD was 2500 - 3500 rpm as a left VAD
was numerically simulated. and 2000 - 2500 rpm as a right VAD, and up to 4.3 L/min (1.1 - 4.3 L/min)
Results: Experimentally, for each heart at each level of degradation, an was achieved for both configurations. In acute calf studies, we success-
increase of pump speed caused a reduction of dp/dt max, showing that fully implanted and maintained hemodynamics using the Advanced VAD.
this measure is indeed load-dependent. We fitted model parameters, Based on these results, the pump will be improved to enhance its charac-
amongst which contractility clv, by matching measured and simulated teristic features for a chronic in vivo study.
time courses of pressures, flow rates, and dp/dt max values in the 0
kRPM case. Our simulations show that dp/dt max also decreases during
the speed ramp protocol while keeping clv constant. Thus the model
replicates load dependence of dpdt max and provides an alternative load-
independent proxy for LV contractility.

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ASAIO CARDIAC ABSTRACTS

209 210
Novel Aortic and Arterial Encircling Technique for Immediate Hemostatic New Technique for Effective Cardiac Deairing in Minimally Invasive
Control Cardiac Surgery: Early In Vivo Testing
J. H. Karimov, T. Miyamoto, K. Fukamachi, J. Cang, S. Gao, R. Dessoffy, J. J. H. Karimov, T. Miyamoto, K. Fukamachi, M. Lobosky, B. Kuban, J. Cang,
Sakai, M. Kander, M. A. Gillinov; The Cleveland Clinic, Cleveland, OH. S. Gao, R. Dessoffy, A. Borowski, M. A. Gillinov, J. Sakai; The Cleveland
Study: Hemostasis for perioperative bleeding from major blood ves- Clinic, Cleveland, OH.
sels can be time-consuming and if ineffectively managed, may lead to Study: Air introduced into the heart during open-heart repair remains a
significant postoperative morbidity and mortality. We are developing an feared complication and a major concern post-surgery. We designed an
encircling band (BND) intended to provide immediate hemostasis from innovative cardiac deairing device (CDS) that enables effective cardiac
arterial bleeding sites. Herein, we describe a novel design and report the deairing during minimally invasive cardiac surgery. The early in vivo feasi-
initial results from in vivo device testing. bility testing is reported herein.
Methods: The BND in vivo study was performed in healthy pigs (n=4), Methods: The CDS concept (Fig. A) was evaluated in acute porcine chest
weight: 69.3 ± 7 kg, operated through a median sternotomy to evaluate models (n=6), weight: 84.8 ± 8 kg. Right thoracotomy was constructed for
the device placement and effectiveness. The BND was fabricated using device insertion in the 5th -7th intercostal space. CDS prototype consisted
medical grade Velcro strip (external side) bonded with proprietary design of a temporary bladder (OD: 6–9 cm), positioned under the inferior car-
silicone-molded sealing grid (internal side) and compared vs. Control diac surface to motion-activate the heart and mobilize the intracardiac air.
bands (smooth surface silicone and textured Dacron). Acute hemorrhage The operational frequency (air inflow and vacuum outflow) parameters
model in full systemic anticoagulation simulated aortic injuries such as were set from external PC-based (LabVIEW) controller (ranged from 1 to
needle-hole (14-gauge; 2.108 mm), scalpel stab (#11 blade) aortic punch 33 Hz).
(4.0-mm) and loose anastomotic suture line (3-0 Prolene). Results: Successful air dislodgement from cardiac walls and septum
Results: The mean systemic arterial pressure ranged between 20 - during CDS activation was observable on echocardiography. The air
170 mm Hg during test. The BND closures showed no blood leaks and introduced through a long needle placed into the left ventricle (LV); the
immediate hemostasis in all types of iatrogenic injuries vs. Control pooled air remained within the LV when the CDS was off. Intrathoracic
(demonstrated presence of blood leaks and oozing). No BND dislodge- visualization of the CDS in action was also recorded using a 10-mm, 30°
ment was occurred at up to 30 min observation. The vascular encircling endoscope (Karl Storz, El Segundo, CA) and confirmed no device dislodge-
device (BND) performed as intended and demonstrated immediate and ment. These results suggest that the CDS was found easy to insert and
complete hemostasis in vivo. Further evaluation should include bio- use and that the current prototype models are effective in dislodging
compatibility tests for long-term device implantation. Figure (A) Artistic intracardiac air. This technology has a significant preventive effect on
rendering of device application; (B) Simulated injury. *- aortic blood “jet”. surgical outcomes through reduction of air-relate complications and
(C) Complete hemostasis with device in place; (D) Proprietary aortic band shortened surgical time. Figure. (A) Device schematic; (B) in vivo set up;
and Control samples. (C) CDS turned OFF; (D) CDS activation.

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ASAIO CARDIAC ABSTRACTS

211 213
Acute Decompensated Heart Failure Therapy: Impella 5.0 versus HVAD Intelligent Control for Dynamic Ventricular Unloading
VenoArterial ECMO R. Wampler1, B. Hull2, J. Karlen3, L. Tompkins3, T. Adams4, S. Koenig3, M. S.
M. Aguillon, C. Runyan, J. Hajj, N. Huie, M. Lindsay, E. Passano, L. S. Czer, Slaughter4; 1CT Surgery, Oregon Health Sciences University, Portland, OR,
R. Cole, J. Moriguchi, F. Esmailian, D. J. Megna, A. Trento, D. Ramzy; Smidt 2
Nexus Mechatronics, Lincoln, CA, 3Bioengineering, University of Louisville,
Heart Institute at Cedars-Sinai, Los Angeles, CA. Louisville, KY, 4CT Surgery, University of Louisville, Louisville, KY.
Study: Over the last decade treatment of patients with decompensated Study: Left Ventricular Assist Devices (LVAD) are operated at constant
heart failure has evolved to include different Mechanical Circulatory Sup- speeds (rpm), consequently, pump flow is passively determined by the
port (MCS) platforms. Historically, the use of VenoArterial Extracorporeal pressure difference between the LV and aorta. Since the diastolic pres-
Membrane Oxygenation (VA ECMO) was the primary intervention. Since sure gradient (~70 mmHg) is much larger than the systolic gradient (~10
2016, the use of the Abiomed Impella 5.0 has become an additional mmHg), the majority of pump flow occurs during systole. This limitation
option for our patients with decompensated heart failure. results in sub-optimal LV volume unloading, LV washing, and dimin-
Methods: Between the years 2016 to 2018, we retrospectively looked ished vascular pulsatility that may be associated with increased risk for
at patients with a primary diagnosis of decompensated heart failure. clinically-significant adverse events, including stroke, bleeding, arterio-
The patients were divided into those who had the Impella 5.0 (n= 72) venous malformations, and aortic insufficiency. To address this need, an
and those who had VA ECMO (n=117). The overall survival of patients on intelligent control strategy using pump speed modulation was devel-
Impella 5.0 and VA ECMO were initially compared along with days on sup- opedto provide dynamic LV unloading during the cardiac cycle to produce
port. Survival outcomes of each group were then broken down to three near-physiologic flow delivery.
sub-groups: Bridge to Recovery (BTR), Bridge to Transplant (BTT), and Methods: The objective of this study was to integrate a novel algorithm
Bridge to Durable MCS device (BTD). to dynamically control Medtronic HVAD pump speed and demonstrate
Results: Overall survival of patients on Impella 5.0 was 79.2% compared proof-of-concept by characterizing hemodynamic performance in a mock
to VA ECMO with 37.6% (p <.0001). Mean days on support were signifi- flow loopprimed with blood analog solution (glycerol-saline, 3 cP) and
cantly different between the two groups with 16 days for the Impella tuned to simulateheart failure over range of heart rates (HR = 60–120
group versus 5 days for the ECMO group (p<.0001). The ability to BTT bpm) and systolic durations (30–40%). Hemodynamic waveforms (LV
or BTD were significantly different between groups (table). Impella 5.0 pressure-volume, aortic pressure-flow, and pump flow) and intrinsic
BTT rate was 45.8% compared to 4.3% for VA ECMO (p<.0001). However, pump parameters (speed, current, power) were recorded and analyzed
there was no difference in the ability to recover patients with Impella for each test condition.
vs. VA ECMO. In conclusion, there was a significantly higher survival for Results: HVAD intelligent control was able to successfully increase pump
patients treated with the Impella 5.0 compared to VA ECMO. The greatest speed from 1800 rpm at systole to 3400 rpm at diastole with rapid motor
difference was seen in the ability to bridge these patients to heart trans- changes (50 ms) by drawing flow directly from the left atrium to increase
plantation. Finally, the Impella 5.0 was a superior option than VA ECMO diastolic augmentation at lower average pump speeds without increas-
for patients with decompensated heart failure, especially given Impella ing LVEDV (Figure 1). The novel flow algorithm was able to increase flow
5.0’s ability to bridge patients to the next therapy. during diastole and improve LV volume unloading. The potential clinical
advantages of this operating mode include better pump efficiency, hemo-
dynamics, reduce embolic stroke, and enhance myocardial recovery.
ECMO Impella 5.0
(N=117) (N=72) p-value

Overall Survival, % 37.6 79.2 <.0001


Vital Status, % <.0001
Alive (BTR) 23.9 20.8
Expired 62.4 20.8
MCS (BTD) 9.4 12.5
Transplant (BTT) 4.3 45.8

81
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ASAIO CARDIAC ABSTRACTS

219 222
Effect of Atrial Inflow Conditions on Ventricular Blood Flow During LVAD Steroid Use in Ex-Vivo Normothermic Heart Perfusion
Support Using Particle Tracking W. B. Weir1, M. Hayes2, M. Langley2, H. Shenton2, B. Schneider2, D. Drake1,
M. Ghodrati1, F. Moscato1, T. Khienwad2, F. Zonta3, P. Aigner1, A. Rojas-Peña3, G. Owens4, R. Bartlett2, J. W. Haft1; 1Cardiac Surgery,
H. Schima4; 1Medical Physics and Biomedical Engineering, Medical Michigan Medicine, Ann Arbor, MI, 2Surgery, Michigan Medicine, Ann
University of Vienna, Ludwig Boltzmann Cluster for Cardiovascular Arbor, MI, 3Surgery, Section of Transplantation, Michigan Medicine, Ann
Research, Vienna, AUSTRIA, 2Medical Physics and Biomedical Engineering, Arbor, MI, 4Pediatrics, Division of Cardiology, Michigan Medicine, Ann
Medical University of Vienna, Vienna, AUSTRIA, 3Institute of Fluid Arbor, MI.
Dynamics and Heat Transfer, Technical University of Vienna, Vienna, Study: Preservation and transportation in cold storage remain the gold
AUSTRIA, 4Medical Physics and Biomedical Engineering, Department of standard for heart transplant. However, the scarcity of donor organs and
Cardiac Surgery, Medical University of Vienna, Ludwig Boltzmann Cluster ischemic time remain limiting factors in maximizing organ usage. Using
for Cardiovascular Research, Vienna, AUSTRIA. a normothermic ex-vivo system and plasma cross-circulation, we aimed
Study: Simulations of the ventricular flow patterns during left ventricular to perfuse ovine hearts for 24 hrs while examining whether intermittent
assist device (LVAD) support are mainly performed with perpendicular steroid dosing contributes to improved organ function.
inflow conditions from the atrium neglecting asymmetries arising due to Methods: Using a modified Langendorff technique, ovine hearts (n=4)
uneven flow contribution of the pulmonary veins. In this study, the influ- were procured from a donor sheep and placed into a boxed normother-
ence of the atrial flow conditions - including rotation and asymmetric flow mic ex-vivo perfusion circuit containing a blood-derived perfusate. The
profiles - on the platelet behavior were investigated via Computational circuit underwent continuous plasma exchange (1L/hr) from an additional
Fluid Dynamics (CFD) simulations. support animal. Hemodynamics, blood gases, aortic pressure, and aortic
Methods: In a patient-specific LVAD-supported left ventricle (LV) model and pulmonary arterial flows were recorded during perfusion. Two hearts
conditions were applied for three different inflow boundary conditions. were perfused with the addition of 200 mg of methylprednisolone given
First, a simulation was performed with perpendicular velocity to the every 4 hours and two hearts without (total n=4). Following 24 hours of
inflow (LAper, flow rate: 3.5 lit/min), second with an additional rotational normothermic perfusion with plasma cross-circulation, perfusion was
component at the inflow (LArot: 35 rpm) and a third simulation was per- stopped and tissue harvested for pathologic analysis.
formed with asymmetric inflow conditions (LAasym: 60%/40% left/right Results: Mean aortic pressure and flow were not different between
flow ratio to replicate physiologic uneven flow distribution of the pulmo- groups (104.3±22.3 vs. 111.29±28.5 mmHg and 178.2±50.7 vs.
nary veins). Platelet motion was simulated with a combination of laminar 168±57.3 mL/min in the non-steroid and steroid groups, respectively).
and the Lagrangian methods for 7 s. For quantitative analysis, platelet Heart function was assessed using left ventricular (LV) systolic pressures
shear stress histories (SH) and residence times (RT) were calculated over which showed overall lower pressures in the steroid vs. non-steroid group
platelet trajectories. (43.7±20.2 mmHg, 73.9±29.8 mmHg, p=0.29). Likewise, there was no sig-
Results: Atrial inflow conditions affect the mean blood velocity magnitude nificant difference among other secondary outcomes including heart rate,
in the apical region of the LV (LAasym: 4.1, LArot: 2.9, LAper: 2.7 cm/s). lactate, and pulmonary artery oxygen saturation with all hearts showing
The cumulative probability that a particle accumulates a higher SH value normal markers of oxygen delivery. Final pathology revealed overall
than 0.6 Pa.s increased under asymmetric inflow conditions (LAasym: greater degree of cellular edema, myofiber degeneration, myocardial
11%, LArot: 5%, LAper: 3%; p<0.05); however the cumulative probability hemorrhage, and endothelial changes among hearts that did not receive
that a particle would linger for more than 7s inside the LV increased with steroids. While unexpected, this suggests that steroids do not play a key
perpendicular inflow conditions (LAasym: 13%, LArot: 18%, LAper: 19%; role in organ function after 24 hours of ex-vivo perfusion.
p<0.05).Neglecting the atrial flow conditions could lead to inaccurate
simulation of ventricular blood flow. Hence, reliable prediction of platelet
behavior traveling through the LV requires the consideration of the atrial
inflow conditions.

223
ASIC-based Miniature Ultrasound Transit Time Flowmeter
J. T. Haberstock, M, C. Drost; Marketing, Transonic, Ithaca, NY.
Methods: Since the invention of the transit-time ultrasound flowmeter 45
year ago, the physical size and power consumption of flow devices have
decreased steadily to the point that we have now designed an Applica-
tion Specific Integrated Chip (ASIC) (12mm x 12mmIn) for Transit-time
Ultrasound Flowmetry.
Results: A flowmeter board incorporating the TSIC8 chip was calibrated in
absolute NIST traceable units [sec] for its pico-second differential transit-
time measurement (ΔTT.) The TSIC8-based flowmeter was bench tested
with flowsensors from 0.6MHz (36mm) to 9.6MHz (0.7mm). Conclusion:
Flowmeter boards incorporating the TSIC8 meet design specifications and
accept derivatives of the full range of Transonic perivascular flowprobes
and tubing flowsensors. Its low power requirements and small size enable
chronic implants/telemetry.

82
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ASAIO CARDIAC ABSTRACTS

224 225
Retrospective Review of Left Ventricular Unloading Strategies During Risk of Pump Thrombosis and Cerebrovascular Events in Continuous
Veno-arterial Extracorporeal Membrane Oxygenation Flow Left Ventricular Assist Device Patients Experiencing
L. Piechura1, A. Coppolino2, H. Mallidi2, S. Keller3; 1General Surgery, Gastrointestinal Bleeding
Brigham and Women’s Hospital, Boston, MA, 2Thoracic Surgery, Brigham T. W. Szymanski1, P. A. Weeks1, C. J. Patel2, M. K. Jezovnik2, S. S. Nathan2,
and Women’s Hospital, Boston, MA, 3Pulmonary and Critical Care M. F. Jumean2, B. Kar2, I. D. Gregoric2; 1Pharmacy, Memorial Hermann -
Medicine, Brigham and Women’s Hospital, Boston, MA. Texas Medical Center, Houston, TX, 2Center for Advanced Heart Failure,
Study: Peripheral veno-arterial extracorporeal membrane oxygenation University of Texas Health Science Center - Houston, Houston, TX.
(ECMO) is a life-saving mechanical circulatory support modality capable Study: The purpose of this study is to assess the incidence of pump
of rapidly restoring perfusion in refractory cardiogenic shock. ECMO thrombosis and stroke in patients with left ventricular assist device (LVAD)
generated retrograde perfusion also acts to increase afterload for the who experience gastrointestinal (GI) bleeding while on support.
failing heart risking left ventricular distention and blood flow stasis in Methods: This was a single-center, retrospective, observational cohort
the cardiopulmonary circulation. Multiple means of LV unloading have study of consecutive patients with LVADs implanted from January 2012 to
been clinically implemented but the optimal method is unknown. We June 2018. Patients were excluded if they died within 30 days or before
retrospectively reviewed outcomes of recent VA ECMO patients to assess discharge following LVAD implantation or did not follow-up with the
impact of LV unloading on survival and duration of mechanical circulatory implanting center after discharge. Comparator groups were established
support to inform future clinical practice. based on patient experiencing gastrointestinal bleeding following LVAD
Methods: We analyzed cases of ECMO alone (n = 29), ECMO and Impella implantation. The primary endpoint assessed was the composite end-
(n = 18), or ECMO and intra-aortic balloon pump (IABP, n = 15) at our point of LVAD pump thrombosis or ischemic stroke. Secondary endpoints
institution between 2015 and 2018. Our primary outcome of interest was assessed were incidence of pump thrombosis, ischemic stroke, and
survival to ECMO decannulation and 30-day mortality. Secondary interests hemorrhagic stroke.
included ECMO-related complications and support strategy logistics. Results: A total of 250 patients were included after screening for exclu-
Results: Patients on ECMO with Impella demonstrated survival-to-decan- sion criteria, 101 (40.4%) in the GI-bleeding group and 149 (59.6%) in the
nulation rates of 78% versus 47% with ECMO and IABP and 52% with non-GI bleeding group. The incidence of pump thrombosis or ischemic
ECMO alone; however, this result is not statistically significant (Fisher’s stroke was greater in the GI-bleeding group (22.8% vs. 12.1%; p=0.036).
exact test, P=0.12). Thirty-day mortality was similar across groups. There Individual outcomes are reported in the table below. Gastrointestinal
were no differences in ECMO-related complications, including lower bleeding in patients with LVADs appears to be associated with a greater
extremity ischemia, intracardiac thrombus, stroke, need for renal replace- risk of pump thrombosis or ischemic stroke, but was not associated with
ment therapy, clinically significant hemolysis, or hemorrhage. No patients an increased risk of hemorrhagic stroke.
in the ECMO and Impella group required an alternative venting method
while 27% with IABP and 3.4% with VA ECMO alone (P=0.01) received a
different means of venting. While limited by small sample sizes, our work
seeks to advance understanding related to VA ECMO and LV unload-
ing strategies to guide optimal patient care in the burgeoning arena of
mechanical circulatory support.

83
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ASAIO CARDIAC ABSTRACTS

227 228
ECMO as a Bridge to Heart-Lung Transplantation and Post-Operative Short-to-shield in Patients with a Heartmate II LVAD
Recovery in a Patient with Dextrocardia, Atrial Septal Defect, and M. M. Patarroyo Aponte, S. Nathan, C. Patel, P. Sen, R. Radovancevic,
Pulmonary Hypertension B. Kar, I. D. Gregoric; Advanced Cardiopulmonary Therapies and
A. Coppolino1, S. Keller2, T. K. Rajab3, H. Mallidi1; 1Thoracic Surgery, Transplantation, The Univ. of Texas Health Science Center-Houston,
Brigham and Women’s Hospital, Boston, MA, 2Pulmonary and Critical Care Houston, TX.
Medicine, Brigham and Women’s Hospital, Boston, MA, 3Cardiac Surgery, Study: Left ventricular assist devices (LVADs) are widely used as part of
Brigham and Women’s Hospital, Boston, MA. the management of patients with advanced heart failure. The short-to-
Study: The optimal support of transplant candidates with advanced pul- shield phenomenon has been related to damage of the internal wiring of
monary hypertension is unknown. We report a case of a patient bridged the driveline and has been reported to be the cause for almost half of all
with VV ECMO to heart-lung transplantation. HMII LVADs pump exchanges. However, the cause of this phenomenon is
Methods: Case report with discussion of pre- and post-transplant man- unknown.
agement and heart-lung transplant procedure. Methods: We reviewed patient records of HMII LVADs from 2012–2018
Results: A 28 year-old woman with dextrocardia, unrepaired atrial septal at our institution. We selected the patients that underwent pump explant
defect, and idiopathic pulmonary hypertension maintained on continuous after a short-to-shield phenomenon was noted. Log files confirmed
intravenous pulmonary vasodilators listed for heart-lung transplantation pump stops. From a total of 210 implanted HMII LVADs, 8 patients were
presented with worsening systemic hypoxia. The patient experienced explanted due to short-to-shield.
progressive pulmonary hypertension complicated by increased right-to- Results: All patients had non-ischemic cardiomyopathy. Of the 8, 5
left atrial shunting resulting in significant systemic hypoxia. Following (62.5%) were male and 7 (87.5%) had an LVAD implant as destination
exhaustion of therapeutic alternatives, the patient was initiated on VV therapy. The average presentation was 702 days post implant (292 - 1370
ECMO support. The patient underwent conscious sedation with place- days). There was no history of specific trauma. Most of the patients had
ment of a central venous catheter in the right internal jugular vein. An minimal changes in their weight; however, one patient gained 64 lbs and
Amplatz extra stiff 160 cm guidewire was advanced through the catheter 2 patients lost 44 and 34 lbs. In a patient with 2 pump exchanges, strenu-
into the inferior vena cava distal to the hepatic vein inlet under transtho- ous physical activity was thought to have contributed to cause of the
racic ultrasound guidance. Following serial dilation, a 31 Fr Avalon dual short-to-shield. Pump exchanges occurred between 6 and 281 days from
lumen catheter was advanced and positioned with ultrasound guidance. the time of short-to shield diagnosis (mean = 123 days). The final report
ECMO support was initiated with immediate improvement in systemic after evaluation of the pump from the company showed no malfunction
oxygenation. The patient was supported with VV ECMO for 23 days during in one case. For the rest of the pumps, the final diagnosis was insulation
which time she actively participated in physical therapy. She underwent breach due to repetitive abrasion of the driveline. In 4 pumps (50%), the
successful heart-lung transplantation with an immediate course compli- exposure of wires was noted mostly between 1 and 9 inches of the pump
cated by profound primary graft dysfunction requiring placement of an housing. Two pumps had a breach of insulation near the metal connector.
arterial cannula into the aortic arch and initiation of central VAV ECMO. In seven cases, external driveline repair was unsuccessfully attempted.
On post-operative day 3, the patient was successfully decannulated and The short-to-shield phenomenon is associated with a breach of insula-
extubated. The patient was discharged home on post-operative day 17. tion in the driveline. However, contrary to what is expected, most of the
The patient continues to do well post-transplant with no evidence of insulation breaches happened at the non-exposed driveline, for which
rejection at 10 months post-transplant. driveline repair is not always successful. Since there is a risk for pump
stops and clinical complications, pump exchange must be considered.

84
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ASAIO CARDIAC ABSTRACTS

229 231
Design Parameters for a Light-weight, Low-power Flowprobe to be In Vitro Investigation of the Effect of the Hvad Lavare Cycle on
integrated within a Ventricular Assist Device Intraventricular Hemodynamics
J. T. Haberstock, M, G. Van Fleet, M; Marketing, Transonic, Ithaca, NY. F. Chassagne1, V. Chivukula1, M. Miramontes1, A. Straccia1, S. Li2, J.
Methods: Background: VADs deliver blood at a controlled rate of flow to Beckman2, K. Koomalsingh3, C. Masri2, T. Dardas2, R. Cheng2, S. Lin2, E.
support failing hearts. Transonic Systems’ flowprobes/sensors, used rou- Minami2, G. Wood2, S. Farris2, F. H. Sheehan2, J. Kirkpatrick2, C. Mahr2,
tinely to test and validate VAD performance during device development, A. Aliseda1; 1Universty of Washington - Department of Mechanical
are now being developed so that they can be integrated directly on a final Engineering, Seattle, WA, 2Universty of Washington - Division of
device, to provide an independent monitor of true delivered flow. Analy- Cardiology, Seattle, WA, 3Universty of Washington - Division of
sis of ultrasound wave behavior as it transitions between materials of dif- Cardiothoracic Surgery, Seattle, WA.
ferent acoustic impedances is necessary before designing a light-weight, Study: The aim of this study is to investigate the left ventricular (LV)
robust, reliable, and low power ultrasonic flowprobe that measures true hemodynamics associated with the HVAD Lavare cycle via in-vitro Particle
volume flow through a titanium tube. Methods: Using PZFlex® software Image Velocimetry (PIV) measurements.
(Weidlinger Associates Inc., Mountain View, CA), the interaction between Methods: A patient-specific LV silicone model is created via CT-segmenta-
the various modes of ultrasound travel and the design parameters tion, 3D printing and casting, and implanted with an HVAD. We investigate
such as material thickness, frequency, angles and signal loss that would the flow of a blood-mimicking fluid, matched in index of refraction to
impact the accuracy of the true volume flow measurement was analyzed. the LV, with time-resolved (1000 frames per second) PIV measurements.
Reviewed was the impact of the ultrasound design parameters as they Physiological inflow waveforms are applied through the mitral valve (MV)
related to overall device shape and mass before multiple design options while keeping the aortic valve closed, with a pump simulating native con-
were simulated around a 12mm circular titanium lumen. tractility and the functioning HVAD, setup for a mean 5L per minute total
Results: The PZFlex 3D simulations of acoustic behavior demonstrated output, running the LAVARE cycle: VAD speed modulated by 200 RPM
that full flow illumination (necessary for flow measurements independent above and below baseline speed for 2 seconds and 1 second respectively,
of flow profile) is reasonably achieved across the titanium flow tube. Tub- once every minute.
ing wall thickness ultrasound frequency and angle of transducer place- Results: The flow field inside the LV was measured under different levels
ment were critical to achieving flow measurement performance similar of synchronization of the LAVARE cycle with the native cardiac rhythm.
to conventional flowprobes by minimizing beam focusing or extraneous The measurements provide the hemodynamics in the LV at different time
ultrasound from sources such as Lamb waves. points of the cardiac cycle, enabling comparison of metrics such as vortic-
ity imparted by MV filling, and stasis around the apical pocket created by
the VAD inflow cannula hemodynamics as a function of HVAD modulation
time delay with respect to peak systole. Comparison with the hemody-
namics without VAD pulsatility highlight the extent to which the LAVARE
cycle can alter LV hemodynamics for several cardiac cycles after actually
taking place. Depending on synchronicity with the cardiac cycle, the VAD
pulsatility has a significant influence on recirculation and stagnation zones
in the apex that may be thrombogenic. Moreover, when the combination
of LV contraction and aortic pressure drives the flow through the pump
down to near-stall conditions, hemodynamic performance suffers and
operation may need to be adjusted to avoid this phenomenon, optimizing
the pulsatility mode beyond in-pump hemodynamics, to improve patient
long-term outcomes in LVAD therapy.

85
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ASAIO CARDIAC ABSTRACTS

232 233
Left Ventricle Assist Device and Gastric Sleeve as a Combination Therapy Atrial Fibrillation Triggers Chaotic Flow in the Left Ventricle and
for Morbidly Obese Transplant Patients Increases LVAD Thrombogenicity
M. Ng1, B. Rodgers1, S. Rehman1, S. Nathan2, K. Bajwa3, B. Akkanti4, M. F. J. Beckman, V. Chivukula, S. Li, K. Koomalsingh, C. Masri, T. Dardas,
Jumean2, S. Kumar2, R. Radovancevic2, B. Kar2, I. D. Gregoric2; 1Clinical R. Cheng, A. Stempien-Otero, S. Lin, E. Minami, G. Wood, S. Farris, J.
Nutrition, Memorial Hermann Hospital Texas Medical Center, Houston, Kirkpatrick, F. Sheehan, N. Akoum, A. Aliseda, C. Mahr; University of
TX, 2Advanced Cardiopulmonary Therapy and Transplantation, University Washington Medical Center, Seattle, WA.
of Texas Health Science Center-Houston, Houston, TX, 3Surgery, University Study: This work investigates the influence of atrial fibrillation (AF) on Left
of Texas Health Science Center-Houston, Houston, TX, 4Divisions of Critical Ventricle (LV) hemodynamics, and the role of chaotic flow in the mitral
Care, Pulmonary and Sleep Medicine, University of Texas Health Science valve (MV) on LVAD thrombogenicity.
Center-Houston, Houston, TX. Methods: We use 3D unsteady CFD to study LV hemodynamics driven
Study: There is a shortage of literature on morbidly obesity heart failure by the combination of MV inflow and LVAD outflow. Two types of MV
patients who receive a left ventricular assist device (LVAD) and bariatric inflow waveforms are used, sinus rhythm (SR) and AF. To avoid con-
surgery as a co-therapy to bridge to transplant (BTT). We report the use founding variables of HR and differences in VAD flow, the AF simulation,
of the gastric sleeve procedure (GS) and LVAD as a combination therapy although random in cycle length and amplitude, preserves the same CO
for morbidly obese patients. and total flow rate as SR. This makes it possible to directly compare the
Methods: This is a retrospective, single-center cohort analysis on 30 mor- effect of AF on hemodynamics and thrombogenicity. We simulate 20
bidly obese patients with end-stage heart failure who were classified as cardiac cycles to obtain long term statistics inside the LV. The distribu-
BTT and received LVAD/GS placement as a co-therapy from January 2013 tions of Platelet Shear Stress History (SSH) and LV Residence Times (RT)
to November 2018. All patients followed the same bariatric protocol and are computed along all trajectories, from MV injection through LVAD
were seen at in the clinic for post-op appointments. outflow to provide markers of platelet activation and aggregation. These
Results: The mean age of patients was 48.5 years (SD ± 12.2) with a two factors are combined into a single thrombogenic risk metric that
mean preoperative BMI of 43.2 (SD ±5.5) and mean preoperative weight shows the integrated impact of AF.
of 135.2 kg (SD ±27.5). At 3 months post-GS/LVAD, 12/30 of the patients Results: AF was directly linked to longer LV platelet RT, particularly for
achieved the target BMI <35. The mean percentage weight loss was outliers that stayed in the LV > 10 seconds, or 5 x median RT. This is
14.9% (SD±4.7), and mean BMI of 36.7. An additional 6 patients achieved consistent with irregular cycle length and variable MV opening in AF.
BMI <35 at 6 months post-GD/LVAD. At 1-year post GS/LVAD, 19/30 of Platelet SSH also showed a longer tail distribution, highlighting that the
the patients achieved BMI <35. At 1.3 years and 2 years post-GS/ LVAD, irregularity in LV filling can influence both RT and SSH and produce a
2 patients achieved explanation of their LVAD devices and no longer wider range of shear stress exposures, away from the homeostatic physi-
required listing for heart transplant. At the time of explants, these two ological average of approximately 1 Pa. This increase in RT and SSH is
patients had a lost 58.4% and 42.3% of their body weight, respectively. correlated (Figure 1). Platelets with extremely long RT do not have lower
For the 19 patients who achieved the target BMI, the average time than average SH, but are subjected to high shear stresses that accumulate
between the GS procedure and eligibility for listing was 11.6 months. The to reach extremely high LV SSH values. Overall, AF during LVAD sup-
average time between the GS procedure and transplant was 16.8 months. port doubles the number of highly thrombogenic platelets. Whenever
Our results show that GS can safely be used as a co-therapy with LVADs possible, maintaining SR in VAD patients should be considered to reduce
as BTT. Out of the 30 patients who received GS, 13 were successfully thrombogenicity.
transplanted, 8 lost sufficient weight to be listed for transplant - indicating
that 70% of patients in our group lost weight and met BMI requirements
for transplant.

86
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ASAIO CARDIAC ABSTRACTS

234 237
The HeartMate 6 Mean Arterial Pressure Significantly Impacts Stroke-Related Mortality in
M. Daneshmand, M. Bishawi, C. Milano, J. Schroder; Duke University, Destination Therapy Patients
Durham, NC. C. Mahr1, J. Teuteberg2, N. Mokadam3, D. Tirschwell4, J. Beckman1, F.
Study: The need for biventricular support poses significant challenges Pagani5, T. Vassiliades6, J. Rogers7; 1Cardiology, University of Washington,
for patients who require a mechanical bridge to transplantation. Recent Seattle, WA, 2Cardiovascular Medicine, Stanford University, Stanford,
improvements in Ventricular Assist Device (VAD) technology has made CA, 3Cardiac Surgery, Ohio State University, Columbus, OH, 4Neurology,
possible the use of 2 centrifugal flow VADs as a total artificial heart University of Washington, Seattle, WA, 5Cardiac Surgery, University of
replacement. Here we describe the use of 2 HM3s as a total artificial Michigan, Ann Arbor, MI, 6Medical Affairs, Medtronic, Framingham, MA,
heart in a patient as a bridge to transplant.
7
Cardiology, Duke University, durham, NC.
Methods: A 37-year-old male with a previous LVAD had the LVAD Study: The ENDURANCE Supplemental Trial (DT2) demonstrated that
explanted secondary to significant LVAD infections and conversion to enhanced blood pressure management significantly reduced the inci-
an extracorporeal LVAD. He had destruction of the left ventricular apex dence of strokes in patients with advanced heart failure on HVAD support.
requiring left atrial cannulation of his extracorporeal LVAD. After recover- This analysis further studies the correlation of average mean arterial
ing from this procedure, while awaiting a suitable donor for transplant, pressure (MAP) to stroke-related mortality for patients in both HVAD and
the patient developed progressive right ventricular and significant aortic Control cohorts.
valve insufficiency. Given the likely prolonged wait for a suitable donor Methods: Retrospective analysis of the DT2 database was performed to
organ, rather than performing aortic valve repair and inserting an extra- identify the MAP for all patients at hospital discharge (DC), and 3, 6, and
corporeal RVAD, the decision was made to proceed with two HM3 VADs 12 months post-VAD implant. The means of these MAPs were allocated
configured as a Total Artificial Heart (TAH). into 1 of 4 cohorts (<70, 70.1–80, 80.1–90, and >90 mmHg). Strokes and
Results: The patient underwent implantation as planned. Postopera- stroke-related deaths were CEC (Clinical Events Committee) adjudicated.
tively using echo guidance, the speeds for the left and right pumps was Those that died of other causes were censored at time of death. All
adjusted using the atrial septum position as a gauge. The post-operative patients were censored at explant of original device for pump exchange
course was complicated by a left MCA Temporal/Parietal CVA that was or transplant. Survival was calculated using Kaplan Meier analysis, with
detected on post-operative day 2. The patient had a good functional time 0 as the day of VAD implant.
recovery from his stroke, and was transferred to the stepdown floor. He Results: Of the 465 patients enrolled in DT2, 438 (148 control, 290 HVAD)
was ambulating daily, and was eventually transplanted successfully after had available MAP. Mean MAP cohort distribution (Table 1) suggests that
30 days of support patients with a mean MAP > 90 mmHg had a higher risk of stroke than
other cohorts. The stroke-related mortality analysis (Figure 1) revealed
a significantly greater stroke-related mortality (p-value=0.02 over 1 year,
0.08 over 2 years) for the HVAD cohort with a mean MAP > 90 mmHg, Not
replicated in the Control group (p value 0.41 and 0.64 over 1 and 2 years).
Conclusion: This analysis of the ENDURANCE Supplemental Trial revealed
significantly greater risk of stroke-related death in HVAD patients with
a mean MAP >90 mmHg, which was not observed in the Control group.
Furthermore, patients with a mean MAP > 90mmHg had an observed
higher risk of stroke in both groups. This study highlights the importance
of blood pressure monitoring and control on reducing neurologic event
risk during long-term VAD support.

87
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ASAIO CARDIAC ABSTRACTS

238 243
Low Shear, High Flow, and Physiologic Pulsatility: The Corwave LVAD Stretchable Electronic Motion Capture in Heart Failure Affords
T. A. Snyder, L. Polverelli, E. Illouz, B. Burg, J. Biasetti, P. Le Blanc, Quantitation While Revealing Motion Signatures
N. Barabino, N. Jem, R. Pruvost, D. Atlani, M. Vernizeau, C. N. H. L. Swanson1, R. C. Slepian1, A. A. Harhash2, K. R. Ammann3, M.
Botterbusch; Corwave, Clichy, FRANCE. Mazumder3, J. A. Garlant3, M. J. Slepian2; 1Department of Physiology,
Study: The Corwave LVAD employs gentle, magnetically driven oscillation College of Medicine, University of Arizona, Tucson, AZ, 2Department
of a membrane for low shear blood propulsion. The purpose of this study of Medicine, Sarver Heart Center, University of Arizona, Tucson, AZ,
was to optimize the blood path, increase hydraulic efficiency, and develop
3
Department of Biomedical Engineering, College of Engineering, University
control algorithms for pulsatile operation. The pumps and controls were of Arizona, Tucson, AZ.
then evaluated by implantation in ovines. Study: Advanced heart failure (HF) is associated with a significant
Methods: The blood path and membrane of the pump were simulated by decrease in exercise capacity and mobility. The six-minute walk test
Fluid-Structure-Interaction fluid dynamic analysis in COMSOL. Perfor- (SMWT) is a clinical tool used to assess progression of HF-related reduc-
mance was evaluated in mock circulation loops under static and dynamic tion in endurance and mobility. Advances in electronics and material
conditions. In vitro hemolysis testing was conducted with ovine and science have introduced wearable sensors constructed with stretchable
porcine blood. Non-hermetic prototype pumps were implanted in a total electronics allowing for detailed study of human motion. We hypoth-
of 25 ovines for acute and chronic implants. esized that combining wearable sensor technology with the SMWT would
Results: Benchtop testing demonstrated that the improved designs reveal details of motion, affording detection of potential signatures asso-
generated 7+ LPM of blood flow against physiologic pressures with low ciated with HF and its progression compared to non-HF controls.
hemolysis. Three control methods were developed: fixed, asynchronous Methods: Wireless, stretchable sensors (BioStampRC, MC10) with
pulsatile, and synchronous pulsatile. During acute implants, oscillation internal tri-axial gyroscope and accelerometer were applied to the medial
frequency was modulated based on sensorless detection of ventricular chest, dominant hand, and both calves of healthy (10F, 7M) and HF (1F,
systole generating dP/dt > 400 mmHg/s. Chronic implants yielded accept- 5M) subjects. Subjects were asked to walk for six minutes at a comfort-
able hemolysis without renal infarcts, but were limited to less than 10 able pace. Distance travelled, angular velocity, and acceleration from all
days due to using non-hermetic pumps. sensors were recorded. Physiological parameters, i.e. heart rate, respira-
Conclusions: A novel blood pump has been developed employing low tory rate, blood pressure, oxygen saturation, dyspnea, and leg fatigue
shear blood propulsion to support the failing heart while restoring were also measured pre-and post-walking.
physiologic pulsatility to address the thromboembolic and bleeding Results: Mean distance walked for HF patients was 178 meters, vs. 388
complications limiting LVAD technology. Future efforts will implement meters for healthy controls. Additionally, HF subjects demonstrated
hermeticity to extend implant durations and explore von Willebrand Fac- 76.53% variability in chest peak angular velocity around the y-axis (side-
tor compatibility. to-side motion around the sagittal plane) between initial (0–5 seconds)
and final walking (355–360 seconds) time points; compared to 24.37%
in controls. These variations correlated positively with ejection fraction
and New York Heart Association (NYHA) HF class. Beyond direct distance
assessment, wearable mobility sensors reveal details of motion previ-
ously uncharacterized. These signatures of motion suggest additional
musculoskeletal effects of HF which are clinically detectable whose serial
assessment may provide an additional physical biomarker for monitoring
the clinical status of HF patients.

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ASAIO CARDIAC ABSTRACTS

246 247
Impact of VAD Speed and MAP on Intraventricular Hemodynamics: Application of the Utah Bleeding Risk Score to LVAD Supported Patients
Influence on Flow Patterns, Platelet Activation and Thrombogenicity at Advocate Christ Medical Center: A Retrospective Study
M. Miramontes1, F. Chassagne1, A. Straccia1, V. K. Chivukula1, J. A. G. Gavrilos, T. Lawrecki, K. Chickerillo, N. Krause, T. Aicher, N. Graney, A.
Beckman2, S. Li2, K. Koomalsingh3, C. Masri1, T. Dardas2, R. Cheng2, S. Lin2, McInerney, M. McDowell, D. Mehta, M. Dia; Advocate Christ Medical
E. Minami2, G. Wood2, S. Farris2, J. Kirkpatrick2, F. H. Sheehan2, C. Mahr2, Center, Oak Lawn, IL.
A. Aliseda1; 1Mechanical Engineering, University of Washington, Seattle, Study: Continuous-flow left ventricular assistant devices (CF-LVAD) have
WA, 2Division of Cardiology, University of Washington, Seattle, WA, improved survival rates in advanced heart failure patients; however,
3
Division of Cardiothoracic Surgery, University of Washington, Seattle, WA. gastrointestinal (GI) bleeding is commonly seen post-implant. The Utah
Study: This study aims to quantify the impact of native contractility, Mean Bleeding Risk Score (UBRS) was developed to estimate bleeding risk in
Arterial Pressure (MAP) and LVAD speed on thrombogenicity in the left this patient population. Seven pre-implant variables are most predictive
ventricle (LV) of LVAD patients, via in-vitro experiments in patient-specific for post-implant GI bleeding. The aim of this study is to evaluate CF-LVAD
flow phantoms. patients at Advocate Christ Medical Center (ACMC) who have experi-
Methods: LV hemodynamics are investigated using in vitro patient-spe- enced GI bleeding post-implant and apply the UBRS tool to this patient
cific flow models created by using medical image segmentation, 3D print- population.
ing and rapid prototyping. Stereo Particle Image Velocimetry (PIV) is used Methods: CF-LVAD recipients (all devices) at ACMC between 2012 and
to analyze hemodynamics’ dependency on mitral valve (MV) flow rate, 2017 who experienced post-implant GI bleeding were evaluated. The
LVAD speed and MAP. The flow is seeded with neutrally buoyant particles, following variables were assessed, and patients were assigned one or two
in a refraction-index-matched blood-mimicking fluid which allows for points for: age >54 years (1 point), history of previous bleeding (2 points),
distortion-free imaging of light scattered by the flow particles. A range of coronary artery disease (1 point), chronic kidney disease (1 point), severe
VAD flows is studied, in conjunction with a pulsatile pump that simulates right ventricular dysfunction (1 point), mean pulmonary artery pressure
native contractility in the LV of a heart failure model. Clinically relevant <18 mm Hg (2 points), and fasting glucose >107 mg/dL (1 point). The
parameters such as preload and afterload are analyzed to elucidate their UBRS, defined as: low (0–1 points), intermediate (2–4), and high risk
impact on LV hemodynamics and associated thrombogenic potential. (5–9), was then applied.
Results: Thrombogenic flow, characterized by stagnation and recircula- Results: Variables assessed are listed in Table 1. UBRSs are listed in Table
tion zones in the apical region, is identified and its influence on platelet 2. The mean UBRS was 2.83. We observed a 23.1% overall incidence of
residence times in the LV quantified. These unfavorable flow patterns post-implant GI bleeding in CF-LVAD supported patients over a five-year
promote platelet activation and aggregation in the LV, prior to entering period, the majority (76.2%) of whom were found to be at intermediate
the LVAD. This LV hemodynamics can contribute to the high incidence risk. Prospective, multicenter validation studies should be conducted
of thromboembolic events. Optimizing of LVAD speed and MAP has the to further elucidate the accuracy and usefulness of this tool in clinical
potential to reduce risk of thromboembolic events. practice.

89
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ASAIO CARDIAC ABSTRACTS

248 258
Use of Nitric Oxide After Lvad Implantation Leads to Worse Outcomes Mechanical Circulatory Support in Coronary Revascularization and
I. D. Gregoric1, M. K. Jezovnik1, M. Ilic1, S. S. Nathan1, Z. Liu1, I. Severe Left Ventricular Dysfunction Permits Bridge to Recovery
A. SalasDeArmas1, M. K. Patel1, M. H. Akay1, R. Radovancevic1, B. N. J. Smith, A. Cole, M. Kamalia, L. D. Joyce, D. L. Joyce; Cardiothoracic
Kar2; 1Advanced Cardiopulmonary Therapies and Transplantation, Surgery, Medical College of Wisconsin, Milwaukee, WI.
THe University of Texas Health SCience Center at Houston, Houston, Study: Severe ventricular dysfunction in ischemic cardiomyopathy
TX, 2Advanced Cardiopulmonary Therapies and Transplantation, The remains a significant risk factor for postoperative morbidity and mortal-
University of Texas Health Science Center at Houston, Houston, TX. ity after coronary artery bypass grafting (CABG). We hypothesized that
Study: Inhaled nitric oxide (iNO) is frequently used as a prophylactic mea- concomitant use of mechanical circulatory support (MCS) at the time of
sure for patients at risk for post-operative right ventricular dysfunction CABG would eliminate low output state (LOS) and promote recovery in
(RVD) after left-ventricular assist device implantation (LVAD). The data on this patient population.
optimal dosage and duration of iNO and clinical outcomes after LVAD are Methods: From 2017 to 2019, seven patients with coronary artery dis-
scarce. We aimed to evaluate patient characteristics and clinical outcomes ease and severe left ventricular dysfunction (ejection fraction [EF] ≤ 30%)
of LVAD patients treated with iNO. presented in varying stages of ischemic heart failure. Four patients met
Methods: We reviewed patient characteristics, hemodynamic and respira- Medicare criteria for destination therapy. Perioperative MCS was used to
tory data, from the Center for Advanced Heart Failure Data Registry from facilitate ventricular unloading during CABG in these patients.
May 2012 to September 2018. 301 patients received their first LVAD in Results: All patients underwent successful CABG with support of either a
this period. We compared 30-day and in-hospital complication rates (RVD, durable (n=3) or percutaneous (n=4) LVAD device. All patients with per-
acute renal dysfunction (ARD), hemorrhagic and ischemic events, death) cutaneous devices were successfully weaned to device removal without
in 215 patients who underwent LVAD implantation and had complete data LOS. Patients with durable LVADs at the time of discharge were supported
sets. Patients who needed concomitant RV support were excluded. with 3.4–5.2 L/min. One patient underwent successful durable LVAD
Results: A total of 215 patients had complete data sets, including 136 iNO explantation 305 days after index implant with an EF of 50%. The remain-
users and 79 non-users. Median duration of iNO therapy was 6 (3–11) ing durable LVAD patients continued to requiring support at most recent
days, median dosage 28 (20–34) PPM. Most of the baseline clinical and follow up. There were no device-related complications. Two patients
hemodynamic characteristics were similar between the groups. Patients with percutaneous LVADs required reoperation for bleeding. In-hospital
treated with iNO had higher rates of ARD than non-users (p<0.001). complications included two episode of GI bleeding requiring transfusion,
The risk of bleeding complications was significantly higher in iNO users one instance of vocal cord paralysis, complete heart block requiring a
(p<0.001). There was no difference in stroke rate (p=0.427). 17 patients pacemaker, and one death due to aspiration. All remaining patients were
died during the hospital stay, all were treated with iNO. Conclusion: This alive at most recent follow up. Here we describe a novel approach to
is the largest and most complete study to evaluate the use of iNO in LVAD coronary revascularization in patients with ischemic cardiomyopathy and
patients. Careful monitoring of renal function and antithrombotic therapy severe ventricular dysfunction utilizing concomitant LVAD implantation at
is advised with iNO therapy. index CABG as a BTR strategy. Experience in this small cohort illustrates
its potential as a viable strategy, however, formal clinical trials are needed
for proper evaluation.

90
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ASAIO CARDIAC ABSTRACTS

260 263
Preoperative Assessment of Left Ventricular Thrombi in Patients Reversal of Heart Failure with Continuous-flow LVAD is Associated with
Undergoing Left Ventricular Assist Device Implantation and Short-term Deactivation of Inflammatory Pathways in Long-Term Survivors
Outcomes of Patients with Left Ventricular Thrombi E. Y. Birati1, R. Kormos2, M. Y. Acker3, J. Wald1, J. Rogers4, C. Milano4,
I. D. Gregoric, M. K. Jezovnik, M. Ilic, S. Shoukat, R. Radovancevic, T. F. Pagani5, T. Vassiliades6, J. Y. Rame3; 1Cardiology, University of
Sharma, S. S. Nathan, I. A. SalasdeArmas, S. Plavljanic, M. K. Patel, M. H. Pennsylvania, Philadelphia, PA, 2Cardiac Surgery, University of Pittsburgh,
Akay, B. Kar; Advanced Cardiopulmonary Therapies and Transplantation, Pittsburgh, PA, 3Cardiac Surgery, University of Pennsylvania, Philadelphia,
The University of Texas Health Science Center at Houston, Houston, TX. PA, 4Cardiology, Duke University, durham, NC, 5Cardiac Surgery, University
Study: Data on patients with left ventricular thrombi (LVT) who receive a of Michigan, Ann Arbor, MI, 6Medical Affairs, Medtronic, Framingham,
left ventricular assist device (LVAD) are scarce. We aimed to analyze the MA.
comparative diagnostic value of a pre-implant transthoracic (TTE) echo- Study: Left ventricular assist device (LVAD) support in advanced heart
cardiogram for LVT detection against the intraoperative findings at LVAD failure patients has been shown to improve overall survival, functional
implantation. We evaluated the prevalence and prognostic relevance of capacity and quality of life. Heart failure induces a pro-inflammatory
LVT up to 30-days post-op. state, contributing to the morbidity of this population. Although activa-
Methods: We reviewed patient characteristics, TTE images, intraopera- tion of inflammatory pathways has been implicated in acute thrombotic
tive findings and perioperative outcomes from our Center Data Registry. events in acute coronary syndromes, correlations in patients on LVAD
Patients who underwent implantation of LVAD from May 2012 to May support has yet to be demonstrated. This post hoc analysis of data from
2018 at our Center were included. the ENDURANCE (DT) and ENDURANCE Supplemental trials (DT2) seeks to
Results: 297 patients received their first LVAD implantation in this time examine the impact of LVADs on inflammation in these patients.
period (age: 57 ± 13 years; male 231 [78%]; race: Caucasian 140 [47 %], Methods: A retrospective analysis of the DT and DT2 trials was per-
African/American 99 [33 %] Hispanic 41 [14%], other 17 [5 %]); ischemic formed. Included were patients with complete C-Reactive Protein (CRP)
cardiomyopathy 151 [51 %], history of atrial fibrillation 116 [39 %]). 271 measures collected over two years: at pre-implant and 3, 6, 12, 18
patients had completed data sets used for analysis. TTE identified LVT in and 24 months post-VAD implant. Complete data was available for 55
26 patients (8.7 %), most of them were left ventricular apical thrombi. As patients receiving and HVAD System and 30 patients receiving the control
compared to those without, patients with LVT were younger and more device, the HeartMate 2 (HM2). Mean data over time by device cohort is
often had arterial hypertension, hyperlipidemia and had an implantable presented.
cardioverter-defibrillator (all P-values < 0.001). Noninvasive diagnosis Results: Mean CRP levels are initially elevated pre-implant, then decline
of LVT had a high sensitivity (93%) and specificity (96%), positive and by over 50% over time in patients in both study population, HVAD and
negative predictive values (52% and 99.6%). In the group of patients with control HM2. The pattern of mean CRP levels is similar in both popula-
preoperatively identified LVT, 4 patients experienced severe adverse out- tions, appearing to level off at 6 months (Figure 1). Although a significant
comes (3 ischemic strokes, 1 limb thromboembolism, 1 pump thrombosis, decrease in CRP levels occurred, CRP remained elevated beyond 6 months
3 of them died) in the first 30-days after LVAD implant. to 2 years (range 5–10 mg/L).
Conclusions: This is the largest study to analyze clinical characteristics and Conclusion: Analysis of the overall mean CRP levels in the DT and DT2
30-day outcomes of LVAD patients with LVT and assessed TTE accuracy trials reveal a significantly improved inflammation profile of destination
compared with intraoperative findings. TTE is a reliable noninvasive therapy patients supported over 2 years with an LVAD. This improvement
method for the assessment of LVT before LVAD implantation. is independent of device type, suggesting a link between deactivation
of inflammation and the reversal of heart failure with mechanical assist
device support. Future studies are required to test the hypothesis that
262 modulation of the inflammatory pathways may impact morbidity and
Percutaneous Coronary Intervention in Patients with Durable LVAD mortality on long term LVAD support.
S. Kuchibhotla1, A. Moctezuma1, V. H. Albornoz Alvarez2, H. Lamba2, L.
Simpson2, J. A. Morgan2, J. K. George2; 1Texas Heart Institute, Houston, TX,
2
Baylor College of Medicine, Houston, TX.
Study: The purpose of this study is to evaluate the incidence and pre-
sentation of patients who received a percutaneous coronary interven-
tion (PCI) at any time after durable Left Ventricular Assist Device (LVAD)
implantation at our institution.
Methods: We retrospectively analyzed the medical charts of all patients
who received a durable LVAD at our institution from 2014 through 2017.
Results: There were 301 LVADs implanted from 2014 through 2017 at our
institution. 22 of those patients underwent coronary angiography at some
point after LVAD implantation. Three patients received PCI and all had a history
of ischemic cardiomyopathy with different acute presentations (arrhythmia,
stable angina, and unstable angina). ECG and TTE were inconclusive in the
diagnosis of acute coronary syndrome (ACS) or obstructive coronary artery
disease. Troponin-I was not drawn in one patient, was normal in another, and
was elevated in the third patient. Two patients had a stent placed in the left cir-
cumflex artery and one patient had a stent placed in the right coronary artery.
Drug-eluting stents were used in two cases and bare metal stent was used in
the other one. Femoral artery was the access site for all three cases. There were
no complications. These results suggest that PCI necessity post-LVAD is rare and
ECG and TTE are often unreliable in the diagnosis of ACS post-LVAD. In addition,
anti-platelet therapy post-PCI is highly variable based on operator. Future stud-
ies need to be done to evaluate diagnostic clues to suggest ACS in this popula-
tion, ideal access site for coronary angiography, and appropriate type of stent
and anti-platelet therapy in this group with high risk for bleeding.

91
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ASAIO CARDIAC ABSTRACTS

267 268
Temporal Adverse Event Profile Following LVAD Implantation via a Should it Stay or Should it Go? A Review of LVAD Explants
Thoracotomy Approach: 2 Year Follow-up of the LATERAL Trial L. S. Eyadiel1, X. Cao2, B. Pisani1; 1Cardiology - Advanced Heart Failure,
G. Wieselthaler1, L. Klein2, A. Cheung3, S. Boyce4, S. Maltais5, M. Strueber6, Wake Forest Baptist Health, Winston Salem, NC, 2Department of Internal
T. Vassiliades7, E. McGee8; 1Cardiac Surgery, University of California Medicine, Wake Forest Baptist Health, Winston Salem, NC.
San Francisco, San Francisco, CA, 2Cardiology, University of California Study: Left ventricular assist devices (LVAD) are implantable, durable,
San Francisco, San Francisco, CA, 3Cardiac Surgery, St. Paul’s Hospital, mechanical circulatory support devices placed in qualifying advanced
Vancouver, BC, CANADA, 4Cardiac Surgery, Washington hospital Center, heart failure (HF) patients resulting in improved quality of life and sur-
Washington, DC, 5Cardiac Surgery, Mayo Clinic, Rochester, MN, 6Cardiac vival. Pump exchange (PEC) due to LVAD complications is an established
Surgery, Newark Beth Israel Medical Center, Newark, NJ, 7Medical procedure. Pump explant (PEP) following myocardial recovery (MR) (EF
Affairs, Medtronic, Framingham, MA, 8Cardiac Surgery, Loyola University, <40%) remains under investigation. Our cohort compared 3 groups of
Maywood, IL. patients who had a) PEP or pump deactivation for MR, b) PEC, and c) PEP
Study: The LATERAL Trial further established the safety and efficacy of due to complications from noncompliance (NC) thus deemed poor can-
HVAD implantation in patients with advanced heart failure using a tho- didates for PEC. NC included poor driveline site care resulting in driveline
racotomy approach. We are now examining the temporal risk of adverse infections and inconsistent anticoagulation resulting in pump thrombus or
events over longer term follow up of patients enrolled in the LATERAL stroke. Outcomes between groups were analyzed.
Trial. Methods: Of the 7 patients in the PEC group, 5 underwent heart trans-
Methods: The LATERAL trial was a multi-center, prospective, non-ran- plant (HT) and 2 had LVAD as destination therapy. The PEP due to NC
domized single arm trial that utilized data from 144 bridge to transplant group included 7 patients. At time of PEP, 3 had EF <40% and 4 had EF
patients enrolled in the Interagency Registry for Mechanically Assisted >25%. 6 of 7 patients in the NC group are alive with a mean survival of
Circulatory Support (INTERMACS®) database at 26 centers in the United 269 days, NYHA Class II-III. Ten patients had LVAD PEP for MR or NC and
States and Canada. The temporal adverse event profile through 2 years were managed with guideline directed medical therapy. 8 are alive, 3 with
was evaluated using the adverse event rate, expressed as events per ongoing MR, 2 who have undergone HT with a mean survival of 1346
patient year (EPPY). days.
Results: The 144 patients (23% women, mean age 54 years, 82% Results: Our cohort showed 80% survival with LVAD PEP for NC or MR.
INTERMACS profile 1–3) had a mean duration of support of 169 days. Although 57% in the NC group had reduced EF, given lack of compli-
The Kaplan Meier survival was 87% at 24 months. Detailed analysis of ance, PEC was not offered. NC is common post-LVAD resulting in adverse
the adverse events over follow-up time intervals of < 30 days, 30 to ≤ events and limited options. Our patients with MR at time of PEP had good
6 months, 6 months to 1 year, showed a decreasing number of adverse survival and 30% have maintained MR. However, 2 required HT and 1 is
events over time (Table 1). These results are comparable or better than undergoing evaluation. PEC patients were compliant and those classified
those observed previously in the BTT+CAP trial of HVAD implanted via a as bridge to transplant ultimately underwent HT. Predictors of sustained
sternotomy approach in a similar population. MR in PEP patients remain unknown. Though limited by low numbers at a
Conclusion: The longer-term follow-up of the LATERAL clinical trial further single site, our cohort demonstrates reasonable short term survival data
validates the safety of the implantation of the HVAD system via the tho- with PEP.
racotomy approach. Adverse events were more likely to occur in the first
30 days, and then were significantly reduced over time. Understanding
the changing risk profiles may aid in improving management of patients
implanted with HVAD system.

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269 270
Complete Sternal-Sparing HeartMate 3 Implantation Produces Excellent Very Long Term Outcomes of LVAD Support
3 Month Outcomes N. Brozzi, R. Cifuentes, I. Saba, S. Chaparro, A. Ghodzisad, A. Badiye, S.
B. Ayers1, K. Wood1, B. Barrus1, J. Alexis2, L. Chen1, C. Cheyne1, S. Prasad1, Vanegas, F. Andreopolus, M. Loebe; Thoracic Transplantation & MCS,
I. Gosev1; 1Cardiac Surgery, University of Rochester, Rochester, NY, University of Miami / Miami Transplant Institute, Miami, FL.
2
Cardiology, University of Rochester, Rochester, NY. Study: Limited data exists on very long term survival on left ventricular
Study: The purpose of this study was to analyze the outcomes of a less assist device (LVAD) support. We present patient characteristics and com-
invasive complete sternal-sparing HeartMate 3 (HM3) implantation plications associated with very long support.
technique. Methods: Retrospective study of our program experience including
Methods: Retrospective review of prospectively collected data was per- primary continuous flow LVAD recipients between January 2009, and
formed on 105 consecutive patients implanted with the HM3 at a single December 2015. Follow up was 100% complete. Patients receiving LVAD
institution. Patients were grouped into two cohorts based on surgical support >3 years were included in the study within long term (>3 years)
approach: traditional median sternotomy (sternotomy cohort) or com- and very long term (>5 years) of support. Patients who were transplanted,
plete sternal-sparing approach via bilateral thoracotomies (CSS cohort). explanted due to recovery, or died before three years were excluded.
Results: Of the 105 patients, 41 (39%) patients were implanted via CSS. Results: Of 81 patients receiving LVAD and alive past the initial six
Preoperative characteristics were similar between cohorts, including a months, 11 (14%) received long term LVAD support beyond three years,
large number of critically-ill Intermacs-1 patients in each group (41% vs and 6 patients (7%) received very long term support beyond 5 years. For
34%, p =0.536). The CSS cohort had better overall in-hospital survival patients in this cohort of long term LVAD support, age at implant was 62
to discharge (93% vs 81%, p=0.153) with a significantly lower incidence (range of 41- 77), male sex was 10 (90%). Devices included axial pump
of postoperative complications (24% vs 50%, p=0.014), including less (Heart Mate II) in 7 (63%), and centrifugal pump (HeartWare) in 4 (37%).
right ventricular failure (7% vs 28%, p=0.012). Ninety-day outcomes Clinical condition at time of LVAD implant included 3, 3 and 5 patients
demonstrated comparable overall survival (93% vs 81%, p=0.153) with INTERMACS I, II, and III respectively. Ten patients required at least 1
fewer hospital readmissions (15% vs 33%, p=0.042) and more time spent hospital readmission, 9 patients required 2, and 8 patients required ≥3
outside the hospital (99% vs 88%, p =0.030). Overall these results dem- readmissions to the hospital during support. Major complications on long
onstrate that the CSS approach is a safe surgical technique that may have term support included stroke in 2 (18%), pump thrombosis in 2 (18%), GI
potential advantages compared to the median sternotomy. bleeding in 4 (36%), and deep drive-line infection in 1 (10%). A total of 9
patients received surgical procedures while on LVAD support, including 1
pump exchange, right Impella removal, inguinal hernia repair, appen-
dectomy, hip replacement, cholecystectomy, and urologic procedures (2
patients) In conclusion, LVAD provide safe & effective support for long
(>3 year) and very long (>5 years) term. Most patients require at lead 1
hospital readmission during long term support, and are able to tolerate
regular surgical procedures as needed.

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271 273
Left Ventricular Assist Device Therapy for Systolic Heart Failure Oncostatin M (OSM): A Novel Biomarker to Predict Infection in (VAD)
Secondary to Peripartum Cardiomyopathy Recipients
G. C. Long, H. Lamba, A. C. Civitello, A. P. Nair, J. A. Morgan; Baylor H. Setiadi, A. M. El Banayosy, J. W. Long; INTEGRIS Advanced Cardiac
College of Medicine, Houston, TX. Care, INTEGRIS Baptist Medical Center, Oklahoma City, OK.
Study: Peripartum cardiomyopathy (PPCM) is an uncommon but severe Study: Infection remains a serious adverse event (AE) limiting VAD
complication of pregnancy, which may require placement of a left therapy. Advanced heart failure patients who have deteriorated prior to
ventricular assist device (LVAD). Several small case studies have reported receiving a VAD often have depleted reserves and activated inflammatory
outcomes of individual PPCM patients after LVAD support; however, none processes that may predispose them to infection. The ability to identify,
have evaluated outcomes in a larger sample size. prior to VAD implant, those who may be at increased risk for post-implant
Methods: Retrospective review of 11 patients at our institution who infections would be important for improving outcomes. We hypoth-
received LVAD implantation from 12/2001 to 06/2017 due to PPM was esize that OSM, a cytokine synthesized by neutrophils, macrophages,
completed in order to describe demographic characteristics, previous monocytes and T lymphocytes in infection and inflammation may be a
comorbid conditions, and outcomes post-LVAD implant. biomarker for predicting postop infection.
Results: PPCM patients were young at presentation (32.8 ± 4.6 years) with Methods: We measured OSM levels using ELISA in blood samples col-
a median pre-operative body mass index of 28.8 kg/m2 (20.6–47.8). Most lected from 41 patients starting a day before, right after VAD implanta-
were Caucasian (36.4%) or African American (36.4%). Almost all patients tion, POD 1,2,3, every other day until discharged and when they returned
(90.9%) had a previously diagnosed comorbidity prior to LVAD implant, for follow-up until 4 months. Patients were divided into 2 groups, Group A
with hypertension (54.5%), diabetes mellitus (45.5%), and ventricular with low OSM levels pre-op and Group B with elevated levels pre-op.
arrhythmias (45.5%) being most common. Post implant adverse events Results: There were 27 patients in Group A (OSM ≤100 pg/mL) and 14
included thrombotic events (36.4%), development of ventricular arrhyth- patients in Group B (OSM >100 pg/mL). OSM levels in Group A spiked
mias (36.4%), and the need for device exchange (36.4%). Additional after implantation and gradually decreased over 3 months. On the other
adverse events included one ischemic and one hemorrhagic stroke (18.2% hand, OSM levels in group B remained elevated throughout this same
total), device infection (18.2%), and right heart failure (18.2%). Overall period. Group B patients had a higher number of infections and sustained
median follow-up was 687 days (39–3824), with 2 patients lost to follow- inflammation (Kaplan-Meier analysis; p=0.003). Routine blood tests
up. Of the remaining 9 patients, mortality was 0% at 30 days and 33.3% at including WBC counts and differentials were not different between the
1 year. Recovery following LVAD explant was observed in 1 (9.1%) patient. two groups. Our findings show that patients with elevated pre-op OSM
Heart transplantation was performed in 3 (27.3%) patients, with 2 addi- levels maintained elevated levels post-op and were more likely to develop
tional patients still currently designated as bridge-to-transplant. Patients post-op infections and sustained inflammatory states. Routine pre-op lab
with PPCM were more commonly young, obese, and either African Ameri- tests were not helpful in differentiating patients who would later develop
can or Caucasian with at least one pre-operative comorbid condition. infections postoperatively from those who did not. This study suggests
Based on median follow-up, overall rate of transplant, and mortality, LVAD that OSM levels measured pre-operatively could be useful for predicting
implantation is an effective treatment for PPCM. risk of infections and prolonged inflammation after VAD implantation.

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274 279
Impact of LVAD Support on Outcomes after Combined Heart-Kidney Outcomes in Patients Supported on Left Ventricular Assist Devices
Transplantation Awaiting Heart and Heart-Kidney Transplant: A UNOS Database Analysis
N. Brozzi1, A. Mattiazzi1, I. Saba1, R. Cifuentes2, N. Narayannkutty3, J. M. P. Weber, J. Choi, E. J. Maynes, R. J. Morris, H. T. Massey, V.
Gaynor1, G. Guerra3, M. Loebe1; 1Thoracic Transplantation & MCS, Tchantchaleishvili; Division of Cardiac Surgery, Thomas Jefferson
University of Miami / Miami Transplant Institute, Miami, FL, 2Nephrology University, Philadelphia, PA.
and Renal Transplantation, University of Miami / Miami Transplant Study: Improvement of left ventricular assist devices (LVADs) has trans-
Institute, Miami, FL, 3Renal Transplantation, University of Miami / Miami lated to better outcomes for patients on LVAD support as a bridge-to-
Transplant Institute, Miami, FL. transplant. However, data is lacking regarding the subset of LVAD patients
Study: Use of left ventricular assistant device (LVAD) as bridge to heart with renal failure awaiting Heart-Kidney transplant (HKTx). We sought to
transplant has increased to over 50% across USA. Renal outcomes on better understand survival of patients in this group.
heart-kidney transplantation (HKT) for patients (pts) supported on LVAD Methods: The United Network for Organ Sharing (UNOS) database
are limited. We aimed to describe our single center experience in this was used to identify adult patients listed for heart transplant (HTx) or
population. HKTx from 01/01/2009 to 03/31/2017. Kaplan Meier analysis assessed
Methods: Retrospective review of combined HKT at our institution within waitlist and post-transplant survival. For waitlisted patients, both death
a 14 years interval (2004–2018). Outcomes assessed were operative sur- and removal from waitlist due to deteriorating medical condition were
vival to hospital discharge, patient and graft survival at long term follow considered events.
up, eGFR by CKD-EPI in adults and CKID in one child, incidence of delay Results: 26638 patients registered for transplant were analyzed. 25111
graft function (DGF), and biopsy proven acute rejection (BPAR). (94%) were listed for HTx, and 1527 (6%) were listed for HKTx. 7683 (29%)
Results: 18 HKT and 1 HK and pancreas transplant were performed, 7 patients listed for HTx had LVAD support. For those listed for HKTx, 441
(39%) of which were bridged with LVAD support for 369 days (range 113 (28%) underwent dialysis alone, 256 (17%) had LVAD support alone, and
- 1186 days). 15 pts (79%) were male with mean aged 47 y.o.(13-66y.o), 85 (6%) were treated with both LVAD and dialysis. 15567 (58%) under-
and race distribution included 2(11%) Caucasians, 12(63%) AA and 5(26%) went HTx, and 621 (2%) underwent HKTx. In these groups, post-transplant
Hispanics. Operative strategy involved 3 patients received simultaneous survival was similar (Fig. 1A, p=.06). LVAD patients listed for HTx had com-
HKT, while 16 patients received staged procedures with kidney transplant parable one year survival to HTx, but HTx survival was significantly greater
performed 28hs 54 min (range 9–47 hs) after heart transplant using in the longer term (Fig. 1B, p=<.001). Patients listed for HKTx treated with
ex-vivo pulsatile perfusion machine for the donor kidney. Operative both dialysis and LVAD had significantly worse waitlist survival compared
survival to hospital discharge was 95% and actuarial 1-year, 3 years and 5 to HKTx recipients (Fig. 1C, p=<.001). Patients listed for HKTx on LVAD only
years survival were 89.5%, 83% and 83% respectively, without difference had significantly greater survival compared to other treatments (Fig. 1D,
between groups (p<.05). With the longest follow up of 14.4 y in 1 patient. p=<.001).
No significant statistical difference was found in eGFR at 1m, 6m, 12 m Conclusion: Post-transplant survival is comparable between HTx and
were 87 + 37, 75 + 35, 67 + 26 mg/dl vs. 93 + 39, 77 + 29, 85 + 20 mg/dl HKTx, and early survival is similar between HTx patients and those listed
respectively in the LVAD and No LVAD cohort. The overall DGF rate was for HTx with LVAD support. However, outcomes on the waitlist for HKTx in
21%, No cases of cardiac graft rejection (grade≥2R) were identified, and LVAD patients on dialysis is significantly worse compared to HKTx recipi-
2 patients had rejection of the kidney graft (1 ATCR and 1 AMR) after ents. This highlights the need to account for this patient population when
one-year post HKT. No significant difference was observed on the need allocating organs.
for renal replacement therapy post HKT, non-fatal major adverse cardiac
events, freedom from graft rejection. Use of LVAD as bridge to HKT did
not increase mortality, nor decrease renal graft function post HKT.

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280 283
Ventricular Arrhythmias Following Continuous-flow Left Ventricular The Impact of LVAD Pulsatility Modes on Thrombogenicity
Assist Device Implantation: A Systematic Review A. Aliseda1, M. Miramontes1, K. Venkat1, F. Chassagne1, A. Straccia1, J.
J. S. Gordon, E. J. Maynes, J. Choi, C. T. Wood, M. P. Weber, R. J. Morris, Beckman2, S. Li2, K. Koomalsingh3, C. Masri2, T. Dardas2, R. Cheng2, A.
H. T. Massey, V. Tchantchaleishvili; Division of Cardiac Surgery, Thomas Stempien-Otero2, S. Lin2, E. Minami2, G. Wood2, S. Farris2, J. Kirkpatrick2,
Jefferson University, Philadelphia, PA. F. H. Sheehan2, S. Rockom2, C. Mahr2; 1Dept. Mechanical Engineering,
Study: Ventricular arrhythmias (VA) are not uncommon after contin- University of Washington, Seattle, WA, 2Dept. Cardiology, University
uous-flow left ventricular assist device (CF-LVAD) implantation. In this of Washington, Seattle, WA, 3Dept. Surgery, University of Washington,
systematic review, we sought to identify the patterns of ventricular Seattle, WA.
arrhythmias that occurred following CF-LVAD implantation and evaluate Study: This study examines the impact of LVAD pulsatility modes on the
their outcomes. instantaneous flow rates and pressures in different points of the systemic
Methods: An electronic search was performed to identify all articles and pulmonary circulation, with a particular emphasis on reducing
reporting the development of VA following CF-LVAD implantation. VA was thrombogenicity
defined as any episode of ventricular fibrillation or sustained (>30 sec- Methods: The response to LVAD pulsatility modes of the entire car-
onds) ventricular tachycardia. Eleven studies were pooled for the analysis diovascular system in a patient-derived computational hemodynamic
that included 393 CF-LVAD patients with VA. lumped parameter model (CHLPM) is analyzed under varying conditions:
Results: The mean patient age was 57.4 years (95%CI 53.5; 61.4) and LVAD speed, mean arterial pressure (MAP) and peripheral vasodilation.
82% [95%CI 73; 88] were male. Overall, 37% [95%CI 19; 60] of patients The CHLPM incorporates systemic and pulmonary circulation in all four
experienced new VA after CF-LVAD implantation while 60% [95%CI 51; cardiac chambers, as well as intrinsic baroreflex, LVAD parallel circulatory
69] of patients had a prior history of VA. Overall, 88% [95%CI 78; 94] were pathways and the aortic valve. We employ LVAD-specific H-Q relationships
supported on HeartMate II, 6% [95%CI 3;14] on Heartware HVAD, and to represent the flow-MAP instantaneous relationship in circulation under
6% [95%CI 2; 13] on other CF-LVADs. CF-LVAD was implanted as bridge to existing LVAD pulsatility profiles for both the HVAD and the HeartMate 3.
transplant in 59% [95%CI 49; 71] and destination therapy in 41% [29; 54]. The dynamical coupling between LVAD performance and patient hemo-
VA was symptomatic in 47% [95%CI 28; 68] of patients and in 50% [95%CI dynamics, in the presence of synchronization / asynchronization of the
37; 52], early VA (< 30 days from CF-LVAD) was observed. Suction events pulsatility mode with the native cardiac cycle is simulated to analyze the
were believed to be the cause of VA in 3% [95%CI 1; 9]. Ablation therapy optimal hemodynamic conditions
was administered in 82% [95%CI 28; 98] of those with VA. The 30-day Results: Hemodynamic parameters, such as MAP, cardiac output, and
mortality rate was 7% [95%CI 5; 11] and long-term survival is shown filling pressures are simulated for VAD patients in the presence pulsatility.
(figure). Mean follow up was 22.6 months [95%CI 4.8; 40.8], during which A range of of systemic vascular resistances and blood pressure manage-
27% [95%CI 17; 39] of patients underwent heart transplantation. ment strategies are incorporated into the model to explore the effects of
Conclusion: A significant number of patients had new onset VA following LVAD pulsatility. We find that even when MAP and baseline LVAD speeds
CF-LVAD placement. VA in CF-LVAD patients is often symptomatic, neces- are optimized, activation of the pulsatility mode introduces a significant
sitates treatment, and carries a worse prognosis. disruption, wherein the instantaneous flow through the LVAD drops,
inducing LV stasis or suction, depending on synchronicity with the native
cardiac rhythm. Thus, LVAD pulsatility modes need to be calibrated to pro-
vide optimal hemodynamic performance for LV and aortic flow, to achieve
better long-term outcomes of LVAD support

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285
Outcomes of Percutaneous Temporary Biventricular Mechanical
Support: A Systematic Review
M. P. Weber, J. Choi, E. J. Maynes, K. W. Prochno, M. A. Austin, S. Patel,
R. J. Morris, H. T. Massey, V. Tchantchaleishvili; Sidney Kimmel Medical
College, Thomas Jefferson University, Philadelphia, PA.
Study: Biventricular use of percutaneous ventricular assist devices
(BiVAD) is a recently developed treatment option for severe cardiogenic
shock. The aim of this systematic review is to identify indications and
outcomes of patients placed on percutaneous BiVAD support.
Methods: An electronic search was performed to identify all relevant case
reports or series. All devices were placed percutaneously. After assess-
ment for inclusion and exclusion criteria, 15 studies were identified.
Results: All 20 patients were supported with a micro-axial LVAD, 12/20
(60%) of those patients were supported with a micro-axial RVAD (RMS),
and the remaining 8/20 (40%) patients were supported with a centrifugal
extracorporeal RVAD (RCS) (table). All patients presented with cardiogenic
shock and of these, 12/20 (60%) presented with a non-ischemic etiology
vs 8/20 (40%) with ischemic disease. For the RMS group, RVAD support
was significantly longer [RMS 5 (IQR 4–7) days vs RCS 1 (IQR 1–2) days,
p=0.03]. Intravascular hemolysis post-BiVAD occurred in three patients
(27.3%) [RMS 3 (33.3%) vs RCS 0 (0%), p=0.94]. Two patients were tran-
sitioned to extracorporeal membrane oxygenation (n=1) and intra-aortic
balloon pump (n=1) support. One patient received a durable VAD, one
patient received a total artificial heart and one patient received heart
transplantation. Estimated 30-day mortality was 15.0% and 78.6% were
discharged alive from the hospital. Kaplan-Meier analysis of estimated
survival is shown.
Conclusions: Both strategies for percutaneous BiVAD support appear to
be viable options for severe cardiogenic shock. Selection and reporting
bias should be kept in mind when interpreting the outcomes that appear
favorable.

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286 288
Evaluation of the Effect of Heart Rate on Real-Time Output of Superior Vena Cava Syndrome from Percutaneous Right Ventricular
HeartMate3 using a Mock Circulation Assist Device Use in the Management of Right Ventricular Failure
J. R. Crosby, E. Betterton, J. Yi, M. Carstens; Banner University Medical B. Badu, M. Cain, A. Mohammed, D. Joyce; Medical College of Wisconsin,
Center Tucson, Tucson, AZ. Milwaukee, WI.
Study: Our center’s patients with a HeartMate 3 (HM3) have communi- Study: Percutaneous right ventricular assist device (RVAD) support via
cated lightheadedness, dizziness and tunnel vision intermittently after right internal jugular (IJ) vein has emerged as a viable solution for treating
implant. In order to troubleshoot these symptoms, we developed a refractory RV failure. Recent reports have shown that RVAD support with
method to visualize real-time cardiac output from a HM3 on a mock circu- this approach can be beneficial in a variety of clinical scenarios includ-
lation loop using a Centrimag flow probe. Because the HM3 only displays ing post cardiotomy RV failure, cardiogenic shock, and severe acute
average cardiac output and power on the hospital monitor and control- hypoxemic respiratory failure with associated RV dysfunction, as well as
ler, real-time VAD cardiac output from the Centrimag allows for in depth decreased mortality compared to surgically implanted RVADs. However,
analysis of pump outflow during HM3’s artificial pulse ramping periods. the safety profile of such devices has not been characterized.
Methods: A Syncardia 70cc TAH in conjunction with a HM3 was con- Methods: A comprehensive retrospective review was completed for all
nected to a Donovan Mock Circulation Tank filled with water. A Centrimag patients receiving percutaneous RVAD support via a right internal jugular
flow probe was positioned on the outflow tubing of the HM3. The TAH route with either 28 or 31F cannula at our institution between April 2017
was set to mimic left-ventricular heart failure. Heart rate of the TAH was and December 2018. Preoperative patient demographics, intraoperative,
varied between low, high, odd and even rates. Real-time output of the and postoperative outcomes were assessed, with specific focus on device
LVAD was visualized on the Centrimag Monitor; a comparison between 60 related complications.
and 61 BPM is shown in Figure 1. Results: Thirty-eight patients (27 men, 71.1%) with mean age of 52
Results: HM3 outflow appeared to be highly sensitive to heart rate. For years ± 15.6 and refractory RV failure were managed with a percutane-
example, when the rate of the TAH was even (60 BPM), the HM3 output ous RVAD inserted through the right IJ. Of these 38 patients, 3 (7.9%)
waveform was consistent, with negative and positive deflections of the patients demonstrated device related superior vena cava (SVC) syndrome
output occurring at the same time in the cardiac cycle every two seconds resulting from obstruction of the SVC with the RVAD cannula. One patient
(coinciding with the artificial pulse cycling); notice that VAD flow regularly managed by head of bed elevation and early removal of the device. Two
drops to 0 LPM in this scenario. However, when the rate of the TAH was were treated by connecting a “venting” tubing to the side port on the
odd (61 BPM), the HM3 output waveform is inconsistent, with negative introducer sheath and placing back into the ECMO circuit to decompress
and positive deflections occurring at different times during the cardiac things. Symptoms resolved in all 3 patients and no deaths resulted from
cycle. These results show that output of the HM3 is highly dependent SVC syndrome.
on heart rate and the time during the cardiac cycle in which the artificial SVC syndrome related to percutaneous RVAD placement is an important,
pulse occurs. Patients may become symptomatic depending on when in but previously undescribed postoperative complication of RVAD use. Early
the cardiac cycle the HM3’s artificial pulse begins. identification allows safe management of this complication, which does
not detract from the safety of percutaneous RVAD support.

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289 290
Opioid Usage in Patients Undergoing Left Ventricular Assist Device Higher Vasoactive Inotropic Score is Associated with Incidence of Acute
Implantation: Correlation to Patient Characteristics and Outcomes? Kidney Injury in Adult Cardiogenic and Respiratory Shock
S. Schettle, H. Alnsasra, A. Clavell, R. Daly, A. Glasgow, E. Habermann, J. T. Nakajima, Y. Tanaka, I. Fisher, K. Kotkar, R. Damino, M. Moon, M.
Stulak; Mayo Clinic, Rochester, MN. Masood, A. Itoh; Washington University in St. Louis, Saint Louis, MO.
Study: Opioid usage in patients undergoing surgical procedures has come Study: Prolonged high-dose inotropic/vasopressor support likely causes
under increased scrutiny. Limited data exists regarding opioid prescribing end-organ damage and poor outcome in severe cardiogenic and respira-
practices and outcomes in patients undergoing LVAD implantation. We tory shock patients. Vasoactive-inotropic score (VIS), a measure of chemi-
sought to examine overall opioid usage, patients receiving high opioids cal cardiovascular support, has been investigated predominantly in infant
post LVAD, and analyze correlations to outcomes. associated with morbidity and mortality. We sought to determine the
Methods: Between 02/2007 and 11/2017, 384 patients underwent significance of VIS in the adult shock patient population.
primary implant of a continuous flow LVAD at our Clinic. Upon dismissal Methods: 187 patients underwent extracorporeal membrane oxygenation
after LVAD implant, 59 pt (15%) received > 200 oral morphine equivalents (ECMO) support for cardiogenic or respiratory shock from 2016 to 2017.
(OME). Patients dismissed on >200 OME were similar in preoperative VIS was calculated based on inotropic/vasopressor dose (weight-based
characteristics to those dismissed with < 200 OME, including destination dose of norepinephrine ×100, vasopressin ×10,000, epinephrine ×100,
therapy (58% vs. 66%, p=0.54), male sex (85% vs. 80%, p=0.25), ischemic milrinone ×10 and dobutamine ×1) recorded at ECMO initiation, 24 and
etiology (48% vs. 44%, p=0.7), right ventricular dysfunction (grade 3 vs. 48 hours later. All clinical outcomes including acute kidney injury (AKI)
grade 3, p=0.65), and preoperative intra-aortic balloon pump (47% vs. and survival were analyzed.
45%, p=0.65); however, less underwent redo sternotomy (20% vs. 37%, Results: A total of 187 patients were included: 86 patients had VIS>15
p=0.014). at 24hr post ECMO initiation while 101 had VIS<15. High VIS at 24hr was
Results: Early after LVAD implantation, patients in the >200 OME group significantly associated with AKI (p=0.01) but not with mortality. Multi-
had similar RV failure compared to the <200 OME group (13% vs. 18%, variate logistic regression model showed that 48hr VIS (AOR 1.03, 95% CI
p=0.42), acute renal failure (19% vs. 28%, p=0.14), and median LOS (20 1.0–1.1) and older age (AOR 1.03, 95%CI 1.02–1.08) were independently
days vs. 18 days, respectively, p=0.13). High OME patients had lower pro- associated with mortality. Higher VIS at the time of ECMO initiation was
longed mechanical ventilation (7% vs. 22%, p=0.007) and more readmis- not a risk factor for worse outcome. High VIS at 24 hours on ECMO was
sions (<6 months) (76% vs. 56%, p=0.0097) with time to first readmission associated with higher incidence of AKI. Also, older age and higher 48hr
significantly shorter (2.2 months vs. 4.9 months, p<0.001). Patients with VIS adversely affected survival. Sustained vasopressor/inotropic dose on
high OME had less complex VAD implant (less redo sternotomies), less ECMO can cause end-organ damage and suboptimal outcome. Further
postoperative morbidity (less prolonged mechanical ventilation), and investigations in VIS with adult patients may help us utilize VIS as a predic-
higher early hospital readmission rates at a shorter time interval from tor of shock outcome.
hospital dismissal. Opioid usage after LVAD did not appear to correlate
with complexity of procedure or increased morbidity, but was associated
with higher readmission. These practice patterns require more in depth
analysis in the setting of greater scrutiny of opioid usage.

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291
Which Type of Impella Should We Select in Cardiogenic Shock Patients
Supported with Extracorporeal Membrane Oxygenation?
T. Nakajima, Y. Tanaka, I. Fisher, K. Kotkar, R. Damiano, M. Moon, M.
Masood, A. Itoh; Washington University in St. Louis, St. Louis, MO.
Study: While Impella 5.0 can be implanted through the axillary artery,
others (2.5 or CP) are often inserted through the femoral artery. Further,
combined support of ECMO and Impella is increasingly utilized in severe
cardiogenic shock patients. We sought to investigate the differences
between Impella types with ECMO support.
Methods: In this retrospective study, 62 patients underwent Impella
insertion with ECMO support for cardiogenic shock from 1/2016 to
4/2018. We divided the patients into two groups: 16 patients with ECMO
plus Impella 5.0 (E+I5) and 46 with ECMO plus Impella 2.5 or CP (E+I2.5/
CP). Baseline characteristics, hemodynamic data, and outcomes were
assessed at the following timepoints: immediately prior to combined
support initiation, 48 hours on combined support, and 30 days. The
primary outcome was all-cause mortality within 30 days of post device
implantation.
Results: After 48 hours, pulmonary artery (PA) systolic pressure was signif-
icantly reduced in both groups, E+I5 (47.0 to 33.0, from pre to 48 hours,
p<0.01) and E+I2.5/CP (46.1 to 31.2, p <0.01) (Figure). Impella flows were
significantly greater in the E+I5 group (3.4 vs. 2.5, p <0.02). There was no
significant difference in ECMO flow between the two groups (3.9 vs. 4.5,
p =0.10). Impella-related vascular complications including bleeding requir-
ing surgery and limb ischemia occurred in 1 case in E+I5 and in 15 cases
in E+I2.5/CP (P=0.04) (Table). Both types of Impella when utilized with
ECMO demonstrated similar survival and ECMO decannulation rates, and
PA pressure reduction. However, vascular complications were prevalent
in groin insertions with Impella 2.5/CP. Considerations of vascular access
may be more important when Impella is utilized with ECMO for severe
cardiogenic shock.

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295
Impact of Less Invasive Extra-Pericardial Placement (LIEPP) of LVAD
Devices on Right Ventricular Dysfunction
P. Bonde, K. Stawiarski, O. Agboola, A. Geirsson, G. McCloskey,
J. Park; Yale University School of Medicine, New Haven, CT.
Study: Less invasive extra-pericardial placement (LIEPP) of LVADs is being
explored to address post-implant adverse events. We examined the differ-
ences in early 90-day right ventricular failure (RVF) between LIEPP versus
standard median sternotomy (MS) approaches.
Methods: A systematic analysis of 173 LVAD patients implanted between
June 2011 and September 2018 was conducted. Six patients were
excluded: four with RVAD placement before LVAD, one with giant cell
myocarditis, and one with >40% missing data. LIEPP was performed in 36
patients and 131 had MS implantation. Outcomes for RVF including RVAD
need and bleeding were compared using Fisher’s test for categorical
variables, Mann-Whitney test for continuous variables, and multivariate
for cause of RVF.
Results: Compared to the MS cohort, the LIEPP group consistent of
patients with greater age (62.8 vs 57.9 yrs) p=0.03; higer INTERMACS pro-
file (INTERMACS 1 =72.2% vs 30.5%) p=0.0004; greater IABP use (44.4%
vs 26.0%) p=0.03; higher preop BUN (mg/dL) 36.5(25.5 - 56.0) vs 28.0
(19.0 - 41.0) p=0.01; and lower preop hemoglobin (g/dL) 10.0 (8.8 - 11.7)
vs 10.6 (9.8 - 12.2) p=0.01. LIEPP showed a significantly lower rate of
bleeding through chest tube output (p=<.0001) and tended to require less
transfusion (p=0.77). There were no RVADs required post LVAD (p=0.03)
with LIEPP and fewer cases of RVF (8.3% vs 13.2%) (p=0.43). Multivariate
regression did not reveal a significant association with RVF or RVAD use
with LIEPP.
LIEPP reduces the early 90-day incidence of RVF and thus need for RVAD.
With the integrity of the pericardium maintained, the LIEPP may prevent
RV dilation and RVF. Likewise, a reduction in blood product use removes
potential influence on pulmonary vascular resistance that can predispose
to RVF. These trends were seen despite the worse preop profile of the
LIEPP group highlighting the preferred choice of LIEPP for poor surgical
candidates.

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79 82
Impact of Plasma-free Hemoglobin (PHb) on Endothelialization of A Standardized Approach to ECMO Cannulation and Training
Coronary Artery Stents Y. Tipograf1, W. D. Gannon2, N. M. Foley2, W. McMaster2, A. S. Shah3,
J. Simoni1, P. Simoni2, J. X. Castillo3, D. E. Wesson4; 1Texas M. Bacchetta1; 1Thoracic Surgery, Vanderbilt University Medical Center,
HemoBioTherapeutics & BioInnovation Center, Lubbock, TX, 2Texas Tech Nashville, TN, 2Vanderbilt University Medical Center, Nashville, TN,
University Health Sciences Center & Covenant Health System, Lubbock, TX, 3
Cardiac Surgery, Vanderbilt University Medical Center, Nashville, TN.
3
Hospital Regional Dr. Valentin Gomez Farias, Zapopan, MEXICO, 4Baylor
Scott & White Health and Wellness Center and Texas A&M College of Study: Deployment of extracorporeal membrane oxygenation (ECMO)
Medicine, Dallas, TX. has increased substantially over the last decade due to technological
advancements and broader indications for use. Despite this influx, stan-
Study: PHb is associated with numerous clinical conditions. PHb is dardized processes for procedural training and operator technique within
elevated in patients with advanced heart failure, on LVAD, during CPB and and across institutions are lacking. A protocolized approach to percuta-
undergoing high risk PCI. PHb-driven endothelial (EC) dysfunction is well neous ECMO cannulation and operator training was developed using a
documented. Impaired EC function and delayed re-endothelialization are simulation-based cadaveric model and procedural checklist.
the major limiting factors of vascular stenting. Methods: Structured teaching was provided in groups of 2 to 4 surgeons.
Methods: This ex-vivo study investigated the effect of PHb on seeding The 3-hour training included a didactic lecture on ECMO configurations
efficiency of human coronary artery EC into stents: sirolimus-eluting (SES) using case studies, instructor demonstration of cannulation using a
and paclitaxel-eluting (PES). The tested Hb level was 150 mg/dL. EC seed- checklist, and trainee cannulation and decannulation of cadavers with
ing efficiency was examined up to 7 days monitoring: (i) growth on the benchmark evaluation by experienced operators. Pre- and post-course
surface, and (ii) growth underneath the stents. EC were evaluated for the tests were distributed to trainees to evaluate content delivery and com-
expression of adhesion molecules and apoptosis. prehension using test score data. A course evaluation was provided at its
Results: An attempt to culture EC on the surface of PES with or without conclusion using a ranking system of 1 (strongly disagree) to 5 (strongly
Hb was unsuccessful. After one day EC deattached and become necrotic. agree).
The growth and proliferation of EC on and under SES was not affected, Results: Seven cardio-thoracic fellows underwent the cannulation course.
unless incubated with Hb, which resulted in inflammatory and early The mean pre-test score was 60.7% and post-test score was 91.1%.
apoptotic responses. The mean individual improvement in test score was 28.5%. All trainees
Conclusions: The stents chemical composition is a determining factor in performed cannulation and decannulation benchmarks. All trainees
endothelialization. PHb is detrimental to endothelialization. marked “strongly agree” when asked if they believed the course improved
their ability to safety perform cannulations. Six trainees (87.5%) marked
“strongly agree” when asked if the course improved their technical skills.
A standardized, measurable approach to cannulation technique and
training may be reproducible across institutions and improve operator
knowledge and technical proficiency.

102
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154 204
ECMO in Post Cardiac Arrest Myocardial Dysfunction, Single Centre Water Infused Surface Protection (WISP) as an Active Method to Prevent
Experience and Treat Thrombotic Complications in Central Venous Catheters
M. Abdalla; Anesthesia and ICU, Cairo University, Cairo, EGYPT. D. W. Sutherland, Jr.1, J. L. Charest2; 1Mechanical Engineering, Boston
Study: Our observational study describes management of five patients University College of Engineering, Boston, MA, 2Draper Laboratory,
with post cardiac arrest myocardial dysfunction. A single center Cambridge, MA.
experience. Study: Central venous catheters (CVCs) are implanted in many dialysis
Methods: Four from five patients were referred from other centers for patients despite high morbidity and mortality rates. A predominant
ECMO, the fifth was referred from our center operating room. complication associated with CVCs is fibrin sheath formation which can
Haemodynamic data were collected during ICU stay including heart rate, lead to flow obstruction and biofilm formation. Current solutions to both
blood pressure, saturation, cardiac output, systemic vascular resistance prevent and treat these complications can be costly, time consuming,
Ventilator parameters were recorded during ICU stay; Inotropes used and ineffective. We propose an active mechanism to both prevent and
were recorded hourly treat the formation of fibrin sheaths and biofilms, Water infused Surface
Echo was done daily and daily measurement of EF and VTI Protection (WISP).
ECMO was used in patients with VTI less than 10 cm and hemodynamic Methods: An in vitro model consisting of a hollow fiber membrane (HFM)
instability in spite of used of inotropes mounted in a concentric test chamber was used to simulate WISP CVC
Results: We had four adult patients less 45 years age and one pediatric functionality. We flowed blood through the HFM while the concentric
patient 14 years old, all had cardiac arrest two intra operative and one chamber was pressurized with saline to create a continuous infusion
patient during hysterosalpinography and two others in intensive care. across the HFM wall. The saline flow across the wall creates a clean fluid
One after myocarditis and the other after septic shock. boundary layer between the blood and HFM wall. In some cases, doped
ECMO was used successfully in two adult patients and complete recovery saline was used in order to deliver drugs to the inner lumen wall of the
of myocardium in less than one week in both patients modeled CVC in order to remove adherent material.
Levosimendan was used successfully in one patient with complete recov- Results: Saline WISP was found to reduce the average blood protein
ery in less than week adsorption up to 96% when compared to a model CVC tested without
Epinephrine and nor epinephrine were used in classic tokotsobo cardio- WISP, as shown in Figure 1 (* denotes P≤0.016, 2-way ANOVA).
myopathy patient with complete recovery Additionally, the WISP was shown to reduce previously adsorbed protein
A pediatric patient with ARDS and heart failure was treated with epineph- films during continuous blood flow, deliver chemical agents, such as
rine and nor epinephrine and showed initial myocardial recovery followed heparin, to the inner lumen wall, and reduce the obstructions caused by
by deterioration and death large inner-lumen thrombotic adhesions.

The novel WISP technology presented here has shown the ability to
prevent protein adsorption, remove pre-adsorbed protein films during
CVC use, deliver drugs to the point of biologic adhesion and reduce the
effect of thrombotic flow occlusions. The functionality that this technol-
ogy presents have the potential to reduce CVC complications, treatment
times, and incurred costs while extending CVC life.

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296
Efficacy of a Bundle Approach for Safety in Adult Patients on ECMO
M. Tukacs; Nursing, Cardiothoracic ICU, Columbia University Irving
Medical Center, New York, NY.
Study: The delivery of extracorporeal membrane oxygenation (ECMO
therapy can be challenging. From January to May 2016, of the 42 ECMO
runs with a femoral cannula (FC) in our Cardiothoracic (CT) ICU, there
were 3 unplanned ECMO decannulations. To standardize care and prevent
events related to ECMO with FC, we created the “ECMO Bundle”, in use
since the third quarter of 2016.
Methods: Two electronic data record systems were retrospectively
reviewed for the CTICU, from September 2016 to December 2018: medi-
cal records to obtain data on the volume of ECMO runs, and institutional
safety event records related to ECMO. Inclusion criteria for the medical
record review were: age >18 years, ECMO with FC. Inclusion criteria for
the event record review also included: unplanned ECMO FC dislodgment,
disconnection and decannulation.
Results: There were 198 ECMO runs, no unplanned FC dislodgment or
decannulation, and 1 unplanned FC disconnection. The disconnection
event was a disconnection of the distal perfusion cannula (DPC) from
the femoral reinfusion cannula likely due to tension on the flow sensor
cable (FSC) attached to the DPC. Attaching an FSC to the DPC was a new
practice, without prior staff education on its clinical implications. The
ECMO Bundle was enhanced to include: monitoring of the FSC and the
DPC connection to the FC, and a more detailed instruction on clamping
points on cannulas in an emergency. Our data shows a bundle approach
for safety in adults on ECMO to be effective. We recommend creating a
bundle including configuration of ECMO cannulas.

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ASAIO NURSING-ALLIED HEALTH-CIR SUPPORT ABSTRACTS

14 16
Effect of Smoking on Surgical Outcomes after Left Ventricular Assist Must I Always Be Burdened by This Gift
Device Implantation and the Relation to Nicotine Cessation Treatments: J. Giordano; Heart/Lung Transplant, Newark Beth Israel Medical Center,
A Pilot Retrospective Study Newark, NJ.
R. Spiller, P. Combs, T. Symalla, C. Labuhn, N. Uriel, V.
Jeevanandam; Cardiac and Thoracic Surgery, University of Chicago, Study: P.C. was 19 years old when she was diagnosed with Hypertrophic
Chicago, IL. Cardiomyopathy. For over 40 years P.C.’s condition was managed with
oral medications. At age 62 P.C.’s health began rapidly declining. She
Study: This retrospective pilot study aimed to elucidate the effect of was referred by her primary cardiologist for an evaluation for cardiac
nicotine on left ventricular assist device (LVAD) implant surgical outcomes transplantation.
and determine how smoking cessation programs could potentially affect Methods: In the pre-transplant phase insight was gained into how P.C.
these results. defined her life. Supportive counseling sessions with P.C. helped to pro-
Methods: A single institution, retrospective analysis of 292 patients that vide a forum for her to explore her hopes and fears as well as her grief as
received a LVAD from 2013–2018 was performed. Each patient was char- she thought about her own death and that of her donor. P.C. underwent
acterized as a current, former, or non-smoker at the time of implant. Con- cardiac transplantation at age 63. She experienced a prolonged hospital
trolling for age, gender, and race, multivariate linear regression was used stay following her transplant due to rejection. P.C. suffered multiple
to assess the effect of smoking on survival, total hospital readmissions episodes of rejection and frequent admissions during her first year post
and hospital readmissions for LVAD-related adverse events (GI bleeding, transplant. P.C. expressed grief over the loss of control of her body as well
driveline infections, sepsis, stroke and hemolysis). We then extrapolated as life as she knew it. P.C. was aware of societal expectations regarding
documentation regarding smoking cessation treatments to explore any this new gift of life she was given. What would it mean if she didn’t exude
relation with nicotine use, outcomes and smoking cessation method. joy? Supportive counseling sessions allowed P.C. to reveal her compli-
Results: Approximately 33% of the patients were never smokers, 55% cated grief in a non- judgmental environment where her feelings could be
were former smokers, and 11% were current smokers. The majority of normalized.
patients were either African-American (48%) or Caucasian (44%) and Results: We as clinicians need to become more aware of the complexity
median age at time of implant was 58 years. Former smokers (p=0.035) of the often, unacknowledged, complicated grief experienced by peri-
and African-Americans (p=0.021) were more likely to be readmitted to transplant patients. Supportive counseling may prove to be an effective
the hospital for any reason. Current smokers (p=0.034) were more likely tool in treating this cohort. Further research to study grief and coping
to be readmitted for hemolysis. African-American (p=0.016) race was a mechanisms in heart transplant patients is needed to better understand
predictor for total number of readmissions for driveline infections. The this population.
Kaplan-Meier analysis did not show any statistically significant differences
based on smoking status. Patients were inconsistently asked about their
smoking status before and after implant. Further, smoking cessation
programs were not offered to all current smokers.
Conclusions: This pilot project illustrates a framework for a multi-
center study which will be implemented to compare nicotine cessation
programs and outcomes to explore techniques, successes and areas of
improvement.

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ASAIO NURSING-ALLIED HEALTH-CIR SUPPORT ABSTRACTS

27
Ventricular Assist Device Program Models: An International Study
K. Meehan1, L. Coyle2, P. Combs1; 1University of Chicago, Chicago, IL,
2
Advocate Christ Medical Center, Oak Lawn, IL.
Study: Advanced technology and improved outcomes have led to rapid
growth in ventricular assist device (VAD) programs. Despite nearly 175
programs in the United States (US) and 350 International programs, a
paucity exists regarding their structure. We sought to study VAD pro-
grams, on a global level, to explore current trends of VAD program models
throughout the world.
Methods: From October 31 to December 1st, 2018, we conducted a
26-question online survey which was administered to 321 individuals.
Four categories of questions were formed (Figure 1): patient manage-
ment, VAD coordinator role, multidisciplinary support, and leadership.
Results: In total, 58 surveys (52 US, 6 international) were obtained and
analyzed. In patient management, the majority (62%, n = 36) of programs
cared for 26–100 VAD patients, followed by 26% (n = 15) that cared for
≤ 25 patients, and 12% (n = 7) of programs that cared for ≥ 100 patients.
Nine programs identified themselves as serving only destination therapy.
In the VAD Coordinator role, advanced practice providers (APPs) were
utilized in 69% of the programs (n = 40). In-hospital rounding was per-
formed equally among APPs and RNs (55%, n = 32), while call was covered
by RNs in 75% (n = 43) of programs. Of note, VAD coordinators were not
involved in research in 21% of programs, and were deemed the primary
person to manage outpatient equipment in 58%. Most programs have a
social worker (90%), clinical nutritionist (74%), pharmacist (72%), pallia-
tive care (66%), and finance coordinator (64%) as part of their multidisci-
plinary team supporting the VAD coordinator role. Only 43% of programs
had a case manager and 33% utilized a pharmacist to manage patient
anticoagulation needs. The program leader was identified as a cardiolo-
gist 31% (n = 18), cardiac surgeon 26% (n = 15) or shared equally 43% (n =
25). This study demonstrates that disparities and similarities exist within
VAD programs regarding their structure. Additional research is warranted
evaluating the effect of program structure on patient outcomes.

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ASAIO NURSING-ALLIED HEALTH-CIR SUPPORT ABSTRACTS

50 Results: Initially 78 surveys were received with the exclusion of 9 surveys


Differences in Mechanical Circulatory Support Programmatic Make-Ups: for lack of completion, leaving a resultant 69 surveys to analyze (return rate
Defining Delineation of Duties 20%). Of those surveyed, 97% (n=67) were in the USA, 40.6%% (n=28) fell
S. E. Schroeder1, M. Baker2; 1MCS, Division of CT surgery, Bryan Heart, in the 34–44 year old age category, nearly 32% (n=22) were in their current
Lincoln, NE, 2Division of Cardiology, Bryan Heart, Lincoln, NE. field for 2–4 years and a resounding 87% (n=60) were Female. Registered
Study: The success of Mechanical Circulatory Support (MCS) programs rely Nurses (RN) made up the primary background (60.9%, n=42), and major-
on the dedication of individuals within the programs. However, questions ity implanted 11–20 MCS devices per year (29%, n=20). There was 52%
continue to arise as to appropriate ratios of patients and how to retain MCS who had >50 patients actively on device (n=36). Team member break
Coordinators. We theorized that the amount of duties and responsibilities down included (mean±SD): Cardiologists 4.06±2.52; Surgeons 2.01±0.98;
placed on the MCS Coordinators have more significance within programs, RN Coordinators 2.47±2.34; Advanced Provider Coordinators 1.67±2.21;
and therefore attempted to more clearly define these roles. Social Workers 1.06±0.92; Dedicated Educators 0.42±1.44; and Dedicated
Methods: Members (n=345) of the MCS Collaboration email group were Assistants 0.78±0.95. MCS Coordinators take on significant responsibilities
asked to complete a self-administered online survey regarding the make- within programs, as demonstrated with Table 1. Program directors need
up of duties in MCS programs. The survey consisted of 26 items using to account for these responsibilities and add necessary resources if able.
multiple choice and “select all that apply” answers, determining more Further research is needed to continue understanding program duty delin-
specifically the delineation of duties amongst the members of each VAD eation for further efforts of Coordinator retention.
program. Respondents were given 30 days to complete the survey and $$MISSING OR BAD TABLE SPECIFICATION
then answers were analyzed. {71416D33-9B47-45BC-BDB5-6ADFB3D25CF0}$$

MCS Coordinator Responsibilities

Response to
Duties Delineation of Duties (n)

Operating Room (Implant and Non-MCS surgeries) Implants 49.3% (34); Non-VAD Surgeries 60.9% (42)
Post Implant Recovery 69.6% (48)
Equipment Management (Ordering and Billing; Monthly Inventory) Ordering and Billing 65.2% (45); Monthly Inventory 44.9% (31)
Hospital Management (Inpatient Rounds; Orders; Dressing changes; Daily Rounds 85.5% (59); Orders47.8% (33); Dressing changes
and Manage of other Non-MCS Related hospital services) (index implant) 49.3% (34) and (readmissions) 31.9% (22); Non-
MCS services 29% (20)
MCS patient follow up (SNF/LTACH/Rehab; Outpatient management; SNF/LTACH/Rehab 55.1% (38); Outpatient Office Visits 98.6%
Anticoagulation Management) (68); Anticoagulation 66.7% (46)
Consults (both inpatient and outpatient) 63.8% (44)
Regulatory Compliance (such as INTERMACS, Joint Commission, 79.7% (55)
Thoratec Connect)
Call Duties (Office hours versus After hours) Day Hours: MCS APP 42% (29) and MCS RN Coordinator
76.8% (53); After Hours: MCS APP 44.9% (31) and MCS RN
Coordinator 63.8% (44)
Education (Pre Implant; Post Implant; Community; Nursing Pre and Post Implant 88.4% for both (61); Community 75.4% (52);
Competency) Nursing Competency 72.5% (50)

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58 96
Patient Health Monitoring & Life Cycle Management of LVAD Through LVAD versus CABG Patients’ Pre and Postoperative Sleep Patterns: An
IOT Enabling Exploratory Analysis
A. S. Rao; Mechanical Engineering, Sreenidhi Institute of Science & J. M. Casida1, R. D’Aoust1, V. T. Ton2; 1Johns Hopkins University School
Technology, Hyderabad, INDIA. of Nursing, Baltimore, MD, 2University of Maryland School of Medicine,
Study: Monitoring the health condition of patients implanted with LVAD’s Baltimore, MD.
during clinical trials and after it is accepted by regulatory authority and Study: Sleep disturbances are prevalent in adult cardiac surgery and
implanted is of vital importance. Capturing and analyzing the data of might be associated with poor outcomes. No data compared sleep
the device like blood flow rate, blood pressure, impeller speed, battery pattern disturbance between left-ventricular assist device (LVAD) and
status, voltage, current and also BP, glucose levels, ECG etc of the patient coronary artery bypass graft (CABG) patients. This study examined sleep
is essential. characteristics and changes during pre- and post-op periods.
Methods: IOT enabling of the medical devices is becoming popular Methods: We prospectively analyzed13 LVAD (mean age 55.5 years) and
now. This information is used to real time health monitoring of patients 20 CABG (mean age 58.5 years) patients included in an observational
implanted with LVAD’s, analysis of this data, making available this data to study. Patients were mostly white (72%) male (69.4%) and married (64%).
patient coordinator, nurse, doctor, hospital,manufacturer of device etc on Over 50% had coronary artery disease, hypertension, and myocardial
demand as per protocol. They will receive the data into their mobiles or infarction. We used a wrist actigraphy placed on non-dominant hands in
computers by wireless. Specialist doctor and others can also get alarm in measuring sleep at 3 consecutive nights within 1-month pre (baseline)
case of emergency. He can analyze the data and suggest further course of and 1 week post-op. Sleep analysis software, descriptive and inferential
immediate action even from a remote place. By incorporating Machine statistics were used for data analyses.
Learning algorithm immediate emergency measures can be suggested Results: Baseline sleep onset latency (SOL) mean scores among CABG
to duty doctor and nurse automatically. The image of patient also can be patients were significantly lower (11.7 min.) than LVAD patients
sent, for viewing the features like infection etc. Data regarding BP,Glucose (12.9 min.), p=.04. LVAD patients tended to have higher sleep efficiency
levels, ECG parameters can be sensed through wearable devices on the index (SEI) than CABG patients post-op (49% vs. 35%), however, not sig-
patient. All the sensor data from LVAD controller and these wearable nificant. LVAD patients’ mean wake after sleep onset (WASO, 205.2 min.),
devices is encrypted and transmitted by wireless through secured server total sleep time (TST, 275.3 min.), and sleep fragmentation (SF, 52%)
and thus data security is ensured. Large number of patients can be moni- scores were abnormal and did not change significantly from baseline.
tored. The data processing can be executed in CLOUD. The manufacturer Although CABG patients’ mean SOL scores remained normal post-op,
can also access the selected data as part of feedback on functioning of their mean SEI, WASO, TST, and SF scores were abnormal and worsened
the LVAD’s. Each LVAD is given a unique number for identification and all post-op.
the data can be archived and retrieved on demand. Conclusion: LVAD and CABG patients suffer from post-op sleep pattern
Results: Hence IOT enabling of LVAD’s will be a big value addition in terms disturbances. Large mechanistic and longitudinal studies are needed to
of real time patient health monitoring, deciding course of action in emer- confirm our findings, identify causes of sleep disturbances, and develop
gency situations, emergency alerts, data warehousing, device evaluation, interventions aimed at reducing sleep disturbances to optimize post-op
device life cycle management etc. recovery outcomes, health, and quality of life.

104
Emergency Line: Bridging the Communication Gap
S. Haverstick1, A. Griffith1, D. Blissick1, T. Colaianne1, H. Haynes1, C.
Johnson1, R. Lucier1, M. Melong1, K. Kasten2; 1Center for Circulatory
Assist, Michigan Medicine, Ann Arbor, MI, 2Emergent Health Partners, Ann
Arbor, MI.
Study: Decrease wait time in communication between LVAD patients and
first responders. When an LVAD patient needs assistance in the outpatient
setting it is imperative that trained personnel are contacted immedi-
ately. A LVAD program relies on hospital operators who are not LVAD or
medically trained to answer after hour calls. After a patient’s caregiver
reported a long wait time during a medical crisis it was recognized that
this delay has potential for adverse outcomes.
Methods: February 2017, a LVAD program totaling 181 patients at a large
teaching hospital changed their on-call process. On-call was changed so
that calls are answered immediately by a twenty-four hour LVAD trained
medical ambulance service, called “VAD Emergency Line”. Patent use of
the “VAD Emergency Line” was continuously assessed. In November 2017
it was recognized that only 57% of patient calls used the “VAD Emergency
Line”, further intervention was needed. In November 2017, patients were
provided visual reminders to ensure compliance.
Results: Although not statistically significant there is clinical significance.
Since implementation of the “VAD Emergency Line” there have been zero
adverse safety events, and an increase in patient satisfaction. Patient use
of the “VAD Emergency Line” increased from 36% in March 2017 to 92%
in July 2018. The use of a “VAD Emergency Line” has increased patient
safety by allowing patients and first responders to speak to LVAD trained
personnel within five minutes in the outpatient setting.

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106 110
SIM: Increasing Nurse Confidence in the Care of Ventricular Assist A Conceptual Definition of Quality of Life for LVAD-DT Recipients:
Device Patients Preliminary Results
S. Haverstick1, C. Johnson1, M. Melong1, D. Rooney2; 1Center for D. E. Dwyer1, J. J. Doering1, J. M. Casida2; 1College of Nursing, University
Circulatory Assist, Michigan Medicine, Ann Arbor, MI, 2Learning Health of Wisconsin-Milwaukee, Milwaukee, WI, 2School of Nursing, Johns
Sciences, Michigan Medicine, Ann Arbor, MI. Hopkins University, Baltimore, MD.
Study: To improve efficacy of education of bedside nurses on ventricular Study: There is no existing definition regarding quality of life (QOL) in
assist devices. The inclusion of simulation into the training of bedside people living with a left ventricular assist device as destination therapy
nurses has shown to improve retention of information shared during (LVAD-DT). The purpose of this study was to explore the conceptual defi-
training. The Center for Circulatory Support included simulation training nition of QOL from the perspective of individuals living with LVAD-DT.
into our standard education for all bedside nurses we considered “VAD Methods: Classical grounded theory was used to uncover core concerns
trained” in our organization. With a pre and post assessment we have of participants and a basic social process explaining patterns of social
shown that our novel SIM curriculum increased bedside nurse confidence behavior over time. A purposeful theoretical sampling of 9 (6 males and
and knowledge in caring for these highly complex patients. 3 females) LVAD-DT recipients independently living at home over 90 days
Methods: Following review of responses from a needs assessment survey post-LVAD implant were selected. Racially and gender diverse participants
completed by from 132 (20.3%) staff nurses at our academic health cen- from various locations in the United States were interviewed via tele-
ter, a team created a novel simulation-based (SIM) curriculum to better phone from 41 to 55 minutes. Interviews were transcribed and analyzed
target learning objectives and provide increased holistic learning experi- using the constant comparison method.
ence for staff nurses who care for VAD patients. Using a pre-post design, Results: Participants’ view QOL as “being able to do what you want to
we evaluate the impact of the SIM course on participating staff nurses’ do, in moderation.” They adjust expectations to normalize the experi-
(n=95) confidence and knowledge. Confidence and self-report knowl- ence and create life similar to pre-LVAD times. Participants realistically
edge ratings were compared using Kruskal-Wallis tests, while changes in hope for future technology and care advancement that will make life
summed knowledge test scores were compared using independent t-test. easier. Despite knowing that the LVAD will be with them for the rest of
We also review learners’ course ratings and impressions provided in their lives, this group of LVAD-DT participants’ view of QOL corresponds
participants’ course evaluation. with other studies of participants with mixed device strategies including
Results: The SIM course positively impacted participants’ confidence and Bridge-to-Transplant and Bridge-to-Recovery. These results are prelimi-
knowledge with statistically significant improvements following the SIM nary; final results will be completed pre-conference.
course, all p values <0.001, with high practical impact, d values > 1.52.
Review of participants’ post-course survey responses indicated 100%
participants found the course helpful. Findings from this study suggest
that staff benefited from this novel SIM course, with increased confidence
and knowledge. Participating nurse staff also found the program to be
valuable, with requests for earlier opportunities for participating in the
SIM course.

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ASAIO NURSING-ALLIED HEALTH-CIR SUPPORT ABSTRACTS

112
Opioid Prescribing Trends in Left Ventricular Assist Device (LVAD)
Patients
S. Schettle, H. Alnsasra, A. Clavell, R. Daly, A. Glasgow, E. Habermann, J.
Stulak; Mayo Clinic, Rochester, MN.
Study: Opioid usage in the LVAD population has not been studied in the
literature. We sought to better understand opioid burden in LVAD patients
at a large implanting center.
Methods: We retrospectively reviewed all patients who underwent VAD
implantation from 01/2007 until 10/2017 at our institution. Data was
abstracted for opioid use pre-LVAD implant. Patients were considered opi-
oid naïve unless opioids were used within 90 days prior to LVAD implant
resulting in opioid tolerant classification. Opioid data was presented as
oral morphine equivalents (OME).
Results: Of 386 LVAD patients, 333 (86.3%) were opioid naïve and 53
(13.7%) were opioid tolerant (Figure 1), 88 (22.8%) received an opioid
prescription at discharge, and 70 (80%) of these 88 patients had an opioid
refill (Figure 2). Greater than 200 OME was prescribed to 58 (66%) of
these 88 patients (Figure 3). These data were all stratified to assess opioid
trends by year (Figures 1–3). VAD patients may require opioids pre-VAD
for other medical co-morbidities. Opioid tolerant patients increased in
frequency from 0% of patients in 2007 to a peak of 25.9% of patients in
2013 and gradually declined thereafter to 12.5% in 2017 (Figure 1). This
mirrors national CDC trends reflecting a peak in 2012 of dispensed opioid
prescriptions with declining trends thereafter. Interestingly, despite a
downward trend in patients prescribed opioids, the mean OME continue
to rise, peaking at greater than 200 in 2016 before declining. This is the
only study reported in the literature describing opioid utilization in LVAD
patients. Larger prospective multicenter trials could be done to optimize
opioid prescribing practices pre-LVAD and assess the impact of these
practices on subsequent LVAD outcome metrics.

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121 123
Tethered to Life...for Life VAD Coordinators’ Nursing Care Time for Patient-Caregiver Care
J. Giordano, B. Dinicola, T. Martin, K. Schmidt; Heart/Lung Transplant, J. M. Casida1, D. Hoff-Nygard2, S. Schroeder3, H. Craddock2, A. Pierzynski2,
Newark Beth Israel Medical Center, Newark, NJ. D. Manker2, E. Cooley2, J. Meggett1; 1Johns Hopkins University School of
Study: January 2015, C.R. was taken emergently to the OR and underwent Nursing, Baltimore, MD, 2Barnes-Jewish Hospital/Washington University,
placement of an implantable Left Ventricular Assist Device (LVAD) as a St. Louis, MO, 3Bryan Heart, Lincoln, NE.
Bridge to Transplant (BTT) and remained hospitalized until July 2015. C.R. Study: Emerging data show the negative association between VAD coordi-
was discharged to a rehab facility where she suffered a vertebral fracture. nators’ work intensity and quality of work life. However, none has quanti-
C.R. continues to require physical rehab on a twice weekly basis and 24 fied the nursing care time directly spent on patients and their caregivers.
hour care. Methods: We employed an exploratory observational study attached to
Methods: C.R. was diagnosed with non-ischemic cardiomyopathy at age a clinical trial involving 20 LVAD patient-caregiver pairs. We collected the
44. She was working full time until age 65 when she became acutely ill. total number of minutes (per encounter) spent by each VAD nurse coor-
C.R. is divorced with one child who lives out of state. When faced with dinator on (a) preparing patients and caregivers for hospital discharge,
the decision to maintain his mother’s life by way of emergent implantable (b) addressing and/or intervening LVAD-related issues post-hospital dis-
VAD he agreed via phone. There was no Advanced Directive for her son charge, and (c) providing re-training as needed. A total of 93 observation
to adhere to. C.R.’s recovery did not go as planned. After discharge she checklists were completed by 5 VAD nurses subsequently analyzed with
required intensive rehabilitation, during which time she was deemed to descriptive statistics.
not be a candidate for heart transplantation and was removed from the Results: Pre-hospital discharge, each nurse spent an average of 42.5
UNOS waitlist. Four years later C.R. continues living with a Destination and 11.5 minutes in teaching a patient-caregiver pair for LVAD care and
Therapy LVAD and requires 24 hour live in aide to assist with ADLs as her validating their learned skills, respectively. An average of 15.5 minutes
only family, her son, has minimal contact with her. was spent on the day of discharge. Post-discharge, the average time spent
Results: Technological advances in durable mechanical circulatory sup- by the nurse to follow-up a patient’s status was 55.3 minutes. Each nurse
port devices have increased the likelihood that they will be more broadly spent an average of at least 26.0 minutes in addressing patient complaints
employed as a treatment option for patients with advanced heart failure. with or without supporting data (eg, abnormal VAD flows). Respective
The growing use of these life sustaining devices raises new ethical con- average times spent on caregiver complaints and follow-up (nurse-initi-
cerns for clinicians. When we are considering emergent durable mechani- ated) ranged from 10.0 to 13.3 minutes. Throughout the 6-month study,
cal circulatory support device implants for our patients, are we merely we found that at months 1 and 3 were the highest number of hours spent
shifting end-of-life trajectories? Are we providing adequate and accurate by the nurse on patient-caregiver re-training with an average of 90.4 and
information to patients and their families so they may make an informed 85.0 minutes, respectively. Overall, this study offers preliminary evidence
decision regarding implantation of these devices? of the direct nursing care time provided on LVAD patients and their
In 2013, The Joint Commission made it mandatory for all patients being caregivers, pre and post-hospital discharge. Further research is needed
considered for mechanical circulatory support to undergo a palliative care to quantify the nurses’ direct and indirect patient/caregiver care time to
evaluation. Extant literature addressing the utility and effectiveness of inform staffing policy in VAD programs nationwide. Reduced work inten-
these evaluations remains at a minimum. Further study on this subject is sity/job stress is crucial for a healthy quality of work life to maximize the
required. effect of VAD nurse coordinators’ roles on patient/caregiver outcomes.

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Designing Digital Systems to Prevent Emotional Fatigue: Promoting Anticoagulation Quality and Frequency of INR Point-of-Care Testing in
Vocalisation and Reflective Practices within MCS Nursing LVAD Patients: A Correlation to Hemocompatibility Related Adverse
L. Feng, N. Gulbransen-Diaz, E. Nusem, K. Straker, C. Wrigley; School Events and Outcomes
of Architecture, Design and Planning, University of Sydney, Sydney, T. Schlöglhofer1, L. Zapusek1, D. Wiedemann2, J. Riebandt2, K. Dimitrov2,
AUSTRALIA. G. Laufer2, F. Moscato3, D. Zimpfer1, H. Schima1; 1Center for Medical
Study: Cardiovascular nurses supporting patients with MCS face a number Physics and Biomedical Engineering, Department of Cardiac Surgery,
of multifaceted challenges which impact their emotional state—with con- Medical University of Vienna, Vienna, AUSTRIA, 2Department of Cardiac
tributors to these challenges including: lack of self-care; limited emotional Surgery, Medical University of Vienna, Vienna, AUSTRIA, 3Center for
self-awareness; and unrealistic expectations of the job. With little offered Medical Physics and Biomedical Engineering, Medical University of
in terms of support for nurses to cope with such challenges, this study Vienna, Vienna, AUSTRIA.
was set to explore the potential benefits of integrating a digital system Study: Anticoagulation therapy in LVAD patients is essential to reduce
(DS) to engage nurses in emotional vocalisation and reflective self-care hemocompatibility related adverse events (HRAE). Vitamin k-antagonist
practices to support their mental wellbeing. dose can be adapted and monitored by INR point-of-care-testing (POCT)
Methods: A two-staged interview approach was employed in this study. in outpatients. The study aims to determine if the frequency of POCT in
The first stage consisted of nine semi-structured interviews (40–60 LVAD outpatients has influence on the quality of anticoagulation therapy,
minutes) with academics and nurses, and explored vicarious trauma, HRAE and clinical outcomes.
resilience and the emotional experiences of MCS nurses. Findings from Methods: This retrospective, pseudo-randomized study included 48
this stage informed initial DS concepts and contributed to the develop- patients who received HMII, HM3 or HVAD implantation between Jan
ment of a high-fidelity prototype. The second stage detailed testing of the 2012 and Oct 2016. Based on the weekly POCT frequency, we compared a
prototype through contextual simulations and semi-structured interviews daily (n=36) and 3x/week (n=12) group, specifically the 1-year antico-
with registered nurses from Sydney (Australia) in twelve sessions (15–30 agulation quality (% of INR Tests in Range) as well as clinical outcomes
minutes). These interviews explored the experiences of nurses as they and HRAE using Kaplan-Meier curves. Based on the achieved quality of
interacted with the DS, with data being analysed thematically using the anticoagulation (% of INR Tests in Range) ranging from 0–60% (poor),
qualitative data analysis software NVivo. 61–70% (acceptable), 71–100% (well controlled) readmissions and HRAEs
Results: It was found that the DS was particularly adept at: providing were compared.
closure and objectivity, increasing self-awareness, and reassessing and Results: Daily and 3x/week groups were similar in demographic and pre-
reframing initial thoughts for MCS nurses. Participants noted that the operative risk factors, INR target (2.0–3.0, p=0.27) and Aspirin daily doses
DS offered them an opportunity to vocalise their feelings, find release (p=0.29). Freedom from any HRAE (38.9% vs. 25.0%, p=0.44), any read-
and process heightened emotions. While it is anticipated that the DS mission (72.2% vs. 75.0%, p=0.97) and 1-year survival (91.7% vs. 91.7%,
will prove to be an appropriate platform for assisting and encouraging car- p=0.98) were comparable in both groups. The % of INR Tests in Range
diovascular nurses to maintain positive mental health practices, further was significantly higher with the daily self-assessments (73.5% vs. 68.4%,
development and testing is required to validate this proposition and p=0.006). Freedom from any neurological event (91.7% vs. 75.0%, p=0.14)
determine the DS’s efficacy. was n.s. higher in the daily POCT group. Well vs. poor controlled INR POCT
patients had a significant higher freedom from any neurological event
(96.0 vs 69.2%, p=0.024) as well as hemorrhagic strokes (100% vs. 76.9%,
p=0.011). In conclusion, daily INR POCT and subsequent dose adjustment
of vitamin-K antagonists result in a better quality of anticoagulation than
3x/week checks.

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Utility of Bedside Valsalva Maneuver to Enhance Detection of Suction Left Ventricular Assist Device Peripheral Equipment Utilization Following
Events in HVAD Patients LVAD Implantation
J. Churgai1, C. Mahr1, S. Li1, J. Bjelkengren1, K. Koomalsingh2, A. Aliseda3, C. M. R. Lawrence, N. M. Strauss, J. Y. Wolfe, A. R. Vest, D. DeNofrio, G.
Masri1, E. Minami1, A. Stempien-Otero1, R. Cheng1, G. Wood1, T. Dardas1, S. Couper, M. S. Kiernan; CardioVascular Center, Tufts Medical Center,
S. Lin1, S. Rockom1, J. Beckman1; 1University of Washington Medical Boston, MA.
Center, Seattle, WA, 2Division of Cardiothoracic Surgery, University of Study: To maintain proper support, LVAD patients require routine and
Washington Medical Center, Seattle, WA, 3Department of Mechanical unplanned replacement of peripheral equipment. Items replaced under
Engineering, University of Washington Medical Center, Seattle, WA. warranty are covered by the manufacturer while all other items are billable
Study: This study uses a standardized bedside Valsalva maneuver to to a patient’s insurer. Equipment tracking is thus a complex process that
enhance detection of sub-clinical suction events in HVAD patients. Given ensures regulatory compliance as well as appropriate billing. The potential
that current centrifugal LVADs lack sensors, many patients experience value of careful equipment management has not been previously reported.
sub-clinical suction events, which fail to trigger a suction alarm. Methods: We analyzed LVAD recipients from our institution from
Methods: A total of 25 simple Valsalva maneuvers were prospectively 1/1/2016 to 8/31/2018. Patients receiving biventricular support and the
tested in a continuous cohort of 17 HVAD patients. While connected to HeartMate 3 were excluded, given limited sample size of the latter. HM
the display, patients were asked to briefly hold their breath and bear 2 and HVAD were analyzed separately due to different requirements as
down. The patients either tested positive (flattening of waveform or outlined in the device instructions for use.
decrease in pulsatility), or negative (no significant change in pulsatility). Results: 96 LVAD recipients were included: mean age 57 years, 83% male,
To reduce confounding variables, patients involved in the study were veri- and 66% BTT. 35 patients received the Abbott HeartMate 2 (including
fied to be near euvolemic by most recent right heart catheterization and 4 exchanges) and 67 patients received the Medtronic HVAD (including
normotensive by Doppler opening pressure at time of testing. 2 exchanges). There were a total of 14,807 and 18,496 days on support
Results: One of the most frequent HVAD alarms is suction, but stored for the HM 2 and HVAD respectively. 25 HM 2 (81%) and 35 HVAD (52%)
suction alarms are neither sensitive nor specific. Many patients experi- patients required at least one replacement component. 14 (56%) HM
ence suction events during activities of daily living, as well as with diurnal 2 patients had equipment replaced as part of scheduled preventative
blood pressure variation not captured by the device. Suction events maintenance. 8 (26%) HM 2 and 18 (27%) HVAD had equipment that was
have been associated with increased thrombogenicity. Of the 25 Valsalva covered under warranty. The type of equipment replaced for each device
maneuver tests, 72% were positive by waveform assessment. By replicat- is presented in Figure 1. The average cost for HM 2 and HVAD replace-
ing real-life scenarios in which preload may be intermittently reduced, we ment equipment was $3,655.00 ± $3,764.41 and $7,379.10 ± $10,221.67,
were able to determine appropriateness of current VAD speed to reduce respectively. The average cost, after accounting for warranties and recalls,
alarm burden and improve quality of life of HVAD patients. Future studies was $2,550.97 ± $2,955.93 for HM 2 and $138.06 ± $435.81 for HVAD.
are needed to evaluate whether this reduces thrombotic complications. Replacement of peripheral equipment is not uncommon for patients on LVAD
support. Replacement costs can be sizable; highlighting the need for meticu-
lous tracking to ensure that equipment is correctly returned and replaced
under warranty and otherwise billed appropriately. Whether rates of replace-
ment increase with longer duration of support requires further investigation.

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What Really Matters? A Qualitative Understanding of Ventricular Assist TelecareVAD - Ideas and Expectations of VAD Patients
Device Stakeholders’ Needs Through Digital Channels T. Berg1, L. Tewarie1, R. Zayat1, C. Benstoem2, R.
K. K. Ko1, J. L. Dunn1, K. Straker1, E. Nusem1, C. Wrigley1, S. Autschbach1; 1Department of Thoracic and Cardiovascular Surgery,
Gregory2; 1School of Architecture, Design and Planning, The University of University Hospital RWTH Aachen, Aachen, GERMANY, 2Department of
Sydney, Sydney, AUSTRALIA, 2Department of Mechanical and Aerospace Surgical Intensive Care and Intermediate Care, University Hospital RWTH
Engineering, Monash University, Melbourne, AUSTRALIA. Aachen, Aachen, GERMANY.
Study: Digital channels play a critical role in managing health and wellbe- Study: The care of patients living with a VAD system does not end with
ing outcomes for patients. Digital channels are established and often used the time of discharge from the implanting clinic or the rehabilitation
to support a VAD patient’s physical health through continued monitoring. center. Rather, this marks the begin of the crucial part of care, through
How such channels could be used to contribute to QoL and wellbeing which patients should experience the benefits of their device. Frequent
outcomes is poorly understood. This study explored a range of digital inpatient stays for adverse events or routine visits to the outpatient clinic,
channels used by VAD patients, caregivers and healthcare practitioners to which are necessary at short intervals, can have lasting negative effects
support the treatment pathway. on this experience on the long run. Reducing the need for face-to-face
Methods: Using online ethnography methods, qualitative data was col- contact while still accessing the patient via telemedicine and other
lected both covertly and overtly from digital channels designed for VAD e-health solutions can reduce both personal and associated costs. The
stakeholders, and from a variety of publicly available online sources. VAD aim of our survey was to gain patient feedback and insights to steer the
stakeholders’ interaction and behaviours as an online user group were development of a needs-based and user-friendly telemedicine support
observed through collecting text, images and videos. Authors used a system.
field diary to record VAD stakeholders’ communication, interactions and Methods: From November 2018 to January 2019, we conducted a survey
opinions. The research identified digital channels VAD stakeholders are among our VAD patients (n=50). To do this, we used a questionnaire
using and how they are using them. Grouping commonalities found in the tailored to our needs, which was based on the Service User Technology
meta-characteristics of VAD stakeholders formed patterns and relation- Acceptance Questionnaire. At the time of the survey, participants were on
ships in the data. Data were thematically analysed into QoL determinants a VAD system for at least one year. Our focus was on:1. General informa-
for VAD stakeholders. tion on the patient,2. Information on the current situation in dealing with
Results: More than 531,165 channels were identified from the initial the VAD system and3. Retrieving their ideas and insights on the use of a
search, resulting in a nonredundant list of 62 digital channels (e.g. Face- telemedicine support system.
book pages, blogs, Instagram and YouTube profiles, websites, apps, etc) Results: A telemedicine application cannot replace the current care
which met the selection criteria. This research identified the QoL deter- structure (56%) and personal contacts (76%). Supplementing the existing
minants to address VAD patient, caregiver and healthcare practitioner’s option of telemedicine support is viewed favorably by the great majority
specific needs (Table). These were grouped into physical, psychosocial of patients without significant data security concerns (76%). There are
and environmental determinants. A well-designed digital channel has the also no concerns about the quality of care when using a combination of
potential to manage and reduce physical and psychosocial burden, high- familiar connection and telemedical support (66%). In a stable applica-
light and address environmental factors, improve the experience at each tion, patients would favor the additional support strategy to gain more
touch point of the VAD implantation journey, and contribute to better independence and mobility.
outcomes in managing wellbeing and QoL for VAD stakeholders.

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Understanding Emotional Demands: Digital Channel Design A New Approach to Driveline Exit Site Care
Opportunities for VAD Patients with Differing Treatment Pathways C. Runyan1, J. Hajj1, M. Lindsay1, N. Huie1, E. Passano1, C. Drucker2,
K. K. Ko1, J. L. Dunn1, K. Straker1, E. Nusem1, C. Wrigley1, S. M. Aguillon1, J. A. Kobashigawa1, D. Ramzy1, J. Chung1, R. Cole1, J.
Gregory2; 1School of Architecture, Design and Planning, The University of Moriguchi1; 1Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA,
Sydney, Sydney, AUSTRALIA, 2Department of Mechanical and Aerospace 2
Cedars-Sinai, Los Angeles, CA.
Engineering, Monash University, Melbourne, AUSTRALIA. Study: There are no universal protocols regarding Mechanical Circula-
Study: Originally designed for Bridge-to-Transplant (BTT) treatment, VADs tory Support (MCS) device driveline exit site care. In our single-center
are being implanted into an increasing number of patients for Destina- program, of the 48 left ventricular assist device (LVAD) patients implanted
tion Therapy (DT). Cognitive Behaviour Therapy (CBT) techniques exists between 2015 and 2016, 27.1 % experienced skin irritation at and around
to support VAD patients’ depression, yet emotional demands of patients the driveline exit site. While our driveline infections rates remained low,
with a VAD for BTT or DT may be different. This research uncovers and with this incidence of skin irritation, we sought to examine the impact of
compares the diverse emotional needs of patients who have experienced an alternative method of cleansing and dressing the driveline exit site on
VAD implantation for BTT and DT and suggests design opportunities for skin irritation, infection rate, and cost.
digital channels that could support a patient’s treatment that includes Methods: We compared documented skin irritation, driveline infection
adaptation, coping and device acceptance. rates, and cost, before and after a change in protocol for exit site care.
Methods: A content analysis methodology was used to chart a range of The initial protocol utilized two Chlorhexidine skin preps, in a circular
digital channels designed for VAD patients, with the aim of reviewing the manner starting at the exit site moving away from the exit site, without
differences and understanding the aspirations of VAD patients undergo- overlap. The exit site was then covered with a Sorbaview dressing. This
ing BTT and DT. The research identified 38 digital channels, with the data occurred every 3 days and as needed. In 2017, in consultation with our
being collected from a range of publicly available online sources and Epidemiology Department and upon literature review, our protocol
analysed thematically. changed to a method of scrubbing the area with one Chlorhexidine skin
Results: The most common themes of BTT patients’ emotional state were prep for 30 seconds. We switched to a clear, occlusive, latex free, and
uncertainty and frustration. They focus on reasons to live, being active, vapor permeable film material. This occurred every 5 days and as needed.
and being an eligible transplant candidate. There is dissonance between If there was drainage or concern for infection, a 2x2 split gauze was added
living now and living for a brighter future. Following the trials of heart with daily changes. We utilized a third-party medical supplier to create a
failure treatment process, DT patients describe their emotional state as new dressing kit, with all materials packaged together.
overwhelmed and fatigued. Such patients prefer to enjoy what is left of Results: Since implementing our new dressing change kit and protocol
life on a day-to-day basis and must accept their current situation. This in 2017, skin irritation has been reduced from 27.1% to 6.3%. Patients
research suggests two possible digital channel design opportunities for report improved comfort and have appreciated the increase to 5 days
supporting the differing patient pathways (Table) - i.e., incorporating Cog- between dressing changes.
nitive Behaviour Therapy (CBT) techniques for the support of BTT patients Conclusion: There has also been no significant change in our already low
to assist with personal coping strategies through thoughts, believes and driveline infection rates. As there is variation among MCS centers for
attitudes; and Acceptance and Commitment Therapy (ACT) techniques driveline exit site care, with a paucity of guidelines, we sought to share
for supporting DT patients to accept, observe self, commit action and our experience with a new dressing kit and protocol as it has positively
increase psychological flexibility. impacted patient satisfaction, with no change in cost or infection rates.

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Left Ventricular Assist Device (LVAD) Metropolitan Emergency Medical Closing the Gap: Introducing the VAD Specialist
Service (EMS) Provider Education Pilot P. S. Blood, K. Lloyd, R. L. Reed; Department of Mechanical Circulatory
B. Rhoades, M. Whitehead, K. Evans, M. Woodard; Cardiothoracic Support, University of Alabama at Birmingham Medical Center,
Transplant Program, Baylor St. Luke’s Medical Center, Houston, TX. Birmingham, AL.
Study: Over 25,000 patients are living with left ventricular assist devices Study: With increasing volume and complexity of patients requiring a
(LVADs). It is estimated that over 400 patients are living with LVAD sup- ventricular assist device (VAD) and rapidly evolving technology, institu-
port in a large metropolitan area. An emergency medical service of 4,000 tions have been forced to consider their model of care delivery. Patient
providers face unique challenges in training their staff to care for LVAD safety, staff and patient competency, and management of the bedside
patients during device and non-device related emergencies. The purpose Registered Nurse (RN) workflow inspired this large academic medical
of the educational pilot was to provide didactic and hands on LVAD train- center to develop the role of the VAD Specialist (VSp). The purpose of this
ing for EMS leadership and implement strategies to optimize LVAD patient analysis is to demonstrate the role of specifically dedicated and trained
care during emergencies and natural disasters. personnel to alleviate the RN’s time away from the clinical area, increase
Methods: We conducted a pilot educational program consisting of seven safety of the care delivery in the hospital, ensure best practice adherence,
didactic and hands on training sessions for the EMS leadership of a large and enhance staff and patient VAD education through multiple venues to
metropolitan. Leadership included medical directors, captains, shift improve outcomes in the VAD population.
supervisors and educators; approximately 60 in total. Methods: A retrospective analysis was conducted of the benefits and
Results: The pilot study identified several areas for optimizing LVAD functions of the VSp from July 1, 2018 to present (7 months).
patient care. Emergency contact protocols were developed for contact- Results: During this time, the VSp alleviated the RN, and the VAD Coor-
ing LVAD coordinators. The Heart Transplant and LVAD Program Medical dinator, of direct patient care by supporting 77% of all procedures per-
Director and EMS Medical Directors met to establish guidelines for formed off the clinical unit (totaling 242 hours). The VSp were present for
patient care during medical emergencies, such as device malfunction VAD equipment reconciliation and safety oversight for 154 discharges and
and initiation of cardiopulmonary resuscitation (CPR) in LVAD patients. 147 admissions, performed 87% of driveline exit site dressing changes
Multiple levels of education were developed for the EMS organization in (totaling 671) and provided 113 hours of individualized patient and
order to accommodate the different levels of providers. A LVAD protocol caregiver education. The VSp taught 42 pre-op and 23 post-op didactic
was developed for the transport of LVAD patients from outlying areas classes for patients and caregivers (326 individuals), provided compe-
into LVAD-equipped medical centers. Finally, communication networks tency assessments of 179 RNs, and provided point of care resourcing or
were established for relaying information during emergencies and natural educational reinforcement to 292 RNs. The VSp is a valuable member to
disasters. the VAD team. By providing relief to the RN with transports off the unit,
Conclusion: LVAD training for a large metropolitan EMS is complex. dressing changes and patient education, the RN is better able to provide
This pilot study established guidelines, protocols, and communication focused care to multiple patients. Additionally, the VSp role decreases
networks for the care of LVAD patients in a metropolitan area. Additional adverse safety events in the VAD population by providing more frequent
studies are needed to validate the efficiency and reproducibility of the oversight, and enriches RN knowledge regarding VAD specific care with
LVAD metropolitan EMS provider education pilot. point of care resourcing and education.

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Reduced Quality of Life in LVAD Patients with Aortic Insufficiency Including an Advance Practice Nurse in the SHOCK Team
C. LaBuhn, V. Jeevanandam, T. Ota, T. Song, D. Onsager, T. Lammy, V. Kagan1, E. Vorovich2, D. Pham1, R. McGregor1; 1Cardiac Surgery,
P. Combs, G. Sayer, G. Kim, J. Raikhelkar, B. Smith, S. Kalantari, N. Northwestern Memorial Hospital, Chicago, IL, 2Cardiology, Northwestern
Uriel; Cardiac Surgery, University of Chicago Medical Center, Chicago, IL. Memorial Hospital, Chicago, IL.
Study: Aortic Insufficiency (AI) is common following left ventricular assist Study: Acute mechanical circulatory support devices (aMCS) and extra-
device (LVAD) implantation. Recently AI was associated with worsening corporeal membrane oxygenation (ECMO) are utilized in patients with
outcomes. The aim of this study was to evaluate if quality of life (QOL) CS and CA. A SHOCK team was developed for patients in CS and CA. An
during LVAD support is affected by the development of AI. advanced practice nurse representing cardiac surgery was added to the
Methods: In this prospective cross sectional study, patients supported SHOCK team to help with management of patients on aMCS.
with an LVAD and followed as an outpatient in a large academic center Methods: The Shock Program was established to provide early, multidisci-
were enrolled. Patients were asked to report their QOL using both the plinary consultation for patients in CS, ideally prior to the development of
EQ-5D and KCCQ QOL surveys. Patients most recent echocardiograms MOF or CA. The E-CPR program was developed to assist our institution’s
were reviewed and interpreted as patients without AI and patients with CA Team on pts undergoing active CPR. Both pathways can be activated
AI (trace to severe AI). Patients QOL was compared between the groups. via our emergency paging system. Activation of the Shock Team results in
Results: Overall, 111 patients were enrolled with mean age 61.1±12.9 an immediate multi-disciplinary conference call comprised of Cardiotho-
(p=0.03), 70 were male, (63.1%, p=.0.03). Patients with AI and without racic Surgery (CTS), Heart Failure Cardiology, Interventional Cardiology,
had similar characteristics aside from HF etiology (Ischemic CMP 42% vs and Critical Care. Activation of the E-CPR Team results in bedside evalu-
27%, p=0.1) and time on support (1022 +/- 804 vs 831 +/- 723, p=0.19). ation by our ECMO Team (CTS, ECMO specialists). An APN was added to
KCCQ was worse in AI patients (44.9±0.7 vs 40.2±0.8, p=0.001), how- the team in order to facilitate communication among team members as
ever, EQ5D was similar (EQ5D 7.97 vs 7.44, p= 0.2). The main difference well as clinical management during and after cannulation of ECMO or
between the groups was shortness of breath and enjoyment of life with initiation of aMCS.
heart failure on the KCCQ and completing usual activities on the EQ-5D. Results: A total of 94 activations among 84 pts occurred during the
referenced time period with overall survival of 32 (38%). There were 52
SHOCK activations among 46 pts; 6 received an intra-aortic balloon pump
(IABP), 11 an Impella device, 7 were placed on VA ECMO, 4 were placed
on VV ECMO and 24 were treated with medical management (MM).
Overall survival among shock pts was 21/46 (46%). In the eCPR cohort, 42
eCPR activations were made among 42 pts. 14 pts were cannulated on VA
ECMO and survival to discharge was 21%. Including an APN in the SHOCK
team helps with collaboration among multi disciplinary team members
and time care of complex advanced heart failure patients. It allows for
consistency of care, facilitates communication among family members as
well as consistent clinical management of aMCS pts who can be medically
complex. Further research is needed to quantify the improvement in
outcomes an APN can have on aMCS pts.

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Preparing for an Emergency: Training Staff to Recognize and Respond to
ECMO Complications
R. Rose1, T. Houchins2, P. Combs3, C. LaBuhn3, V. Jeevanandam3, T.
Song3; 1AMCS/ECMO Department, University of Chicago Medicine,
Chicago, IL, 2Medical Intensive Care Unit, University of Chicago Medicine,
Chicago, IL, 3Cardiothoracic Surgery, University of Chicago Medicine,
Chicago, IL.
Study: Staff caring for Extracorporeal Membrane Oxygenation (ECMO)
patients are often less experienced with Mechanical Circulatory Support
(MCS) devices than their Cardiothoracic (CT)-ICU colleagues. While they
may understand the basic function and purpose of ECMO, their lack of
regular exposure may leave them unprepared for ECMO related emergen-
cies. Additional ECMO complication and emergency training should be
provided for staff in these areas. Assessment of this training should be
performed to ensure the training is effective.
Methods: Our institution developed a training program concentrating on
the recognition and response to ECMO complications and emergencies.
To assess the efficacy of the training, learners were presented with five
ECMO case scenarios, all describing an ECMO complication or emer-
gency. The learners were asked to identify the cause of the complication/
emergency. They were also timed to assess how quickly they provided
an answer. There answer was further scored as correct or incorrect. Fol-
lowing this, learners attended a four-hour didactic and hands on ECMO
training, focusing on complications, specifically how patients present
in these emergencies. Afterwards, they were again presented with five
ECMO emergency situations and asked to identify the cause and were
again timed to assess how quickly they identified the problem.
Results: Following the training accuracy in identifying causes of ECMO
complications increased from an average of 38% to 96% and average
response time improved from 51 to 26 seconds. Focusing on ECMO com-
plications and emergency responses while educating nursing staff results
in a decrease in response time to identify complications and an increase
in accuracy of identifying the cause. Further assessment of knowledge
retention and ongoing training sessions should be performed.

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ASAIO PEDIATRIC ABSTRACTS

47 54
Human Factors Design of Pediatric Ventricular Assist System Use of Protek Duo Cannula for Temporary Support in Pediatric VAD
J. F. Antaki1, C. Southard2, C. Johnson2, J. Space2, B. Bernstein3, M. Patients
Beale4; 1Biomedical Engineering, Cornell University, Ithaca, NY, 2Daedalus, M. Ploutz1, B. Sanders2, M. Alaeddine3, J. Gentile3, D. Velez3; 1Cardiology,
Pittsburgh, PA, 3Daedalus, Daedalus, Pittsburgh, PA, 4Daedaus, Phoenix Children’s Hospital, Phoenix, AZ, 2Perfusion, Phoenix Children’s
Pittsburgh, PA. Hospital, Phoenix, AZ, 3Cardiovascular Surgery, Phoenix Children’s
Study: The use of ventricular assist devices (VADs) in the pediatric popula- Hospital, Phoenix, AZ.
tion presents several unique human factors design challenges. In addition Study: The ProTek Duo (Cardiac Assist Inc) is a dual-lumen catheter used
to matters of usability, considerations are needed to avoid operator error. with the Tandem Heart for RV support or for percutaneous ECMO cannu-
This study was undertaken to address human factors design consider- lation. Having dual lumens is advantageous as a single catheter can serve
ations of the patient controller, hospital monitor, batteries, driveline, as both inflow and outflow. Additionally, only a small incision is neces-
connectors, carry cases, and external garments. sary, avoiding a sternotomy. We describe a novel cannulation strategy in
Methods: A systematic approach was adopted that first considers use 2 pediatric patients by which the ProTek Duo cannula is inserted through
environments from operating room through critical care, hospital ward, the LV apex, delivering the inflow port within the LV and the outflow port
and ultimately the school playground. Consideration was given to wide to the aorta.
range of needs, capabilities, and limitations of the users who interact with Methods: Case 1: 10 year old, 48 kg male presented with dilated cardio-
the hardware: patients, caregivers, surgeons and clinical staff. Conceptual myopathy and malignant ventricular arrhythmias requiring temporary
designs were developed on paper, and then translated to low-fidelity pro- VAD support as a bridge to durable support. Through a left anterior chest
totypes after team-based evaluation. Hazard analyses (IHA, FMECA, and incision, the ventricular apex was identified. A ProTek Duo cannula was
FTA) were performed to reveal aspects of the design requiring additional then inserted using the Seldinger technique and connected to a continu-
attention. ous flow LVAD. The patient was maintained on support for 6 days without
Results: Contextual evaluation with a sample set of end-users was per- complication until implantation of a Syncardia Total Artificial Heart.
formed to evaluate, discriminate, and optimize these design components. Case 2: 18 year old, 89 kg female with transplant graft dysfunction who
This process resulted in a modular design that includes a bassinet for required temporary VAD support as resuscitation to determine candidacy
infants, and a stuffed toy for young children. In addition to safety and for durable VAD. A ProTek Duo cannula was inserted through a left tho-
usability criteria, both designs alleviate some of the anxiety and fear of racic incision using the Seldinger technique and connected to a Maquet
interaction. We intend to incorporate these designs into a future Pedia- Cardiohelp system for LVAD support. Unfortunately, the patient devel-
FlowTM clinical trial. oped RV failure requiring placement of an additional ProTek Duo cannula
and Maquet Cardiohelp for RV support. The patient remained on support
for 35 days before passing away from irreversible end organ failure.
Results: The ProTek Duo cannula offers an alternative for temporary VAD
cannulation in pediatric patients. Potential benefits include a smaller inci-
sion and avoidance of a sternotomy. While the cannula may be modified
to adjust for patient-specific anatomy, its size may be potentially limiting
in smaller patients. Further study is needed to determine its safety profile
with longer duration of use.

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ASAIO PEDIATRIC ABSTRACTS

59 74
Measuring the Frequency of Stroke in Children on VAD Support: More Evolution of Vascular Access for the Artificial Placenta: From Two-Vessel
Difficult Than it Appears? Single-Lumen Venovenous Cannulation to Single-Vessel Cannulation
R. R. Clough1, S. J. Wilkens2, C. S. Almond2, J. M. Murray1, D. N. Rosenthal2, with Tidal Flow
R. R. Shetty1, K. Maeda2, S. Chen2, E. Y. Liu1, M. Tracey1, L. K. Kent1, A. J. C. Kading1, G. Lautner2, M. W. Langley1, M. M. Jeakle1, T. L. Fegan1, R.
Shiu1; 1Lucile Packard Childrens Hospital Stanford, Palo Alto, CA, 2Stanford A. Pfannes1, M. A. Reiber1, S. C. Toor1, J. M. Toomasian1, R. H. Bartlett1,
University, Palo Alto, CA. A. Rojas-Pena1, G. B. Mychaliska1; 1Department of General Surgery,
Study: The stroke rate on VAD support is an important quality benchmark ECLS Laboratory, University of Michigan, Ann Arbor, MI, 2LSA Chemistry,
for ventricular assist device (VAD) programs. However, interpretability of University of Michigan, Ann Arbor, MI.
stroke rates within and across centers is complicated by the rareness of Study: The modalities of vascular access for the extracorporeal Artificial
stroke events, variable definitions of stroke and inconsistent denomina- Placenta (AP) have undergone many iterations over the past decade. We
tors. We sought to develop program consensus on a meaningful stroke hypothesized that single lumen jugular cannulation using tidal flow ECLS
frequency measure to support quality improvement work and clinical is a feasible alternative to venovenous (VV) umbilical-jugular cannulation
research. and maintains fetal circulation, stable hemodynamics and adequate gas
Methods: The VAD Quality Improvement Program at a single center exchange for 24 hours.
reviewed the challenges and published literature to develop a definition Methods: Three preterm lambs at EGA 118–124 days (term 145 days)
and numerical format for transparent reporting of stroke events capable were delivered via caesarian section and underwent VV ECLS with a
of detecting improvement trends among rare events at a single center. single-lumen jugular cannula utilizing tidal flow AP support (Figures 1, 2).
Results: There was consensus that the program lacks a definition and Echocardiography was used to document fetal circulation. Hemodynam-
numerical measure for stroke that is sensitive to changes in rare events. ics, circuit flow and gas exchange were monitored and evaluated. Target
Limitations include inconsistent stroke definitions (i.e. ischemic and fetal parameters were as follows: mean arterial pressure 40-60mmHg,
hemorrhagic strokes alone vs PEDIMACS-defined neurological dysfunc- heart rate 140–240 beats per minute (bpm), SatO2% 60–80%, PaO2
tion, includes seizure); labile swings in monthly rates due to low event 25-50mmHg, PaCO2 30-55mmHg, oxygen delivery >5ccO2/dL/kg/min,
rates; wide variety of denominators (e.g. month, year, 1000 days or 100 and circuit flow 100 ± 25 cc/kg/min.
patient-months); and, inconsistent definitions for early vs. late stroke. Results: All animals survived 24 hours and maintained fetal circulation. The
Consensus was achieved on defining stroke as an ischemic, hemor- observed mean arterial pressure was 41.52 ± 9.10 mmHg and the mean
rhagic and subdural stroke post-implant, use of a rolling 12-month stroke heart rate 180.98 ± 29.65 bpm. Mean circuit flow was 96.98 ± 17.12 cc/kg/
incidence reported per 1000 days of support (similar to CLABSIs), with min. Mean arterial SatO2% 72.22 ± 11.36%, mean PaO2 of 42.85 ± 10.19
the early stroke defined as ≤30 days. Six-year data review of all VAD mmHg, mean PaCO2 of 52.73 ± 8.15 mmHg and mean oxygen delivery of
patients at our institution revealed 27 total strokes: 12 ischemic, 7 hemor- 4.54 ± 1.45 ccO2/dL / kg/min, consistent with normal fetal blood gas values.
rhagic, and 8 subdural. The overall average incidence of stroke was 1.6 Single-lumen jugular cannulation using tidal flow is a promising vascular
event/1000 days (early stoke incidence 5.8/1000 days vs late 0.6/1000 access strategy for AP support. Successful miniaturization holds great
days, P<0.001). Programmatic consensus can be achieved on a definition potential for clinical translation to support extremely premature infants.
and quality measure for transparent reporting of stroke events in children
on VAD support. The most effective way to reduce the overall stroke rate
would be targeted interventions to reduce the number of strokes before
30 days.

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ASAIO PEDIATRIC ABSTRACTS

76 93
Survival and Neurologic Outcomes of Extracorporeal Membrane First North American Clinical Experience with the Jarvik 2015: A Case
Oxygenation in Patients with Congenital Heart Disease Series
H. Taka1, Y. Kotani2, T. Douguchi1, M. Nishimura1, A. Miyamoto1, D. J. A. Spinner, H. P. Tunuguntla, S. W. Denfield, W. J. Dreyer, S. Choudhry,
Takanami1, H. Itoh3, Y. Kuroko2, T. Iwasaki4, S. Kasahara2; 1Clinical A. G. Cabrera, J. F. Price, S. C. Tume, J. Teruya, E. O. McCullum, B. A.
Engineering, Okayama Univercity Hospital, Okayama, JAPAN, Elias, J. M. McMullen, Z. M. Binsalamah, J. S. Heinle, C. A. Caldarone, I.
2
Cardiovascular Surgery, Okayama Univercity Hospital, Okayama, Adachi; Baylor College of Medicine / Texas Children’s Hospital, Houston,
JAPAN, 3Medical Engineering, Faculty of Health Sciences, Junshin TX.
Gakuen Univercity, Fukuoka, JAPAN, 4Pediatric Anesthesiology, Okayama Study: The unmet need for a pediatric-specific continuous-flow ventricu-
Univercity Hospital, Okayama, JAPAN. lar assist device (cfVAD) has long been recognized. The Jarvik 2015 is the
Study: We sought to evaluate survival and neurological outcome after first cfVAD specifically designed for children.
venoarterial extracorporeal membrane oxygenation (ECMO) in patients Methods: We aim to describe the first North American single-center
with congenital heart disease. experience of patients supported with the Jarvik 2015.
Methods: We retrospectively reviewed a medical record of 37 patients Results: Patient (Pt) 1 is a 4-year-old (12 kg, BSA 0.5 m2) with a small, non-
(<16 years) who received ECMO between January 2011 and December apex forming left ventricle (LV), multiple ventricular septal defects, and
2017. Indication of ECMO was failure to wean from cardiopulmonary severe biventricular dysfunction. Pt 2 is a 10-month old (7.3 kg, BSA 0.4
bypass in 18 patients, extracorporeal membrane resuscitation (ECPR) in m2) with LV non-compaction cardiomyopathy with moderately depressed
13 patients and others in 6 patients. Median duration of ECPR was 48 right ventricular (RV) and severely depressed LV systolic function. Pt 3 is
(interquartile [IQR] range: 38–53) minutes. Survivors were evaluated neu- a 13-month old (9.1 kg, BSA 0.4 m2) with hypoplastic left heart syndrome
rological outcomes by Pediatric Cerebral Performance Category (PCPC) s/p Norwood palliation, bidirectional Glenn, and 21 mm St. Jude HP
scale 1 year after hospital discharge. ECMO parameters of favorable mechanical tricuspid valve with severely depressed systemic RV function.
outcome (PCPC≦2) and unfavorable outcome were compared. All 3 patients had evidence of end organ failure despite mechanical ven-
Results: Median age and body weight was 5 (0.87–24) months and 3.5 tilation and inotropic support prior to device implant. Pt 1 was success-
(3.2–9.4) kg, respectively. Median ECMO duration was 160 (91–286) fully bridged to heart transplant after 53 days of support (RPM 15,000)
hours. Twenty-nine patients (78%) were successfully weaned from ECMO. without complications. Pt 2 has been supported for 64 days (RPM 14,000)
Overall survival to hospital discharge was 59%. Survivors had a shorter and now shows signs of myocardial recovery such that device explant is
ECMO duration (108 [77–155] vs 286 [186–454] hours, p=0.002) and less currently being considered. Pt 3 has been supported for 16 days (RPM
required peritoneal dialysis for oliguria (14 vs 73%, p<0.001) compared 16,000) with recovery of end-organ function. In all cases, there were
to non-survivors. Of 22 survivors, 15 (68%) patients had a favorable no intraoperative complications. There has been power variation with
outcome. Risk factor for unfavorable outcome included ECPR as indication absence of flow reversal through the device. Anti-coagulation has been
and cardiopulmonary resuscitation (CPR) of longer than 40 minutes. In achieved with bivalirudin (goal partial thromboplastin time 60–80 sec-
conclusion, although an excellent survival from the use of ECMO was onds). Markers for hemolysis have been elevated, and there has been 1
obtained, neurologic outcome was not satisfactory when required a thrombotic event. Patient 2 had an ischemic stroke, but she now has only
longer CPR before ECMO establishment. minimal deficit. This single-center case series represents the beginning of
the era of pediatric cfVAD support specifically designed for small children,
including those with complex congenital heart disease who may not have
otherwise been candidates for adult cfVAD support.

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ASAIO PEDIATRIC ABSTRACTS

101 178
Computational Fluid Dynamics of a Novel Blood Turbine-Venous Assist Mechanically Assisted Fontan Completion for Bridge to Heart
Device Transplant: A Case Series
K. Pekkan1, I. B. Aka1, E. Ermek1, R. Turkoz2; 1Department of Mechanical J. A. Spinner, H. P. Tunuguntla, S. W. Denfield, W. J. Dreyer, S. Choudhry,
Engineering, Koc University, Istanbul, TURKEY, 2School of Medicine, A. G. Cabrera, J. F. Price, B. A. Elias, J. M. McMullen, Z. M. Binsalamah, M.
Department of Cardiovascular Surgery, Acibadem University, Istanbul, Imamura, E. D. McKenzie, J. S. Heinle, C. A. Caldarone, I. Adachi; Baylor
TURKEY. College of Medicine / Texas Children’s Hospital, Houston, TX.
Study: Long-term pediatric ventricular assist devices (pVAD) for single- Study: Ventricular assist device (VAD) support for children with a Glenn
ventricle pediatric patients are challenged due to the need for external circulation is challenging. The 6-month post-VAD survival in a Glenn
drive power. To address this challenge an aortic blood turbine coupled circulation is 52% compared to 95% in a Fontan circulation. In Glenn-VAD
to a pVAD that require es no external power was introduced first-time in physiology, the uneven decompressive effect of the VAD is limited only to
literature (Pekkan et.al JTCVS, 2018) (Fig 1).The objective of the present the lower body systemic venous system, resulting in a worsened systemic
study is to analyze the hemodynamics of the blood turbine section and its venous pressure differential and worsened hypoxia. We hypothesize
coupling performance to the right-side assist through computational fluid that a concomitantly placed continuous flow VAD at Fontan comple-
dynamics (CFD). tion provides a more favorable circulation for children with a Glenn and
Methods: Turbomachinery design and lumped parameter modeling were ventricular dysfunction.
used to calculate the power generation with low aortic turbine flow Methods: Three patients with single ventricle anatomy underwent a
(10–20% of total cardiac output) at 20 to 90 mmHg systemic head, for non-fenestrated extracardiac Fontan with concomitant HeartWare HVAD
a range of blade trail angles. This information leads to the initial design placement in the systemic right ventricle as a bridge to heart transplant
parameters of the pump side. A transient, sliding mesh, Newtonian blood (HTx).
CFD, with 17M meshes is used. An iterative alternation of flow rate and Results: Patient 1 was 6-years-old (21 kg; BSA 0.8 m2), highly sensi-
the pressure was designed for torque matching for adult and pediatric tized, and INTERMACS 1. He was supported 500 days (453 outpatient),
flow conditions. Results are validated through pulsatile mock-up tests. underwent successful HTx, and has no graft complications 32 months
Results: A six bladed 38 mm diameter turbine and five bladed 32 mm post-HTx. Patient 2 was 3-years-old (13 kg; BSA 0.6 m2), INTERMACS 1,
pump impeller were manufactured and tested. Computed pressure and and supported 195 days (30 outpatient) before successful HTx with no
flow rates compared well with the in vitro measurements. CFD results early graft complications. Patient 3 was 6-years-old (17 kg; BSA 0.7 m2),
demonstrated low shear flow and attached streamlines (Fig 1). pVAD highly sensitized, and INTERMACS 2. She was supported 157 days (125
generates 6.2 (pediatric) and 4.3 (adult) mmHg head. Maximum wall outpatient) and underwent successful HTx with no early graft complica-
shear stress in the turbine was 200 Pa and between 160 to 70 Pa in the tions. Patient 2 had an intraoperative ischemic stroke (now with minimal
pump. A velocity jet reaching to 2 m/s was observed in the turbine volute deficit) due to an unreachable mobile thrombus in his rudimentary left
inlet. Narrow volute of the turbine requires further optimization. An ventricle. There were no other VAD complications in 852 total days of VAD
integrated CFD model is required to address the torque matching support. All 3 patients were deteriorating on mechanical ventilatory and
between the turbine and the pump as the relative position of both inotropic support, and they were becoming very poor HTx candidates.
impeller blades was found to be important for optimal performance. The However, mechanically assisted Fontan completion significantly improved
novel blood turbine concept is encouraging to eliminate the drive-line cyanosis (from 70s to high 90s), hemodynamics, and organ function. All 3
infections passively and will allow long-term Fontan device implantation. patients were safely discharged home, underwent significant physical and
nutritional rehabilitation, and underwent HTx in a significantly improved
condition.

Figure 1. Velocity streamlines at 800 rpm.

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ASAIO PEDIATRIC ABSTRACTS

251 DLC body for easy insertion (Fig A) and were easily untied for umbrellas’
deployment (Fig B) after proper DLC positioning (Fig C). This DLC was
Evaluation of New DLC-based Cavopulmonary Assist in Failing Fontan
tested in a failing Fontan simulation mock loop and in our established fail-
Simulation Loop/Sheep Model
ing Fontan sheep model (n=2).
L. Li1, D. Wang1, G. Zhao2, S. Topaz2, M. Chang1, J. Wang1, C. Ballard-Croft1,
Results: Our bench test successfully simulated severe failing Fontan
J. B. Zwischenberger1; 1Surgery, University of Kentucky, Lexington, KY, 2W-
circulation with high central venous pressure (CVP,18 mm Hg) and low
Z Biotech, LLC, Lexington, KY.
cardiac output (1.0 l/min, Table). At 4.4 l/min Fontan assist flow, the
Study: We are developing an improved double lumen cannula (DLC)- DLC-based CPAD decreased CVP to 6 mm Hg and achieved up to 4.2 l/min
based cavopulmonary assist device (CPAD) to achieve total failing Fontan total PA flow, demonstrating negligible recirculation and 96% efficiency.
support. This DLC-based CPAD was tested in a failing Fontan simulation In the failing Fontan sheep model, the DLC was easily inserted from right
mock loop and in our established failing Fontan sheep model. jugular vein into extra cardiac conduit. The slipknots were easily untied in
Methods: The DLC was fabricated with newly designed memory alloy both sheep. At up to 4 l/min pump flow, the CPAD normalized the sheep’s
reinforced paired self-opening umbrellas. These umbrellas were located hemodynamics similar to the bench test. Our newly designed DLC with
between the superior/inferior vena cava drainage ports and the pulmo- memory alloy reinforced paired membrane umbrellas provides total CPA
nary artery (PA) infusion port to prevent recirculation, ensuring high CPA with very low recirculation and high performance. In our failing Fontan
performance. Cascade slipknots were used to tie the umbrellas to the sheep model, the slipknots allow easy DLC insertion and deployment.

Fontan Assist CVP PAP DLC Drainage DLC Infusion PA flow-CO Efficiency Recirculation
Flow (mmHg) (mmHg) pressure (mmHg) Pressure (mmHg) (l/min) % %

Unassisted 18 14 NA NA 1.0 NA NA
Failing Fontan
2.8 l/min 15 34 -78 111 2.6 93.2 6.8
3.2 l/min 13 38 -110 150 3.2 99.7 0.3
3.9 l/min 9 43 -144 203 3.9 98.6 1.4
4.4 l/min 6 45 -196 263 4.2 95.6 4.4

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ASAIO PEDIATRIC ABSTRACTS

259 265
In Vitro and In Vivo Performance of a Portable Pediatric Artificial Pump- Reduction in Incidence of Pump Exchanges for Suspected Thrombosis:
Lung Device Impact of Collaborative Learning
M. Rahman, Z. Berk, J. Zhang, C. Pasrija, R. G. Conway, B. P. Griffith, Z. J. F. Zafar1, C. Villa2, C. Tjossem3, D. Rosenthal4, C. VanderPluym5, J. Conway6,
Wu; Department of Surgery, University of Maryland School of Medicine, P. Krack2, R. Jaquiss7, A. Lorts2, D. Morales1; 1Congenital Heart Surgery,
Baltimore, MD. Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, 2Cardiology,
Study: The purpose of this study was to evaluate hemodynamics, gas Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, 3Berlin Heart
transfer, and biocompatibility performance of a newly developed portable Inc., Woodlands, TX, 4Cardiology, Lucile Packard Children’s Hospital, Palo
pediatric artificial pump-lung (PediPL) in in-vitro bench and in-vivo animal Alto, CA, 5Cardiology, Boston Children’s Hospital, Boston, MA, 6Cardiology,
experiments. Stollery Children’s Hospital, Edmonton, AB, CANADA, 7Congenital Heart
Methods: The PediPL device consists of a centrifugal flow blood pump Surgery, Children’s Medical Center/UT Southwestern Medical Center,
and a radial outside-in oxygenator. The oxygenation unit is 85 mm Dallas, TX.
(diameter) x 48 mm (height) with a membrane surface area of 0.4 m2. Study: Anticoagulation management in children on mechanical circulatory
A circulatory flow loop was constructed to assess the pumping function support (MCS) is evolving rapidly, with variability in practice and out-
and gas transfer performance with heparinized ovine blood. Four animal comes across centers. A novel collaboration, Advanced Cardiac Therapies
experiments were conducted in an ovine model to investigate the pediat- Improving Outcomes Network (ACTION), focused on harmonization of
ric pump-lung in-vivo performance. The device was surgically implanted MCS management across centers with bivalirudin protocol being one of
between the right atrium and pulmonary artery. The device flow rate and the first protocols. This study evaluates trends in pump exchanges for
gas transfer performance were measured daily. Plasma free hemoglobin suspected thrombus over time as it relates to timing of ACTION initiatives
and blood biochemistry were assessed twice a week. At the endpoint of and changing bivalirudin use across centers.
each animal experiment, necropsy was conducted in each animal and the Methods: Berlin Heart EXCOR database was reviewed for incidence of
explanted device was examined for any gross thrombosis. pump exchanges due to suspected thrombus, from years 2015–2018
Results: The in-vitro data demonstrated that the PediPL was capable of at ACTION sites. This data was plotted against ACTION initiatives on a
generating flow up to 3.0 L/min against a backpressure up to 300 mmHg U control chart and significant changes were analyzed. Furthermore an
at 3500 rpm. The oxygen transfer rate was about 160 ml/min at a blood ACTION collaborative survey is underway regarding use of bivalirudin and
flow rate of 3.0 L/min. Two sheep successfully survived for 30 days and adaptation of the ACTION initiated protocol across sites.
were electively terminated. Two animal experiments ended early due to Results: Patients were similar in age, weight, support duration and
surgical complication and device damage, respectively. The oxygen trans- diagnosis during all years studied. (Table 1). A significant reduction in
fer rate was 102 ± 5 mL/min at a flow rate of 1.83 ± 0.22 L/min in the ani- pump exchanges per 100 device days was noted in 2017 (0.4 [0.3–0.7])
mals and the outlet blood was fully oxygen saturated (>96%). The device and 2018 (0.3 [0.2–0.5]) compared to prior years: 2015 (1.0 [0.7–1.4]) and
flow and oxygen transfer were stable over 30 days. The animal necropsy 2016 (0.9 [0.6–1.4]; p<0.001. On a control chart, this change correlates
results and blood chemistry indicated that the animals had a normal end- in timing with ACTION launch and harmonization protocol for bivalirudin
organ function. The explanted PediPL devices were free of gross thrombus (Figure). The survey will identify centers’ practices as it relates to use of
in the flow-path and membranes. The PediPL exhibited the capability of bivalirudin and adaptation of protocol at each site in the network.
providing respiratory or cardiopulmonary support for pediatric patients There is over 60% reduction in pump exchanges during the study period.
with excellent biocompatibility and long-term reliability. Despite the absence of controlled clinical trials, there has been a rapid
expansion in use of bivalirudin in this patient population during this time.
Timing of ACTION initiatives, especially bivalirudin harmonization protocol
correlates with reduction in pump exchanges. This highlights the potential
role of learning networks in improving outcomes for a unique group of
patients being cared for at various sites.

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ASAIO PEDIATRIC ABSTRACTS

278 302
I Will Survive! A Single-center Outpatient Pediatric Ventricular Assist Is the Serum Level of Salusin-â Associated with Hypertension and
Device Experience Atherosclerosis in the Pediatric Population?
H. P. Tunuguntla1, K. Puri1, S. Choudhry1, J. A. Spinner1, W. J. Dreyer2, A. Wasilewska, U. Kolakowska, E. Kuroczycka- Saniutycz; Pediatric
A. G. Cabrera1, J. F. Price1, S. W. Denfield1, B. Elias3, J. M. McMullen3, Z. Nephrology Department, Medical University of Bialystok, Bialystok,
Binsalamah3, I. Adachi3; 1Pediatric Cardiology, Texas Children’s Hospital, POLAND.
Houston, TX, 2Pediatric Cardiology, Baylor College of Medicine, Houston, Study: Salusins are recently identified endogenous bioactive peptides
TX, 3Congenital Heart Surgery, Texas Children’s Hospital, Houston, TX. that have hypotensive and bradycardiac effects. Salusin-β is involved in
Study: Though the use of durable ventricular assist device (VAD) support the pathogenesis of human atherosclerosis.
has increased in the pediatric population, only a minority of patients Methods: This was a prospective cohort study of a young patient popula-
(pts) get discharged from the hospital. Our aim is to describe our single tion with hypertension (HTN). Based on ambulatory blood pressure
center experience with discharging pediatric patients on durable VAD and monitoring (ABPM), the adolescents were categorized into two groups,
frequency of readmission. namely, a hypertensive group consisting of patients with essential (pri-
Methods: All pts <19 years of age who underwent durable VAD implant mary) HTN (HTN group) and a group consisting of patients with white-
between 2008–2017 with potential for discharge were included. Demo- coat HTN [reference (R) group]. Correlations between serum salusin-β
graphics, frequency of non-elective readmissions, and outcomes to date level and clinical, laboratory and ambulatory blood pressure (BP) variables
including transplant (HTx), death, or ongoing support were evaluated. were assessed.
Results: There were 56 durable VADs implanted in 53 pts. There were Results: The median salusin-β concentration was significantly higher in
52 primary implants, 2 re-implants, and 2 distinct VADs in the same pt patients with essential HTN than in those with white-coat HTN (R group).
at different times. Of 56 VAD implants, 44 (79%) were discharged from Salusin-β was positively correlated with the body mass index Z-score,
the hospital. Devices included HeartMate II (n= 8), HeartWare (n= 34), systolic and diastolic blood pressure (BP) from three independent mea-
and Syncardia (n = 2). The discharged cohort had a median age of 13.6 surements, mean systolic BP during the daytime, triglyceride (TG) level,
years at implant (IQR 9.3, 16.0; range 5.0–18.4); with diagnoses including and atherogenic index (TG/high-density lipoprotein-cholesterol ratio).
cardiomyopathy (n=32), congenital heart disease (n=11), and graft failure The results of this preliminary study suggest that salusin-β may play an
(n=1). Median duration of VAD support among the discharged cohort was important role in the pathogenesis of HTN in a young population. Further
176 days (IQR 99, 435). There were 110 readmissions over 19,364 VAD research should focus on the role of salusin-β in the mechanism of essen-
support days. The median readmission rate per 100 VAD days of support tial HTN and the assessment of possible correlations between salusin-β
was 0.6 (IQR 0.2, 0.9). The median time to first hospitalization was 57 and other well-known markers of atherosclerosis in both teenagers and
days (IQR 19.7, 165.5). The 30-day readmission rate after discharge from adults. This research should serve as a base for future studies in this field.
VAD implant hospitalization was 18% (8/44). All discharged patients
survived with 18 children returning to school on VAD. Of the discharged
VADs, 29 (66%, 29/44) were bridged to transplant, 11 (25%, 11/44)
remain on VAD support, and 4 (7%, 4/44) were explanted. Children on
durable VAD support can be safely discharged and primarily managed as
an outpatient with low readmission rate.

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ASAIO PULMONARY ABSTRACTS

26 46
Simple New Method to Measure Cardiac Output in VV ECMO Patients Long-Term ECMO-Connection - Numerical Investigation of the
N. Krivitski1, G. Galyanov1, J. Gehron2, D. Bandorski3, A. Connection to the Common Iliac Veins
Boning2; 1Transonic Systems Inc., Ithaca, NY, 2Department of N. B. Steuer1, K. Hugenroth1, T. Beck1, J. Spillner2, R. Kopp3, T. Schmitz-
Cardiovascular Surgery, University Hospital of Giessen, Gießen, GERMANY, Rode4, U. Steinseifer5, G. Wagner1, J. Arens1; 1Department of Cardiovascular
3
Department of Pulmonary Medicine, University Hospital of Giessen, Engineering, Institute of Applied Medical Engineering, RWTH Aachen
Gießen, GERMANY. University, Aachen, GERMANY, 2Clinic for Cardiothoracic Surgery, University
Study: Right heart failure caused by pulmonary hypertension may Hospital RWTH Aachen, Aachen, GERMANY, 3Department of Anesthesiology,
frequently occur during the treatment of ARDS with VV ECMO. Early University Hospital RWTH Aachen, Aachen, GERMANY, 4Institute of Applied
diagnosis of decreased cardiac output (CO) may help effective treatment. Medical Engineering, RWTH Aachen University, Aachen, GERMANY,
Published data suggests that CO measured by thermodilution is inac-
5
Monash Institute of Medical Engineering and Department of Mechanical
curate in VV ECMO, especially at high recirculation (R%). The aim of the and Aerospace Engineering, Monash University, Melbourne, AUSTRALIA
study is to develop a simple noninvasive CO measurement technology for and Department of Cardiovascular Engineering, Institute of Applied Medical
VV ECMO patients. Engineering, RWTH Aachen University, Aachen, GERMANY.
Methods: Recirculation R%(1) and arterial saturation SaO2 (1) are Study: Currently used cannulae for ECMO are associated with complications,
measured first at high pump flow Qb1. Then flow is decreased to Qb2 such as thrombosis and distal limb ischemia, especially in the long-term use.
for 2–3 minutes to produce decrease of ΔSaO2 for 6% or more. At new Therefore, we hypothesise that connecting hemodynamically optimized
level of SaO2 (2), R%(2) is measured. Assuming that CO did not change or conduits directly to the native vessels could reduce the risk of complications.
changed negligibly and lung oxygenation was negligible, the following two In this study, the feasibility of conduits to directly connect an ECMO system to
equations can be produced: CO=Qb1*(1-R%(1)/100)*(100-SvO2 (1))/[SaO2 the common iliac veins (CIV), providing sufficient blood flow for CO2 removal,
(1)-SvO2 (1)]; CO=Qb2*(1-R%(2)/100)*(100-SvO2 (2))/[SaO2 (2)-SvO2 (2)], was investigated. However, to facilitate this novel connection, recirculation of
where SvO2(1) and SvO2(2) are venous saturations of blood returned from the blood and high shear zones due to inflow jets must be avoided.
organs at Qb1 and Qb2, respectively. Considering the range of changes Methods: CT-imaging data of 22 patients with healthy vessels was seg-
of SvO2 up to the level of ΔSaO2, these equations can be mathemati- mented, analysed, and a reference model was selected. This model was
cally solved for CO and SvO2. Clinical protocol. Ten adult patients whose used for computational fluid dynamics simulations with a blood flow in
ΔSaO2 decreased by 6% or more as Qb was decreased, were included each CIV of 1 L/min. Initially, a sensitivity analysis regarding recirculation
in the study. R% was measured by the ELSA monitor (Transonic Systems and wall shear stress (WSS) was conducted, using as variables: proximity
Inc. USA), and SaO2 by fingertip oximeter. Reproducibility test: CO was of in- and outflow and conduit diameter, rotational angle, and blood flow
calculated twice. After first CO measurement, Qb was changed to produce (50 %, 100 % and 150 % of CIV flow, to deliberately cause recirculation).
ΔSaO2 that 1–5% different from the first ΔSaO2. R% was measured and Subsequently, the connection was optimized regarding the before men-
second CO was calculated. tioned parameters. Mesh independency was assured.
Results: Recorded and calculated parameters are presented in the table. We validated the simulations using a silicone model. The inflow stream
Calculated by equations SvO2 values may be larger than observed in veins was dyed with ink. A color sensor was used to measure the fraction of ink
if the lungs are partially working. in the outflow, enabling a quantification of recirculation.
Results: The simulations were in good agreement with the validation
Results of Cardiac Output and SvO2 Calculations measurements.
WSS was in physiological range for all design points. Highest and lowest
Qb, R, SaO2, CO, CI, SvO2, recirculation were 29.79 % and 0.14 %, respectively. The rotational angle
Parameters l/min % % l/min l/min/m2 % shows the highest influence on recirculation, but decreases with proxim-
ity of in- and outflow. Overall, an inflow jet directed on a vessel wall leads
Mean±SD 3.9±0.9 14±14 93±4 4.40±0.9 2.49±0.51 68±12 to a separation of the flow and thereby to an increased recirculation.
Range 2–6.2 0–50 82–100 3.05–6.18 1.82–3.69 47–88 Therefore, an inflow angled in the natural blood flow direction of the
inferior vena cava is crucial for this connection.
The coefficient of variation (reproducibility) between the two CO mea-
surements calculated at different ΔSaO2 was 6.9%.
Conclusion: New method to calculate CO is noninvasive, easy to perform
and has good reproducibility. The next step is to validate the current
methodology.

126
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ASAIO PULMONARY ABSTRACTS

49 142
7-day In Vivo Performance of a Low-Flow Extracorporeal CO2 Removal A Quantitative Approach to Detection of Increased Circuit Resistance
Device during ECMO
A. May1, R. Orizondo1, B. Frankowski1, E. Kocyildirim1, J. D’Cunha2, W. V. Dhamotharan, R. Orizondo, W. J. Federspiel; Bioengineering,
Federspiel1; 1McGowan Institute for Regenerative Medicine, Pittsburgh, University of Pittsburgh, Pittsburgh, PA.
PA, 2University of Pittsburgh Medical Center, Pittsburgh, PA. Study: Blood flow rate through an ECMO circuit is a critical parameter
Study: Extracorporeal CO2 removal (CO2R) devices have been found to that is primarily affected by pump speed, hemorheology and circuit resis-
significantly benefit patients with ARDS or acute exacerbations of COPD. tance. Common technical complications such as thrombosis, kinking, and
These systems operate similarly to ECMO, but with the specific goal of cannula occlusion decrease flow through increased resistance. Flow limi-
removing CO2 from the blood at blood flow rates below 1 L/min. Our tation within the oxygenator is detectable via transmembrane resistance.
Modular Extracorporeal Lung Assist System (ModELAS) is an integrated Flow limitation due to increased resistance from other complications,
pump-lung with 3 distinct respiratory support applications including however, is not as readily detectable and can be difficult to recognize dur-
adult low-flow CO2 removal. The CO2R configuration of the ModELAS ing flow changes due to variations in blood viscosity or pump speed. This
is intended for 7 days of use and designed to remove 35 - 50% of the study aimed to develop a quantitative real-time approach for detection of
metabolically produced CO2. This study aimed to characterize the in vivo increased circuit resistance.
performance of the device in a 7-day ovine model. Methods: Dimensional analysis was used to derive dependence between
Methods: The ModELAS consists of a centrifugal pump and a cylindrical, blood rheology, pump speed and flow rate to characterize expected flow
stacked fiber bundle (0.65 m2). In vivo device performance was evaluated variation unrelated to changes in circuit resistance. A custom pump-lung
in 40 - 60 kg sheep (n=3). The 15.5 Fr Hemolung dual lumen catheter under development was used in vitro to acquire device-specific flow data
was placed in the right external jugular vein via a surgical cut down. The at 0.5–3.5 L/min in a circuit free of complication. The setup consisted of
animals were recovered and tethered within a pen. The targeted blood a dual lumen catheter, tubing, and heated reservoir and was primed with
flow rate was 0.5 L/min. Animal hemodynamics were measured hourly blood analog solutions of varying viscosities (simulating 16–34% HCT).
and CO2 removal was measured daily. Blood chemistry and plasma free Data were collected during circuit manipulation simulating cannula occlu-
hemoglobin (pfhb) were measured 5 times during each study. The target sion and kinks to determine the detection ability of this approach.
ACT was 1.5 - 2 times the baseline ACT and was achieved via continuous Results: Flow rates measured within the un-manipulated circuit for
heparin infusion. varying viscosities and pump speeds collapsed on to a single curve (R2
Results: All animals survived the study duration. Two animals had = 0.99) when plotted in dimensionless form. This enabled real-time
elevated creatinine and BUN levels on post-operative day (POD) 3. Both calculation of an expected flow rate over anticipated ranges of viscosity
biomarkers were within the normal range on POD 6 suggesting an acute and pump speeds. Simulated partial cannula occlusion and tubing kink
renal issue. One animal became anemic due to a hematoma unrelated were immediately recognizable via a 10–20% reduction in observed flow
to the device or surgery. Pfhb ranged from 7 - 58 mg/dL. Elevated pfhb from expected flow. This work demonstrates a noninvasive approach to
occurred in one animal with elevated kidney biomarkers before normaliz- detecting ECMO flow limitations due to increased circuit resistance. Such
ing by POD 7. Average CO2R was 72 ± 5 mL CO2/min. One device contained a tool could be integrated into system controllers and may enable easier
thrombus in the bundle and at the pivot-bearings, however the ACTs recognition and resolution of circuit-related complications.
during the study were below the target range 25% of the time. All other
devices were free of thrombi. These studies supported favorable results
with positive low-flow CO2R performance of the ModELAS.

127
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ASAIO PULMONARY ABSTRACTS

192 240
How a CFD Model Can Help to Predict Gas Transfer in Artificial Lungs Long-term Evaluation of an Ultra Compact ECMO System with Built-in
Early during Development Monitors in Chronic Animal Experiments for Up to 5 Weeks
A. Kaesler1, G. Wagner1, T. Schmitz-Rode1, U. Steinseifer2, J. Arens1; 1Dept. N. Katagiri, Y. Takewa, T. Tsukiya, T. Mizuno, J. Shimamura, E.
of Cardiovascular Engineering, Institute for Applied Medical Engineering, Tatsumi; Artificial Organs, National Cerebral and Cardiovascular Center
Aachen, GERMANY, 2Monash Institute of Medical Engineering and Research Institute, Suita, Osaka, JAPAN.
Department of Mechanical and Aerospace Engineering, Monash Study: ECMO system has been used for a several days to a few weeks to
University, Melbourne, AUSTRALIA and Department of Cardiovascular treat patients with severe respiratory/circulatory failure, while device
Engineering, Institute of Applied Medical Engineering, RWTH Aachen exchanges and complications due to its poor durability and thrombo-
University, Aachen, GERMANY. resistant property are still risks in long-term use. In addition, lack of por-
Study: In previous work, we introduced a novel approach to predict oxy- tability and operability due to large and complicated apparatus are also
gen transfer with Computational Fluid Dynamics (CFD) in fiber membrane problematic issues. We have been developing a durable ECMO system
oxygenators. Our model was able to predict oxygen transfer in micro which can solve these problems. In this study, we developed a prototype
oxygenators (MOs) with a specific fiber configuration (Kaesler et al. 2018). of a compact ECMO system with built-in monitors and evaluated its dura-
We are currently applying the model to a full fiber bundle and introducing bility and biocompatibility in a series of chronic animal experiments.
a method to reduce computational effort. In this presentation, we also Methods: This system is consisted of a pre-connected blood circuit unit,
want to outline our vision on how the model will help to predict oxygen a pump driver unit integrating with measurement instruments and a gas
transfer in any given full membrane device in the future. cylinder unit. Prototype of the circuit unit was consisted of a centrifugal
Methods: In vitro: Three devices with a stacked fiber configuration and pump (BIOFLOAT NCVC) with hydrodynamically bearings, a membrane
spacers between each layer were potted by rotating the device around oxygenator (BIOCUBE6000) and circuit connectors including built-in
its central axis targeting a bundle diameter of 23.3 mm (Fig 1a). All sensors or probes. The entire blood-contacting surface of the circuit was
devices were tested according to DIN EN ISO 7199 with porcine blood at treated with heparin bonding material (T-NCVC). Prototype of the driver
four blood flows; three pre- and post-oxygenator blood samples were unit was made as compact (W298 x D205 x H260 mm, 6.8 kg). Veno-arte-
analyzed per blood flow. CFD: The geometry of the MOs was simplified to rial bypass ECMO using this system was conducted for 3 cases of 4 weeks
a quasi-2D domain and one periodic element. While gaps between fibers or 1 case of 5 weeks using goats (48.0, 49.5, 49.0, 44.3 kg). Heparin was
are constant within each layer, the relative position between individual continuously administrated to control ACT between 150–200 sec.
fiber layers is random in clinically used oxygenators (Fig. 1b). We explored Results: The ECMO could run for scheduled periods without any device
the effect this may have on flow distribution and gas transfer for three exchange and each monitor was stable in all cases. 2.5 L/min of bypass
randomly generated configurations. flow rate could be maintained. Oxygen and Carbon dioxide transfer rates
Results: Fig 2 illustrates in vitro (MO 1–3) and the CFD results. We were were kept at sufficient levels (136 ± 27 and 112 ± 27 mL/min, respec-
able to show (i) that the model predicts oxygen transfer with reasonable tively). After the experiments, thrombus formation was hardly observed
accuracy (Fig.2), (ii) that the effect of exact relative position of individual in the each blood circuits including the built-in monitors. In conclusions,
fiber layers on flow distribution and gas transfer is small (CFD error bars), the ultra compact ECMO system was developed and demonstrated
and (iii) that the periodic element approach we used was valid. long-term durability, stability of monitor functions and thrombo-resistant
property for up to 35 days.

128
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ASAIO RENAL ABSTRACTS

15 91
The Study of Autophagy and Oxidative Stress in Patients with Renal In Vivo Evaluation of Novel PEGylated Small Intestinal Submucosa
Transplantation: Relation to Allograft Function and Survival Vascular Grafts for Arteriovenous Connection: Exploring Microscopic
Y. A. Issa1, M. A. Zeidan1, N. A. Barghash1, H. A. El Aggan2, F. D. El Structure-Function Relationships
Farjani3; 1Medical Biochemistry, Alexandria University, Faculty of K. T. Valencia Rivero1, J. C. Cruz1, W. R. Wagner2, N. F. Sandoval3, J.
Medicine, Alexandria, EGYPT, 2Internal Medicine department, Nephrology C. Briceño4; 1Bogotá D.C., Universidad de Los Andes, Bogotá D.C.,
and Transplantation Unit, Alexandria University, Faculty of Medicine, COLOMBIA, 2University of Pittsburgh, Pittsburgh, PA, 3Fundación
Alexandria, EGYPT, 3Medical Biochemistry, Faculty of Medicine, University Cardioinfantil - Cardiology Institute, Bogotá D.C., COLOMBIA, 4Universidad
of Misurata -Libya, Misurata, LIBYAN ARAB JAMAHIRIYA. de Los Andes, Bogotá D.C., COLOMBIA.
Study: The transplanted kidney is faced with a considerable number of Study: Hemodialysis is one of the most used renal replacement therapies
stresses that compromise tissue viability and can lead to graft dysfunc- to artificially clean blood waste and it is in the need of a functional
tion and loss. Such stresses may mediate autophagy. This study aimed at vascular access. Most common vascular access are vascular grafts, a small
assessing the association of serum levels of Autophagy protein 5 (Atg5), diameter connection between an artery and its adjacent vein. Complica-
malondialdehyde (MDA) and total antioxidant capacity (TAC) with renal tions of current vascular grafts are thrombogenesis and reduced patency
allograft function and survival in a sample of Egyptian patients with renal rates due to turbulences, low blood pressure, or collapse.
transplant. Methods: In this study a C-shaped vascular grafts was manufactured
Methods: The study included three groups of 15 patients each; Group I: with small intestinal submucosa (SIS) and the consequent conjugation
renal transplantation patients with stable renal function, group II: renal of Polyethylene Glycol (PEG) on its surface, to reduce thrombogenesis in
transplantation patients with chronic allograft dysfunction and group III: comparison with commercially available ePTFE vascular grafts. Molecular
healthy subjects representing controls. All groups were evaluated regard- weight and concentration of PEG molecules were systematically varied to
ing complete history taking and clinical evaluation. Laboratory investiga- gain insights into the underlying structure-function relationships.
tions included: CBC, renal function tests, and complete urine analysis with Results: Chemical, thermal and mechanical properties of the SIS-PEG 400
measurement of urinary protein /urinary creatinine ratio. Serum levels [6 equivalents] were analyzed, as well as cytotoxicity and in vitro platelet
of C-reactive protein(HsCRP), Atg5, malondialdehyade (MDA) and total deposition. Conjugation levels obtained produced no significant changes
antioxidant capacity (TAC) were assessed. Therapeutic drug monitoring in thermal properties, while mechanical properties as structural stability
was done for all transplanted patients. and graft compliance were considerably improved approaching that of
Results: Serum levels of both Atg5 and MDA were significantly higher native vessels. Platelet deposition was altered leading to a 95% reduction
in group II than in groups I and controls (p =0.002, p< 0.001 con- compared with pristine SIS, and 92% with respect to ePTFE. Swine animal
secutively). TAC level showed significant difference between the three models were also made to test in vivo immune response, patency rates,
groups (p=0.006). Atg5 level was positively correlated with S.Cr, HsCRP, and extent of regeneration. H&E stain corroborated SIS-PEG 400 biocom-
cyclosporine trough level, and MDA level, and negatively correlated with patibility and ability to promote regeneration. The obtained results set
e-GFR and TAC level in group I and II. Renal fibrosis was positively cor- solid foundations for the further design of a multiparametric, regenera-
related with serum creatinine, HsCRP, cyclosporine trough level, MDA, tive, small diameter vascular graft model, and introduce an alternative to
and Atg5 level, and was negatively correlated with e-GFR level in group II. ePTFE vascular grafts for hemodialysis access.
Conclusions: Increased serum levels of ATG5 and MDA can predict future
deterioration of renal allograft.

129
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ASAIO RENAL ABSTRACTS

92
A Fundamental and Direct Attack on Volume Control in Dialysis Patients
E. F. Leonard1, S. Cortell2, A. Bansal3, R. von Gutfeld4, A. J.
Autz5; 1Columbia University, New York, NY, 2Medicine, Columbia
University, New York, NY, 3Medicine, University of Colorado, Aurora, CO,
4
Chemical Enginering, Columbia University, New York, NY, 5Biomedical
Engineering, Columbia University, New York, NY.
Study: Combining dialysis and ultrafiltration makes both inefficient and
yields poor volume control. They cause solute sequestration in skeletal
muscle and the serious patient discomfort via hypotension which can
reach 100 mmHg during a 3 hour treatment. We have published a clinical
study in which 12 HD patients received UF 6 days/week and HD 2 days/
week. They had more efficient HD (KT/V) and better BP control than when
receiving conventional thrice weekly HD.
Methods: We have tested a very small UF system that provides 1 ml/min
UF (10–12 Kg/week) with a small continuous extracorporeal blood flow
of 20 ml/min. The system has a non-occlusive pump, a hollow-fiber ultra-
filter and an internet connected variable resistance to supply the back
pressure for UF. The pump can run for s 72 hours without recharging.
We have demonstrated, in vitro using reconstituted banked blood, that
the filter will provide UF for 72 hours without fouling.This system (Patent
pending) is to be managed by the dialysis clinic. The patient would wear
a reusable component consisting (battery, pump, and a “smart resistor”
to control the UF rate and a disposable component -filter and tubing-- to
be changed at the dialysis center: blood tubing and filter through which
blood flows continuously at about 20 ml/min, with UF discharging into a
collection bag The system is refreshed (inspected, filter changed, battery
replaced) in the clinic during each dialysis visit. The “smart resistor can
measure, record, and report pressure via an internet connection. The
patient manages the collection bag, reporting any unexpected rate or
appearance of filtrate.
Results: Recent developments in making blood tubing thromboresistant
(already in clinical use with PICT lines) and additives that confer similar
resistance to semipermeable fibers (not yet tested in-vivo) would greatly
lessen the risk of thrombogenesis.

130
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ASAIO RENAL ABSTRACTS

128 132
Gradual Escalation of Blood Flow and Dialysate/Replacement Drainage with Normal Saline in Two Directions for Washing of the
Fluid Bicarbonate Concentration Improved Clinical Tolerability of Clogging Filter During Cell-free and Concentrated Ascites Reinfusion
Hemodiafiltration in Maintenance Hemodialysis Patients Therapy
G. Becs1, J. Balla1, T. Fülöp2; 1Department of Medicine, University of N. Igata1, J. Nishioka2, T. Komatsu3, S. Kobayashi3, Y. Ohnishi3, M.
Debrecen Medical and Health Sciences Center, Debrecen, HUNGARY, Fukuhara4, H. Tanaka5, T. Tomonari6, T. Takayama5, M. Sogabe7, T.
2
Medicine, Medical University of South Carolina, Charleston, SC. Okahisa7; 1Student lab, Tokushima University, Tokushima city, JAPAN,
Study: Some challenges during HDF are unique and not well documented 2
Tokushima University, Tokushima city, JAPAN, 3Clinical Engineering,
in literature. We observed a series of end-stage renal disease (ESRD) Tokushima University Hospital, Tokushima city, JAPAN, 4Public
patients complaining of chest discomfort during start of hemodiafiltra- School Teachers, Shikoku Central Hospital, Shikokuchuo city, JAPAN,
tion (HDF); these patients tolerated HDF with only gradual escalation 5
Gastroenterology and oncology, Tokushima University Graduate School,
of blood flow (QB), bicarbonate (HCO3) concentrations in both dialysis/ Tokushima city, JAPAN, 6Tokushima University Graduate School, Tokushima
post-replacement fluids, as well as manual limitation of hemofiltration city, JAPAN, 7General medicine and community health science, Tokushima
(HF) rate. University Graduate School, Tokushima city, JAPAN.
Methods: We reviewed general clinical features and treatment charac- Study: Cell-free and Concentrated Ascites Reinfusion Therapy(CART)is an
teristics of nine ESRD patients empirically titrated to individual gradual effective and safe therapy for patients with refractory ascites. As the main
escalation protocols. Results expressed with means (±SD) unless other- target disease for CART changed from liver cirrhosis to advanced cancer,
wise noted. the quantity and viscosity of treated ascites increased. For treatment of
Results: Mean (SD) age was 61.5 (11.8) years, 55.6% female, all Caucasian a large amount of ascites using CART, a measure against filter clogging is
with median dialysis vintage 8 month [25–75% range: 4.5, 43] and dry necessary. In this study we established an effective washing system with
weight 92.5 (40.7) kg. Prescribed HDF regimen included treatment time normal saline for a clogged filtration filter and evaluated the efficacy of
254.4 (8.8) min, QB 342 (81) mL/min, Na+ 137 (1) mEq/L, HCO3 33.6 (2.5) this system through clinical evaluation.
mEq/L and fluid temperature 36.1 (0.3) Co. Hemodialysis autoflow ratio Methods: We developed a novel, specialized CART machine in 2018. This
was 1.26 (0.13), weekly target HF rate was 63 L. During gradual start, QB machine can wash a clogged filtration filter automatically when the TMP
was increased from 217 (35) to 283 (66) mL/min, HCO3 24 to 28.2 (0.6) exceeds a set point. Simulated ascites, consisting of intravenous fat emul-
mEq/L between 5–25 min in 10 min increments. Most patients received sion (soybean oil), substitute plasma agent (hydroxyethylated starch),
gradual escalation of post-dilutional HF rate (25 - 50 mL/min; then auto- and normal saline, were used to clog the filtration filter and the effective
substitution). All patients reached target QB, HCO3 concentration and HF washing method was investigated. As the direction of filtration of the
rate by 30 min and currently asymptomatic. Monthly labs revealed predi- simulated ascites was inside-out, the direction of washing with normal
alysis hemoglobin 11.2 (1.3) g/dL, HCO3 20.5 (3.2) mEq/L and albumin of saline was outside-in.
3.8 (0.6) g/dL. Predialysis BUN measured 51.5 (19) mg/dL, last Kt/V cal- Results: In the experiment using simulated ascites, TMPs of the clogging
culated 1.14 (0.26) without residual urine output included. Clinical toler- filtration filters were decreased upon washing with normal saline. Drain-
ability of HDF is an important clinical outcome and may be different from age in two directions at the entrance and exit sides of the hollow fiber
regular hemodialysis. The clinical phenomenon of gradual HDF escalation reduced TMP early. On clinical evaluations, when normal CART using
should be prospectively studied in larger cohorts in protocolized fashion. our machine equipped with this system was administered, filtration and
concentration of the total dose were possible, with a large quantity of
(more than 5 L) high-density carcinomatous ascites. The aggregate in the
header part at the entrance of the hollow fiber was easily removable by
drainage in the opposite direction. These results indicate that drainage in
two directions using normal saline is effective in washing a clogged filter
during CART.

131
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ASAIO RENAL ABSTRACTS

133 Results: Focusing on APD application, it is observed that peristaltic


pumps produce lower pumping rates as compared to membrane pump.
IMENGiTi: A Working Prototype of a Portable Tidal Peritoneal Dialysis
A peristaltic dosing pump only has a maximum pumping rate of 100 mL/
System
min, making it unsuitable for APD pumping application. On the other
A. A. Hamzah1, B. Y. Majlis1, A. H. Abdul Gafor2; 1Institute of
hand, miniaturized peristaltic rotary pump has a pumping rate of
Microengineering and Nanoelectronics, Universiti Kebangsaan Malaysia,
100–190 mL/min, which is deemed sufficient for APD application, since
Bangi, Selangor, MALAYSIA, 2Hospital Canselor Tuanku Mukhriz (HCTM),
the tidal portable APD system operates around the clock, as compared
Universiti Kebangsaan Malaysia, Kuala Lumpur, MALAYSIA.
to the nightly operated APD system. Moreover, peristaltic pumps are
Study: A prototype for performing continuous tidal peritoneal dialysis more suitable to be installed into a portable APD system due to their
system on end-stage renal disease (ESRD) patients is developed. The compact size. Despite having higher pumping rate, a typical membrane
portable system could continuously perform tidal APD on ESRD patients pump would occupy a space of 1 cubic liter. In terms of vibration, the
with a lower dialysate pump-in and pump out rate. We investigate the miniaturized peristaltic pump produces medium vibration at 150 mL/
efficiency of the pumping system in terms of pumping rate and vibration. min pumping, and high vibration at 190 mL/min pumping. A survey per-
Methods: Dialysate pump-in and pump-out were studied at various formed on 10 patients indicated that medium vibration is acceptable,
pumping rates. Two types of peristaltic pumps, namely dosing pump and while high vibration causes tickling discomfort on abdomen area. Pump
miniaturized rotary pump, were compared in terms of pumping rate and vibrations transverse through the peritoneal catheter via transfer set.
vibration. For each cycle, 1 liter of dialysate fluid is pumped in, dwelled It is suggested that the miniaturized peristaltic rotary pump is further
for 4 hours, and pumped out. The pumping rates were benchmarked packaged and damped at transfer tube’s inlet to produce a vibration
against typical APD’s inflow rate of 350 mL/min and outflow rate of free portable APD system.
230 mL/min.

Pumping rate and vibration of various APD pumps

Peristaltic Peristaltic Peristaltic


Peristaltic Peristaltic miniaturized miniaturized miniaturized
Membrane pump dosing pump dosing pump pump pump pump
(typical APD) Low mode High mode Low mode Medium mode High mode

Pump in rate (mL/min) 350 20 100 120 150 190


Pump-out rate (mL/min) 230 20 100 120 150 190
Vibration low low low low medium high

132
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ASAIO RENAL ABSTRACTS

135 presence of PBTs in human plasma. Diffusion experiments using dialysate


Mixed Matrix Membrane for Achieving Endotoxin Free Dialysate contaminated with bacterial culture filtrates from P. aeruginosa and S.
Combined with High Removal of Uremic Toxins From Human Plasma maltophilia are were also performed to assess the ability of the MMM to
I. Geremia1, R. Bansal2, D. Stamatialis1; 1Bioartificial organs, University act as a safety-barrier to avoid transfer of pyrogens to the plasma. A PES/
of Twente, Enschede, NETHERLANDS, 2University of Twente, Enschede, PVP membrane without sorbent particles is used as control.
NETHERLANDS. Results: Our results show that the MMM can remove in vitro approxi-
mately 10 times more endotoxins from dialysate compared to commercial
Study: For a single hemodialysis session nearly 500 liters of water are
dialysis membranes while no transfer of pyrogens occurs to the blood
consumed for obtaining pyrogen-free dialysate. Here, we present the plasma compartment. In fact, endotoxins from dialysate and protein-
application a mixed matrix membrane consisting of activated carbon sor- bound toxins from human plasma can be removed simultaneously. We
bent particles incorporated within a porous polymer matrix for achieving estimate that 0.15m2 of MMM is needed to totally remove the daily pro-
endotoxin-free dialysate and high removal of uremic toxins from human duction of the protein-bound toxins indoxyl sulfate and hippuric acid and
plasma in one step. to completely remove endotoxins in a wearable artificial kidney (WAK)
Methods: In this study, we have investigated the adsorption of endotox- device. Our results could open up new possibilities for dialysis therapy
ins from E. coli and P. aeruginosa on the MMM in both static and dynamic with low water consumption including WAK and where purity and scarcity
conditions. Dynamic adsorption of LPS on the MMM is also investigated in of water are limiting factor for hemodialysis treatment.

133
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ASAIO RENAL ABSTRACTS

149 Results: Our study with NaCl shows the ability to provide a commercial
Large Animal Hemodialysis Model for the Benchtop: LAHMB dialysis delivery system with a suitable model of a large animal for testing
K. Hill, B. Ezzat, J. L. McGrath, D. G. Johnson; Biomedical Engineering, (see Figure 3). The pressure measured at the afferent access was 6 kPa
University of Rochester, Rochester, NY. and at the efferent access was 1 kPa, which allowed the dialysis system
Study: There is a need for reliable, efficient, and cost-effective testing to operate without raising alarms. We hypothesize that an in vitro large
methods for small format dialyzers without resorting to animal model animal HD model for the benchtop (LAHMB) can yield results comparable
studies. We designed a large animal hemodialysis (HD) model for the to those attained from animal model studies directly, allowing for a reduc-
benchtop that mimics the concentration of uremic toxins in the intravas- tion in the number of animals used in the development of a miniaturized
cular fluid volume (blood) and arteriovenous fistula access for hemodialy- HD system and providing a platform for testing commercial hemodialyzer
sis that can be used to test both commercially available and miniaturized filters. Bench top results from the micro hemodialysis delivery system will
HD systems. be compared to results from previous animal studies and large animal
Methods: Figure 1 shows the LAHMB with a hemodialysis delivery studies planned in the coming year.
system. We have built a minimally viable product (see Figure 2) and
conducted four-hour dialysis (dialyzing salt) with a hemodialysis delivery
system (2008T, Fresenius Medical Care, MA, USA) and an Optiflux F160NR
hemodialysis cartridge. The model provided pressurized fluid flow
containing analytes (NaCl) in phosphate buffered saline (PBS). The fluid
can range from PBS to bovine serum or bovine blood with the volume of
fluid in the system matched to the animal’s circulatory system (e.g. 2 L to
4 L in sheep). We used a Masterflex L/S peristaltic pump system (Cole
Parmer, IL, USA) and a 5 L Nalgene carboy for the reservoir. For monitor-
ing the pressure, we selected uProcess™ software (LabSmith, CA, USA).

134
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ASAIO RENAL ABSTRACTS

196 201
The Great Dilemma of IntraDialytic Hypotension Definition: A Miniature Libs Sensor for Real-time and In-line Multicomponent
Comparative Approach Analysis of Dialysis Fluids
G. Casagrande, L. Possenti, M. L. Costantino; Department of Chemistry, M. P. Oderwald; The Netherlands Organisation for Applied Scientific
Materials and Chemical Engineering, Politecnico di Milano, Milano, ITALY. Research TNO, Delft, NETHERLANDS.
Study: Intra-dialysis hypotension (IDH) is the most diffused hemodialy- Study: Blood values of CKD patients are typically measured every few
sis complication. Its recognition, based on clinician’s ability to identify weeks. The treatment is ‘blind’ to sudden or day to day changes in the
patients’ specific symptoms, makes it difficult reaching a univocal defini- patient’s condition or diet.
tion that should be required to develop automatic IDH prevention sys- TNO developed a non-invasive sensor for the real-time, in-line monitoring
tems. Different literature IDH identification criteria, applied to the same of the electrolytes Na+, K+ and Ca2+ in spent dialysate, to enable individual-
dataset, were here compared. ized and enhanced dialysis treatments, and to reduce complications.
Methods: The DialysIS DataBase, populated during DialysIS Project, In near-term, a drift may be earlier detected and dialysis treatment may
INTERREG IT-CH2007-13, was used. Data refer to 142 patients (1050 be adjusted on an inter-dialysis level. In mid-term, the sensor can be used
sessions), enrolled in 4 centers. IDH identification criteria have been clas- for intra-dialysis adjustments and in the long term, electrolyte sensors
sified as: 1- ‘only symptoms based’, KDOQI and Tilser criteria considered; may be used in closed loop.
2- ‘hybrid’ (symptoms and pressure variations), Chesterton and IDH_D Methods: Laser Induced Breakdown Spectroscopy (LIBS) sensors allow
criteria; 3- ‘only pressure threshold based’, Flythe, Dubin and Palmer simultaneous multi-element analysis.
criteria. The three groups of criteria were compared in term of patient’s A focused pulsed laser ignites a plasma (the fourth fundamental state
proneness to IDH and frequency of events. of matter) in the fluid. The light emitted by the plasma contains spectral
Results: Depending on the used group criteria a large number of pressure lines that correspond to the relevant electrolytes (Na+, K+, Ca2+). This spec-
conditions is identified as being IDH or not (33,2% of the clinical data). trum is measured with a spectrometer. The shape and intensity of the
All the criteria agreed in identifying as IDH only the 1,6% of the analysed spectral lines is related to the concentration of the specific electrolytes.
data. Group 1 criteria identified the lowest number of IDH, with respect The complexity and expensive components hindered the development
to groups 2–3 (p<0,05); similar differences were observed in the prone- towards low-cost, user-friendly LIBS devices so far.
ness to IDH. The ‘only symptoms based’ criteria seem to be too specific TNO has now developed a prototype of a compact LIBS sensor for the in-
to identify as IDH a number of pressure conditions, which instead are line detection of sodium, potassium and calcium in (spent) dialysate. Due
reported in the literature as correlated with increased long-term mortal- to its innovative design, it can be manufactured with relatively low costs
ity risk. Group 2 and 3 criteria display similar IDH identification ability, of goods at high production volume.
however, group 3 criteria appear more suitable for implementation in Results: Water samples containing sodium, potassium and calcium have
automatic systems not accounting for symptomatology. been measured.
For sodium, in the range of 110–165 mM, a precision of 2–3 mM was
demonstrated.
For potassium, in the range of 0.5 to 20 mM, a precision of 0.2–0.3 mM
was achieved.
For calcium, the most challenging element, a detection limit of 1.5 mM
was measured and a precision of 2–3 mM in the range of 2 to 20 mM.
The performance of this technology is currently being further investi-
gated, including a small pilot study on spent dialysate samples.

135
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ASAIO RENAL ABSTRACTS

206 239
Feasibility of Wearable Fluid Status Monitoring of End Stage Renal Possible Resolution to Problem of Massive Disposal and Replacement of
Disease Patients Artificial Kidney Filtrate
S. Lee1, W. Groenendaal1, J. Vranken2, C. J. Smeets2, M. K. Schoutteten2, A. A. J. Lande; Northport Navigable Waters Institution, Northport, MI.
Weigand2, F. P. Wieringa1, P. M. Vandervoort2, C. Van Hoof3; 1Connected Study: Inspiration from filtration emphasis in KidneyX competition:
Health Solution, IMEC, Eindhoven, NETHERLANDS, 2Future Health “Non-fouling and able to maintain continuous performance (duration
Departmen, Ziekenhuis Oost-Limburg, Genk, BELGIUM, 3Connected Health determined by product and clinical context). Generates a filtrate of at
Solution, IMEC, Leuven, BELGIUM. least 40L/day (~30mL/minute for 24-hour therapy. Size selective, with no
Study: Bio-impedance (BioZ) is a promising technology to monitor fluid loss of essential blood proteins (e.g. albumin). Component materials and
status in patients with fluid imbalance like congestive heart failure (CHF) design must be biocompatible and hemocompatible”. Filtration appears
or chronic kidney disease (CKD), in particular End Stage Renal Disease to imply one-way flow of liquids (albumin and larger excluded) out from a
(ESRD). Previously, we developed a low-power compact-sized wearable patient’s blood, through the relatively large pores in a passive membrane.
sensor, that simultaneously measures ECG, BioZ, and motion, which Accumulation requires inconvenient disposal and subsequent irksome
showed a good correlation with fluid status in CHF patients. The local (and expensive?} replacement of filtrate, presumably through a patient
measurement offers the possibility to design a wearable patch form factor intravenous or device (or oral?).
for continuous, comfortable, and real-time monitoring. In this study, we Methods: Why not then seek an alternative to the massive accumula-
applied our sensors to ESRD patients during hemodialysis and verified tion and almost as massive replacement? We propose a tidal scheme
whether localized BioZ data correlated with ultra-filtrated volume (UFV). whereby relatively frequent bursts of soiled filtrate, directed away from
In addition, patient opinions about wearable monitoring were assessed the patient, alternate with bursts of sorbent cleansed filtrate-dialysate
using a questionnaire. directed back toward the patient. No more irksome mass collection and
Methods: 23 ESRD patients were monitored using our wearable sensor replacement required.
during routine hemodialysis. Each patient was followed for multiple Results: Bidirectional bursts occurring perhaps 8 times per minute (4
dialysis sessions, resulting in 92 dialysis sessions in total. The sensor times each way) in volumes of perhaps ~7 ½ ml. Unidirectional sum
was attached to the left thorax side and measured single lead ECG, BioZ, 30 ml/min, same as conventional continuous filtration, but without the
and motion throughout the entire dialysis session. For an additional 18 large accumulation and subsequent replacement. Additional advantages:
patients, questionnaires were taken to investigate willingness and prefer- Reversing flow through membrane, avoids fouling. Cleansing of filtrate
ences with respect to wearable fluid status monitoring. while on the far side of the membrane from the patient. by circulation
Results: Median correlation coefficient between BioZ and UFV was 0.983, through a sorbent cartridge. Is the A/V pressure differential available
and lower and upper interquartile is 0.932 and 0.994, respectively. The from our “InSitu Debranched Vein Fistula Conduit (VFC) access, sufficient
questionnaire showed that 66.7% of the patients is interested in using a to filter blood? If not sufficient and resistance lowering strategies are not
wearable device for fluid monitoring and prefers a small (83.3%), invis- adequate, then addition of a small, supplementary, recirculating blood
ible (77.8%) and light-weight (77.8%) form factor. These results indicate pump might be considered. Also applies to pumping dialysate through a
that wearable BioZ monitoring devices meeting these desires could be a resistant sorbent cartridge? Why not try Tidal Filtration?
promising way to provide novel insights in the fluid shifts in CKD patients,
possibly even extended into daily life when not on dialysis.

136
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ASAIO Author Index

Aaronson, K.,�������������������������������������������������������������������������������������������� 57 Bansal, A.,����������������������������������������������������������������������������������������������� 130


Abada, E.,������������������������������������������������������������������������������������������������� 30 Bansal, R.,����������������������������������������������������������������������������������������������� 133
Abdalla, M.,�������������������������������������������������������������������������������������������� 103 Barabino, N.,��������������������������������������������������������������������������������������������� 88
Abdltawab, M.,����������������������������������������������������������������������������������������� 70 Barboza, M.,��������������������������������������������������������������������������������������������� 21
Abdul Gafor, A. H.,���������������������������������������������������������������������������������� 132 Barghash, N. A.,�������������������������������������������������������������������������������������� 129
Abdullah, M.,�������������������������������������������������������������������������������������������� 70 Barone, H.,������������������������������������������������������������������������������������������������ 53
Acker, M. Y.,���������������������������������������������������������������������������������������������� 91 Barrus, B.,������������������������������������������������������������������������������������������������� 93
Adachi, I.,���������������������������������������������������������������������������������121, 122, 125 Barth, E. J.,������������������������������������������������������������������������������������������������ 20
Adams, J.,���������������������������������������������������������������������� 8, 18, 27, 65, 78, 79 Bartlett, R. H.,������������������������������������������������������������������������18, 24, 30, 120
Adams, T.,������������������������������������������������������������������������������������������� 27, 81 Bartlett, R.,����������������������������������������������������������������������������������������������� 82
Adhikari, S.,����������������������������������������������������������������������������������������������� 72 Baturalp, T.,������������������������������������������������������������������������������������������������ 3
Adia, M.,��������������������������������������������������������������������������������������������������� 70 Bauer, T.,��������������������������������������������������������������������������������������������������� 62
Afshar, K.,�������������������������������������������������������������������������������������������������� 70 Beale, M.,����������������������������������������������������������������������������������������������� 119
Agboola, O.,�������������������������������������������������������������������������������������������� 101 Beck, T.,�������������������������������������������������������������������������������������������������� 126
Agnew, R.,������������������������������������������������������������������������������������������������� 59 Becker, M.,������������������������������������������������������������������������������������������������ 22
Agrafiotis, E.,���������������������������������������������������������������������������������������������� 7 Beckman, J. A.,������������������������������������������������������������������48, 52, 64, 72, 89
Aguillon, M.,������������������������������������������������������������������������������������� 81, 115 Beckman, J.,��������������������������������������������������������� 22, 74, 85, 86, 87, 96, 113
Aicher, T.,�������������������������������������������������������������������������������������������� 71, 89 Becs, G.,�������������������������������������������������������������������������������������������������� 131
Aigner, P.,�������������������������������������������������������������������������������������������� 76, 82 Bekbossynov, S.,��������������������������������������������������������������������������������������� 51
Ajmal, M.,������������������������������������������������������������������������������������������������� 49 Bekbossynova, M.,������������������������������������������������������������������������������������ 51
Aka, I. B.,������������������������������������������������������������������������������������������������� 122 Benjamin, M. M.,�������������������������������������������������������������������������������������� 47
Akar, A. R.,������������������������������������������������������������������������������������������������ 50 Benstoem, C.,����������������������������������������������������������������������������������������� 114
Akay, M. H.,����������������������������������������������������������������������������������������� 90, 91 Berg, T.,��������������������������������������������������������������������������������������������������� 114
Akhmerov, A.,������������������������������������������������������������������������������������������� 58 Bergeron, H. E.,����������������������������������������������������������������������������������������� 13
Akiyama, M.,��������������������������������������������������������������������������������������������� 58 Berk, Z.,�������������������������������������������������������������������������������������������������� 124
Akkanti, B.,����������������������������������������������������������������������������������������������� 86 Bernstein, B.,������������������������������������������������������������������������������������������ 119
Akoum, N.,������������������������������������������������������������������������������������������������ 86 Betterton, E.,�������������������������������������������������������������������������������������������� 98
Al Saadi, T.,����������������������������������������������������������������������������������������������� 71 Beyerle, T.,������������������������������������������������������������������������������������������������ 17
Al-Kindi, S.,����������������������������������������������������������������������������������������������� 63 Biasetti, J.,������������������������������������������������������������������������������������������������� 88
Alaeddine, M.,���������������������������������������������������������������������������������������� 119 Biermann, D.,�������������������������������������������������������������������������������������������� 47
Alali, Z.,����������������������������������������������������������������������������������������������������� 12 Binsalamah, Z. M.,�������������������������������������������������������������������������� 121, 122
Albornoz Alvarez, V. H.,���������������������������������������������������������������������������� 91 Binsalamah, Z.,��������������������������������������������������������������������������������������� 125
Alexis, J.,��������������������������������������������������������������������������������������������� 46, 93 Birati, E. Y.,������������������������������������������������������������������������������������������������ 91
Alharethi, R.,��������������������������������������������������������������������������������������������� 70 Bishawi, M.,���������������������������������������������������������������������������������������������� 87
Ali, S.,�������������������������������������������������������������������������������������������������� 54, 65 Bitar, A.,���������������������������������������������������������������������������������������������������� 57
Aliseda, A.,����������������������������������������������� 22, 52, 64, 72, 85, 86, 89, 96, 113 Bjelkengren, J.,����������������������������������������������������������������������������64, 72, 113
Allen, J.,���������������������������������������������������������������������������������������������������� 40 Blaha, C.,��������������������������������������������������������������������������������������������� 29, 37
Almond, C. S.,����������������������������������������������������������������������������������������� 120 Bletcher, K.,������������������������������������������������������������������������������������35, 36, 38
Alnsasra, H.,�������������������������������������������������������������������������������������� 99, 110 Blissick, D.,���������������������������������������������������������������������������������������������� 108
Ameduri, R.,���������������������������������������������������������������������������������������������� 73 Blood, P. S.,��������������������������������������������������������������������������������������������� 116
Ammann, K. R.,����������������������������������������������������������������������������������� 31, 88 Bluestein, D.,�������������������������������������������������������������������������������������� 38, 40
Anders, I.,��������������������������������������������������������������������������������������������������� 7 Blume, V.,������������������������������������������������������������������������������������������������� 70
Andossova, S.,������������������������������������������������������������������������������������������ 51 Boccon, D.,������������������������������������������������������������������������������������������������ 20
Andrade, A.,������������������������������������������������������������������� 7, 12, 23, 66, 71, 72 Bock, E.,���������������������������������������������������������������������������������������������������� 21
Andreopolus, F.,���������������������������������������������������������������������������������������� 93 Bonde, P.,�������������������������������������������������������������������������������������43, 44, 101
Antaki, J. F,������������������������������������������������������������������������������������������������ 69 Boning, A.,���������������������������������������������������������������������������������������������� 126
Antaki, J. F.,����������������������������������������������������������������������������������32, 78, 119 Borowski, A.,��������������������������������������������������������������������������������������������� 80
Antaki, J.,�������������������������������������������������������������������������������������������������� 31 Borrego, L. Bautista,����������������������������������������������������������������������������������� 4
Aras, M.,��������������������������������������������������������������������������������������������������� 74 Botterbusch, C. N.,������������������������������������������������������������������������������������ 88
Arce, F. T.,������������������������������������������������������������������������������������������������� 38 Boucher, S. G.,�������������������������������������������������������������������������������������������� 6
Arens, J.,������������������������������������������������������������������������������������30, 126, 128 Bovendeerd, P.,����������������������������������������������������������������������������������������� 79
Arimura, K.,������������������������������������������������������������������������������������������������� 3 Boyce, S.,�������������������������������������������������������������������������������������������������� 92
Atillo, C. T.,������������������������������������������������������������������������������������������������ 29 Briceño, J. C.,������������������������������������������������������������������������������������ 34, 129
Atlani, D.,�������������������������������������������������������������������������������������������������� 88 Brown, M. C.,�������������������������������������������������������������������������������������������� 60
Auld, J. P.,�������������������������������������������������������������������������������������������������� 48 Brozzi, N.,�������������������������������������������������������������������������������������������� 93, 95
Austin, M. A.,�������������������������������������������������������������������������������������������� 97 Brynedal Ignell, N.,����������������������������������������������������������������������������������� 14
Autschbach, R.,��������������������������������������������������������������������������������������� 114 Buchan, S.,������������������������������������������������������������������������������������������������ 30
Autz, A. J.,����������������������������������������������������������������������������������������������� 130 Burch, M.,������������������������������������������������������������������������������������������������� 58
Ayers, B.,��������������������������������������������������������������������������������������������������� 93 Burg, B.,���������������������������������������������������������������������������������������������������� 88
Bacchetta, M.,���������������������������������������������������������������������������������������� 102 Burgreen, G. W.,��������������������������������������������������������������������������������������� 69
Badiye, A.,������������������������������������������������������������������������������������������������� 93 Burns, J.,��������������������������������������������������������������������������������������������������� 59
Badu, B.,��������������������������������������������������������������������������������������������������� 98 Byram, N.,���������������������������������������������������������������� 8, 18, 19, 27, 65, 78, 79
Bajwa, K.,�������������������������������������������������������������������������������������������������� 86 Cabrera, A. G.,�������������������������������������������������������������������������121, 122, 125
Baker, M.,������������������������������������������������������������������������������������������������ 107 Cain, M.,��������������������������������������������������������������������������������������������������� 98
Balla, J.,��������������������������������������������������������������������������������������������������� 131 Caine, W. T.,���������������������������������������������������������������������������������������������� 70
Ballard-Croft, C.,������������������������������������������������������������������������������������� 123 Cakici, M.,������������������������������������������������������������������������������������������������� 50
Bandorski, D.,����������������������������������������������������������������������������������������� 126 Caldarone, C. A.,����������������������������������������������������������������������������� 121, 122

137
ASAIO Author Index

Cang, J.,���������������������������������������������������������������������������������������������������� 80 Craddock, H.,������������������������������������������������������������������������������������������ 111


Cao, X.,������������������������������������������������������������������������������������������������������ 92 Creutzfeldt, C. J.,��������������������������������������������������������������������������������� 64, 72
Cardoso, J.,����������������������������������������������������������������������������������������������� 12 Crompton, D.,������������������������������������������������������������������������������������������� 10
Carlson, L. A.,�������������������������������������������������������������������������������������������� 61 Crosby, J. R.,���������������������������������������������������������������������������������������������� 98
Carr, B.,����������������������������������������������������������������������������������������������������� 30 Cruz, J. C.,����������������������������������������������������������������������������������������� 34, 129
Carstens, M.,��������������������������������������������������������������������������������������������� 98 Cuda, A.,��������������������������������������������������������������������������������������������������� 11
Casagrande, G.,�������������������������������������������������������������������������������������� 135 Cuellar, M.,����������������������������������������������������������������������������������������������� 34
Casas, F.,����������������������������������������������������������������������������������������������������� 6 Curran, K.,������������������������������������������������������������������������������������������������� 51
Casida, J. M.,����������������������������������������������������������������������������108, 109, 111 Cysyk, J. P.,�������������������������������������������������������������������������������������35, 36, 38
Cassidy, B. M.,������������������������������������������������������������������������������������������� 60 Czer, L. S.,�������������������������������������������������������������������������������������������������� 81
Castillo, J. X.,������������������������������������������������������������������������������������������� 102 Daly, R.,��������������������������������������������������������������������������������������������� 99, 110
Catapano, G.,�������������������������������������������������������������������������������������������� 11 Damato, A.,����������������������������������������������������������������������������������������������� 77
Cavalheiro, A.,������������������������������������������������������������������������������������������� 23 Damiano, R. J.,������������������������������������������������������������������������������������������ 77
Cesarovic, N.,�������������������������������������������������������������������������������������������� 76 Damiano, R.,������������������������������������������������������������������������������������� 76, 100
Chan, C.,����������������������������������������������������������������������������������������������������� 6 Damino, R.,����������������������������������������������������������������������������������������������� 99
Chang, M.,���������������������������������������������������������������������������������������������� 123 Daneshmand, M.,������������������������������������������������������������������������������������� 87
Chaparro, S.,��������������������������������������������������������������������������������������� 70, 93 Dapunt, O. E.,��������������������������������������������������������������������������������������������� 7
Charest, J. L.,������������������������������������������������������������������������������������������� 103 Dardas, T.,������������������������������������������������ 52, 64, 72, 74, 85, 86, 89, 96, 113
Chassagne, F.,�������������������������������������������������������������� 52, 64, 72, 85, 89, 96 Dasse, K. A.,���������������������������������������������������������������������������������������������� 27
Chatterjee, S.,������������������������������������������������������������������������������������������� 49 Dasse, K.,�������������������������������������������������������������������������������������������������� 68
Chen, C.,��������������������������������������������������������������������������������������������� 23, 68 Day, S. W.,������������������������������������������������������������������������������������������� 13, 41
Chen, E.,��������������������������������������������������������������������������������������������������� 79 De Gaetano, F.,����������������������������������������������������������������������������������������� 20
Chen, H.,��������������������������������������������������������������������������������������������������� 15 De Marco, T.,��������������������������������������������������������������������������������������������� 74
Chen, L.,���������������������������������������������������������������������������������������������������� 93 DeNofrio, D.,������������������������������������������������������������������������������������������� 113
Chen, Q.,��������������������������������������������������������������������������������������������������� 58 Deb, A. K.,������������������������������������������������������������������������������������������������� 61
Chen, S.,�������������������������������������������������������������������������������������������������� 120 Dees, L.,���������������������������������������������������������������������������������������������������� 59
Chen, Z.,���������������������������������������������������������������������������������������������������� 26 Demertizis, S.,������������������������������������������������������������������������������������������� 20
Cheng, R.,������������������������������������������������ 52, 64, 72, 74, 85, 86, 89, 96, 113 Denfield, S. W.,������������������������������������������������������������������������121, 122, 125
Cheung, A.,����������������������������������������������������������������������������������������������� 92 Deo, S.,����������������������������������������������������������������������������������������������������� 63
Cheyne, C.,������������������������������������������������������������������������������������������������ 93 Dessoffy, R.,�������������������������������������������������������������������������������8, 27, 79, 80
Chickerillo, K.,������������������������������������������������������������������������������������� 71, 89 Dhamotharan, V.,������������������������������������������������������������������������������������ 127
Chinta, A.,������������������������������������������������������������������������������������������������� 40 Dia, M.,����������������������������������������������������������������������������������������������� 70, 89
Chivukula, V. K.,���������������������������������������������������������������������������������������� 89 Dikinov, N.,����������������������������������������������������������������������������������������������� 74
Chivukula, V.,���������������������������������������������������������������������22, 52, 74, 85, 86 Dimitrov, K.,�������������������������������������������������������������������������������������������� 112
Choi, J. H.,������������������������������������������������������������������������������������������������� 48 Dinicola, B.,��������������������������������������������������������������������������������������������� 111
Choi, J.,������������������������������������������������������������������������������61, 62, 95, 96, 97 Do, A. P.,��������������������������������������������������������������������������������������������������� 51
Chorpenning, K.,��������������������������������������������������������������������������������������� 61 Doering, J. J.,������������������������������������������������������������������������������������������ 109
Choudhry, S.,���������������������������������������������������������������������������121, 122, 125 Doose, C.,������������������������������������������������������������������������������������������������� 22
Chung, J.,�������������������������������������������������������������������������������������53, 58, 115 Dornia, C.,��������������������������������������������������������������������������������������������������� 2
Churgai, J.,���������������������������������������������������������������������������������������������� 113 Dougherty, C. M.,������������������������������������������������������������������������������������� 48
Cifuentes, R.,�������������������������������������������������������������������������������������� 93, 95 Douguchi, T.,������������������������������������������������������������������������������������������� 121
Civitello, A. C.,������������������������������������������������������������������������������������������ 94 Doxtater, B.,���������������������������������������������������������������������������������������� 35, 36
Civitello, A.,����������������������������������������������������������������������������������������������� 49 Drake, D.,�������������������������������������������������������������������������������������������������� 82
Clavell, A.,����������������������������������������������������������������������������������������� 99, 110 Dreyer, W. J.,����������������������������������������������������������������������������121, 122, 125
Clavien, P.,�������������������������������������������������������������������������������������������������� 4 Drešar, P.,�������������������������������������������������������������������������������������������������� 15
Clipp, M.,�������������������������������������������������������������������������������������������������� 73 Drigo, E.,����������������������������������������������������������������������������������������������� 7, 21
Clough, R. R.,������������������������������������������������������������������������������������������ 120 Drost, C.,��������������������������������������������������������������������������������������������������� 82
Clubb, F. J.,�������������������������������������������������������������������������������16, 17, 19, 28 Drucker, C.,��������������������������������������������������������������������������������������������� 115
Colaianne, T.,������������������������������������������������������������������������������������������ 108 Dunn, J. L.,�������������������������������������������������������������������������������������� 114, 115
Cole, A.,���������������������������������������������������������������������������������������������������� 90 Dunn, J.,���������������������������������������������������������������������������������������������������� 14
Cole, R.,���������������������������������������������������������������������������������53, 58, 81, 115 Durdu, M. S.,��������������������������������������������������������������������������������������������� 50
Colvin, M.,������������������������������������������������������������������������������������������������ 57 Dutkowski, P.,��������������������������������������������������������������������������������������������� 4
Combs, P.,������������������������������������������������������������������������105, 106, 117, 118 Dwyer, D. E.,������������������������������������������������������������������������������������������� 109
Comisso, M.,��������������������������������������������������������������������������������������������� 53 Dzhetybayeva, S.,������������������������������������������������������������������������������������� 51
Conger, J.,������������������������������������������������������������������������������������������������� 68 D’Aoust, R.,��������������������������������������������������������������������������������������������� 108
Conway, J.,���������������������������������������������������������������������������������������������� 124 D’Cunha, J.,��������������������������������������������������������������������������������������������� 127
Conway, R. G.,����������������������������������������������������������������������������������������� 124 D’Souza, G. A.,������������������������������������������������������������������������������������ 69, 73
Cooley, E.,����������������������������������������������������������������������������������������������� 111 Edelman, E.,���������������������������������������������������������������������������������������������� 28
Coppolino, A.,������������������������������������������������������������������������������������� 83, 84 Edenhoffer, N. P.,�������������������������������������������������������������������������������������� 17
Cortell, S.,����������������������������������������������������������������������������������������������� 130 El Aggan, H. A.,��������������������������������������������������������������������������������������� 129
Costantino, M. L.,����������������������������������������������������������������������������� 20, 135 El Banayosy, A. M.,������������������������������������������������������������������������������������ 94
Cotts, W.,���������������������������������������������������������������������������������������66, 71, 72 El Farjani, F. D.,��������������������������������������������������������������������������������������� 129
Couper, G. S.,������������������������������������������������������������������������������������������ 113 El-Baz, A. S.,������������������������������������������������������������������������������������������ 4, 16
Covelli, S.,������������������������������������������������������������������������������������������������� 20 El-Sayed Ahmed, M.,�������������������������������������������������������������������������������� 59
Covino, A.,������������������������������������������������������������������������������������������������ 11 ElAmm, C.,������������������������������������������������������������������������������������������������ 63
Coyle, L.,������������������������������������������������������������������������������������������������� 106 Elgudin, Y.,������������������������������������������������������������������������������������������������ 63

138
ASAIO Author Index
Elias, B. A.,�������������������������������������������������������������������������������������� 121, 122 Glasgow, A.,�������������������������������������������������������������������������������������� 99, 110
Elias, B.,�������������������������������������������������������������������������������������������������� 125 Gologorsky, R. C.,�������������������������������������������������������������������������������������� 37
Emerson, D.,��������������������������������������������������������������������������������������������� 58 Gonsior, M.,���������������������������������������������������������������������������������������������� 32
Entwistle, J. W.,������������������������������������������������������������������������������48, 61, 62 Gonzalez, G.,��������������������������������������������������������������������������������������������� 13
Erben, Y.,��������������������������������������������������������������������������������������������������� 56 Gordon, J. S.,��������������������������������������������������������������������������������������� 62, 96
Ermek, E.,����������������������������������������������������������������������������������������������� 122 Gosev, I.,��������������������������������������������������������������������������������������������� 46, 93
Ertas, A.,����������������������������������������������������������������������������������������������������� 3 Goswami, R.,��������������������������������������������������������������������������������������������� 59
Eshmuminov, D.,����������������������������������������������������������������������������������������� 4 Gottschalk, U.,������������������������������������������������������������������������������������������ 47
Esmailian, F.,��������������������������������������������������������������������������������������� 53, 81 Graf, R.,������������������������������������������������������������������������������������������������������� 4
Etheridge, W.,������������������������������������������������������������������������������������������� 49 Graham, K.,����������������������������������������������������������������������������������������������� 70
Evans, K.,������������������������������������������������������������������������������������������������ 116 Granegger, M.,������������������������������������������������������������������������������������������ 76
Eyadiel, L. S.,��������������������������������������������������������������������������������������������� 92 Graney, N.,������������������������������������������������������������������������������������������ 71, 89
Ezzat, B.,������������������������������������������������������������������������������������������������� 134 Gregoric, I. D.,��������������������������������������������������������������������83, 84, 86, 90, 91
Farahmand, M.,���������������������������������������������������������������������������������������� 54 Gregory, S.,����������������������������������������������������������������������������1, 14, 114, 115
Farres, H.,������������������������������������������������������������������������������������������������� 56 Griffith, A.,���������������������������������������������������������������������������������������������� 108
Farris, S.,���������������������������������������������������������������������� 52, 74, 85, 86, 89, 96 Griffith, B. P.,������������������������������������������������������������������������������������������� 124
Federspiel, W. J.,������������������������������������������������������������������������������������� 127 Grimme, W.,��������������������������������������������������������������������������������������������� 12
Federspiel, W.,���������������������������������������������������������������������������������������� 127 Grinstein, J.,���������������������������������������������������������������������������������������������� 66
Fegan, T. L.,��������������������������������������������������������������������������������������������� 120 Groenendaal, W.,������������������������������������������������������������������������������������ 136
Feng, L.,�������������������������������������������������������������������������������������������������� 112 Guerra, G.,������������������������������������������������������������������������������������������������ 95
Fernando, U.,�������������������������������������������������������������������������������������������� 30 Gulbransen-Diaz, N.,������������������������������������������������������������������������������� 112
Filho, D.,���������������������������������������������������������������������������������������������� 12, 23 Gumus, F.,������������������������������������������������������������������������������������������������� 50
Fischer, I.,�������������������������������������������������������������������������������������������������� 77 Gupta, A.,������������������������������������������������������������������������������������������������� 54
Fisher, I.,��������������������������������������������������������������������������������������76, 99, 100 Gurung, S.,������������������������������������������������������������������������������������������������ 14
Fishman, A.,���������������������������������������������������������������������������������������������� 53 Gushurst, M.,�������������������������������������������������������������������������������������������� 66
Fissell, W. H.,����������������������������������������������������������������������������������������� 5, 29 Habermann, E.,��������������������������������������������������������������������������������� 99, 110
Fissell, W.,������������������������������������������������������������������������������������������������� 37 Haberstock, J. T.,��������������������������������������������������������������������������������� 82, 85
Fixsen, L.,�������������������������������������������������������������������������������������������������� 75 Hadi, A.,���������������������������������������������������������������������������������������������������� 67
Foley, N. M.,�������������������������������������������������������������������������������������������� 102 Haft, J. W.,������������������������������������������������������������������������������������������������� 82
Fonseca, J.,������������������������������������������������������������������������������������������� 7, 12 Haft, J.,������������������������������������������������������������������������������������������������������ 57
Fragomeni, G.,������������������������������������������������������������������������������������������ 11 Hagedorn, C.,���������������������������������������������������������������������������������������������� 4
Frankman, Z.,�������������������������������������������������������������������������������������������� 11 Hahn, J.,���������������������������������������������������������������������������������������������������� 69
Frankowski, B.,���������������������������������������������������������������������������������������� 127 Hajj, J.,�����������������������������������������������������������������������������������������53, 81, 115
Fraser, J.,����������������������������������������������������������������������������������������������������� 6 Hakaim, A. G.,������������������������������������������������������������������������������������������� 56
Fraser, K.,�������������������������������������������������������������������������������������������������� 76 Hamzah, A. A.,���������������������������������������������������������������������������������������� 132
Fratto, P.,��������������������������������������������������������������������������������������������������� 11 Han, J.,������������������������������������������������������������������������������������������������������ 55
Frazier, O. H.,�������������������������������������������������������������������������������������������� 68 Hanawa, H.,���������������������������������������������������������������������������������������������� 57
Fujii, Y.,����������������������������������������������������������������������������������������������������� 57 Handy, K.,�������������������������������������������������������������������������������������������������� 68
Fukamachi, K.,��������������������������������������������� 8, 18, 19, 27, 65, 78, 79, 80, 80 Harhash, A. A.,������������������������������������������������������������������������������������������ 88
Fuketa, M.,������������������������������������������������������������������������������������������������ 10 Harhash, A.,���������������������������������������������������������������������������������������������� 40
Fukuhara, M.,����������������������������������������������������������������������������������������� 131 Hasn, H.,��������������������������������������������������������������������������������������������������� 70
Fülöp, T.,������������������������������������������������������������������������������������������������� 131 Haverstick, S.,��������������������������������������������������������������������������������� 108, 109
Galyanov, G.,������������������������������������������������������������������������������������������� 126 Hayes, M.,������������������������������������������������������������������������������������������������� 82
Gampa, G. K.,�������������������������������������������������������������������������������������������� 15 Haynes, H.,��������������������������������������������������������������������������������������������� 108
Gannon, W. D.,���������������������������������������������������������������������������������������� 102 Hebl, V.,���������������������������������������������������������������������������������������������������� 70
Gao, S.,����������������������������������������������������������������������������������������������� 80, 80 Hefti, M.,���������������������������������������������������������������������������������������������������� 4
Garacci, E.,������������������������������������������������������������������������������������������������ 47 Heinle, J. S.,������������������������������������������������������������������������������������ 121, 122
Garlant, J. A.,�������������������������������������������������������������������������������������������� 88 Heith, C.,��������������������������������������������������������������������������������������������������� 73
Gavrilos, G.,���������������������������������������������������������������������������������������������� 89 Herbert, S. A.,������������������������������������������������������������������������������������������� 60
Gawlikowski, M.,�������������������������������������������������������������������������������������� 32 Herbertson, L. H.,������������������������������������������������������������������������������� 69, 73
Gaynor, J.,������������������������������������������������������������������������������������������������� 95 Hergesell, V.,����������������������������������������������������������������������������������������������� 7
Gehron, J.,���������������������������������������������������������������������������������������������� 126 Hernandes, M.,����������������������������������������������������������������������������������������� 21
Geirsson, A.,��������������������������������������������������������������������������43, 43, 44, 101 Herrington, J.,������������������������������������������������������������������������������������� 64, 72
Geith, M. A.,����������������������������������������������������������������������������������������������� 7 Hesselmann, F.,����������������������������������������������������������������������������������������� 30
Gellman, B.,���������������������������������������������������������������������������������������������� 27 Hetts, S.,��������������������������������������������������������������������������������������������������� 30
Gentile, J.,����������������������������������������������������������������������������������������������� 119 Hill, K.,���������������������������������������������������������������������������������������������������� 134
George, J. K.,��������������������������������������������������������������������������������������������� 91 Hirschl, R. B.,��������������������������������������������������������������������������������������� 18, 30
Geremia, I.,��������������������������������������������������������������������������������������������� 133 Hoff-Nygard, D.,�������������������������������������������������������������������������������������� 111
Ghodrati, M.,�������������������������������������������������������������������������������������������� 82 Holzapfel, G. A.,������������������������������������������������������������������������������������������ 7
Ghodzisad, A.,������������������������������������������������������������������������������������������� 93 Hong, S.,��������������������������������������������������������������������������������������������������� 28
Gillinov, M. A.,������������������������������������������������������������������������������������ 80, 80 Horan, D. P.,���������������������������������������������������������������������������������������� 48, 61
Gilmer, J. T.,���������������������������������������������������������������������������������������������� 13 Horvath, D. J.,����������������������������������������������������������������������8, 19, 65, 78, 79
Ginn-Hedman, A.,��������������������������������������������������������������������16, 19, 28, 61 Horvath, D. W.,����������������������������������������������������������������������������������� 19, 78
Giordano, J.,����������������������������������������������������������������������������������� 105, 111 Hossainy, S.,���������������������������������������������������������������������������������������������� 31
Giridharan, G. A.,�����������������������������������������������������������������������������4, 16, 17 Houchins, T.,������������������������������������������������������������������������������������������� 118
Giridharan, G.,������������������������������������������������������������������������������������ 39, 66 Hsu, P.,������������������������������������������������������������������������������������������������ 23, 26

139
ASAIO Author Index

Hudson, B. J.,�������������������������������������������������������������������������������������������� 13 Katagiri, N.,��������������������������������������������������������������������������������������������� 128


Huebler, M.,���������������������������������������������������������������������������������������������� 76 Katz, J.,������������������������������������������������������������������������������������������������������ 15
Hugenroth, K.,���������������������������������������������������������������������������������������� 126 Kaulfus, C. N.,������������������������������������������������������������������������������������� 28, 61
Hughes, C.,����������������������������������������������������������������������������������������������� 51 Kazi, F. M.,������������������������������������������������������������������������������������������������� 72
Huie, N.,���������������������������������������������������������������������������������������53, 81, 115 Keller, S.,����������������������������������������������������������������������������������������28, 83, 84
Hull, B.,����������������������������������������������������������������������������������������������������� 81 Kent, L. K.,����������������������������������������������������������������������������������������������� 120
Hussain, S.,����������������������������������������������������������������������������������������� 66, 72 Kern, K.,���������������������������������������������������������������������������������������������������� 40
Ibeh, C.,�����������������������������������������������������������������������������������������64, 64, 72 Kfoury, A. G.,��������������������������������������������������������������������������������������������� 70
Igata, N.,������������������������������������������������������������������������������������������� 10, 131 Khan, M. A.,���������������������������������������������������������������������������������������������� 72
Iguchi, S.,���������������������������������������������������������������������������������������������������� 5 Khienwad, T.,�������������������������������������������������������������������������������������������� 82
Ilic, M.,������������������������������������������������������������������������������������������������ 90, 91 Khoo, C.,��������������������������������������������������������������������������������������������������� 31
Illouz, E.,��������������������������������������������������������������������������������������������������� 88 Ki, K.,����������������������������������������������������������������������������������������������6, 58, 101
Imamura, M.,������������������������������������������������������������������������������������������ 122 Kiernan, M. S.,���������������������������������������������������������������������������������������� 113
Inan, M. B.,����������������������������������������������������������������������������������������������� 50 Kim, E.,������������������������������������������������������������������������������������������������������ 37
Inoue, M.,��������������������������������������������������������������������������������������������������� 6 Kim, G.,��������������������������������������������������������������������������������������������������� 117
Iqbal, Z.,������������������������������������������������������������������������������������������������������ 5 Kirkpatrick, J.,�������������������������������������������������������������� 52, 74, 85, 86, 89, 96
Ishibashi, K.,���������������������������������������������������������������������������������������������� 45 Kitahara, D.,���������������������������������������������������������������������������������������������� 60
Issa, Y. A.,������������������������������������������������������������������������������������������������ 129 Kitamura, S.,��������������������������������������������������������������������������������������������� 10
Itoh, A.,����������������������������������������������������������������������������������76, 77, 99, 100 Klein, L.,���������������������������������������������������������������������������������������������� 74, 92
Itoh, H.,��������������������������������������������������������������������������������������������������� 121 Ko, K. K.,������������������������������������������������������������������������������������������ 114, 115
Ivers, D.,���������������������������������������������������������������������������������������������� 39, 40 Ko, K.,���������������������������������������������������������������������������������������������������� 1, 14
Iwasaki, T.,���������������������������������������������������������������������������������������������� 121 Kobashigawa, J. A.,��������������������������������������������������������������������������� 53, 115
Jacob, S.,��������������������������������������������������������������������������������������������������� 59 Kobayashi, S.,������������������������������������������������������������������������������������������ 131
James, R. L.,���������������������������������������������������������������������������������������������� 65 Kocyildirim, E.,���������������������������������������������������������������������������������������� 127
Janis, A. D.,������������������������������������������������������������������������������������������������� 8 Koeling, T.,������������������������������������������������������������������������������������������������ 57
Jansen, P.,������������������������������������������������������������������������������������������������� 52 Koenig, G. B.,�������������������������������������������������������������������������������������������� 27
Jaquiss, R.,���������������������������������������������������������������������������������������������� 124 Koenig, S. C.,��������������������������������������������������������������������������������������������� 27
Jeakle, M. M.,����������������������������������������������������������������������������������� 18, 120 Koenig, S.,������������������������������������������������������������������������������������������������� 81
Jeakle, M.,������������������������������������������������������������������������������������������������ 24 Kolakowska, U.,��������������������������������������������������������������������������������������� 125
Jeevanandam, V.,���������������������������������������������������������������66, 105, 117, 118 Komatsu, T.,�������������������������������������������������������������������������������������������� 131
Jem, N.,����������������������������������������������������������������������������������������������������� 88 Koomalsingh, K,���������������������������������������������������������������������������������������� 52
Jessen, S. L.,�����������������������������������������������������������������������������������16, 19, 61 Koomalsingh, K. J.,������������������������������������������������������������������������������������ 64
Jezovnik, M. K.,������������������������������������������������������������������������������83, 90, 91 Koomalsingh, K.,�������������������������������������������� 64, 72, 74, 85, 86, 89, 96, 113
Jhun, C.,�����������������������������������������������������������������������������������������35, 36, 38 Kopp, R.,������������������������������������������������������������������������������������������������� 126
Johnson, C.,�����������������������������������������������������������������������������108, 109, 119 Kormos, R.,����������������������������������������������������������������������������������������������� 91
Johnson, D. G.,���������������������������������������������������������������������������������������� 134 Kotani, Y.,������������������������������������������������������������������������������������������������ 121
Jonas, T.,��������������������������������������������������������������������������������������������������� 17 Kotkar, K.,������������������������������������������������������������������������������������76, 99, 100
Jones, C.,��������������������������������������������������������������������������������������������������� 46 Kotturru, V. M.,����������������������������������������������������������������������������������������� 15
Jorgensen, M. S.,�������������������������������������������������������������������������������������� 56 Kozlik-Feldmann, R.,��������������������������������������������������������������������������������� 47
Joshi, A.,��������������������������������������������������������������������������������������������� 71, 72 Krack, P.,������������������������������������������������������������������������������������������������� 124
Joyce, D. L.,����������������������������������������������������������������������������������������������� 90 Krause, N.,������������������������������������������������������������������������������������������������ 89
Joyce, D.,��������������������������������������������������������������������������������������������������� 98 Krenkel, L.,�������������������������������������������������������������������������������������������������� 2
Joyce, L. D.,����������������������������������������������������������������������������������������������� 90 Kresh, J. Y.,������������������������������������������������������������������������������������������������ 12
Jumean, M. F.,������������������������������������������������������������������������������������ 83, 86 Krisher, J.,������������������������������������������������������������������������������������������� 13, 41
Jung, J. H.,������������������������������������������������������������������������������������������������� 18 Krivitski, N.,�������������������������������������������������������������������������������������������� 126
K, E. K.,������������������������������������������������������������������������������������������������������ 15 Kroslowitz, B. J.,���������������������������������������������������������������������������������������� 28
Kading, J. C.,�������������������������������������������������������������������������������������� 18, 120 Kuban, B. D.,������������������������������������������������������������������������8, 19, 65, 78, 79
Kado, Y.,������������������������������������������������������������������������� 8, 18, 19, 27, 65, 79 Kuban, B.,������������������������������������������������������������������������������������������������� 80
Kaesler, A.,���������������������������������������������������������������������������������������� 30, 128 Kuchibhotla, S.,����������������������������������������������������������������������������������������� 91
Kagan, V.,������������������������������������������������������������������������������������������������ 117 Kukla, L.,��������������������������������������������������������������������������������������������������� 71
Kagawa, M.,���������������������������������������������������������������������������������������������� 10 Kumagai, K.,���������������������������������������������������������������������������������������������� 58
Kakinuma, H.,������������������������������������������������������������������������������������������� 60 Kumar, S.,�������������������������������������������������������������������������������������������������� 86
Kalantari, S.,�������������������������������������������������������������������������������������������� 117 Kung, E. O.,����������������������������������������������������������������������������������������������� 54
Kamada, A.,������������������������������������������������������������������������������������������������ 5 Kuroczycka- Saniutycz, E.,����������������������������������������������������������������������� 125
Kamalia, M.,���������������������������������������������������������������������������������������������� 90 Kuroko, Y.,����������������������������������������������������������������������������������������������� 121
Kameneva, M. V.,�������������������������������������������������������������������������������� 10, 32 Kurtyka, P.,������������������������������������������������������������������������������������������������ 32
Kanamarlapudi, V.,������������������������������������������������������������������������������ 54, 65 Kustosz, R.,����������������������������������������������������������������������������������������������� 32
Kander, M.,����������������������������������������������������������������������������������������������� 80 Kutyifa, V.,������������������������������������������������������������������������������������������������� 46
Kapis, A.,��������������������������������������������������������������������������������������������������� 32 Kwon, O.,���������������������������������������������������������������������������������������������������� 1
Kar, B.,��������������������������������������������������������������������������������83, 84, 86, 90, 91 LaBuhn, C.,�������������������������������������������������������������������������������105, 117, 118
Karimov, J. H.,���������������������������������������������� 8, 18, 19, 27, 65, 78, 79, 80, 80 Labuhn, C.,�������������������������������������������������������������������������������105, 117, 118
Karlen, J.,�������������������������������������������������������������������������������������������������� 81 Lala, A.,����������������������������������������������������������������������������������������������������� 77
Karnib, M.,������������������������������������������������������������������������������������������ 63, 63 Lamba, H.,�������������������������������������������������������������������������������������49, 91, 94
Kasahara, S.,������������������������������������������������������������������������������������������� 121 Lammy, T.,����������������������������������������������������������������������������������������������� 117
Kassemos, M.,������������������������������������������������������������������������������������������ 74 Lande, A. J.,�������������������������������������������������������������������������������������������� 136
Kasten, K.,����������������������������������������������������������������������������������������������� 108 Landolfo, K.,���������������������������������������������������������������������������������������������� 59

140
ASAIO Author Index

Langley, M. W.,��������������������������������������������������������������������������������������� 120 Martin, A. K.,�������������������������������������������������������������������������������������������� 56


Langley, M.,���������������������������������������������������������������������������������������������� 82 Martin, T.,����������������������������������������������������������������������������������������������� 111
Lashin, S.,�������������������������������������������������������������������������������������������������� 70 Masood, M. F.,������������������������������������������������������������������������������������������ 77
Latrémouille, C.,��������������������������������������������������������������������������������������� 52 Masood, M.,������������������������������������������������������������������������������� 76, 99, 100
Laufer, G.,����������������������������������������������������������������������������������������������� 112 Masri, C.,������������������������������������������������������� 52, 64, 74, 85, 86, 89, 96, 113
Lautner, G.,��������������������������������������������������������������������������������������� 18, 120 Masri, S. C.,����������������������������������������������������������������������������������������������� 72
Lautner-Csorba, O. I.,�������������������������������������������������������������������������������� 18 Massey, H. T.,���������������������������������������������������������������48, 61, 62, 95, 96, 97
Lawrecki, T.,���������������������������������������������������������������������������������������������� 89 Mattiazzi, A.,��������������������������������������������������������������������������������������������� 95
Lawrence, M. R.,������������������������������������������������������������������������������������� 113 May, A.,��������������������������������������������������������������������������������������������������� 127
Le Blanc, P.,����������������������������������������������������������������������������������������������� 88 Maynes, E. J.,���������������������������������������������������������������48, 61, 62, 95, 96, 97
Leal, E.,������������������������������������������������������������������������������������������������������� 7 Mazumder, M.,����������������������������������������������������������������������������������������� 88
Leao, T.,����������������������������������������������������������������������������������������������������� 21 Mazur, H.,������������������������������������������������������������������������������������������������� 67
Lee, S.,���������������������������������������������������������������������������������������������������� 136 McCloskey, G.,���������������������������������������������������������������������������������������� 101
Lehle, K.,����������������������������������������������������������������������������������������������������� 2 McCulloch, M.,����������������������������������������������������������������������������������������� 70
Leibich, P.,������������������������������������������������������������������������������������� 35, 36, 38 McCullum, E. O.,������������������������������������������������������������������������������������� 121
Lemme, F.,������������������������������������������������������������������������������������������������ 76 McDowell, M.,������������������������������������������������������������������������������������������ 89
Leonard, E. F.,����������������������������������������������������������������������������������������� 130 McGee, E.,������������������������������������������������������������������������������������������������ 92
Leoni-Moreno, J.,�������������������������������������������������������������������������������������� 59 McGrath, J. L.,����������������������������������������������������������������������������������������� 134
Levin, L.,���������������������������������������������������������������������������������������������������� 74 McGregor, R.,������������������������������������������������������������������������������������������ 117
Levy, W. C.,������������������������������������������������������������������������������������������ 64, 64 McHugh, K.,���������������������������������������������������������������������������������������������� 73
Levy, W.,���������������������������������������������������������������������������������������������������� 72 McInerney, A.,������������������������������������������������������������������������������������������ 89
Li, L.,������������������������������������������������������������������������������������������������� 88, 123 McKenzie, E. D.,�������������������������������������������������������������������������������������� 122
Li, M.,�������������������������������������������������������������������������������������������������������� 20 McMaster, W.,���������������������������������������������������������������������������������������� 102
Li, S.,�������������������������������������������� 20, 52, 54, 64, 65, 74, 85, 86, 89, 96, 113 McMullen, J. M.,��������������������������������������������������������������������� 121, 122, 125
Li, T.,���������������������������������������������������������������������������������������������������������� 33 McNitt, S.,������������������������������������������������������������������������������������������������� 46
Li, Y.,���������������������������������������������������������������������������������������������������������� 42 Medalion, B.,�������������������������������������������������������������������������������������� 63, 63
Liberato, A. S.,������������������������������������������������������������������������������������������� 48 Medina, M. L.,������������������������������������������������������������������������������������������ 34
Lima, L. M.,����������������������������������������������������������������������������������������� 25, 35 Medressova, A.,���������������������������������������������������������������������������������������� 51
Lin, F.,�������������������������������������������������������������������������������������������������������� 68 Meehan, K.,�������������������������������������������������������������������������������������������� 106
Lin, H.,������������������������������������������������������������������������������������������������������� 26 Meggett, J.,��������������������������������������������������������������������������������������������� 111
Lin, S.,������������������������������������������������ 52, 64, 64, 72, 74, 85, 86, 89, 96, 113 Megna, D. J.,��������������������������������������������������������������������������������������������� 81
Lindsay, M.,��������������������������������������������������������������������������������� 53, 81, 115 Megna, D.,������������������������������������������������������������������������������������������������ 58
Liu, E. Y.,�������������������������������������������������������������������������������������������������� 120 Mehta, D.,������������������������������������������������������������������������������������������� 72, 89
Liu, Z.,������������������������������������������������������������������������������������������������������� 90 Mehta, N. A.,�������������������������������������������������������������������������������������������� 17
Lloyd, K.,������������������������������������������������������������������������������������������������� 116 Meki, M. H.,���������������������������������������������������������������������������������������� 16, 17
Loayza, J. B.,������������������������������������������������������������������������������������������������ 6 Meki, M.,���������������������������������������������������������������������������������������������������� 4
Lobl, T. J.,���������������������������������������������������������������������������������������������������� 8 Melong, M.,������������������������������������������������������������������������������������ 108, 109
Lobosky, M.,��������������������������������������������������������������������������������������������� 80 Menallo, G.,���������������������������������������������������������������������������������������������� 32
Loebe, M.,������������������������������������������������������������������������������������������ 93, 95 Menne, M. F.,������������������������������������������������������������������������������������������� 22
Long, G. C.,����������������������������������������������������������������������������������������������� 94 Meyerhoff, M. E.,�������������������������������������������������������������������������������������� 18
Long, J. W.,������������������������������������������������������������������������������������������������ 94 Meyers, A.,����������������������������������������������������������������������������������������������� 40
Lopata, R.,������������������������������������������������������������������������������������������������� 75 Milano, C.,������������������������������������������������������������������������������������������ 87, 91
Lorts, A.,������������������������������������������������������������������������������������������������� 124 Minami, E.,���������������������������������������������� 52, 64, 72, 74, 85, 86, 89, 96, 113
Lorusso, R.,����������������������������������������������������������������������������������������������� 75 Miramontes, M.,����������������������������������������������������������������������52, 85, 89, 96
Louis, C.,��������������������������������������������������������������������������������������������� 46, 46 Mitamura, Y.,���������������������������������������������������������������������������������������������� 3
Low, K. W.,������������������������������������������������������������������������������������������������ 14 Mitchel, S.,������������������������������������������������������������������������������������������ 63, 63
Luc, J. G.,��������������������������������������������������������������������������������������������������� 48 Miyagi, P.,������������������������������������������������������������������������������������������������� 23
Lucchi, J.,�������������������������������������������������������������������������������������������������� 12 Miyamoto, A.,����������������������������������������������������������������������������������������� 121
Lucier, R.,������������������������������������������������������������������������������������������������ 108 Miyamoto, T.,����������������������������������������������� 8, 18, 19, 27, 65, 78, 79, 80, 80
Lukic, B.,��������������������������������������������������������������������������������������������� 35, 36 Mizuno, T.,���������������������������������������������������������������������������������������� 59, 128
Ly, J.,��������������������������������������������������������������������������������������������������������� 37 Moctezuma, A.,���������������������������������������������������������������������������������������� 91
Lyon, H.,���������������������������������������������������������������������������������������������������� 28 Mohammed, A.,��������������������������������������������������������������������������������� 47, 98
Lytle, F.,����������������������������������������������������������������������������������������������������� 63 Mokadam, N.,������������������������������������������������������������������������������������������� 87
Ma, L. J.,���������������������������������������������������������������������������������������������������� 24 Molteni, A.,����������������������������������������������������������������������������������������������� 14
Macaluso, G.,�������������������������������������������������������������������������������� 66, 71, 72 Montalto, A.,�������������������������������������������������������������������������������������������� 53
Macedo, G.,���������������������������������������������������������������������������������������������� 70 Moon, M. R.,��������������������������������������������������������������������������������������������� 77
Maeda, K.,���������������������������������������������������������������������������������������������� 120 Moon, M.,����������������������������������������������������������������������������������� 76, 99, 100
Mahr, C.,�������������������������������� 22, 48, 52, 64, 72, 74, 85, 86, 87, 89, 96, 113 Moore, S. P.,���������������������������������������������������������������������������������������������� 60
Majlis, B. Y.,��������������������������������������������������������������������������������������������� 132 Morales, D.,�������������������������������������������������������������������������������������������� 124
Major, T. C.,����������������������������������������������������������������������������������������� 18, 24 Moran, B.,��������������������������������������������������������������������������������������������������� 8
Makey, I.,�������������������������������������������������������������������������������������������������� 59 Morgan, A.,����������������������������������������������������������������������������������������� 25, 35
Malinauskas, R.,���������������������������������������������������������������������������������������� 13 Morgan, J. A.,�������������������������������������������������������������������������������������� 91, 94
Mallidi, H.,������������������������������������������������������������������������������������������ 83, 84 Morgan, J.,������������������������������������������������������������������������������������������������ 49
Maltais, S.,������������������������������������������������������������������������������������������������ 92 Moriguchi, J.,�������������������������������������������������������������������������53, 58, 81, 115
Maning, J.,������������������������������������������������������������������������������������������������ 70 Morreale, C.,��������������������������������������������������������������������������������������������� 66
Manker, D.,��������������������������������������������������������������������������������������������� 111 Morris, R. J.,�����������������������������������������������������������������48, 61, 62, 95, 96, 97

141
ASAIO Author Index

Moscato, F.,�������������������������������������������������������������������������������������� 82, 112 Patel-Raman, S.,��������������������������������������������������������������������������������������� 39


Motokawa, M.,����������������������������������������������������������������������������������������� 45 Patel-Ramen, S.,��������������������������������������������������������������������������������������� 66
Moyer, J.,�������������������������������������������������������������������������������������������������� 37 Patibandla, P. K.,��������������������������������������������������������������������������������������� 16
Muller, X.,��������������������������������������������������������������������������������������������������� 4 Patil, A. J. ,�������������������������������������������������������������������������������������������������� 5
Murashige, T.,��������������������������������������������������������������������������������������������� 6 Patil, A. J.,������������������������������������������������������������������������������������������������� 29
Murray, J. M.,������������������������������������������������������������������������������������������ 120 Pauwaa, S.,������������������������������������������������������������������������������������66, 71, 72
Musumeci, F.,������������������������������������������������������������������������������������������� 53 Peeters, K.,������������������������������������������������������������������������������������������������ 75
Muñoz-Camargo, C.,��������������������������������������������������������������������������������� 34 Pekkan, K.,���������������������������������������������������������������������������������������������� 122
Mychaliska, G. B.,����������������������������������������������������������������������������� 18, 120 Pena, M. S.,����������������������������������������������������������������������������������������������� 13
Müller, G.,������������������������������������������������������������������������������������������������� 47 Perlès, J.,��������������������������������������������������������������������������������������������������� 52
Nair, A. P.,������������������������������������������������������������������������������������������������� 94 Petit, P.,����������������������������������������������������������������������������������������������������� 27
Nair, A.,����������������������������������������������������������������������������������������������������� 49 Petterson, N.,�������������������������������������������������������������������������������������������� 75
Nakajima, T.,��������������������������������������������������������������������������76, 77, 99, 100 Pfannes, R. A.,���������������������������������������������������������������������������������������� 120
Nakakita, T.,������������������������������������������������������������������������������������������������ 5 Pham, A.,�������������������������������������������������������������������������������������������������� 59
Nakamura, Y.,���������������������������������������������������������������������������������������������� 5 Pham, D.,������������������������������������������������������������������������������������������������ 117
Narayannkutty, N.,������������������������������������������������������������������������������������ 95 Pham, S. M.,��������������������������������������������������������������������������������������� 56, 59
Nathan, S. S.,���������������������������������������������������������������������������������83, 90, 91 Phimister, A.,�������������������������������������������������������������������������������������������� 73
Nathan, S.,������������������������������������������������������������������������������������������ 84, 86 Piazza, V.,�������������������������������������������������������������������������������������������������� 53
Neary, M.,������������������������������������������������������������������������������������������������� 17 Piechura, L.,���������������������������������������������������������������������������������������������� 83
Nelson, J.,������������������������������������������������������������������������������������������������� 70 Pieper, I. L.,����������������������������������������������������������������������������������������������� 54
Netuka, I.,������������������������������������������������������������������������������������������������� 52 Pieper, I.,��������������������������������������������������������������������������������������������������� 14
Newman, R.,��������������������������������������������������������������������������������������������� 12 Pierzynski, A.,����������������������������������������������������������������������������������������� 111
Newswanger, R. K.,������������������������������������������������������������������������35, 36, 38 Pihera, L. D.,���������������������������������������������������������������������������������������� 25, 35
Nezami, F.,������������������������������������������������������������������������������������������������ 28 Pimenta, F.,������������������������������������������������������������������������������������������������� 7
Ng, M.,�������������������������������������������������������������������������������86, 108, 109, 123 Pisani, B.,�������������������������������������������������������������������������������������������������� 92
Nicolo, F.,�������������������������������������������������������������������������������������������������� 53 Plavljanic, S.,��������������������������������������������������������������������������������������������� 91
Nishikiori, K.,�������������������������������������������������������������������������������������������� 60 Ploutz, M.,���������������������������������������������������������������������������������������������� 119
Nishimura, M.,���������������������������������������������������������������������������������������� 121 Poh, Y.,������������������������������������������������������������������������������������������������������ 33
Nishioka, J.,��������������������������������������������������������������������������������������� 10, 131 Poitier, B.,������������������������������������������������������������������������������������������������� 52
Nusem, E.,���������������������������������������������������������������������1, 14, 112, 114, 115 Polakowski, A. R.,�����������������������������������������������������������������8, 18, 27, 65, 79
Oderwald, M. P.,������������������������������������������������������������������������������������� 135 Polikaitis, L. C.,������������������������������������������������������������������������������������������ 19
Ohnishi, Y.,���������������������������������������������������������������������������������������������� 131 Poling, C.,�������������������������������������������������������������������������������������������������� 30
Okahisa, T.,��������������������������������������������������������������������������������������� 10, 131 Polverelli, L.,��������������������������������������������������������������������������������������������� 88
Okamoto, E.,����������������������������������������������������������������������������������������������� 3 Possenti, L.,��������������������������������������������������������������������������������������������� 135
Olanisa, L.,������������������������������������������������������������������������������������������������ 53 Potkay, J. A.,���������������������������������������������������������������������������������������� 24, 30
Oldsman, M. R.,���������������������������������������������������������������������������������������� 59 Prasad, S.,������������������������������������������������������������������������������������������� 46, 93
Oliveira, G.,����������������������������������������������������������������������������������������������� 63 Price, J. F.,��������������������������������������������������������������������������������121, 122, 125
Olman, M.,������������������������������������������������������������������������������������������������ 53 Prochno, K. W.,����������������������������������������������������������������������������������������� 97
Onder, C.,���������������������������������������������������������������������������������������������������� 4 Pruvost, R.,����������������������������������������������������������������������������������������������� 88
Onsager, D.,�������������������������������������������������������������������������������������������� 117 Puri, K.,��������������������������������������������������������������������������������������������������� 125
Oono, M.,������������������������������������������������������������������������������������������������� 10 Pya, Y.,������������������������������������������������������������������������������������������������ 51, 52
Orejola, C. A.,�������������������������������������������������������������������������������������������� 29 Rao, A. S.,������������������������������������������������������������������������������������������������ 108
Orejola, W. C.,������������������������������������������������������������������������������������������� 29 Radovancevic, R.,���������������������������������������������������������������������84, 86, 90, 91
Orizondo, R. A.,����������������������������������������������������������������������������������������� 10 Rahman, M.,������������������������������������������������������������������������������������������� 124
Orizondo, R.,����������������������������������������������������������������������������������� 127, 127 Raikhelkar, J.,������������������������������������������������������������������������������������������ 117
Osuna-Orozco, R.,������������������������������������������������������������������������������������� 22 Raitz, G.,��������������������������������������������������������������������������������������������������� 70
Ota, T.,���������������������������������������������������������������������������������������������������� 117 Rajab, T. K.,����������������������������������������������������������������������������������������������� 84
Owens, G.,������������������������������������������������������������������������������������������������ 82 Rajesh, S.,������������������������������������������������������������������������������������������������� 32
Paden, M. L.,��������������������������������������������������������������������������������������� 25, 35 Rame, J. Y.,������������������������������������������������������������������������������������������������ 91
Pagani, F. D.,��������������������������������������������������������������������������������������������� 78 Ramos, V.,������������������������������������������������������������������������������������������������� 60
Pagani, F.,���������������������������������������������������������������������������������������57, 87, 91 Ramzy, D.,������������������������������������������������������������������������������53, 58, 81, 115
Pahlm, F.,�������������������������������������������������������������������������������������������������� 14 Rasmusson, B.,����������������������������������������������������������������������������������������� 70
Pappas, P. S.,��������������������������������������������������������������������������������������������� 72 Reed, R. L.,���������������������������������������������������������������������������������������������� 116
Pappas, P.,������������������������������������������������������������������������������������������� 66, 71 Reeves, G. R.,�������������������������������������������������������������������������������������������� 62
Parikh, U.,������������������������������������������������������������������������������������������������� 49 Rehman, S.,����������������������������������������������������������������������������������������������� 86
Park, C.,������������������������������������������������������������������������������������������������������ 9 Reiber, M. A.,������������������������������������������������������������������������������������������ 120
Park, J.,����������������������������������������������������������������������������������������43, 44, 101 Reibson, J. D.,��������������������������������������������������������������������������������35, 36, 38
Partida, C.,������������������������������������������������������������������������������������������������ 74 Reichenspurner, H.,���������������������������������������������������������������������������������� 47
Pasrija, C.,����������������������������������������������������������������������������������������������� 124 Reid, B. B.,������������������������������������������������������������������������������������������������ 70
Passano, E.,����������������������������������������������������������������������������������53, 81, 115 Retta, S. M.,���������������������������������������������������������������������������������������������� 69
Patarroyo Aponte, M. M.,������������������������������������������������������������������������� 84 Rhoades, B.,�������������������������������������������������������������������������������������������� 116
Patel, C. J.,������������������������������������������������������������������������������������������������ 83 Richardson, B. E.,�������������������������������������������������������������������������������������� 73
Patel, C.,���������������������������������������������������������������������������������������������������� 84 Riebandt, J.,�������������������������������������������������������������������������������������������� 112
Patel, M. K.,���������������������������������������������������������������������������������������� 90, 91 Rinaldi, J. E.,���������������������������������������������������������������������������������������������� 69
Patel, P.,���������������������������������������������������������������������������������������������������� 59 Riso, A.,����������������������������������������������������������������������������������������������������� 47
Patel, S. P.,������������������������������������������������������������������������������������������������ 48 Rizvi, S. A.,������������������������������������������������������������������������������������������������ 48
Patel, S.,���������������������������������������������������������������������������������������������� 61, 97 Robinson, C. B.,����������������������������������������������������������������������������������������� 28

142
ASAIO Author Index

Robinson, C. R.,���������������������������������������������������������������������������������� 54, 65 Setiadi, H.,������������������������������������������������������������������������������������������������ 94


Roche, E. T.,������������������������������������������������������������������������������������������������ 9 Severyn, D.,����������������������������������������������������������������������������������������������� 66
Rockom, S.,��������������������������������������������������������������������������������������� 96, 113 Shafii, A.,��������������������������������������������������������������������������������������������������� 49
Rodefeld, M. D.,���������������������������������������������������������������������������������������� 17 Shah, A. S.,���������������������������������������������������������������������������������������������� 102
Rodgers, B.,����������������������������������������������������������������������������������������������� 86 Shaheen, R.,���������������������������������������������������������������������������������������������� 37
Rodriguez, M. A.,�������������������������������������������������������������������������������������� 34 Shaimerden, K.,���������������������������������������������������������������������������������������� 51
Rogers, J.,�������������������������������������������������������������������������������������������� 87, 91 Sharma, P.,������������������������������������������������������������������������������������������������ 15
Rojas-Pena, A.,���������������������������������������������������������������������������������� 18, 120 Sharma, T.,������������������������������������������������������������������������������������������������ 91
Rojas-Peña, A. H.,������������������������������������������������������������������������������������� 24 Shawky, A.,����������������������������������������������������������������������������������������������� 70
Rojas-Peña, A.,������������������������������������������������������������������������������������ 30, 82 Sheehan, F. H.,�������������������������������������������������������������������������������85, 89, 96
Roka Moiia, Y.,������������������������������������������������������������������������������������������ 40 Sheehan, F.,�����������������������������������������������������������������������������������52, 74, 86
Roka-Moiia, Y.,������������������������������������������������������������������������������������ 20, 38 Shenton, H.,���������������������������������������������������������������������������������������������� 82
Rolland, S.,������������������������������������������������������������������������������������������������ 14 Sheriff, J.,�������������������������������������������������������������������������������������������� 38, 40
Rooney, D.,��������������������������������������������������������������������������������������������� 109 Shetty, R. R.,�������������������������������������������������������������������������������������������� 120
Rose, R.,�������������������������������������������������������������������������������������������������� 118 Shimamura, J.,���������������������������������������������������������������������������������������� 128
Rosenberg, G.,�������������������������������������������������������������������������������35, 36, 38 Shin, S.,����������������������������������������������������������������������������������������������� 69, 70
Rosenthal, D. N.,������������������������������������������������������������������������������������� 120 Shishibori, M.,������������������������������������������������������������������������������������������ 10
Rosenthal, D.,����������������������������������������������������������������������������������������� 124 Shiu, A.,�������������������������������������������������������������������������������������������������� 120
Rossi, M.,�������������������������������������������������������������������������������������������������� 11 Shoukat, S.,����������������������������������������������������������������������������������������������� 91
Rowinski, D. H.,����������������������������������������������������������������������������������������� 42 Siedlecki, C. A.,������������������������������������������������������������������������������35, 36, 38
Rowlands, G. W.,��������������������������������������������������������������������������������������� 78 Silva, E.,���������������������������������������������������������������������������������������������������� 12
Roy, S.,���������������������������������������������������������������������������������������5, 29, 30, 37 Silva, M.,��������������������������������������������������������������������������������������������������� 23
Ruiz, A. A.,�������������������������������������������������������������������������������������������������� 6 Simmonds, M.,������������������������������������������������������������������������������������������� 6
Runyan, C.,�����������������������������������������������������������������������������������53, 81, 115 Simoni, J.,����������������������������������������������������������������������������������������������� 102
Rutten, M.,������������������������������������������������������������������������������������75, 75, 79 Simoni, P.,����������������������������������������������������������������������������������������������� 102
Saba, I.,����������������������������������������������������������������������������������������������� 93, 95 Simpson, L.,���������������������������������������������������������������������������������������������� 91
Sabry, A.,��������������������������������������������������������������������������������������������������� 70 Sirlak, M.,�������������������������������������������������������������������������������������������������� 50
Sachweh, J.,���������������������������������������������������������������������������������������������� 47 Slaughter, M. S.,���������������������������������������������������������������������������������� 27, 81
Sahagian, K.,��������������������������������������������������������������������������������������������� 29 Slepian, M. J.,�������������������������������������������������������� 13, 20, 31, 38, 40, 60, 88
Saiki, Y.,����������������������������������������������������������������������������������������������������� 58 Slepian, R. C.,�������������������������������������������������������������������������������������������� 88
Sakai, J.,���������������������������������������������������������������������������������������������� 80, 80 Smeets, C. J.,������������������������������������������������������������������������������������������� 136
SalasDeArmas, I. A.,���������������������������������������������������������������������������� 90, 91 Smith, B.,������������������������������������������������������������������������������������������������ 117
SalasdeArmas, I. A.,���������������������������������������������������������������������������� 90, 91 Smith, H.,�������������������������������������������������������������������������������������������������� 70
Sampaio, L. C.,������������������������������������������������������������������������������������������ 68 Smith, N. J.,����������������������������������������������������������������������������������������������� 90
Samuels, L. E.,������������������������������������������������������������������������������������� 61, 62 Smith, P. A.,����������������������������������������������������������������������������������������������� 68
Sanders, B.,��������������������������������������������������������������������������������������������� 119 Smith, R.,�������������������������������������������������������������������������������������������� 39, 40
Sandoval, N. F.,��������������������������������������������������������������������������������� 34, 129 Smolenski, R.,������������������������������������������������������������������������������������������� 11
Santandreu, A.,����������������������������������������������������������������������������������������� 37 Snyder, T. A.,��������������������������������������������������������������������������������������������� 88
Santos Filho, D.,���������������������������������������������������������������������������������������� 23 Sobieski, M. A.,����������������������������������������������������������������������������������������� 27
Santos, B.,������������������������������������������������������������������������������������������������� 21 Sogabe, M.,��������������������������������������������������������������������������������������� 10, 131
Sareyyupoglu, B.,�������������������������������������������������������������������������������� 63, 63 Solomon, R.,��������������������������������������������������������������������������������������������� 51
Sarode, D.,������������������������������������������������������������������������������������������������ 37 Someya, T.,����������������������������������������������������������������������������������������������� 60
Sarsour, N.,����������������������������������������������������������������������������������������������� 57 Song, T.,������������������������������������������������������������������������������������������ 117, 118
Sasaki, K.,�������������������������������������������������������������������������������������������������� 58 Sorrells, W. S.,������������������������������������������������������������������������������������������� 56
Sayer, G.,������������������������������������������������������������������������������������������������� 117 Southard, C.,������������������������������������������������������������������������������������������� 119
Scheib, C. M.,�������������������������������������������������������������������������������������������� 36 Space, J.,������������������������������������������������������������������������������������������������� 119
Scheib, C.,������������������������������������������������������������������������������������������� 35, 38 Spencer-Bearham, D. M.,������������������������������������������������������������������������� 60
Schettle, S.,��������������������������������������������������������������������������������������� 99, 110 Spiliopoulos, S.,������������������������������������������������������������������������������������������ 7
Schima, H.,�����������������������������������������������������������������������������������76, 82, 112 Spiller, R.,������������������������������������������������������������������������������������������������ 105
Schlanstein, P.,������������������������������������������������������������������������������������������ 30 Spillner, J.,����������������������������������������������������������������������������������������������� 126
Schlöglhofer, T.,�������������������������������������������������������������������������������������� 112 Spinner, J. A.,���������������������������������������������������������������������������121, 122, 125
Schmidt, K.,��������������������������������������������������������������������������������������������� 111 Stamatialis, D.,���������������������������������������������������������������������������������������� 133
Schmitz-Rode, T.,�����������������������������������������������������������������������22, 126, 128 Stanton, B.,����������������������������������������������������������������������������������������������� 67
Schneider, B. A.,���������������������������������������������������������������������������������������� 18 Starling, R. C.,������������������������������������������������������������������������������������� 18, 27
Schneider, B.,�������������������������������������������������������������������������������������������� 82 Stauder, E. L.,�������������������������������������������������������������������������������������������� 70
Schoutteten, M. K.,��������������������������������������������������������������������������������� 136 Stawiarski, K.,����������������������������������������������������������������������������������������� 101
Schroder, J.,���������������������������������������������������������������������������������������������� 87 Steiner, M.,����������������������������������������������������������������������������������������������� 73
Schroeder, S. E.,�������������������������������������������������������������������������������������� 107 Steinseifer, U.,����������������������������������������������������������������������������22, 126, 128
Schroeder, S.,������������������������������������������������������������������������������������������ 111 Stempien-Otero, A.,���������������������������������������������������������64, 72, 86, 96, 113
Schuler, M.,������������������������������������������������������������������������������������������������� 4 Steuer, N. B.,������������������������������������������������������������������������������������������� 126
Schweiger, M.,������������������������������������������������������������������������������������������ 76 Straccia, A.,������������������������������������������������������������������������������52, 85, 89, 96
Sciamanna, C.,������������������������������������������������������������������������������������ 71, 72 Straker, K.,����������������������������������������������������������������������1, 14, 112, 114, 115
Seetharam, K.,������������������������������������������������������������������������������������������ 77 Strauss, N. M.,���������������������������������������������������������������������������������������� 113
Selby, V.,���������������������������������������������������������������������������������������������������� 74 Streur, M. M.,������������������������������������������������������������������������������������������� 48
Sels, J.,������������������������������������������������������������������������������������������������������ 75 Stroth, K.,�������������������������������������������������������������������������������������������������� 70
Sen, P.,������������������������������������������������������������������������������������������������ 52, 84 Strueber, M.,��������������������������������������������������������������������������������������������� 92
Sethu, P.,����������������������������������������������������������������������������������������������� 4, 16 Stulak, J.,������������������������������������������������������������������������������������������� 99, 110

143
ASAIO Author Index

Subbotina, I.,�������������������������������������������������������������������������������������������� 47 Uriel, N.,����������������������������������������������������������������������������������������� 105, 117


Sueuchi, T.,����������������������������������������������������������������������������������������������� 10 Utiyama, B.,������������������������������������������������������������������������������������������ 7, 12
Sugiura, A.,����������������������������������������������������������������������������������������������� 60 Vainchtein, D.,������������������������������������������������������������������������������������������ 12
Sundarajan, S.,������������������������������������������������������������������������������������������ 47 Valencia Rivero, K. T.,������������������������������������������������������������������������������ 129
Sutherland, D. W.,����������������������������������������������������������������������������������� 103 Van FleetM, MG.,������������������������������������������������������������������������������������� 85
Suzuki, T.,�������������������������������������������������������������������������������������������������� 58 Van Hoof, C.,������������������������������������������������������������������������������������������� 136
Suzuki, Y.,�������������������������������������������������������������������������������������������������� 58 Vandenberghe, S.,������������������������������������������������������������������������������������ 20
Suárez, N. A.,�������������������������������������������������������������������������������������������� 34 VanderPluym, C.,������������������������������������������������������������������������������������ 124
Swanson, H. L.,����������������������������������������������������������������������������������������� 88 Vandervoort, P. M.,��������������������������������������������������������������������������������� 136
Sweedo, A. L.,������������������������������������������������������������������������������������������� 38 Vanegas, S.,����������������������������������������������������������������������������������������������� 93
Symalla, T.,���������������������������������������������������������������������������������������������� 105 Vassiliades, T.,��������������������������������������������������������������������������������87, 91, 92
Szymanski, T. W.,��������������������������������������������������������������������������������������� 83 Velez, D.,������������������������������������������������������������������������������������������������� 119
Taite, L. J.,������������������������������������������������������������������������������������������������� 17 Venkat, K.,������������������������������������������������������������������������������������������� 72, 96
Taka, H.,�������������������������������������������������������������������������������������������������� 121 Vernizeau, M.,������������������������������������������������������������������������������������������ 88
Takahashi, G.,������������������������������������������������������������������������������������������� 58 Vest, A. R.,���������������������������������������������������������������������������������������������� 113
Takanami, D.,������������������������������������������������������������������������������������������ 121 Vidula, H.,������������������������������������������������������������������������������������������������� 46
Takaoka, Y.,����������������������������������������������������������������������������������������������� 10 Villa, C.,��������������������������������������������������������������������������������������������������� 124
Takayama, T.,������������������������������������������������������������������������������������ 10, 131 Vorovich, E.,�������������������������������������������������������������������������������������������� 117
Takewa, Y.,���������������������������������������������������������������������������������������� 59, 128 Voskoboynikov, N.,����������������������������������������������������������������������������������� 60
Tamagawa, M.,����������������������������������������������������������������������������������������� 22 Vranken, J.,��������������������������������������������������������������������������������������������� 136
Tamez, D.,������������������������������������������������������������������������������������������� 60, 61 van de Vosse, F.,��������������������������������������������������������������������������������� 75, 79
Tanaka, H.,���������������������������������������������������������������������������������������� 60, 131 von Gutfeld, R.,��������������������������������������������������������������������������������������� 130
Tanaka, Y.,������������������������������������������������������������������������������76, 77, 99, 100 von Rohr, P. Rudolf,������������������������������������������������������������������������������������� 4
Taner, B.,��������������������������������������������������������������������������������������������������� 59 von Stumm, M.,���������������������������������������������������������������������������������������� 47
Tang, P. C.,������������������������������������������������������������������������������������������������� 57 Wagner, G.,������������������������������������������������������������������������������������� 126, 128
Tansley, G.,�������������������������������������������������������������������������������������������������� 6 Wagner, W. R.,���������������������������������������������������������������������������������� 32, 129
Tashtish, N.,���������������������������������������������������������������������������������������� 63, 63 Wald, J.,���������������������������������������������������������������������������������������������������� 91
Tatooles, A. J.,������������������������������������������������������������������������������������������� 72 Walk, R.,��������������������������������������������������������������������������������������������������� 20
Tatooles, A.,���������������������������������������������������������������������������������������� 66, 71 Walther, C.,����������������������������������������������������������������������������������������������� 49
Tatsumi, E.,��������������������������������������������������������������������������������������� 59, 128 Wampler, R.,��������������������������������������������������������������������������������������������� 81
Taylor, D. A.,���������������������������������������������������������������������������������������������� 17 Wang, D.,������������������������������������������������������������������������������������������������ 123
Tchantchaleishvili, V.,���������������������������������������������������������61, 62, 95, 96, 97 Wang, J.,������������������������������������������������������������������������������������������������� 123
Terada, K.,������������������������������������������������������������������������������������������������� 10 Wang, Y.,����������������������������������������������������������������������������������������������� 4, 68
Teruya, J.,������������������������������������������������������������������������������������������������ 121 Wasilewska, A.,��������������������������������������������������������������������������������������� 125
Teuteberg, J.,�������������������������������������������������������������������������������������������� 87 Watanabe, N.,��������������������������������������������������������������������������������������������� 6
Tewarie, L.,��������������������������������������������������������������������������������������������� 114 Weber, M. P.,���������������������������������������������������������������������48, 62, 95, 96, 97
Thomas, M.,���������������������������������������������������������������������������������������������� 59 Weeks, B. R.,����������������������������������������������������������������������������16, 19, 28, 61
Thompson, A.,������������������������������������������������������������������������������������ 24, 30 Weeks, P. A.,��������������������������������������������������������������������������������������������� 83
Thompson, E. A.,�������������������������������������������������������������������������������������� 48 Weigand, A.,������������������������������������������������������������������������������������������� 136
Tibbitt, M.,�������������������������������������������������������������������������������������������������� 4 Weir, W. B.,����������������������������������������������������������������������������������������������� 82
Ting, P.,����������������������������������������������������������������������������������������������������� 77 Weir, W.,��������������������������������������������������������������������������������������������������� 30
Tipograf, Y.,��������������������������������������������������������������������������������������������� 102 Weiss, W. J.,�����������������������������������������������������������������������������������35, 36, 38
Tirschwell, D. L.,���������������������������������������������������������������������������������������� 64 Wesson, D. E.,����������������������������������������������������������������������������������������� 102
Tirschwell, D.,��������������������������������������������������������������������������������64, 72, 87 Whitehead, M.,�������������������������������������������������������������������������������������� 116
Tjossem, C.,�������������������������������������������������������������������������������������������� 124 Wiedemann, D.,�������������������������������������������������������������������������������������� 112
Tkatch, C.,������������������������������������������������������������������������������������������������� 12 Wieringa, F. P.,���������������������������������������������������������������������������������������� 136
Tomonari, T.,������������������������������������������������������������������������������������������� 131 Wieselthaler, G.,��������������������������������������������������������������������������������� 74, 92
Tompkins, L. H.,���������������������������������������������������������������������������������������� 27 Wilkens, S. J.,������������������������������������������������������������������������������������������ 120
Tompkins, L.,��������������������������������������������������������������������������������������������� 81 Williams, C.,���������������������������������������������������������������������������������������� 15, 51
Ton, V. T.,������������������������������������������������������������������������������������������������� 108 Winkelman, J. W.,������������������������������������������������������������������������������������� 60
Ton, V.,������������������������������������������������������������������������������������������������������ 59 Wolfe, J. Y.,���������������������������������������������������������������������������������������������� 113
Toomasian, J. M.,������������������������������������������������������������������������������������ 120 Wood, C. T.,���������������������������������������������������������������������������������������������� 96
Toor, S. C.,����������������������������������������������������������������������������������������������� 120 Wood, G.,������������������������������������������������������� 52, 64, 74, 85, 86, 89, 96, 113
Topaz, S.,������������������������������������������������������������������������������������������������� 123 Wood, K.,�������������������������������������������������������������������������������������������������� 93
Torii, K.,����������������������������������������������������������������������������������������������������� 60 Woodard, M.,����������������������������������������������������������������������������������������� 116
Tracey, M.,���������������������������������������������������������������������������������������������� 120 Woolley, J.,������������������������������������������������������������������������������������������ 39, 66
Tran, J.,����������������������������������������������������������������������������������������������������� 13 Wright, N.,������������������������������������������������������������������������������������������������ 37
Trento, A.,������������������������������������������������������������������������������������������������� 81 Wrigley, C.,���������������������������������������������������������������������1, 14, 112, 114, 115
Trobiano, T. J.,������������������������������������������������������������������������������������������� 59 Wu, T.,������������������������������������������������������������������������������������������������������� 26
Trumble, D. R.,������������������������������������������������������������������������������������������ 55 Wu, W.,����������������������������������������������������������������������������������������������������� 69
Tsukiya, T.,���������������������������������������������������������������������������������������� 59, 128 Wu, Z. J.,������������������������������������������������������������������������������������������������� 124
Tsutsumi, H.,��������������������������������������������������������������������������������������������� 60 Xu, X.,���������������������������������������������������������������������������������������������������������� 4
Tukacs, M.,���������������������������������������������������������������������������������������������� 104 Yamamoto, K.,�������������������������������������������������������������������������������������������� 5
Tume, S. C.,��������������������������������������������������������������������������������������������� 121 Yasuoka, D.,���������������������������������������������������������������������������������������������� 60
Tunuguntla, H. P.,���������������������������������������������������������������������121, 122, 125 Yeager, E.,��������������������������������������������������������������������������������������35, 36, 38
Turkoz, R.,����������������������������������������������������������������������������������������������� 122 Yee, C.,������������������������������������������������������������������������������������������������������ 30
Umimoto, K.,���������������������������������������������������������������������������������������������� 5 Yi, J.,���������������������������������������������������������������������������������������������������������� 98

144
ASAIO Author Index

Yip, D.,������������������������������������������������������������������������������������������������������ 59 Zhang, J.,������������������������������������������������������������������������������������������������� 124


Yoshioka, I.,����������������������������������������������������������������������������������������������� 58 Zhang, L.,�������������������������������������������������������������������������������������������������� 23
Yousef, H.,������������������������������������������������������������������������������������������������� 14 Zhang, P. Huang,��������������������������������������������������������������������������������������� 12
Zacharias, M.,������������������������������������������������������������������������������������������� 63 Zhao, G.,������������������������������������������������������������������������������������������������� 123
Zafar, F.,�������������������������������������������������������������������������������������������������� 124 Zhou, S.,���������������������������������������������������������������������������������������������������� 77
Zalewski, J.,����������������������������������������������������������������������������������������������� 32 Zhu, Y.,������������������������������������������������������������������������������������������������ 23, 26
Zanath, E.,������������������������������������������������������������������������������������������� 63, 63 Zhussupbekov, M.,������������������������������������������������������������������������������������ 69
Zapusek, L.,��������������������������������������������������������������������������������������������� 112 Zimpfer, D.,��������������������������������������������������������������������������������������������� 112
Zayat, R.,������������������������������������������������������������������������������������������������� 114 Zonta, F.,��������������������������������������������������������������������������������������������������� 82
Zeidan, M. A.,����������������������������������������������������������������������������������������� 129 Zwischenberger, J. B.,����������������������������������������������������������������������������� 123

145

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