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Pediatric Mechanical Circulatory Support

Article · July 2014

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 Pediatric Mechanical Circulatory Support
Michael A. Maymi, CPNP-AC*, Dipankar Gupta, M.D.**, Wendy E. Barras, CPNP-AC***, Joseph Philip, M.D.****,
Frederick Jay Fricker, M.D.*****, Mark S Bleiweis, M.D.******, Jai P Udassi, M.D.****
Pediatrics, Cardiology, Intensive Care unit and Congenital Heart Center, Shands Childrens Hospital, University of
Florida College of Medicine, Gainnesville, Florida, *Pediatric Intensive Care Unit Nurse Practitioner,
**Fellow Pediatric Cardiology & Critical Care Medicine, Department of Pediatrics, Congenital Heart Center,
***Pediatric Intensive Care Unit, UF Health Shands Children’s Hospital, Gainesville, FL****Assistant Professor,
Division of Cardiology, Congenital Heart Center, *****Professor & Chief, Division of Pediatric Cardiology,
******Professor & Cardiothoracic Surgeon & Director Congenital Heart Center, University of Florida College of
Medicine, Gainesville, Florida, USA

Key words: ECMO, Mechanical circulatory support, bridge a child while awaiting transplants especially
Ventricular assist device, Syncardia, Berlin EXCOR for the longer waiting periods for available donors.

ECMO was ¿rst used in 1975 and was developed

Introduction
History: Today the use of mechanical circulatory
support (MCS) has become essential in the survival
of the child with severe heart failure refractory to
medical management. The two methods to provide
MCS in children are: (a) Extracorporeal membrane
oxygenation (ECMO) and (b) ventricular assist
devices (VAD). Although ECMO has been widely
used in pediatric patients over the past several
decades, the ¿rst ventricular assist device in an adults
goes back almost ¿fty years. Dr. Hall made the ¿rst
attempt implementing the ¿rst VAD in an adult patient
in 1963 with the ¿rst successful surgical placement
in 1966 by Dr. Debakey1. The development of the
ventricular assist device for the adult population has
grown tremendously over the past several decades
offering a wide variety of devices. Some older
children with heart failure have bene¿ted from the
currently available adult sized devices. In 1991 the
Berlin Heart was made available to pediatric patients,
¿rst using adult sized VAD’s and now with smaller
pediatric sized devices1. It is now more common to
bridge to transplant with pediatric ventricular assist
devices, however there continues the need for more
sophisticated technology to be able to improve
outcomes further. The use of VADs can successfully
Correspondence:
Jai P Udassi, MD, University of Florida,
Department of Pediatrics, Congenital Heart Center, 1600 SW
Archer Road - Box 100296, Gainesville, FL 32610-0296, USA.
Tel: 352-273-5422; Fax: 352-273-5927
E-mail: udassjp@peds.uÀ.edu
primarily to support the neonate with respiratory
failure2. It was later expanded to be used in patients
that could not be weaned off cardiac bypass, children
with low cardiac output syndrome following
cardiac surgery, and in children who had developed
unrelenting cardiac arrest. The use of ECMO has
some advantages. Firstly, it can be rapidly deployed
and it can be initiated in the operating room or at
the bedside. Unlike VADs that only offer cardiac
support, ECMO can provide both pulmonary and
cardiac support. ECMO has a longer history of use,
whichgives us the advantage of more experience
with the technology. The main disadvantage is that it
is generally limited to short term use due to the risks
of infection, bleeding, and thrombosis2.
Indications
Before a child can be placed on MCS, an evaluation
should be conducted at a transplant center3. The
assessment and timing are critical during the
evaluation process of MCS. The standards used
for cardiac transplant evaluation have not changed
signi¿cantly over the last 15 years3. But there is still
debate on what is the most optimal time to initiate
MCS. There are no de¿ned guidelines in place at the
present time but there does seem to be a consensus
on MCS selection and initiation. The decision in
pediatrics is individualized and dependent upon
each centers experiences with MCS. Centers for
Medicare & Medicaid Services have necessary

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PEDIATRIC CARDIAC INTENSIVE CARE - 2
requirements for destination therapy which include
life expectancy < 2 years, not a candidate for heart
transplantation, failure to respond to optimal medical
management for at least 60 of the last 90 days, left
ventricular ejection fraction < 25%, and continued
need for intravenous inotropic therapy limited by
symptomatic hypotension, decreasing renal function,
or worsening pulmonary congestion3.
Indications for MCS are going to differ depending on
which type of therapy is utilized. ECMO is initiated for
short-term cardiac or pulmonary support. Indications
include malignant arrhythmias, decompensation
requiring cardiopulmonary resuscitation, acute
cardiac infectious processes including myocarditis
and Kawasaki Disease, acute cardiac graft rejection,
inability to wean from cardiopulmonary bypass, and
when there is uncertainty regarding the candidate
for long-term VAD placement1. VAD placement is
considered for short or long-term cardiac support.
VAD indications include severe left ventricular
dysfunction, chronic complication from myocarditis
or endocarditis, chronic cardiomyopathy, refractory
cardiogenic shock, end-stage congenital heart
disease, and as a bridge to transplantation4.
Contraindications
Contraindications should be considered when
considering MCS. In pediatrics this has been an area of
great debate with the introduction of long-term therapy
now available. There are clear absolute contraindications,
which include irreversible conditions including multi-
system organ failure, severe neurological damage,
renal failure, hepatic failure, irreversible septic
shock, and incurable malignancy5. There are relative
contraindications that include signi¿cant bleeding or
coagulopathy, major intracranial hemorrhage (> grade
I), and neurological disorders with poor quality of life6.
Complications
MCS is associated with several complications with
some being device-speci¿c. ECMO complications
primarily include hemorrhage, severe hemolysis,
hypotension, air in the circuit, embolism, and
infections. VAD complications are associated with
neurological, hematologic, gastrointestinal, and
immunological issues5. Complications of the Berlin
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Pediatric Mechanical Circulatory Support
Heart include neurological events including stroke,
hemorrhage after implantation, and infections7.
Thoratec complications include infections, prolonged
ventilation, bleeding, neurological complications,
and severe hypertension during support7. HeartMate
complications include bleeding, infection, and
neurologic events7
Complications with MCS should be evaluated on
an individualized basis and centers should have in
place an algorithm on when to discontinue MCS. For
example if a severe neurological injury occurs while
a patient is on MCS, a multidisciplinary approach
including the family should be used to determine if
MCS should be discontinued and how this is going to
be accomplished.
Short term mechanical circulatory support
ECMO in general is used for short-term support.
As mentioned earlier it can be rapidly deployed.
It requires either a veno-venous (VV) or veno-
arterial (VA) canulation. The utilization of VV
ECMO is primarily for pulmonary support with
gas exchange occurring as it passes across the
membrane oxygenator. The use of VA canulation
offers both cardiopulmonarysupport and assists
systemiccirculation6. It delivers an increased partial
pressure of oxygen in arterial blood at much lower
Àow rates. ECMO does not inherently decompress
the systemic ventricle in congenital heart disease
patients that have had a two-ventricle repair.
However it does decrease the blood Àow entering the
pulmonary vasculature and returns it to arterial blood
thereby decreasing workload of the myocardium
and decreasing oxygen consumption. Additional left
atrial canulation is needed to decrease compression
of left sided heart structures6.
ECMO comes with its disadvantages such as
bleeding, thrombosis, infection, end organ
dysfunction, decreased mobility, and limited time to
use2. In regards to bleeding patients, there is increased
exposure to blood products. This can become a
long-term problem for organ allocation due to the
increased development of panel reactive antigens
(PRA), allosensitization and human leukocyte
antigen (HLA) incompatibilities.
JOURNAL OF PEDIATRIC CRITICAL CARE
PEDIATRIC CARDIAC INTENSIVE CARE - 2
Centrifugal pumps
The centrifugal pump is placed via cannulas that arise
from sternal or thoracotomy incision and can provide
both univentricular or biventricular support4. There are
both adult and pediatric sized VAD’s that can be used
to offer most pediatric patients. LevitronixCentrimag
(Fig 1) and PediMag (Fig 2) are the most popular
centrifugal pumps at this time. The pediatric VAD
can be used on patients 10 kg or less2. It is designed
for short-term use. The VAD uses a magnet and rotor
cones, which spin to create a centrifugal force to move
blood into and out of the device. The rotors are shaped
to accelerate blood circumferentially and move it to
the outer rim of the pump4. The adult Centrimag has
the capability to provide Àows of about 10 liters/min
whereas the pediatric PediMag can Àow as low as 0.4
liters to 1.7 liters/min. Advantages of the centrifugal
pumps are that they do not require an oxygenator,
there is a lower priming volume compared to other
MCS devices, there is decreased risk of hemolysis,
adequate decompression of the left ventricle, patients
can be easily transported, and the operational expenses
are lower1,4.
Figure 1: Centrimag (Reprinted with the permission of Thoratec
Corporation)
Vol. 1 - No.3 July - September 2014
Pediatric Mechanical Circulatory Support
Figure 2: Pedimag (Reprinted with the permission of Thoratec
Corporation)
Intra-aortic balloon pump (IABP)
The IABP is used in adults for acute left ventricular
dysfunction. The IABP has not been widely used
in children due to the availability of ECMO and
other VADs, the dif¿culty in placing the catheter,
aortic elasticity in children, and balloon timing
synchronization with higher heart rates8. However
for adolescents the IABP may be a viable choice. The
catheter is placed in the femoral artery with the tip
of the catheter positioned just above the renal artery
and approximately two centimeters below the left
subclavian artery. Cardiac output is augmented with
the timing of balloon inÀation during diastole, which
is identi¿ed on the monitor screen with the dicrotic
notch. This balloon inÀation creates backpressure
to perfuse the coronary arteries. Once the balloon
is rapidly deÀated, the left ventricle is assisted with
forward Àow and decreases myocardial workload.
The IABP also aids in decreasing myocardial
consumption, lowers left ventricular end diastolic
pressure and left atrial pressure8.
Long term mechanical circulatory support
The Berlin Heart has become a popular long-term
bridge to transplant, ventricular assist device in
children. It is a laptop-based unit (Fig 3) that utilizes
a pressure and vacuum to move the VAD, gortex to
pump blood in and out of the ventricle. The machine
offers threecompressors; the ¿rst two will drive the
right and left VAD while the third is a back up. The
188 JOURNAL OF PEDIATRIC CRITICAL CARE
PEDIATRIC CARDIAC INTENSIVE CARE - 2
device can be used a single right or left VAD or
biventricular VAD. The biventricular VAD can offer
synchronous ¿lling where both VADs empty and ¿ll
in concert. There is also asynchronous ¿lling where
as the right empties and the left ¿lls9. This is a very
good option for very small children with limited space
in the chest cavity. VADS come in a variety of sizes
from 10 ml to 80 ml VAD ¿ll volumes (Fig4). The
internal surface of the cannulas are smooth silicon
with the external surface is made up of a Dacron
velour. This external surface allows for scar tissue to
form and to tightly seal the entrance site to decrease
the incidence of ascending infections9.
Figure 3: EXCOR Driving Unit (Courtesy: Berlin Heart, The
Woodlands, Texas)
Figure 4: EXCOR Pediatric Pump Range (Courtesy: Berlin
Heart, The Woodlands, Texas)
Vol. 1 - No.3 July - September 2014
Pediatric Mechanical Circulatory Support
Since the VAD part of the cannulas rest outside the
patient’s body they can be assessed for ¿brin and
clot formation per protocol. Fig 5 shows a Berlin
EXCOR BiVAD implanted in a pediatric torso (Fig5).
Assessment of the VAD ¿lling and emptying can also
be observed with a convex and concaved shape of
the gortex sheet. The Berlin Heart has its advantages
of allowing for long-term cardiac support and is an
excellent bridge to transplant option for children of
all sizes. It allows for mobility, rehabilitation, and
does not require the patient to be intubated4. It does
require consistent low dose anticoagulation, which
can be dif¿cult to maintain therapeutic levels.
Figure 5: EXCOR Pediatric torso (Courtesy: Berlin Heart, The
Woodlands, Texas)
Syncardia total artificial heart
The FDA approved the Syncardia Total Arti¿cial Heart
(TAH) in 1994 for use in the United States. It has
been used on over 1100 adults nationally. Syncardia is
implanted surgically by excising the native right and
left ventricles and replacing them with the right and
left TAH (Fig 6). Pneumatic cannulas are attached and
arise from the chest with surgical closure. The cannulas
are connected to device that allows for air pressure to
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PEDIATRIC CARDIAC INTENSIVE CARE - 2
Figure 6: SynCardia Implantation (Courtesy SynCardia
Systems, Inc.)
Figure 7: 70 & 50 cc Total Artificial Hearts (Courtesy
SynCardia Systems,Inc.)
move the VAD diaphragm, which controls ¿lling and
emptying of the VAD chamber. Because the native
ventricles are removed and replaced by the VAD, the
patient no longer has a heart rhythm. There are no
arrhythmias, no need to use inotropic medications,
no issues with the aortic valve, and no left ventricular
thrombus formation. Currently the VAD comes in one
size, which is a 70 ml VADand a 50 ml smaller pump is
scheduled for use in smaller adults and children (Fig 7).
The diaphragm is pneumatically driven, balances left
and right-sided output and increases output in response
to elevated venous return (Starling-like response).
InÀow valve is 27 mm and outÀow valve is 25 mm. Due
to the size of the VAD, patients have to be screened to
ensure the device can be ¿tted as per anterior posterior
dimensions of the chest via radiographic imaging and
CT scan. The Syncardia utilizes a partial ¿ll which is
about 50 to 60 ml and complete ejection, so that that the
Vol. 1 - No.3 July - September 2014 190
Pediatric Mechanical Circulatory Support
Figure 8: Syncardia TAH with Freedom Driver (Courtesy
SynCardia Systems, Inc.)
chamber ¿lls with enough volume for adequate cardiac
output and can completely empty. This eliminates
residual blood volume stasis in the device reducing
any chances of thrombus formation. There is active
ejection with the pneumatic driver pushing air in for
ejection. Passive ¿lling is used for partial ¿lling. The
large driver comes with a laptop display to evaluate for
partial ¿lling and complete ejection. The end user can
identify compete ejection with a “Àag” display at the
end of ejection phase. The display also shows heart
rate, ¿lling volumes, and cardiac output. There are some
considerations when using the Syncardia: (a) Central
lines cannot be utilized as they may interfere with
valve closure on the mechanical valves(b) Peripherally
inserted central catheters have been used but are placed
in the left upper extremity with the use of Àuoroscopy
and only seated in the midline position (c) The patients
on the total arti¿cial heart need to be on diuretics and
should maintain central venous pressures of <10 mmHg
to ensure a partial ¿ll (d) Blood pressure is managed
with the use of vasoconstrictors and vasodilators so
that the clinician can manipulate the systemic vascular
resistanceto treat hemodynamics (e) Blood product
replacement is minimized due to the nature of hemolysis
seen with the arti¿cial pump. Some centers tolerate
hematocrit of about 17-20% as long as the patient is
hemodynamically stable and asymptomatic. Syncardia
has a Freedom driver, which is a portable, wearable and
is undergoing FDA-approved investigational device
exemption clinical study in the USA (Fig 8).
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PEDIATRIC CARDIAC INTENSIVE CARE - 2
Axial flow devices
The Heart Mate II is an axial Àow device that creates
Àow by a rotational impeller that has an internal
impeller, which spins about 8000 rpms1. The device
also is anchored in the apex of the left ventricle
with a conduit that pumps blood to the aorta. It is
the most commonly implanted device worldwide
with more than 10,000 patients already implanted.
It offers continuous Àow for a left ventricular assist
device. The FDA has approved Heartmate II to be
used as a bridge to transplant or destination therapy.
The advantages of the Heart Mate II are that it is
smaller, with lower energy requirement and reduced
cost (Fig 9,10). It does not require a large priming
volume and it is very portable allowing the patient
to have an improved quality of life while awaiting
transplantation.
Figure 9: Heartmate II (Reprinted with the permission of
Thoratec Corporation)
One of the newer devices available on the market is
the Heart Ware left ventricular assist device. It utilizes
centrifugal continuous Àow with the use of a hybrid
magnetic bearing1. The device also is anchored in the
apex of the left ventricle with a conduit that pumps
blood to the aorta.
Vol. 1 - No.3 July - September 2014
Pediatric Mechanical Circulatory Support
Other devices that will be available soon are the
DebakeyHeart Assist 5, which is currently in clinical
trials.
The University of Pittsburgh is currently working
on the PediaFlow device, which is a pediatric VAD
that utilizes axial Àow. It is intended to have better
biocompatibility because there is less blood contact
with the impeller. It is a smaller design compared
to other axial Àow devices with size dimension of
about two AA batteries. This device incorporates a
valveless turbo design that limits the amount of blood
contact with the device.
Figure 10: Heart Mate II with external equipment (Courtesy
Thoratec Corporation)
Anticoagulation
Anticoagulation while on MCS is integral part of
the management. The blood has continuous contact
with foreign substances and this produces a cascade
of events causing a shift from normal homeostasis
to a hypercoaguable state. Anticoagulation and
monitoring will depend on the device implanted.
Unfractioned Heparin (UFH) is still the gold standard
of laboratory management10. Heparin is reliable and
predictable anticoagulant in use however requires the
patient to be on a drip continuously. AntithrombinIII
(AT III) is produced in the liver and is a natural
inhibitor of most clotting factors. Most of its
anticoagulation effects are with inhibiting thrombin
and factor Xa. Once AT III is bound to unfractionated
heparin it has a 1000 times greater inhibitory effect10.
191 JOURNAL OF PEDIATRIC CRITICAL CARE
 PEDIATRIC CARDIAC INTENSIVE CARE - 2
Unfractionated heparin increases antithrombotic
effect of tissue factor pathway inhibitor (TFPI) by
2-4 times through increasing the af¿nity of factor
Xa10. Additional anticoagulation monitoring includes
activated clotting time (ACT), activated partial
thrombaplastin time (aPTT), thromboelastography
(TEG) and platelet function testing. Baseline
coagulation studies should be completed prior to
initiation of MCS. (Fig 11)
Figure 11: TEG Analysis (Reprinted from Transfusion
Medicine Reviews Vol 26(1), Bollinger D, et al. Pg 1-13, 2012,
with permission from Elsevier
The Impella 2.5 uses Heparin and follows Factor Xa
levels 0.3-0.5 and aPTT 45-55s11. This is typically
initiated concurrently with implantation of device.
The RotaÀow VAD uses Heparin and follows Factor
Xa level between 0.3-0.5 with aPTT 55-65 s or ACT
180-20011. Anticoagulation is started within 24-48 hrs
after surgery, once postoperative bleeding has stopped.
Heparin is usually started at 10-15 units/kg/hr and
titrated according to the PTT goal. The Berlin Heart
EXCOR VAD follows the Edmonton Antithrombotic
Protocol, which includes low molecular weight
heparin (LMWH) with a target anti-Xa 0.35-0.510.
No anticoagulation is typically started in the ¿rst 24
hours. For chronic management patient is usually
transitioned toLovenoxfor children < 12 months with
a goal anti-Xa 0.6-1.0 and Warfarin for children >
12 months with an international normalized ratio
2.7-3.510. Antiplatelet therapy with dipyridamole and
aspirin are also used in this protocol10. Antiplatelet
and TEG monitoring are followed very closely10.
The HeartMate II uses LMWH and follows UFH
and aPTT 55-65 s or 1.5 – 1.8x normal11. Long-term
therapy utilizes warfarin and antiplatelet therapy.
INR is targeted at 1.5-2 and antiplatelet monitoring
Vol. 1 - No.3 July - September 2014
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Pediatric Mechanical Circulatory Support
with TEGs, platelet mapping (with ADP suppression
and arachidonic acid suppression)11.
Conclusion
Earlier ECMO was the primary mode of cardiac
support however technological advancements have
made available multiple VAD options for pediatric
patients. As the organ availability is limited and the
waiting time for heart transplants is increasing, use
of VADs has seen a rapid increase. As newer devices
are manufactured which are smaller and more suited
to the needs of pediatric population we anticipate
a signi¿cant decline in the morbidity and mortality
associated with use of VADs.
References
1. Stiller, B., I. Adachi, and C. D. Fraser, Jr. “Pediatric
Ventricular Assist Devices.” [In eng].PediatrCrit Care Med
14, no. 5 Suppl 1 (Jun 2013): S20-6.
2. Jaquiss, R. D., and R. A. Bronicki. “An Overview of
Mechanical Circulatory Support in Children.” [In eng].
PediatrCrit Care Med 14, no. 5 Suppl 1 (Jun 2013): S3-6.
3. Wilson, S. R., G. H. Mudge, Jr., G. C. Stewart, and M.
M. Givertz. “Evaluation for a Ventricular Assist Device:
Selecting the Appropriate Candidate.” [In eng].Circulation
119, no. 16 (Apr 28 2009): 2225-32.
4. Hazinski, Mary Fran. Nursing Care of the Critically Ill Child.
3rd ed. St. Louis, Mo.: Elsevier/Mosby, 2013.
5. O’Connor, M. J., and J. W. Rossano. “Ventricular Assist
Devices in Children.” [In eng]. CurrOpinCardiol29, no. 1
(Jan 2014): 113-21.
6. Reuter-Rice, Karin, and Beth Bolick. Pediatric Acute Care: A
Guide for Interprofessional Practice. Burlington, MA: Jones
& Bartlett Learning, 2012.
7. Fuchs, A., and H. Netz. “Ventricular Assist Devices in
Pediatrics.” [In eng]. Images PaediatrCardiol3, no. 4 (Oct
2001): 24-54.
8. Collison, S. P., and K. S. Dagar. “Mechanical Circulatory
Support for Acute Cardiac Failure in Children: The Options
Available.” [In eng].Indian Heart J 58, no. 4 (Jul-Aug 2006):
345-9.
9. Gazit, A. Z., S. K. Gandhi, and C. Canter C. “Mechanical
Circulatory Support of the Critically Ill Child Awaiting Heart
Transplantation.” [In eng].CurrCardiol Rev 6, no. 1 (Feb
2010): 46-53.
10. Annich, G., and I. Adachi. “Anticoagulation for Pediatric
Mechanical Circulatory Support.” [In eng].PediatrCrit Care
Med 14, no. 5 Suppl 1 (Jun 2013): S37-42.
11. Cooper, D. S., and R. Pretre. “Clinical Management of
Pediatric Ventricular Assist Devices.” [In eng].PediatrCrit
Care Med 14, no. 5 Suppl 1 (Jun 2013): S27-36.
192 JOURNAL OF PEDIATRIC CRITICAL CARE