Ventricular Assist Device

Therapy Update-
TCH experience

Barbara A. Elias BSN, RN CCRN

VAD Coordinator
Congenital Heart Surgery
 Disclosures
•I will be discussing the off-label use of medical
devices

•Authorization granted by parents/patients for photo

images utilized during this presentation

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 Objectives

•Explain indications for VAD therapy

•Describe different forms of VAD therapy

•Explain potential complications of VAD therapy

•Describe VAD therapy trends unique to TCH

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 Indications for MCS intervention
•All states of cardiac failure that are either reversible (variable
period of time) or that require transplantation
•Patient population
-CMO/Myocarditis
-Malignant arrhythmia

-Failure to wean off CPB and post op arrest

-Failing Fontan? /Single Ventricle?

-TCAD- re-transplant?

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 Current MCS Protocol at TCH
Child in need of Cardiopulmonary VA ECMO
Respiratory mechanical support support
only Cardiac only

VV ECMO VAD Lung Recovery

NO BiVAD
YES Expected Recovery biventricular • HeartWare ®
Lung (<2 weeks) support needed
• Syncardia® TAH 50cc: BSA >1.2
Transplant Acute process:
Chronic and <1.8
• Myocarditis NO
only LV process: • Syncardia® TAH 70cc: BSA >1.7
• Acute graft support
rejection • DCM
needed
• Unknown process • End stage CHD

Short-term VAD Long-term VAD

Bridge to decision
•Rotaflow® (any size) •EXCOR Berlin®: >5kg and BSA <0.7
•Impella® 2.5/CP (BSA>0.7) •Jarvik 2015®: >8kg and <30kg
•Impella®5.0: LV>7cm, Ao >1.5 •HeartWare®: BSA ≥0.7
•(Heartmate III: BSA ≥ 1.2)

Recovery (BTR) Heart Transplant Bridge to Candidacy (BTC)

(BTT) Destination (DT)

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Individualized VAD Strategy
üCareful evaluation of the patient’s disease process

üConsideration of prior surgeries (Sternotomy, how many more?)

üSelection of the optimal assist device (size, flow needed, BSA)

üAppropriate cannulas (Inflow/outflow position, size of cannula, bridging

Berlin w/ Rotaflow?)

üPersonalized flow calculations

Weight x 150 (constant) = 100% flow (Ex: 9kg x 150 = 1350mls for 100% Flow)
(10cc Berlin Pump X 130 BPM = 1300cc/min approx. 100% Flow)

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 Contraindications
•Catastrophic neurologic injury/ intracranial hemorrhage

•MSOF, uncontrolled sepsis/active infection – *Fungal

•Multiple anomalies/metabolic disease

•Active bleeding/Anticoagulation intolerance

•Hypercoagulable

•Too small or too big

•Number of Sternotomy procedures- How many is too many?

Congenital staging procedures?

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 Assist Devices utilized at TCH
Berlin Heart® HeartWare® Heartmate II®
Heartmate III®

Jarvik 2015® SynCardia® Impella®

Rotaflow®

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 Device Variations
•HeartWare ® (Long term), Heartmate 3 ® (Long term), and Rotaflow ® (Short term)
- Centrifugal Flow (Mag- Lev)- 3rd Generation

•Jarvik ®, Heartmate II ® (Long term) and Impella ® (Short term)

- Axial Flow- 2nd Generation

•Berlin Heart ® and SynCardia ® (Long term)

- Pneumatic-Pulsatile Pump- 1st Generation

Intracorporeal / Paracorporeal / Extracorporeal………

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 Short Term VAD Support
Indications
- Need for post operative support
•Failure to wean from bypass
•Bridging between forms of MCS
•Temporary RV Support ( w/ LVAD)
- Low cardiac output state
•Not related to surgery

•Myocarditis
•Cardiomyopathy
•Acute transplant rejection

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 Impella (Axial flow)
ØMotor size is 12 fr.

ØCan flow up to 2.5- 5.0LPM (RP for right sided support)

ØHas been used in tandem with ECMO

ØPlacement is key

ØInsertion in Cath lab/OR

ØUse: 2015- present

Ø (N: 31)

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 Maquet Rotaflow (Centrifugal flow)
Constrained Vortex
-Negative Pressure at Inlet of pump

-Positive Pressure at Outlet of pump

Complications:
-Hemolysis/Thrombosis
-Bleeding
-Temperature maintenance
-Air entrapment
Use: 2009 - present N: 48

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 Long Term VAD Support:
Centrifugal Pumps
A magnetically levitated pump rotates and causes
fluid to accelerate before being released at the
outflow port.

- Pump inlet is under

negative pressure which
draws in fluid.

- Pump outlet (CO or flow)

is PRELOAD dependent and
AFTERLOAD sensitive.

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 Ø Magnetically suspended Impeller- Hydrodynamic-no bearings,
HeartWare ® made of Titanium- Continuous Flow
Ø Operating speeds of 1800 to 4000 RPM
Ø Can Flow up to 10 LPM
Ø Recommended BSA ≥0.7
Ø Power sources: Battery/Wall/Car adaptors
Ø 6 hrs to charge fully depleted batteries
Ø No Pump Pocket
Ø Smallest patient @ TCH: 13.2kg

Ø Percutaneous drive line connects to

external controller.
Ø A portion of the drive like contains a
woven polyester fabric which
encourages tissue in-growth at the
skin exit site.

Ø Use: 2011- present (N: 55)

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 HeartWare® Used to adjust device parameters
Clinical screen Monitor Displays real time and historical
pump information (flow/power,
alarms)
(Password Protected)

Controller
Regulates pump function and
monitors the system
Indicates alarms and battery life
Displays alarms/intervention
Controller has 30 day data storage

Lithium Ion Each battery allows up to 6 -12hrs of operation

Batteries Recharges up to 500 cycles

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 HeartWare® Pump Waveform Characteristics
Flow Waveform
Heart Rate
Maximum value of the HVAD flow waveform (PEAK) Beginning of
> 2 liters above trough) Diastole
Waveform
Peak
• Minimum value of the HVAD flow waveform (TROUGH)

• Trough value should be Flow

>2 L/min and there should be Pulsatility
>2 L/min of pulsatility
Waveform
Trough

Flow Pulsatility Beginning of

Systole

• Difference between waveform maximum (peak) and minimum

(trough)

• Dependent on heart contractility and

HVAD operating points NOTE: Flow waveforms provide additional information about the patient
- Systole à max HVAD flow condition, preload/afterload/potential conditions
- Diastole à min HVAD flow (RV failure, Tamponade, dysrhythmia)

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 Long Term VAD Support:
Axial Flow Pumps
Works off of the same principle as
the Archimedes screw.

Advantageous over pulsatile pumps

because of their valve free structure
with continuous flow.

Axial pumps operate at higher

RPMs (>8000) compared to
centrifugal pumps at lower RPMs
(>2000) which can potentially lead
to clinical implications such as
hemolysis.

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 Heartmate II ®
Ø Most widely used ventricular assist device in
the world, made of Titanium
Ø Limiting factor is the pump size because a
pump “pocket” must be created for
implantation
Ø Recommended for patients w/ BSA >1.3
Ø Delivers up to 12 liters flow
Ø Power sources: Battery/wall
Ø Battery support: 10-12hrs (pair)
Ø 4 hr recharge time (fully depleted batteries)
Ø Controller supplies 15minutes emergency
power (accidental power d/c)
Ø Controller displays speed/flow/power,
records alarms/data-event recording
Ø Use: 2008-2014 (N: 17)

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 Clinical Screen
•Access to:
- Setting adjustments
- (Speed/alarm limits)
- Alarm log file
- Save/transfer data

•Displays:
- Primary operating parameters
- Information updated every second
- Alarms color coded
(red-high priority, yellow- low priority)

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 LONG TERM VAD Support:
Pneumatic (Pulsatile) Pumps- Berlin Heart ®
ØFirst generation of ventricular assist devices

ØPneumatic driver (compressor) / Hand pump

ØDiaphragm separates the blood/air chamber

ØTri-leaflet polyurethane valves (unidirectional flow)

ØMulti cannula: Atria/ Apex/ Arterial (diameter 5mm -12mm)

ØMulti size: 10, 15, 25, 30, 50, 60mls

ØUse: 9/2005- present

Ø(N: 55)

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 Driver (IKUS®)-Pump Console
Ø A sturdy mobile driving unit called the IKUS controls the Berlin
pump
Ø Houses compressors (3) and pressure/suction regulators
Ø Displays information about the pump parameters
Ø Access for pump setting adjustments (Password protected)
Ø Computer logs alarms
Ø 30 minute battery supply (hours of service)
Ø Alert every 10 minutes (when on battery)
Ø Power display/hours of service
Ø Hand pump (loss of power)
Ø Weight: 219 pounds

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Long Term VAD Support: Pneumatic (Pulsatile)
Pumps: SynCardia® Total Artificial Heart (TAH)
Size limitation: (10cm AP measured at T10; Pump size: 50mls / 70-mls)

No Rhythm (Complete Caridectomy)

Pneumatic driver (C2 or Freedom driver-pulsatile)

Powered by Wall adaptor/ battery/ hand-pump

Made of Polyurethane, 4 Mechanical valves (25mm)

Use: 5/2011 - present

(N: 2)

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 SynCardia® TAH System
70cc TAH 50cc TAH
400 ml 270 ml

Implantable TAH

Drivelines

External
Driver

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22
 What we have learned…
VAD Operating Characteristics
• Conditions that may lead to a decrease in preload:
- Compromised right ventricular volume (e.g. RVF, Tamponade)
- Low intravascular volume
Preload

- Increase in pump speed (a volume/speed mismatch)

- Increased ventilator settings (Peep, PS)

• A reduction in preload may lead to:

- Reduced VAD Flow (Cardiac Output)
- Suction condition (Chamber Collapse)

• Conditions that may lead to an increase (or high) afterload:

- Increased system vascular resistance, kink outflow graph
Afterload

- Increased pump speed

• A high afterload may lead to:

- Retrograde flow/flow stagnation (increased risk of pump thrombosis)
- Reduced VAD flow (Cardiac Output)

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 Protocol Tests Result/Range/Indication
PT-INR (Coumadin) HeartWare/Jarvik: 2-3 (often 2.5-3)
Berlin/TAH : 2.5-3.5
PTT 60-80 (VAD- Heparin- varies with patient)
PTT Hepzyme 70-80 (VAD- BiVAL- varies with patient)
ACT 180-200 (ECMO)

DIC panel Daily (if on BiVAL)à Monday/Thursday

ECMO panel Daily (if on Heparin)àMonday/Thursday
Fibrinogen** Increases w/ inflammation
D- Dimer ** Increase as fibrin formation
Anti-Thrombin** Treat when <100

Heparin 0.3-0.5 units/mL (Berlin, TAH)

0.2-0.4 (HeartWare)
LDH, Plasma Hgb, U/A for blood Daily daily when assessing for hemolysis
LDH Isoenzymes **(Misc Labs in EPIC- send out) When LDH >1000
ECHO Monthly (VAD optimization, inflow cannula, AI, AV opening)
CXR Daily->monthly (Effusion, pneumothorax, pump placement)
VS Per unit policy: DOPPLER BP STANDARD OF CARE on continuous
flow VAD’s (70-80mmHg)

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 TCH VAD program approach ~
Benefits of Extended VAD Support
ØNutritional Optimization (BSA growth)
ØStability of home, care system-support system
ØMedication/care/clinic compliance
ØBetter Transplant Candidacy

Pre VAD 1 Year Post VAD support

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 Potential Complications
associated w/ VAD therapy…
•Driveline infections

•Device Malfunction, driveline integrity

•Gastrointestinal bleeding (AVM’s) rare in younger pts

•Epistaxis

•Thromboembolic events
(Improvement w/ BiVAL)

•Renal failure

• Psychosocial issues and risk taking behaviors

•What’s new to help reduce associated complications...

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 Mechanical updates~ New Devices
Jarvik 2015® Pump (Axial flow)
Pumpkin Clinical Trial

Flow: 1 - 3.5 liters per minute (LPM)

Running Speed: 10,000 to 18,000 rpm

Power consumption: < 7 watts

Afterload sensitive

-Goal Doppler: 40-50mmHg (8-10kg)

-Goal Doppler: 50-60mmHg (10-20kg)

No Inflow

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 Jarvik 2015® Pump (Axial flow)
Used for >8kg and <30kg (Fits 6 kg)

Controller displays power /alarms

(no flow, speed adjusted with dial)

Power: 1 or 2 batteries (19.5hrs each)

Battery charge time 6 hrs

Use: 2018 – present (N: 4)

Jarvik supported-
see controller and batteries

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 System Components Overview

Lithium-ion Battery

FlowMaker Controller

Jarvik 2015 VAD

Li-ion Battery Charger

Y Cable Li-ion Battery Cable Extension Cable

See IU475 §6 for further detail 29

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 Jarvik 2015 Performance (HQ curve)
Typical MAP (via arterial pressure line or doppler) = 60 mmHg
Typical CVP (via venous pressure line or estimated) = 10 mmHg
Pressure drop across VAD (outlet P – inlet P) = 60 – 10 = 50 mmHg
Pump speed = 16,000 rpm

DP = 50 mmHg

PO = 2.4 LPM

See IU0475 §1 for further detail 30

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 Mechanical updates ~ New Devices
Heartmate III® (Centrifugal flow)
• Made of Titanium-Fully Magnetically Levitated
• Large pump gap-space designed to reduce blood trauma across rotor
• Artificial pulse (automatic speed ramp every 2 seconds by 2000rpm)
• Textured blood contacting surfaces (creates pseudo-neo-intima)
• Full support (2 – 10 L/min)
• Modular Driveline (replacement of portion if damaged)
• Pocket Controller displays 6 recent alarms, flow/speed/power/PI
• Battery supply 10-12 hrs/mobile power unit
• Requires BSA ≥ 1.2

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 Power Module (Hmate II)
System Components

14 V Li-Ion Batteries (Hmate II) Universal Battery

Charger (Hmate II)

System Monitor (Hmate II)

Pocket Controller (NEW)
Go Gear
Mobile Power Wearable's
Unit (NEW) (Hmate II)

Modular Driveline (NEW)

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 TCH VAD program approach…
Ø VAD evaluation protocol checklist
Ø VAD training pre -> post implant
Ø Close the Pre-implant education loop
with patient/families meeting (VAD
Ambassadors)

Ø VAD Rounding list

Ø VAD D/C protocol
Ø Protocols: bleeding/stroke
Ø Community outreach post-implant
Ø 24hr VAD Call phone “HOT LINE”
Ø 3D CT pre-op “Virtual Fit”

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 HeartWare® Placement Techniques
•The standard Intra-
pericardial placement often
results in unfavorable inflow
arrangement

•Infra-diaphragmatic
placement decreases angle
of inlet to septum

Page 34
Adachi, I. A modified implantation technique of the HeartWare ventricular assist device for pediatric patients.
J Heart Lung Transplant 2015 Jan;34(1):134-6
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 HeartWare® HVAD
Driveline Placement Technique
“Rectus Sparing Approach”
Ø Driveline is the Achilles’ Heel of
implantable VAD’s
Ø Less developed abdominal wall
muscles in sick children
Ø Reduce trauma to tunneling track
Ø Reduces postoperative
pain/inflammation
Ø Assists in prevention of driveline
infections
Ø Better “seeding” “ingrowth” of the
driveline (anchored!)

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Image © 2014 Texas Children’s Hospital
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 TCH VAD approach~
Complicated Anatomy

Fontan ~ Single Ventricle

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 TCH VAD approach ~
Can a heart remodel / recover?

HeartWare® Recovery on Device to Explant !

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 TCH VAD program
approach…individualized care

Some dressings/vad packs too big, some too smallà find the size that works

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 TCH VAD program ~ Dedicated VAD Clinic
-Regimented Outpatient protocol
-Labs
-Doppler BP management
-Screening speed adjustment ECHO
-RHC
-Cardiac CT

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 Community Integration- Outreach back
to local area

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 Home discharge locations of
current TCH VAD supported
patients as of 4/2019

Snyder Dallas

Round Rock
Austin Orange
Houston LaPorte
Clear Lake

Laredo

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 Patients return to home, school,
celebrating family and life...

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 Camp Pump it Up….
(Letting kids be kids)

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 1st Annual TCH
VAD Celebration Day 6/30/2018

Coming to 8/9/2019- 2nd Annual TCH SUPER-HERO VAD CELEBRATION DAY…save the
date…details to come…

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 Key Points

•Pediatric patients can be implanted with CF adult devices

•Pediatric VAD patients have good outcomes and can be discharged home safely

•Children can return to school and travel with CF devices

•Pediatric VAD patients learn a “NEW NORMAL way of life”

•Pediatric MCS is entering a new era w/ a PARADYGM SHIFT

•Device related complications may increase w/ prolonged support

•Multi-Disciplinary approach is necessary for successful outcomes !

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 Challenges
Program development-financial support-education
Availability of technology
Sizing of device to fit child - inflow cannula placement
Timing of device implant, transitioning to adult program
Anatomic/Congenital challenges/Prior Surgery

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 Future Directions…..
üSmaller device “Miniaturized”

ü“Water Proof”

üLonger battery supply

üDurable components

ü Internal charging pad

ü“Cordless” driveline

ü“Pediatric friendly”

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 Future Developments

Synergy (CicuLite)®
Heart Assist 5 ®

Pedia Flow®

HeartWare® MVAD
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 If I only had a
“Heart” -VAD

Thank you !!
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