Outpatient Treatment of MCS Patient

F. Bennett Pearce, MD Professor of Pediatrics

Med Director Heart Transplant COA

I DO NOT HAVE ANY RELEVANT FINANCIAL RELATIONSHIPS WITH ANY COMMERCIAL INTERESTS TO DISCLOSE.

Disclosure Statement

History of MCS

•  ADULT –  1963 Successful VAD –  1980s-1990s FDA

approval –  1998 REMATCH

begins –  2000 continuous flow

devices –  Destination rx

replacing transplant

•  PEDIATRIC –  1980’s ECMO –  1990’s ECMO, Adult

VAD implants –  1991-Berlin Heart

Excor-Germany –  June 2000-Berlin Heart

First US implant –  2011 Berlin Heart FDA

approval BTT

1963 VAD

Figure 1

Source: The Journal of Heart and Lung Transplantation 2010; 29:1119-1128 (DOI:10.1016/j.healun.2010.08.009 )

Copyright © 2010 International Society for Heart and Lung Transplantation Terms and Conditions

Pediatric VAD 1990s

•  1993-2002, 2375 children listed for transplant

•  99 VAD, median age 13 y

•  Length 57 d •  77% successful bridge •  Transplant outcome

similar to non-VAD

THORATEC

•  Paracorporeal •  Pneumatic •  Mechanical tilting disc

valves •  Thoralon® •  HR down to 20-lower

rates allow blood stasis

Figure 5. Survival to transplantation of heart disease.

Copyright © American Heart Association

MORTALITY RISK FACTORS

Pediatric Specific Device Miniaturization

•  1991 •  Berlin Heart Prototype •  8 year old/27kg •  Cardiogenic shock •  Extubted/

ambulatory-8 days support

•  Successful transplant

Mechanical left ventricular support as a bridge to cardiac transplantation in childhood

Berlin Heart

•  10,25,30,50,60 ml. stroke volume

•  Pneumatic •  Carmeda coating •  2003 18 children

bridged to Tx. 72% survival (Germany)

•  Total experience 45-5 recovered function

Chest X-Ray on Admission

ECMO

5 Weeks into Berlin Heart

Journal of Thoracic and Cardiovascular Surgery 2009

NEJM Aug 2012

Berlin Heart

•  800 US implants •  80-90/year •  In hospital •  Portable control

unit

REMATCH Trial 2001

•  1998-2001 •  129 NYHA Class IV •  Heart Mate XVE

pulsatile, intracorporeal

•  DT 365d •  52% Device, 25%

medical

Original Article Advanced Heart Failure Treated with Continuous-

Flow Left Ventricular Assist Device

Mark S. Slaughter, M.D., Joseph G. Rogers, M.D., Carmelo A. Milano, M.D., Stuart D. Russell, M.D., John V. Conte, M.D., David Feldman, M.D., Ph.D., Benjamin Sun, M.D.,

Antone J. Tatooles, M.D., Reynolds M. Delgado, III, M.D., James W. Long, M.D., Ph.D., Thomas C. Wozniak, M.D., Waqas Ghumman, M.D., David J. Farrar, Ph.D., O.

Howard Frazier, M.D., for the HeartMate II Investigators

N Engl J Med Volume 361(23):2241-2251

December 3, 2009

Pulsatile-Flow (Panel A) and Continuous-Flow (Panel B) Left Ventricular Assist Devices (LVADs)

Slaughter MS et al. N Engl J Med 2009;361:2241-2251

Survival Rates in Two Trials of Left Ventricular Assist Devices (LVADs) as Destination Therapy.

Fang JC. N Engl J Med 2009;361:2282-2285.

Adverse Events and Associated Relative Risks from the As-Treated Analysis, According to Treatment Group

Slaughter MS et al. N Engl J Med 2009;361:2241-2251

Continuous Flow VAD

•  Axial Flow-HM2 •  Centrifugal Flow-

HeartWare •  Smaller •  Valveless •  Magnetic levitation

AXIAL 63ml/390g

CENTRIFUGAL50ml/160g

Copyright ©2008 The American Association for Thoracic Surgery

John R. et al.; J Thorac Cardiovasc Surg 2008;136:1318-1323

No Caption Found

0

200

400

600

800

1000

1200

1400

1600

2006 2007 2008 2009 2010 2011

Pulsatile Flow Intracorporeal LVAD Pump

Continuous Flow Intracorporeal LVAD Pump

Impl

ants

per

yea

r

Cont Intra Pump 1 1 458 808 1445 692 Puls Intra TAH 2 22 22 22 27 4 Puls Intra Pump 71 219 154 36 6 1 Puls Para Pump 18 61 74 71 35 32

Pulsatile Flow Paracorporeal LVAD Pump

Primary Implant Enrollment: n=4366

: June 2006 – June 2011

Pulsatile Flow Intracorporeal TAH

Figure 3 12/14/2011

Pediatric Device Evolution

•  2010 ASAIO J •  4 adolescents •  Heart Mate 2 •  Intracorporeal •  Continuous flow •  Support 85-128d

Pediatric Device Evolution HeartWare

•  HeartWare •  Intrapericardial •  Magnetic suspension

of impellar •  1-10 l/min •  2 month support-

rehab, hospital d/c •  Successful transplant

Ann Thor Surg 2012

INTERMACS/PEDIMACS

•  INTERMACS-2006 •  CMMS mandatory for DT with approved devices •  >10000 patients •  PEDIMACS-2012-durable support, excluding

ECMO

PEDIMACS

•  Goal is to have registry of all VADs placed in children in North America

•  From September 2012 to March 2014 – 117 devices – 102 patients – 29 hospitals

Age at Implant

0UTPATIENT VADS IN AL

Birmingham News April 10, 2015

Current CF Devices

HM2

HVAD

ECHOCARDIOGRAPHY

•  Artifacts •  septal position •  MR •  Aortic Valve •  RV

ECHOCARDIOGRAPHY

•  Artifacts •  septal position •  MR •  Aortic Valve •  RV

ECHOCARDIOGRAPHY

•  Artifacts •  septal position •  MR •  Aortic Valve •  RV

ECHOCARDIOGRAPHY

•  Artifacts •  septal position •  MR •  Aortic Valve •  RV

ECHOCARDIOGRAPHY

•  Artifacts •  septal position •  MR •  Aortic Valve •  RV

ECHOCARDIOGRAPHY

•  Artifacts •  septal position •  MR •  Aortic Valve •  RV-function/TR

CARDIAC CATH

SUCTION EVENT

•  Acute septal shift •  Septum obstructs

inflow •  Reduced preload •  high RPM •  Acute Drop in flow

SUCTION EVENT

ECHO LV Tach

Normal Operation Parameters

Blood Pressure

Low pulsatility MAP 60-80 Brachial Artery Doppler

Fig. 1

The Journal of Heart and Lung Transplantation 2013 32, S91-S92DOI: (10.1016/j.healun.2013.01.996) Copyright © 2013 Terms and Conditions

ANTICOAGULATION

•  Warfarin, INR 2-3 •  ASA 325 •  Anti-platelet •  Heparin infusion

for low INR •  Heparin infusion-

procedures

Thrombosis

•  Markers of hemolysis

•  LDH>600 •  PFH>40 •  Pump design

change

Acquired VW Deficiency

•  VW multimers-destroyed shear stress

• é mucosal bleeding

•  GI bleeding

Intestinal angioectasia •  Thin walled

mucosal vessels •  reduced pulse

pressure •  Anywhere in colon •  Reduce anticog •  Octreotide,

thalidomide NEJM now Feb 2015

Mechanisms implicated in gastrointestinal (GI) tract bleeding in patients with axial-flow left ventricular assist devices (LVADs): Patients treated with axial-flow LVADS are at increased

risk of developing GI tract bleeding.

Jorge Suarez et al. Circ Heart Fail. 2011;4:779-784

Copyright © American Heart Association, Inc. All rights reserved.

HOME WOUND CARE •  Gloves/Mask •  Remove Dressing •  Clean Exit Site •  New Bandage •  REPORT

– Redness/swelling – Odor/warmth/100.5 – Drainage

SITE CARE

CF VAD SUMMARY

•  Optimum pump speed 2400-3200RPM •  Flow index 2.0-2.6 •  Power 4-4.5 Watts, alarm at +2Watts •  CF pumps are prelaod dependent and

afterload sensitive •  Warfarin INR 2-3, ASA

CF VAD SUMMARY

•  OK to defibrillate •  CPR OK-check driveline •  Not MRI compatible •  Local ER/EMS notification and training •  Family training, onging education

OUO VADIS?

•  Miniaturization •  Longer support, Ped DT? •  “good” VAD> “bad”

transplant •  PumpKIN •  Recovery enhancement

MVAD

Levee Road, Convent, LA Andrew Boyd

Acknowledgements

•  SPCS and sponsors •  Mike Warren-CEO-COA •  COA Pediatric Cardiology, CV

Surgery, CICU, Nurse Practitioners, Perfusion, Nursing, Respiratory, Child Life, Social Services, Counselors, Transplant Coordinators, Ped Cardiology Office Staff, Pastoral Care

•  Bruno and Russell Family Foundations

•  Families and Children with Cong Heart Disease