Outpatient Treatment of MCS Patient F. Bennett Pearce, MD Professor of Pediatrics Med Director Heart Transplant COA
Disclosure Statement I DO NOT HAVE ANY RELEVANT FINANCIAL RELATIONSHIPS WITH ANY COMMERCIAL INTERESTS TO DISCLOSE.
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
MORTALITY RISK FACTORS Figure 5. Survival to transplant Copyright American Heart Association
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
No Caption Found John R. et al.; J Thorac Cardiovasc Surg 2008;136:1318-1323
: June 2006 June 2011 Implants per year 1600 1400 1200 1000 800 600 400 200 Primary Implant Enrollment: n=4366 Continuous Flow Intracorporeal LVAD Pump Pulsatile Flow Intracorporeal TAH Pulsatile Flow Intracorporeal LVAD Pump Pulsatile Flow Paracorporeal LVAD Pump 0 2006 2007 2008 2009 2010 2011 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 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 supportrehab, 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 HVAD HM2
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 infusionprocedures
Thrombosis Markers of hemolysis LDH>600 PFH>40 Pump design change
Acquired VW Deficiency VW multimersdestroyed 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 Levee Road, Convent, LA Andrew Boyd MVAD
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