Download - Outpatient Treatment of MCS Patient
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