outpatient treatment of mcs patient
TRANSCRIPT
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Outpatient Treatment of MCS Patient
F. Bennett Pearce, MD Professor of Pediatrics
Med Director Heart Transplant COA
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I DO NOT HAVE ANY RELEVANT FINANCIAL RELATIONSHIPS WITH ANY COMMERCIAL INTERESTS TO DISCLOSE.
Disclosure Statement
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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
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1963 VAD
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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
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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
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THORATEC
• Paracorporeal • Pneumatic • Mechanical tilting disc
valves • Thoralon® • HR down to 20-lower
rates allow blood stasis
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Figure 5. Survival to transplantation of heart disease.
Copyright © American Heart Association
MORTALITY RISK FACTORS
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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
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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
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Chest X-Ray on Admission
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ECMO
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5 Weeks into Berlin Heart
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Journal of Thoracic and Cardiovascular Surgery 2009
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NEJM Aug 2012
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Berlin Heart
• 800 US implants • 80-90/year • In hospital • Portable control
unit
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REMATCH Trial 2001
• 1998-2001 • 129 NYHA Class IV • Heart Mate XVE
pulsatile, intracorporeal
• DT 365d • 52% Device, 25%
medical
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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
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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
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Survival Rates in Two Trials of Left Ventricular Assist Devices (LVADs) as Destination Therapy.
Fang JC. N Engl J Med 2009;361:2282-2285.
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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
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Continuous Flow VAD
• Axial Flow-HM2 • Centrifugal Flow-
HeartWare • Smaller • Valveless • Magnetic levitation
AXIAL 63ml/390g
CENTRIFUGAL50ml/160g
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Copyright ©2008 The American Association for Thoracic Surgery
John R. et al.; J Thorac Cardiovasc Surg 2008;136:1318-1323
No Caption Found
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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
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Pediatric Device Evolution
• 2010 ASAIO J • 4 adolescents • Heart Mate 2 • Intracorporeal • Continuous flow • Support 85-128d
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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
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INTERMACS/PEDIMACS
• INTERMACS-2006 • CMMS mandatory for DT with approved devices • >10000 patients • PEDIMACS-2012-durable support, excluding
ECMO
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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
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Age at Implant
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0UTPATIENT VADS IN AL
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Birmingham News April 10, 2015
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Current CF Devices
HM2
HVAD
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ECHOCARDIOGRAPHY
• Artifacts • septal position • MR • Aortic Valve • RV
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ECHOCARDIOGRAPHY
• Artifacts • septal position • MR • Aortic Valve • RV
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ECHOCARDIOGRAPHY
• Artifacts • septal position • MR • Aortic Valve • RV
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ECHOCARDIOGRAPHY
• Artifacts • septal position • MR • Aortic Valve • RV
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ECHOCARDIOGRAPHY
• Artifacts • septal position • MR • Aortic Valve • RV
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ECHOCARDIOGRAPHY
• Artifacts • septal position • MR • Aortic Valve • RV-function/TR
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CARDIAC CATH
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SUCTION EVENT
• Acute septal shift • Septum obstructs
inflow • Reduced preload • high RPM • Acute Drop in flow
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SUCTION EVENT
ECHO LV Tach
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Normal Operation Parameters
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Blood Pressure
Low pulsatility MAP 60-80 Brachial Artery Doppler
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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
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ANTICOAGULATION
• Warfarin, INR 2-3 • ASA 325 • Anti-platelet • Heparin infusion
for low INR • Heparin infusion-
procedures
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Thrombosis
• Markers of hemolysis
• LDH>600 • PFH>40 • Pump design
change
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Acquired VW Deficiency
• VW multimers-destroyed shear stress
• é mucosal bleeding
• GI bleeding
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Intestinal angioectasia • Thin walled
mucosal vessels • reduced pulse
pressure • Anywhere in colon • Reduce anticog • Octreotide,
thalidomide NEJM now Feb 2015
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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.
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HOME WOUND CARE • Gloves/Mask • Remove Dressing • Clean Exit Site • New Bandage • REPORT
– Redness/swelling – Odor/warmth/100.5 – Drainage
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SITE CARE
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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
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CF VAD SUMMARY
• OK to defibrillate • CPR OK-check driveline • Not MRI compatible • Local ER/EMS notification and training • Family training, onging education
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OUO VADIS?
• Miniaturization • Longer support, Ped DT? • “good” VAD> “bad”
transplant • PumpKIN • Recovery enhancement
MVAD
Levee Road, Convent, LA Andrew Boyd
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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