Advanced Heart Failure Therapies: Cardiac Transplantation and Mechanical Circulatory Support
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Michael A. Samara, MD, FACC
Advanced Heart Failure Therapies Cardiac Transplantation and Mechanical Circulatory Support
Advanced Heart Failure/Transplant/Mechanical Circulatory Support Minneapolis Heart Institute at Abbott Northwestern Hospital Part of Allina Health Minneapolis, MN
Innovation Summit 2014 September 26, 2014
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Heart Failure: The Final Cardiovascular Disease
CORONARY DEATH
Deaths/100,000 population
HEART FAILURE
Prevalence/100,000 population
National Hospital Discharge Survey Data. Centers for Disease Control and Prevention National Center for Health Statistics and National Heart, Lung, and Blood Institute
1980 1990 2000 1980 1990 2000
Improved survival in other CV diseases has led to expansion of the HF Population.
Surv
ival
(%)
100
80
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20
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Time (months) J Heart Lung Transplant 2011;30:402–7
Advanced Heart Failure is Cardiac Cancer
Stage IV Pancreatic Cancer
NYHA FC IV (Medical Therapy)
NOTE: This figure includes only the heart transplants that are reported to the ISHLT Transplant Registry. As such, the presented data may not mirror the changes in the number of heart transplants performed worldwide
ISHLT 2011
J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
Heart Transplantation Survival by Era
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Surv
ival
(%)
Years
1982-1992 (N = 25,138) 1993-2002 (N = 37,193) 2003-6/2010 (N = 24,021)
HALF-LIFE 1982-1992: 8.5 years; 1993-2002: 10.9 years; 2003-6/2010: NA
1982-1992 vs. 1993-2002: p < 0.0001 1982-1992 vs. 2003-6/2010: p <0.0001 1993-2002 vs. 2003-6/2010: p <0.0001
1-year 94% 3-year 90%
MHI at ANW
~ 240 M US Population ≥ 20 years old
6.24 M HF = 2.6% of the population
3.12 M Systolic HF = 50% of HF population
374,400 Stage C/D
NYHA IIIb-IV
93,600 Target VAD/Tx Population
Projected Advanced HF Therapy Population
1 US Census Bureau Statistics (2007) 2 Heart and Stroke Statistics, American Heart Association
3 Cardiovascular Round Table research and analysis, The Advisory Board company (2009)
280,800 Disqualifying Comorbidities
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There are currently approximately
100,000 potential candidates in the
United States.
Likely several hundred in the Allina System.
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Europe
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NOTE: This figure includes only the heart transplants that are reported to the ISHLT Transplant Registry. As such, the presented data may not mirror the changes in the number of heart transplants performed worldwide.
Heart Transplant Volumes Reported by Year
ISHLT 2011
J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
U.S. Chronic VAD Implants vs. Heart Transplants, 2007-2012
Projected U.S. VAD implants by Indication (Estimates), 2013-2016
~1,325
~1,850 ~2,150
~2,750
~3,400
~2,200 ~2,150 ~2,200 ~2,300 ~2,300
2012 2010 2009 2008 2007
2,233
3,702
2016
5,935
2013 2015
5,089
2,193
2,895
2014
4,468
2,103
2,365
3,906
1,993
1,914
Source: Thoratec Estimates; Average analyst projections for VAD market (Wells Fargo, JP Morgan, Credit Suisse, Oppenheimer)
VADs Transplants
VAD Implants have Already Surpassed Transplant Volumes
Bridge to Transplant Destination
Indications • Post-cardiotomy Shock • Acute Myocardial Infarctions • Cardiac Arrest • Acute on chronic decompensated systolic heart failure • Acute fulminant myocarditis Why Early Application of MCS Makes Sense • Decompress the ventricle(s) • Lung protection • Wean off toxic levels of inotropes/pressors • Correct metabolic derangements • Preserve end-organ function
Cardiogenic Shock
Venoarterial Extracorporeal Membrane Oxygenation
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VA ECMO
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Total Patients
Survived ECLS (%) Survived to
Discharge (%)
Respiratory 5,146 3,317 64% 2,905 56%
Cardiac 4,042 2,255 56% 1,636 40% ECPR 1,238 476 38% 355 29%
Expanding Use of Extracorporeal Life Support
65%
SHOCK TEAM • Interventional Cardiologist • Heart Failure Cardiologist • Intensivist • Cardiothoracic Surgeon • Vascular Surgeon • ICU Nurse • Perfusionist
RAPID TRIAGE AND INITIATION • Performed in cath lab • Rapid assessment of
hemodynamics • 20% of patients with ongoing
CPR at time of cannulation
ETIOLOGY OF REFRACTORY
FAILURE
CARDIO-PULMONARY
Pulmonary + RV
RA-LA ECMO
Pulmonary + LV/BiV
VA ECMO
CARDIAC
RV Failure pRVAD
LV Failure pLVAD
BiV Failure pRVAD/pLVAD
PULMONARY VV ECMO
Tailored Approach to Temporary MCS in Refractory Failure
• Centrimag • Rotaflow
• Centrimag • Rotaflow
• Centrimag • Rotaflow
• Centrimag • Rotaflow • Tandem • PVAD
• Impella 5 • Tandem • PVAD
• Tandem • PVAD
• Bridge to Transplant*: Inserted for short to intermediate term support in patients actively listed for transplant
• Destination Therapy*: Inserted with the intention of long term support in patients who are not transplant candidates
• Bridge to Recovery: Inserted for short term support in a condition that is anticipated to reverse (e.g., fulminant myocarditis, EtOH cardiomyopathy, etc.)
• Bridge to Decision: Inserted for support when ultimate therapy is not able to be determined at the time of implantation
Defined Indications for Durable VADs
*only designations currently recognized by regulatory/payor community ~20% crossover in clinical trials (BTT!"DT)
• >18,000 implants
• Axial continuous-flow from LV to ascending aorta
• Easy surgical implantation • Smaller pre-peritoneal pocket
• Electrically powered • Batteries & line power
• Silent, vibration-free operation • Flow range: 3-10 L/min
• Designed for extended durability with single moving part
HeartMate II® LVAD
Summary of HeartMate II ® BTT Outcomes
Reference Study Enrollment period n Survival at 180
days Miller, Pagani, Russell et al NEJM 357:885-896, 2007
HM II Pivotal Trial 3/05- 5/06 133 79%
Pagani, Miller, Russell et al JACC 54:312-321, 2009
HM II Pivotal Trial 3/05- 3/07 281 84%
Starling, Naka, Boyle et al JACC 57:1890-1898, 2011
Post Approval Study 4/08 – 8/08 169 91%
Summary of HeartMate II® Destination Therapy Outcomes
Reference Study Enrollment period n
One-Year Survival
Two-Year Survival
Slaughter, Rogers, Milano et al NEJM 2009;361:2241-51.
HM II Pivotal Trial 3/05- 5/07 134 68% 58%
Park, S et al Circ Heart Failure 2012;5:241-8.
HM II Pivotal Trial 5/07- 3/09 311 74% 64%
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Met
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JAAC 2009;54(4):312-21.
HeartMate II® BTT Trial Improvement in 6-minute Walk and NYHA Class
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Baseline 1 mo 3 mo 6 mo
% o
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NYHA II
NYHA I
59%
83% 82%
0%
NYHA Functional Class 6-minute Walk
1. J Amer Coll Cardiol. 2011;57(19):1890-1898. 2. Stroke. 2006;37(2):562-571. 3. Two-Year Outcomes in the Destination Therapy Post-FDA-Approval Study with a Continuous Flow Left Ventricular Assist Device: A Prospective
Study Using the INTERMACS Registry. U.P. Jorde, S.S. Kushwaha, A.J. Tatooles, et al. Presented at the ISHLT annual meeting, April 25, 2013.
Device Related Infection
Bleeding Requiring Surgery
Pump Replacement
Isc Stroke Hem Stroke Hemolysis Thrombus
Trial Post-Approval Study
0.06
0.031
0.47
0.22 0.07
0.052
0.024
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0.024 0.027
0.23
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0.057
0.026
Eve
nts
/ pat
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yea
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Note: 3x scale difference for Device infection and Bleeding requiring surgery compared to others
. . . Since the trial adverse event occurrence continues to decline3
HeartMate II® BTT Trial Adverse Event Rates are Falling with Clinical Experience
Heartware HVAD® Centrifugal/Radial Flow LVAD
J Am Coll Cardiol. 2011;57(12):1375-1382
Circulation. 2012;125:3191-3200
Aorta LV apex
• Centrifugal pump with hybrid magnetic/hydrodynamic impeller suspension "
• 3,500 implants worldwide
• Approved for use in EU in January 2009
• FDA approved for BTT only in US
HeartWare® System
Small pump attaches directly to the heart
Thin, flexible driveline cable exits skin
A small controller & batteries run the pump
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device.
Months
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Perc
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68%
58% 55%
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52%
NEJM 2001; 345:1435-43 NEJM 2009; 361:2241-2251
Continued Stepwise Improvement in Survival in Clinical Trials
OMM Rose 2001
XVE DT Slaughter 2009 XVE DT Rose 2001
HMII DT Slaughter 2009
HMII BTT Pagani 2009
Heartware BTT 2013
88%
75% ~90% 1-year survival in Bridge to Transplant Patients* ~70% 1-year survival in Destination Therapy Patients*
Total Artificial Heart
Inlet Cannula in Left Atrium
Pump to the Subclavian Artery
Subcutaneous pump implanted like a pacemaker
CircuLite®: A Permanent, Partial Support LVAD with Minimally Invasive Implantation
European Journal of Cardio-thoracic Surgery, 39 (2011) 693-698.
Can early, partial support alter the natural history of
advanced HF?
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