INTERMACS Profile 1 and Beyond. INTERMACS Patient Profiles. Defining the Population with Advanced Heart Failure

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1 NTERMACS Profile 1 and Beyond Congress on ECMO Therapy October 19, 2013 Hershey, PA Disclosures Consultant: Thoratec Corporation Principal nvestigator, HeartWare ENDURANCE trial Joseph G. Rogers, M.D. Associate Professor of Medicine Senior Vice Chief for Clinical Affairs, Division of Cardiology Medical Director, Cardiac Transplant and Mechanical Circulatory Support Program Duke University NTERMACS Patient Profiles Rogers Reclassification Nearly dead Actively dying Working toward death Probable shock. May actually need inotropes Unable to perform activities without symptoms Symptoms limit ADLs Symptoms with minimal activity Circulation 2011;123: Defining the Population with Advanced Heart Failure AHA/ACC classification Stage C Stage D NYHA classifications NTERMACS Profiles Class Class b/v Class V ? Range of DT Approval and CMS Coverage Approved NTERMACS 6: Exertion limited NTERMACS 5: Exertion intolerant NTERMACS 4: Resting symptoms on oral therapy Not Broadly Generally Accepted Accepted Ambulatory Class B and V Less Sick Sick Patients with advanced cardiogenic shock 1. Hypotension 2. Elevated filling pressures 3. Reduced organ perfusion and function 4. Acidosis NTERMACS 1-3: notrope-dependent Slide Concept: David Farrar, PhD

2 Clinical Trial Data Supporting Any Approach for Patients with Advanced Cardiogenic Shock: A Comprehensive Review Contemporary Outcomes in Cardiogenic Shock: Results of the ABP-Shock Trial On the basis of the findings of ABP-SHOCK trial, we must move forward with the understanding that a cardiovascular condition with a 40% mortality at 30 days remains unacceptable. N Engl J Med 2012;367: N Engl J Med 2012;367: Challenges with MCS for Cardiogenic Shock: nterposing Non-Uniform Patient Characteristics Rapidity of implementation Ability to provide bi-ventricular support Ability to provide ventilatory support Sufficiency of hemodynamic support Unique challenge of RV support Bridge to decision solution (low cost/high efficacy) Limited alternatives

3 Proposed Management Algorithm for Patients in Cardiogenic Shock Rogers JG, Milano CA, The role for mechanical support in cardiogenic shock, AHA Publication, 2009 Novel Mechanical Approaches to Treat Acute Cardiogenic Shock Need controlled clinical trials of novel mechanical circulatory assist devices for acute heart failure mpella 5.0 in Post-Cardiotomy Shock Results of the Recover 1 Registry 16 patients Mean duration of support=3.7±2.9 days Mean flow=4 l/min Survival (1 death, 1 stroke) 30-day=94% 180-day=81% 360- day=75% J Thorac Cardiovasc Surg 2013;145:548-54

4 TandemHeart in Cardiogenic Shock: TH Experience 118 patients with refractory cardiogenic shock Nearly 50% had just received or were receiving CPR Mean support duration=5.8 days J Am Coll Cardiol 2011;57: Mechanically Assisted Circulation: Contemporary Devices and Outcomes Bridge to Transplant Bridge to Transplant Destination Therapy Ann Thorac Surg 2011;92: Circulation 2012;125: Circ Heart Failure 2012;5: MN WALK V V NYHA CLASS KCCQ J Am Coll Cardiol 2010; 55: Characteristics of Durable VAD-Treated Patients in Clinical Trials HeartMate VE BTT (2001; n=280) REMATCH (2001;N=129) NTrEPD (2007;n=55) HM BTT + CAP (2009; n=281) HM DT (2009; n=200) Age EF Na BUN Cr Alb PCWP C % notropes % ABP Hemodynamic parameters obtained on optimal medical therapy

5 Who is Receiving MCS in the NTERMACS Registry? J Heart Lung Transplant 2013; 32: Patient Outcomes Stratified by NTERMACS Profile J Heart Lung Transplant 2013; 32: mportance of RV Function on VAD Outcomes Post-VAD RV failure contributes to: Hepatic congestion Renal failure Bleeding Prolonged mechanical ventilation MSOF Prolonged LOS Parameter Desirable Value RVSW [(mpa-mcvp) x SV/BSA] > 300 mmhg ml/m 2 J Thorac Cardiovasc Surg 2010;139: CVP <15 mmhg CVP:PCWP Ratio < 0.63 Presence of tricuspid regurgitation PVR and TPG Minimal to moderate PVR <4 Woods Units and TPG <15 mmhg RV size Need for preoperative ventilator support RVEDV <200 ml and RVESV <177 ml None J Heart Lung Transplant 2010: (4 Suppl):S1-39.

6 mplications of Bi-Ventricular Mechanical Support Survival Adverse Events J Heart Lung Transplant 2013; 32: mplantable Devices for Uni- or Biventricular Support in Acute Cardiogenic Shock Modified Univentricular Mechanical Support

7 Strategies for BiVentricular Support 30-day survival 82% Circulation 2011; 124 (suppl1):s179-s186 ECMO for Cardiac Failure Systematic Review 67 papers Mostly case reports and single center series (n=5-169) Cardiac conditions Cardiac arrest, cardiogenic shock, post-cardiotomy, myocarditis, post-transplant # Reports Median Survival (%) Range Cardiac Arrest Cardiogenic Shock Post-cardiotomy Myocarditis Post-tx cardiac dysfunction 2 57,91 J ntensive Care Med :13-26 Summary and Conclusions The morbidity and mortality associated with acute cardiogenic shock remains unacceptably high Management strategies for cardiogenic shock include Temporary percutaneous devices Temporary implantable devices Durable implantable LVADs Novel LVAD configurations for bi-ventricular support ECMO Carefully performed clinical trials are needed to clearly define the relative risks and benefits of these support strategies

8 TH Approach to Management of Advanced Cardiogenic Shock J Am Coll Cardiol 2011;57:688-96