Ventricular Assist Device: Are Early Interventions Superior? Hamang Patel, MD Section of Cardiomyopathy & Heart Transplantation

Ventricular Assist Device: Are Early Interventions Superior? Hamang Patel, MD Section of Cardiomyopathy & Heart Transplantation

Objectives Current rationale behind use of MCS Patient Selection Earlier? New Technology Heartmate 3

A Patient with Advanced HF 63 y/o, Male, Ischemic CM, NYHA IIIB, EF 20%, BP 110/70 lisinopril 10 BID, carvedilol 12.5 mg BID, simvastatin 40 mg QD, furosemide 60 mg BID, spironolactone 12.5 mg qd QRS 150 ms Has had 2 admissions to the hospital in the last 6 months for heart failure exacerbations

A Patient with Advanced HF Uptitrate carvedilol to 25 mg BID, lisinopril 20 mg BID, and spironolactone to 25 mg qd Patient still having significant symptoms of shortness of breath with exertion, blood pressures now in the 90s systolic Right heart catheterization: CO 3.7/ CI 1.67 PA 65/32 PCWP 27 RA 13 NEXT After LVAD first STEP? admit?

Advanced HF: Guidelines A B C D Stage High risk for developing heart failure (HF) Asymptomatic HF Symptomatic HF Refractory end-stage HF Hunt SA, et al. Circulation 2005;112:1825-1852. Patient Description Hypertension Coronary artery disease Diabetes mellitus Obesity and metabolic syndrome Patients using cardiotoxins Family history of cardiomyopathy Previous myocardial infarction LV remodeling including LVH Asymptomatic valvular disease Known structural heart disease Shortness of breath and fatigue Reduced exercise tolerance ACE-I, -Blocker, ARB, Aldosterone Antagonist, Digitalis, Hyd/NTG ICD or CRT-D in selected patients Marked symptoms at rest despite maximal medical therapy (e.g., those who are recurrently hospitalized or cannot be safely discharged from the hospital without specialized interventions) All measures under Stages A, B, and C Cardiac transplantation Chronic inotropes Mechanical Support (LVAD) Hospice

Continuous Outpatient Inotropic Support 36 inotrope-dependent patients EF < 20% Class IV symptoms Hypoperfusion and end-organ dysfunction 46 rehospitalizations Median survival=3.4 months (0.2-26.3) Most patients died at home 51% 26% 6% Hershberger, et. al J Cardiac Failure 2003;9:180-7.

Who Benefits From VAD therapy? Patients with an unacceptably limited prognosis and/or Patients with an unacceptable quality of life secondary to congestive heart failure symptoms All other appropriate medical and surgical options have been exhausted 7

INTERMACS profiles at baseline- HMII BTT trial # # pts (%) Description Recommended Time to MCS 1 41 (24%) Critical cardiogenic shock ( crash and burn ) 2 63 (37%) Progressive decline (inotrope dependent) 3 33 (20%) Stable, but inotrope dependant or stable temp circ support) Within Hours Within a few days Within a few weeks 4 21 (12%) Recurrent advanced heart failure Within weeks-months 5 4 (2%) Exertion tolerant Variable 6 3 (2%) Exertion limited Variable 7 4 (2%) Advanced NYHA III Not candidate for MCS

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Durable Device Options Heartmate II HeartWare

HeartMate III Designed to be Hemocompatible Leveraging Full MagLev Flow Technology Features Full MagLev Flow Technology Large, consistent pump gaps designed to reduce blood trauma Artificial pulse Wide range of operation Advanced Design for Surgical Ease Engineered apical attachment Modular Driveline Designed for an Active Lifestyle Pocket Controller 22 CAUTION Investigational device. Limited by US Federal law to investigational ClinicalTrials.gov Identifier: NCT02224755 US-HM3-04150222

MOMENTUM III Clinical Study: HeartMate III is designed for a broad range of advanced heart failure patients to restore blood flow while improving survival, functional status and quality of life. Subject criteria LVEF <25% NYHA Class III with dyspnea upon mild physical activity, or NYHA functional class IV Potential Candidate Inotrope dependent OR CI <2.2 while not on Inotropes Adults with BSA >1.2 m 2 23 CAUTION Investigational device. Limited by US Federal law to investigational ClinicalTrials.gov Identifier: NCT02224755 US-HM3-04150222

Summary and Conclusions Advanced Heart Failure very poor long term survival Non-transplant candidates benefit from mechanical support Patient selection and timing of implantation important role in survival post LVAD 24

When to Consider Advanced Therapies Class III/IV Heart Failure Symptoms LVEF < 30% Early End Stage Organ Dysfunction Hemodynamic Instability Ventricular Arrhythmias Hospitalization for HF in the Past 6 Months Intolerance or Withdrawal of Oral Agents Non-Responsive to CRT/BiV Pacing Being Considered for or Currently on Inotropes Considering Hospice