Two-Year Outcomes in Real World Patients Treated with Heartmate 3TM Left Ventricular Assist Device for Advanced Heart Failure: Data from the ELEVATE Registry

Abstract

Summary of Objectives Heartmate 3 (HM3), a fully magnetically levitated continuous flow left ventricular assist device (LVAD), has been approved for treatment of advanced heart failure. The ELEVATE registry collects real world data with the HM3 out to 2 years. Methods A total of 540 patients implanted at 26 centers were included between January 2015 and February 2017. Of these, 463 were primary implants, 19 were pump upgrades, and in 58 patients only anonymized survival data was collected. Data collection on the primary implants and pump upgrades included baseline demographics, survival, adverse events, quality of life measured by EQ-5D visual analogue scale (EQ5D VAS) and 6-minute walk distance (6MWD). Endpoints Baseline characteristics of the primary implants included a mean age of 55.6 ± 11.7 years, predominantly male (89%), 48% ischemic etiology and 70% on inotropes. The majority of patients (66%) were BTT, 70% were INTERMACS 1-3 and 8% patients were implanted with ECMO. Mean 6MWD showed poor functional capacity (104 ± 140 m) and measures of quality of life were significantly impaired (EQ5D VAS 35 ± 19). Hemodynamics before implant included: CI 1.9 ± 0.6 L/min/m2, PCWP 24.8 ± 9.4 mmHg and CVP 10.8 ± 6.7 mmHg. As of September 4, 2018 in the primary implant group, there was 0.2% confirmed pump thrombosis, 32% major bleeding, 13% sepsis, 25% driveline infection and 9% stroke events. At 2 years the 6MWD improved to 350 meters and the EQ-5D VAS improved to 67 ± 20. The Kaplan Meier 2-year survival in the primary implant group was 84 ± 2%. The complete 2-year data will be available at the time of presentation. Conclusion The real world ELEVATE Registry 2-year data demonstrates high survival, low adverse event rates, low incidence of pump thrombosis and improved functional capacity in a sick patient population.