Six-Month Outcomes in Postapproval HeartMate3 Patients: A Single-Center US Experience

Abstract

Background The European CE Mark approval study and the MOMENTUM 3 trial demonstrated safety and a reduction in hemocompatibility-related adverse events with use of HeartMate 3 (HM3) device. This single center study investigated the real-world experience in HM3 patients since FDA approval. Methods This retrospective, observational study included patients implanted with the HM3 LVAD as a primary implant between October 2017-March 2020. Patients were divided into trial group and postapproval group. Primary endpoint was survival at 6 months. Secondary endpoints were adverse events including pump thrombosis (requiring pump exchange), stroke, renal failure, acute limb ischemia, re-exploratory for bleeding, gastrointestinal bleeding, right ventricular failure, and driveline infection. Results A total of 189 patients were implanted with HM3 device during the study period. 174 patients met the inclusion criteria: 82 patients in the trial group and 92 patients in the postapproval group. The postapproval group had younger patients, higher pre-operative mean international normalized ratio, and greater numbers of patients with bridge to transplant (BTT) indications, IINTERMACS profile 1, and use of mechanical assist devices (other than IABP) than the trial group. Other characteristics between the two groups were comparable. Overall survival at 6 months in the postapproval group was 93.3% vs. 93.8% ( p=0.88). The postapproval group demonstrated a statistically significant lower incidence of re-explorative surgery for bleeding (10.9% vs 46.3, p=0.01) than the trial group. Conclusion In this single-center study, the real-world 6-month survival in the postapproval group was comparable to the trial results. Further studies are needed to monitor long-term outcomes.