Introduction

The use of left ventricular assist devices (LVADs) for advanced heart failure has become a standard of care either as a bridge to transplant (BTT) or as destination therapy (DT).1,2 Older generation LVADs were associated with many device-related adverse events, such as pump thrombosis, bleeding, stroke, and infections.2-5 The HeartMate 3 (HM3) (Abbott Laboratories, Illinois), a new generation continuous-flow LVAD (CF-LVAD) with fully magnetically levitated rotors, demonstrated a reduction in the incidence of hemocompatibility-related adverse events during the 2-year follow-up in the MOMENTUM 3 trial.6
After the completion of the MOMENTUM 3 trial, the HM3 device received US Food and Drug Administration (FDA) approval in 2018. Long-term survival observed in both US and European (CE Mark trial) clinical trials was similar to that seen with the previously approved devices but with a significant reduction in hemocompatibility-related adverse events, such as freedom from pump thrombosis and pump failure and reduced incidence of stroke.6-9 The only experience regarding outcomes during the postapproval phase comes from the European ELEVATE registry, which also supported the findings of reduced adverse events and a real-world survival of 92% at 6-month follow-up.10
However, no such real-world survival data exist for patients implanted in the United States during the postapproval phase, except for the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data. The aim of this study was to provide real-world US data since FDA-approval of the device.