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.