First experiences with HeartMate 3 follow-up and adverse events

Abstract

Background: The novel HeartMate 3 (HM3) left ventricular assist device (LVAD) received its CE mark in October 2015. It is a new compact LVAD featuring fully magnetically levitated pump, artificial pulse, large pump gaps, and a modular driveline. Here, we present outcomes and adverse events of a single-center cohort 6 months after HM3 implantation.

Methods: We retrospectively studied a patient cohort of 27 patients who were supported with the HM3 at a single institution. We excluded patients with biventricular assist devices and other types of assist devices as well as LVAD exchange and re-operative procedures.

Results: Twenty-seven patients were enrolled into the study. Within 1 year after HM3 implantation, 1 patient received a heart transplant and 3 patients died. Thirty-day survival was 88.9% and 6 months 85.2%. No pump thrombosis and no strokes were observed within 6 months. Right heart failure was diagnosed in 1 patient after HM3 implantation (3.7%). No technical complications of the pump were documented. No pump exchanges were necessary.

Conclusions: The novel LVAD HM3 has already shown good CE mark trial results. Within this first report after the CE mark trial, the 6-month survival after HM3 implantation was 85.2%. The HM3 showed excellent midterm results with 0% stroke and 0% pump thrombosis rates 6 months after implantation.

Keywords: HeartMate 3; LVAD; Left ventricular assist device; complications; outcomes; survival.