Title : Heart mate 3 left ventricular assist device superiority demonstrated in momentum 3 trial
Abstract:
HeartMate 3 (HM3) left ventricular assist device (LVAD), a fully magnetically levitated centrifugal-flow pump has been evaluated in MOMENTUM 3, the largest LVAD trial ever conducted demonstrating excellent survival and safety outcomes with HeartMate 3™ LVAD. It has been published in 2021.
The trial enrolled 2200 HM3 implanted patients and compared outcomes. The survival rate was 81%, being the highest published 2-year survival rate for any LVAD. The study showed that HM3 patients had the lowest hemocompatibility-related adverse events of any LVAD, withonly 9% major strokes and 1% thrombosis complication events at 2 years. HeartMate 3 LVAD provides immediate, significant, andsustained improvements in Functional Capacity and Quality of Life: 79% of patients improved from NYHA Class IIIB/IV at baseline to
NYHA Class I/II by 6 months, with sustained better condition in 80% of patients through 2 years (P< 0.0001).
The quality of life resulted upgraded more than thirty points according to the Kansas City cardiomyopathy (KCCM) score and was solid through 2 years. The average 6 minutes’ walk increased from 136 to 323 meters.These results were consistent, despite the inclusion of sicker patients in the second series of enrolment (more intra-aortic balloon pump use and INTERMACS profile1), who were more often intended for destination therapy.
Conclusions:
The primary results of accumulating HM3 LVAD experience in 2200 patients suggest a lower adverse event burden and similar survival to heart transplantation at 2 years, with higher quality of life compared to other LVAD devices.
Although ‘unstable’ INTERMACS profile 1–2 patients demonstrate slightly lower survival when compared with the
more stable INTERMACS 3 profile (who also require inotropic therapy), the composite primary endpoint (survival free of disabling stroke or reoperation to replace or remove a malfunctioning device) is similar between groups.
These data provide confidence that the HM3 pump performs well throughout even in the presence of clinical severity.