Title : Heart mate 3 left ventricular assist device as a bridge for transplant or destination therapy
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 series included patients treated as a bridge for Heart transplant and for destination therapy. 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, with only 9% major strokes and 1% thrombosis complication events at 2 years. HeartMate 3 LVAD provides immediate, significant, and sustained 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 and results are consistent in patients for destination therapy and for bridge to transplantation.