Transplant Trial Watch

Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial.

Mehra, M. R., et al.

JAMA 2022; 328(12): 1233-1242.


Aims
The aim of this observational study was to report the 5-year follow-up of the MOMENTUM randomised controlled trial that compared the safety and efficacy of a centrifugal-flow left ventricular assist device (LVAD) versus an axial-flow device in patients with advanced-stage heart failure.

Interventions
Participants in the original trial were randomly assigned to either the centrifugal-flow pump group or the axial-flow pump group.

Participants
1020 patients with advanced-stage heart failure who were eligible for therapy with a left ventricular assist device (IDE trial’s per-protocol population).

Outcomes
The composite outcome was survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump 5 years following the implant. Other outcomes were patient outcomes (including transplant, explant/permanent deactivation, or withdrawal) and survival, and frequency and incidence of serious adverse events.

Follow-up
5 years

CET Conclusions
This paper reports observational long-term follow-up of the MOMENTUM 3 study, in which patients were randomised to a centrifugal-flow or axial-flow left-ventricular assist device (LVAD). Patients who were still receiving LVAD therapy at 2 years were enrolled, and the primary endpoint was a composite of survival to transplant, recovery, or LVAD support free of stroke. The authors report a significantly higher incidence of the composite endpoint in those patients on the centrifugal-flow device (54% vs 29%) as well as higher overall survival. The authors report significant challenges in obtaining data for the composite endpoint particularly in relation to incidence of stroke, due to a combination of delays in set-up and enrolling participating centres, and the COVID pandemic. This means that there is a significant amount of missing data in the non-survival endpoints. However, the improvement in overall survival seen suggests that there is a real benefit to the fully-magnetic centrifugal flow device.

Trial registration
ClinicalTrials.gov - NCT02224755; ClinicalTrials.gov - NCT03982979

Funding source
Industry funded