MOMENTUM 3 study of HeartMate 3 LVAD meets primary endpoint in heart failure

Abbott announced new late-breaking data from the MOMENTUM 3 study, the world's largest randomized controlled trial to assess outcomes in patients receiving a HeartMate 3 left ventricular assist device (LVAD) heart pump to treat advanced heart failure. In reviewing data across the complete 1,028 patient cohort, MOMENTUM 3 met its primary endpoint of event free survival while showcasing improved rates of overall survival, quality of life and a reduction in adverse events with the HeartMate 3 LVAD.

Analysis of the study's full cohort of patients after two years showed a number of benefits from Abbott's HeartMate 3 LVAD in comparison to the HeartMate II LVAD. Firstly it met and exceeded primary endpoint (demonstrated superiority) for improved survival: The long-term cohort showed a survival rate of 79 percent at two years with the HeartMate 3 LVAD (vs. 76.7 percent); a p-value of <0.0001. It also improved quality of life and patients with the HeartMate 3 device had a significant +30 point improvement in Quality of Life scores (KCCQ Quality of Life score)—six times greater than the level that physicians would consider meaningful. Additionally, compared to their pre-implant assessment, patients with the HeartMate 3 device could walk nearly two football fields further in six minutes.

Finally at two years, 98.6 percent of patients avoided thrombosis (clotting) in their pump (vs. 86.1 percent). In addition, 90.1 and 95.0 percent of patient avoided all strokes and debilitating stroke, respectively (vs. 80.6 and 92.5 percent). The data were presented at the American College of Cardiology's 68th Annual Scientific Session and published in The New England Journal of Medicine.

See: "A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report." Mandeep R. Mehra et al. NEJM March 17, 2019 DOI: 10.1056/NEJMoa1900486