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 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 left ventricular assist device (LVAD). The data, presented during a late-breaking session at the American College of Cardiology’s 68th Annual Scientific Session and published in The New England Journal of Medicine, further confirms Abbott’s HeartMate 3 device has elevated the performance of LVAD therapy and provides physicians superior outcomes when compared to the previous generation, HeartMate II—long considered the gold standard in LVAD therapy—for patients living with advanced heart failure.
“The data from MOMENTUM 3 are a remarkable combination of high survival and low adverse event rates, which is exactly what physicians have been seeking from LVAD therapy as these devices have evolved over time,” said John B. O’Connell, M.D., medical director for mechanical circulatory support at Abbott. “We have now confirmed that long-term patient success is directly related to the specific design of the pump as opposed to implant technique.” LVADs, also known as heart pumps, are small, implantable mechanical devices that pump blood through the body in people living with the most advanced stage of heart failure. People living with an LVAD may be awaiting a heart transplant or are not candidates for a heart transplant and need a device to pump blood from their heart to the rest of their body.
“The final outcomes seen in MOMENTUM 3 herald a new era in LVAD therapy for our patients, characterized by longer overall survival while avoiding complications of stroke, bleeding and the need for surgically replacing malfunctioning pumps,” said Mandeep R. Mehra, M.D., medical director of Brigham and Women’s Hospital Heart and Vascular Center in Boston. “The data is exciting because they truly demonstrate that advances in engineering that led to design improvements in the pump are associated with a major impact on long-term outcomes in patients suffering from advanced-stage heart failure.”
MOMENTUM 3 Results: Setting a New Standard in LVAD Therapy
The MOMENTUM 3 study data compared the HeartMate 3 LVAD to the HeartMate II LVAD in treating people living with advanced (New York Heart Association Class IIIB or IV) heart failure. Initial data from the MOMENTUM 3 study included a six-month and two-year follow-up with a subset of 366 patients, both of which met their primary endpoints. The final analysis presented includes the full cohort of 1,028 patients. Analysis of the study’s full cohort of patients after two years showed the following benefits from Abbott’s HeartMate 3 LVAD in comparison to the HeartMate II LVAD:
- Met and Exceeded Primary Endpoint (demonstrated superiority)- 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.
- Improved Quality of Life- 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.
- Lowest Adverse Event Rates in a Randomized Controlled Trial- 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). – Medical Buyer Bureau