ORLANDO, Fla., March 11, 2018 /PRNewswire/ -- Abbott (NYSE: ABT) announced new late-breaking clinical trial data from the MOMENTUM 3 clinical study, the largest left ventricular assist device (LVAD) trial in the world to evaluate patients in need of both short-term and long-term support in a single study. The data were published online in The New England Journal of Medicine (NEJM) and presented during a late-breaking session at the American College of Cardiology's (ACC) 67th Annual Scientific Session.

"The long-term data for the pivotal MOMENTUM 3 trial demonstrate overall survival of 83 percent at 2-years and marked improvement in clinical outcomes for our patients suffering with advanced heart failure," said Mandeep R. Mehra, M.D., medical director of Brigham and Women's Hospital Heart and Vascular Center in Boston. "We have seen greater pump durability—mostly driven by an absence of confirmed pump thrombosis—as well as a significantly lowered stroke rate without an increase in other adverse events."

The MOMENTUM 3 study data—which will be submitted to the U.S. Food and Drug Administration (FDA) to support consideration of a long-term (destination therapy) indication for Abbott's HeartMate 3 LVAD—compared the HeartMate 3 LVAD to the HeartMate II LVAD in treating advanced heart failure. The HeartMate II is the most widely used LVAD in the world for long-term support. More than 1,000 patients with New York Heart Association (NYHA) Class IIIB or IV heart failure participated in the study. Patients were followed for a short-term endpoint of six months and a long-term endpoint of two years.
Patients who participated in the MOMENTUM 3 study received the following benefits from Abbott's HeartMate 3 system:

Superior Rates of Event-Free Survival. The long-term cohort met its primary endpoint with 77.9 percent event free survival (survival free from disabling stroke and device removal due to malfunction), showing superiority over the HeartMate II LVAD at 56.4 percent.
Improved Survival. Patients with the HeartMate 3 LVAD had a survival rate of 82.8 percent at two years compared to 76.2 percent for those with the HeartMate II LVAD.
Low Pump Thrombosis. Rates remained very low at 1.2 percent suspected thrombosis for the HeartMate 3 LVAD, with no reoperations, pump replacements or urgent transplants occurring at two years.
Lower Stroke Rate. Stroke rate was significantly lower (10 percent) for the HeartMate 3 LVAD compared to the HeartMate II LVAD (19 percent).
In addition, patients receiving HeartMate 3 LVAD had significant improvements compared to the HeartMate II LVAD in functional capacity and quality of life scores at two years compared to baseline. Rates of all other adverse events were similar between the HeartMate 3 LVAD and historical rates seen in the HeartMate II LVAD, which is the most widely used and extensively studied LVAD commercially available.

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