New late-breaking clinical trial data from the MOMENTUM 3 clinical study shows overall survival of 83% at 2-years and marked improvement in clinical outcomes for our patients suffering with advanced heart failure. 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% at 2-years and marked improvement in clinical outcomes for our patients suffering with advanced heart failure,” said Mandeep R. Mehra, 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 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.
In the MOMENTUM 3 study the long-term cohort met its primary endpoint with 77.9% of patients achieving event free survival (survival free from disabling stroke and device removal due to malfunction), which is superior to the HeartMate II LVAD which had a rate of 56.5%. Patients with the HeartMate 3 LVAD had a survival rate of 82.8% at two years compared to 76.2% for those with the HeartMate II LVAD. There were low rates of pump thrombosis with a rate of 1.2% suspected thrombosis for the HeartMate 3 LVAD, with no reoperations, pump replacements or urgent transplants occurring at two years. Stroke rate were also significantly lower (10%) for the HeartMate 3 LVAD compared to the HeartMate II LVAD (19%).
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.
The MOMENTUM 3 Investigation Device Exemption (IDE) study is a prospective, multi-centre, randomised, unblinded study evaluating the safety and effectiveness of the HeartMate 3 LVAD when used for the treatment of advanced, refractory, left ventricular heart failure. This study included all-comers, which means researchers evaluated the device regardless of whether the patient needed a short-term support option while awaiting transplantation or a long-term support option for those who are not candidates for cardiac transplantation.