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NEW ORLEANS -- The next generation HeartMate 3 left ventricular assist device (LVAD) improved outcomes for heart failure patients -- both bridge to transplant and destination therapy -- compared with the current generation device, the MOMENTUM 3 trial showed.
The rate of freedom from disabling stroke or reoperation to replace or remove the device at 6 months after implantation was 86.2% with HeartMate 3 and 76.8% with HeartMate II, a relative 45% reduction in risk (P<0.001 for noninferiority, P=0.04 for superiority).
The difference was driven by reoperation for pump malfunction (0.7% vs 7.7%, P=0.002) with no difference in either death or disabling stroke (modified Rankin score greater than 3), , of Brigham and Women's Hospital in Boston, and colleagues reported here at the American Heart Association meeting.
The findings from a trial of 294 patients with New York Heart Association class IIIb or IV heart failure randomized to the two devices were published simultaneously online in the New England Journal of Medicine.
And the new centrifugal-flow device designed to reduce thrombosis risk -- with a magnetically-levitated, continuous-flow pump that provides an artificial pulse -- appeared to do just that. No recipients had suspected or confirmed pump thrombosis, compared with 14 cases (10.1%) in the axial-flow pump group.
That difference means it's not just an incremental device upgrade but one with big implications for patients, commented of Northwestern University in Chicago and a past president of the AHA.
"Any patient we can save from that outcome, and more importantly prevent from that outcome, is critical to us," he told 鶹ý, noting the morbidity and cost of these major operations to replace thrombosed pumps. "These are the kind of things that can profoundly change a patient's quality of life."
As this technology gets better and safer, perhaps it can become an option for less severely ill heart failure patients, he suggested, although the persistent stroke and infection risks remain an issue for now.
Gastrointestinal bleeding occurred in equal proportions of patients in the two groups. Overall stroke rates were similar as well (7% HeartMate 3 versus 10% HeartMate II, P=0.39), as were infections and right heart failure.
"Clearly additional long-term data is necessary to determine if there will be a significant impact on survival, adverse events, and quality of life that will make LVAD support a viable or even competitive alternative to heart transplant," said discussant, of the University of Louisville, Kentucky, who noted participation in the trial and having done "a significant amount of preclinical work on the device."
Mehra noted that the manufacturer intends to file for regulatory approval of the HeartMate 3 based on the 6 month results, although a 24 month follow-up in a longer-term cohort within in the trial is ongoing.
Disclosures
The trial was funded by St. Jude Medical.
Mehra disclosed nonfinancial support from St. Jude Medical and personal fees from Stealth Biotherapeutics, Medtronic, Johnson & Johnson (Janssen), and Teva Pharmaceuticals.
Primary Source
New England Journal of Medicine
Source Reference: "A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure" N Engl J Med 2016; DOI: 10.1056/NEJMoa1610426.