MOMENTUM 3: Reoperations and Strokes Reduced with Heart Mate 3 LVAD at Two Years
The HeartMate 3 left ventricular assist device (LVAD) markedly reduced the need for more surgery and reduced strokes in patients with advanced heart failure at two years after implantation, according to results of the MOMENTUM 3 trial presented by Mandeep R. Mehra, MD, FACC, on Sunday, March 11 in a Late-Breaking Clinical Trial session at ACC.18 in Orlando, FL. The study was simultaneously published in the New England Journal of Medicine.
HeartMate 3 is the first fully implantable heart pump that uses magnetic levitation technology and has wide blood-flow passages to reduce shear stress, is frictionless with no mechanical bearings and produces an intrinsic pulse to reduce stasis and avert thrombosis. The MOMENTUM 3 study was conducted to ascertain over the long-term whether the HeartMate 3 could optimally support patients who wait for extended periods or are ineligible for heart transplantation.
A total of 1,028 patients with NYHA IIIB or IV heart failure at 69 centers in the U.S. were randomized to surgical implantation with either a HeartMate 3 or HeartMate II LVAD, a mechanical bearing axial continuous-flow blood pump. The primary endpoint was two-year survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.
Six-month outcomes for 294 patients were reported in November 2016. The current study reports outcomes for 366 patients (HeartMate 3, n=190; Heart Mate II, n=176) who completed two years of follow-up. The primary endpoint in the intention-to-treat analysis was achieved by significantly more patients with HeartMate 3 compared with those with HeartMate II (79.5 vs. 60.2 percent). Survival was 82.8 percent with HeartMate 3 versus 76.2 percent with HeartMate II (non significant).
Freedom from reoperation was achieved by significantly more patients with HeartMate 3 than with HeartMate II (98.4 vs. 83.0 percent). None of the HeartMate 3 patients had pump thrombosis requiring reoperation, but this was required in 12.2 percent of HeartMate II patients. Freedom from disabling strokes was similar in both groups (92.8 vs. 92.5 percent), but significantly more patients with HeartMate 3 versus HeartMate II were free of any stroke (89.9 vs. 80.8 percent).
“All of the benefit seen with the HeartMate 3 was in reducing the rate of nondisabling strokes,” Mehra said. “Disabling stroke was a low-frequency event—occurring in 5 to 7 percent of all patients in the trial. The overall stroke rate at two years is the lowest recorded to date in an LVAD trial.”
Keywords: ACC18, ACC Annual Scientific Session, Reoperation, Quality of Life, Heart Failure, Stroke, Hemodynamics, Dyspnea, Exercise, Heart-Assist Devices
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