Heart pump trial points to better overall survival, fewer adverse events
For patients with advanced-stage heart failure, the new HeartMate 3 centrifugal-flow left ventricular assist device (LVAD) proved superior to the axial-flow HeartMate II, which was previously considered the gold standard in LVAD therapy. Both pumps are made by Abbott.
The MOMENTUM 3 trial, presented as a late-breaking session at the American College of Cardiology Scientific Session and published simultaneously in the New England Journal of Medicine, confirmed certain benefits of HeartMate 3.
“HeartMate 3 has significantly improved the performance of LVAD therapy,” said cardiologist Nir Uriel, MD, professor of medicine at the University of Chicago and a co-author of the study. “This trial demonstrated that the new pump produced better outcomes than its predecessor.”
“MOMENTUM 3 is an important step forward for patients living with advanced heart failure,” Uriel added. “The study results will allow for wider use of the technology thanks to a significantly improved adverse event profile.”
Advantages to HeartMate 3 include less need for pump replacement, less risk of pump thrombosis or bleeding, fewer disabling strokes and fewer days spent in the hospital. Both patient groups, those who received either Heartmate II or 3, improved their performance in a six-minute walk test. There were no significant differences in quality-of-life measures.
The study authors calculated that “for every 10 patients who received the centrifugal-low pump rather than the axial-flow pump, 2.2 pump-thrombosis events, 2 strokes, and 6.8 bleeding events (3.6 gastrointestinal bleeds) were averted over a two-year period.”
The authors caution, however, that a “significant residual risk of bleeding persists.” They suggest that physicians investigate “whether a reduction in the exposure of patients with these pumps to antiplatelet or anticoagulation therapy would be beneficial.”
The study enrolled 1,028 patients: 516 in the centrifugal-flow pump group and 512 in the axial-pump flow group. Seventy-seven percent of the centrifugal-flow group, compared to 65 percent in the axial-flow group, were alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at two years.
“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 the study’s lead author, Mandeep Mehra, MD, medical director of Brigham and Women’s Hospital Heart and Vascular Center in Boston.
The data are exciting, he said, 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.”
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