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ORLANDO -- The HeartMate 3 advantage appears durable to 2 years, with still no pump thrombosis requiring reoperation and fewer replacements or disabling strokes compared with the prior-generation device, the MOMENTUM 3 trial showed.
The primary composite endpoint of survival at 2 years free of disabling stroke (modified Rankin score of >3) and of reoperation to replace or remove a malfunctioning device came out 79.5% in the centrifugal-flow HeartMate 3 pump compared with 60.2% in the axial-flow HeartMate II pump group, which was significant both for noninferiority and for superiority with a hazard ratio of 0.46.
The trial previously showed similarly superior results at 6 months with the newer device, approved for bridge-to-transplant or bridge to myocardial recovery in 2017 but not yet for destination therapy.
Now, the 2-year findings affirm "durability of the HeartMate 3 LVAS [left ventricular assist system] to optimally support patients who wait for extended periods for heart transplantation or are ineligible for heart transplantation," reported Joseph Cleveland, Jr., MD, of the University of Colorado at Aurora, at the American College of Cardiology (ACC) annual meeting.
The findings were simultaneously published in the .
Again, the advantage of the newer device was driven by less reoperation for pump malfunction (1.6% vs 17.0%, HR 0.08, P<0.001). While two HeartMate 3 recipients did have suspected or confirmed pump thrombosis, none required operation.
These results set a "new standard for pump failure rate in this field," said ACC session discussant Robert Guyton, MD, of Emory University in Atlanta.
Disclosures
The study was sponsored by Abbott, which provided the devices and consulted on the trial protocol.
Mehra disclosed relevant relationships with Abbott (previously St. Jude Medical), Medtronic, Janssen (Johnson & Johnson), Mesoblast, Portola, NuPulseCV, and Bayer.
Cleveland disclosed relevant relationships with Abbott.
Januzzi disclosed relevant relationships with Abbott Laboratories, Critical Diagnostics, Phillips, and Roche Diagnostics, AbbVie, Amgen, Boehringer Ingelheim, Janssen, and Siemens, as well as support from Cleveland Heart Labs, Novartis, Prevencio, and Singulex.
Primary Source
New England Journal of Medicine
Mehra M, et al "Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure" New Engl J Med 2018 DOI:10.1056/NEJMoa1800866.