The HeartMate 3 left ventricular assist system may be safe and effective, according to the results of the MOMENTUM 3 Trial presented Nov. 16 during AHA 2016 and simultaneously published in the New England Journal of Medicine.

Mandeep R. Mehra, MD, FACC, et al., evaluated the safety and comparative effectiveness of the HeartMate 3 left ventricular assist system to the HeartMate II system in a prospective randomized, controlled trial of advanced heart failure (HF) patients. Patients were randomized to receive HeartMate 3 or the HeartMate II irrespective of the intended use as either bridge to transplantation or destination therapy – those ineligible for a transplant. The primary endpoint of the analysis evaluated if HeartMate 3 worked as well as or better than (non-inferior) HeartMate II in terms of survival free of debilitating stroke or reoperation to replace or remove the pump.

The results of the trial show that the HeartMate 3 provides incremental improvement in clinical outcomes due to reduction in the rate of reoperation for pump malfunction without an apparent difference in other adverse events.

The researchers also found no significant between-group differences in the rates of death or disabling stroke but reoperation for pump malfunction was less frequent in the Heartmate 3 group than the HeartMate II group.

Keywords: AHA16, American Heart Association, AHA Annual Scientific Sessions, Heart-Assist Devices, Heart Failure, Cardiac Surgical Procedures, Stroke

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