Durable left ventricular assist devices (LVADs) have demonstrated improved survival rates in patients with advanced heart failure (HF) compared with those of pharmacological therapy.¹ Sequential design improvements with each generation have led to the development of the HeartMate 3 (Abbott Laboratories, Abbott Park, Illinois) LVAD, which is a fully magnetically levitated centrifugal pump that provides frictionless, wide blood-flow passages and intrinsic pulsatility.² The MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3) compared outcomes of patients with HF randomized to the HeartMate 3 LVAD versus an axial-flow LVAD (HeartMate II [Abbott Laboratories, Abbott Park, Illinois]). At 2 years, the HeartMate 3 LVAD demonstrated an improved survival rate free of disabling stroke or pump exchange, lower risk of gastrointestinal tract bleeding, and 92% reduction in LVAD thrombosis. The overall patient survival rate was similar between the two groups (81% vs. 80%).³

These findings resulted in Food and Drug Administration (FDA) approval of the HeartMate 3 for destination therapy in 2018, conditional on an extended evaluation to 5 years of follow-up. The composite of 5-year survival to transplantation, recovery, or LVAD support free of debilitating stroke or reoperation for pump replacement occurred in 65% in the HeartMate 3 group versus 48% in the HeartMate II group (p < 0.001). The Kaplan-Meier overall survival rate at 5 years was significantly higher in the HeartMate 3 group as well: 58% versus 49% (p = 0.003). Hemocompatibility-related adverse events were significantly lower with the HeartMate 3 LVAD: device thrombosis, 0.01 versus 0.108 events/patient-years; stroke, 0.05 versus 0.136 events/patient-years; and bleeding, 0.43 versus 0.765 events/patient-years. Infection, cardiac arrhythmias, and right ventricular failure rates were similar between the two LVADs.⁴

This 5-year follow-up of the MOMENTUM 3 confirmed better composite outcomes and higher likelihood of survival with the HeartMate 3 LVAD than with the previous-generation LVAD. The time may come when the survival with LVAD support is comparable to that seen with heart transplantation.

References

1. Rose EA, Gelijns AC, Moskowitz AJ, et al.; Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med 2001;345:1435-43.
2. Sidhu K, Lam PH, Mehra MR. Evolving trends in mechanical circulatory support: clinical development of a fully magnetically levitated durable ventricular assist device. Trends Cardiovasc Med 2020;30:223-9.
3. Mehra MR, Uriel N, Naka Y, et al.; MOMENTUM 3 Investigators. A fully magnetically levitated left ventricular assist device - final report. N Engl J Med 2019;380:1618-27.
4. Mehra MR, Goldstein DJ, Cleveland JC, et al. Five-year outcomes in patients with fully magnetically levitated vs axial-flow left ventricular assist devices in the MOMENTUM 3 randomized trial. JAMA 2022;328:1233-42.

Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure

Keywords: ESC Congress, ESC22, Heart Failure, Reoperation, United States Food and Drug Administration, Follow-Up Studies, Thrombosis, Arrhythmias, Cardiac, Laboratories

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