USA: Patients with advanced heart failure who received a fully magnetically levitated centrifugal-flow LVAD had a better composite outcome and a higher likelihood of overall survival at five years compared to those who received axial-flow LVAD, according to results from a follow-up study of the MOMENTUM 3 trial. The findings of the study got published in the Journal of the American Medical Association (JAMA).
Pharmacological therapy for chronic heart failure has proven beneficial; despite this, some patients exhibit refractoriness to treatment. Patients with refractory heart failure cannot tolerate drug therapy, have worse quality of life, and have a poor prognosis.
Durable left ventricular assist device (LVAD) therapy has emerged as an essential option for treating patients with advanced heart failure refractory to pharmacological support. However, outcomes, including survival beyond two years, remains poorly characterized. Considering this, Mandeep R. Mehra, Brigham and Women’s Hospital, Boston, Massachusetts, and colleagues reported results from the MOMENTUM 3 randomized trial based on an observational follow-up study.
They reported the composite endpoint of survival to transplant, recovery, or LVAD support free of a debilitating stroke, or reoperation for pump replacement five years following implant in patients who received the fully magnetically levitated centrifugal-flow HeartMate 3 or axial-flow HeartMate II LVAD in the MOMENTUM 3 randomized trial and were still receiving LVAD therapy at the 2-year follow-up.
MOMENTUM 3 randomized clinical trial — The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 — showed that the fully magnetically levitated centrifugal-flow LVAD versus the axial-flow pump resulted in better outcomes driven by greater hemocompatibility two years following the implant.
The researchers reported the following findings:
- A total of 477 patients (295 enrolled and 182 provided limited data) of 536 patients still receiving LVAD support at two years contributed to the extended-phase analysis (median age, 62 y; 18% women).
- The 5-year Kaplan-Meier estimate of survival to transplant, recovery or LVAD support free of debilitating stroke or reoperation to replace the pump in the centrifugal-flow vs. axial-flow group was 54.0% vs. 29.7% (hazard ratio, 0.55).
- Overall, Kaplan-Meier survival was 58.4% in the centrifugal-flow group vs. 43.7% in the axial-flow group (hazard ratio, 0.72).
- Serious adverse events of stroke, bleeding, and pump thrombosis were less frequent in the centrifugal-flow pump group.
“Per-protocol analyses found that receipt of a fully magnetically levitated LVAD vs. axial-flow LVAD was associated with a better composite outcome and a higher likelihood of overall survival at five years,” the researchers wrote.
“These findings support the use of the fully magnetically levitated LVAD,” they conclude.
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. Published online September 08, 2022. doi:10.1001/jama.2022.16197