A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report

TLDR

Patients with advanced heart failure receiving a fully magnetically levitated centrifugal‑flow left ventricular assist device experienced lower rates of pump thrombosis and disabling stroke than those receiving a mechanical‑bearing axial‑flow device. In a randomized trial of 1,028 patients, the primary endpoint was 2‑year survival free of disabling stroke or reoperation to replace or remove a malfunctioning device, with a secondary endpoint of pump replacement at 2 years. The magnetically levitated device achieved 76.9% versus 64.8% of patients alive and free of disabling stroke or reoperation at 2 years (RR 0.84, 95% CI 0.78–0.91, P < 0.001) and required pump replacement in only 2.3% versus 11.3% of patients (RR 0.21, 95% CI 0.11–0.38, P < 0.001), with lower event rates for stroke, major bleeding, and gastrointestinal hemorrhage. Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov NCT02224755.

Abstract

In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device.We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years.This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group.Among patients with advanced heart failure, a fully magnetically levitated centrifugal-flow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).