A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report.
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.).
Mehra, MR; Uriel, N; Naka, Y; Cleveland, JC; Yuzefpolskaya, M; Salerno, CT; Walsh, MN; Milano, CA; Patel, CB; Hutchins, SW; Ransom, J; Ewald, GA; Itoh, A; Raval, NY; Silvestry, SC; Cogswell, R; John, R; Bhimaraj, A; Bruckner, BA; Lowes, BD; Um, JY; Jeevanandam, V; Sayer, G; Mangi, AA; Molina, EJ; Sheikh, F; Aaronson, K; Pagani, FD; Cotts, WG; Tatooles, AJ; Babu, A; Chomsky, D; Katz, JN; Tessmann, PB; Dean, D; Krishnamoorthy, A; Chuang, J; Topuria, I; Sood, P; Goldstein, DJ; MOMENTUM 3 Investigators,
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