A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report.
Citation: New England Journal of Medicine. 380(17):1618-1627, 2019 04 25.PMID: 30883052Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Equivalence Trial | Journal Article | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Heart Failure/th [Therapy] | *Heart-Assist Devices | *Prosthesis Design | Adolescent | Adult | Aged | Aged, 80 and over | Disease-Free Survival | Female | Heart-Assist Devices/ae [Adverse Effects] | Humans | Intention to Treat Analysis | Kaplan-Meier Estimate | Male | Middle Aged | Prosthesis Failure | Reoperation/sn [Statistics & Numerical Data] | Stroke/et [Etiology]Year: 2019Local holdings: Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - presentISSN:- 0028-4793
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
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Journal Article | MedStar Authors Catalog | Article | 30883052 | Available | 30883052 |
Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - present
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.
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.).
Copyright (c) 2019 Massachusetts Medical Society.
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.
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