MedStar Authors catalog › Details for: A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report.
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A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report.

by Molina, Ezequiel J; Sheikh, Farooq.
Citation: New England Journal of Medicine. 380(17):1618-1627, 2019 04 25..Journal: The New England journal of medicine.Published: ; 2019ISSN: 0028-4793.Full author list: Mehra MR; Uriel N; Naka Y; Cleveland JC Jr; 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; the MOMENTUM 3 Investigators.UI/PMID: 30883052.Subject(s): Adolescent | Adult | Aged | Aged, 80 and over | Disease-Free Survival | Female | *Heart Failure/th [Therapy] | Heart-Assist Devices/ae [Adverse Effects] | *Heart-Assist Devices | Humans | Intention to Treat Analysis | Kaplan-Meier Estimate | Male | Middle Aged | *Prosthesis Design | Prosthesis Failure | Reoperation/sn [Statistics & Numerical Data] | Stroke/et [Etiology]Institution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Equivalence Trial | Journal Article | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tOnline resources: Click here to access online Digital Object Identifier: https://dx.doi.org/10.1056/NEJMoa1900486 (Click here) Abbreviated citation: N Engl J Med. 380(17):1618-1627, 2019 04 25.Local Holdings: Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - present.Abstract: 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.Abstract: 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.Abstract: 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.Abstract: 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.).Abstract: Copyright (c) 2019 Massachusetts Medical Society.

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