A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report.

MedStar author(s):
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
Name of journal: The New England journal of medicineAbstract: 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.All authors: Aaronson K, Babu A, Bhimaraj A, Bruckner BA, Chomsky D, Chuang J, Cleveland JC Jr, Cogswell R, Cotts WG, Dean D, Ewald GA, Goldstein DJ, Hutchins SW, Itoh A, Jeevanandam V, John R, Katz JN, Krishnamoorthy A, Lowes BD, Mangi AA, Mehra MR, Milano CA, Molina EJ, MOMENTUM 3 Investigators, Naka Y, Pagani FD, Patel CB, Ransom J, Raval NY, Salerno CT, Sayer G, Sheikh F, Silvestry SC, Sood P, Tatooles AJ, Tessmann PB, the MOMENTUM 3 Investigators, Topuria I, Um JY, Uriel N, Walsh MN, Yuzefpolskaya MFiscal year: FY2019Digital Object Identifier: Date added to catalog: 2019-05-21
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Item type Current library Collection Call number Status Date due Barcode
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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