TY  - BOOK
AU  - Molina, Ezequiel J
AU  - Sheikh, Farooq
TI  - A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report
SN  - 0028-4793
PY  - 2019///
KW  - *Heart Failure/th [Therapy]
KW  - *Heart-Assist Devices
KW  - *Prosthesis Design
KW  - Adolescent
KW  - Adult
KW  - Aged
KW  - Aged, 80 and over
KW  - Disease-Free Survival
KW  - Female
KW  - Heart-Assist Devices/ae [Adverse Effects]
KW  - Humans
KW  - Intention to Treat Analysis
KW  - Kaplan-Meier Estimate
KW  - Male
KW  - Middle Aged
KW  - Prosthesis Failure
KW  - Reoperation/sn [Statistics & Numerical Data]
KW  - Stroke/et [Etiology]
KW  - MedStar Heart & Vascular Institute
KW  - Equivalence Trial
KW  - Journal Article
KW  - Randomized Controlled Trial
KW  - Research Support, Non-U.S. Gov't
N1  - Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - present
N2  - 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
UR  - https://dx.doi.org/10.1056/NEJMoa1900486
ER  -