A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report.
A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report.
- 2019
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.
English
0028-4793
10.1056/NEJMoa1900486 [doi]
*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]
MedStar Heart & Vascular Institute
Equivalence Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
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.
English
0028-4793
10.1056/NEJMoa1900486 [doi]
*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]
MedStar Heart & Vascular Institute
Equivalence Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't