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A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure.
- Source :
-
New England Journal of Medicine . 2/2/2017, Vol. 376 Issue 5, p440-450. 11p. - Publication Year :
- 2017
-
Abstract
- <bold>Background: </bold>Continuous-flow left ventricular assist systems increase the rate of survival among patients with advanced heart failure but are associated with the development of pump thrombosis. We investigated the effects of a new magnetically levitated centrifugal continuous-flow pump that was engineered to avert thrombosis.<bold>Methods: </bold>We randomly assigned patients with advanced heart failure to receive either the new centrifugal continuous-flow pump or a commercially available axial continuous-flow pump. Patients could be enrolled irrespective of the intended goal of pump support (bridge to transplantation or destination therapy). The primary end point was a composite of survival free of disabling stroke (with disabling stroke indicated by a modified Rankin score >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove the device at 6 months after implantation. The trial was powered for noninferiority testing of the primary end point (noninferiority margin, -10 percentage points).<bold>Results: </bold>Of 294 patients, 152 were assigned to the centrifugal-flow pump group and 142 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 131 patients (86.2%) in the centrifugal-flow pump group and in 109 (76.8%) in the axial-flow pump group (absolute difference, 9.4 percentage points; 95% lower confidence boundary, -2.1 [P<0.001 for noninferiority]; hazard ratio, 0.55; 95% confidence interval [CI], 0.32 to 0.95 [two-tailed P=0.04 for superiority]). There were no significant between-group differences in the rates of death or disabling stroke, but reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (1 [0.7%] vs. 11 [7.7%]; hazard ratio, 0.08; 95% CI, 0.01 to 0.60; P=0.002). Suspected or confirmed pump thrombosis occurred in no patients in the centrifugal-flow pump group and in 14 patients (10.1%) in the axial-flow pump group.<bold>Conclusions: </bold>Among patients with advanced heart failure, implantation of a fully magnetically levitated centrifugal-flow pump was associated with better outcomes at 6 months than was implantation of an axial-flow pump, primarily because of the lower rate of reoperation for pump malfunction. (Funded by St. Jude Medical; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755 .). [ABSTRACT FROM AUTHOR]
- Subjects :
- *HEART failure
*CARDIOVASCULAR system abnormalities
*HEART assist devices
*VENTRICULAR outflow obstruction
*HEART diseases
*HEART failure treatment
*CLINICAL trials
*COMPARATIVE studies
*RESEARCH methodology
*MEDICAL cooperation
*PROGNOSIS
*PROSTHETICS
*COMPLICATIONS of prosthesis
*RESEARCH
*STROKE
*THROMBOSIS
*EVALUATION research
*RANDOMIZED controlled trials
*KAPLAN-Meier estimator
Subjects
Details
- Language :
- English
- ISSN :
- 00284793
- Volume :
- 376
- Issue :
- 5
- Database :
- Academic Search Index
- Journal :
- New England Journal of Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 121060802
- Full Text :
- https://doi.org/10.1056/NEJMoa1610426