A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure
- PMID: 27959709
- DOI: 10.1056/NEJMoa1610426
A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure
Abstract
Background: 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.
Methods: 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).
Results: 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.
Conclusions: 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 .).
Comment in
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Heart failure: New centrifugal-flow pump for advanced heart failure.Nat Rev Cardiol. 2017 Jan;14(1):1. doi: 10.1038/nrcardio.2016.199. Epub 2016 Dec 1. Nat Rev Cardiol. 2017. PMID: 27905480 No abstract available.
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Mechanical Circulatory Support Devices - In Progress.N Engl J Med. 2017 Feb 2;376(5):487-489. doi: 10.1056/NEJMe1613755. N Engl J Med. 2017. PMID: 28146667 No abstract available.
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HeartMate 3-a "Step" in the right direction.J Thorac Dis. 2017 May;9(5):E457-E460. doi: 10.21037/jtd.2017.04.39. J Thorac Dis. 2017. PMID: 28616308 Free PMC article. No abstract available.
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The evolution of left ventricular assist devices-a moment to reflect.J Thorac Dis. 2017 May;9(5):E492-E494. doi: 10.21037/jtd.2017.03.72. J Thorac Dis. 2017. PMID: 28616319 Free PMC article. No abstract available.
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Novel centrifugal pump for heart failure patients: initial success and future challenges.J Thorac Dis. 2017 Jun;9(6):1429-1431. doi: 10.21037/jtd.2017.05.68. J Thorac Dis. 2017. PMID: 28740649 Free PMC article. No abstract available.
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