A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure

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.).

Medienart:	Artikel

Erscheinungsjahr:	2017
Erschienen:	2017

Enthalten in:	Zur Gesamtaufnahme - volume:376
Enthalten in:	The New England journal of medicine - 376(2017), 5, Seite 440

Sprache:	Englisch

Beteiligte Personen:

Mandeep R Mehra [VerfasserIn] Yoshifumi Naka [Sonstige Person] Nir Uriel [Sonstige Person] Daniel J Goldstein [Sonstige Person] Joseph C Cleveland Jr [Sonstige Person] Paolo C Colombo [Sonstige Person] Mary N Walsh [Sonstige Person] Carmelo A Milano [Sonstige Person] Chetan B Patel [Sonstige Person] Ulrich P Jorde [Sonstige Person] Francis D Pagani [Sonstige Person] Keith D Aaronson [Sonstige Person] David A Dean [Sonstige Person] Kelly McCants [Sonstige Person] Akinobu Itoh [Sonstige Person] Gregory A Ewald [Sonstige Person] Douglas Horstmanshof [Sonstige Person] James W Long [Sonstige Person] Christopher Salerno [Sonstige Person]

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PPN (Katalog-ID):	OLC1991145330