A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure

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

来源：New England Journal of Medicine, 2017, 376(5): 440-450.

DOI：10.1056/NEJMoa1610426

• VENTRICULAR ASSIST DEVICE
• THROMBOSIS
• SUPPORT
• MULTICENTER
• DIAGNOSIS
• PROTOCOL
• OUTCOMES
• THERAPY
• TRIAL

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.

• 出版日期2017-2-2