Two Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure
Background In an early analysis of this trial, use of a magnetically levitated centrifugal continuous flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical bearing axial continuous flow pump, at 6 months in patients with advanced heart failure. Methods In a randomized noninferiority and superiority trial, we compared the centrifugal flow pump with the axial flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy) The composite primary end point was survival at 2 years free of disabling stroke (with disabling stroke indicated by a modified Rankin score of >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove a malfunctioning device. The noninferiority margin for the risk difference (centrifugal flow pump group minus axial flow pump group) was 10 percentage points. Results Of 366 patients, 190 were assigned to the centrifugal flow pump group and 176 to the axial flow pump group. In the intention to treat population, the primary end point occurred in 151 patients (79.5% in the centrifugal flow pump group, as compared with 106 (60.2% in the axial flow pump group (absolute difference, 19.2 percentage points; 95% lower confidence boundary, 9.8 percentage points [P<0.001 for noninferiority] hazard ratio, 0.46; 95% confidence interval [CI] 0.31 to 0.69 [P<0.001 for superiority] Reoperation for pump malfunction was less frequent in the centrifugal flow pump group than in the axial flow pump group (3 patients [1.6% vs. 30 patients [17.0% hazard ratio, 0.08; 95% CI, 0.03 to 0.27; P<0.001) The rates of death and disabling stroke were similar in the two groups, but the overall rate of stroke was lower in the centrifugal flow pump group than in the axial flow pump group (10.1% vs. 19.2% hazard ratio, 0.47; 95% CI, 0.27 to 0.84, P=0.02) Conclusions In patients with advanced heart failure, a fully magnetically levitated centrifugal flow pump was superior to a mechanical bearing axial flow pump with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.
The New England journal of medicine