TY - JOUR
T1 - Two-year outcomes with a magnetically levitated cardiac pump in heart failure
AU - Mehra, M. R.
AU - Goldstein, D. J.
AU - Uriel, N.
AU - Cleveland, J. C.
AU - Yuzefpolskaya, M.
AU - Salerno, C.
AU - Walsh, M. N.
AU - Milano, C. A.
AU - Patel, C. B.
AU - Ewald, G. A.
AU - Itoh, A.
AU - Dean, D.
AU - Krishnamoorthy, A.
AU - Cotts, W. G.
AU - Tatooles, A. J.
AU - Jorde, U. P.
AU - Bruckner, B. A.
AU - Estep, J. D.
AU - Jeevanandam, V.
AU - Sayer, G.
AU - Horstmanshof, D.
AU - Long, J. W.
AU - Gulati, S.
AU - Skipper, E. R.
AU - O'Connell, J. B.
AU - Heatley, G.
AU - Sood, P.
AU - Naka, Y.
N1 - Publisher Copyright:
Copyright © 2018 Massachusetts Medical Society.
PY - 2018/4/12
Y1 - 2018/4/12
N2 - 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-f low 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-f low 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.)
AB - 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-f low 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-f low 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.)
UR - http://www.scopus.com/inward/record.url?scp=85045467883&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa1800866
DO - 10.1056/NEJMoa1800866
M3 - Article
C2 - 29526139
AN - SCOPUS:85045467883
SN - 0028-4793
VL - 378
SP - 1386
EP - 1395
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 15
ER -