Two-year outcomes with a magnetically levitated cardiac pump in heart failure

M. R. Mehra, Daniel J. Goldstein, N. Uriel, J. C. Cleveland, M. Yuzefpolskaya, C. Salerno, M. N. Walsh, C. A. Milano, C. B. Patel, G. A. Ewald, A. Itoh, D. Dean, A. Krishnamoorthy, W. G. Cotts, A. J. Tatooles, Ulrich P. Jorde, B. A. Bruckner, J. D. Estep, V. Jeevanandam, G. Sayer & 8 others D. Horstmanshof, J. W. Long, S. Gulati, E. R. Skipper, J. B. O'Connell, G. Heatley, P. Sood, Y. Naka

Research output: Contribution to journalArticle

150 Citations (Scopus)

Abstract

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.)

Original languageEnglish (US)
Pages (from-to)1386-1395
Number of pages10
JournalNew England Journal of Medicine
Volume378
Issue number15
DOIs
StatePublished - Apr 12 2018
Externally publishedYes

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Heart Failure
Stroke
Reoperation
Confidence Intervals
Survival
Equipment and Supplies
Transplantation
Mortality
Population

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Mehra, M. R., Goldstein, D. J., Uriel, N., Cleveland, J. C., Yuzefpolskaya, M., Salerno, C., ... Naka, Y. (2018). Two-year outcomes with a magnetically levitated cardiac pump in heart failure. New England Journal of Medicine, 378(15), 1386-1395. https://doi.org/10.1056/NEJMoa1800866

Two-year outcomes with a magnetically levitated cardiac pump in heart failure. / Mehra, M. R.; Goldstein, Daniel J.; Uriel, N.; Cleveland, J. C.; Yuzefpolskaya, M.; Salerno, C.; Walsh, M. N.; Milano, C. A.; Patel, C. B.; Ewald, G. A.; Itoh, A.; Dean, D.; Krishnamoorthy, A.; Cotts, W. G.; Tatooles, A. J.; Jorde, Ulrich P.; Bruckner, B. A.; Estep, J. D.; Jeevanandam, V.; Sayer, G.; Horstmanshof, D.; Long, J. W.; Gulati, S.; Skipper, E. R.; O'Connell, J. B.; Heatley, G.; Sood, P.; Naka, Y.

In: New England Journal of Medicine, Vol. 378, No. 15, 12.04.2018, p. 1386-1395.

Research output: Contribution to journalArticle

Mehra, MR, Goldstein, DJ, Uriel, N, Cleveland, JC, Yuzefpolskaya, M, Salerno, C, Walsh, MN, Milano, CA, Patel, CB, Ewald, GA, Itoh, A, Dean, D, Krishnamoorthy, A, Cotts, WG, Tatooles, AJ, Jorde, UP, Bruckner, BA, Estep, JD, Jeevanandam, V, Sayer, G, Horstmanshof, D, Long, JW, Gulati, S, Skipper, ER, O'Connell, JB, Heatley, G, Sood, P & Naka, Y 2018, 'Two-year outcomes with a magnetically levitated cardiac pump in heart failure', New England Journal of Medicine, vol. 378, no. 15, pp. 1386-1395. https://doi.org/10.1056/NEJMoa1800866
Mehra, M. R. ; Goldstein, Daniel J. ; Uriel, N. ; Cleveland, J. C. ; Yuzefpolskaya, M. ; Salerno, C. ; Walsh, M. N. ; Milano, C. A. ; Patel, C. B. ; Ewald, G. A. ; Itoh, A. ; Dean, D. ; Krishnamoorthy, A. ; Cotts, W. G. ; Tatooles, A. J. ; Jorde, Ulrich P. ; Bruckner, B. A. ; Estep, J. D. ; Jeevanandam, V. ; Sayer, G. ; Horstmanshof, D. ; Long, J. W. ; Gulati, S. ; Skipper, E. R. ; O'Connell, J. B. ; Heatley, G. ; Sood, P. ; Naka, Y. / Two-year outcomes with a magnetically levitated cardiac pump in heart failure. In: New England Journal of Medicine. 2018 ; Vol. 378, No. 15. pp. 1386-1395.
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abstract = "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.)",
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TY - JOUR

T1 - Two-year outcomes with a magnetically levitated cardiac pump in heart failure

AU - Mehra, M. R.

AU - Goldstein, Daniel 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, Ulrich 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.

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.)

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