A fully magnetically levitated circulatory pump for advanced heart failure

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

Research output: Contribution to journalArticle

294 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)440-450
Number of pages11
JournalNew England Journal of Medicine
Volume376
Issue number5
DOIs
StatePublished - Feb 2 2017

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

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Mehra, M. R., Naka, Y., Uriel, N., Goldstein, D. J., Cleveland, J. C., Colombo, P. C., ... Salerno, C. (2017). A fully magnetically levitated circulatory pump for advanced heart failure. New England Journal of Medicine, 376(5), 440-450. https://doi.org/10.1056/NEJMoa1610426

A fully magnetically levitated circulatory pump for advanced heart failure. / Mehra, Mandeep R.; Naka, Yoshifumi; Uriel, Nir; Goldstein, Daniel J.; Cleveland, Joseph C.; 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.

In: New England Journal of Medicine, Vol. 376, No. 5, 02.02.2017, p. 440-450.

Research output: Contribution to journalArticle

Mehra, MR, Naka, Y, Uriel, N, Goldstein, DJ, Cleveland, JC, Colombo, PC, Walsh, MN, Milano, CA, Patel, CB, Jorde, UP, Pagani, FD, Aaronson, KD, Dean, DA, McCants, K, Itoh, A, Ewald, GA, Horstmanshof, D, Long, JW & Salerno, C 2017, 'A fully magnetically levitated circulatory pump for advanced heart failure', New England Journal of Medicine, vol. 376, no. 5, pp. 440-450. https://doi.org/10.1056/NEJMoa1610426
Mehra, Mandeep R. ; Naka, Yoshifumi ; Uriel, Nir ; Goldstein, Daniel J. ; Cleveland, Joseph C. ; 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. / A fully magnetically levitated circulatory pump for advanced heart failure. In: New England Journal of Medicine. 2017 ; Vol. 376, No. 5. pp. 440-450.
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abstract = "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.",
author = "Mehra, {Mandeep R.} and Yoshifumi Naka and Nir Uriel and Goldstein, {Daniel J.} and Cleveland, {Joseph C.} and Colombo, {Paolo C.} and Walsh, {Mary N.} and Milano, {Carmelo A.} and Patel, {Chetan B.} and Jorde, {Ulrich P.} and Pagani, {Francis D.} and Aaronson, {Keith D.} and Dean, {David A.} and Kelly McCants and Akinobu Itoh and Ewald, {Gregory A.} and Douglas Horstmanshof and Long, {James W.} and Christopher Salerno",
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T1 - A fully magnetically levitated circulatory pump for advanced heart failure

AU - Mehra, Mandeep R.

AU - Naka, Yoshifumi

AU - Uriel, Nir

AU - Goldstein, Daniel J.

AU - Cleveland, Joseph C.

AU - Colombo, Paolo C.

AU - Walsh, Mary N.

AU - Milano, Carmelo A.

AU - Patel, Chetan B.

AU - Jorde, Ulrich P.

AU - Pagani, Francis D.

AU - Aaronson, Keith D.

AU - Dean, David A.

AU - McCants, Kelly

AU - Itoh, Akinobu

AU - Ewald, Gregory A.

AU - Horstmanshof, Douglas

AU - Long, James W.

AU - Salerno, Christopher

PY - 2017/2/2

Y1 - 2017/2/2

N2 - 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.

AB - 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.

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