A fully magnetically levitated left ventricular assist device - Final report

M. R. Mehra, N. Uriel, Y. Naka, J. C. Cleveland, M. Yuzefpolskaya, C. T. Salerno, M. N. Walsh, C. A. Milano, C. B. Patel, S. W. Hutchins, J. Ransom, G. A. Ewald, A. Itoh, N. Y. Raval, S. C. Silvestry, R. Cogswell, R. John, A. Bhimaraj, B. A. Bruckner, B. D. Lowes & 20 others J. Y. Um, V. Jeevanandam, G. Sayer, A. A. Mangi, E. J. Molina, F. Sheikh, K. Aaronson, F. D. Pagani, W. G. Cotts, A. J. Tatooles, A. Babu, D. Chomsky, J. N. Katz, P. B. Tessmann, D. Dean, A. Krishnamoorthy, J. Chuang, I. Topuria, P. Sood, Daniel J. Goldstein

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

BACKGROUND In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device. METHODS We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years. RESULTS This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group. CONCLUSIONS Among patients with advanced heart failure, a fully magnetically levitated centrifugalflow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.

Original languageEnglish (US)
Pages (from-to)1618-1627
Number of pages10
JournalNew England Journal of Medicine
Volume380
Issue number17
DOIs
StatePublished - Apr 25 2019

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Heart-Assist Devices
Stroke
Reoperation
Equipment and Supplies
Heart Failure
Confidence Intervals
Gastrointestinal Hemorrhage
Survival
Thrombosis
Transplantation
Hemorrhage

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Mehra, M. R., Uriel, N., Naka, Y., Cleveland, J. C., Yuzefpolskaya, M., Salerno, C. T., ... Goldstein, D. J. (2019). A fully magnetically levitated left ventricular assist device - Final report. New England Journal of Medicine, 380(17), 1618-1627. https://doi.org/10.1056/NEJMoa1900486

A fully magnetically levitated left ventricular assist device - Final report. / Mehra, M. R.; Uriel, N.; Naka, Y.; Cleveland, J. C.; Yuzefpolskaya, M.; Salerno, C. T.; Walsh, M. N.; Milano, C. A.; Patel, C. B.; Hutchins, S. W.; Ransom, J.; Ewald, G. A.; Itoh, A.; Raval, N. Y.; Silvestry, S. C.; Cogswell, R.; John, R.; Bhimaraj, A.; Bruckner, B. A.; Lowes, B. D.; Um, J. Y.; Jeevanandam, V.; Sayer, G.; Mangi, A. A.; Molina, E. J.; Sheikh, F.; Aaronson, K.; Pagani, F. D.; Cotts, W. G.; Tatooles, A. J.; Babu, A.; Chomsky, D.; Katz, J. N.; Tessmann, P. B.; Dean, D.; Krishnamoorthy, A.; Chuang, J.; Topuria, I.; Sood, P.; Goldstein, Daniel J.

In: New England Journal of Medicine, Vol. 380, No. 17, 25.04.2019, p. 1618-1627.

Research output: Contribution to journalArticle

Mehra, MR, Uriel, N, Naka, Y, Cleveland, JC, Yuzefpolskaya, M, Salerno, CT, Walsh, MN, Milano, CA, Patel, CB, Hutchins, SW, Ransom, J, Ewald, GA, Itoh, A, Raval, NY, Silvestry, SC, Cogswell, R, John, R, Bhimaraj, A, Bruckner, BA, Lowes, BD, Um, JY, Jeevanandam, V, Sayer, G, Mangi, AA, Molina, EJ, Sheikh, F, Aaronson, K, Pagani, FD, Cotts, WG, Tatooles, AJ, Babu, A, Chomsky, D, Katz, JN, Tessmann, PB, Dean, D, Krishnamoorthy, A, Chuang, J, Topuria, I, Sood, P & Goldstein, DJ 2019, 'A fully magnetically levitated left ventricular assist device - Final report', New England Journal of Medicine, vol. 380, no. 17, pp. 1618-1627. https://doi.org/10.1056/NEJMoa1900486
Mehra MR, Uriel N, Naka Y, Cleveland JC, Yuzefpolskaya M, Salerno CT et al. A fully magnetically levitated left ventricular assist device - Final report. New England Journal of Medicine. 2019 Apr 25;380(17):1618-1627. https://doi.org/10.1056/NEJMoa1900486
Mehra, M. R. ; Uriel, N. ; Naka, Y. ; Cleveland, J. C. ; Yuzefpolskaya, M. ; Salerno, C. T. ; Walsh, M. N. ; Milano, C. A. ; Patel, C. B. ; Hutchins, S. W. ; Ransom, J. ; Ewald, G. A. ; Itoh, A. ; Raval, N. Y. ; Silvestry, S. C. ; Cogswell, R. ; John, R. ; Bhimaraj, A. ; Bruckner, B. A. ; Lowes, B. D. ; Um, J. Y. ; Jeevanandam, V. ; Sayer, G. ; Mangi, A. A. ; Molina, E. J. ; Sheikh, F. ; Aaronson, K. ; Pagani, F. D. ; Cotts, W. G. ; Tatooles, A. J. ; Babu, A. ; Chomsky, D. ; Katz, J. N. ; Tessmann, P. B. ; Dean, D. ; Krishnamoorthy, A. ; Chuang, J. ; Topuria, I. ; Sood, P. ; Goldstein, Daniel J. / A fully magnetically levitated left ventricular assist device - Final report. In: New England Journal of Medicine. 2019 ; Vol. 380, No. 17. pp. 1618-1627.
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abstract = "BACKGROUND In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device. METHODS We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years. RESULTS This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9{\%}) in the centrifugal-flow pump group, as compared with 332 (64.8{\%}) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95{\%} confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3{\%}] vs. 57 patients [11.3{\%}]; relative risk, 0.21; 95{\%} CI, 0.11 to 0.38; P<0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group. CONCLUSIONS Among patients with advanced heart failure, a fully magnetically levitated centrifugalflow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.",
author = "Mehra, {M. R.} and N. Uriel and Y. Naka and Cleveland, {J. C.} and M. Yuzefpolskaya and Salerno, {C. T.} and Walsh, {M. N.} and Milano, {C. A.} and Patel, {C. B.} and Hutchins, {S. W.} and J. Ransom and Ewald, {G. A.} and A. Itoh and Raval, {N. Y.} and Silvestry, {S. C.} and R. Cogswell and R. John and A. Bhimaraj and Bruckner, {B. A.} and Lowes, {B. D.} and Um, {J. Y.} and V. Jeevanandam and G. Sayer and Mangi, {A. A.} and Molina, {E. J.} and F. Sheikh and K. Aaronson and Pagani, {F. D.} and Cotts, {W. G.} and Tatooles, {A. J.} and A. Babu and D. Chomsky and Katz, {J. N.} and Tessmann, {P. B.} and D. Dean and A. Krishnamoorthy and J. Chuang and I. Topuria and P. Sood and Goldstein, {Daniel J.}",
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TY - JOUR

T1 - A fully magnetically levitated left ventricular assist device - Final report

AU - Mehra, M. R.

AU - Uriel, N.

AU - Naka, Y.

AU - Cleveland, J. C.

AU - Yuzefpolskaya, M.

AU - Salerno, C. T.

AU - Walsh, M. N.

AU - Milano, C. A.

AU - Patel, C. B.

AU - Hutchins, S. W.

AU - Ransom, J.

AU - Ewald, G. A.

AU - Itoh, A.

AU - Raval, N. Y.

AU - Silvestry, S. C.

AU - Cogswell, R.

AU - John, R.

AU - Bhimaraj, A.

AU - Bruckner, B. A.

AU - Lowes, B. D.

AU - Um, J. Y.

AU - Jeevanandam, V.

AU - Sayer, G.

AU - Mangi, A. A.

AU - Molina, E. J.

AU - Sheikh, F.

AU - Aaronson, K.

AU - Pagani, F. D.

AU - Cotts, W. G.

AU - Tatooles, A. J.

AU - Babu, A.

AU - Chomsky, D.

AU - Katz, J. N.

AU - Tessmann, P. B.

AU - Dean, D.

AU - Krishnamoorthy, A.

AU - Chuang, J.

AU - Topuria, I.

AU - Sood, P.

AU - Goldstein, Daniel J.

PY - 2019/4/25

Y1 - 2019/4/25

N2 - BACKGROUND In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device. METHODS We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years. RESULTS This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group. CONCLUSIONS Among patients with advanced heart failure, a fully magnetically levitated centrifugalflow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.

AB - BACKGROUND In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device. METHODS We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years. RESULTS This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group. CONCLUSIONS Among patients with advanced heart failure, a fully magnetically levitated centrifugalflow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.

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DO - 10.1056/NEJMoa1900486

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