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; 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; D. J. Goldstein

doi:10.1056/NEJMoa1900486

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. LowesJ. 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, D. J. Goldstein

Research output: Contribution to journal › Article › peer-review

735 Scopus citations

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 centrifugal-flow 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. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).

Original language	English (US)
Pages (from-to)	1618-1627
Number of pages	10
Journal	New England Journal of Medicine
Volume	380
Issue number	17
DOIs	https://doi.org/10.1056/NEJMoa1900486
State	Published - Apr 25 2019

Bibliographical note

Publisher Copyright:
© 2019 Massachusetts Medical Society.

Keywords

Adolescent
Adult
Aged
Aged, 80 and over
Disease-Free Survival
Female
Heart Failure/therapy
Heart-Assist Devices/adverse effects
Humans
Intention to Treat Analysis
Kaplan-Meier Estimate
Male
Middle Aged
Prosthesis Design
Prosthesis Failure
Reoperation/statistics & numerical data
Stroke/etiology

PubMed: MeSH publication types

Equivalence Trial
Research Support, Non-U.S. Gov't
Randomized Controlled Trial
Journal Article

Publisher link

10.1056/NEJMoa1900486

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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., ... 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

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

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title = "A fully magnetically levitated left ventricular assist device - Final report",

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 centrifugal-flow 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. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).",

keywords = "Adolescent, Adult, Aged, Aged, 80 and over, Disease-Free Survival, Female, Heart Failure/therapy, Heart-Assist Devices/adverse effects, Humans, Intention to Treat Analysis, Kaplan-Meier Estimate, Male, Middle Aged, Prosthesis Design, Prosthesis Failure, Reoperation/statistics & numerical data, Stroke/etiology",

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, {D. J.}",

note = "Publisher Copyright: {\textcopyright} 2019 Massachusetts Medical Society.",

year = "2019",

month = apr,

day = "25",

doi = "10.1056/NEJMoa1900486",

language = "English (US)",

volume = "380",

pages = "1618--1627",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

number = "17",

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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, D. 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 centrifugal-flow 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. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).

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 centrifugal-flow 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. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).

KW - Adolescent

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Disease-Free Survival

KW - Female

KW - Heart Failure/therapy

KW - Heart-Assist Devices/adverse effects

KW - Humans

KW - Intention to Treat Analysis

KW - Kaplan-Meier Estimate

KW - Male

KW - Middle Aged

KW - Prosthesis Design

KW - Prosthesis Failure

KW - Reoperation/statistics & numerical data

KW - Stroke/etiology

UR - http://www.scopus.com/inward/record.url?scp=85063625597&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85063625597&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1900486

DO - 10.1056/NEJMoa1900486

M3 - Article

C2 - 30883052

AN - SCOPUS:85063625597

SN - 0028-4793

VL - 380

SP - 1618

EP - 1627

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 17

ER -

A fully magnetically levitated left ventricular assist device - Final report

Abstract

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Keywords

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