Long-term use of a left ventricular assist device for end-stage heart failure

Eric A. Rose, Annetine C. Gelijns, Alan J. Moskowitz, Daniel F. Heitjan, Lynne W. Stevenson, Walter Dembitsky, James W. Long, Deborah D. Ascheim, Anita R. Tierney, Ronald G. Levitan, John T. Watson, Nuala S. Ronan, Peter A. Shapiro, Ronald M. Lazar, Leslie W. Miller, Lopa Gupta, Patrice Desvigne-Nickens, Paul Meier, O. Howard Frazier, Patrice Desvigne-NickensMehmet C. Oz, Victor L. Poirier

Research output: Contribution to journalArticle

2857 Citations (Scopus)

Abstract

Background: Implantable left ventricular assist devices have benefited patients with end-stage heart failure as a bridge to cardiac transplantation, but their long-term use for the purpose of enhancing survival and the quality of life has not been evaluated. Methods: We randomly assigned 129 patients with end-stage heart failure who were ineligible for cardiac transplantation to receive a left ventricular assist device (68 patients) or optimal medical management (61). All patients had symptoms of New York Heart Association class IV heart failure. Results: Kaplan-Meier survival analysis showed a reduction of 48 percent in the risk of death from any cause in the group that received left ventricular assist devices as compared with the medical-therapy group (relative risk, 0.52; 95 percent confidence interval, 0.34 to 0.78; P = 0.001). The rates of survival at one year were 52 percent in the device group and 25 percent in the medical-therapy group (P = 0.002), and the rates at two years were 23 percent and 8 percent (P = 0.09), respectively. The frequency of serious adverse events in the device group was 2.35 (95 percent confidence interval, 1.86 to 2.95) times that in the medical-therapy group, with a predominance of infection, bleeding, and malfunction of the device. The quality of life was significantly improved at one year in the device group. Conclusions: The use of a left ventricular assist device in patients with advanced heart failure resulted in a clinically meaningful survival benefit and an improved quality of life. A left ventricular assist device is an acceptable alternative therapy in selected patients who are not candidates for cardiac transplantation.

Original languageEnglish (US)
Pages (from-to)1435-1443
Number of pages9
JournalNew England Journal of Medicine
Volume345
Issue number20
DOIs
StatePublished - Nov 15 2001

Fingerprint

Heart-Assist Devices
Heart Failure
Heart Transplantation
Group Psychotherapy
Equipment and Supplies
Quality of Life
Confidence Intervals
Survival
Kaplan-Meier Estimate
Survival Analysis
Complementary Therapies
Cause of Death
Survival Rate
Hemorrhage
Infection

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Rose, E. A., Gelijns, A. C., Moskowitz, A. J., Heitjan, D. F., Stevenson, L. W., Dembitsky, W., ... Poirier, V. L. (2001). Long-term use of a left ventricular assist device for end-stage heart failure. New England Journal of Medicine, 345(20), 1435-1443. https://doi.org/10.1056/NEJMoa012175

Long-term use of a left ventricular assist device for end-stage heart failure. / Rose, Eric A.; Gelijns, Annetine C.; Moskowitz, Alan J.; Heitjan, Daniel F.; Stevenson, Lynne W.; Dembitsky, Walter; Long, James W.; Ascheim, Deborah D.; Tierney, Anita R.; Levitan, Ronald G.; Watson, John T.; Ronan, Nuala S.; Shapiro, Peter A.; Lazar, Ronald M.; Miller, Leslie W.; Gupta, Lopa; Desvigne-Nickens, Patrice; Meier, Paul; Howard Frazier, O.; Desvigne-Nickens, Patrice; Oz, Mehmet C.; Poirier, Victor L.

In: New England Journal of Medicine, Vol. 345, No. 20, 15.11.2001, p. 1435-1443.

Research output: Contribution to journalArticle

Rose, EA, Gelijns, AC, Moskowitz, AJ, Heitjan, DF, Stevenson, LW, Dembitsky, W, Long, JW, Ascheim, DD, Tierney, AR, Levitan, RG, Watson, JT, Ronan, NS, Shapiro, PA, Lazar, RM, Miller, LW, Gupta, L, Desvigne-Nickens, P, Meier, P, Howard Frazier, O, Desvigne-Nickens, P, Oz, MC & Poirier, VL 2001, 'Long-term use of a left ventricular assist device for end-stage heart failure', New England Journal of Medicine, vol. 345, no. 20, pp. 1435-1443. https://doi.org/10.1056/NEJMoa012175
Rose, Eric A. ; Gelijns, Annetine C. ; Moskowitz, Alan J. ; Heitjan, Daniel F. ; Stevenson, Lynne W. ; Dembitsky, Walter ; Long, James W. ; Ascheim, Deborah D. ; Tierney, Anita R. ; Levitan, Ronald G. ; Watson, John T. ; Ronan, Nuala S. ; Shapiro, Peter A. ; Lazar, Ronald M. ; Miller, Leslie W. ; Gupta, Lopa ; Desvigne-Nickens, Patrice ; Meier, Paul ; Howard Frazier, O. ; Desvigne-Nickens, Patrice ; Oz, Mehmet C. ; Poirier, Victor L. / Long-term use of a left ventricular assist device for end-stage heart failure. In: New England Journal of Medicine. 2001 ; Vol. 345, No. 20. pp. 1435-1443.
@article{9542affacad14c86b4c0bce74060d4f5,
title = "Long-term use of a left ventricular assist device for end-stage heart failure",
abstract = "Background: Implantable left ventricular assist devices have benefited patients with end-stage heart failure as a bridge to cardiac transplantation, but their long-term use for the purpose of enhancing survival and the quality of life has not been evaluated. Methods: We randomly assigned 129 patients with end-stage heart failure who were ineligible for cardiac transplantation to receive a left ventricular assist device (68 patients) or optimal medical management (61). All patients had symptoms of New York Heart Association class IV heart failure. Results: Kaplan-Meier survival analysis showed a reduction of 48 percent in the risk of death from any cause in the group that received left ventricular assist devices as compared with the medical-therapy group (relative risk, 0.52; 95 percent confidence interval, 0.34 to 0.78; P = 0.001). The rates of survival at one year were 52 percent in the device group and 25 percent in the medical-therapy group (P = 0.002), and the rates at two years were 23 percent and 8 percent (P = 0.09), respectively. The frequency of serious adverse events in the device group was 2.35 (95 percent confidence interval, 1.86 to 2.95) times that in the medical-therapy group, with a predominance of infection, bleeding, and malfunction of the device. The quality of life was significantly improved at one year in the device group. Conclusions: The use of a left ventricular assist device in patients with advanced heart failure resulted in a clinically meaningful survival benefit and an improved quality of life. A left ventricular assist device is an acceptable alternative therapy in selected patients who are not candidates for cardiac transplantation.",
author = "Rose, {Eric A.} and Gelijns, {Annetine C.} and Moskowitz, {Alan J.} and Heitjan, {Daniel F.} and Stevenson, {Lynne W.} and Walter Dembitsky and Long, {James W.} and Ascheim, {Deborah D.} and Tierney, {Anita R.} and Levitan, {Ronald G.} and Watson, {John T.} and Ronan, {Nuala S.} and Shapiro, {Peter A.} and Lazar, {Ronald M.} and Miller, {Leslie W.} and Lopa Gupta and Patrice Desvigne-Nickens and Paul Meier and {Howard Frazier}, O. and Patrice Desvigne-Nickens and Oz, {Mehmet C.} and Poirier, {Victor L.}",
year = "2001",
month = "11",
day = "15",
doi = "10.1056/NEJMoa012175",
language = "English (US)",
volume = "345",
pages = "1435--1443",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "20",

}

TY - JOUR

T1 - Long-term use of a left ventricular assist device for end-stage heart failure

AU - Rose, Eric A.

AU - Gelijns, Annetine C.

AU - Moskowitz, Alan J.

AU - Heitjan, Daniel F.

AU - Stevenson, Lynne W.

AU - Dembitsky, Walter

AU - Long, James W.

AU - Ascheim, Deborah D.

AU - Tierney, Anita R.

AU - Levitan, Ronald G.

AU - Watson, John T.

AU - Ronan, Nuala S.

AU - Shapiro, Peter A.

AU - Lazar, Ronald M.

AU - Miller, Leslie W.

AU - Gupta, Lopa

AU - Desvigne-Nickens, Patrice

AU - Meier, Paul

AU - Howard Frazier, O.

AU - Desvigne-Nickens, Patrice

AU - Oz, Mehmet C.

AU - Poirier, Victor L.

PY - 2001/11/15

Y1 - 2001/11/15

N2 - Background: Implantable left ventricular assist devices have benefited patients with end-stage heart failure as a bridge to cardiac transplantation, but their long-term use for the purpose of enhancing survival and the quality of life has not been evaluated. Methods: We randomly assigned 129 patients with end-stage heart failure who were ineligible for cardiac transplantation to receive a left ventricular assist device (68 patients) or optimal medical management (61). All patients had symptoms of New York Heart Association class IV heart failure. Results: Kaplan-Meier survival analysis showed a reduction of 48 percent in the risk of death from any cause in the group that received left ventricular assist devices as compared with the medical-therapy group (relative risk, 0.52; 95 percent confidence interval, 0.34 to 0.78; P = 0.001). The rates of survival at one year were 52 percent in the device group and 25 percent in the medical-therapy group (P = 0.002), and the rates at two years were 23 percent and 8 percent (P = 0.09), respectively. The frequency of serious adverse events in the device group was 2.35 (95 percent confidence interval, 1.86 to 2.95) times that in the medical-therapy group, with a predominance of infection, bleeding, and malfunction of the device. The quality of life was significantly improved at one year in the device group. Conclusions: The use of a left ventricular assist device in patients with advanced heart failure resulted in a clinically meaningful survival benefit and an improved quality of life. A left ventricular assist device is an acceptable alternative therapy in selected patients who are not candidates for cardiac transplantation.

AB - Background: Implantable left ventricular assist devices have benefited patients with end-stage heart failure as a bridge to cardiac transplantation, but their long-term use for the purpose of enhancing survival and the quality of life has not been evaluated. Methods: We randomly assigned 129 patients with end-stage heart failure who were ineligible for cardiac transplantation to receive a left ventricular assist device (68 patients) or optimal medical management (61). All patients had symptoms of New York Heart Association class IV heart failure. Results: Kaplan-Meier survival analysis showed a reduction of 48 percent in the risk of death from any cause in the group that received left ventricular assist devices as compared with the medical-therapy group (relative risk, 0.52; 95 percent confidence interval, 0.34 to 0.78; P = 0.001). The rates of survival at one year were 52 percent in the device group and 25 percent in the medical-therapy group (P = 0.002), and the rates at two years were 23 percent and 8 percent (P = 0.09), respectively. The frequency of serious adverse events in the device group was 2.35 (95 percent confidence interval, 1.86 to 2.95) times that in the medical-therapy group, with a predominance of infection, bleeding, and malfunction of the device. The quality of life was significantly improved at one year in the device group. Conclusions: The use of a left ventricular assist device in patients with advanced heart failure resulted in a clinically meaningful survival benefit and an improved quality of life. A left ventricular assist device is an acceptable alternative therapy in selected patients who are not candidates for cardiac transplantation.

UR - http://www.scopus.com/inward/record.url?scp=0035892018&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0035892018&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa012175

DO - 10.1056/NEJMoa012175

M3 - Article

C2 - 11794191

AN - SCOPUS:0035892018

VL - 345

SP - 1435

EP - 1443

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 20

ER -