Advanced heart failure treated with continuous-flow left ventricular assist device

Mark S. Slaughter, Joseph G. Rogers, Carmelo A. Milano, Stuart D. Russell, John V. Conte, David Feldman, Benjamin Sun, Antone J. Tatooles, Reynolds M. Delgado, James W. Long, Thomas C. Wozniak, Waqas Ghumman, David J. Farrar, O. Howard Frazier

Research output: Contribution to journalArticle

1955 Citations (Scopus)

Abstract

BACKGROUND: Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy. New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices. METHODS: In this randomized trial, we enrolled patients with advanced heart failure who were ineligible for transplantation, in a 2:1 ratio, to undergo implantation of a continuous-flow device (134 patients) or the currently approved pulsatile-flow device (66 patients). The primary composite end point was, at 2 years, survival free from disabling stroke and reoperation to repair or replace the device. Secondary end points included survival, frequency of adverse events, the quality of life, and functional capacity. RESULTS: Preoperative characteristics were similar in the two treatment groups, with a median age of 64 years (range, 26 to 81), a mean left ventricular ejection fraction of 17%, and nearly 80% of patients receiving intravenous inotropic agents. The primary composite end point was achieved in more patients with continuous-flow devices than with pulsatile-flow devices (62 of 134 [46%] vs. 7 of 66 [11%]; P<0.001; hazard ratio, 0.38; 95% confidence interval, 0.27 to 0.54; P<0.001), and patients with continuous-flow devices had superior actuarial survival rates at 2 years (58% vs. 24%, P = 0.008). Adverse events and device replacements were less frequent in patients with the continuous-flow device. The quality of life and functional capacity improved significantly in both groups. CONCLUSIONS: Treatment with a continuous-flow left ventricular assist device in patients with advanced heart failure significantly improved the probability of survival free from stroke and device failure at 2 years as compared with a pulsatile device. Both devices significantly improved the quality of life and functional capacity. (ClinicalTrials.gov number, NCT00121485.).

Original languageEnglish (US)
Pages (from-to)2241-2251
Number of pages11
JournalNew England Journal of Medicine
Volume361
Issue number23
DOIs
StatePublished - Dec 3 2009

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Heart-Assist Devices
Heart Failure
Equipment and Supplies
Pulsatile Flow
Quality of Life
Survival
Survival Rate
Stroke
Equipment Failure
Reoperation
Stroke Volume
Therapeutics
Transplantation

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Slaughter, M. S., Rogers, J. G., Milano, C. A., Russell, S. D., Conte, J. V., Feldman, D., ... Frazier, O. H. (2009). Advanced heart failure treated with continuous-flow left ventricular assist device. New England Journal of Medicine, 361(23), 2241-2251. https://doi.org/10.1056/NEJMoa0909938
Slaughter, Mark S. ; Rogers, Joseph G. ; Milano, Carmelo A. ; Russell, Stuart D. ; Conte, John V. ; Feldman, David ; Sun, Benjamin ; Tatooles, Antone J. ; Delgado, Reynolds M. ; Long, James W. ; Wozniak, Thomas C. ; Ghumman, Waqas ; Farrar, David J. ; Frazier, O. Howard. / Advanced heart failure treated with continuous-flow left ventricular assist device. In: New England Journal of Medicine. 2009 ; Vol. 361, No. 23. pp. 2241-2251.
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abstract = "BACKGROUND: Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy. New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices. METHODS: In this randomized trial, we enrolled patients with advanced heart failure who were ineligible for transplantation, in a 2:1 ratio, to undergo implantation of a continuous-flow device (134 patients) or the currently approved pulsatile-flow device (66 patients). The primary composite end point was, at 2 years, survival free from disabling stroke and reoperation to repair or replace the device. Secondary end points included survival, frequency of adverse events, the quality of life, and functional capacity. RESULTS: Preoperative characteristics were similar in the two treatment groups, with a median age of 64 years (range, 26 to 81), a mean left ventricular ejection fraction of 17{\%}, and nearly 80{\%} of patients receiving intravenous inotropic agents. The primary composite end point was achieved in more patients with continuous-flow devices than with pulsatile-flow devices (62 of 134 [46{\%}] vs. 7 of 66 [11{\%}]; P<0.001; hazard ratio, 0.38; 95{\%} confidence interval, 0.27 to 0.54; P<0.001), and patients with continuous-flow devices had superior actuarial survival rates at 2 years (58{\%} vs. 24{\%}, P = 0.008). Adverse events and device replacements were less frequent in patients with the continuous-flow device. The quality of life and functional capacity improved significantly in both groups. CONCLUSIONS: Treatment with a continuous-flow left ventricular assist device in patients with advanced heart failure significantly improved the probability of survival free from stroke and device failure at 2 years as compared with a pulsatile device. Both devices significantly improved the quality of life and functional capacity. (ClinicalTrials.gov number, NCT00121485.).",
author = "Slaughter, {Mark S.} and Rogers, {Joseph G.} and Milano, {Carmelo A.} and Russell, {Stuart D.} and Conte, {John V.} and David Feldman and Benjamin Sun and Tatooles, {Antone J.} and Delgado, {Reynolds M.} and Long, {James W.} and Wozniak, {Thomas C.} and Waqas Ghumman and Farrar, {David J.} and Frazier, {O. Howard}",
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Slaughter, MS, Rogers, JG, Milano, CA, Russell, SD, Conte, JV, Feldman, D, Sun, B, Tatooles, AJ, Delgado, RM, Long, JW, Wozniak, TC, Ghumman, W, Farrar, DJ & Frazier, OH 2009, 'Advanced heart failure treated with continuous-flow left ventricular assist device', New England Journal of Medicine, vol. 361, no. 23, pp. 2241-2251. https://doi.org/10.1056/NEJMoa0909938

Advanced heart failure treated with continuous-flow left ventricular assist device. / Slaughter, Mark S.; Rogers, Joseph G.; Milano, Carmelo A.; Russell, Stuart D.; Conte, John V.; Feldman, David; Sun, Benjamin; Tatooles, Antone J.; Delgado, Reynolds M.; Long, James W.; Wozniak, Thomas C.; Ghumman, Waqas; Farrar, David J.; Frazier, O. Howard.

In: New England Journal of Medicine, Vol. 361, No. 23, 03.12.2009, p. 2241-2251.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Advanced heart failure treated with continuous-flow left ventricular assist device

AU - Slaughter, Mark S.

AU - Rogers, Joseph G.

AU - Milano, Carmelo A.

AU - Russell, Stuart D.

AU - Conte, John V.

AU - Feldman, David

AU - Sun, Benjamin

AU - Tatooles, Antone J.

AU - Delgado, Reynolds M.

AU - Long, James W.

AU - Wozniak, Thomas C.

AU - Ghumman, Waqas

AU - Farrar, David J.

AU - Frazier, O. Howard

PY - 2009/12/3

Y1 - 2009/12/3

N2 - BACKGROUND: Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy. New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices. METHODS: In this randomized trial, we enrolled patients with advanced heart failure who were ineligible for transplantation, in a 2:1 ratio, to undergo implantation of a continuous-flow device (134 patients) or the currently approved pulsatile-flow device (66 patients). The primary composite end point was, at 2 years, survival free from disabling stroke and reoperation to repair or replace the device. Secondary end points included survival, frequency of adverse events, the quality of life, and functional capacity. RESULTS: Preoperative characteristics were similar in the two treatment groups, with a median age of 64 years (range, 26 to 81), a mean left ventricular ejection fraction of 17%, and nearly 80% of patients receiving intravenous inotropic agents. The primary composite end point was achieved in more patients with continuous-flow devices than with pulsatile-flow devices (62 of 134 [46%] vs. 7 of 66 [11%]; P<0.001; hazard ratio, 0.38; 95% confidence interval, 0.27 to 0.54; P<0.001), and patients with continuous-flow devices had superior actuarial survival rates at 2 years (58% vs. 24%, P = 0.008). Adverse events and device replacements were less frequent in patients with the continuous-flow device. The quality of life and functional capacity improved significantly in both groups. CONCLUSIONS: Treatment with a continuous-flow left ventricular assist device in patients with advanced heart failure significantly improved the probability of survival free from stroke and device failure at 2 years as compared with a pulsatile device. Both devices significantly improved the quality of life and functional capacity. (ClinicalTrials.gov number, NCT00121485.).

AB - BACKGROUND: Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy. New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices. METHODS: In this randomized trial, we enrolled patients with advanced heart failure who were ineligible for transplantation, in a 2:1 ratio, to undergo implantation of a continuous-flow device (134 patients) or the currently approved pulsatile-flow device (66 patients). The primary composite end point was, at 2 years, survival free from disabling stroke and reoperation to repair or replace the device. Secondary end points included survival, frequency of adverse events, the quality of life, and functional capacity. RESULTS: Preoperative characteristics were similar in the two treatment groups, with a median age of 64 years (range, 26 to 81), a mean left ventricular ejection fraction of 17%, and nearly 80% of patients receiving intravenous inotropic agents. The primary composite end point was achieved in more patients with continuous-flow devices than with pulsatile-flow devices (62 of 134 [46%] vs. 7 of 66 [11%]; P<0.001; hazard ratio, 0.38; 95% confidence interval, 0.27 to 0.54; P<0.001), and patients with continuous-flow devices had superior actuarial survival rates at 2 years (58% vs. 24%, P = 0.008). Adverse events and device replacements were less frequent in patients with the continuous-flow device. The quality of life and functional capacity improved significantly in both groups. CONCLUSIONS: Treatment with a continuous-flow left ventricular assist device in patients with advanced heart failure significantly improved the probability of survival free from stroke and device failure at 2 years as compared with a pulsatile device. Both devices significantly improved the quality of life and functional capacity. (ClinicalTrials.gov number, NCT00121485.).

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