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著者: 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, HeartMate II Investigators
雑誌名: N Engl J Med. 2009 Dec 3;361(23):2241-51. doi: 10.1056/NEJMoa0909938. Epub 2009 Nov 17.
Abstract/Text
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.)
2009 Massachusetts Medical Society
PMID 19920051 N Engl J Med. 2009 Dec 3;361(23):2241-51. doi: 10.1056/NEJMoa0909938. Epub 2009 Nov 17.
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