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However, the 2-year survival rate among patients with a left ventricular assist device in the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial ( number, NCT00000607) was only 23%, as compared with 8% among patients receiving medical therapy. The survival status, functional capacity, and quality of life were superior in the patients treated with the pulsatile left ventricular assist devices. To date, only two completed trials, one randomized 12 and one nonrandomized, 13 have evaluated patients with advanced heart failure who were ineligible for transplantation and compared optimal medical therapy with the use of a pulsatile left ventricular assist device. The paucity of effective therapies for advanced heart failure led to the evaluation of mechanical circulatory-support devices as permanent therapy. 10,11 Cardiac transplantation is available for only a minority of patients, because of a lack of suitable donor hearts. Continuous intravenous inotropic support may improve clinical status in the short term but results in a survival rate at 1 year of only 10 to 30%. 1-9 However, heart failure commonly progresses and becomes refractory to current treatments. Medical and electrical therapies for systolic heart failure have improved outcomes and altered the natural history of the disease.
( number, NCT00121485.) IntroductionĬomparison of Volume-Displacement Pump and Axial-Flow Pump LVADs (01:48) Both devices significantly improved the quality of life and functional capacity.
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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. The quality of life and functional capacity improved significantly in both groups. Adverse events and device replacements were less frequent in patients with the continuous-flow device. 7 of 66 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. The primary composite end point was achieved in more patients with continuous-flow devices than with pulsatile-flow devices (62 of 134 vs. 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. Secondary end points included survival, frequency of adverse events, the quality of life, and functional capacity. The primary composite end point was, at 2 years, survival free from disabling stroke and reoperation to repair or replace the device. 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). New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices.
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. The most trusted, influential source of new medical knowledge and clinical best practices in the world.
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