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
Advocate Christ Medical Center, Oak Lawn, IL, USA.
N Engl J Med. 2009 Dec 3;361(23):2241-51. doi: 10.1056/NEJMoa0909938. Epub 2009 Nov 17.
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.
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.
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.
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.)
与药物治疗相比，晚期心力衰竭患者使用植入式搏动血流左心室辅助装置治疗时，生存率和生活质量有所提高。新型连续血流装置体积更小，可能比搏动血流装置更耐用。
在这项随机试验中，我们以2:1的比例招募了不符合移植条件的晚期心力衰竭患者，分别接受连续血流装置植入（134例患者）或目前已获批准的搏动血流装置植入（66例患者）。主要复合终点是在2年时无致残性中风且无需再次手术修复或更换装置的生存情况。次要终点包括生存率、不良事件发生率、生活质量和功能能力。
两个治疗组的术前特征相似，中位年龄为64岁（范围26至81岁），平均左心室射血分数为17%，近80%的患者接受静脉注射正性肌力药物。连续血流装置组达到主要复合终点的患者比搏动血流装置组更多（134例中的62例[46%] vs. 66例中的7例[11%]；P<0.001；风险比，0.38；95%置信区间，0.27至0.54；P<0.001），连续血流装置组患者在2年时的精算生存率更高（58% vs. 24%，P = 0.008）。连续血流装置组患者的不良事件和装置更换频率更低。两组患者的生活质量和功能能力均有显著改善。
与搏动装置相比，晚期心力衰竭患者使用连续血流左心室辅助装置治疗显著提高了2年时无中风和装置故障生存的概率。两种装置均显著改善了生活质量和功能能力。（临床试验注册号，NCT00121485。）
