Long-term use of a left ventricular assist device for end-stage heart failure
Long-term use of a left ventricular assist device for end-stage heart failure
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DOI：
10.1056/nejmoa012175
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发表时间：
2001-11-15
影响因子：
158.5
通讯作者：
Meier, P
中科院分区：
文献类型：
--
作者：
Rose, EA;Gelijns, AC;Meier, P
背景：植入式左心室辅助装置作为心脏移植的过渡手段使终末期心力衰竭患者受益，但其以提高生存率和生活质量为目的的长期使用情况尚未得到评估。
方法：我们将129例不符合心脏移植条件的终末期心力衰竭患者随机分组，分别接受左心室辅助装置治疗（68例）或优化内科治疗（61例）。所有患者均有纽约心脏协会（NYHA）心功能Ⅳ级心力衰竭的症状。
结果：Kaplan - Meier生存分析显示，与内科治疗组相比，接受左心室辅助装置治疗组的全因死亡风险降低了48%（相对风险为0.52；95%置信区间为0.34 - 0.78；P = 0.001）。1年生存率在装置组为52%，在内科治疗组为25%（P = 0.002）；2年生存率分别为23%和8%（P = 0.09）。装置组严重不良事件的发生频率是内科治疗组的2.35倍（95%置信区间为1.86 - 2.95），主要不良事件为感染、出血和装置故障。装置组患者1年时的生活质量显著改善。
结论：在晚期心力衰竭患者中使用左心室辅助装置可带来具有临床意义的生存益处并改善生活质量。对于不适合心脏移植的特定患者，左心室辅助装置是一种可接受的替代治疗方法。
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.