Use of a continuous-flow device in patients awaiting heart transplantation
Use of a continuous-flow device in patients awaiting heart transplantation
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DOI：
10.1056/nejmoa067758
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发表时间：
2007-08-30
影响因子：
158.5
通讯作者：
Frazier, O. H.
中科院分区：
文献类型：
--
作者：
Miller, Leslie W.;Pagani, Francis D.;Frazier, O. H.
背景资料：左心室辅助装置的使用是难治性心力衰竭患者的可接受疗法，但目前的脉动容积置换装置具有限制（包括较大的泵尺寸和有限的长期机械耐久性），这减少了该技术的广泛采用。连续流泵是较新类型的左心室辅助装置，旨在克服这些局限性。研究方法：在一项前瞻性、多中心研究中，没有同期对照组，133例在心脏移植等待名单上的终末期心力衰竭患者接受了连续流泵植入术。主要结局是在180天时接受移植、心脏恢复或持续机械支持同时仍符合移植条件的患者比例。我们还评估了功能状态和生活质量。结果：100例患者（75%）发生了主要结局。支助的中位持续时间为126天（范围：1至600天）。支持期间的生存率在6个月时为75%，在12个月时为68%。在3个月时，治疗与功能状态（根据纽约心脏协会分级和6分钟步行试验结果）和生活质量（根据明尼苏达心力衰竭生活和堪萨斯城心肌病问卷）的显著改善相关。主要不良事件包括术后出血、卒中、右心衰竭和经皮电极导线感染。2例患者发生泵血栓形成。结论：连续流左心室辅助装置可以为等待心脏移植的患者提供至少6个月的有效血流动力学支持，改善功能状态和生活质量。（ClinicalTrials.gov编号，NCT 00121472。）新英格兰医学杂志2007;357：885-96。
Background: The use of left ventricular assist devices is an accepted therapy for patients with refractory heart failure, but current pulsatile volume-displacement devices have limitations (including large pump size and limited long-term mechanical durability) that have reduced widespread adoption of this technology. Continuous-flow pumps are newer types of left ventricular assist devices developed to overcome some of these limitations. Methods: In a prospective, multicenter study without a concurrent control group, 133 patients with end-stage heart failure who were on a waiting list for heart transplantation underwent implantation of a continuous-flow pump. The principal outcomes were the proportions of patients who, at 180 days, had undergone transplantation, had cardiac recovery, or had ongoing mechanical support while remaining eligible for transplantation. We also assessed functional status and quality of life. Results: The principal outcomes occurred in 100 patients (75%). The median duration of support was 126 days (range, 1 to 600). The survival rate during support was 75% at 6 months and 68% at 12 months. At 3 months, therapy was associated with significant improvement in functional status (according to the New York Heart Association class and results of a 6-minute walk test) and in quality of life (according to the Minnesota Living with Heart Failure and Kansas City Cardiomyopathy questionnaires). Major adverse events included postoperative bleeding, stroke, right heart failure, and percutaneous lead infection. Pump thrombosis occurred in two patients. Conclusions: A continuous-flow left ventricular assist device can provide effective hemodynamic support for a period of at least 6 months in patients awaiting heart transplantation, with improved functional status and quality of life. (ClinicalTrials.gov number, NCT00121472.) N Engl J Med 2007;357:885-96.