A Prospective Feasibility Trial Investigating the Use of the Impel la 2.5 System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (The PROTECT I Trial) Initial US Experience
A Prospective Feasibility Trial Investigating the Use of the Impel la 2.5 System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (The PROTECT I Trial) Initial US Experience
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DOI：
10.1016/j.jcin.2008.11.005
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发表时间：
2009-02-01
影响因子：
11.3
通讯作者：
O'Neill, William W.
中科院分区：
文献类型：
--
作者：
Dixon, Simon R.;Henriques, Jose P. S.;O'Neill, William W.
目的我们试图评估Impel la 2.5系统（Abiomed Inc.，Danvers，马萨诸塞州）在接受高危经皮冠状动脉介入治疗（PCI）的患者中的应用。背景Impella 2.5是一种小型化经皮心脏辅助装置，可提供从左心室到体循环的高达2.5 l/min的正向血流。结果所有患者均成功植入Impella 2.5装置。循环支持的平均持续时间为1.7 ± 0.6 h（范围：0.4 - 2.5 h）。PCI期间的平均泵流量为2.2 +/- 0.3 l/min。30天时，主要不良心脏事件的发生率为20%（2例患者发生围手术期心肌梗死; 2例患者在第12天和第14天死亡）。没有主动脉瓣损伤、心脏穿孔或肢体缺血的证据。2例患者（10%）发生轻度、一过性溶血，无临床后遗症。结论Impella 2.5系统安全、易植入，可为高危PCI患者提供良好的血流动力学支持。(The ACT I试验; NCT 00534859）（J Am科尔心脏病学Intv 2009;2：91-6）（C）2009年美国心脏病学会基金会
Objectives We sought to evaluate the safety and feasibility of the Impel la 2.5 system (Abiomed Inc., Danvers, Massachusetts) in patients undergoing high-risk percutaneous coronary intervention (PCI).Background The Impella 2.5 is a miniaturized percutaneous cardiac assist device, which provides up to 2.5 l/min forward flow from the left ventricle into the systemic circulation.Methods In a prospective, multicenter study, 20 patients underwent high-risk PCI with minimally invasive circulatory support employing the Impella 2.5 system. All patients had poor left ventricular function (ejection fraction 10 min).Results The Impella 2.5 device was implanted successfully in all patients. The mean duration of circulatory support was 1.7 +/- 0.6 h (range: 0.4 to 2.5 h). Mean pump flow during PCI was 2.2 +/- 0.3 l/min. At 30 days, the incidence of major adverse cardiac events was 20% (2 patients had a periprocedural myocardial infarction; 2 patients died at days 12 and 14). There was no evidence of aortic valve injury, cardiac perforation, or limb ischemia. Two patients (10%) developed mild, transient hemolysis without clinical sequelae. None of the patients developed hemodynamic compromise during PCI.Conclusions The Impella 2.5 system is safe, easy to implant, and provides excellent hemodynamic support during high-risk PCI. (The PROTECT I Trial; NCT00534859) (J Am Coll Cardiol Intv 2009;2:91-6) (C) 2009 by the American College of Cardiology Foundation