Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
J Am Coll Cardiol. 2009 Dec 15;54(25):2430-4. doi: 10.1016/j.jacc.2009.09.018.
This retrospective multicenter registry evaluated the safety and feasibility of left ventricular (LV) support with the Impella 2.5 (Abiomed Europe GmbH, Aachen, Germany) during high-risk percutaneous coronary intervention (PCI).
Patients with complex or high-risk coronary lesions, such as last remaining vessel or left main lesions, are increasingly being treated with PCI. Because periprocedural hemodynamic compromise and complications might occur rapidly, many of these high-risk procedures are being performed with mechanical cardiac assistance, particularly in patients with poor LV function. The Impella 2.5, a percutaneous implantable LV assist device, might be a superior alternative to the traditionally used intra-aortic balloon pump.
The Europella registry included 144 consecutive patients who underwent a high-risk PCI. Safety and feasibility end points included incidence of 30-day adverse events and successful device function.
Patients were older (62% >70 years of age), 54% had an LV ejection fraction < or = 30%, and the prevalence of comorbid conditions was high. Mean European System for Cardiac Operative Risk Evaluation score was 8.2 (SD 3.4), and 43% of the patients were refused for coronary artery bypass grafting. A PCI was considered high-risk due to left main disease, last remaining vessel disease, multivessel coronary artery disease, and low LV function in 53%, 17%, 81%, and 35% of the cases, respectively. Mortality at 30 days was 5.5%. Rates of myocardial infarction, stroke, bleeding requiring transfusion/surgery, and vascular complications at 30 days were 0%, 0.7%, 6.2%, and 4.0%, respectively.
This large multicenter registry supports the safety, feasibility, and potential usefulness of hemodynamic support with Impella 2.5 in high-risk PCI.
本回顾性多中心注册研究评估了在高危经皮冠状动脉介入治疗（PCI）期间使用 Impella 2.5（德国亚琛的 Abiomed Europe GmbH）进行左心室（LV）支持的安全性和可行性。
越来越多的复杂或高危冠状动脉病变患者，如仅剩的血管或左主干病变，接受 PCI 治疗。由于围手术期血流动力学不稳定和并发症可能迅速发生，许多这些高危手术都采用机械心脏辅助，尤其是在 LV 功能差的患者中。Impella 2.5 是一种经皮植入式 LV 辅助装置，可能是传统使用的主动脉内球囊泵的更好替代选择。
Europella 注册研究纳入了 144 例接受高危 PCI 的连续患者。安全性和可行性终点包括 30 天不良事件发生率和设备功能成功。
患者年龄较大（62%>70 岁），54%的患者左心室射血分数<或=30%，合并症患病率较高。平均欧洲心脏手术风险评估系统评分 8.2（SD 3.4），43%的患者因冠状动脉旁路移植术而被拒绝。由于左主干疾病、仅剩的血管疾病、多支冠状动脉疾病和低 LV 功能，分别有 53%、17%、81%和 35%的 PCI 被认为是高危的。30 天死亡率为 5.5%。30 天心肌梗死、中风、需要输血/手术的出血和血管并发症的发生率分别为 0%、0.7%、6.2%和 4.0%。
这项大型多中心注册研究支持在高危 PCI 中使用 Impella 2.5 进行血流动力学支持的安全性、可行性和潜在有用性。
