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经皮左心室辅助Impella-2.5 辅助装置在急性心源性休克中的应用:Impella-EUROSHOCK 注册研究结果。

Percutaneous left-ventricular support with the Impella-2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry.

机构信息

Department of Internal Medicine I., Friedrich-Schiller University, Erlanger Allee, Jena, Germany.

出版信息

Circ Heart Fail. 2013 Jan;6(1):23-30. doi: 10.1161/CIRCHEARTFAILURE.112.967224. Epub 2012 Dec 4.

Abstract

BACKGROUND

Acute cardiogenic shock after myocardial infarction is associated with high in-hospital mortality attributable to persisting low-cardiac output. The Impella-EUROSHOCK-registry evaluates the safety and efficacy of the Impella-2.5-percutaneous left-ventricular assist device in patients with cardiogenic shock after acute myocardial infarction.

METHODS AND RESULTS

This multicenter registry retrospectively included 120 patients (63.6±12.2 years; 81.7% male) with cardiogenic shock from acute myocardial infarction receiving temporary circulatory support with the Impella-2.5-percutaneous left-ventricular assist device. The primary end point evaluated mortality at 30 days. The secondary end point analyzed the change of plasma lactate after the institution of hemodynamic support, and the rate of early major adverse cardiac and cerebrovascular events as well as long-term survival. Thirty-day mortality was 64.2% in the study population. After Impella-2.5-percutaneous left-ventricular assist device implantation, lactate levels decreased from 5.8±5.0 mmol/L to 4.7±5.4 mmol/L (P=0.28) and 2.5±2.6 mmol/L (P=0.023) at 24 and 48 hours, respectively. Early major adverse cardiac and cerebrovascular events were reported in 18 (15%) patients. Major bleeding at the vascular access site, hemolysis, and pericardial tamponade occurred in 34 (28.6%), 9 (7.5%), and 2 (1.7%) patients, respectively. The parameters of age >65 and lactate level >3.8 mmol/L at admission were identified as predictors of 30-day mortality. After 317±526 days of follow-up, survival was 28.3%.

CONCLUSIONS

In patients with acute cardiogenic shock from acute myocardial infarction, Impella 2.5-treatment is feasible and results in a reduction of lactate levels, suggesting improved organ perfusion. However, 30-day mortality remains high in these patients. This likely reflects the last-resort character of Impella-2.5-application in selected patients with a poor hemodynamic profile and a greater imminent risk of death. Carefully conducted randomized controlled trials are necessary to evaluate the efficacy of Impella-2.5-support in this high-risk patient group.

摘要

背景

急性心肌梗死后心源性休克与持续低心输出量导致的高院内死亡率相关。Impella-EUROSHOCK 注册研究评估了 Impella-2.5 经皮左心室辅助装置在急性心肌梗死后心源性休克患者中的安全性和疗效。

方法和结果

这项多中心回顾性注册研究纳入了 120 例(63.6±12.2 岁;81.7%为男性)急性心肌梗死后心源性休克患者,他们接受 Impella-2.5 经皮左心室辅助装置进行临时循环支持。主要终点为 30 天死亡率。次要终点分析了血流动力学支持开始后血浆乳酸的变化,以及早期主要心脑血管不良事件的发生率和长期生存率。研究人群 30 天死亡率为 64.2%。在植入 Impella-2.5 经皮左心室辅助装置后,乳酸水平从 5.8±5.0 mmol/L 降至 24 小时和 48 小时的 4.7±5.4 mmol/L(P=0.28)和 2.5±2.6 mmol/L(P=0.023)。18 例(15%)患者发生早期主要心脑血管不良事件。34 例(28.6%)、9 例(7.5%)和 2 例(1.7%)患者分别发生血管入路部位大出血、溶血和心包填塞。年龄>65 岁和入院时乳酸水平>3.8 mmol/L 是 30 天死亡率的预测因素。随访 317±526 天后,生存率为 28.3%。

结论

在急性心肌梗死后急性心源性休克患者中,Impella 2.5 治疗是可行的,可降低乳酸水平,提示器官灌注改善。然而,这些患者的 30 天死亡率仍然很高。这可能反映了在选择的血流动力学特征较差且死亡风险更大的患者中,使用 Impella-2.5 的最后手段特征。需要进行精心设计的随机对照试验来评估 Impella-2.5 支持在这一高危患者群体中的疗效。

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