体外膜肺氧合治疗心源性休克：多中心随机ECMO-CS试验的1年结果

Extracorporeal membrane oxygenation in the therapy of cardiogenic shock: 1-year outcomes of the multicentre, randomized ECMO-CS trial.

作者信息

Ostadal Petr, Rokyta Richard, Karasek Jiri, Kruger Andreas, Vondrakova Dagmar, Janotka Marek, Naar Jan, Smalcova Jana, Hubatova Marketa, Hromadka Milan, Volovar Stefan, Seyfrydova Miroslava, Linhart Ales, Belohlavek Jan

机构信息

Department of Cardiology, Second Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic.

Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Charles University, Pilsen, Czech Republic.

出版信息

Eur J Heart Fail. 2025 Jan;27(1):30-36. doi: 10.1002/ejhf.3398. Epub 2024 Aug 8.

DOI:10.1002/ejhf.3398

PMID:39113628

Abstract

AIMS

Among patients with cardiogenic shock, immediate initiation of extracorporeal membrane oxygenation (ECMO) did not demonstrate any benefit at 30 days. The present study evaluated 1-year clinical outcomes of the Extracorporeal Membrane Oxygenation in the therapy of Cardiogenic Shock (ECMO-CS) trial.

METHODS AND RESULTS

The ECMO-CS trial randomized 117 patients with severe or rapidly progressing cardiogenic shock to immediate initiation of ECMO or early conservative strategy. The primary endpoint for this analysis was 1-year all-cause mortality. Secondary endpoints included a composite of death, resuscitated cardiac arrest or implantation of another mechanical circulatory support device, duration of mechanical ventilation, and the length of intensive care unit (ICU) and hospital stays. In addition, an unplanned post-hoc subgroup analysis was performed. At 1 year, all-cause death occurred in 40 of 58 (69.0%) patients in the ECMO arm and in 40 of 59 (67.8%) in the early conservative arm (hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.66-1.58; p = 0.93). The composite endpoint occurred in 43 (74.1%) patients in the ECMO group and in 47 (79.7%) patients in the early conservative group (HR 0.83, 95% CI 0.55-1.25; p = 0.29). The durations of mechanical ventilation, ICU stay and hospital stay were comparable between groups. Significant interaction with treatment strategy and 1-year mortality was observed in subgroups according to baseline mean arterial pressure (MAP) indicating lower mortality in the subgroup with low baseline MAP (<63 mmHg: HR 0.58, 95% CI 0.29-1.16; p = 0.017).

CONCLUSIONS

Among patients with severe or rapidly progressing cardiogenic shock, immediate initiation of ECMO did not improve clinical outcomes at 1 year compared to the early conservative strategy. However, immediate ECMO initiation might be beneficial in patients with advanced haemodynamic compromise.

摘要

目的

在心源休克患者中，立即启动体外膜肺氧合（ECMO）在30天时未显示出任何益处。本研究评估了心源休克体外膜肺氧合治疗（ECMO-CS）试验的1年临床结局。

方法与结果

ECMO-CS试验将117例严重或快速进展的心源休克患者随机分为立即启动ECMO组或早期保守治疗组。该分析的主要终点是1年全因死亡率。次要终点包括死亡、复苏的心脏骤停或植入另一种机械循环支持装置的复合终点、机械通气时间、重症监护病房（ICU）住院时间和住院时间。此外，进行了一项非计划的事后亚组分析。1年时，ECMO组58例患者中有40例（69.0%）发生全因死亡，早期保守治疗组59例患者中有40例（67.8%）发生全因死亡（风险比[HR]1.02，95%置信区间[CI]0.66-1.58；p = 0.93）。ECMO组43例（74.1%）患者和早期保守治疗组47例（79.7%）患者发生复合终点（HR 0.83，95%CI 0.55-1.25；p = 0.29）。两组之间的机械通气时间、ICU住院时间和住院时间相当。根据基线平均动脉压（MAP）在亚组中观察到治疗策略与1年死亡率之间存在显著交互作用，表明基线MAP较低的亚组死亡率较低（<63 mmHg：HR 0.58，95%CI 0.29-1.16；p = 0.017）。