Institut für Herzinfarktforschung, Ludwigshafen, Germany; Klinikum Ludwigshafen, Ludwigshafen, Germany.
Heart Center Leipzig at University of Leipzig and Leipzig Heart Science, Leipzig, Germany.
Lancet. 2023 Oct 14;402(10410):1338-1346. doi: 10.1016/S0140-6736(23)01607-0. Epub 2023 Aug 26.
Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used in patients with cardiogenic shock despite the lack of evidence from adequately powered randomised clinical trials. Three trials reported so far were underpowered to detect a survival benefit; we therefore conducted an individual patient-based meta-analysis to assess the effect of VA-ECMO on 30-day death rate.
Randomised clinical trials comparing early routine use of VA-ECMO versus optimal medical therapy alone in patients presenting with infarct-related cardiogenic shock were identified by searching MEDLINE, Cochrane Central Register of Controlled Trials, Embase, and trial registries until June 12, 2023. Trials were included if at least all-cause death rate 30 days after in-hospital randomisation was reported and trial investigators agreed to collaborate (ie, providing individual patient data). Odds ratios (ORs) as primary outcome measure were pooled using logistic regression models. This study is registered with PROSPERO (CRD42023431258).
Four trials (n=567 patients; 284 VA-ECMO, 283 control) were identified and included. Overall, there was no significant reduction of 30-day death rate with the early use of VA-ECMO (OR 0·93; 95% CI 0·66-1·29). Complication rates were higher with VA-ECMO for major bleeding (OR 2·44; 95% CI 1·55-3·84) and peripheral ischaemic vascular complications (OR 3·53; 95% CI 1·70-7·34). Prespecified subgroup analyses were consistent and did not show any benefit for VA-ECMO (p ≥0·079).
VA-ECMO did not reduce 30-day death rate compared with medical therapy alone in patients with infarct-related cardiogenic shock, and an increase in major bleeding and vascular complications was observed. A careful review of the indication for VA-ECMO in this setting is warranted.
Foundation Institut für Herzinfarktforschung.
尽管缺乏充分有力的随机临床试验证据，静脉-动脉体外膜肺氧合（VA-ECMO）在心源性休克患者中的应用日益增多。目前已报告的三项试验均因样本量不足而无法检测到生存获益；因此，我们进行了一项基于个体患者的荟萃分析，以评估 VA-ECMO 对 30 天死亡率的影响。
通过检索 MEDLINE、Cochrane 对照试验中心注册库、Embase 和试验注册库，搜索了比较梗死相关心源性休克患者早期常规使用 VA-ECMO 与单纯最佳药物治疗的随机临床试验，直至 2023 年 6 月 12 日。如果至少报告了住院随机分组后 30 天的全因死亡率，并且试验研究者同意合作（即提供个体患者数据），则纳入试验。主要结局测量的比值比（ORs）采用逻辑回归模型进行汇总。本研究已在 PROSPERO（CRD42023431258）注册。
确定并纳入了四项试验（n=567 例患者；284 例 VA-ECMO，283 例对照组）。总体而言，早期使用 VA-ECMO 并未降低 30 天死亡率（OR 0.93；95%CI 0.66-1.29）。VA-ECMO 的并发症发生率更高，主要出血（OR 2.44；95%CI 1.55-3.84）和外周缺血性血管并发症（OR 3.53；95%CI 1.70-7.34）。预先设定的亚组分析结果一致，并未显示 VA-ECMO 有任何获益（p≥0.079）。
与单纯药物治疗相比，VA-ECMO 并未降低梗死相关心源性休克患者的 30 天死亡率，并且观察到主要出血和血管并发症增加。在这种情况下，有必要仔细审查 VA-ECMO 的适应证。
基金会心脏病研究基金会。
