Article Impact Level: HIGH Data Quality: STRONG Summary of The Lancet, S0140673623016070. https://doi.org/10.1016/S0140-6736(23)01607-0 Dr. Uwe Zeymer et al.
Points
- VA-ECMO, a treatment for cardiogenic shock, lacks strong evidence from adequately powered clinical trials.
- An individual patient-based meta-analysis was conducted to assess VA-ECMO’s impact on 30-day mortality.
- Four trials with 567 patients showed no significant reduction in 30-day death rates with early VA-ECMO use.
- VA-ECMO was associated with higher rates of major bleeding and peripheral vascular complications.
- The study recommends carefully reconsidering VA-ECMO indications in infarct-related cardiogenic shock cases.
Summary
Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a treatment increasingly employed in patients with cardiogenic shock, though the lack of evidence from sufficiently powered randomized clinical trials has raised concerns. Three prior trials were deemed underpowered to detect a survival benefit, prompting a patient-based meta-analysis. The study aimed to evaluate the effect of VA-ECMO on the 30-day death rate.
The authors conducted a search encompassing MEDLINE, Cochrane Central Register of Controlled Trials, Embase, and trial registries until June 12, 2023. They identified randomized clinical trials comparing early VA-ECMO use versus optimal medical therapy alone in patients with infarct-related cardiogenic shock. Inclusion criteria necessitated reporting the 30-day all-cause death rate post-in-hospital randomization and providing individual patient data by trial investigators. Logistic regression models were used to pool primary outcome measures, expressed as odds ratios (ORs). The study was registered with PROSPERO (CRD42023431258).
Four trials, comprising 567 patients (284 receiving VA-ECMO and 283 in the control group), were included in the analysis. The overall analysis showed no significant reduction in the 30-day death rate with early VA-ECMO use (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). Pre-specified subgroup analyses consistently failed to demonstrate any benefit for VA-ECMO (pinteraction ≥0·079).
The study concluded that early VA-ECMO use did not reduce the 30-day mortality rate compared to medical therapy alone in patients with infarct-related cardiogenic shock. Instead, it was associated with an increased risk of major bleeding and vascular complications. The authors recommend a cautious review of VA-ECMO indications in this clinical context.
Link to the article: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01607-0/fulltext
References Zeymer, U., Freund, A., Hochadel, M., Ostadal, P., Belohlavek, J., Rokyta, R., Massberg, S., Brunner, S., Lüsebrink, E., Flather, M., Adlam, D., Bogaerts, K., Banning, A., Sabaté, M., Akin, I., Jobs, A., Schneider, S., Desch, S., & Thiele, H. (2023). Venoarterial extracorporeal membrane oxygenation in patients with infarct-related cardiogenic shock: An individual patient data meta-analysis of randomised trials. The Lancet, S0140673623016070. https://doi.org/10.1016/S0140-6736(23)01607-0
