Original Title: Utilización de la membrana de oxigenación extracorpórea (ECMO) para la reanimación de pacientes con parada cardíaca extrahospitalaria

Authors' objectives: To evaluate the effectiveness and safety of in-hospital use of ECMO to treat cardiac arrest that occurs in an out-of-hospital setting and is not reversed with standard cardiopulmonary resuscitation techniques.

Authors' results and conclusions: The previous systematic review (2022) included 13 primary studies, two of which are prospective studies, one is an RCT and 10 were retrospective studies. The update included seven studies, of which three are RCTs and four are retrospective comparative observational studies. The 20 studies included (13 from the review and 7 from the update) evaluated the efficacy of extracorporeal resuscitation (ECPR) versus standard cardiopulmonary resuscitation (CPR) in the management of out-of-hospital cardiac arrest. The meta-analysis included a total of 18,620 patients, of whom 16,701 underwent CPR and 1,919 underwent ECPR. The sample size of the studies reviewed was highly variable. The mean age was 61 years for the CPR group and 56 years for the ECPR group. There were more men than women in both groups. The risk of bias of the primary studies was assessed using the tool RoB or ROBINS-I, depending on study design, with most studies showing a moderate/high risk of bias, although a few randomised clinical trials had a low to medium risk of bias. The studies analysed survival and favourable neurological outcomes at different points, including at discharge, at one month, at three months and at six months. All the studies analysed the variable CPC 1–2, either as primary or as secondary objective. For the evidence on survival, an aggregate analysis of the survival data at discharge, at one month and at three and six months of follow-up was carried out. ECPR performance was associated with higher chances of survival at discharge, with quality of evidence classified as moderate. Survival at six months could be meta-analysed in two studies only, showing significant differences in favour of ECMO, although these results should be taken with caution owing to the difference between patients in the two studies. The quality of evidence was also classified as moderate. For the results on survival with good neurological status, an aggregate analysis of the data at various points of follow-up was carried out. At discharge, ECPR performance was associated with higher chances of survival with good neurological status, although with high heterogeneity. At one month, the results were favourable to standard CPR, with high heterogeneity. At three months, ECPR performance was associated with higher chances of survival with good neurological status, with moderate heterogeneity. At six months, ECPR performance was also associated with higher chances of survival with good neurological status, with moderate heterogeneity. The quality of evidence was classified as moderate in all cases. For the study of safety, studies with a comparison group were considered, as in the case of effectiveness. The variables were the complications or adverse effects of the intervention. However, the reference review did not provide any data on safety or intervention-related complications. Of the studies selected for the update, only three of the seven primary studies included data on adverse effects and complications for both alternatives. The most common complications described in the studies were bleeding, sepsis or multiple organ failure, kidney failure and respiratory, neurological, infectious and metabolic complications.

Authors' methods: First, a comprehensive literature search was conducted in systematic review (SR) databases and health technology assessment reports. The search located a systematic review of 2022 that served as starting point, as it answered the effectiveness and safety questions that are the object of this study. The primary study search was carried out for the period covering January 2021 to February 2023. Both searches were conducted in the main biomedical databases and literature repositories: Medline, Embase, Cochrane, etc. After reading the titles and summaries of the articles that resulted from the search, those studies that answered the research question in PICOD format were selected. Our analysis included only studies with adults ≥18 years who experienced refractory OHCA, and which included treatment groups with CPR and ECPR. Randomised clinical trials and prospective and retrospective observational studies with a comparator group, which presented efficacy results (survival, survival with good neurological status) and/or treatment safety, were included. Studies that used other resuscitation techniques, as well as narrative reviews and primary studies without a comparator group, were excluded. The selection of studies, the data extraction and the evidence synthesis process were all carried out by peers, with the information being synthesised in tables produced using the tool FLC 3.0. The quality of evidence was assessed through different scales according to study design (AMSTAR 2, RoB 2, ROBINS-I) and the assessment of the strength of evidence was performed using the GRADE system.

Project Status: Completed

URL for project: http://hdl.handle.net/20.500.11940/18621

Year Published: 2024

URL for published report: http://hdl.handle.net/20.500.11940/18621

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Scientific Advice Unit, avalia-t; The Galician Health Knowledge Agency (ACIS)

Contact Address: Conselleria de Sanidade, Xunta de Galicia, San Lazaro s/n 15781 Santiago de Compostela, Spain. Tel: 34 981 541831; Fax: 34 981 542854;

Contact Name: avalia-t@sergas.es

Contact Email: avalia-t@sergas.es

Copyright: <p>Galician Agency for Health Technology Assessment (AVALIA-T)</p>