PMID- 36335478 OWN - NLM STAT- MEDLINE DCOM- 20230208 LR - 20230915 IS - 1524-4539 (Electronic) IS - 0009-7322 (Linking) VI - 147 IP - 6 DP - 2023 Feb 7 TI - Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial. PG - 454-464 LID - 10.1161/CIRCULATIONAHA.122.062949 [doi] AB - BACKGROUND: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly being used for circulatory support in patients with cardiogenic shock, although the evidence supporting its use in this context remains insufficient. The ECMO-CS trial (Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock) aimed to compare immediate implementation of VA-ECMO versus an initially conservative therapy (allowing downstream use of VA-ECMO) in patients with rapidly deteriorating or severe cardiogenic shock. METHODS: This multicenter, randomized, investigator-initiated, academic clinical trial included patients with either rapidly deteriorating or severe cardiogenic shock. Patients were randomly assigned to immediate VA-ECMO or no immediate VA-ECMO. Other diagnostic and therapeutic procedures were performed as per current standards of care. In the early conservative group, VA-ECMO could be used downstream in case of worsening hemodynamic status. The primary end point was the composite of death from any cause, resuscitated circulatory arrest, and implementation of another mechanical circulatory support device at 30 days. RESULTS: A total of 122 patients were randomized; after excluding 5 patients because of the absence of informed consent, 117 subjects were included in the analysis, of whom 58 were randomized to immediate VA-ECMO and 59 to no immediate VA-ECMO. The composite primary end point occurred in 37 (63.8%) and 42 (71.2%) patients in the immediate VA-ECMO and the no early VA-ECMO groups, respectively (hazard ratio, 0.72 [95% CI, 0.46-1.12]; P=0.21). VA-ECMO was used in 23 (39%) of no early VA-ECMO patients. The 30-day incidence of resuscitated cardiac arrest (10.3.% versus 13.6%; risk difference, -3.2 [95% CI, -15.0 to 8.5]), all-cause mortality (50.0% versus 47.5%; risk difference, 2.5 [95% CI, -15.6 to 20.7]), serious adverse events (60.3% versus 61.0%; risk difference, -0.7 [95% CI, -18.4 to 17.0]), sepsis, pneumonia, stroke, leg ischemia, and bleeding was not statistically different between the immediate VA-ECMO and the no immediate VA-ECMO groups. CONCLUSIONS: Immediate implementation of VA-ECMO in patients with rapidly deteriorating or severe cardiogenic shock did not improve clinical outcomes compared with an early conservative strategy that permitted downstream use of VA-ECMO in case of worsening hemodynamic status. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02301819. FAU - Ostadal, Petr AU - Ostadal P AUID- ORCID: 0000-0001-9550-222X AD - Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic (P.O., A.K., D.V., M.J., J.N.). FAU - Rokyta, Richard AU - Rokyta R AD - Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Charles University, Pilsen, Czech Republic (R.R., M. Hromadka, S.V., M. Seyfrydova). FAU - Karasek, Jiri AU - Karasek J AD - Hospital Liberec, Liberec, Czech Republic (J.K.). AD - 2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital, Prague, Liberec, Czech Republic (J.K., J.S., M. Hubatova, A.L., J.B.). FAU - Kruger, Andreas AU - Kruger A AD - Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic (P.O., A.K., D.V., M.J., J.N.). FAU - Vondrakova, Dagmar AU - Vondrakova D AD - Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic (P.O., A.K., D.V., M.J., J.N.). FAU - Janotka, Marek AU - Janotka M AD - Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic (P.O., A.K., D.V., M.J., J.N.). FAU - Naar, Jan AU - Naar J AUID- ORCID: 0000-0002-7630-7039 AD - Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic (P.O., A.K., D.V., M.J., J.N.). FAU - Smalcova, Jana AU - Smalcova J AUID- ORCID: 0000-0002-4418-7984 AD - 2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital, Prague, Liberec, Czech Republic (J.K., J.S., M. Hubatova, A.L., J.B.). FAU - Hubatova, Marketa AU - Hubatova M AD - 2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital, Prague, Liberec, Czech Republic (J.K., J.S., M. Hubatova, A.L., J.B.). FAU - Hromadka, Milan AU - Hromadka M AD - Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Charles University, Pilsen, Czech Republic (R.R., M. Hromadka, S.V., M. Seyfrydova). FAU - Volovar, Stefan AU - Volovar S AD - Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Charles University, Pilsen, Czech Republic (R.R., M. Hromadka, S.V., M. Seyfrydova). FAU - Seyfrydova, Miroslava AU - Seyfrydova M AD - Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Charles University, Pilsen, Czech Republic (R.R., M. Hromadka, S.V., M. Seyfrydova). FAU - Jarkovsky, Jiri AU - Jarkovsky J AD - Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic (J.J., M. Svoboda). FAU - Svoboda, Michal AU - Svoboda M AD - Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic (J.J., M. Svoboda). AD - Institute of Biostatistics and Analyses, Ltd, Brno, Czech Republic (M. Svoboda). FAU - Linhart, Ales AU - Linhart A AD - 2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital, Prague, Liberec, Czech Republic (J.K., J.S., M. Hubatova, A.L., J.B.). FAU - Belohlavek, Jan AU - Belohlavek J AD - 2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital, Prague, Liberec, Czech Republic (J.K., J.S., M. Hubatova, A.L., J.B.). CN - ECMO-CS Investigators LA - eng SI - ClinicalTrials.gov/NCT02301819 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20221106 PL - United States TA - Circulation JT - Circulation JID - 0147763 SB - IM CIN - Circulation. 2023 Feb 7;147(6):465-468. PMID: 36745696 CIN - Circulation. 2023 Aug 29;148(9):803. PMID: 37639506 CIN - Circulation. 2023 Aug 29;148(9):804. PMID: 37639508 MH - Humans MH - Shock, Cardiogenic/diagnosis/therapy MH - *Extracorporeal Membrane Oxygenation/methods MH - *Heart Arrest MH - Hemodynamics MH - Hospital Mortality MH - Retrospective Studies OTO - NOTNLM OT - clinical trial OT - shock, cardiogenic OT - therapy EDAT- 2022/11/07 06:00 MHDA- 2023/02/09 06:00 CRDT- 2022/11/06 13:59 PHST- 2022/11/07 06:00 [pubmed] PHST- 2023/02/09 06:00 [medline] PHST- 2022/11/06 13:59 [entrez] AID - 10.1161/CIRCULATIONAHA.122.062949 [doi] PST - ppublish SO - Circulation. 2023 Feb 7;147(6):454-464. doi: 10.1161/CIRCULATIONAHA.122.062949. Epub 2022 Nov 6.