PMID- 37850383 OWN - NLM STAT- MEDLINE DCOM- 20231115 LR - 20240403 IS - 1524-4539 (Electronic) IS - 0009-7322 (Linking) VI - 148 IP - 20 DP - 2023 Nov 14 TI - Early Left Ventricular Unloading or Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation: The EARLY-UNLOAD Randomized Clinical Trial. PG - 1570-1581 LID - 10.1161/CIRCULATIONAHA.123.066179 [doi] AB - BACKGROUND: Although venoarterial extracorporeal membrane oxygenation (VA-ECMO) is beneficial for the treatment of profound cardiogenic shock, peripheral VA-ECMO cannulation can increase left ventricular afterload, thus compromising myocardial recovery. We investigated whether early routine left ventricular unloading can reduce 30-day mortality compared with the conventional approach in patients with cardiogenic shock undergoing VA-ECMO. METHODS: This randomized clinical trial involved 116 patients with cardiogenic shock undergoing VA-ECMO from March 2021 to September 2022 at Chonnam National University Hospital, Gwangju, South Korea. The patients were randomly assigned to undergo either early routine left ventricular unloading with transseptal left atrial cannulation within 12 hours after randomization (n=58) or the conventional approach, which permitted rescue transseptal left atrial cannulation in case of an increased left ventricular afterload (n=58). The primary outcome was all-cause mortality within 30 days. RESULTS: All 116 randomized patients (mean age, 67.6+/-13.5 years; 34 [29.3%] women) completed the trial. At 30 days, all-cause death had occurred in 27 (46.6%) patients in the early group and 26 (44.8%) patients in the conventional group (hazard ratio, 1.02 [95% CI, 0.59-1.74]; P=0.942). Crossover to rescue transseptal left atrial cannulation occurred in 29 patients (50%) in the conventional group according to a clear indication. Time to rescue transseptal cannulation in the conventional group was a median of 21.8 (interquartile range, 12.4-52.2) hours after randomization. There were no significant differences in other secondary outcomes between the 2 groups except for a shorter time to disappearance of pulmonary congestion in the early group (median, 3 [interquartile range, 2-6] versus 5 [interquartile range, 3-7] days; P=0.027). CONCLUSIONS: Among patients with cardiogenic shock undergoing VA-ECMO, early routine left ventricular unloading with transseptal left atrial cannulation did not reduce 30-day mortality compared with the conventional strategy, which permitted rescue transseptal left atrial cannulation. These findings should be cautiously interpreted until the results of multicenter trials using other unloading modalities become available. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04775472. FAU - Kim, Min Chul AU - Kim MC AUID- ORCID: 0000-0001-6026-1702 AD - Division of Cardiology, Department of Internal Medicine (M.C.K., Y.L., S.H.L., Y.S., J.H.A., D.Y.H., K.H.C., D.S.S., Y.J.H., J.H.K., M.H.K., Y.A.), Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea. FAU - Lim, Yongwhan AU - Lim Y AUID- ORCID: 0000-0002-2405-1676 AD - Division of Cardiology, Department of Internal Medicine (M.C.K., Y.L., S.H.L., Y.S., J.H.A., D.Y.H., K.H.C., D.S.S., Y.J.H., J.H.K., M.H.K., Y.A.), Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea. FAU - Lee, Seung Hun AU - Lee SH AUID- ORCID: 0000-0002-2337-7826 AD - Division of Cardiology, Department of Internal Medicine (M.C.K., Y.L., S.H.L., Y.S., J.H.A., D.Y.H., K.H.C., D.S.S., Y.J.H., J.H.K., M.H.K., Y.A.), Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea. FAU - Shin, Yoonmin AU - Shin Y AD - Division of Cardiology, Department of Internal Medicine (M.C.K., Y.L., S.H.L., Y.S., J.H.A., D.Y.H., K.H.C., D.S.S., Y.J.H., J.H.K., M.H.K., Y.A.), Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea. FAU - Ahn, Joon Ho AU - Ahn JH AD - Division of Cardiology, Department of Internal Medicine (M.C.K., Y.L., S.H.L., Y.S., J.H.A., D.Y.H., K.H.C., D.S.S., Y.J.H., J.H.K., M.H.K., Y.A.), Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea. FAU - Hyun, Dae Young AU - Hyun DY AUID- ORCID: 0000-0002-0038-0125 AD - Division of Cardiology, Department of Internal Medicine (M.C.K., Y.L., S.H.L., Y.S., J.H.A., D.Y.H., K.H.C., D.S.S., Y.J.H., J.H.K., M.H.K., Y.A.), Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea. FAU - Cho, Kyung Hoon AU - Cho KH AUID- ORCID: 0000-0002-0377-6352 AD - Division of Cardiology, Department of Internal Medicine (M.C.K., Y.L., S.H.L., Y.S., J.H.A., D.Y.H., K.H.C., D.S.S., Y.J.H., J.H.K., M.H.K., Y.A.), Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea. FAU - Sim, Doo Sun AU - Sim DS AUID- ORCID: 0000-0003-4162-7902 AD - Division of Cardiology, Department of Internal Medicine (M.C.K., Y.L., S.H.L., Y.S., J.H.A., D.Y.H., K.H.C., D.S.S., Y.J.H., J.H.K., M.H.K., Y.A.), Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea. FAU - Hong, Young Joon AU - Hong YJ AUID- ORCID: 0000-0003-0192-8161 AD - Division of Cardiology, Department of Internal Medicine (M.C.K., Y.L., S.H.L., Y.S., J.H.A., D.Y.H., K.H.C., D.S.S., Y.J.H., J.H.K., M.H.K., Y.A.), Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea. FAU - Kim, Ju Han AU - Kim JH AD - Division of Cardiology, Department of Internal Medicine (M.C.K., Y.L., S.H.L., Y.S., J.H.A., D.Y.H., K.H.C., D.S.S., Y.J.H., J.H.K., M.H.K., Y.A.), Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea. FAU - Jeong, Myung Ho AU - Jeong MH AUID- ORCID: 0000-0001-7319-8562 AD - Division of Cardiology, Department of Internal Medicine (M.C.K., Y.L., S.H.L., Y.S., J.H.A., D.Y.H., K.H.C., D.S.S., Y.J.H., J.H.K., M.H.K., Y.A.), Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea. FAU - Jung, Yong Hun AU - Jung YH AD - Department of Emergency Medicine (Y.H.J.), Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea. FAU - Jeong, In-Seok AU - Jeong IS AD - Department of Thoracic and Cardiovascular Surgery (I.-S.J.), Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea. FAU - Ahn, Youngkeun AU - Ahn Y AUID- ORCID: 0000-0003-2022-9366 AD - Division of Cardiology, Department of Internal Medicine (M.C.K., Y.L., S.H.L., Y.S., J.H.A., D.Y.H., K.H.C., D.S.S., Y.J.H., J.H.K., M.H.K., Y.A.), Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea. LA - eng SI - ClinicalTrials.gov/NCT04775472 PT - Journal Article PT - Randomized Controlled Trial DEP - 20231018 PL - United States TA - Circulation JT - Circulation JID - 0147763 SB - IM MH - Humans MH - Female MH - Middle Aged MH - Aged MH - Aged, 80 and over MH - Male MH - Shock, Cardiogenic MH - *Extracorporeal Membrane Oxygenation/methods MH - *Atrial Fibrillation MH - Heart Ventricles MH - Heart Atria MH - Retrospective Studies OTO - NOTNLM OT - cardiogenic OT - clinical trial OT - extracorporeal membrane oxygenation OT - shock COIS- Disclosures None. EDAT- 2023/10/18 06:44 MHDA- 2023/11/15 06:42 CRDT- 2023/10/18 05:28 PHST- 2023/11/15 06:42 [medline] PHST- 2023/10/18 06:44 [pubmed] PHST- 2023/10/18 05:28 [entrez] AID - 10.1161/CIRCULATIONAHA.123.066179 [doi] PST - ppublish SO - Circulation. 2023 Nov 14;148(20):1570-1581. doi: 10.1161/CIRCULATIONAHA.123.066179. Epub 2023 Oct 18.