PMID- 37415397 OWN - NLM STAT- MEDLINE DCOM- 20230731 LR - 20230801 IS - 2055-5822 (Electronic) IS - 2055-5822 (Linking) VI - 10 IP - 4 DP - 2023 Aug TI - Early left ventricular unloading after extracorporeal membrane oxygenation: rationale and design of EARLY-UNLOAD trial. PG - 2672-2679 LID - 10.1002/ehf2.14450 [doi] AB - AIMS: The clinical benefits of venoarterial extracorporeal membrane oxygenation (VA-ECMO) for profound cardiogenic shock are well known. However, peripheral VA-ECMO increases the left ventricular afterload, thus compromising myocardial recovery. Recent studies have revealed the benefit of left ventricular unloading using various methods applied at different times. The EARLY-UNLOAD trial compares the clinical outcomes of early left ventricular unloading and conventional approach after VA-ECMO. METHODS AND RESULTS: The EARLY-UNLOAD trial is a single-centre, open-label, randomized trial that recruited 116 patients with cardiogenic shock undergoing VA-ECMO. Patients meeting the inclusion criteria were randomized in a 1:1 ratio to two groups: routine left ventricular unloading via intracardiac echocardiography-guided transseptal left atrial cannulation within 12 h of VA-ECMO initiation or conventional approach that indicates rescue left ventricular unloading if clinical signs of an increased left ventricular afterload are present. The primary endpoint is the cumulative incidence of all-cause death within 30 days, and patients will be followed-up for 12 months. A key secondary endpoint is a composite measure of all-cause death and rescue transseptal left atrial cannulation in the conventional group (suggestive of VA-ECMO treatment failure) within 30 days. The enrolment of patients was finished in September 2022. CONCLUSIONS: The EARLY-UNLOAD trial is the first randomized controlled trial to compare early left ventricular unloading and conventional approach after VA-ECMO using the same unloading modality. The results could impact clinical practice to overcome the haemodynamic issues associated with VA-ECMO. CI - (c) 2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. FAU - Kim, Min Chul AU - Kim MC AD - Department of Internal Medicine, Division of Cardiology, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea. FAU - Lim, Yongwhan AU - Lim Y AD - Department of Internal Medicine, Division of Cardiology, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea. FAU - Lee, Seung Hun AU - Lee SH AD - Department of Internal Medicine, Division of Cardiology, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea. FAU - Shin, Yoonmin AU - Shin Y AD - Department of Internal Medicine, Division of Cardiology, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea. FAU - Ahn, Joon Ho AU - Ahn JH AD - Department of Internal Medicine, Division of Cardiology, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea. FAU - Hyun, Dae Young AU - Hyun DY AD - Department of Internal Medicine, Division of Cardiology, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea. FAU - Cho, Kyung Hoon AU - Cho KH AD - Department of Internal Medicine, Division of Cardiology, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea. FAU - Sim, Doo Sun AU - Sim DS AD - Department of Internal Medicine, Division of Cardiology, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea. FAU - Hong, Young Joon AU - Hong YJ AD - Department of Internal Medicine, Division of Cardiology, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea. FAU - Kim, Ju Han AU - Kim JH AD - Department of Internal Medicine, Division of Cardiology, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea. FAU - Jeong, Myung Ho AU - Jeong MH AD - Department of Internal Medicine, Division of Cardiology, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea. FAU - Jung, Yong Hun AU - Jung YH AD - Department of Emergency Medicine, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea. FAU - Jeong, In-Seok AU - Jeong IS AD - Department of Thoracic and Cardiovascular Surgery, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea. FAU - Ahn, Youngkeun AU - Ahn Y AD - Department of Internal Medicine, Division of Cardiology, Chonnam National University Medical School, Chonnam National University Hospital, Gwangju, South Korea. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20230706 PL - England TA - ESC Heart Fail JT - ESC heart failure JID - 101669191 SB - IM MH - Humans MH - Shock, Cardiogenic/therapy MH - *Extracorporeal Membrane Oxygenation/methods MH - *Atrial Fibrillation MH - Heart Ventricles/diagnostic imaging MH - Hemodynamics PMC - PMC10375154 OTO - NOTNLM OT - Cardiogenic shock OT - Clinical trial OT - Extracorporeal life support OT - Extracorporeal membrane oxygenation OT - Left ventricular unloading COIS- None declared. EDAT- 2023/07/07 06:42 MHDA- 2023/07/31 11:41 PMCR- 2023/07/06 CRDT- 2023/07/07 02:15 PHST- 2023/05/09 00:00 [revised] PHST- 2022/08/12 00:00 [received] PHST- 2023/06/21 00:00 [accepted] PHST- 2023/07/31 11:41 [medline] PHST- 2023/07/07 06:42 [pubmed] PHST- 2023/07/07 02:15 [entrez] PHST- 2023/07/06 00:00 [pmc-release] AID - EHF214450 [pii] AID - 10.1002/ehf2.14450 [doi] PST - ppublish SO - ESC Heart Fail. 2023 Aug;10(4):2672-2679. doi: 10.1002/ehf2.14450. Epub 2023 Jul 6.