Incidence of death or disability at 6 months after extracorporeal membrane oxygenation in Australia: a prospective, multicentre, registry-embedded cohort study
Carol L Hodgson 1, Alisa M Higgins 2, Michael J Bailey 2, Shannah Anderson 3, Stephen Bernard 4, Bentley J Fulcher 2, Denise Koe 5, Natalie J Linke 2, Jasmin V Board 6, Daniel Brodie 7, Heidi Buhr 8, Aidan J C Burrell 9, D James Cooper 9, Eddy Fan 10, John F Fraser 11, David J Gattas 8, Ingrid K Hopper 5, Sue Huckson 12, Edward Litton 13, Shay P McGuinness 14, Priya Nair 15, Neil Orford 16, Rachael L Parke 17, Vincent A Pellegrino 6, David V Pilcher 18, Jayne Sheldrake 6, Benjamin A J Reddi 19, Dion Stub 4, Tony V Trapani 2, Andrew A Udy 9, Ary Serpa Neto 20; EXCEL Study Investigators on behalf of the International ECMO Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group
Lancet Respir Med. 2022 Nov;10(11):1038-1048. doi: 10.1016/S2213-2600(22)00248-X. Epub 2022 Sep 26.
Abstract
Background: Extracorporeal membrane oxygenation (ECMO) is an invasive procedure used to support critically ill patients with the most severe forms of cardiac or respiratory failure in the short term, but long-term effects on incidence of death and disability are unknown. We aimed to assess incidence of death or disability associated with ECMO up to 6 months (180 days) after treatment.
Methods: This prospective, multicentre, registry-embedded cohort study was done at 23 hospitals in Australia from Feb 15, 2019, to Dec 31, 2020. The EXCEL registry included all adults (≥18 years) in Australia who were admitted to an intensive care unit (ICU) in a participating centre at the time of the study and who underwent ECMO. All patients who received ECMO support for respiratory failure, cardiac failure, or cardiac arrest during their ICU stay were eligible for this study. The primary outcome was death or moderate-to-severe disability (defined using the WHO Disability Assessment Schedule 2.0, 12-item survey) at 6 months after ECMO initiation. We used Fisher’s exact test to compare categorical variables. This study is registered with ClinicalTrials.gov, NCT03793257.
Findings: Outcome data were available for 391 (88%) of 442 enrolled patients. The primary outcome of death or moderate-to-severe disability at 6 months was reported in 260 (66%) of 391 patients: 136 (67%) of 202 who received veno-arterial (VA)-ECMO, 60 (54%) of 111 who received veno-venous (VV)-ECMO, and 64 (82%) of 78 who received extracorporeal cardiopulmonary resuscitation (eCPR). After adjustment for age, comorbidities, Acute Physiology and Chronic Health Evaluation (APACHE) IV score, days between ICU admission and ECMO start, and use of vasopressors before ECMO, death or moderate-to-severe disability was higher in patients who received eCPR than in those who received VV-ECMO (VV-ECMO vs eCPR: risk difference [RD] -32% [95% CI -49 to -15]; p<0·001) but not VA-ECMO (VA-ECMO vs eCPR -8% [-22 to 6]; p=0·27).
Interpretation: In our study, only a third of patients were alive without moderate-to-severe disability at 6 months after initiation of ECMO. The finding that disability was common across all areas of functioning points to the need for long-term, multidisciplinary care and support for surviving patients who have had ECMO. Further studies are needed to understand the 180-day and longer-term prognosis of patients with different diagnoses receiving different modes of ECMO, which could have important implications for the selection of patients for ECMO and management strategies in the ICU.
Funding: The National Health and Medical Research Council of Australia.
Copyright © 2022 Elsevier Ltd. All rights reserved.
Conflict Of Interest Statement
Declaration of interests CLH leads the bi-national EXCEL registry, with funding from the Australian National Health and Medical Research Council (NHMRC) and the Heart Foundation of Australia (HFA), holds an NHMRC investigator grant, and is on the executive committee of the International ECMO Network (ECMONet). AMH, AJCB, and DJC receive research support from NHMRC. AMH, MJB, SB, BJF, NJL, DJC, DJG, IKH, DVP, TVT, and AAU received funding for the EXCEL registry from NHMRC and HFA. DB is Chair of the Executive Committee of ECMONet and President-elect of ELSO, receives research support from ALung Technologies, and has been on medical advisory boards for Abiomed, Xenios, Medtronic, and Cellenkos. DJC holds an NHMRC practitioner fellowship. EF is on the executive committee of ECMONet and the steering committee of the Extracorporeal Life Support Organization (ELSO). JFF and VAP are on the Executive Committee of ECMONet. JFF is President of the Asia-Pacific Chapter of ELSO, Chair of the Queensland Cardiovascular Research Network, co-founder of BiVACOR, and receives research support from Xenios, Mallenkrodt Getinge, and MERA (all ECMO companies). DS received research support from a HFA fellowship. AAU is on the executive committee of the Australian and New Zealand Intensive Care Society Clinical Trials Group. All other authors declare no competing interests.