Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: A randomized controlled trial (COMICS).

Autor:	Angelini GD; Bristol Medical School, University of Bristol, Bristol, UK., Reeves BC; Bristol Medical School, University of Bristol, Bristol, UK., Culliford LA; Bristol Medical School, University of Bristol, Bristol, UK., Maishman R; Bristol Medical School, University of Bristol, Bristol, UK., Rogers CA; Bristol Medical School, University of Bristol, Bristol, UK., Anastasiadis K; Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece., Antonitsis P; Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece., Argiriadou H; Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece., Carrel T; University Hospital Bern, Bern, Switzerland., Keller D; University Hospital Bern, Bern, Switzerland., Liebold A; Universitätsklinikum Ulm, Ulm, Germany., Ashkaniani F; Universitätsklinikum Ulm, Ulm, Germany., El-Essawi A; Universitätsmedizin Göttingen, Göttingen, Germany., Breitenbach I; Klinikum Braunschweig, Braunschweig, Germany., Lloyd C; University Hospitals Plymouth NHS Trust, Plymouth, UK., Bennett M; University Hospitals Plymouth NHS Trust, Plymouth, UK., Cale A; Hull University Teaching Hospitals NHS Trust, Hull, UK., Gunaydin S; Numune Training and Research Hospital in Ankara, Ankara, Turkey., Gunertem E; Numune Training and Research Hospital in Ankara, Ankara, Turkey., Oueida F; Saud Al-Babtain Cardiac Centre, Dammam, Saudi Arabia., Yassin IM; Saud Al-Babtain Cardiac Centre, Dammam, Saudi Arabia., Serrick C; University Health Network, Toronto, ON, Canada., Murkin JM; University of Western Ontario, London, ON, Canada., Rao V; University Health Network, Toronto, ON, Canada., Moscarelli M; Anthea Hospital Bari, Italy., Condello I; Anthea Hospital Bari, Italy., Punjabi P; Imperial College Healthcare, London, UK., Rajakaruna C; University Hospitals Bristol NHS Foundation Trust, Bristol, UK., Deliopoulos A; AHEPA University Hospital, Thessaloniki, Greece., Bone D; University Hospitals Bristol NHS Foundation Trust, Bristol, UK., Lansdown W; University Hospitals Bristol NHS Foundation Trust, Bristol, UK., Moorjani N; Royal Papworth Hospital, Cambridge, UK., Dennis S; Royal Papworth Hospital, Cambridge, UK.
Jazyk:	angličtina
Zdroj:	Perfusion [Perfusion] 2024 Jun 04, pp. 2676591241258054. Date of Electronic Publication: 2024 Jun 04.
DOI:	10.1177/02676591241258054
Abstrakt:	Introduction: The trial hypothesized that minimally invasive extra-corporeal circulation (MiECC) reduces the risk of serious adverse events (SAEs) after cardiac surgery operations requiring extra-corporeal circulation without circulatory arrest. Methods: This is a multicentre, international randomized controlled trial across fourteen cardiac surgery centres including patients aged ≥18 and <85 years undergoing elective or urgent isolated coronary artery bypass grafting (CABG), isolated aortic valve replacement (AVR) surgery, or CABG + AVR surgery. Participants were randomized to MiECC or conventional extra-corporeal circulation (CECC), stratified by centre and operation. The primary outcome was a composite of 12 post-operative SAEs up to 30 days after surgery, the risk of which MiECC was hypothesized to reduce. Secondary outcomes comprised: other SAEs; all-cause mortality; transfusion of blood products; time to discharge from intensive care and hospital; health-related quality-of-life. Analyses were performed on a modified intention-to-treat basis. Results: The trial terminated early due to the COVID-19 pandemic; 1071 participants (896 isolated CABG, 97 isolated AVR, 69 CABG + AVR) with median age 66 years and median EuroSCORE II 1.24 were randomized (535 to MiECC, 536 to CECC). Twenty-six participants withdrew after randomization, 22 before and four after intervention. Fifty of 517 (9.7%) randomized to MiECC and 69/522 (13.2%) randomized to CECC group experienced the primary outcome (risk ratio = 0.732, 95% confidence interval (95% CI) = 0.556 to 0.962, p = 0.025). The risk of any SAE not contributing to the primary outcome was similarly reduced (risk ratio = 0.791, 95% CI 0.530 to 1.179, p = 0.250). Conclusions: MiECC reduces the relative risk of primary outcome events by about 25%. The risk of other SAEs was similarly reduced. Because the trial terminated early without achieving the target sample size, these potential benefits of MiECC are uncertain.
Databáze:	MEDLINE
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