{Reference Type}: Journal Article
{Title}: Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: A randomized controlled trial (COMICS).
{Author}: Angelini GD;Reeves BC;Culliford LA;Maishman R;Rogers CA;Anastasiadis K;Antonitsis P;Argiriadou H;Carrel T;Keller D;Liebold A;Ashkaniani F;El-Essawi A;Breitenbach I;Lloyd C;Bennett M;Cale A;Gunaydin S;Gunertem E;Oueida F;Yassin IM;Serrick C;Murkin JM;Rao V;Moscarelli M;Condello I;Punjabi P;Rajakaruna C;Deliopoulos A;Bone D;Lansdown W;Moorjani N;Dennis S;
{Journal}: Perfusion
{Volume}: 0
{Issue}: 0
{Year}: 2024 Jun 4
{Factor}: 1.581
{DOI}: 10.1177/02676591241258054
{Abstract}: <B>BACKGROUND: </B>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.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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).<BR><B>CONCLUSIONS: </B>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.