Definitions of major bleeding for predicting mortality in critically ill adult patients who survived 24 hours while supported with peripheral veno-arterial extracorporeal membrane oxygenation for cardiogenic shock: a comparative historical cohort study.

Abstract

The severity of bleeding events is heterogeneously defined during peripheral veno-arterial extracorporeal membrane oxygenation (pVA-ECMO). We studied three bleeding definitions in pVA-ECMO: the Extracorporeal Life Support Organization (ELSO)-serious bleeding, the Bleeding Academic Research Consortium (BARC), and the universal definition of postoperative bleeding (UPDB) classifications. We included consecutive adult patients supported by pVA-ECMO for refractory cardiogenic shock admitted to Lille academic hospitals between January 2013 and December 2019. We assessed the association of bleeding definitions with the primary endpoint of 28-day all-cause mortality with the use of multivariate models accounting for time-dependent and competing variables. We compared models' performances using the Harrell's C-Index and the Akaike information criteria. Twenty-eight-day mortality occurred in 128/308 (42%) 308 patients. The ELSO-serious bleeding (hazard ratio [HR],1.67; 95% confidence interval [CI],1.09 to 2.56) and BARC ≥ type2 (HR,1.55; 95% CI,1.01 to 2.37) were associated with 28-day mortality (Harrell's C-index, 0.69; 95% CI,0.63 to 0.74 for both). Predictors of ELSO-serious bleeding were postcardiotomy, body mass index, baseline platelets count, fibrinogen, and hemoglobin levels. Extracorporeal Life Support Organization-serious bleeding and BARC ≥ type2 are relevant definitions of major bleeding regarding their association with mortality in critically ill patients who survived the first 24hr while supported with pVA-ECMO for cardiogenic shock. CERAR (IRB 00010254-2022-050, Paris, France); first submitted on 18 April 2022.