Retrospective cohort study links congenital heart surgery with CPB to early postoperative cerebral desaturation events in infants.
This retrospective cohort study included 397 infants aged >1 month and ≤1 year undergoing elective congenital heart surgery with cardiopulmonary bypass in a cardiac intensive care unit setting. The primary outcome was early postoperative cerebral desaturation events (CDEs). The incidence of CDEs was 16.88% overall, with 18.1% in the development cohort and 14.2% in the validation cohort. No specific adverse events, discontinuations, or tolerability data were reported.
A predictive model demonstrated discrimination with a C-statistic of 0.798 (95% CI 0.729–0.857) in the development cohort and 0.767 (95% CI 0.629–0.886) in the validation cohort. Decision curve analysis suggested potential clinical usefulness across clinically relevant threshold probabilities. However, the study notes that external validation is required before clinical implementation.
Limitations include the retrospective design, lack of reported adverse events, and reliance on internal validation only. As an association study, causality cannot be inferred. These findings highlight the need for further prospective validation before integrating the model into routine practice for this specific population.