The Impact of Utilizing Combined Factor Concentrates for Hemostasis Management in Pediatric Pulmonary Artery Reconstruction: A Propensity Score‐Matched Cohort Study

BACKGROUND: Bleeding after cardiopulmonary bypass in pediatric patients undergoing pulmonary artery reconstruction is a major source of morbidity. Factor concentrates have emerged as off-label therapy to achieve hemostasis while minimizing transfusion. In 2020, our institution implemented a standardized hemostasis management pathway combining factor concentrates. AIMS: This study evaluates the impact of the pathway on blood product transfusion and thromboembolism for patients undergoing pulmonary artery reconstruction with cardiopulmonary bypass. METHODS: We conducted a retrospective propensity score-matched cohort study comparing pediatric patients undergoing pulmonary artery reconstruction before and after pathway implementation. The pre-pathway cohort received activated 4-factor prothrombin complex concentrate for refractory bleeding with variable dosing, whereas the post-pathway cohort received both fibrinogen and activated 4-factor prothrombin complex concentrates in standardized doses. The primary efficacy outcome was total blood product transfused after cardiopulmonary bypass. The primary safety outcome was thromboembolism incidence at seven and 30 days postoperatively. Secondary outcomes included 24-h chest tube output, time to extubation, length of stay, 30-day mortality, and acute kidney injury. RESULTS: A total of 97 pre-pathway patients and 178 post-pathway patients were included in the final data set for statistical analysis. After propensity score matching, 87 patients remained in each cohort. The post-pathway cohort was associated with a statistically significant reduction in total blood products transfused (30.4 mL/kg vs. 47.9 mL/kg, mean difference 17.6 mL/kg, 95% CI [9.82-25.9], p < 0.0001). There was no statistically significant difference in seven-day (11.5% post-pathway vs. 8.0% pre-pathway, OR 1.48, 95% CI 0.51-4.32, p = 0.468) or 30-day (18.4% post-pathway vs. 9.2% pre-pathway, OR 2.23, 95% CI 0.84-5.87, p = 0.106) thromboembolism rates. There were no significant differences in secondary outcomes. CONCLUSIONS: A hemostasis management pathway utilizing combined factor concentrates was associated with significantly reduced post-bypass transfusion requirements in pediatric pulmonary artery reconstruction. We observed a higher incidence of post-operative thromboembolism, with a twofold increase at 30 days, although statistical significance was not reached. The majority of post-operative thromboembolism was associated with indwelling lines. Prospective multicenter studies are needed to validate safety, efficacy and generalizability of utilizing combined factor concentrates in pediatric patients.