Reduced thrombotic risk with recombinant factor VIIa in neonatal cardiac surgery

The study objective was to assess the effect of intraoperative recombinant factor VII administration on postoperative outcomes in neonates.

Neonates were identified who underwent arterial switch operation, tetralogy of Fallot repair, aortic arch reconstruction, or interrupted aortic arch with ventricular septal defect repair between 2015 and 2022. Patients who received 15 mL/kg or more cryoprecipitate or 24 mL/kg or more platelets intraoperatively were included to create comparable groups. Inverse probability of treatment weighting was used to account for covariate imbalance. Generalized Poisson regression was used to analyze count data for thrombotic events. Linear regression was used for continuous outcomes.

There were 364 neonates who underwent the operations of interest. After exclusions, 33 patients received recombinant factor VII and 122 patients received a large volume of blood product transfusion but did not receive recombinant factor VII. After adjusting for covariates with inverse probability of treatment weighting, no differences in duration of intubation, intensive care unit or hospital length of stay, 30-day mortality, volume of postoperative transfusion, or rate of arterial thrombi were observed with recombinant factor VII administration. The rate of total thrombi (rate ratio: 0.27, 95% CI, 0.08-0.90, P = .03) and deep vein thrombi (rate ratio: 0.12, 95% CI, 0.02-0.70, P = .02) were significantly less with recombinant factor VII administration.

The rates of thrombosis appeared to be less in patients who received recombinant factor VII. This was driven by lower venous thrombotic complications. These findings suggest that factor VII remains a viable option in the setting of severe, uncontrolled bleeding in neonates undergoing congenital cardiac surgery.