Thrombotic risk of recombinant factor seven in pediatric cardiac surgery: a single institution experience.

Background: Recombinant activated factor seven (rFVIIa) is increasingly being used as a hemostatic adjunct in pediatric cardiac surgery. We evaluated the thrombotic safety profile of rFVIIa in pediatric congenital heart disease (CHD) surgery.

Methods: This was a retrospective matched case-control study over six years at a single institution. Patients who received rFVIIa after CHD surgery were matched to controls based on age, diagnosis, and procedure. We compared thrombosis, hemorrhage, transfusions, length of stay, and repeat procedures between groups.

Results: Twenty-five patients received rFVIIa (mean dose: 70 mcg/kg); 50 controls were matched. There was no significant difference in the rate of thrombosis between patients who received rFVIIa and controls (8% vs 4%). After rFVIIa, there was a significant reduction in transfusion volume (median 77.1 mL/kg vs 14.6 mL/kg; p < 0.001) as well as a significant decrease in hemorrhagic chest tube output (8.3 +/- 1.6 mL/kg/hour vs 1.4 +/- 0.3 mL/kg/hour; mean +/- standard error of the mean; p < 0.001). No difference was seen in intensive care unit or hospital length of stay or mortality between patients receiving rFVIIa and controls.

Conclusions: The rFVIIa therapy did not increase thrombotic complications when used as rescue therapy after CHD surgery but did appear to decrease bleeding complications in this small cohort.