Recombinant factor VIIa to control excessive bleeding following surgery for congenital heart disease in pediatric patients.

The purpose of this article is to evaluate the efficacy of recombinant factor VII (rFVIIa) in the treatment of bleeding following cardiac surgery in a pediatric population. The study included a case series of postcardiac surgical patients with chest tube output of = 4 mL/kg/h for the initial 3 postoperative hours who received rFVIIa. Chest tube output for the 3 hours before and the 3 hours after rFVIIa was compared using a paired t test. In addition, chest tube output for the initial 3 postoperative hours and the 3 hours following rFVIIa was compared to 8 control patients who did not require rFVIIa. Recombinant factor VIIa was administered to 9 children (age = 9 +/- 4 years) following repair of tetralogy of Fallot (6), closure of ventricular septal defect (1), closure of sinus venosus atrial septal defect (1), and mitral valve repair (1). Chest tube output for the initial 3 postoperative hours prior to the administration of rFVIIa was 5.8 +/- 2.8 mL/kg/h and decreased to 2.0 +/- 1.3 mL/kg/h for the 3 hours following the administration of rFVIIa (P =.002). In the patients that did not receive rFVIIa, chest tube output for the first 3 postoperative hours was 1.6 +/- 0.9 mL/kg/h and 1.2 +/- 0.6 mL/kg/h for the next 3 hours (P = nonsignificant when compared to chest tube output for the 3 hours following rFVIIa in patients who received rFVIIa). No adverse effects were noted. Recombinant factor VIIa decreased chest tubing bleeding following cardiac surgery in children. Given its potential therapeutic impact, rFVIIa warrants further investigation in the pediatric cardiac population.