OBJECTIVES Postoperative hemorrhage is a recognized complication of pediatric cardiac surgery. Both the immature coagulation system and increased susceptibility to hemodilution increase the likelihood of pediatric patients developing coagulopathy when compared with adult counterparts. Treatment options remain limited. Recombinant factor VII (rFVIIa) is a hemostatic agent increasingly used to reduce hemorrhage in other surgical settings, the role of which is
unclear in this population. This article systematically reviews the published literature on the use of rFVIIa in pediatric cardiac surgery. DATA SOURCES AND STUDY SELECTION A systematic literature search identified reports of rFVIIa administration in pediatric patients undergoing cardiac surgery. Where possible, individual patient-specific data were extracted and pooled statistical analysis was performed. DATA EXTRACTION AND SYNTHESIS Twenty-nine articles reporting on the administration of rFVIIa to 169 patients were identified. rFVIIa has been administered to patients with predefined congenital abnormalities of hemostasis to arrest hemorrhage refractory to other interventions and prophylactically in the hope of reducing blood loss. Treatment regimens vary widely, in terms of both first and cumulative dose. Data on chest tube blood loss and two markers of coagulation were pooled and analyzed, and significant improvements were demonstrated. Mortality was 4.4% for the entire cohort but 20% of patients on extracorporeal membrane oxygenation suffered significant thromboembolic complications. CONCLUSIONS rFVIIa has an increasingly accepted role in the management of patients with congenital coagulopathies undergoing major surgery. However, randomized trials are required to define the role of rFVIIa as an adjunct to control major hemorrhage in the pediatric cardiac surgical population. Any future work must focus not only on benefits but also on patient safety, particularly, risk of morbid thromboembolic complication.