Recombinant activated factor seven in pediatric cardiac surgery—does thrombotic risk outweigh hemostatic benefit?

Therapies employed to attenuate perioperative bleeding following cardiopulmonary bypass (CPB) in children include antifibrinolytic therapy, allogenic blood product transfusion, and recombinant factor concentrates. Recombinant activated factor seven (rFVIIa) (Novoseven RT, Novo Nordisk A/S, Denmark) is a factor concentrate with federal drug administration (FDA) approval for treatment of bleeding in Hemophilia A and B with inhibitors, Congenital Factor Seven deficiency, and Glanzmann’s Thrombasthenia. Off label rFVIIa is frequently administered as rescue therapy for recalcitrant perioperative bleeding post-CPB and has been linked to decreased transfusion requirements, chest tube output, and need for surgical re-exploration (1-3). However, concerns remain regarding the safety of rFVIIa in this setting, specifically related the development of thrombotic complications (4).