Recombinant activated factor VII in cardiac surgery

Background and objective: Recombinant activated factor VII (rFVIIa) is a pharmacologic compound approved for the use in patients with congenital or acquired hemophilia and inhibiting antibodies toward factor VIII or IX. In recent years its use has been proposed in surgical patients demonstrating a lifethreatening bleeding, refractory to the standard therapies. The present study is a review of the clinical information available on the use of rFVIIa in cardiac surgery patients. Methods: Current literature was investigated using a Pubmed search with appropriate key words (rFVIIa OR recombinant activated factor VII AND cardiac surgery). Results: 35 articles were found. These are 11 case reports, 12 case series, 5 review articles, 3 retrospective studies, 2 letters to the Editor, and only one prospective, double-blinded, randomized clinical trial (RCT). The majority of the case reports and case series report a beneficial effect of this drug in the treatment of refractory bleeding. Comparative retrospective studies show conflicting results, and the only RCT demonstrate a significant reduction of allogeneic blood products use in patients treated with rFVIIa. No definitive information is available with respect to thromboembolic complications and general safety of this therapy. Conclusions: rFVIIa is a promising agent for intractable bleeding in surgical patients. However, large prospective randomized trials are needed to define efficacy, dose, and potential side-effects.