614 c  2008 Wiley Periodicals, Inc. Factor Eight Inhibitor Bypassing Activity (FEIBA) for Refractory Bleeding in Cardiac Surgery: Review of Clinical Outcomes Leora B. Balsam, M.D., Tomasz A. Timek, M.D., and Marc P. Pelletier, M.D. Stanford Program in Cardiac Surgery at El Camino Hospital, Mountain View, California ABSTRACT Background: Refractory postoperative bleeding complicates a significant number of cardiac sur- gical procedures and results in both morbidity and mortality. Conventional strategies to effect hemostasis include surgical reexploration and administration of blood products. In some cases, bleeding remains in- tractable despite these methods, and alternatives are needed. Herein, we report our experience with the use of factor eight inhibitor bypassing activity (FEIBA), a coagulation factor concentrate, for refractory post- operative bleeding. Methods: A retrospective review of the experience with FEIBA at a university-affiliated cardiac surgery program between February 2004 and January 2007 was performed. Results: Sixteen patients received FEIBA for refractory postoperative bleeding. The majority (69%) received a single dose, either in- traoperatively or postoperatively. The recipients of multiple doses were more likely to undergo operative reexploration. Blood product utilization and hourly chest tube output were decreased significantly following administration of FEIBA. Three deaths occurred (19%), two from multisystem organ failure and one from respiratory failure. Thrombotic events included the development of a clotted hemothorax in one patient and distal extremity ischemia in another. Conclusions: FEIBA administration is associated with decreased blood product utilization and chest tube output in patients with refractory postoperative bleeding. doi: 10.1111/j.1540-8191.2008.00686.x (J Card Surg 2008;23:614-621) Excessive blood loss following cardiac surgery oc- curs in up to 10% of cases and is a predictor of neg- ative outcome. 1 The risk factors for such bleeding in- clude increased patient age, cardiopulmonary bypass (CPB) time over 150 minutes, nonelective surgery, re- operation, preoperative renal or liver dysfunction, and preoperative use of antiplatelet agents. 2-4 The treat- ment begins with careful attention to hemostasis in the operating room and continues with conventional therapies including reversal of heparin effect with pro- tamine, transfusion of blood products, and correction of hypothermia. Reoperation for bleeding occurs in 3 to 5% of cardiac cases and is an independent risk factor for morbidity and mortality. 5-7 In patients undergoing reexploration, a surgical source of bleeding is found in approximately 50% of cases. 6-8 In the remainder, dif- fuse bleeding secondary to a generalized coagulopathy is noted. A variety of factors contribute to the coagulopathy in cardiac surgery patients. 8,9 Preoperative risk factors include pre-existing disease states (eg, renal or liver dysfunction) and exposure to certain drugs, including Address for correspondence: Leora B. Balsam, M.D., Department of Cardiothoracic Surgery, Stanford University School of Medicine, Falk Cardiovascular Research Building, 300 Pasteur Drive, Stanford, CA 94305. Fax: +650-725-3846; e-mail: lbalsam@stanford.edu thrombolytics, aspirin, clopidogrel, and coumadin. CPB adversely affects the hemostatic system in a variety of ways. The platelet number falls secondary to hemodi- lution, and platelet function is impaired by hypothermia and contact with the CPB circuit. Coagulation factor lev- els fall secondary to hemodilution. Fibrinolysis is aug- mented, likely due to the release of tissue plasminogen activator and endothelial cell activation. Finally, incom- plete heparin reversal following CPB can contribute to the coagulopathy. 8 In some patients, refractory blood loss continues despite conventional therapy. Refractory blood loss depletes hospital resources, including blood product supply, and can result in hemodynamic instability and end organ damage. Moreover, massive blood product transfusion is associated with adverse outcomes, in- cluding transfusion-associated lung injury, transfusion reactions (hemolytic and nonhemolytic), and transmis- sion of viruses, and in the cardiac surgery patient, can result in volume overload, myocardial edema, and car- diac dysfunction. In such patients, rescue therapy with antifibrinolytics, desmopressin, and recombinant factor VII has been described. 8 Factor eight inhibitor bypassing activity (FEIBA) is a plasma-derived activated prothrombin complex con- centrate that is Food and Drug Administration ap- proved for the prophylaxis and treatment of bleeding in hemophilia patients with neutralizing antibodies to