Safety and efficacy of prothrombin complex concentrates for the treatment of coagulopathy after cardiac surgery.

OBJECTIVE: Coagulopathy is an important cause of bleeding after complex cardiac surgery. The conventional treatment for coagulopathy is transfusion, which is associated with adverse outcomes. We report our initial experience with the prothrombin complex concentrate FEIBA (factor VIII inhibitor bypassing activity) for the rescue treatment of coagulopathy and life-threatening bleeding after cardiac surgery. METHODS: Twenty-five patients who underwent cardiac surgery with coagulopathy and life-threatening bleeding refractory to conventional treatment received FEIBA as rescue therapy at our institution. This cohort represents approximately 2% of patients undergoing cardiac surgery in our university-based practice during the study. RESULTS: The patients were at high risk for postoperative coagulopathy with nearly all patients having at least 2 risk factors for this. Aortic root replacement (Bentall or valve-sparing procedure) and heart transplant with or without left ventricular assist device explant were the most common procedures. The mean FEIBA dose was 2154 units. The need for fresh frozen plasma and platelet transfusion decreased significantly after FEIBA administration (P = .0001 and P < .0001). The mean internationalized normalized ratio decreased from 1.58 to 1.13 (P < .0001). Clinical outcomes were excellent. No patient returned to the operating room for reexploration. There was no hospital mortality and all patients were discharged home. One patient who had a central line and transvenous pacemaker developed an upper extremity deep vein thrombosis. CONCLUSIONS: Our initial experience with FEIBA administration for the rescue treatment of postoperative coagulopathy and life-threatening bleeding has been favorable. Further studies are indicated to confirm its efficacy and safety and determine specific clinical indications for its use in patients undergoing cardiac surgery.