Recombinant activated factor VIIa in patients of cardiovascular surgery is save and effective

Objectives: Hemorrhage is a major complication after cardiovascular surgery with associated morbidity and mortality. This study analyses outcomes after use of recombinant factor VII (rVII) in cardiovascular patients with severe bleeding.

Methods: All patients excluding VAD and pediatric cases who received rVII after cardiovascular surgery at a University Medical Center between 01/2005 and 05/2006 were included in this retrospective study. Primary endpoint was survival, bleeding and side effects after therapy with rVII.

Results: Thirty two adult patients received 67±23µg/kg of rVII. Surgical procedures included coronary artery bypass grafting N=8, valve replacement N=8, type A dissection N=12, others N=4. All patients were bleeding with high drainage output prior to treatment and received massive transfusion of 15±10 packed red blood cells, 15±10 fresh frozen plasma, 11±11 platelets). rVII was given either intraoperatively (N=5), in the early postoperative phase (N=27) or after the first surgical revision (N=4). Overall success rate, i.e. cessation of bleeding, was accomplished in 29 patients (91%). In 23 patients (71%), application of rVII alone stopped the bleeding. A total of 9 patients needed an additional surgical intervention for hemostasis (7 non-surgical, 2 surgical causes). Four out of these nine patients received rVII after revision. Overall mortality was 25% (8/32). Five died of MOF after cessation of bleeding, three patients died with ongoing hemorrhage. No major side effects were observed.

Conclusion: Recombinant activated factor VIIa in patients of cardiovascular surgery appears save and effective and can stop bleeding even after massive transfusion with severe coagulopathy. The associated morbidity seems low with no major side effects observed.