Recombinant activated factor VII: Treating postoperative hemorrhage in cardiac surgery

Abstract

Background. The purpose of this study is to review the effect of recombinant activated factor VII (rFVIIa) as rescue therapy in continuing severe postoperative hemorrhage, despite conventional measures in a series of cardiac patients at our institution. Methods. A series of all patients who received rFVIIa as rescue therapy for uncontrollable postoperative hemorrhage after cardiac surgery over a 2-year period was analyzed. We assessed and compared the use of blood products, coagulation indicators (international normalized ratio [INR], activated partial thromboplastin [APTT], and fibrinogen), and platelet levels immediately before and after the rFVIIa was given. Results. Twelve patients received rFVIIa. Eight patients (75%) had thoracic aortic surgery. Bleeding stopped in all cases. Prior to the administration of rFVIIa, mean blood product usage was the following: fresh frozen plasma (FFP) 18.7 units (range, 10-40); packed cells 7.7U (range, 0-18); cryoprecipitate 19.5U (range, 8-32); and platelets 22.5U (range, 10-40). The mean coagulation results immediately prior to rFVIIa were the following: INR 2.0 (range, 1.3-8.5); APTT 60 seconds (range, 30-220); fibrinogen 3.2 gm/L (range, 1.6-6.4), and platelet count was 174,000 (range, 78,000-257,000). After rFVIIa administration the mean blood product usage was the following: FFP 0U (range, 0-2); red cells 0U (range, 0-1); cryoprecipitate 0 (range, 0); and platelets 0 (range, 0); p less than 0.0005. The mean INR was 0.9 (range, 0.7-1.5), p less than 0.001; mean APTT was 42 seconds (range, 30-87), mean fibrinogen was 3.1 (range, 1.7-4.5), and the mean platelet count was 170,000 (range, 93,000-289,000); p values not significant. There were no thrombotic complications, no cardiac ischemic events, and no deaths. Conclusions. Our results support the use of rFVIIa as rescue therapy in severe, uncontrollable, nonsurgical, postoperative hemorrhage after cardiac surgery as efficacious and safe. © 2006 by The Society of Thoracic Surgeons.