Recombinant activated factor VII: treating postoperative hemorrhage in cardiac surgery.

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.