Abstract 17412: Comparative Study of Factor Eight Inhibitor Bypass Activity and Recombinant Activated Factor VII in Refractory Post-Cardiopulmonary Bypass Bleeding
Introduction. Profuse post-CPB bleeding occurs in up to 29% of cardiac surgical patients. Studies have shown rFVIIa to be a useful rescue procoagulant in bleeding refractory to conventional hemostatic measures. Recently, FEIBA, available for <30% the cost of rFVIIa, has also been utilized in this setting. While efficacious, both compounds have been associated with thromboembolic events. This retrospective cohort study compares FEIBA and rFVIIa in treating refractory post-CPB bleeding.
Methods. We reviewed records of all adult cardiac surgical patients who received FEIBA or rFVIIa from January 1, 2005 to September 30, 2010. Primary outcomes included total numbers of thromboembolic events in the first 30 post-operative days. Secondary outcomes included 30-day mortality, transfusion requirements prior to and after FEIBA or rFVIIa administration, and number of reoperations for excessive bleeding.
Results. Of 2619 cases performed during the study period, 107 patients received FEIBA, and 61 received rFVIIa. There were no significant demographic differences between the cohorts, but patients in the rFVIIa group had significantly longer CPB times (305 v. 244 min) and were more frequently undergoing reoperations (56% v. 35%). There were no differences in the number of thrombembolic events, 30-day mortality, re-operations for bleeding, or overall transfusion requirements with the exception of platelets (FEIBA 1.7 v. rFVIIa 3.1). The most common thrombotic events in the FEIBA and rFVIIa cohorts were pulmonary embolism (5.6%) and stroke (6.6%), respectively.
Discussion. This study contains the largest case series of FEIBA utilization in cardiac surgical patients to date, and suggests that FEIBA and rFVIIa may have similar efficacy and safety profiles when used for refractory post-CPB bleeding. FEIBA may represent an economically viable alternative to rFVIIa in this setting. Further studies are required to define the roles of these procoagulants in cardiac surgery.
- © 2011 by American Heart Association, Inc.