OBJECTIVE:Postcardiopulmonary bypass hemorrhage remains a serious complication of cardiac surgery. Given concerns regarding adverse effects of blood product transfusion and limited efficacy of current antifibrinolytics, procoagulant medications, including recombinant factor VIIa (rFVIIa) and factor eight inhibitor bypass activity (FEIBA), increasingly have been used in managing refractory bleeding. While effective, these medications are associated with thromboembolic complications. This study compared the efficacy and risk of adverse events of rFVIIa and FEIBA in cardiac surgical patients with refractory bleeding.DESIGN:This retrospective study evaluated 168 patients who underwent cardiac surgery and received either FEIBA or rFVIIa to manage postbypass hemorrhage. Demographic, clinical, and outcomes data were collected and statistical analysis performed to compare thromboembolic event rates, relative efficacy, and 30-day mortality following administration of these medications.SETTING:Single university hospital.PARTICIPANTS:Patients undergoing cardiac surgery.INTERVENTIONS:None.MEASUREMENTS AND MAIN RESULT:Sixty-one patients received rFVIIa, and 107 received FEIBA. Demographics, surgical procedures, and preoperative anticoagulation were similar between the cohorts; however, the rFVIIa cohort had longer durations of cardiopulmonary bypass (305.1 v 243.8 min, p<0.01). There were no significant differences in the number of thromboembolic events, 30-day mortality, or rates of revision surgery. Neither group demonstrated a clear relationship between dosage and occurrence of thromboembolic events. The rFVIIa cohort received more platelets than the FEIBA cohort (3.13 v 1.67 units, p = 0.01), but transfusion rates of other blood products were similar.CONCLUSIONS:This study suggests that rFVIIa and FEIBA have similar efficacy and adverse event profiles in managing intractable postbypass hemorrhage in cardiac surgical patients. Further prospective studies are required.

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.

IntroductionProfuse bleeding following cardiac surgery due to coagulopathy is a major problem, requiring multiple blood products. Recently recombinant activated Factor VII (rFVIIa) has been introduced to acutely promote haemostasis [1Levy J.H. Tanaka K.A. Prohemostatic agents to prevent perioperative blood loss.Semin Thromb Hemost. 2008; 34: 439-444Crossref PubMed Scopus (8) Google Scholar]. Serious embolic complications have been reported. Factor VIII inhibitor bypass activity (FEIBA) is used as an alternative, with the same reported risk factors [2Turecek P.L. Váradi K. Gritsch H. et al.FEIBA: mode of action.Haemophilia. 2004; 10: 3-9Crossref PubMed Google Scholar]. This retrospective study presents a comparison between rFVIIA and FEIBA in two cohorts of bleeding patients.MethodThe data collection included the period January 1, 2005 until March 1, 2009. Out of 2,580 patients, two groups could be identified: 78 received rFVIIa and 59 FEIBA. The primary endpoints were the total number of embolic events of stroke, myocardial infarction (MI), deep vein thrombosis (DVT) and pulmonary embolism (PE). Secondary outcomes focused on 30 day mortality, amount of blood products used postoperatively and number of reoperations due to bleeding together with costs.ResultsThe two groups did not differ in demographics, types of surgery and bypass times. Mean dose: rVIIa 91.0 mcg/kg, FEIBA 19 units/kg. The outcomes for rVIIA vs. FEIBA were: stroke 7 vs. 1%, MI 1.4 vs. 1%, DVT 0 vs. 3%, PE 2.8 vs. 4%. Mortality was 15 vs. 10%, reoperations 25 vs. 15%. The amount of blood products used was similar. The costs of FEIBA were 25% of the rFVIIa costs.DiscussionBoth rFVIIa and FEIBA were introduced to treat patients with haemophilia. They are frequently used as procoagulants to treat intractable bleeding in surgical patients. The findings in this study confirm the reported serious embolic complications with both compounds, in spite of the relatively low dose. Since our findings suggest that FEIBA is as effective as rVIIA, but significantly cheaper, it may be preferred to rVIIa. IntroductionProfuse bleeding following cardiac surgery due to coagulopathy is a major problem, requiring multiple blood products. Recently recombinant activated Factor VII (rFVIIa) has been introduced to acutely promote haemostasis [1Levy J.H. Tanaka K.A. Prohemostatic agents to prevent perioperative blood loss.Semin Thromb Hemost. 2008; 34: 439-444Crossref PubMed Scopus (8) Google Scholar]. Serious embolic complications have been reported. Factor VIII inhibitor bypass activity (FEIBA) is used as an alternative, with the same reported risk factors [2Turecek P.L. Váradi K. Gritsch H. et al.FEIBA: mode of action.Haemophilia. 2004; 10: 3-9Crossref PubMed Google Scholar]. This retrospective study presents a comparison between rFVIIA and FEIBA in two cohorts of bleeding patients.