Factor VIII inhibitor bypass activity and recombinant activated factor VII in cardiac surgery.

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.