Characteristics Associated with Mortality in 623 Patients Who Received Recombinant Factor VIIa for Bleeding in Cardiac Surgery

Authors: Mitchell, A; Lorbiecki, K; Alkhatib, C; Gessouroun, A; He, J; Kim, J; Zoubek, S; Whisenhunt, M; Zorn, T; Flynn, BC

Affiliations: University of Kansas Medical Center, Kansas City, KS. Department of Anesthesiology, University of Kansas Medical Center. Kansas City, KS. Department of Biostatistics, University of Kansas Medical Center. Kansas City, KS. Department of Pharmacy, University of Kansas Medical Center. Kansas City, KS. Department of Cardiac Surgery, University of Kansas Medical Center. Kansas City, KS. Department of Anesthesiology, Division of Critical Care, University of Kansas Medical Center.

Publication: Journal of Cardiothoracic and Vascular Anesthesia; 2025; 39. 2948–2952

ABSTRACT: OBJECTIVES Activated recombinant factor VII (rFVIIa) has been used to treat cardiac surgical bleeding in an off-label manner. Due to the high risk of mortality with ongoing hemorrhage, assessing the risk of potential thrombotic effects of rFVIIa administration is important. This report analyzes the characteristics associated with mortality in patients who received very-low-dose rFVIIa for nonsurgical bleeding. DESIGN A retrospective cohort study. SETTING A tertiary care hospital. PARTICIPANTS There were 7,724 patients who had cardiac surgery from January 2012 to January 2025 with 623 receiving rFVIIa. The average dose of rFVIIa given was 18 μg/kg (min-max, 6-55 μg/kg). INTERVENTIONS rFVIIa was administered perioperatively in doses of 0.5- to 1-mg aliquots.

MEASUREMENTS AND MAIN RESULTS Of the 623 patients, 66 died and 557 survived. The median dose of rFVIIa given was not different in survivors versus nonsurvivors (2.17 v 2.79 mg, respectively; p = 0.001). Procedure type was associated with mortality (p = 0.004) as patients receiving rFVIIa for heart transplant, ventricular assistance device, or other complex procedure had a mortality rate of 29.5%. with the majority of these being ventricular assist device patients. Those who underwent aortic procedures (n = 250) had a mortality rate of 12.4%. Of the 103 patients undergoing coronary artery bypass grafting who received rFVIIa, all but one patient survived. Mortality was higher in patients who had emergent or urgent surgical procedures (p < 0.001), preoperative cardiogenic shock (p = 0.021), longer cardiopulmonary bypass time (p = 0.005), postoperative cardiac arrest (p = 0.001), and received more blood products (p < 0.001). There were no associations between mortality and stroke (p = 0.071) or infections (p = 1.00). CONCLUSION rFVIIa can be administered to cardiac surgical patients with characteristics associated with mortality that are similar to cardiac surgical patients who did not receive rFVIIa.