CHARACTERIZATION OF THROMBOEMBOLIC EVENTS AFTER RECOMBINANT COAGULATION FACTOR VIIa (rFVIIa - NOVOSEVEN®) USE IN CARDIAC SURGERY: A DESCRIPTIVE PILOT STUDY

Authors: Boden, D; Bouchand, C; David, C-H; Rigal, J-C; Bonsergent, M

Affiliations: Pharmacy department, Nantes University Hospital, 44000 Nantes, France. Pharmacy department, Nantes University Hospital, 44000 Nantes, France. Cardio-thoracic surgery department, Nantes University Hospital, 44000 Nantes, France. Anesthesia and surgical intensive care department, Nantes University Hospital, 44000 Nantes, France.

Publication: Annales pharmaceutiques francaises; 2025

ABSTRACT: OBJECTIVES: Cardiac surgery carries a high risk of bleeding. In the event of massive bleeding, the administration of rFVIIa may be necessary. However, due to the thromboembolic risk, the use of this factor is only recommended for severe bleeding that does not respond to standard treatments. Our aim was to describe the use of rFVIIa in bleeding situations in cardiac surgery and the thromboembolic events after administration. METHODS: This is a monocentric observational study including patients who received rFVIIa from January 2019 to December 2021 for the treatment of massive bleeding associated with cardiac surgery. Data collected included population characteristics, surgery, bleeding management, rFVIIa prescription and incidence of postoperative thromboembolic events. RESULTS: A total of 67 patients were included. Most of the operations were for aortic dissection (46%) and valve replacement (33%), and 54% of the cases were urgent procedures. Labile blood products were systematically used in the treatment of bleeding. The average total dose of rFVIIa per patient was 10 ± 5 mg, i.e. an average total dose/weight of 129 ± 67 μg/kg. Postoperative thromboembolic events occurred in 22 patients (33%), in 73% of cases in the superior vena cava (head, neck and upper extremities). CONCLUSIONS: Our study allowed us to describe the use of rFVIIa in massive bleeding in cardiac surgery. The average total dose of rFVIIa administered was higher in patients with thromboembolic events than in those who did not. A more robust study will be conducted to investigate the attributability of rFVIIa to the occurrence of postoperative thromboembolic events.