Survey of the Use of Fibrinogen Concentrate during Cardiovascular Surgery in Japan / 日本心臓血管外科学会雑誌

ABSTRACT

Background: A review committee for unapproved and off-label drugs with high medical needs determined that the indication of fibrinogen concentrate for cardiovascular surgery would be publicly acceptable in 2021. However, the Japanese Society of Cardiovascular Surgery is required the conduct of several surveys demonstrating that fibrinogen concentrate can be used properly in medical settings. A questionnaire concerning the use of fibrinogen concentrate in cardiovascular surgery was one such required survey. Methods: A questionnaire concerning the use of fibrinogen concentrate was conducted in December 2021 at 551 certified training facilities of the Japanese Board of Cardiovascular Surgery, and responses were received from 375 facilities (68%). Results: Fibrinogen concentrate was used in 98 centers (26%). Aortic surgery (thoracic/thoracoabdominal) (50%) and cardiac redo surgery (24%) were eligible common surgeries requiring fibrinogen concentrate, and the intraoperative measurement of fibrinogen levels was performed in 77% of centers. The triggers for the use of fibrinogen concentrate were a fibrinogen level <150 mg/dl in 30%, <100 mg/dl in 20% and massive bleeding tendency in 40%. Of note, only 39 facilities (10%) were able to prepare cryoprecipitate in-hospital, and 34 centers (9%) used it for cardiovascular surgery. One hundred and seven centers (29%) planned to apply for facility accreditation for the use of fibrinogen concentrate, and 40 facilities (10%) answered that they would decide based on the situation. The expected number of annual cases in which fibrinogen concentrate would be used for cardiovascular surgery reached 4,860 cases <10 cases in 52 centers, 10-19 cases in 50 centers, 20-49 cases in 31 centers, 50-99 cases in 12 centers and ≥100 cases in 2 centers. Conclusion: We conducted a questionnaire on the use of fibrinogen concentrate. Intraoperative fibrinogen level measurement was performed at approximately 80% of institutions, and the annual number of cases likely to use fibrinogen concentrate was predicted to reach about 5,000 cases. However, only 10% of centers used cryoprecipitates prepared in-hospital.