OBJECTIVES: Cerebrospinal fluid leak (CSFL) after craniotomy may incur serious sequelae, such as meningitis and hematoma. A porcine-derived fibrin sealant (FS) has been introduced and used in conjunction with sutures for dural closure at hospitals in China. This study aimed to evaluate the cost-effectiveness of using FS for the treatment of intraoperative CSFL.

METHODS: A decision tree was constructed in R 3.6.3 to assess the cost-effectiveness of using FS with sutures compared to sutures alone for treatment of intra-operative CSFL from the perspective of the Chinese healthcare system. Efficacy and safety information were extracted from a randomized, single-blinded clinical trial comparing the two interventions (NCT03110783). Costs were obtained through the analysis of real-world databases of provincial procurement costs. All costs were converted to USD based on the published exchange rate on 12/23/2020 (6.5400 RMB to 1 USD). The effectiveness of the interventions was measured both as the success rate of CSFL treatment and as the reduction of postoperative complications.

RESULTS: The CSFL treatment success rate was higher in patients using FS with sutures than using sutures alone (97.8% vs. 49.2%). Postoperative complication rates were lower for the group with FS (9.5% vs. 14.5%). Higher costs for using FS ($248.5 vs. $7.7) were offset by savings from higher treatment success rate and lower post-operative complication rates. The FS group saved $375.0 in additional CSFL repairs compared to the sutures group ($18.1 vs. $393.0), and $66.7 in treatment for complications ($131.9 vs. $198.6). Total costs per patient were lower by $200.8 in the FS plus suture group ($398.5 vs. $599.3).

CONCLUSIONS: The cost effectiveness analysis demonstrated that using FS with sutures could provide improved clinical outcomes at reduced costs. FS used in combination with sutures was the dominant strategy vs sutures alone for the treatment of intra-operative CSFL.