Validation of Efficacy and Safety of TachoSil® Tissue Sealant for Vessel Transposition in Microvascular Decompression

Abstract

BACKGROUND AND OBJECTIVES: Use of TachoSil® as the transposition material of microvascular decompression (MVD) for hemifacial spasm (HFS) and trigeminal neuralgia (TN) is easy and safe to perform, but the efficacy and safety of this technique are unknown. This study attempted to validate the efficacy and safety of TachoSil® as a transposition material of MVD. METHODS: A retrospective study of the surgical results and complications of 63 patients (35 HFS and 28 TN) treated by the TachoSil® technique between January 2011 and December 2021 was conducted. The efficacy of the treatment was evaluated by Kaplan–Meier survival analysis. Magnetic resonance imaging follow-up study was performed to detect any adverse events including a mass formation. RESULTS: The rate of complete disappearance of HFS was 91.4% at 1 year and estimated to be 85.7% after a 10-year follow-up. The rate of no pain without medication for TN was 85.4% at 1 year and estimated to be 69.0% after a 9-year follow-up. These surgical results are comparable with those previously reported. Flaking of TachoSil® releasing the offending artery was only recognized in one case (1.6%). Therefore, TachoSil® can be considered as an effective transposition material for MVD. TachoSil® did not increase the rate of acute and subacute adverse events such as inflammation and delayed facial palsy. Magnetic resonance imaging follow-up identified no abnormalities including mass that suggested granuloma formation. CONCLUSION: The efficacy of the TachoSil® technique for HFS and TN and the reliability of TachoSil® as an adhesive material in MVD were verified. No adverse events associated with TachoSil® use in MVD were found. We conclude that the TachoSil® technique has relatively long efficacy and safety for MVD.