TachoSil

TachoSil is a collagen sponge coated with the human coagulation factors fibrinogen and thrombin.

The sponge is manufactured from horse tendons. TachoSil reacts upon contact with blood, other body fluids, or saline to form a clot that glues it to the tissue surface. Hemostasis is reached in a few minutes, and the sponge is absorbed by the body within several weeks.

Corza has acquired the assets and licenses that support the development and commercialization of TachoSil®, while Takeda maintains ownership of the manufacturing facility in Linz, Austria.

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• Dura Closure Tactics to Prevent CSF Leakage in Microvascular Decompression Surgery
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Some patients experience hypersensitivity or allergy. In rare cases, it could turn into a severe hypersensitive reaction. Those who are prone to having a systemic reaction to horse proteins or human blood products are not good candidates for use of TachoSil.

Among the several autologous fibrin sealants (FS) available, TachoSil(®) (Takeda Austria GmbH, Linz, Austria) stands out for its hemostatic and aerostatic properties, the latter being demonstrated even in high-risk patients after pulmonary resections for primary lung cancers. Several papers available in the literature demonstrated TachoSil(®)'s effectiveness in controlling intraoperative and postoperative bleeding in different surgical branches, including hepatic and pancreatic surgery, as well as cardiac and thoracic surgery. However, the use of TachoSil(®) to control diffuse bleeding following major resections for advanced lung cancers, with the requirement of the chest wall and vertebral body resection for oncological radicality, was never published so far. In this paper, we report three cases of pulmonary lobectomy associated with chest wall resection and hemivertebrectomy for primary malignant lung neoplasms and for a recurrence of malignant solitary fibrous tumor of the pleura in which we used TachoSil(©), which demonstrated its efficacy in controlling diffuse bleeding following resection ¹⁾ in the management of diffuse bleeding after chest wall and spinal surgical resection for aggressive thoracic neoplasms. J Thorac Dis. 2016 Jan;8(1):E152-E156. PubMed PMID: 26904247. )).

It is used during surgery to stop local bleeding on internal organs (hemostasis). The sponge is manufactured from horse tendons. TachoSil reacts upon contact with blood, other body fluids, or saline to form a clot that glues it to the tissue surface. Hemostasis is reached in a few minutes, and the sponge is absorbed by the body within several weeks.

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 ²⁾.

Spitaels et al. aimed to compare the efficacy of a fibrin-coated collagen fleece (TachoSil) versus a dural sealant (DuraSeal) to prevent postoperative CSF leakage. We perform a retrospective study comparing two methods of sellar closure during endoscopic endonasal transsphenoidal surgery (EETS) for pituitary neuroendocrine tumor resection: TachoSil patching versus DuraSeal packing. Data concerning diagnosis, reconstruction technique, and surgical outcomes were analyzed. The primary endpoint was the postoperative CSF leak rate. We reviewed 198 consecutive patients who underwent 219 EETS for pituitary neuroendocrine tumor between February 2007 and July 2018. Intraoperative CSF leak occurred in 47 cases (21.5%). A total of 33 postoperative CSF leaks were observed (15.1%). A reduction of postoperative CSF leaks in the TachoSil application group compared to the conventional technique using Duraseal was observed (7.7% and 18.2%, respectively; p = 0.062; Pearson exact test) although non-statistically significant. Two patients required lumbar drainage, and no revision repair was necessary to treat postoperative CSF rhinorrhea in the Tachosil group. Fibrin-coated collagen fleece patching may be a valuable method to prevent postoperative cerebrospinal fluid (CSF) leaks during EETS for pituitary neuroendocrine tumor resection ³⁾.

The use of TachoSil® as a dural sealant in intradural extramedullary tumors surgery ⁴⁾.

662 patients undergoing craniotomy were included. Three hundred fifty-two were treated with dural sutures alone, and in 310, TachoSil was added after the primary suture. Our primary endpoint was the rate of postoperative complications associated with CSF leakage. Secondary endpoints included functional, disability, and neurological outcomes. A systematic review according to PRISMA guidelines was performed to identify studies comparing primary dural closure with and without additional sealants. Postoperative complications associated with CSF leakage occurred in 24 (7.74%) and 28 (7.95%) procedures with or without TachoSil, respectively (p = 0.960). Multivariate analysis confirmed no significant differences in complication rates between the two groups (aOR 0.97, 95% CI 0.53-1.80, p = 0.930). There were no significant disparities in postoperative functional, disability, or neurological scores. The systematic review identified 661 and included 8 studies in the qualitative synthesis. None showed significant superiority of additional sealants over standard technique regarding complications, rates of revision surgery, or outcome. According to our findings, we summarize that the routinary use of TachoSil and similar products as adjuncts to primary dural sutures after intracranial surgical procedures is safe but without a clear advantage in complication avoidance or outcome. Future studies should investigate whether their use is beneficial in high-risk settings ⁵⁾.

A case of a patient who underwent cervical arthroplasty complicated by an anterior meningocele 1 month after the first surgery. Imaging revealed a compressive anterior meningocele in relation to the clinically progressive worsening. Revision surgery consisted of a combination of closure of the gap with a fatty patch covered with a TachoSil patch, followed by reinsertion of a new cervical prosthesis. At the last follow-up at 1 year, the patient showed no residual effects of the complication, and the mobility of the disc prosthesis was not impaired by it. Clinical results of the arthroplasty are also very satisfactory. Although these types of complications are rare, it is important to have a consensus on the management of anterior meningocele. TachoSil appears to be a satisfactory option for the management of these complications ⁶⁾.