TY - JOUR
T1 - Effectiveness and safety of Tachosil® as a ventricular sealant
T2 - an observational cohort study
AU - Teixidor-Rodríguez, Pilar
AU - Brugada-Bellsolà, Ferran
AU - Menéndez-Girón, Sebastián
AU - Tardáguila-Serrano, Manuel
AU - González-Crespo, Antonio
AU - Nuñez-Marín, Fidel
AU - Montané, Eva
AU - Busquets-Bonet, Jordi
AU - Muñoz-Narbona, Lucia
AU - Domínguez-Alonso, Carlos Javier
N1 - © 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Austria, part of Springer Nature.
PY - 2024/9/27
Y1 - 2024/9/27
N2 - PURPOSE: Surgery close to or in contact with the ventricular system is challenging due to the complications. We sought to evaluate the effectiveness and safety of TachoSil® as a ventricular sealant in preventing complications after cranial surgery with an open ventricular system (OVS).METHODS: This is a single-center and prospective cohort study We included patients who underwent elective surgery for supratentorial craniotomy and periventricular pathology between December 2020 and November 2023. We registered surgical complications arising from CSF dynamics (such as percutaneous cerebrospinal fluid (CSF) leakage, hydrocephalus, pseudomeningocele), infections, and other complications (postsurgical hematoma) adverse drug reactions (ADRs), reintervention or hospital readmission up to 90 days after surgery.RESULTS: Forty interventions were performed on 39 patients, whose median age was 56 years. Eleven patients (28.2%) had antecedents of previous surgery in the same location, 5 (12.8%) had previously received radiotherapy and chemotherapy, and 11 (28.2%) were smokers. Twenty-four patients (60%) underwent surgery for high-grade glioma, 8 (20%) for low-grade gliomas, 6 (15%) for metastasis and 2 (5%) for meningioma. Throughout the study and up to 90 days after surgery, none of the patients presented an ADR. Only 2 patients (5%) presented with a surgery complications derived from ventricular opening (one patient with a percutaneous CSF leakage and one patients with external hydrocephalus). Both patients resolved with a ventriculoperitoneal shunt.CONCLUSIONS: TachoSil® is a dural sealant that can be used safely and effectively intraparenchymally in patients whose surgery involves a ventricular opening. Only 5% of treated patients presented complications arising from CSF hydrodynamics. No patients had pseudomeningocele, infections or complications related to the use of this sealant. To confirm these positive results, randomized and comparative clinical trials assessing the efficacy of TachoSil® in patients after cranial surgery with an OVS are essential.TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: This study was registered in the Clinical Trials.gov (NCT05717335). Date May 1st, 2022.
AB - PURPOSE: Surgery close to or in contact with the ventricular system is challenging due to the complications. We sought to evaluate the effectiveness and safety of TachoSil® as a ventricular sealant in preventing complications after cranial surgery with an open ventricular system (OVS).METHODS: This is a single-center and prospective cohort study We included patients who underwent elective surgery for supratentorial craniotomy and periventricular pathology between December 2020 and November 2023. We registered surgical complications arising from CSF dynamics (such as percutaneous cerebrospinal fluid (CSF) leakage, hydrocephalus, pseudomeningocele), infections, and other complications (postsurgical hematoma) adverse drug reactions (ADRs), reintervention or hospital readmission up to 90 days after surgery.RESULTS: Forty interventions were performed on 39 patients, whose median age was 56 years. Eleven patients (28.2%) had antecedents of previous surgery in the same location, 5 (12.8%) had previously received radiotherapy and chemotherapy, and 11 (28.2%) were smokers. Twenty-four patients (60%) underwent surgery for high-grade glioma, 8 (20%) for low-grade gliomas, 6 (15%) for metastasis and 2 (5%) for meningioma. Throughout the study and up to 90 days after surgery, none of the patients presented an ADR. Only 2 patients (5%) presented with a surgery complications derived from ventricular opening (one patient with a percutaneous CSF leakage and one patients with external hydrocephalus). Both patients resolved with a ventriculoperitoneal shunt.CONCLUSIONS: TachoSil® is a dural sealant that can be used safely and effectively intraparenchymally in patients whose surgery involves a ventricular opening. Only 5% of treated patients presented complications arising from CSF hydrodynamics. No patients had pseudomeningocele, infections or complications related to the use of this sealant. To confirm these positive results, randomized and comparative clinical trials assessing the efficacy of TachoSil® in patients after cranial surgery with an OVS are essential.TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: This study was registered in the Clinical Trials.gov (NCT05717335). Date May 1st, 2022.
KW - Cerebrospinal fluid leakage
KW - Complications
KW - Effectiveness
KW - Pseudomeningocele
KW - Ventricular entry
KW - Ventricular opening
UR - http://www.scopus.com/inward/record.url?scp=85205152213&partnerID=8YFLogxK
UR - http://www.ncbi.nlm.nih.gov/pubmed/39331127
UR - https://www.mendeley.com/catalogue/8a0311f0-85ba-3203-a746-b95f3d78b3ba/
U2 - 10.1007/s00701-024-06276-8
DO - 10.1007/s00701-024-06276-8
M3 - Article
C2 - 39331127
SN - 0001-6268
VL - 166
JO - Acta Neurochirurgica
JF - Acta Neurochirurgica
IS - 1
M1 - 384
ER -