Effectiveness and safety of Tachosil® as a ventricular sealant: an observational cohort study

IF 1.9 3区医学 Q3 CLINICAL NEUROLOGY

Acta Neurochirurgica Pub Date : 2024-09-27 DOI:10.1007/s00701-024-06276-8

Pilar Teixidor-Rodríguez, Ferran Brugada-Bellsolà, Sebastián Menéndez-Girón, Manuel Tardáguila-Serrano, Antonio González-Crespo, Fidel Nuñez-Marín, Eva Montané, Jordi Busquets-Bonet, Lucia Muñoz-Narbona, Carlos Javier Domínguez-Alonso

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引用次数: 0

Abstract

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 1^st, 2022.

查看原文本刊更多论文

Tachosil® 作为心室密封剂的有效性和安全性：一项观察性队列研究。

目的：由于并发症的存在，靠近或接触脑室系统的手术具有挑战性。我们试图评估 TachoSil® 作为脑室密封剂在预防开放脑室系统 (OVS) 颅脑手术后并发症方面的有效性和安全性：这是一项单中心前瞻性队列研究。我们纳入了在 2020 年 12 月至 2023 年 11 月期间接受选择性开颅手术和脑室周围病变的患者。我们对 CSF 动态变化引起的手术并发症（如经皮脑脊液（CSF）漏、脑积水、假脑膜）、感染和其他并发症（术后血肿、药物不良反应（ADR）、再次介入或术后 90 天内再次入院）进行了登记：39名患者接受了40次介入治疗，中位年龄为56岁。11名患者（28.2%）曾在同一部位接受过手术，5名患者（12.8%）曾接受过放疗和化疗，11名患者（28.2%）是吸烟者。24名患者（60%）因高级别胶质瘤接受了手术，8名（20%）因低级别胶质瘤接受了手术，6名（15%）因转移瘤接受了手术，2名（5%）因脑膜瘤接受了手术。在整个研究期间和手术后 90 天内，没有一名患者出现不良反应。只有两名患者（5%）出现了脑室开放引起的手术并发症（一名患者出现经皮脑脊液漏，一名患者出现外部脑积水）。这两名患者都通过脑室腹腔分流术得到了缓解：结论：TachoSil® 是一种硬脑膜密封剂，可安全有效地用于手术涉及脑室开口的患者。在接受治疗的患者中，只有 5% 的患者出现了 CSF 流体力学并发症。没有患者出现假性脑积水、感染或与使用这种密封剂有关的并发症。为了证实这些积极的结果，有必要进行随机对比临床试验，评估 TachoSil® 对使用 OVS 进行颅脑手术的患者的疗效：本研究已在 Clinical Trials.gov (NCT05717335) 上注册。日期为 2022 年 5 月 1 日。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Acta Neurochirurgica 医学-临床神经学

CiteScore

4.40

自引率

4.20%

发文量

342

审稿时长

1 months

期刊介绍： The journal "Acta Neurochirurgica" publishes only original papers useful both to research and clinical work. Papers should deal with clinical neurosurgery - diagnosis and diagnostic techniques, operative surgery and results, postoperative treatment - or with research work in neuroscience if the underlying questions or the results are of neurosurgical interest. Reports on congresses are given in brief accounts. As official organ of the European Association of Neurosurgical Societies the journal publishes all announcements of the E.A.N.S. and reports on the activities of its member societies. Only contributions written in English will be accepted.