Schebesch Karl-Michael, Hrbac Tomas, Jančálek Radim, Krska Lukas, Marquez-Rivas Javier, Solar Peter
Department of Neurosurgery, University Medical Centre of Regensburg, Regensburg, DEU.
Department of Neurosurgery, Faculty Hospital Ostrava, University of Ostrava, Ostrava, CZE.
Cureus. 2023 Jan 30;15(1):e34387. doi: 10.7759/cureus.34387. eCollection 2023 Jan.
Background and objectives Cerebrospinal fluid (CSF) leakage is a significant complication in cranial and spinal interventions. Hemostatic patches such as Hemopatch are therefore used to support the watertight closure of the dura mater. Recently, we published the results of a large registry documenting the effectiveness and safety of Hemopatch in various surgical specialties, including neurosurgery. Here we aimed to analyze the outcomes from the neurological/spinal cohort of this registry in more detail. Methods Based on the data from the original registry, we performed a post hoc analysis for the neurological/spinal cohort. The Hemopatch registry was designed as a prospective, multicenter, single-arm observational study. All surgeons were familiar with the application of Hemopatch and it was used at the discretion of the responsible surgeon. The neurological/spinal cohort was open for patients of any age if they had received Hemopatch during an open or minimally invasive cranial or spinal procedure. Patients with known hypersensitivity to bovine proteins or brilliant blue, intraoperative pulsatile severe bleeding, or an active infection at the potential target application site (TAS) were excluded from the registry. For the posthoc evaluation, we stratified the patients of the neurological/spinal cohort into two sub-cohorts: cranial and spinal. We collected information about the TAS, intraoperative achievement of watertight closure of the dura, and occurrence of postoperative CSF leaks. Results The registry comprised 148 patients in the neurological/spinal cohort when enrolment was stopped. The dura was the application site for Hemopatch in 147 patients (in one patient in the sacral region after tumor excision), of which 123 underwent a cranial procedure. Twenty-four patients underwent a spinal procedure. Intraoperatively, watertight closure was achieved in 130 patients (cranial sub-cohort: 119; spinal sub-cohort: 11). Postoperative CSF leakage occurred in 11 patients (cranial sub-cohort: nine; spinal sub-cohort: two). We observed no serious adverse events related to Hemopatch. Conclusion Our post hoc analysis of real-world data from a European registry confirms the safe and effective use of Hemopatch in neurosurgery, including cranial and spinal procedures, as also observed in some case series.
背景与目的 脑脊液漏是颅脑和脊柱手术中的一种重要并发症。因此，诸如Hemopatch之类的止血贴片被用于支持硬脑膜的水密性闭合。最近，我们发表了一项大型登记研究的结果，记录了Hemopatch在包括神经外科在内的各种外科专业中的有效性和安全性。在此，我们旨在更详细地分析该登记研究中神经科/脊柱科队列的结果。方法 基于原始登记研究的数据，我们对神经科/脊柱科队列进行了事后分析。Hemopatch登记研究设计为一项前瞻性、多中心、单臂观察性研究。所有外科医生均熟悉Hemopatch的应用，由负责的外科医生自行决定使用。神经科/脊柱科队列对任何年龄的患者开放，只要他们在开放性或微创性颅脑或脊柱手术中接受了Hemopatch。已知对牛蛋白或亮蓝过敏、术中搏动性严重出血或潜在目标应用部位（TAS）存在活动性感染的患者被排除在登记研究之外。对于事后评估，我们将神经科/脊柱科队列的患者分为两个亚队列：颅脑和脊柱。我们收集了有关TAS、术中硬脑膜水密性闭合的完成情况以及术后脑脊液漏发生情况的信息。结果 登记研究停止入组时，神经科/脊柱科队列中有148例患者。147例患者的硬脑膜是Hemopatch的应用部位（1例为肿瘤切除术后骶骨区域的患者），其中123例接受了颅脑手术。24例患者接受了脊柱手术。术中，130例患者实现了水密性闭合（颅脑亚队列：119例；脊柱亚队列：11例）。11例患者发生了术后脑脊液漏（颅脑亚队列：9例；脊柱亚队列：2例）。我们未观察到与Hemopatch相关的严重不良事件。结论 我们对来自欧洲一项登记研究的真实世界数据进行的事后分析证实，Hemopatch在神经外科手术（包括颅脑和脊柱手术）中的使用是安全有效的，一些病例系列中也观察到了这一点。
