背景和目的脑脊液(CSF)泄漏是颅脑和脊柱介入治疗中的重要并发症。因此,使用诸如Hemopatch®的止血贴片来支持硬脑膜的水密闭合。最近,我们发表了一个大型注册的结果,记录了Hemopatch®在各种外科专业中的有效性和安全性,包括神经外科.在这里,我们旨在更详细地分析该注册的神经/脊髓队列的结果。方法根据原始注册表的数据,我们对神经/脊髓队列进行了事后分析.Hemopatch®注册表被设计为一个前瞻性的,多中心,单臂观察性研究。所有外科医生都熟悉Hemopatch®的应用,并由负责的外科医生自行决定使用。神经/脊柱队列对任何年龄的患者开放,如果他们在开放或微创颅骨或脊柱手术期间接受了Hemopatch®。已知对牛蛋白或亮蓝过敏的患者,术中搏动性严重出血,或从注册表中排除潜在目标应用位点(TAS)的活动性感染。对于posthoc评估,我们将神经/脊髓队列的患者分为两个亚组:头颅和脊髓.我们收集了有关TAS的信息,术中取得硬脑膜水密闭合,以及术后脑脊液漏的发生。结果登记包括148例患者在神经/脊髓队列中,当登记停止时。硬脑膜是Hemopatch®在147例患者中的应用部位(在肿瘤切除后的骶骨区域的一名患者中),其中123人接受了颅骨手术。24名患者接受了脊柱手术。术中,130例患者实现了水密性闭合(头颅亚组:119例;脊柱亚组:11例).术后脑脊液漏发生在11例患者中(头颅亚组:9例;脊柱亚组:2例)。我们没有观察到与Hemopatch®相关的严重不良事件。结论我们对来自欧洲注册的现实世界数据的事后分析证实了Hemopatch®在神经外科中的安全有效使用。包括头颅和脊柱手术,在一些案例系列中也观察到了。
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.