Real-World Data on the Usage of Hemopatch® as a Hemostat and Dural Sealant in Cranial and Spinal Neurosurgery

Abstract

Background and objectivesCerebrospinal 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. MethodsBased 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. ResultsThe 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 subcohort: 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 ® . ConclusionOur 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.

Hemopatch®as a primary dural sealant in cranial neurosurgery: Technical note and a retrospective study

“…Overall, the evidence suggests that Hemopatch® may be a valuable alternative to traditional methods of dural repair in neurosurgery. 16,17 It offers several advantages, including ease of use, durability, and a lower risk of complications. Further research is needed to fully understand the potential benefits and risks of the Hemopatch® as a dural substitute; however, the initial evidence is promising.…”