J 2023

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

SCHEBESCH, Karl-Michael, Tomas HRBAC, Radim JANČÁLEK, Lukas KRSKA, Javier MARQUEZ-RIVAS et. al.

Basic information

Original name

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

Authors

SCHEBESCH, Karl-Michael (guarantor), Tomas HRBAC (203 Czech Republic), Radim JANČÁLEK (203 Czech Republic, belonging to the institution), Lukas KRSKA (203 Czech Republic), Javier MARQUEZ-RIVAS and Peter SOLÁR (703 Slovakia, belonging to the institution)

Edition

CUREUS JOURNAL OF MEDICAL SCIENCE, PALO ALTO, CUREUS INC, 2023, 2168-8184

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30210 Clinical neurology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

Impact factor

Impact factor: 1.200 in 2022

RIV identification code

RIV/00216224:14110/23:00131036

Organization unit

Faculty of Medicine

DOI

UT WoS

000994470800052

Keywords in English

hemopatch (R); watertight closure; csf fistula; csf leakage; dura mater; supratentorial; infratentorial; cranial; spinal; neurosurgery

Tags

Tags

International impact, Reviewed
Změněno: 21/6/2023 14:15, Mgr. Tereza Miškechová

Abstract

V originále

Background and objectivesCerebrospinal fluid (CSF) leakage is a significant complication in cranial and spinal interventions. Hemostatic patches such as Hemopatch (R) 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 (R) 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 (R) registry was designed as a prospective, multicenter, single-arm observational study. All surgeons were familiar with the application of Hemopatch (R) 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 (R) 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 (R) 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 (R) .ConclusionOur post hoc analysis of real-world data from a European registry confirms the safe and effective use of Hemopatch (R) in neurosurgery, including cranial and spinal procedures, as also observed in some case series.