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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00159816%3A_____%2F23%3A00078680" target="_blank" >RIV/00159816:_____/23:00078680 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00843989:_____/23:E0110176

Výsledek na webu

<a href="https://www.cureus.com/articles/121858-real-world-data-on-the-usage-of-hemopatch-as-a-hemostat-and-dural-sealant-in-cranial-and-spinal-neurosurgery#!/" target="_blank" >https://www.cureus.com/articles/121858-real-world-data-on-the-usage-of-hemopatch-as-a-hemostat-and-dural-sealant-in-cranial-and-spinal-neurosurgery#!/</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.7759/cureus.34387" target="_blank" >10.7759/cureus.34387</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30218 - General and internal medicine

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2023

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Cureus Journal of Medical Science

ISSN

2168-8184

e-ISSN

2168-8184

Svazek periodika

15

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

—

Kód UT WoS článku

000994470800052

EID výsledku v databázi Scopus

—