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Histological and magnetic resonance imaging assessment of Liqoseal in a spinal in vivo pig model

Animal Models and Experimental Medicine 2023年第1期6卷 74-80页

作者： Emma M.H.Slot Wilhelmina Bergmann ahmet kinaci Bart de Boer Nizar Moayeri Saskia Redegeld Sander van Thoor Tristan P.C.van Doormaal Department of Neurology and Neurosurgery University Medical Center UtrechtUtrechtthe Netherlands Department of Translational Neuroscience Brain CenterUniversity Medical Center UtrechtUtrechtthe Netherlands Department of Biomolecular Health Sciences Division of PathologyFaculty of Veterinary MedicineUtrecht UniversityUtrechtthe Netherlands Department of Neurosurgery Elizabeth TweeSteden ziekenhuisTilburgthe Netherlands Brain Technology Institute Utrechtthe Netherlands Department of Neurosurgery Clinical Neuroscience CenterUniversity Hospital ZurichZurichSwitzerland

Background:Liqoseal (Polyganics,B.V.) is a dural sealant patch for preventing postoperative cerebrospinal fluid (CSF) leakage.It has been extensively tested preclinically and CE (Conformite Européenne) approved for human use after a first cranial in-human study.However,the safety of Liqoseal for spinal application is still unknown.The aim of this study was to assess the safety of spinal Liqoseal application compared with cranial application using histology and magnetic resonance imaging characteristics.Methods:Eight female Dutch Landrace pigs underwent laminectomy,durotomy with standard suturing and Liqoseal application.Three control animals underwent the same procedure without sealant application.The histological characteristics and imaging characteristics of animals with similar survival times were compared to data from a previous cranial porcine model.Results:Similar foreign body reactions were observed in spinal and cranial dura.The foreign body reaction consisted of neutrophils and reactive fibroblasts in the first3 days,changing to a chronic granulomatous inflammatory reaction with an increasing number of macrophages and lymphocytes and the formation of a fibroblast layer on the dura by day 7.Mean Liqoseal plus dura thickness reached a maximum of 1.2mm(range 0.7-2.0mm) at day 7.Conclusion:The spinal dural histological reaction to Liqoseal during the first 7days was similar to the cranial dural reaction.Liqoseal did not swell significantly in both application areas over time.Given the current lack of a safe and effective dural sealant for spinal application,we propose that an in-human safety study of Liqoseal is the logical next step.

关键词： reaction resonance magnetic

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Safety and biodegradability of a synthetic dural sealant patch(Liqoseal)in a porcine cranial model

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Animal Models and Experimental Medicine 2021年第4期4卷 398-405页

作者： ahmet kinaci Wilhelmina Bergmann Sander van Thoor Saskia Redegeld Albert van der Zwan Tristan P.C.van Doormaal Department of Neurology and Neurosurgery Brain CenterUniversity Medical Centre UtrechtUtrechtThe Netherlands Brain Technology Institute UtrechtThe Netherlands Division of Pathology Faculty of Veterinary MedicineUtrecht UniversityUtrechtThe Netherlands Department of Neurosurgery Clinical Neuroscience CenterUniversity Hospital ZurichZurichSwitzerland

Background:Liqoseal consists of a watertight layer of poly(ester)ether urethane and an adhesive layer containing polyethylene glycol-N-hydroxysuccinimide(PEG-NHS).It is designed to prevent cerebrospinal fluid(CSF)leakage after intradural surgery.This study assessed the safety and biodegradability of Liqoseal in a porcine craniotomy model.Methods:In 32 pigs a craniotomy plus durotomy was performed.In 15 pigs Liqoseal was implanted,in 11 control pigs no sealant was implanted and in 6 control pigs a control dural sealant(Duraseal or Tachosil)was implanted.The safety of Liqoseal was evaluated by clinical,MRI and histological assessment.The degradation of Liqoseal was histologically estimated.Results:Liqoseal,2 mm thick before application,did not swell and significantly was at maximum mean thickness of 2.14(±0.37)mm at one month.The foreign body reaction induced by Liqoseal,Duraseal and Tachosil were comparable.Liqoseal showed no adherence to the arachnoid layer and was completely resorbed between 6 and 12 months postoperatively.In one animal with Liqoseal,an epidural fluid collection containing CSF could not be excluded.Conclusion:Liqoseal seems to be safe for intracranial use and is biodegradable.The safety and performance in humans needs to be further assessed in clinical trials.

关键词： cerebrospinal fluid leakage craniotomy dura in vivo model sealant

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