Ex vivo and in vivo evaluation of transsphenoidal Liqoseal application to prevent cerebrospinal fluid leakage

Emma M H Slot; Nadia Colmer; Carlo Serra; David Holzmann; Luca Regli; Tristan P C van Doormaal

doi:10.1007/s00701-022-05477-3

Ex vivo and in vivo evaluation of transsphenoidal Liqoseal application to prevent cerebrospinal fluid leakage

Acta Neurochir (Wien). 2023 Jun;165(6):1511-1521. doi: 10.1007/s00701-022-05477-3. Epub 2023 Jan 9.

Authors

Emma M H Slot^{1

2}, Nadia Colmer¹, Carlo Serra³, David Holzmann⁴, Luca Regli³, Tristan P C van Doormaal^{5

6

7}

Affiliations

¹ Department of Neurology and Neurosurgery, University Medical Center Utrecht, Utrecht, The Netherlands.
² Department of Translational Neuroscience, University Medical Center, Utrecht Brain Center, Utrecht University, Utrecht, The Netherlands.
³ Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zurich, Zurich, Switzerland.
⁴ Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Zurich, Zurich, Switzerland.
⁵ Department of Neurology and Neurosurgery, University Medical Center Utrecht, Utrecht, The Netherlands. Theodorus.vandoormaal@usz.ch.
⁶ Department of Translational Neuroscience, University Medical Center, Utrecht Brain Center, Utrecht University, Utrecht, The Netherlands. Theodorus.vandoormaal@usz.ch.
⁷ Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zurich, Zurich, Switzerland. Theodorus.vandoormaal@usz.ch.

Abstract

Background: Despite improvements in closure techniques by using a vital nasoseptal flap, the use of sealing materials, and improved neurosurgical techniques, cerebrospinal fluid (CSF) leak after transsphenoidal surgery still is a clinically relevant problem. Liqoseal® (Polyganics bv, Groningen, The Netherlands) is a CE-approved bioresorbable sealant patch for use as an adjunct to standard methods of cranial dural closure to prevent CSF leakage. This study aims to evaluate the application of Liqoseal in transsphenoidal surgery ex vivo and in vivo.

Methods: 1. We created an ex vivo setup simulating the sphenoidal anatomy, using a fluid pump and porcine dura positioned on a conus with the anatomical dimensions of the sella to evaluate whether the burst pressure of Liqoseal applied to a bulging surface was above physiological intracranial pressure. Burst pressure was measured with a probe connected to dedicated computer software. Because of the challenging transsphenoidal environment, we tested in 4 groups with varying compression weight and time for the application of Liqoseal. 2. We subsequently describe the application of Liqoseal® in 3 patients during transsphenoidal procedures with intraoperative CSF leakage to prevent postoperative CSF leakage.

Results: 1. Ex vivo: The overall mean burst pressure in the transsphenoidal setup was 231 (± 103) mmHg. There was no significant difference in mean burst pressure between groups based on application weight and time (p = 0.227). 2. In Vivo: None of the patients had a postoperative CSF leak. No nose passage problems were observed. One patient had a postoperative meningitis and ventriculitis, most likely related to preoperative extensive CSF leakage. Postoperative imaging did not show any local infection, swelling, or other device-related adverse effects.

Conclusions: We assess the use of Liqoseal® to seal a dural defect during an endoscopic transsphenoidal procedure as to be likely safe and potentially effective.

Keywords: Case report; Cerebrospinal fluid leakage; Device; Transsphenoidal surgery.

MeSH terms

Animals
Cerebrospinal Fluid Leak* / prevention & control
Neurosurgical Procedures / methods
Polyethylene Glycols*
Postoperative Complications / prevention & control
Postoperative Complications / surgery
Swine

Substances

Liqoseal
Polyethylene Glycols