A systematic review of the Woven EndoBridge device-do findings in pre-clinical animal models compare to clinical results?

René Aquarius; Danique Elbertsen; Joost de Vries; Hieronymus D Boogaarts; Kimberley E Wever

doi:10.1007/s00701-023-05638-y

A systematic review of the Woven EndoBridge device-do findings in pre-clinical animal models compare to clinical results?

Acta Neurochir (Wien). 2023 Jul;165(7):1869-1879. doi: 10.1007/s00701-023-05638-y. Epub 2023 Jun 8.

Authors

René Aquarius¹, Danique Elbertsen², Joost de Vries³, Hieronymus D Boogaarts³, Kimberley E Wever²

Affiliations

¹ Department of Neurosurgery, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525GA, Nijmegen, Gelderland, The Netherlands. rene.aquarius@radboudumc.nl.
² Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, Gelderland, The Netherlands.
³ Department of Neurosurgery, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525GA, Nijmegen, Gelderland, The Netherlands.

Abstract

Background: The Woven Endobridge (WEB) is designed to treat intracranial wide-neck bifurcation aneurysms, preventing subarachnoid hemorrhage. The translational value of animal models used for WEB device testing is unknown. With this systematic review, we aim to identify the existing animal models used in testing the WEB device and compare the efficacy and safety outcomes to those of prospective clinical studies.

Methods: This study was funded by ZonMw: project number 114024133. A comprehensive search was performed in PubMed and in EMBASE via the Ovid interface. The following exclusion criteria were used: 1) not an original full-length research paper, 2) not an in vivo animal study or a human study, 3) no WEB implantation, 4) if in humans: not a prospective study. The SYRCLE risk of bias tool (animal studies) and the Newcastle-Ottawa quality assessment scale for cohort studies (clinical studies) were used to assess risks of bias. A narrative synthesis was performed.

Results: Six animal studies and 17 clinical studies met the inclusion criteria. The rabbit elastase aneurysm model was the only animal model used to assess WEB device performance. Safety outcomes were never reported in animal studies. Efficacy outcomes were more heterogeneous in animal studies than in clinical studies, which could be due to limited external validity of the animal models in terms of aneurysm induction and dimensions. Both animal and clinical studies were predominantly single-arm studies, and were at unclear risk of several types of bias.

Conclusions: The rabbit elastase aneurysm model was the only pre-clinical animal model used to assess WEB device performance. Safety outcomes were not evaluated in animal studies and could therefore not be compared to clinical outcomes. Efficacy outcomes were more heterogeneous in animal studies than in clinical studies. Future research should focus on improving methodology and reporting in order to draw accurate conclusions on the performance of the WEB device.

Keywords: Endovascular procedures; Intracranial aneurysm; Systematic review; Woven endobridge device.

Publication types

Systematic Review
Review
Research Support, Non-U.S. Gov't

MeSH terms

Animals
Embolization, Therapeutic* / methods
Endovascular Procedures* / methods
Humans
Intracranial Aneurysm* / therapy
Models, Animal
Prospective Studies
Rabbits
Retrospective Studies
Treatment Outcome