Department of Neurosurgery, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525GA, Nijmegen, Gelderland, The Netherlands.
Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, Gelderland, The Netherlands.
Acta Neurochir (Wien). 2023 Jul;165(7):1869-1879. doi: 10.1007/s00701-023-05638-y. Epub 2023 Jun 8.
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.
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.
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.
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.
Woven Endobridge（WEB）旨在治疗颅内宽颈分叉动脉瘤，预防蛛网膜下腔出血。用于 WEB 设备测试的动物模型的转化价值尚不清楚。通过本系统评价，我们旨在确定用于 WEB 设备测试的现有动物模型，并将其疗效和安全性结果与前瞻性临床研究进行比较。
本研究由 ZonMw 资助：项目编号 114024133。通过 Ovid 界面在 PubMed 和 EMBASE 中进行了全面搜索。使用了以下排除标准：1）非原创全文研究论文，2）非体内动物研究或人体研究，3）未植入 WEB，4）如果是人体研究：非前瞻性研究。使用 SYRCLE 偏倚风险工具（动物研究）和纽卡斯尔-渥太华队列研究质量评估量表（临床研究）评估偏倚风险。进行了叙述性综合。
有 6 项动物研究和 17 项临床研究符合纳入标准。兔弹性蛋白酶动脉瘤模型是唯一用于评估 WEB 设备性能的动物模型。动物研究从未报告过安全性结果。动物研究中的疗效结果比临床研究更为混杂，这可能是由于动脉瘤诱导和尺寸方面的动物模型的外部有效性有限。动物研究和临床研究主要都是单臂研究，并且存在多种类型偏倚的风险不明确。
兔弹性蛋白酶动脉瘤模型是唯一用于评估 WEB 设备性能的临床前动物模型。动物研究中未评估安全性结果，因此无法与临床结果进行比较。动物研究中的疗效结果比临床研究更为混杂。未来的研究应侧重于改进方法学和报告，以便对 WEB 设备的性能得出准确的结论。
