From the Division of Neuroradiology, Department of Radiology (Y.-L.L., E.Y.-L.C., R.L.), Queen Mary Hospital, Hong Kong, China.
Nuffield Department of Primary Care Health Sciences (A.R.), University of Oxford, Oxford, UK.
AJNR Am J Neuroradiol. 2021 Jan;42(2):327-333. doi: 10.3174/ajnr.A6919. Epub 2020 Dec 31.
Newer flow diverters are enhanced with antithrombogenic surface modifications like the Pipeline Embolization Device with Shield Technology and the Derivo Embolization Device and are purported to facilitate deployment and reduce ischemic events.
Our aim was to review the safety and efficacy of surface-modified flow diverters in treating patients with cerebral aneurysms.
We used Preferred Reporting Items for Systematic Reviews and Meta-Analyses-compliant systematic review and meta-analysis covering 3 major data bases and gray literature between 2014 and 2019.
Two reviewers independently reviewed human studies of surface-modified flow diverters for eligibility based on predetermined criteria.
The random effects model and Freeman-Tukey arcsine transformation were used to pool efficacy outcomes (technical success, aneurysm occlusion at 6 and 12 months) and safety outcomes (mortality, morbidity, all ischemia, and serious ischemia). Subgroup analysis was performed to compare outcomes between 2 different flow diverters.
Eight single-arm case series involving 911 patients and 1060 aneurysms were included. The median follow-up was 8.24 months. Pooled estimate for technical success was 99.6%, while the aneurysm occlusion at 6 and 12 months were 80.5%, and 85.6%, respectively. Pooled estimates for mortality, morbidity, total ischemia, and serious ischemia rates were 0.7%, 6.0%, 6.7%, and 1.8%, respectively. Most studies were of good quality, and no significant heterogeneity was observed.
Limitations include a retrospective, observational design in some studies; heterogeneous and underreported antiplatelet therapy; and potential performance and ecologic bias.
Early-to-midterm safety and efficacy for surface-modified flow diverters appear comparable with older devices, especially for small, unruptured anterior circulation aneurysms. Long-term clinical data are required to further corroborate these results.
新型血流导向装置具有抗血栓表面改性,如 Pipeline Embolization Device with Shield Technology 和 Derivo Embolization Device,据称可便于置放并减少缺血性事件。
我们旨在评估表面改性血流导向装置治疗颅内动脉瘤患者的安全性和有效性。
我们使用符合系统评价和荟萃分析首选报告项目的系统评价和荟萃分析,涵盖了 2014 年至 2019 年的 3 个主要数据库和灰色文献。
两位审查员根据预定标准独立审查表面改性血流导向装置的人类研究的资格。
使用随机效应模型和 Freeman-Tukey 反正弦变换来汇总疗效结果(技术成功率、6 个月和 12 个月时的动脉瘤闭塞)和安全性结果(死亡率、发病率、所有缺血和严重缺血)。进行亚组分析以比较两种不同血流导向装置之间的结果。
纳入了 8 项单臂病例系列研究,涉及 911 名患者和 1060 个动脉瘤。中位随访时间为 8.24 个月。技术成功率的汇总估计值为 99.6%,6 个月和 12 个月时的动脉瘤闭塞率分别为 80.5%和 85.6%。死亡率、发病率、总缺血和严重缺血发生率的汇总估计值分别为 0.7%、6.0%、6.7%和 1.8%。大多数研究质量较高,且未观察到显著异质性。
局限性包括一些研究中存在回顾性、观察性设计;抗血小板治疗存在异质性和报告不足;以及潜在的表现和生态偏倚。
表面改性血流导向装置的早期至中期安全性和有效性似乎与较旧装置相当,特别是对于小的、未破裂的前循环动脉瘤。需要长期的临床数据来进一步证实这些结果。