Introduction

The Flow Redirection Endoluminal Device (FRED; MicroVention) is a dual-layered flow diverter used for the treatment of intracranial aneurysms. The objective of this systematic review was to compile device-related safety and effectiveness data.

Methods

The literature from January 1, 2013 to April 30, 2021 was searched for studies describing use of the FRED for intracranial aneurysm treatment irrespective of aneurysm location and morphology. The review included anterior and posterior circulation ruptured and unruptured saccular, fusiform or dissection, and blister aneurysms. MeSH terms related to “flow re-direction endoluminal device” and “FRED for aneurysms” were used. Data related to indication, complications, and rates of aneurysm occlusion were retrieved and analyzed.

Results

Twenty-two studies with 1729 intracranial aneurysms were included in this review. Overall reported morbidity was 3.9% (range 0–20%). Overall procedure-related mortality was 1.4% (range 0–6%). Complication rates fell into 5 categories: technical (3.6%), ischemic (3.8%), thrombotic or stenotic (6%), hemorrhagic (1.5%), and non-neurological (0.8%). The aneurysm occlusion rate between 0 and 3 months (reported in 11 studies) was 47.8%. The occlusion rate between 4 and 6 months (reported in 14 studies) was 73.8%. Occlusion rates continued to increase to 75.1% at 7–12 months (reported in 10 studies) and 86.6% for follow-up beyond 1 year (reported in 10 studies).

Conclusion

This review indicated that the FRED is a safe and effective for the treatment of intracranial aneurysms. Future studies should directly compare the FRED with other flow diverters for a better understanding of comparative safety and effectiveness among the different devices.

中文翻译：

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治疗颅内动脉瘤的腔内血流改向装置 (FRED)：系统评价

介绍

流改向腔内装置 (FRED; MicroVention) 是一种双层分流器，用于治疗颅内动脉瘤。该系统评价的目的是汇编与器械相关的安全性和有效性数据。

方法

检索了 2013 年 1 月 1 日至 2021 年 4 月 30 日的文献，以寻找描述使用 FRED 治疗颅内动脉瘤的研究，无论动脉瘤的位置和形态如何。审查包括前循环和后循环破裂和未破裂的囊状、梭状或夹层，以及泡状动脉瘤。使用与“流动重定向腔内装置”和“动脉瘤 FRED”相关的 MeSH 术语。检索并分析了与适应症、并发症和动脉瘤闭塞率相关的数据。

结果

本综述纳入了 22 项研究，涉及 1729 个颅内动脉瘤。总体报告的发病率为 3.9%（范围 0–20%）。总体手术相关死亡率为 1.4%（范围 0–6%）。并发症发生率分为 5 类：技术性 (3.6%)、缺血性 (3.8%)、血栓性或狭窄性 (6%)、出血性 (1.5%) 和非神经性 (0.8%)。0 至 3 个月的动脉瘤闭塞率（在 11 项研究中报告）为 47.8%。4 至 6 个月的闭塞率（在 14 项研究中报告）为 73.8%。阻塞率在 7-12 个月时继续增加到 75.1%（在 10 项研究中报告），在超过 1 年的随访中增加到 86.6%（在 10 项研究中报告）。

结论

该综述表明FRED治疗颅内动脉瘤安全有效。未来的研究应该直接将 FRED 与其他分流器进行比较，以便更好地了解不同设备之间的比较安全性和有效性。