FRED X flow diversion stent for intracranial aneurysms: a systematic review and meta-analysis.

IF 2.6 3区医学 Q2 CLINICAL NEUROLOGY

Neuroradiology Pub Date : 2025-09-19 DOI:10.1007/s00234-025-03755-2

Ali Mortezaei, Muhammed Amir Essibayi, Leila Ghorbi, Jamal Behnood, Khaled M Taghlabi, Ibrahim Mohammadzadeh, Bardia Hajikarimloo, Mohammad Amin Habibi, Ahmed Abdelsalam, Jayro Toledo, Luis Guada, Redi Rahmani, David J Altschul, Alex N Hoang, Adib A Abla, Robert M Starke, Amir H Faraji

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引用次数: 0

Abstract

Background: The Flow Re-Direction Endoluminal Device X (FRED^TM-X, MicroVention, Inc., Terumo Corporation, USA), introduces a dual-layer structure and antithrombotic surface technology, designed to address the limitations of earlier devices in reducing material thrombogenicity and promoting better vessel endothelialization for brain aneurysm. Herein, we present the first systematic review and meta-analysis summarizing available literature to reach a consensus regarding the safety and effectiveness of FRED^TM-X.

Methods: A literature search was performed in four electronic databases, PubMed/MEDLINE, Embase, Google Scholar, and Web of Science, for studies that evaluated FRED-X in managing intracranial aneurysms. Proportions were pooled employing the inverse variance method, and binary outcomes were analyzed using odds ratio (OR) and 95% confidence interval (CI). The primary outcome was an aneurysm occlusion at the final follow-up.

Results: Eight studies involving 480 patients and 531 aneurysms were included. Most patients were female (81.5%), with a mean age of 56.2 years. Most aneurysms were unruptured (84.1%, 95%CI = 66% - 96.5%) and located in the anterior circulation (86.7%, 95%CI = 75.9% - 94.8%), primarily in the internal carotid artery (64.2%). Procedural data showed a mean procedure time of 68.2 (SD = 38.1) minutes and a fluoroscopy time of 23.5 (SD = 11.7) minutes. The mean aneurysm size was 6.4 mm (SD = 5.1). In-stent stenosis occurred in 1.2% of cases. Adequate occlusion was achieved in 85.9% (95%CI = 79% - 91.8%) of patients at the last follow-up. Symptomatic complications occurred in 4% (95%CI = 0.7% - 9%) of patients, and the overall mortality rate was 0.34% (95%CI = 0.0% - 1.7%).

Conclusion: The FRED-X flow diverter is safe and effective in treating intracranial aneurysms. It has low complication rates, minimal in-stent stenosis, and efficient procedural metrics. Long-term studies must confirm its durability and potential for broader applications.

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FRED X颅内动脉瘤分流支架：系统回顾和荟萃分析。

背景：流量重定向腔内装置X （FREDTM-X, MicroVention, Inc., Terumo Corporation， USA）引入了一种双层结构和抗血栓表面技术，旨在解决早期设备在减少材料血栓性和促进脑动脉瘤血管内皮化方面的局限性。在此，我们提出了第一个系统综述和荟萃分析，总结了现有文献，以达成关于FREDTM-X的安全性和有效性的共识。方法：在PubMed/MEDLINE、Embase、谷歌Scholar和Web of Science四个电子数据库中进行文献检索，以评估FRED-X治疗颅内动脉瘤的研究。采用反方差法合并比例，采用比值比（OR）和95%置信区间（CI）分析二元结果。在最后的随访中，主要结果是动脉瘤闭塞。结果：纳入8项研究，涉及480例患者和531个动脉瘤。患者以女性居多（81.5%），平均年龄56.2岁。大多数动脉瘤未破裂（84.1%,95%CI = 66% ~ 96.5%），位于前循环（86.7%,95%CI = 75.9% ~ 94.8%），主要位于颈内动脉（64.2%）。手术资料显示平均手术时间为68.2 （SD = 38.1）分钟，透视时间为23.5 （SD = 11.7）分钟。动脉瘤平均大小为6.4 mm （SD = 5.1）。1.2%的病例发生支架内狭窄。在最后一次随访中，85.9% （95%CI = 79% - 91.8%）的患者获得了充分的咬合。4%的患者出现症状性并发症（95%CI = 0.7% ~ 9%），总死亡率为0.34% （95%CI = 0.0% ~ 1.7%）。结论：FRED-X分流器治疗颅内动脉瘤安全有效。它并发症发生率低，支架内狭窄最小，手术指标有效。长期研究必须证实其耐久性和更广泛应用的潜力。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Neuroradiology 医学-核医学

CiteScore

5.30

自引率

3.60%

发文量

214

审稿时长

4-8 weeks

期刊介绍： Neuroradiology aims to provide state-of-the-art medical and scientific information in the fields of Neuroradiology, Neurosciences, Neurology, Psychiatry, Neurosurgery, and related medical specialities. Neuroradiology as the official Journal of the European Society of Neuroradiology receives submissions from all parts of the world and publishes peer-reviewed original research, comprehensive reviews, educational papers, opinion papers, and short reports on exceptional clinical observations and new technical developments in the field of Neuroimaging and Neurointervention. The journal has subsections for Diagnostic and Interventional Neuroradiology, Advanced Neuroimaging, Paediatric Neuroradiology, Head-Neck-ENT Radiology, Spine Neuroradiology, and for submissions from Japan. Neuroradiology aims to provide new knowledge about and insights into the function and pathology of the human nervous system that may help to better diagnose and treat nervous system diseases. Neuroradiology is a member of the Committee on Publication Ethics (COPE) and follows the COPE core practices. Neuroradiology prefers articles that are free of bias, self-critical regarding limitations, transparent and clear in describing study participants, methods, and statistics, and short in presenting results. Before peer-review all submissions are automatically checked by iThenticate to assess for potential overlap in prior publication.