辫子及其他:从 PREMIER 数据中对管道设备辫子稳定性的综合研究。

IF 4.5 1区 医学 Q1 NEUROIMAGING Journal of NeuroInterventional Surgery Pub Date : 2025-01-27 DOI:10.1136/jnis-2024-022350
Fernanda Rodriguez-Erazú, Gustavo M Cortez, Demetrius K Lopes, Salvador F Gutierrez-Aguirre, Otavio Frederico De Toledo, Amin Aghaebrahim, Eric Sauvageau, David F Kallmes, Jens Fiehler, Ricardo A Hanel
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引用次数: 0

摘要

背景:管道栓塞装置(PED)已越来越多地用于治疗脑动脉瘤;然而,人们对新型拉伸填充管技术装置的辫子稳定性表示担忧:利用 PREMIER 试验的数据评估早期 PED 的辫子稳定性:在 PREMIER 试验中,对所有使用 PED(经典和 Flex)治疗的连续颅内动脉瘤进行了辫状稳定性审查(鱼嘴、前缩短、辫状凸起、辫状塌陷)。术后即刻锥形束 CT 和血管造影与 1 年和 2 年的随访进行了比较。分析包括安全性(用改良兰金量表(mRS)评分衡量,包括 mRS 分数+1 和良好临床结果(mRS 分数 0-2))、血管狭窄程度≥50%、有效性(用雷蒙德-罗伊量表衡量)和再治疗率:133/141个动脉瘤拥有完整的数据集。8/133(6%)个动脉瘤出现辫状变形。读片者之间的一致性非常好(κ=0.83)。据统计,辫状变形与支架内血管狭窄>50%有显著相关性(P=0.029),但不影响有效性或安全性。1年后,1/133(0.75%)的患者发现了鱼嘴现象,导致血管狭窄>50%。6/133(4.5%)例出现前缩短,1/133(0.75%)例出现辫状凹凸,并伴有严重的支架内狭窄。另有四例(3.0%)无症状的支架内狭窄是由于新生内膜增生引起的,但辫状结构未发生变化。在2年的随访中,没有发现新的辫状稳定变形:我们的研究表明,在 PREMIER 试验中,接受 PED Classic 和 Flex 治疗的患者辫状结构稳定性极佳。试验注册号:NCT02186561:NCT02186561.
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Braids and beyond: a comprehensive study on pipeline device braid stability from PREMIER data.

Background: The pipeline embolization device (PED) has been increasingly used to treat brain aneurysms; however, concerns have been raised about braid stability with newer drawn filled tubing technology devices.

Objective: To evaluate braid stability of PED early generations using data from the PREMIER trial.

Methods: All consecutive intracranial aneurysms treated with PED (Classic and Flex) within the PREMIER trial were reviewed for braid stability (fish mouthing, foreshortening, braid bump, braid collapsing). Immediate postprocedure cone-beam CT and angiography were compared with 1- and 2- years' follow-up. Analyses included safety, measured with the modified Rankin Scale (mRS) score, including +1 mRS point and a good clinical outcome (mRS score 0-2), vessel stenosis ≥50%, effectiveness measured with Raymond-Roy Scale, and re-treatment rates.

Results: 133/141 aneurysms had a complete dataset. 8/133 (6%) aneurysms showed braid deformations. Inter-reader agreement was excellent (κ=0.83). Braid deformations were statistically significantly associated with in-stent vessel stenosis >50% (P=0.029), without impact on effectiveness or safety. Fish mouthing was found in 1/133 (0.75%) at 1 year, causing >50% vessel stenosis. Foreshortening occurred in 6/133 (4.5%), and braid bump in 1/133 (0.75%) associated with severe in-stent stenosis. Four other cases (3.0%) of asymptomatic in-stent stenosis due to neointimal hyperplasia were seen without braid changes. No new braid stability deformations were found at the 2-year follow-up.

Conclusion: Our study demonstrates excellent braid stability among patients treated with the PED Classic and Flex in the PREMIER trial. Within the uncommon braid changes observed, none affected the PED safety or efficacy.

Trial registration number: NCT02186561.

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来源期刊
CiteScore
9.50
自引率
14.60%
发文量
291
审稿时长
4-8 weeks
期刊介绍: The Journal of NeuroInterventional Surgery (JNIS) is a leading peer review journal for scientific research and literature pertaining to the field of neurointerventional surgery. The journal launch follows growing professional interest in neurointerventional techniques for the treatment of a range of neurological and vascular problems including stroke, aneurysms, brain tumors, and spinal compression.The journal is owned by SNIS and is also the official journal of the Interventional Chapter of the Australian and New Zealand Society of Neuroradiology (ANZSNR), the Canadian Interventional Neuro Group, the Hong Kong Neurological Society (HKNS) and the Neuroradiological Society of Taiwan.
期刊最新文献
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