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386例患者中使用和不使用表面改性技术的血流导向装置(FRED-X、FRED、PED Shield和PED)的安全性和有效性比较分析:单中心经验及系统评价和网状Meta分析

Comparative analysis of safety and efficacy of flow diversion with and without surface modification technology, FRED-X, FRED, PED shield and PED in 386 patients: A single center experience with systematic review and network meta analysis.

作者信息

Roy Joanna M, Musmar Basel, El Naamani Kareem, Ahmed Meah T, Kaul Anand, Amaravadi Cheritesh, Sizdahkhani Saman, Karadimas Spyridon, Gooch Michael R, Jabbour Pascal, Rosenwasser Robert, Tjoumakaris Stavropoula I

机构信息

Department of Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA.

Department of Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA.

出版信息

J Neurol Sci. 2025 Jan 15;468:123336. doi: 10.1016/j.jns.2024.123336. Epub 2024 Dec 5.

Abstract

INTRODUCTION

The FRED-X is a newer generation flow diverting stent (FDS) with surface modification that has demonstrated favorable efficacy in treating intracranial aneurysms. Our study provides an analysis of patients treated using FRED-X compared to FRED, PED Shield and PED.

MATERIALS AND METHODS

This was a retrospective single center study and a systematic review with network meta analysis of patients who underwent flow diversion using FRED-X, FRED, PED Shield or PED. Multivariate logistic regression was used to assess long-term outcomes of interest- angiographic occlusion, in-stent stenosis and functional outcome at 6- and 12-month follow up.

RESULTS

386 patients with 386 aneurysms were included. The average age of the cohort was 56.2 years, and 81 % was female. PED had significantly higher aneurysm occlusion rates compared to FRED-X at 6- and 12-months (OR: 3.03, 95 % CI: 1.36-6.62 and OR: 4.01, 95 % CI: 1.26-12.2), with higher odds of absent in-stent stenosis (OR: 9.03, 95 % CI: 3.63-23.3 and OR: 9.58, 95 % CI: 2.56-33.8) at 6- and 12-months, respectively. Rates of stroke, TIA, ICH and mortality were not significantly different across cohorts. All patients were functionally independent on follow-up. A network meta-analysis revealed no significant difference in occlusion rates among each of the included FDS.

CONCLUSION

Our study revealed comparable 12-month occlusion rates and in-stent stenosis between surface modified devices, FRED-X and PED Shield. In addition, angiographic results were comparable between FRED-X and the first generation FRED, however classic PED demonstrated higher rates of angiographic occlusion with lower in-stent stenosis.

摘要

引言

FRED-X是新一代具有表面改性的血流导向支架(FDS),已在治疗颅内动脉瘤方面显示出良好疗效。我们的研究对使用FRED-X与FRED、PED Shield和PED治疗的患者进行了分析。

材料与方法

这是一项回顾性单中心研究,也是一项对使用FRED-X、FRED、PED Shield或PED进行血流导向治疗的患者进行网络荟萃分析的系统评价。采用多变量逻辑回归评估感兴趣的长期结局——在6个月和12个月随访时的血管造影闭塞、支架内狭窄和功能结局。

结果

纳入386例患者的386个动脉瘤。队列的平均年龄为56.2岁,81%为女性。与FRED-X相比,PED在6个月和12个月时的动脉瘤闭塞率显著更高(OR:3.03,95%CI:1.36 - 6.62;OR:4.01,95%CI:1.26 - 12.2),在6个月和12个月时分别具有更高的无支架内狭窄几率(OR:9.03,95%CI:3.63 - 23.3;OR:9.58,95%CI:2.56 - 33.8)。各队列间的卒中、短暂性脑缺血发作、颅内出血和死亡率无显著差异。所有患者在随访时功能均独立。网络荟萃分析显示,纳入的每种FDS的闭塞率无显著差异。

结论

我们的研究表明,表面改性装置FRED-X和PED Shield之间的12个月闭塞率和支架内狭窄相当。此外,FRED-X与第一代FRED的血管造影结果相当,但经典PED显示出更高的血管造影闭塞率和更低的支架内狭窄率。

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