Neuroform Atlas 支架治疗颅内动脉瘤的安全性和有效性:系统综述、元分析和元回归。

Umar Akram, Shahzaib Ahmed, Zain Ali Nadeem, Mona Shahriari, Hamza Ashraf, Haider Ashfaq, Eeshal Fatima, Muhammad A Raza, Aimen Nadeem, Zuha Majid, Arsalan Nadeem, Tayyab Ahmad, Ammara Akram, Sana Rehman, Abeer Sarwar, Janet Mei, Francis Deng, Licia P Luna, Nathan Hyson, Vivek S Yedavalli
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引用次数: 0

摘要

背景:颅内动脉瘤(IAs)是蛛网膜下腔出血的主要原因。支架辅助卷曲,尤其是使用 Neuroform Atlas 支架(NAS),已被证明比单独卷曲治疗这些动脉瘤更有效。目的:进行系统回顾和荟萃分析,研究 NAS 治疗 IAs 的有效性和安全性:我们在PubMed、Embase、Cochrane CENTRAL图书馆和clinicaltrials.gov上进行了全面的文献检索:我们纳入了使用NAS治疗破裂和未破裂IAs的研究,涵盖所有年龄段的实验性、观察性和病例系列研究。动脉瘤闭塞率采用雷蒙德-罗伊分类法(Raymond-Roy classification,RROC)进行评估。此外,还记录了改良Rankin量表(mRS)和与支架使用相关的不良事件:统计分析在 R 4.3.2 版本中使用 "meta "和 "metasens "软件包进行。我们以比例及其相应的置信区间(CIs)来报告结果。我们还进行了元回归、撇除和敏感性分析,以确认结果的稳健性:共纳入了 42 项研究,包括 2434 名平均年龄为 51 至 73 岁的参与者。在血管造影结果中,95%的患者达到最终 RROC 1/RROC 2,82%的患者达到最终 RROC 1,12%的患者达到 RROC 2,5%的患者达到 RROC 3。此外,93%的患者mRS分级为0级,5%的患者mRS分级为1级,3%的患者mRS分级为2级,2%的患者mRS分级为3级,0%的患者mRS分级为4级,0%的患者mRS分级为5级,1%的患者mRS分级为6级。所有不良事件的发生率均低于5%:由于特定病因数据有限,我们无法分析与支架置入和并发症相关的死亡率。尽管纳入了大量研究,但对比研究仍然很少:尽管我们的研究结果的推广性有限,但本研究表明,NAS 对治疗内膜异位症非常有效,闭塞率高,不良事件发生率低。该支架的性能得到了全面分析的支持,凸显了其在治疗破裂和未破裂动脉瘤方面的安全性和有效性:缩写:NAS = Neuroform Atlas支架;IA = 颅内动脉瘤;SAC = 支架辅助卷曲。
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Safety And Efficacy of the Neuroform Atlas Stent for Treatment of Intracranial Aneurysms: A Systematic Review, Meta-Analysis and Meta-Regression.

Background: Intracranial aneurysms (IAs) are the major cause of subarachnoid hemorrhage. Stent-assisted coiling, especially with the Neuroform Atlas stent (NAS), has proven more effective than coiling alone for treating these aneurysms.

Purpose: To perform a systematic review and meta-analysis to investigate the efficacy and safety of NAS in treating IAs.

Data sources: A comprehensive literature search was conducted on PubMed, Embase, Cochrane CENTRAL library, and clinicaltrials.gov from inception till June 2024.

Study selection: We included studies on ruptured and unruptured IAs treated with the NAS, covering experimental, observational, and case series across all age groups. The aneurysm occlusion rate was assessed using the Raymond-Roy classification (RROC). The modified Rankin Scale (mRS) and adverse events related to stent use were also recorded.

Data analysis: The statistical analysis was conducted on R version 4.3.2 using the packages "meta" and "metasens". We reported our results as proportions with their corresponding confidence intervals (CIs). Meta-regression, leave-one-out and sensitivity analyses were conducted to confirm the robustness of our results.

Data synthesis: A total of 42 studies including 2434 participants with a mean age of 51 to 73 years were included. Among angiographic outcomes, the final RROC 1/RROC 2 was achieved in 95% of the patients, final RROC 1 in 82%, RROC 2 in 12%, and RROC 3 in 5% of the patients. Additionally, 93% of the patients showed mRS grade 0, 5% showed mRS grade 1, 3% showed mRS grade 2, 2% showed mRS grade 3, 0% showed mRS grade 4, 0% showed mRS grade 5, and 1% showed mRS grade 6. All adverse events had a ≤ 5% rate.

Limitations: Due to limited cause-specific data, we were unable to analyse mortality specific to the stent placement and complications. Despite the large number of studies included, comparative studies were still observed to be scarce.

Conclusions: Although the generalizability of our findings is limited, this study demonstrates that NAS is highly effective for treating IAs, with high occlusion rates and a low incidence of adverse events. The stent's performance, supported by comprehensive analysis, highlights its safety and efficacy in managing both ruptured and unruptured aneurysms.

Abbreviations: NAS = Neuroform Atlas stent; IA = Intracranial aneurysm; SAC = stent-assisted coiling.

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