Fabian Wenz, Tamara Wiedemann, Gabriel Je Rinkel, Nima Etminan
{"title":"Flow diverter treatment for saccular unruptured intracranial aneurysms: A systematic review focussing on study quality and initial outcomes.","authors":"Fabian Wenz, Tamara Wiedemann, Gabriel Je Rinkel, Nima Etminan","doi":"10.1177/23969873251370992","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Flow-diverting (FD) stents are increasingly used to treat small, unruptured intracranial aneurysms (UIA), but high-quality, unbiased data on initial complications and clinical outcomes were limited in previous literature reviews. We updated the literature review to assess quality, potential bias, complications and short-term outcomes in studies on FD-stents for UIAs.</p><p><strong>Patients and methods: </strong>We systematically searched PubMed, Embase and Cochrane Library until January 9, 2025 for studies on FD-stents for UIAs. We assessed methodological quality using the methodological index for non-randomised studies (poor: 0-9, moderate: 10-13, good: 14-16), and financial conflicts of interest. The primary outcome was neurological outcome according to a validated outcome scale at 1-3 months after treatment. Secondary outcomes were clinical worsening and complications.</p><p><strong>Results: </strong>We included 13 studies with 743 patients and 806 UIAs, of which 88.4% (95% CI: 85.7%-91.2%) were <10 mm. All studies were uncontrolled. The methodological quality was poor in six and moderate in seven studies. Financial conflicts of interest were reported in six studies. At 1-3 months after treatment, the proportion of patients were for mRS ⩾1 13.3% (95% CI: 10.0%-16.6%), mRS ⩾2 5.3% (95% CI: 3.2%-7.5%), mRS ⩾3 2.4% (95% CI: 0.1%-3.9%) and neurological worsening 3.1% (95% CI: 1.5%-4.6%). Complications within 3 months occurred in 12.7% (95% CI: 10.3%-15.0%).</p><p><strong>Discussion and conclusion: </strong>The literature on FD-stents is methodologically weak and potentially biased by financial interests but still shows relevant proportions of complications and post-treatment morbidity. Currently, there are no good data supporting the use of FD-stents for UIAs where standard treatment options are available. Randomised-controlled trials are needed to compare safety, efficacy and durability between FD-stents and coiling or clipping.</p>","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":" ","pages":"23969873251370992"},"PeriodicalIF":4.5000,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12420651/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Stroke Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/23969873251370992","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Flow-diverting (FD) stents are increasingly used to treat small, unruptured intracranial aneurysms (UIA), but high-quality, unbiased data on initial complications and clinical outcomes were limited in previous literature reviews. We updated the literature review to assess quality, potential bias, complications and short-term outcomes in studies on FD-stents for UIAs.
Patients and methods: We systematically searched PubMed, Embase and Cochrane Library until January 9, 2025 for studies on FD-stents for UIAs. We assessed methodological quality using the methodological index for non-randomised studies (poor: 0-9, moderate: 10-13, good: 14-16), and financial conflicts of interest. The primary outcome was neurological outcome according to a validated outcome scale at 1-3 months after treatment. Secondary outcomes were clinical worsening and complications.
Results: We included 13 studies with 743 patients and 806 UIAs, of which 88.4% (95% CI: 85.7%-91.2%) were <10 mm. All studies were uncontrolled. The methodological quality was poor in six and moderate in seven studies. Financial conflicts of interest were reported in six studies. At 1-3 months after treatment, the proportion of patients were for mRS ⩾1 13.3% (95% CI: 10.0%-16.6%), mRS ⩾2 5.3% (95% CI: 3.2%-7.5%), mRS ⩾3 2.4% (95% CI: 0.1%-3.9%) and neurological worsening 3.1% (95% CI: 1.5%-4.6%). Complications within 3 months occurred in 12.7% (95% CI: 10.3%-15.0%).
Discussion and conclusion: The literature on FD-stents is methodologically weak and potentially biased by financial interests but still shows relevant proportions of complications and post-treatment morbidity. Currently, there are no good data supporting the use of FD-stents for UIAs where standard treatment options are available. Randomised-controlled trials are needed to compare safety, efficacy and durability between FD-stents and coiling or clipping.
期刊介绍:
Launched in 2016 the European Stroke Journal (ESJ) is the official journal of the European Stroke Organisation (ESO), a professional non-profit organization with over 1,400 individual members, and affiliations to numerous related national and international societies. ESJ covers clinical stroke research from all fields, including clinical trials, epidemiology, primary and secondary prevention, diagnosis, acute and post-acute management, guidelines, translation of experimental findings into clinical practice, rehabilitation, organisation of stroke care, and societal impact. It is open to authors from all relevant medical and health professions. Article types include review articles, original research, protocols, guidelines, editorials and letters to the Editor. Through ESJ, authors and researchers have gained a new platform for the rapid and professional publication of peer reviewed scientific material of the highest standards; publication in ESJ is highly competitive. The journal and its editorial team has developed excellent cooperation with sister organisations such as the World Stroke Organisation and the International Journal of Stroke, and the American Heart Organization/American Stroke Association and the journal Stroke. ESJ is fully peer-reviewed and is a member of the Committee on Publication Ethics (COPE). Issues are published 4 times a year (March, June, September and December) and articles are published OnlineFirst prior to issue publication.