Journal of NeuroInterventional Surgery最新文献

{"title":"Transradial cerebral angiography: predicting left ICA selective angiography success using pre-diagnostic aortic arch factors.","authors":"Jin Eun, Seung Yoon Song, Sang Hyuk Im, Hae Kwan Park","doi":"10.1136/jnis-2024-022842","DOIUrl":"https://doi.org/10.1136/jnis-2024-022842","url":null,"abstract":"<p><strong>Background: </strong>Transradial cerebral angiography (TRA) is a convenient but challenging procedure, particularly for selecting the left internal carotid artery (ICA) and vertebral artery.</p><p><strong>Objective: </strong>To predict the selection of the left ICA using CT and MR images acquired before TRA.</p><p><strong>Methods: </strong>Overall, 306 patients with TRA were enrolled and divided into either the group with success (264 patients) or the failure (42 patients) group. The following anatomical factors were measured: A1 (subclavian artery angle), A2 (right subclavian-innominate artery angle), A3 (innominate-left common carotid artery angle), D1 (aorta to right subclavian artery length), and D2 (innominate-to-left common carotid artery length).</p><p><strong>Results: </strong>The median values for A1, A2, A3, D1, and D2 were 81.57° (IQR 69.26-94.14), 147.03° (125.73-161.09), 24.73 (15.85-37.72°), 34.73 mm (29.68-38.48), and 13.15 mm (11.33-15.64), respectively, with significant differences observed between the successful and failure groups in A3 (26.88° vs 15.50°; P<0.001), D1 (34.24 mm vs 37.62 mm; P<0.001), and D2 (12.78 mm vs 14.91 mm; P<0.001). The aortic arch type did not affect success (P=0.134), while patients in the failure group were significantly older (P<0.001). A predictive logistic regression model was developed, revealing differing factor impacts when controlling variables. The model (area under the curve 0.87) highlights data complexity and enables user-friendly prediction of left ICA-selective TRA success (https://je0000000342227505.shinyapps.io/icatra/).</p><p><strong>Conclusion: </strong>This study demonstrated that the success of left ICA selective angiography can be predicted using aortic arch images, providing a basis for the extension of TRA.</p>","PeriodicalId":16411,"journal":{"name":"Journal of NeuroInterventional Surgery","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143523633","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and efficacy of tirofiban versus traditionaldualantiplatelettherapy in endovasculartreatment of intracranialaneurysms: asystematicreview and meta-analysis.","authors":"ZhenKun Xiao, XuYi Hu, LiangJie Deng, JianHua Liu, Aihua Liu","doi":"10.1136/jnis-2024-023021","DOIUrl":"https://doi.org/10.1136/jnis-2024-023021","url":null,"abstract":"<p><strong>Background: </strong>The selection of antiplatelet agents plays a crucial role in ensuring the safety and efficacy of endovascular treatment for intracranial aneurysms (IA). Currently, the primary agents used include tirofiban and traditional dual antiplatelet therapy (DAPT). Due to the lack of high-level consolidated evidence in this field, we conducted the first systematic review and meta-analysis aimed at comparing the safety and efficacy of tirofiban vs traditional DAPT in the endovascular treatment of IA.</p><p><strong>Methods: </strong>Studies published before November 1, 2024, were searched in PubMed, Embase, Web of Science, and Cochrane Central Register of Controlled Trials. The primary outcome was thrombosis, and secondary outcomes included intracranial hemorrhage (ICH), non-intracranial bleeding events (NoICH-BE), ischemic stroke (IS), and follow-up prognosis. Relative risks (RRs) were synthesized for comparison between tirofiban and DAPT groups.</p><p><strong>Results: </strong>Nine studies involving 2481 patients were included. Tirofiban significantly reduced the risk of thrombosis compared with DAPT (RR, 0.292; 95% CI, 0.174 to 0.492; P<0.001). It did not increase risks of ICH (RR, 0.633; P=0.125), NoICH-BE (RR, 0.253; P=0.259), IS (RR, 0.730; P=0.172), or poor prognosis (RR, 0.981; P=0.896).</p><p><strong>Conclusion: </strong>Tirofiban effectively lowers the risk of thrombosis without increasing bleeding or adverse prognosis risks compared with DAPT. It shows promise as an alternative antiplatelet therapy for IA treatment, but further large-scale studies are needed to confirm these findings.</p>","PeriodicalId":16411,"journal":{"name":"Journal of NeuroInterventional Surgery","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143501996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Catheterization complications of intra-arterial chemotherapy for retinoblastoma.","authors":"Craig Schreiber, Gary Kocharian, Natasha Kharas, Jared Knopman, Jasmine H Francis, David H Abramson, Y Pierre Gobin","doi":"10.1136/jnis-2024-022881","DOIUrl":"https://doi.org/10.1136/jnis-2024-022881","url":null,"abstract":"<p><strong>Background: </strong>Intra-arterial chemotherapy (IAC) is a growing method of therapy for retinoblastoma (Rb). There is an absence of data to support the safety of catheterization with intra-arterial infusion in this pediatric population OBJECTIVE: To focus on the non-ocular catheter/procedural-related complications that our practice has experienced in order to lay a foundation for practices interested in performing these procedures and hopefully, to help prevent them from occurring.</p><p><strong>Methods: </strong>This is a retrospective review of the patient population with Rb treated in our center from May 2006 through May 2024. Every procedure performed was reviewed for non-ocular catheterization-related complications. This review included complications of access, the distal vessel (thrombosis, stenosis, and dissection), and non-ocular infarcts.</p><p><strong>Results: </strong>There were 2281 vascular access events, and 2681 distal catheterization procedures were performed for IAC infusion on 623 pediatric patients with Rb. Mean age of the population was 18.9 months. There were 31 complications directly related to catheterization: 7 (0.3%) related to femoral artery access and 24 (0.9%) were distal vessel injuries. Two (0.07% of total catheterizations) of the distal vessel injuries were asymptomatic cerebral infarcts diagnosed on follow-up MRI.</p><p><strong>Conclusion: </strong>Catheterization with IAC can be performed safely in this young pediatric population. There is a trend for fewer complications when using the smallest catheter system possible for procedures.</p>","PeriodicalId":16411,"journal":{"name":"Journal of NeuroInterventional Surgery","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rising tide of middle meningeal artery embolization for chronic subdural hematomas: current volumes and future growth compared with cerebral aneurysm and stroke interventions.","authors":"Ansaar T Rai, Paul S Link, Dhairya A Lakhani","doi":"10.1136/jnis-2025-023109","DOIUrl":"https://doi.org/10.1136/jnis-2025-023109","url":null,"abstract":"<p><strong>Background: </strong>To estimate the current number of middle meningeal artery embolization (MMAE) procedures for subdural hematomas (SDH) and project growth compared with endovascular treatments for cerebral aneurysms and acute ischemic stroke (AIS).</p><p><strong>Methods: </strong>Estimates of SDH admissions were obtained from the National Inpatient Sample and Medicare Inpatient 100% Standard Analytic Files for 2019-23. MMAE volumes (2019-23) were estimated by cross referencing international classification of diseases, 10th revision, clinical modification (ICD-10 CM) codes for non-acute, non-traumatic SDH with ICD-10 procedure coding system (ICD-10 PCS) codes for surgical and endovascular interventions during the same admission to approximate MMAE volumes. These estimates were compared with volumes of endovascular cerebral aneurysm and AIS treatments, with projections based on historical growth rates.</p><p><strong>Results: </strong>MMAE procedures increased significantly, from 4014 in 2019 to 20 836 in 2023, representing a 51% compound annual growth rate (CAGR). In comparison, endovascular aneurysm treatments grew from 34 754 to 42 491 (5% CAGR) and AIS procedures from 34 451 to 44 822 (7% CAGR). In the next 5 years, MMAE is projected to surpass other neurovascular procedures, with an estimated 79 483 procedures, compared with 79 405 for AIS and 56 942 for aneurysms, by 2029. Annual SDH admissions remained steady at just over 200 000 from 2019 to 2022, with most (~66%) managed medically. Only an estimated 2% of SDH admissions received an MMAE procedure in 2019, rising to 8% in 2022.</p><p><strong>Conclusion: </strong>MMAE procedures have seen rapid adoption and may become the dominant neurovascular intervention, with potential implications for healthcare infrastructure and workforce planning.</p>","PeriodicalId":16411,"journal":{"name":"Journal of NeuroInterventional Surgery","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of drug-coated balloon with bare-metal stent in patients with symptomatic intracranial atherosclerotic stenosis: the AcoArt sICAS randomized clinical trial.","authors":"Gaoting Ma, Dapeng Sun, BaiXue Jia, Li Ling, Thanh N Nguyen, Xuan Sun, Bo Yu, Changming Wen, Tao Cheng, Wenhuo Chen, Ju Han, Hongxing Han, Geng Guo, Jianghua Yu, Liping Wei, Rui Huang, Gengsheng Mao, Qingyu Shen, Xinguang Yang, Bo Wang, Gang Luo, Xiaochuan Huo, Feng Gao, Dapeng Mo, Ning Ma, Zhongrong Miao","doi":"10.1136/jnis-2024-022768","DOIUrl":"https://doi.org/10.1136/jnis-2024-022768","url":null,"abstract":"<p><strong>Background: </strong>Restenosis after stenting with a standard bare-metal stent (BMS) is the main cause of stroke recurrence for symptomatic intracranial atherosclerotic stenosis (sICAS). Whether a drug-coated balloon (DCB) could reduce the risk of restenosis for such patients is unknown. We aimed to investigate the efficacy and safety of DCB in reducing 6 month restenosis in patients with sICAS.</p><p><strong>Methods: </strong>A prospective, multicenter, randomized, open-label, blinded endpoint clinical trial was conducted at 13 stroke centers across China. Eligible patients aged 18-80 years with sICAS defined as a recent transient ischemic attack (<180 days) or ischemic stroke (14-180 days) before enrollment attributed to a 70-99% atherosclerotic stenosis of a major intracranial artery were recruited between June 4, 2021 and September 15, 2022 (final follow-up: April 13, 2023). Patients were randomly assigned to receive a DCB (n=90) or BMS at a 1:1 ratio. The primary outcome was the post-procedure incidence of restenosis in the target lesion at 6 months (165-225 days). The safety outcome was post-procedure target vessel-related stroke (hemorrhage or ischemia) or death at 30 days.</p><p><strong>Results: </strong>Among 201 randomized patients, 180 were confirmed eligible (mean age 58 years) and completed the trial. Compared with BMS, DCB was associated with a lower rate of post-procedure incidence of restenosis in the target lesion at 6 months (6.9% vs 32.9%, OR 0.15, 95% CI 0.05 to 0.42, P=0.0003). Regarding the safety outcome, post-procedure target vessel-related stroke (hemorrhage or ischemia) or death at 30 days did not differ between the two groups (4.4% vs 5.6%, OR 0.79, 95%CI 0.21 to 3.05, P=0.73).</p><p><strong>Conclusion: </strong>DCB was superior to BMS in reducing the incidence of restenosis without increasing the risk of target vessel-related stroke or death within 6 months. Further trials comparing the outcomes of DCB with medical management for sICAS are warranted.</p><p><strong>Trial registration number: </strong>ClinicalTrials.gov Identifier: NCT04631055.</p>","PeriodicalId":16411,"journal":{"name":"Journal of NeuroInterventional Surgery","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Do scoring systems help us to estimate prognosis after mechanical thrombectomy? Data from the German Stroke Registry.","authors":"Marianne Hahn, Sonja Gröschel, Roman Paul, Luis Weitbrecht, Maria Protopapa, Sebastian Reder, Ahmed E Othman, Klaus Gröschel, Timo Uphaus","doi":"10.1136/jnis-2024-022772","DOIUrl":"https://doi.org/10.1136/jnis-2024-022772","url":null,"abstract":"<p><strong>Background: </strong>Numerous scoring systems have been developed to individualize estimation of functional outcome after endovascular thrombectomy (EVT) of acute ischemic stroke. The aim of our study was to assess their utility for clinical practice based on a large cohort from real-world care of EVT.</p><p><strong>Methods: </strong>For 13 082 patients included in the German Stroke Registry Endovascular Treatment (GSR-ET) (July 2015 to December 2021), we calculated the following prognostic tools: pre-interventional PRE-, Totaled Health Risks in Vascular Events - Endovascular therapy (THRIVE-EVT)- and Computed Tomography for Late Endovascular Reperfusion (CLEAR) scores and post-interventional MR PREDICTS@24 hours and BET-score. Area under the receiver operating characteristic curve (AUC) analyses in the total cohort and pre-defined subgroups were performed to determine each tool's prognostic value for good functional outcome (modified Rankin Scale (mRS) 0-2) and mortality at 90-day follow-up.</p><p><strong>Results: </strong>All pre-interventional tools achieved a moderate prognostic value for predicting good functional outcome (PRE: AUC (95% confidence interval): 0.757 (0.747-0.768), THRIVE-EVT: 0.751 (0.740-0.761), CLEAR: 0.731 (0.72-0.742)), had a higher predictive value than the admission National Institute of Health Stroke Scale ((NIHSS); 0.705 (0.694-0.716), all P<0.001), but were inferior to the NIHSS 24 hours after EVT (0.864 (0.855-0.872), all P<0.001). Predictive capacity for mortality was less accurate (AUC range: 0.697-0.729). Subgroup analyses revealed that the PRE-score was most robust at predicting good functional outcome, whereas the THRIVE-EVT score was superior in predicting mortality. Post-interventionally, MR PREDICTS@24 hours yielded high predictive accuracy for good functional outcome and mortality (both AUC >0.85), superior to 24-hour NIHSS for all subgroups, except patients <50 years of age.</p><p><strong>Conclusion: </strong>Pre-interventional scoring tools predict functional outcome after EVT better than stroke severity alone. Post-interventionally, the MR PREDICTS@24 hours tool adds predictive value to the 24-hour NIHSS as a single prognostic feature. Multivariate prognostic tools incorporating (post-)procedural information enable individualization of prognosis assessment after EVT under routine-care conditions.</p>","PeriodicalId":16411,"journal":{"name":"Journal of NeuroInterventional Surgery","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143501989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Thrombectomy for medium vessel occlusions: too far too soon?","authors":"Michael Chen, Edgar A Samaniego, Mario Martínez-Galdámez, Reade Andrew De Leacy, Joshua A Hirsch, David Fiorella, Felipe C Albuquerque","doi":"10.1136/jnis-2025-023248","DOIUrl":"https://doi.org/10.1136/jnis-2025-023248","url":null,"abstract":"","PeriodicalId":16411,"journal":{"name":"Journal of NeuroInterventional Surgery","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143515575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CTA-based deep-learning integrated model for identifying irregular shape and aneurysm size of unruptured intracranial aneurysms.","authors":"Ke Tian, Zhenyao Chang, Yi Yang, Peng Liu, Mahmud Mossa-Basha, Michael R Levitt, Dihua Zhai, Danyang Liu, Hao Li, Yang Liu, Jinhao Zhang, Cijian Cao, Chengcheng Zhu, Peng Jiang, Qingyuan Liu, Hongwei He, Yuanqing Xia","doi":"10.1136/jnis-2024-022784","DOIUrl":"https://doi.org/10.1136/jnis-2024-022784","url":null,"abstract":"<p><strong>Background: </strong>Artificial intelligence can help to identify irregular shapes and sizes, crucial for managing unruptured intracranial aneurysms (UIAs). However, existing artificial intelligence tools lack reliable classification of UIA shape irregularity and validation against gold-standard three-dimensional rotational angiography (3DRA). This study aimed to develop and validate a deep-learning model using computed tomography angiography (CTA) for classifying irregular shapes and measuring UIA size.</p><p><strong>Methods: </strong>CTA and 3DRA of UIA patients from a referral hospital were included as a derivation set, with images from multiple medical centers as an external test set. Senior investigators manually measured irregular shape and aneurysm size on 3DRA as the ground truth. Convolutional neural network (CNN) models were employed to develop the CTA-based model for irregular shape classification and size measurement. Model performance for UIA size and irregular shape classification was evaluated by intraclass correlation coefficient (ICC) and area under the curve (AUC), respectively. Junior clinicians' performance in irregular shape classification was compared before and after using the model.</p><p><strong>Results: </strong>The derivation set included CTA images from 307 patients with 365 UIAs. The test set included 305 patients with 350 UIAs. The AUC for irregular shape classification of this model in the test set was 0.87, and the ICC of aneurysm size measurement was 0.92, compared with 3DRA. With the model's help, junior clinicians' performance for irregular shape classification was significantly improved (AUC 0.86 before vs 0.97 after, P<0.001).</p><p><strong>Conclusion: </strong>This study provided a deep-learning model based on CTA for irregular shape classification and size measurement of UIAs with high accuracy and external validity. The model can be used to improve reader performance.</p>","PeriodicalId":16411,"journal":{"name":"Journal of NeuroInterventional Surgery","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical outcomes after stenting treatment in patients with idiopathic intracranial hypertension and intrinsic versus extrinsic venous sinus stenosis.","authors":"Xu Tong, Zhongao Guan, Xiaoqing Li, Shuran Wang, Shuang Song, Yawen Gan, Fangguang Chen, Jie He, Ketao Tu, Zhenfei Yu, Dapeng Mo","doi":"10.1136/jnis-2024-022760","DOIUrl":"https://doi.org/10.1136/jnis-2024-022760","url":null,"abstract":"<p><strong>Background: </strong>Endovascular stenting is a promising treatment for patients with idiopathic intracranial hypertension (IIH) and venous sinus stenosis (VSS). However, data on the impact of stenosis type on clinical outcomes of patients undergoing stenting treatment remain limited. This prospective cohort study aimed to compare post-stenting outcomes in patients with IIH and intrinsic versus extrinsic VSS.</p><p><strong>Methods: </strong>Patients with IIH and VSS undergoing stenting at a tertiary hospital in China were enrolled consecutively from 2017 to 2023. Based on digital subtraction angiography, high-resolution MRI, and intravascular ultrasound findings, patients were categorized into two groups: intrinsic or extrinsic stenosis. At 6 months post-stenting, clinical outcomes including cerebrospinal fluid (CSF) pressure, headache, visual impairment, and papilledema were recorded. Multivariable regression models were used to explore the relationship between stenosis type and clinical outcomes.</p><p><strong>Results: </strong>In total, 92 patients were included, 60 with intrinsic stenosis and 32 with extrinsic stenosis. At 6 months, the intrinsic group had lower CSF pressure (median 180 vs 210 mmH₂O, β coefficient -31.8, 95% CI -54.0 to -9.6) and a higher rate of complete symptom resolution (81.7% vs 40.6%, OR 8.88, 95% CI 2.60 to 30.30) than the extrinsic group. Additionally, 36.8% (95% CI 10.5% to 77.2%) of the effect of stenosis type on complete symptom resolution at 6 months was mediated through reduction in CSF pressure.</p><p><strong>Conclusion: </strong>This single-center study suggested that patients with IIH and intrinsic VSS had lower CSF pressure and better symptom recovery compared with those with extrinsic VSS at 6 months post-stenting. Further validation in other centers and populations is needed.</p><p><strong>Trial registration number: </strong>ChiCTR.org.cn, ChiCTR-ONN-17010421.</p>","PeriodicalId":16411,"journal":{"name":"Journal of NeuroInterventional Surgery","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The River study: the first prospective multicenter trial of a novel venous sinus stent for the treatment of idiopathic intracranial hypertension.","authors":"Athos Patsalides, Kyle M Fargen, Jason M Davies, Srikanth R Boddu, Marc Dinkin, Ryan Priest, Howard D Pomeranz, Y Pierre Gobin, Adnan H Siddiqui","doi":"10.1136/jnis-2024-022540","DOIUrl":"https://doi.org/10.1136/jnis-2024-022540","url":null,"abstract":"<p><strong>Background: </strong>The River stent is the first stent specifically designed for intracranial venous sinuses. We report the 1-year results of the River trial, performed to obtain Humanitarian Device Exemption approval of the River stent in the United States (US).</p><p><strong>Methods: </strong>The River trial was a prospective, open-label, multicenter, single-arm trial which enrolled 39 subjects at 5 US centers. Eligible patients had clinical diagnosis of idiopathic intracranial hypertension (IIH) with severe headaches or visual field loss and had failed medical therapy. The primary safety endpoint was the 1-year rate of major adverse events compared with cerebrospinal fluid (CSF) shunting using historical controls. The primary benefit endpoint was a composite at 1 year of clinical improvement and absence of venous sinus stenosis. Secondary endpoints included improvement in pulsatile tinnitus, visual symptoms, quality of life (QOL) scores, and medications.</p><p><strong>Results: </strong>All procedures were technically successful. There was one serious adverse event, a gastrointestinal hemorrhage observed 2 months after the procedure while the patient was still on dual antiplatelet therapy. The primary safety endpoint was met with a rate of major adverse event of 5.4% versus 51.7% for CSF shunts. The primary benefit endpoint was achieved in 60% of trial participants. Additional improvements were also observed in opening CSF pressure, headaches, papilledema, pulsatile tinnitus, visual symptoms, and QOL scores. Post hoc analysis demonstrated that subjects with minimal or absent papilledema at baseline showed similar improvement compared with subjects with papilledema at baseline, in terms of headaches, pulsatile tinnitus, and QOL.</p><p><strong>Conclusions: </strong>The River study 1- year results establish safety and suggest efficacy for venous sinus stenting in IIH subjects who have failed medical therapy.</p>","PeriodicalId":16411,"journal":{"name":"Journal of NeuroInterventional Surgery","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}