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Introduction: The Woven EndoBridge (WEB) device is emerging as a novel therapy for intracranial aneurysms, but its use for off-label indications requires further study. Using machine learning, we aimed to develop predictive models for complete occlusion after off-label WEB treatment and to identify factors associated with occlusion outcomes., Methods: This multicenter, retrospective study included 162 patients who underwent off-label WEB treatment for intracranial aneurysms. Baseline, morphological, and procedural variables were utilized to develop machine-learning models predicting complete occlusion. Model interpretation was performed to determine significant predictors. Ordinal regression was also performed with occlusion status as an ordinal outcome from better (Raymond Roy Occlusion Classification [RROC] grade 1) to worse (RROC grade 3) status. Odds ratios (OR) with 95 % confidence intervals (CI) were reported., Results: The best performing model achieved an AUROC of 0.8 for predicting complete occlusion. Larger neck diameter and daughter sac were significant independent predictors of incomplete occlusion. On multivariable ordinal regression, higher RROC grades (OR 1.86, 95 % CI 1.25-2.82), larger neck diameter (OR 1.69, 95 % CI 1.09-2.65), and presence of daughter sacs (OR 2.26, 95 % CI 0.99-5.15) were associated with worse aneurysm occlusion after WEB treatment, independent of other factors., Conclusion: This study found that larger neck diameter and daughter sacs were associated with worse occlusion after WEB therapy for aneurysms. The machine learning approach identified anatomical factors related to occlusion outcomes that may help guide patient selection and monitoring with this technology. Further validation is needed., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: The Woven EndoBridge (WEB) device was approved to treat wide-necked bifurcation aneurysms. The device is designed as an intrasaccular flow disruptor covering aneurysm widths up to 10 mm. Although prior studies combined all aneurysm sizes, it is known that aneurysms behave differently in response to endovascular treatment based on their size. Therefore, the authors' objective was to identify ideal middle cerebral artery (MCA) aneurysm width and neck sizes most suitable for WEB treatment., Methods: The WorldWideWEB consortium is a large multicenter retrospective database that analyzes intracranial aneurysms treated with the WEB device. In this study, all unruptured MCA bifurcation aneurysms with available measurements were included. Cutoff values based on aneurysm width and neck in relation to aneurysm occlusion status were measured using the receiver operating characteristic (ROC) curve. Propensity score matching (PSM) was then used to compare treatment outcomes between aneurysms smaller and larger than the cutoff value for both width and neck size., Results: The ideal cutoff values for MCA bifurcation aneurysm width and neck were 6.1 mm and 4.6 mm, respectively. On PSM, 87 matched pairs were compared based on width size (≤ 6.1 mm and > 6.1 mm), and 77 matched pairs were compared based on neck size (≤ 4.6 mm and > 4.6 mm). There was a significant difference in adequate aneurysm occlusion between aneurysms smaller and larger than those cutoff values for both widths (93% vs 76%, p = 0.0017) and neck sizes (90% vs 70%, p = 0.0026). The retreatment rate was also significantly higher for larger aneurysms in both parameters., Conclusions: This study shows that MCA bifurcation aneurysms ≤ 6.1 mm in width and ≤ 4.6 mm in neck size are significantly better candidates for WEB treatment, leading to improved occlusion status and reduced retreatment rate, which are important considerations when using WEB devices.

Background: Long-term data showing the benefits of endovascular thrombectomy for stroke with large infarct are scarce. The TENSION trial showed the safety and efficacy of endovascular thrombectomy in patients with ischaemic stroke and large infarct at 90 days. We aimed to investigate the safety and efficacy at 12 months of endovascular thrombectomy in patients who were enrolled in the TENSION trial., Methods: TENSION was an open-label, blinded endpoint, randomised trial done at 40 hospitals across Europe and one hospital in Canada. We included patients (aged ≥18 years) with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and who had a large infarct, as indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 on standard-of-care stroke imaging. We randomly assigned patients (1:1) to receive either endovascular thrombectomy with medical treatment or medical treatment only up to 12 h from stroke onset. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days. Here, we report the prespecified 12-month follow-up analyses for functional outcome (using the simplified modified Rankin Scale questionnaire), quality of life (using the Patient-Reported Outcomes Measurement Information System 10-item [PROMIS-10] and EQ-5D questionnaires), post-stroke anxiety and depression (using the Patient Health Questionnaire-4 [PHQ-4]), and overall survival. Outcomes (except survival) were assessed in the intention-to-treat population; the survival analysis was based on treatment received. This trial is registered with ClinicalTrials.gov, NCT03094715, and is completed., Findings: We enrolled patients between July 17, 2018, and Feb 21, 2023, when the trial was stopped early for efficacy. 253 patients were randomly assigned, 125 (49%) to endovascular thrombectomy and 128 (51%) to medical treatment only. Median follow-up was 8·36 months (IQR 0·02-12·00). Endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better functional outcome at 12 months (adjusted common odds ratio 2·39 [95% CI 1·47-3·90]). Endovascular thrombectomy was also associated with a better quality of life compared with medical treatment only, as reflected by median scores on the EQ-5D questionnaire index (0·7 [IQR 0·4-0·9] vs 0·4 [0·2-0·7]), median scores for health status on the EQ-5D questionnaire visual analogue scale (50 [IQR 35-70] vs 30 [5-60]), and median global physical health scores on the PROMIS-10 questionnaire (T-score 39·8 [IQR 37·4-50·8] vs 37·4 [32·4-44·9]); although there was not enough evidence to suggest a difference between groups in global mental health scores on PROMIS-10 (41·1 [IQR 36·3-48·3] vs 38·8 [31·3-44·7]) or the numbers of patients reporting anxiety (13 [22%] of 58 vs 15 [42%] of 36) and depression (18 [31%] vs 18 [50%]) on PHQ-4. Overall survival was slightly better in the endovascular thrombectomy group compared with medical treatment only (adjusted hazard ratio 0·70 [95% CI 0·50-0·99])., Interpretation: In patients with acute ischaemic stroke from large vessel occlusion with established large infarct, compared with medical treatment only, endovascular thrombectomy was associated at 12 months after stroke with better functional outcome, quality of life, and overall survival. These findings suggest that the benefits of endovascular thrombectomy in patients with an ischaemic stroke and a large infarct are sustained in the long term and support the use of endovascular thrombectomy in these patients., Funding: European Union Horizon 2020 Research and Innovation Programme., Competing Interests: Declaration of interests MB reports funding from the European Union Horizon 2020 and Deutsche Forschungsgemeinschaft (payments to the institution); honoraria for lectures from Novartis, Boehringer Ingelheim, and Seagen; consulting fees from NeuroScios and Boehringer Ingelheim; and a role as Editor-in-Chief of Clinical Neuroradiology (Springer), outside the submitted work. JF reports funding from the European Commission; personal consulting fees from Acandis, Cerenovus, Medtronic, Microvention, Phenox, Roche, and Stryker; consulting at Philips (no payments); payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Penumbra and Tonbridge; support for attending meetings or travel from Medtronic and Penumbra; and stock or stock options from Tegus medical, eppdata, and Vastrax, outside the submitted work. JF also reports participation in a Data Safety Monitoring Board (DSMB) or Advisory Board at Phenox (personal fees) and Stryker (personal fees), and a role as past president of ESMINT. SB reports funding from the EU Horizon 2020 research and innovation programme (payments made to the institution; support for attending meetings or travel), outside the submitted work. AHA reports unrestricted research grants from Boehringer Ingelheim and honoraria for lectures from BMS/Pfizer, Teva, Roche, Abbvie, Lundbeck, Novartis, outside the submitted work. AHA also reports participation in Advisory Boards for MSD, BMS/Pfizer, Lundbeck, Lilly, and Abbvie. BF reports research grants from Carlos III Institute of Health (ISCIII), personal payment for educational lectures from Servicio Madrileño de Salud, payment to the institution for lectures from Euromedice, personal payment for educational lectures from Takeda, support for attending meetings from Daichii Sankyo, and receipt of materials for research from Abbot, outside the submitted work. MDH reports funding from Nil, a grant to the University of Calgary for the TEMPO-2 trial from Boehringer Ingelheim, a grant to the University of Calgary from Biogen, a grant to the University of Calgary for the ESCAPE-NA1 trial and ESCAPE-NEXT trial from NoNO, a grant to the University of Calgary for the ESCAPE-NA1 trial and ESCAPE-NEXT trial from the Canadian Institute for Health Research, a grant to the University of Calgary for the HERMES collaboration from Medtronic, and a grant to the University of Calgary for the QuICR Alberta Stroke Program; some of the funds were used for the ESCAPE-NA1 trial from Alberta Innovates. MDH also reports consulting fees from Sun Pharma Brainsgate (paid work for adjudication of clinical trial outcomes), US Patent 62/086,077 (licensed to Circle NVI), US Patent 10,916,346 (licensed to Circle NVI), and private stock ownership from Circle and PUreWeb, outside the submitted work. MDH reports participation as DSMC Chair of the RACECAT trial (end 2020), participation as DSMC Chair of the Oncovir Hiltonel trial (ongoing), participation as DSMC Chair of the DUMAS trial (ongoing), participation as DSMB member of the ARTESIA trial (ongoing), participation as DSMB member of the BRAIN-AF trial (ongoing), a role as President of the Canadian Neurological Sciences Federation (not for profit), and as Board Member of the Canadian Stroke Consortium (not for profit). AK reports grants from the European Commission for the TENSION study (payment to the institution), outside the submitted work. LP reports consulting fees from Balt, consulting fees from Microvention, consulting fees from Phenox, and support for attending meetings or travel for the TENSION investigator meeting (transport and accommodation was reimbursed by the organization), outside the submitted work. CZS reports grants from Health Research Foundation of Central Denmark Region, outside the submitted work. RAB reports speakers fees from Novo Nordisk and Beyer, outside the submitted work. HD reports financial compensation for the start-up fee and the obligatory payment to the hospital administration paid by the sponsor (Medical University Heidelberg) to the Clinical Division (no personal payments), personal consulting fees from Stryker, speakers honorary from Medtronic, and support for attending meetings or travel from Medtronic, outside the submitted work. HD also reports a role as past President of the Austrian Society of Interventional Radiology and past president Austrian Society of Neuroradiology. FD reports consulting fees from Cerenovus, Balt, Cerus Endovascular, and Microvention; payment for expert testimony from Cerenovus; and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Cerenovus, Stryker, Acandis, Asahi, Penumbra, Medtronic, Tonbridge, Inspire, and Q'Apel, outside the submitted work. FD also reports participation in a DSMB or Advisory Board at Cerenovus and Microvention and previous roles as Associate Editor for Journal of Interventional Surgery, Journal of Clinical Medicine, and Clinical Neuroradiology. FF reports consulting fees from eppdata and support for attending meetings or travel from Microvention, Medtronic, Cerebrovascular Research and Education Foundation, and Acandis, outside the submitted work. SG reports consulting fees from eppdata, outside the submitted work. CH reports consulting fees from Brainomix and lecture fees from Stryker, outside the submitted work. SH-J reports funding for data collection and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Terumo, outside the submitted work. MG reports research grants from Medtronic and Cerenovus (payments to the University of Calgary); royalties or licenses from Microvention (systems of intracranial access); personal consulting fees from Microvention, Medtronic, Stryker, Mentice, Philips, and Penumbra; and stock or stock options from Circle Neurovascular, outside the submitted work. FCK was chair of the German Stroke Registry (unpaid). RM reports payments for stroke lecture from TMC Academy, outside the submitted work. MM reports grants from Balt, Medtronic, MicroVention, and Stryker; consulting fees from Siemens; and support for attending meetings or travel from Europa Group, outside the submitted work. SM-H reports consulting fees from Terumo and Boston Scientific Corporation and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Terumo and Boston Scientific Corporation, outside the submitted work. NM reports provision of study materials, outside the submitted work. PP reports support for attending meetings or travel for the TENSION investigator meeting (transport and accommodation was reimbursed by the organisation), outside the submitted work. MP reports grants from the German Research Foundation, speaker honoraria unrelated from Merck Serono and Bayer, and support for attending meetings or travel from Merck Serono (travel reimbursement) and Bayer (travel reimbursement), outside the submitted work. VP reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Boehringer Ingelheim, Daichii Sankyo, AstraZeneca and BMS, and support for attending meetings or travel from NoNo (travel reimbursement). PAR reports consulting fees to the institution from Boehringer Ingelheim and Bayer, and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Boehringer Ingelheim, Bayer, Pfizer, and BMS (all made to the institution), outside the submitted work. ES reports grants from Hamburg Innovation and Hertie Foundation, outside the submitted work. DFV reports research grants from MicroVention, consulting fees from Medtronic, and paid lectures from Cerenovus/Johnson & Johnson, outside the submitted work. WW reports consulting fees to the institution from Abbvie, and consulting fees to the institution from BMS, GSK, and Servier, outside the submitted work. GT reports funding from the European Commission (EU Horizon 2020 research and innovation programme, payments to the institution); personal consulting fees from Acandis, AstraZeneca, Bayer, Boehringer Ingelheim, and Stryker; and personal payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Acandis, Alexion, Amarin, Bayer, Boehringer Ingelheim, BristolMyersSquibb/Pfizer, Daiichi Sankyo, Stryker, outside the submitted work. GT also reports participation as DSMB member for the TEA Stroke Trial (no payments) and ReSCInD trial (no payments), a role as speaker of the Commission for Cerebrovascular Diseases of the German Society of Neurology (no payments), and member of the Board of Directors of the European Stroke Organisation (no payments). All other declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.)

Background: Endovascular treatment with the woven endobridge (WEB) device has been widely utilized for managing intracranial aneurysms. However, predicting the probability of achieving adequate occlusion (Raymond-Roy classification 1 or 2) remains challenging., Objective: Our study sought to develop and validate a predictive calculator for adequate occlusion using the WEB device via data from a large multi-institutional retrospective cohort., Methods: We used data from the WorldWide WEB Consortium, encompassing 356 patients from 30 centers across North America, South America, and Europe. Bivariate and multivariate regression analyses were performed on a variety of demographic and clinical factors, from which predictive factors were selected. Calibration and validation were conducted, with variance inflation factor (VIF) parameters checked for collinearity., Results: A total of 356 patients were included: 124 (34.8%) were male, 108 (30.3%) were elderly (≥65 years), and 118 (33.1%) were current smokers. Mean maximum aneurysm diameter was 7.09 mm (SD 2.71), with 112 (31.5%) having a daughter sac. In the multivariate regression, increasing aneurysm neck size (OR 0.706 [95% CI: 0.535-0.929], p  = 0.13) and partial aneurysm thrombosis (OR 0.135 [95% CI: 0.024-0.681], p  = 0.016) were found to be the only statistically significant variables associated with poorer likelihood of achieving occlusion. The predictive calculator shows a c -statistic of 0.744. Hosmer-Lemeshow goodness-of-fit test indicated a satisfactory model fit with a p -value of 0.431. The calculator is available at: https://neurodx.shinyapps.io/WEBDEVICE/., Conclusion: The predictive calculator offers a substantial contribution to the clinical toolkit for estimating the likelihood of adequate intracranial aneurysm occlusion by WEB device embolization., Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The Woven EndoBridge (WEB) device is primarily used for treating wide-neck intracranial bifurcation aneurysms under 10 mm. Limited data exists on its efficacy for large aneurysms. We aim to assess angiographic and clinical outcomes of the WEB device in treating large versus small aneurysms. We conducted a retrospective review of the WorldWide WEB Consortium database, from 2011 to 2022, across 30 academic institutions globally. Propensity score matching (PSM) was employed to compare small and large aneurysms on baseline characteristics. A total of 898 patients were included. There was no significant difference observed in clinical presentations, smoking status, pretreatment mRS, presence of multiple aneurysms, bifurcation location, or prior treatment between the two groups. After PSM, 302 matched pairs showed significantly lower last follow-up adequate occlusion rates (81% vs 90%, p = 0.006) and higher retreatment rates (12% vs 3.6%, p < 0.001) in the large aneurysm group. These findings may inform treatment decisions and patient counseling. Future studies are needed to further explore this area., (© 2024. The Author(s).)

Background: Mechanical thrombectomy (MT) is the standard of care for patients with a stroke and large vessel occlusion. Clot composition is not routinely assessed in clinical practice as no specific diagnostic value is attributed to it, and MT is performed in a standardized 'non-personalized' approach. Whether different clot compositions are associated with intrinsic likelihoods of recanalization success or treatment outcome is unknown., Methods: We performed a prospective, non-randomized, single-center study and analyzed the clot composition in 60 consecutive patients with ischemic stroke undergoing MT. Clots were assessed by ex vivo multiparametric MRI at 9.4 T (MR microscopy), cone beam CT, and histopathology. Clot imaging was correlated with preinterventional CT and clinical data., Results: MR microscopy showed red blood cell (RBC)-rich (21.7%), platelet-rich (white,38.3%) or mixed clots (40.0%) as distinct morphological entities, and MR microscopy had high accuracy of 95.4% to differentiate clots. Clot composition could be further stratified on preinterventional non-contrast head CT by quantification of the hyperdense artery sign. During MT, white clots required more passes to achieve final recanalization and were not amenable to contact aspiration compared with mixed and RBC-rich clots (maneuvers: 4.7 vs 3.1 and 1.2 passes, P<0.05 and P<0.001, respectively), whereas RBC-rich clots showed higher probability of first pass recanalization (76.9%) compared with white clots (17.4%). White clots were associated with poorer clinical outcome at discharge and 90 days after MT., Conclusion: Our study introduces MR microscopy to show that the hyperdense artery sign or MR relaxometry could guide interventional strategy. This could enable a personalized treatment approach to improve outcome of patients undergoing MT., Competing Interests: Competing interests: KK-J received research support from Novartis Pharma GmbH, unrelated to this work (Nürnberg, Germany). DFB reports consultancy for Medtronic and payed lectures for Cerenovus, and a research grant by MicroVention, unrelated to this work. KS received funding from the Olympia-Morata-Program of the Medical Faculty of Heidelberg University and from the Daimler-Benz-Foundation unrelated to this work. CU received travel funding and/or speaker honoraria from Cerenovus unrelated to this work. CH reports consultancy payments by Brainomix and lecture fees by Stryker. LS reports research support and consultancy fees from Novartis, Roche, Bristol-Myers Squibb, and Merck. MB served on the scientific advisory board of ECASS, TENSION, Springer, Boehringer, BBRaun, and Vascular Dynamics; received speaker honoraria from Guerbet, Bayer, Novartis, Codman, Roche, and Teva; is coeditor of Clinical Neuroradiology; and received research support from Novartis Pharma GmbH (Nürnberg, Germany), Guerbet, Siemens, Bayer Healthcare, Hopp Foundation, European Union, and DFG. MOB received funding from DFG (SFB1389 and Emmy Noether program, BR 6153/1-1) and Novartis Pharma GmbH, unrelated to this work. UN, DS, MF, GB, AK, VS, TH, FSe, FP, NS, JJ, TC, SHa, FSa, SHe, PAR, WW and MAM report no disclosures relevant for this work., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Purpose: Despite the numerous studies evaluating the occlusion rates of aneurysms following WEB embolization, there are limited studies identifying predictors of occlusion. Our purpose was to identify predictors of aneurysm occlusion and the need for retreatment., Materials and Methods: This is a review of a prospectively maintained database across 30 academic institutions. We included patients with previously untreated cerebral aneurysms embolized using the WEB who had available intraprocedural data and long-term follow-up., Results: We studied 763 patients with a mean age of 59.9 (SD, 11.7) years. Complete aneurysm occlusion was observed in 212/726 (29.2%) cases, and contrast stasis was observed in 485/537 (90.3%) of nonoccluded aneurysms. At the final follow-up, complete occlusion was achieved in 497/763 (65.1%) patients, and retreatment was required for 56/763 (7.3%) patients. On multivariable analysis, history of smoking, maximal aneurysm diameter, and the presence of an aneurysm wall branch were negative predictors of complete occlusion (OR, 0.5, 0.8, and 0.4, respectively). Maximal aneurysm diameter, the presence of an aneurysm wall branch, posterior circulation location, and male sex increase the chances of retreatment (OR, 1.2, 3.8, 3.0, and 2.3 respectively). Intraprocedural occlusion resulted in a 3-fold increase in the long-term occlusion rate and a 5-fold decrease in the retreatment rate ( P < .001), offering a specificity of 87% and a positive predictive value of 85% for long-term occlusion., Conclusions: Intraprocedural occlusion can be used to predict the chance of long-term aneurysm occlusion and the need for retreatment after embolization with a WEB device. Smoking, aneurysm size, and the presence of an aneurysm wall branch are associated with decreased chances of successful treatment., (© 2024 by American Journal of Neuroradiology.)

The Woven EndoBridge (WEB) device has been widely used to treat intracranial wide neck bifurcation aneurysms. Initial studies have demonstrated that approximately 90% of patients have same or improved long-term aneurysm occlusion after the initial 6-month follow up. The aim of this study is to assess the long-term follow-up in aneurysms that have achieved complete occlusion at 6 months. We also compared the predictive value of different imaging modalities used. This is an analysis of a prospectively maintained database across 13 academic institutions. We included patients with previously untreated cerebral aneurysms embolized using the WEB device who achieved complete occlusion at first follow-up and had available long-term follow-up. A total of 95 patients with a mean age of 61.6 ± 11.9 years were studied. The mean neck diameter and height were 3.9 ± 1.3 mm and 6.0 ± 1.8 mm, respectively. The mean time to first and last follow-up was 5.4 ± 1.8 and 14.1 ± 12.9 months, respectively. Out of all the aneurysms that were completely occluded at 6 months, 84 (90.3%) showed complete occlusion at the final follow-up, and 11(11.5%) patients did not achieve complete occlusion. The positive predictive value (PPV) of complete occlusion at first follow was 88.4%. Importantly, this did not differ between digital subtraction angiography (DSA), magnetic resonance angiography (MRA), or computed tomography angiography (CTA). This study underlines the importance of repeat imaging in patients treated with the WEB device even if complete occlusion is achieved short term. Follow-up can be performed using DSA, MRA or CTA with no difference in positive predictive value., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: This study was conducted to investigate the impact of antiplatelet administration in the periprocedural period on the occurrence of thromboembolic complications (TECs) in patients undergoing treatment using the Woven EndoBridge (WEB) device for intracranial wide-necked bifurcation aneurysms. The primary objective was to assess whether the use of antiplatelets in the pre- and postprocedural phases reduces the likelihood of developing TECs, considering various covariates., Methods: A retrospective multicenter observational study was conducted within the WorldWideWEB Consortium and comprised 38 academic centers with endovascular treatment capabilities. Univariable and multivariable logistic regression analyses were performed to determine the association between antiplatelet use and TECs, adjusting for covariates. Missing predictor data were addressed using multiple imputation., Results: The study comprised two cohorts: one addressing general thromboembolic events and consisting of 1412 patients, among whom 103 experienced TECs, and another focusing on symptomatic thromboembolic events and comprising 1395 patients, of whom 50 experienced symptomatic TECs. Preprocedural antiplatelet use was associated with a reduced likelihood of overall TECs (OR 0.32, 95% CI 0.19-0.53, p < 0.001) and symptomatic TECs (OR 0.49, 95% CI 0.25-0.95, p = 0.036), whereas postprocedural antiplatelet use showed no significant association with TECs. The study also revealed additional predictors of TECs, including stent use (overall: OR 4.96, 95% CI 2.38-10.3, p < 0.001; symptomatic: OR 3.24, 95% CI 1.26-8.36, p = 0.015), WEB single-layer sphere (SLS) type (overall: OR 0.18, 95% CI 0.04-0.74, p = 0.017), and posterior circulation aneurysm location (symptomatic: OR 18.43, 95% CI 1.48-230, p = 0.024)., Conclusions: The findings of this study suggest that the preprocedural administration of antiplatelets is associated with a reduced likelihood of TECs in patients undergoing treatment with the WEB device for wide-necked bifurcation aneurysms. However, postprocedural antiplatelet use did not show a significant impact on TEC occurrence.

Background: The Woven EndoBridge (WEB) devices have been used for treating wide neck bifurcation aneurysms (WNBAs) with several generational enhancements to improve clinical outcomes. The original device dual-layer (WEB DL) was replaced by a single-layer (WEB SL) device in 2013. This study aimed to compare the effectiveness and safety of these devices in managing intracranial aneurysms., Methods: A multicenter cohort study was conducted, and data from 1,289 patients with intracranial aneurysms treated with either the WEB SL or WEB DL devices were retrospectively analyzed. Propensity score matching was utilized to balance the baseline characteristics between the two groups. Outcomes assessed included immediate occlusion rate, complete occlusion at last follow-up, retreatment rate, device compaction, and aneurysmal rupture., Results: Before propensity score matching, patients treated with the WEB SL had a significantly higher rate of complete occlusion at the last follow-up and a lower rate of retreatment. After matching, there was no significant difference in immediate occlusion rate, retreatment rate, or device compaction between the WEB SL and DL groups. However, the SL group maintained a higher rate of complete occlusion at the final follow-up. Regression analysis showed that SL was associated with higher rates of complete occlusion (OR: 0.19; CI: 0.04 to 0.8, p = 0.029) and lower rates of retreatment (OR: 0.12; CI: 0 to 4.12, p = 0.23)., Conclusion: The WEB SL and DL devices demonstrated similar performances in immediate occlusion rates and retreatment requirements for intracranial aneurysms. The SL device showed a higher rate of complete occlusion at the final follow-up., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Introduction: This study focuses on long-term outcomes after aneurysm treatment with either the Flow Re-Direction Endoluminal Device (FRED) or the FRED Jr. to investigate the durability of treatment effect and long-term complications., Methods: This study is based on a retrospective analysis of a prospectively maintained patient data base. Patients treated with either FRED or FRED Jr. between 2013 and 2017 at our institution, and thus a possibility for ≥ 5 years of follow-up, were included. Aneurysm occlusion rates, recurrence rates, modified Rankin scale score shifts to baseline, and delayed complications were assessed., Results: In this study 68 patients with 84 aneurysms had long-term follow-up with a mean duration of 57.3 months and 44 patients harboring 52 aneurysms had a follow-up ≥ 5 years with a mean follow-up period of 69.2 months. Complete occlusion was reached in 77.4% at 2 years and increased to 84.9% when the latest available imaging result was considered. Younger age and the absence of branch involvement were predictors for aneurysm occlusion in linear regression analysis. After the 2‑year threshold, there were 3 reported symptomatic non-serious adverse events. Of these, one patient had a minor stroke, one a transitory ischemic attack and one had persistent mass effect symptoms due to a giant aneurysm, none of these resulted in subsequent neurological disability., Conclusion: This long-term follow-up study demonstrates that the FRED and FRED Jr. are safe and effective for the treatment of cerebral aneurysms in the long term, with high rates of complete occlusion and low rates of delayed adverse events., (© 2023. The Author(s).)

Importance: Stent retriever-based thrombectomy is highly beneficial in large vessel occlusion (LVO) strokes. Many stent retriever designs are currently available, but comparison of these technologies in well-conducted studies is lacking., Objective: To determine whether thrombectomy for LVO stroke with the pRESET stent retriever is noninferior to treatment with the Solitaire stent retriever., Design, Setting, and Participants: This study was a multicenter, prospective, randomized, controlled, open-label, adaptive, noninferiority trial with blinded primary end point evaluation. Between October 2019 and February 2022, multicenter participation occurred across 19 research hospitals and/or universities in the US and 5 in Germany. Patients with LVO stroke were enrolled and included up to 8 hours after symptom onset., Interventions: Patients underwent 1:1 randomization to thrombectomy with the pRESET or Solitaire stent retriever., Main Outcomes and Measures: The primary outcome was the difference in the rate of 90-day functional independence across the 2 devices, using a -12.5% noninferiority margin for the lower bound of the 1-sided 95% CI of the difference between pRESET and Solitaire retrievers., Results: Of 340 randomized patients, 170 (50.0%) were female, and the median (IQR) age was 73.0 (64.0-82.0) years. The study procedure was completed in 322 of the 340 randomized patients. The primary end point of 90-day functional independence was achieved by 95 patients (54.9%; 95% CI, 48.7-61.1) in the pRESET group and in 96 (57.5%; 95% CI, 51.2-63.8) in the Solitaire group (absolute difference, -2.57%; 95% CI, -11.42 to 6.28). As the lower bound of the 95% CI was greater than -12.5%, the pRESET retriever was deemed noninferior to the Solitaire retriever. The noninferiority of pRESET over Solitaire was also observed in the secondary clinical end point (90-day shift in modified Rankin Scale score) and in both angiographic end points (Expanded Treatment in Cerebral Infarction [eTICI] score of 2b50 or greater within 3 passes: 146 of 173 [84.4%] vs 149 of 167 [89.2%]; absolute difference, -4.83%; 95% CI, -10.84 to 1.19; eTICI of 2c or greater following the first pass: 76 of 173 [43.7%] vs 74 of 167 [44.3%]; absolute difference, -0.63%; 95% CI, -9.48 to 8.21). Symptomatic intracranial hemorrhage occurred in 0 patients in the pRESET group and 2 (1.2%) in the Solitaire group. Mortality occurred in 25 (14.5%) in the pRESET group and in 24 (14.4%) in the Solitaire group at 90 days. Findings of the per-protocol and as-treated analyses were in concordance with findings of the intention-to-treat analysis., Conclusions and Relevance: In this study, among patients with LVO stroke, thrombectomy with the pRESET stent retriever was noninferior to thrombectomy with the Solitaire stent retriever. Findings suggest that pRESET offers a safe and effective option for flow restoration and disability reduction in patients with LVO stroke.

Background: The Woven EndoBridge (WEB) device is frequently used for the treatment of intracranial aneurysms. Postoperative management, including the use of aspirin, varies among clinicians and institutions, but its impact on the outcomes of the WEB has not been thoroughly investigated., Methods: This was a retrospective, multicenter study involving 30 academic institutions in North America, South America, and Europe. Data from 1492 patients treated with the WEB device were included. Patients were categorized into two groups based on their postoperative use of aspirin (aspirin group: n=1124, non-aspirin group: n=368). Data points included patient demographics, aneurysm characteristics, procedural details, complications, and angiographic and functional outcomes. Propensity score matching (PSM) was applied to balance variables between the two groups., Results: Prior to PSM, the aspirin group exhibited significantly higher rates of modified Rankin scale (mRS) mRS 0-1 and mRS 0-2 (89.8% vs 73.4% and 94.1% vs 79.8%, p<0.001), lower rates of mortality (1.6% vs 8.6%, p<0.001), and higher major compaction rates (13.4% vs 7%, p<0.001). Post-PSM, the aspirin group showed significantly higher rates of retreatment (p=0.026) and major compaction (p=0.037) while maintaining its higher rates of good functional outcomes and lower mortality rates. In the multivariable regression, aspirin was associated with higher rates of mRS 0-1 (OR 2.166; 95% CI 1.16 to 4, p=0.016) and mRS 0-2 (OR 2.817; 95% CI 1.36 to 5.88, p=0.005) and lower rates of mortality (OR 0.228; 95% CI 0.06 to 0.83, p=0.025). However, it was associated with higher rates of retreatment (OR 2.471; 95% CI 1.11 to 5.51, p=0.027)., Conclusions: Aspirin use post-WEB treatment may lead to better functional outcomes and lower mortality but with higher retreatment rates. These insights are crucial for postoperative management after WEB procedures, but further studies are necessary for validation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice., Methods: In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715., Findings: From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone., Interpretation: Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection., Funding: EU Horizon 2020., Competing Interests: Declaration of interests MB reports funding from EU Horizon 2020 and Deutsche Forschungsgemeinschaft (payments to the institution); honoraria for lectures from Novartis, Boehringer Ingelheim, and Seagen; and consulting fees from NeuroScios and Boehringer Ingelheim and is an editor in chief of Clinical Neuroradiology (Springer). JF reports funding from the European Commission; personal consulting fees from Acandis, Cerenovus, Medtronic, Microvention, Phenox, Stryker, and Roche; consulting at Philips (no payments); payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Penumbra and Tonbridge; support for attending meetings or travel from Medtronic and Penumbra; stock or stock options from Tegus Medical, Eppdata, and Vastrax; and participation in a Data Safety Monitoring Board or Advisory Board at Phenox (personal fees) and Stryker (personal fees) and is a past president of ESMINT. SB reports funding from the EU Horizon 2020 research and innovation programme (754640; payments made to the institution); and support for attending meetings or travel from Medtronic and Penumbra; AHA reports unrestricted research grants from Boehringer Ingelheim; honoraria for lectures from BMS/Pfizer, Teva, Roche, Abbvie, Lundbeck, and Novartis; and participation in Advisory Boards for MSD, BMS/Pfizer, Lundbeck, Lilly, and Abbvie. BF reports research grants from Carlos III Institute of Health; personal payment for educational lectures from Servicio Madrileño de Salud; payment for lectures from Euromedice to the institution; personal payment for educational lectures from Takeda; support for attending meetings from Daiichi Sankyo; receipt of materials for research from Abbot. MDH reports funding from Nil; grants to the University of Calgary for the TEMPO-2 trial from Boehringer Ingelheim, Biogen, NoNO (ESCAPE-NA1 trial and ESCAPE-NEXT trial), Canadian Institute for Health Research (ESCAPE-NA1 trial and ESCAPE-NEXT trial), Medtronic (HERMES collaboration), Alberta Innovates (QuICR Alberta Stroke Program); that some of the funds were used for the ESCAPE-NA1 trial from Alberta Innovates; consulting fees from Sun Pharma Brainsgate (paid work for adjudication of clinical trial outcomes); US patents 62/086,077 (licensed to Circle NVI) and 10,916,346 (licensed to Circle NVI); private stock ownership from Circle and PUreWeb; participation as data and safety monitoring committee chair of the RACECAT trial (end 2020), the Oncovir Hiltonel trial (ongoing), and the DUMAS trial (ongoing); participation as a data and safety monitoring committee member of the ARTESIA trial (ongoing), and the BRAIN-AF trial (ongoing); and is president of the Canadian Neurological Sciences Federation (not for profit) and a Board member of the Canadian Stroke Consortium (not for profit). AK reports grants from the European Commission for the TENSION study (payment to the institution). LP reports consulting fees from Balt, Microvention, and Phenox; and support for attending meetings or travel for the TENSION investigator meeting (transport and accommodation was reimbursed by the organization). CZS reports grants from Novo Nordisk Foundation and Health Research Foundation of Central Denmark Region. RAB reports speakers fees from Novo Nordisk and Beyer. HD reports financial compensation for the start-up fee and the obligatory payment to the hospital administration paid by the sponsor (Medical University Heidelberg) to the clinical division (no personal payments); personal consulting fees from Stryker; speakers honorary from Medtronic; support for attending meetings or travel from Medtronic; and past presidency of the Austrian Society of Interventional Radiology and past presidency Austrian Society of Neuroradiology. FD reports consulting fees from Cerenovus, Phenox, Balt, Cerus Endovascular, Stryker; payment for expert testimony from Cerenovus; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Cerenovus, Stryker, Acandis, Asahi, and Penumbra; participation in a Data Safety Monitoring Board or Advisory Board at Cerenovus; and previously work as an associate editor for Journal of NeuroInterventional Surgery and Journal of Clinical Medicine. FF reports consulting fees from Eppdata and support for attending meetings or travel from Microvention, Medtronic, Cerebrovascular Research and Education Foundation (CREF), and Acandis. SG reports consulting fees from Eppdata. CH reports consulting fees from Brainomix and lecture fees from Stryker. SH-J reports funding for data collection, payment, or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from Terumo. MG reports research grants from Medtronic and Cerenovus (payments to the University of Calgary); royalties or licenses from Microvention (systems of intracranial access); personal consulting fees from Microvention, Medtronic, Stryker, Mentice, Philips, and Penumbra; and stock or stock options from Circle Neurovascular. CFK was chair of the German stroke registry (unpaid). RM reports payments for a stroke lecture from TMC Academy. MM reports grants from Balt, Medtronic, MicroVention, and Stryker; consulting fees from Siemens; and support for attending meetings or travel from Europa Group. SM-H reports consulting fees from Terumo and Boston Scientific Corporation; payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from Terumo and Boston Scientific Corporation. NM reports the provision of study materials. PP reports support for attending meetings or travel for the TENSION investigator meeting (transport and accommodation was reimbursed by the organisation). MP reports grants from the German Research Foundation (DFG SFB 1158 A10, DFG KFO 5001 P02, DFG KFO 5001 Z, and DFG SFB TR 240 B02); speaker honoraria unrelated from Merck Serono and Bayer; and support for attending meetings or travel from Merck Serono (travel reimbursement) and Bayer (travel reimbursement). PAR reports consulting fees to the institution from Boehringer Ingelheim and Bayer; and payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from Boehringer Ingelheim, Bayer, Pfizer, and BMS (all made to the institution). ES reports grants from Hamburg Innovation and Hertie Foundation. DFV reports research grants from MicroVention; consulting fees from Medtronic; and paid lectures from Cerenovus and Johnson & Johnson. WW reports consulting fees to the institution from Abbvie, BMS, GSK, and Servier. GT reports funding from the European Commission (EUHorizon 2020 research and innovation programme, 754640; payments to the institution); personal consulting fees from Acandis, AstraZeneca, Bayer, Boehringer Ingelheim, and Stryker; personal payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Acandis, Alexion, Marin, Bayer, Boehringer Ingelheim, BristolMyersSquibb/Pfizer, Daiichi Sankyo, and Stryker; participation as DSMB member for the TEA Stroke Trial (no payments) and ReSCInD trial (no payments); work as a speaker of the Commission for Cerebrovascular Diseases of the German Society of Neurology (DGN; no payments); and membership of the Board of Directors of the European Stroke Organisation (ESO; no payments). All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

As a complication of subarachnoid hemorrhage (SAH), vasospasm substantially contributes to its morbidity and mortality. We aimed at analyzing predictors of outcome for these patients including the role of endovascular treatment (ET). Our database was screened for patients with SAH treated in our Neuro-ICU from 2009 to 2019. Clinical parameters including functional outcome (modified Rankin Scale, mRS of 0-2 or 3-6 at discharge and after a median follow-up of 18 months) and details about ET were gathered on 465 patients, 241 (52%) of whom experienced vasospasm. Descriptive analyses were performed to identify explanatory variables for the dichotomized mRS score. A logistic regression model was fitted on 241 patients with vasospasm including age, Hunt and Hess Score, extraventricular drainage (EVD), forced hypertension, ET and delayed cerebral ischemia (DCI). The model found a Hunt and Hess Score of 5 (OR = 0.043, p = 0.008), requirement of EVD (OR = 0.161, p < 0.001), forced hypertension (OR = 0.242, p = 0.001), ET (OR = 0.431, p = 0.043) and DCI (OR = 0.229, p < 0.001) to be negative predictors of outcome while age was not. Use of intraarterial nimodipine alone (OR = 0.778, p = 0.705) or including balloon angioplasty (OR = 0.894, p = 0.902) and number of ETs per patient (OR = 0.757, p = 0.416) were not significant in a separate model with otherwise identical variables. While DCI is clearly associated with poor outcome, the influence of ET on outcome remains inconclusive. Limited by their retrospective nature and an indication bias, these data encourage a randomized assessment of ET., (© 2023. Deutsche Gesellschaft für Neurologie e.V.)

Objective: The Woven EndoBridge (WEB) device is an intrasaccular flow disruptor designed for wide-necked bifurcation aneurysms. These aneurysms may require the use of a concomitant stent. The objective of this study was to determine the clinical and radiological outcomes of patients undergoing stent-assisted WEB treatment. In addition, the authors also sought to determine the predictors of a concomitant stent in aneurysms treated with the WEB device., Methods: The data for this study were taken from the WorldWideWEB Consortium, an international multicenter cohort including patients treated with the WEB device. Aneurysms were classified into two groups based on treatment: stent-assisted WEB and WEB device alone. The authors compared clinical and radiological outcomes of both groups. Univariable and multivariable binary logistic regression analyses were performed to determine factors that predispose to stent use., Results: The study included 691 intracranial aneurysms (31 with stents and 660 without stents) treated with the WEB device. The adequate occlusion status did not differ between the two groups at the latest follow-up (83.3% vs 85.6%, p = 0.915). Patients who underwent stenting had more thromboembolic (32.3% vs 6.5%, p < 0.001) and procedural (16.1% vs 3.0%, p < 0.001) complications. Aneurysms treated with a concomitant stent had wider necks, greater heights, and lower dome-to-neck ratios. Increasing neck size was the only significant predictor for stent use., Conclusions: This study demonstrates that there is no difference in the degree of aneurysm occlusion between the two groups; however, complications were more frequent in the stent group. In addition, a wider aneurysm neck predisposes to stent assistance in WEB-treated aneurysms.

Background: The Woven EndoBridge (WEB) device is a novel intrasaccular flow disruptor tailored for bifurcation aneurysms. We aim to describe the degree of aneurysm occlusion at the latest follow-up, and the rate of complications of aneurysms treated with the WEB device stratified according to rupture status., Methods: Our data were taken from the WorldWideWeb Consortium, an international multicenter cohort including patients treated with the WEB device. Aneurysms were classified into two groups: ruptured and unruptured. We compared clinical and radiologic outcomes of both groups. Propensity score matching (PSM) was done to match according to age, gender, bifurcation, location, prior treatment, neck, height, dome width, daughter sac, incorporated branch, pretreatment antiplatelets, and last imaging follow-up., Results: The study included 676 patients with 691 intracranial aneurysms (529 unruptured and 162 ruptured) treated with the WEB device. The PSM analysis had 55 pairs. In both the unmatched (85.8% vs 84.3%, p=0.692) and matched (94.4% vs 83.3%, p=0.066) cohorts there was no significant difference in the adequate occlusion rate at the last follow-up. Likewise, there were no significant differences in both ischemic and hemorrhagic complications between the two groups. There was no documented aneurysm rebleeding after WEB device implantation., Conclusion: There was no significant difference in both the radiologic outcomes and complications between unruptured and ruptured aneurysms. Our findings support the feasibility of treatment of ruptured aneurysms with the WEB device., Competing Interests: Competing interests: JDBD: Honoraria from Medtronic. Travel grant from Microvention. MD: No relevant relationships NA: No relevant relationships RWR: Grants from National Institutes of Health, Heitman foundation, Society of vascular and interventional neurology; Advisory board participation for Rapid medical; Site PI for Microvention and Penumbra JEV: No relevant relationships AG : No relevant relationships SVL: No relevant relationships LR: No relevant relationships AAB: No relevant relationships ES: No relevant relationships KP: No relevant relationships KEL: No relevant relationships GS : No relevant relationships MAM: No relevant relationships IL: No relevant relationships PMR: No relevant relationships JAV: Fees from MicroVention for proctoring cases for new physician users of the Woven EndoBridge device; Medtronic travel expense VŽ: Participation on the data safety monitoring board or advisory board for KBC Sestre Milosrdnice, Zagreb / OB Nova Gradiška MUH: No relevant relationships CR: No relevant relationships HR: No relevant relationships VMT: No relevant relationships SM: No relevant relationships SG: No relevant relationships PH: No relevant relationships NA: No relevant relationships JDR: No relevant relationships YR: No relevant relationships CMS: No relevant relationships OG: No relevant relationships MP: No relevant relationships ALK: No relevant relationships CM: No relevant relationships SE: No relevant relationships RMS: Supported by the NREF, Joe Niekro Foundation, Brain Aneurysm Foundation, Bee Foundation, and the National Institutes of Health (R01NS111119-01A1, UL1TR002736, and KL2TR002737) through the Miami Clinical and Translational Science Institute, from the National Center for Advancing Translational Sciences and the National Institute on Minority Health and Health Disparities. AH: Consulting or speaker fees from Medtronic, MicroVention, Stryker, Penumbra, Cerenovus, Genentech, GE Healthcare, Scientia, Balt, Viz.ai, Insera Therapeutics, Proximie, NeuroVasc, NovaSignal, Vesalio, and Galaxy Therapeutics. AS: No relevant relationships AN: No relevant relationships JJ: Consulting and speaker fees from Cerenovus MP: No relevant relationships JS: No relevant relationships CPF: No relevant relationships MBB: No relevant relationships MM: Grants from Balt, Medtronic, MicroVention, and Stryker. MMS: No relevant relationships JB: No relevant relationships BTJ: No relevant relationships RAD: No relevant relationships TH: No relevant relationships RT: Medtronic Stocks CU: No relevant relationships BL : No relevant relationships PP: No relevant relationships ASP: Grants from NIH, Microvention, Cerenovus, Medtronic and Stryker; Consulting fees from Neurovascular, Stryker NeurovascularBalt, Q’Apel Medical, Cerenovus, Microvention, Imperative Care, Agile, Merit, CereVasc and Arsenal Medical; stock options from InNeuroCo, Agile, Perfuze, Galaxy and NTI GP: No relevant relationships CJG: Grants to institution from Medtronic and Penumbra; consulting fees from Stryker and MicroVention. HA: Proctoring fees from MicroVention. Grants to institution from the National Institutes of Health; consulting fees from Amnis Therapeutics, Apellis Pharmaceuticals, Boston Scientific, Canon Medical Systems, Cardinal Health 200, Cerebrotech Medical Systems, Cerenovus, Cerevatech Medical, Cordis, Corindus, EndoStream Medical, Imperative Care, Integra, IRRAS, Medtronic, MicroVention, Minnetronix Neuro, Penumbra, Q’Apel Medical, Rapid Medical, Serenity Medical, Silk Road Medical, StimMed, Stryker Neurovascular, Three Rivers Medical, VasSol, Viz.ai, and W.L. Gore & Associates; payment for participation on the steering committees for the Cerenovus EXCELLENT and ARISE II Trial; Medtronic SWIFT PRIME, VANTAGE, EMBOLISE, and SWIFT DIRECT Trials; MicroVention FRED Trial and CONFIDENCE Study; MUSC POSITIVE Trial; Penumbra 3D Separator Trial, COMPASS Trial, INVEST Trial, MIVI Neuroscience EVAQ Trial; Rapid Medical SUCCESS Trial; InspireMD C-GUARDIANS IDE Pivotal Trial; stock or stock options in Adona Medical, Amnis Therapeutics, Bend IT Technologies, BlinkTBI, Buffalo Technology Partners, Cardinal Consultants, Cerebrotech Medical Systems, Cerevatech Medical, Cognition Medical, CVAID, E8, EndoStream Medical, Imperative Care, Instylla, International Medical Distribution Partners, Launch NY, NeuroRadial Technologies, Neurotechnology Investors, Neurovascular Diagnostics, Perflow Medical, Q’Apel Medical, QAS.ai, Radical Catheter Technologies, Rebound Therapeutics (purchased in 2019 by Integra Lifesciences), Rist Neurovascular (purchased in 2020 by Medtronic), Sense Diagnostics, Serenity Medical, Silk Road Medical, Songbird Therapy, Spinnaker Medical, StimMed, Synchron, Three Rivers Medical, Truvic Medical, Tulavi Therapeutics, Vastrax, VICIS, and Viseon AFD: Consulting fees from Cerenovus, Penumbra, Medtronic, Stryker, Oculus, and Koswire. No relevant relationships RD: No relevant relationships PK: No relevant relationships. VK: No relevant relationships. PL: No relevant relationships SB: No relevant relationships CJS: Participation on the data safety monitoring board or advisory board for Zoll Circulation JK: No relevant relationships PJ: No relevant relationships ST: No relevant relationships FC: No relevant relationships NL: Honoraria for lectures from Cerenovus, Stryker, and CrossMed. MAA: Funding to institution from MicroVention for WEBIT trial; proctoring fees from MicroVention. HHC: No relevant relationships CC: Consulting fees from MicroVention, Stryker, Medtronic, MIVI, and Cerenovus. ABP: Grant to institution from Medtronic; consulting fees from MicroVention, Medtronic, and Q’Apel; workstation for research from Siemens AAD: No relevant relationships, (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: Individual regions of the Alberta Stroke Programme Early CT Score (ASPECTS) may contribute differently to the clinical symptoms in large vessel occlusion (LVO). Here, we investigated whether the predictive performance on clinical outcome can be increased by considering specific ASPECTS subregions., Methods: A consecutive series of patients with LVO affecting the middle cerebral artery territory and subsequent endovascular treatment (EVT) between January 2015 and July 2020 was analyzed, including affected ASPECTS regions. A multivariate logistic regression was performed to assess the individual impact of ASPECTS regions on good clinical outcome (defined as modified Rankin scale after 90 days of 0-2). Machine-learning-driven logistic regression models were trained (training = 70%, testing = 30%) to predict good clinical outcome using i) cumulative ASPECTS and ii) location-specific ASPECTS, and their performance compared using deLong's test. Furthermore, additional analyses using binarized as well as linear clinical outcomes using regression and machine-learning techniques were applied to thoroughly assess the potential predictive properties of individual ASPECTS regions and their combinations., Results: Of 1109 patients (77.3 years ± 11.6, 43.8% male), 419 achieved a good clinical outcome and a median NIHSS after 24 h of 12 (interquartile range, IQR 4-21). Individual ASPECTS regions showed different impact on good clinical outcome in the multivariate logistic regression, with strongest effects for insula (odds ratio, OR 0.56, 95% confidence interval, CI 0.42-0.75) and M5 (OR 0.53, 95% CI 0.29-0.97) regions. Accuracy (ACC) in predicting good clinical outcome of the test set did not differ between when considering i) cumulative ASPECTS and ii) location-specific ASPECTS (ACC = 0.619, 95% CI 0.58-0.64 vs. ACC = 0.629, 95% CI 0.60-0.65; p = 0.933)., Conclusion: Cumulative ASPECTS assessment in LVO remains a stable and reliable predictor for clinical outcome and is not inferior to a weighted (location-specific) ASPECTS assessment., (© 2023. The Author(s).)

Swift diagnosis and treatment play a decisive role in the clinical outcome of patients with acute ischemic stroke (AIS), and computer-aided diagnosis (CAD) systems can accelerate the underlying diagnostic processes. Here, we developed an artificial neural network (ANN) which allows automated detection of abnormal vessel findings without any a-priori restrictions and in <2 minutes. Pseudo-prospective external validation was performed in consecutive patients with suspected AIS from 4 different hospitals during a 6-month timeframe and demonstrated high sensitivity (≥87%) and negative predictive value (≥93%). Benchmarking against two CE- and FDA-approved software solutions showed significantly higher performance for our ANN with improvements of 25-45% for sensitivity and 4-11% for NPV (p ≤ 0.003 each). We provide an imaging platform ( https://stroke.neuroAI-HD.org ) for online processing of medical imaging data with the developed ANN, including provisions for data crowdsourcing, which will allow continuous refinements and serve as a blueprint to build robust and generalizable AI algorithms., (© 2023. Springer Nature Limited.)

Purpose: Acute intraprocedural thrombosis (AIT) is a severe complication of flow diverter stent (FDS) implantation for the treatment of intracranial aneurysms. Even though device-related thromboembolic complications are well known, there are no acknowledged risk factors nor defined surveillance protocols for their early detection. This study aimed to demonstrate that an angiographic active surveillance is effective to detect and treat AIT. Furthermore, we investigated risk factors for the occurrence of AIT., Methods: A prospective institutional protocol consisting of a defined observation period of 30 min following FDS deployment was established to detect AIT. Overall incidence, as well as the efficacy and safety of AIT treatment were assessed. Moreover, radiological and clinical outcomes of patients with AIT were analyzed. The influence of various patient- and procedure-related factors on the occurrence of AIT was investigated using multivariable forward logistic regression., Results: During active surveillance twelve cases of AIT were observed among a total of 161 procedures (incidence: 7.5%). The median time of first observation was 15.5 min (IQR 9.5) after FDS implantation. The early recognition of AIT ensured a prompt treatment with intravenous application of a glycoprotein IIb/IIIa inhibitor, which led to complete thrombus resolution in all cases without hemorrhagic complications. Patients with pre-existing arterial hypertension and side branches originating from the aneurysmal sac had a higher risk of AIT (respectively OR, 9.844; OR, 3.553). There were two cases of re-thrombosis in the short-term postoperative period, of whom one died. The remaining patients with AIT had a good clinical outcome., Conclusion: Active surveillance for 30 min after FDS implantation is an effective strategy for early detection and ensuing treatment of AIT and can thus prevent secondary sequalae. Hypertension and side branches originating from the aneurysmal sac may increase the risk of AIT., (© 2022. The Author(s).)

Background and Purpose: Flow diversion has gradually become a standard treatment for intracranial aneurysms of the anterior circulation. Recently, the off-label use of the flow diverters to treat posterior circulation aneurysms has also increased despite initial concerns of rupture and the suboptimal results. This study aimed to explore the change in complication rates and treatment outcomes across time for posterior circulation aneurysms treated using flow diversion and to further evaluate the mechanisms and variables that could potentially explain the change and outcomes., Materials and Methods: A retrospective review using a standardized data set at multiple international academic institutions was performed to identify patients with ruptured and unruptured posterior circulation aneurysms treated with flow diversion during a decade spanning January 2011 to January 2020. This period was then categorized into 4 intervals., Results: A total of 378 procedures were performed during the study period. Across time, there was an increasing tendency to treat more vertebral artery and fewer large vertebrobasilar aneurysms ( P = .05). Moreover, interventionalists have been increasingly using fewer overlapping flow diverters per aneurysm ( P = .07). There was a trend toward a decrease in the rate of thromboembolic complications from 15.8% in 2011-13 to 8.9% in 2018-19 ( P = .34)., Conclusions: This multicenter experience revealed a trend toward treating fewer basilar aneurysms, smaller aneurysms, and increased usage of a single flow diverter, leading to a decrease in the rate of thromboembolic and hemorrhagic complications., (© 2022 by American Journal of Neuroradiology.)

Background: We studied the effects of endovascular treatment (EVT) and the impact of the extent of recanalization on cerebral perfusion and oxygenation parameters in patients with acute ischemic stroke (AIS) and large vessel occlusion (LVO)., Methods: Forty-seven patients with anterior LVO underwent computed tomography perfusion (CTP) before and immediately after EVT. The entire ischemic region (T max >6 s) was segmented before intervention, and tissue perfusion (time-to-maximum (T max ), time-to-peak (TTP), mean transit time (MTT), cerebral blood volume (CBV), cerebral blood flow (CBF)) and oxygenation (coefficient of variation (COV), capillary transit time heterogeneity (CTH), metabolic rate of oxygen (CMRO 2 ), oxygen extraction fraction (OEF)) parameters were quantified from the segmented area at baseline and the corresponding area immediately after intervention, as well as within the ischemic core and penumbra. The impact of the extent of recanalization (modified Treatment in Cerebral Infarction (mTICI)) on CTP parameters was assessed with the Wilcoxon test and Pearson's correlation coefficients., Results: The T max , MTT, OEF and CTH values immediately after EVT were lower in patients with complete (as compared with incomplete) recanalization, whereas CBF and COV values were higher (P<0.05) and no differences were found in other parameters. The ischemic penumbra immediately after EVT was lower in patients with complete recanalization as compared with those with incomplete recanalization (P=0.002), whereas no difference was found for the ischemic core (P=0.12). Specifically, higher mTICI scores were associated with a greater reduction of ischemic penumbra volumes (R²=-0.48 (95% CI -0.67 to -0.22), P=0.001) but not of ischemic core volumes (P=0.098)., Conclusions: Our study demonstrates that the ischemic penumbra is the key target of successful EVT in patients with AIS and largely determines its efficacy on a tissue level. Furthermore, we confirm the validity of the mTICI score as a surrogate parameter of interventional success on a tissue perfusion level., Competing Interests: Competing interests: Additionally, the authors disclose the following relationships with companies unrelated to this research project. SN: consultancy: Brainomix, Boehringer Ingelheim; payment for lectures including service on speakers' bureaus: Pfizer, Medtronic, Bayer AG. CH: consultancy: Brainomix, Oxford, UK; comments: <€10,000. CU: travel/accommodation/meeting expenses unrelated to activities listed: MicroVention, Stryker. SH: grants/grants pending: Deutsche Forschungsgemeinschaft (DFG) - SFB 1118. MB: board membership: Data and Safety Monitoring Board for Vascular Dynamics, Guerbet, Boehringer Ingelheim; consultancy: Codman, Roche Diagnostics, Guerbet, Boehringer Ingelheim, BBRaun, Merck; grants/grants pending: DFG, Hopp Foundation, Novartis, Siemens, Guerbet, Stryker, Covidien, EU; payment for lectures including service on speakers' bureaus: Novartis, Roche Diagnostics, Guerbet, Teva Pharmaceutical Industries, Bayer AG, Codman. MM: board membership: Codman; consultancy: Medtronic, MicroVention, Stryker; payment for lectures including service on speakers' bureaus: Medtronic, MicroVention, Stryker; grants/grants pending: Balt. *Money paid to the institution. JARP: payment for lectures including service on speakers' bureaus: Siemens; travel/accommodation/meeting expenses unrelated to activities listed: Stryker, MicroVention. PAR: consultancy: Bayer, Pfizer, Daiichi Sankyo; personal fees: Boehringer Ingelheim., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Concomitant acute ischemic stroke (AIS) caused by large vessel occlusion (LVO), and acute upper extremity arterial occlusion causing upper limb ischemia (ULI) is a rarely observed coincidence. The first-line treatment for AIS is mechanical thrombectomy (MT), with or without additional intravenous thrombolysis, while there are different pharmacological, surgical and endovascular treatment options for an acute occlusion of the UL arteries. Here, we describe the practicability, efficacy and safety of neurointerventional devices and techniques for MT of upper extremity arterial occlusions., Materials and Methods: A retrospective analysis of prospectively collected patient databases from four neurovascular centers was performed. Clinical and imaging data, as well as procedural parameters, were assessed., Results: Seven out of 6138 patients (incidence: 0.11%) presenting with an AIS due to the occlusion of craniocervical arteries requiring MT and a concomitant occlusion of the brachial (4/7), axillary (2/7), or ulnar (1/7) artery causing acute ULI were identified. Craniocervical MT was technically successful in all cases. Subsequent MT of the upper limb was performed using neurointerventional thrombectomy techniques, most frequently stent retriever thrombectomy (in 4/7 cases) and direct aspiration (in 7/7 cases). MT achieved successful recanalization in 6/7 cases, and the UL completely recovered in all six cases. In one case, recanalization was not successful, and the patient still had a marginally threatened extremity after the procedure, which improved after pharmacological therapy., Conclusion: In the rare case of AIS requiring MT and concomitant acute upper extremity arterial occlusion, MT of the UL arteries using neurointerventional devices and techniques is practical, effective, and safe.

Background: Flow diversion is a common endovascular treatment for cerebral aneurysms, but studies comparing different types of flow diverters are scarce., Objective: To perform a propensity score matched cohort study comparing the Pipeline Embolization Device (PED) and Flow Redirection Intraluminal Device (FRED) for posterior circulation aneurysms., Methods: Consecutive aneurysms of the posterior circulation treated at 25 neurovascular centers with either PED or FRED were collected. Propensity score matching was used to control for age, duration of follow-up imaging, adjunctive coiling, and aneurysm location, size, and morphology; previously ruptured aneurysms were excluded. The two devices were compared for the following outcomes: procedural complications, aneurysm occlusion, and functional outcome., Results: A total of 375 aneurysms of the posterior circulation were treated in 369 patients. The PED was used in 285 (77.2%) and FRED in 84 (22.8%) procedures. Aneurysms treated with the PED were more commonly fusiform and larger than those treated with FRED. To account for these important differences, propensity score matching was performed resulting in 33 PED and FRED unruptured aneurysm pairs. No differences were found in occlusion status and neurologic thromboembolic or hemorrhagic complications between the two devices. The proportion of patients with favorable functional outcome was higher with FRED (100% vs 87.9%, p=0.04)., Conclusion: Comparative analysis of PED and FRED for the treatment of unruptured posterior circulation aneurysms did not identify significant differences in aneurysm occlusion or neurologic complications. Variations in functional outcomes warrant additional investigations., Competing Interests: Competing interests: Ajith Thomas: DSMB SCENT trial by STRYKER. Funds paid to institution.Ramesh Grandhi: Consultant for Medtronic neurovascular, BALT neurovascular and Cerenovus.Christoph Griessenauer: Consultant for Stryker and received research funding from Medtronic.Naci Kocer: Consultant and proctoring agreement with MicroVention.Philipp Taussky:Reply: Consultant for Medtronic, Stryker, Cerenovus.Peter Kan: Consultant for Stryker, Medtronic, MicroVention, and Cerenovus.Vincent Tutino: Co-founder of Neurovascular Diagnostics, Inc.Monika Killer: Research grant from MicroVention/Terumo.Waleed Brinjikji: Microvention and Cerenovus consultant.Tom Marotta: Medtronic proctoring.Timo Krings: Consultant for Stryker, Medtronic, Penumbra, Cerenovus. stockholder in Marblehead Inc, royalties from Thieme.Clemens Schirmer: Research Support from Penumbra. Shareholder in Neurotechnology Investors.Giuseppe Lanzino: Consultant for Superior Medical Editing and Nested Knowledge.Christian Ulfert: Consulting fees from Johnson & Johnson.Charles Matouk: Consultant for Medtronic, Penumbra, Silk Road MedicalMarkus Mohlenbruch: Consultant for Medtronic, MicroVention, Stryker. Grants/grants pending: Balt (money paid to the institution), MicroVention (money paid to the institution). Payment for lectures includings service on speakers bureaus: Medtronic, MicroVention, and Stryker.Marshall Cress: Consulting for Cannon and Cerenovus.None related to this study and none are declared for the reminder of the authors., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Purpose: This study assessed the predictive performance and relative importance of clinical, multimodal imaging, and angiographic characteristics for predicting the clinical outcome of endovascular treatment for acute ischemic stroke., Methods: A consecutive series of 246 patients with acute ischemic stroke and large vessel occlusion in the anterior circulation who underwent endovascular treatment between April 2014 and January 2018 was analyzed. Clinical, conventional imaging (electronic Alberta Stroke Program Early CT Score, acute ischemic volume, site of vessel occlusion, and collateral score), and advanced imaging characteristics (CT-perfusion with quantification of ischemic penumbra and infarct core volumes) before treatment as well as angiographic (interval groin puncture-recanalization, modified Thrombolysis in Cerebral Infarction score) and postinterventional clinical (National Institutes of Health Stroke Scale score after 24 hours) and imaging characteristics (electronic Alberta Stroke Program Early CT Score, final infarction volume after 18-36 hours) were assessed. The modified Rankin Scale (mRS) score at 90 days (mRS-90) was used to measure patient outcome (favorable outcome: mRS-90 ≤2 versus unfavorable outcome: mRS-90 >2). Machine-learning with gradient boosting classifiers was used to assess the performance and relative importance of the extracted characteristics for predicting mRS-90., Results: Baseline clinical and conventional imaging characteristics predicted mRS-90 with an area under the receiver operating characteristics curve of 0.740 (95% CI, 0.733-0.747) and an accuracy of 0.711 (95% CI, 0.705-0.717). Advanced imaging with CT-perfusion did not improved the predictive performance (area under the receiver operating characteristics curve, 0.747 [95% CI, 0.740-0.755]; accuracy, 0.720 [95% CI, 0.714-0.727]; P =0.150). Further inclusion of angiographic and postinterventional characteristics significantly improved the predictive performance (area under the receiver operating characteristics curve, 0.856 [95% CI, 0.850-0.861]; accuracy, 0.804 [95% CI, 0.799-0.810]; P <0.001). The most important parameters for predicting mRS 90 were National Institutes of Health Stroke Scale score after 24 hours (importance =100%), premorbid mRS score (importance =44%) and final infarction volume on postinterventional CT after 18 to 36 hours (importance =32%)., Conclusions: Integrative assessment of clinical, multimodal imaging, and angiographic characteristics with machine-learning allowed to accurately predict the clinical outcome following endovascular treatment for acute ischemic stroke. Thereby, premorbid mRS was the most important clinical predictor for mRS-90, and the final infarction volume was the most important imaging predictor, while the extent of hemodynamic impairment on CT-perfusion before treatment had limited importance.

Background and Purpose: To quantify workflow metrics in patients receiving stroke imaging (noncontrast-enhanced computed tomography [CT] and CT-angiography) in either a computed-tomography scanner suite (CT-Transit [CTT]) or an angio-suite (direct transfer to angio-suite-[DTAS]-using flat-panel CT) before undergoing mechanical thrombectomy., Methods: Prospective, single-center investigator initiated randomized controlled trial in a comprehensive stroke center focusing on time from imaging to groin puncture (primary end point) and time from hospital admission to final angiographic result (secondary end point) in patients receiving mechanical thrombectomy for anterior circulation large vessel occlusion after randomization to the CTT or DTAS pathway., Results: The trial was stopped early after the enrollment of n=60 patients (CTT: n=34/60 [56.7 %]; DTAS: n=26/60 [43.3%]) of n=110 planned patients because of a preplanned interim analysis. Time from imaging to groin puncture was shorter in DTAS-patients (in minutes, median [interquartile range]: CTT: 26 [23-32]; DTAS: 19 [15-23]; P value: 0.001). Time from hospital admission to stroke imaging was shorter in patients randomized to DTAS (CTT: 12 (7-18); DTAS: 21 (15-25), P value: 0.007). Time from hospital admission to final angiographic reperfusion was comparable between patient groups (CTT: 78 [58-92], DTAS: 80 [66-118]; P value: 0.067)., Conclusions: This trial showed a reduction in time from imaging to groin-puncture when patients are transferred directly to the angiosuite for advanced stroke-imaging compared with imaging in a CT scanner suite. This time saving was outweighed by a longer admission to imaging time and could not translate into a shorter time to final angiographic reperfusion in this trial.

Promising results from recent clinical trials on the approved antisense oligonucleotide nusinersen in pediatric patients with 5q-linked spinal muscular atrophy (SMA) still have to be confirmed in adult patients but are hindered by a lack of sensitive biomarkers that indicate an early therapeutic response. Changes in the overall neurochemical composition of cerebrospinal fluid (CSF) under therapy may yield additive diagnostic and predictive information. With this prospective proof-of-concept and feasibility study, we evaluated non-targeted CSF proteomic profiles by mass spectrometry along with basic CSF parameters of 10 adult patients with SMA types 2 or 3 before and after 10 months of nusinersen therapy, in comparison with 10 age- and gender-matched controls. These data were analyzed by bioinformatics and correlated with clinical outcomes assessed by the Hammersmith Functional Rating Scale Expanded (HFMSE). CSF proteomic profiles of SMA patients differed from controls. Two groups of SMA patients were identified based on unsupervised clustering. These groups differed in age and expression of proteins related to neurodegeneration and neuroregeneration. Intraindividual CSF differences in response to nusinersen treatment varied between patients who clinically improved and those who did not. Data are available via ProteomeXchange with identifier PXD016757. Comparative CSF proteomic analysis in adult SMA patients before and after treatment with nusinersen-identified subgroups and treatment-related changes and may therefore be suitable for diagnostic and predictive analyses., (© 2020 The Authors. Journal of Neurochemistry published by John Wiley & Sons Ltd on behalf of International Society for Neurochemistry.)

Background and Purpose: Flow diversion for the posterior circulation remains a promising treatment option for selected posterior circulation aneurysms. The Flow-Redirection Intraluminal Device (FRED) system has not been previously assessed in a large cohort of patients with posterior circulation aneurysms. The purpose of the present study was to assess safety and efficacy of FRED in this location., Materials and Methods: Consecutive patients with posterior circulation aneurysms treated at 8 centers participating in the European FRED study (EuFRED) between April 2012 and January 2019 were retrospectively reviewed. Complication and radiographic and functional outcomes were evaluated., Results: Eighty-four patients (median age, 54 years) with 84 posterior circulation aneurysms were treated with the FRED. A total of 25 aneurysms (29.8%) had previously ruptured, even though most aneurysms were diagnosed incidentally (45.2%). The intradural vertebral artery was the most common location (50%), and saccular, the most common morphology (40.5%). The median size was 7 mm. There were 8 (9.5%) symptomatic thromboembolic and no hemorrhagic complications. Thromboembolic complications occurred mostly (90.9%) in nonsaccular aneurysms. On last follow-up at a median of 24 months, 78.2% of aneurysms were completely occluded. Functional outcome at a median of 27 months was favorable in 94% of patients. All mortalities occurred in patients with acute subarachnoid hemorrhage and its sequelae., Conclusions: The largest cohort of posterior circulation aneurysms treated with the FRED to date demonstrated favorable safety and efficacy profiles of the device for this indication. Treatment in the setting of acute subarachnoid hemorrhage was strongly related to mortality, regardless of whether procedural complications occurred., (© 2020 by American Journal of Neuroradiology.)