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Background and purposeDistal ACA aneurysms remain difficult to treat with endovascular therapy, but improved technology and experience allows for the treatment of some of these aneurysms with excellent results. The purpose of this study was to assess the status of endovascular treatment of distal ACA aneurysms by comparing our results with recent endovascular and microsurgical series of distal ACA aneurysms.Materials and methodsBetween 2000 and 2008, a total of 22 consecutive patients (14 women; mean age, 58.4 years) with distal ACA aneurysms underwent coil placement at Barrow Neurological Institute. Clinical presentations, radiographic findings, endovascular management, and outcomes were reviewed retrospectively.ResultsOf the 22 patients, 13 (59%) presented with subarachnoid hemorrhage. Six patients were HH grade I or II, 1 was grade III, 5 were grade IV, and 1 was grade V. Frontal lobe hematomas occurred in 5 patients with ruptured aneurysms. The mean aneurysm size was 7.5 mm (range, 2.8-25 mm); 55% were smaller than 7 mm. Twelve aneurysms (55%) arose from the origin of the callosomarginal artery (55%). Complete occlusion was achieved in 50% of the cases and near-complete occlusion in 45%. The few periprocedural complications included 1 retroperitoneal hematoma and 1 intraoperative rupture. Four patients had thromboembolic events adequately treated intraprocedurally with abciximab. No deaths occurred in the patients treated.ConclusionsThe characteristics of the patients and aneurysms treated in our series were comparable to previous reports of endovascular treatment of ACA aneurysms with respect to rupture status. Periprocedural morbidity and mortality rates in our series fared well compared with previous reports, as did our combined rate of complete or near-complete occlusions. Recent advances in endovascular devices and techniques have improved outcomes of distal ACA aneurysms.

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.)

Background: Injury to the internal carotid artery (ICA) during functional endoscopic sinus surgery is a rare but potentially fatal complication. Although treatment algorithms have been developed, guidelines for effectively managing iatrogenic ICA injury have not been established. A case of ICA perforation during functional endoscopic sinus surgery treated with cerebral bypass utilizing a cephalic vein graft is presented., Observations: A woman in her late 50s presented with a left cavernous ICA injury that had occurred during endoscopic nasal polypectomy at an outside hospital. Hemostasis was achieved with intranasal Foley catheter placement. Left common carotid artery angiography revealed a high-flow carotid-cavernous fistula. Cerebral revascularization was chosen as the optimal procedure. The initial intent was to use a radial artery graft, but the radial artery was found to be occluded intraoperatively. Postoperatively, the patient experienced decreased vision and left eye movement but was otherwise neurologically intact. Postoperative angiography showed complete resolution of the fistula., Lessons: In cases involving ICA injury and carotid-cavernous fistula formation, microsurgical trapping with high-flow bypass is a favorable treatment option. The cephalic vein is a viable graft option when unexpected challenges arise with a radial artery graft. https://thejns.org/doi/10.3171/CASE24222.

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.

Competing Interests: Competing interests: AFD and FCA serve on the Editorial Board of the Journal of NeuroInterventional Surgery. The other authors have no personal, financial, or institutional interest in any of the drugs, materials, or devices described in this manuscript.

Competing Interests: Competing interests: None declared.

Background: This study assessed neurological outcomes and variables associated with favorable outcomes in aneurysmal subarachnoid hemorrhage patients with low functional status (Glasgow Coma Scale [GCS] score ≤8) on postbleed day 7 (PBD7)., Methods: A retrospective analysis was conducted of all patients in the Barrow Ruptured Aneurysm Trial (January 1, 2014-July 31, 2019) treated for a ruptured aneurysm and who had a GCS score ≤8 on PBD7. The primary outcome was a favorable neurological outcome (modified Rankin Scale score ≤2) at last follow-up., Results: Of 312 patients, 63 had low GCS scores at PBD7. These patients had a significantly greater proportion of poor Hunt and Hess scale grades (≥4) (44/63 [70%] vs. 49/249 [19.7%], P < 0.001) and poor Fisher grades (grade = 4) (58/63 [92%] vs. 174/249 [69.9%], P < 0.001) compared to patients who did not have low GCS scores on PBD7, but no differences were found in age, sex, anterior location, aneurysm size, or type of treatment. Of the 63 patients, 7 (11%) experienced a favorable neurological outcome. On univariate analysis, none of the physical examination reflexes predicted a favorable neurological outcome. The middle cerebral artery aneurysm territory was the only significant predictor of a favorable neurological outcome by multivariate analysis (odds ratio, 10.8; 95% confidence interval, 1.16-100], P = 0.04)., Conclusions: This study yielded no significant physical examination findings that predict a favorable outcome in patients with a GCS score ≤8 on PBD7. This finding may inform the decision of whether to prolong hospital management or arrange for end-of-life care., (Copyright © 2024 Elsevier Inc. All rights reserved.)

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).)

Purpose: Intracranial aneurysms present significant health risks, as their rupture leads to subarachnoid haemorrhage, which in turn has high morbidity and mortality rates. There are several elements affecting the complexity of an intracranial aneurysm. However, criteria for defining a complex intracranial aneurysm (CIA) in open surgery and endovascular treatment could differ, and actually there is no consensus on the definition of a "complex" aneurysm. This DELPHI study aims to assess consensus on variables defining a CIA., Methods: An international panel of 50 members, representing various specialties, was recruited to define CIAs through a three-round Delphi process. The panelists participated in surveys with Likert scale responses and open-ended questions. Consensus criteria were established to determine CIA variables, and statistical analysis evaluated consensus and stability., Results: In open surgery, CIAs were defined by fusiform or blister-like shape, dissecting aetiology, giant size (≥ 25 mm), broad neck encasing parent arteries, extensive neck surface, wall calcification, intraluminal thrombus, collateral branch from the sac, location (AICA, SCA, basilar), vasospasm context, and planned bypass (EC-IC or IC-IC). For endovascular treatment, CIAs included giant size, very wide neck (dome/neck ratio ≤ 1:1), and collateral branch from the sac., Conclusions: The definition of aneurysm complexity varies by treatment modality. Since elements related to complexity differ between open surgery and endovascular treatment, these consensus criteria of CIAs could even guide in selecting the best treatment approach., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Austria, part of Springer Nature.)

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.)

Transcirculation catheterization, also known as the retrograde approach, involves the navigation of a catheter or other endovascular device from one arterial circulation to the other (right to left, or anterior to posterior).1-4 We present a case of a complex vertebrobasilar junction aneurysm previously treated by bilateral vertebral artery deconstruction, precluding antegrade access (video 1). Following the creation of a protective occipital artery to posterior inferior cerebellar artery (PICA) bypass, the patient was treated with transcirculation placement of a Pipeline embolization device (PED).5-9 The right internal carotid artery was accessed with a guide catheter using a transradial approach. The microwire-microcatheter combination was then tracked through the right posterior communicating artery, down the basilar trunk, and to the left PICA. The PED was successfully deployed from the left vertebral artery to the mid-basilar artery. At 3-month follow-up, the aneurysm was completely obliterated. The nuances of transcirculation technique, especially for flow diversion, are discussed. (Used with permission from Barrow Neurological Institute, Phoenix, Arizona, USA.)neurintsurg;jnis-2023-021363v1/V1F1V1Video 1Transcirculation retrograde placement of a Pipeline embolization device for treatment of a vertebrobasilar junction aneurysm previously treated by bilateral vertebral artery deconstruction, precluding antegrade access., Competing Interests: Competing interests: AFD and FCA serve on the Editorial Board of the Journal of NeuroInterventional Surgery (JNIS)., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Melphalan, which is poorly soluble at room temperature, is widely used for the treatment of retinoblastoma by selective ophthalmic artery infusion. Evomela, a propylene glycol-free formulation of melphalan with improved solubility and stability, has recently been used as an alternative.To compare the safety and efficacy of Evomela with standard-formulation melphalan (SFM) in the treatment of retinoblastoma by selective ophthalmic artery infusion., Methods: We performed a retrospective case-control study of patients with retinoblastoma undergoing selective ophthalmic artery infusion with SFM or Evomela at a single institution. Cycle-specific percent tumor regression (CSPTR) was estimated by comparing photos obtained during pretreatment examination under anesthesia (EUA) with those obtained during post-treatment EUA 3-4 weeks later. CSPTR, ocular salvage rates, complication rates, operation times (unadjusted and adjusted for difficulty of ophthalmic artery catheterization), and intraprocedural dose expiration rates were compared between Evomela- and SFM-treated groups. Univariate and multivariate analyses were performed., Results: Ninety-seven operations (melphalan: 45; Evomela: 52) for 23 patients with 27 retinoblastomas were studied. The ocular salvage rate was 79% in the SFM-treated group and 69% in the Evomela-treated group. Multivariate regression controlling for tumor grade, patient age, and treatment history revealed no significant differences in ocular salvage rate, CSPTR, complication rates, or operation times. Although the dose expiration rate was higher for the SFM-treated group, the difference was not statistically significant. Notably, there were no ocular or cerebral ischemic complications., Conclusion: Evomela has non-inferior safety and efficacy relative to SFM when used for the treatment of retinoblastoma by selective ophthalmic artery infusion., Competing Interests: Competing interests: FCA is presently on the editorial board of the Journal of Neurointerventional Surgery., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

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: Disorders of consciousness impair early recovery after aneurysmal subarachnoid hemorrhage (aSAH). Modafinil, a wakefulness-promoting agent, is efficacious for treating fatigue in stroke survivors, but data pertaining to its use in the acute setting are scarce. This study sought to assess the effects of modafinil use on mental status after aSAH., Methods: Modafinil timing and dosage, neurological examination, intubation status, and physical and occupational therapy participation were documented. Repeated-measures paired tests were used for a before-after analysis of modafinil recipients. Propensity score matching (1:1 nearest neighbor) for modafinil and no-modafinil cohorts was used to compare outcomes., Results: Modafinil (100-200 mg/day) was administered to 21% (88/422) of aSAH patients for a median (IQR) duration of 10.5 (4-16) days and initiated 14 (7-17) days after aSAH. Improvement in mentation (alertness, orientation, or Glasgow Coma Scale score) was documented in 87.5% (77/88) of modafinil recipients within 72 hours and 86.4% (76/88) at discharge. Of 37 intubated patients, 10 (27%) were extubated within 72 hours after modafinil initiation. Physical and occupational therapy teams noted increased alertness or participation in 47 of 56 modafinil patients (83.9%). After propensity score matching for baseline covariates, the modafinil cohort had a greater mean (SD) change in Glasgow Coma Scale score than the no-modafinil cohort at discharge (2.2 [4.0] vs. -0.2 [6.32], P = 0.003)., Conclusions: A temporal relationship with improvement in mental status was noted for most patients administered modafinil after aSAH. These findings, a favorable adverse-effect profile, and implications for goals-of-care decisions favor a low threshold for modafinil initiation in aSAH patients in the acute-care setting., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Biosimilar medicines are defined as biological products highly similar to an already licensed biological product (RP). The market entry of biosimilars is expected to reduce the costs of biological treatments., Objective: This study aims to evaluate the range of differences between the prices of biosimilars and the corresponding RP for biologicals approved in four countries., Method: This is a cross-national comparison of pricing of biosimilars in Argentina, Australia, Brazil, and Italy. The study examined online price databases provided by the national authorities of the investigated countries. Biosimilar price difference was calculated by subtracting the unit price of the biosimilar by the unit price of the RP, and then dividing it by the unit price of the RP. The results were presented as percentage., Results: Brazil had the highest median price reduction (- 36.3%) in biosimilars price, followed by Italy (- 20.0%) and Argentina (- 18.6%). All the biosimilars in Italy were priced below the RP presenting a minimum reduction of 6.3%, while in Australia, most of the prices of biosimilars were equal to the RP. In Argentina, one infliximab-biosimilar displayed price above the RP (40.7%) while the lower priced brand had a reduction of 14.4%. Brazil had four biosimilars with prices above the respective RP, including isophane insulin (1), insulin glargine (1) and somatropin (2)., Conclusion: The study revealed a marked dispersion in the price's differences between biosimilars and RP across the studied countries. Governments should evaluate whether their policies have been successful in improving affordability of biological therapies., (© 2024. The Author(s), under exclusive licence to The Drug Information Association, Inc.)

Background: Middle meningeal artery (MMA) embolization for endovascular treatment of chronic subdural hematoma (cSDH) is growing in popularity. cSDH volume and midline shift were analyzed in the immediate postoperative window after MMA embolization., Methods: A retrospective analysis of cSDHs managed via MMA embolization from January 1, 2018 to March 30, 2021 was performed at a large quaternary center. Pre- and postoperative cSDH volume and midline shift were quantified with CT. Postoperative CT was obtained 12 to 36 hours after embolization. Paired t-tests were used to determine significant reduction. Multivariate analysis was performed using logistic and linear regression for percent improvement from baseline volume., Results: In total, 80 patients underwent MMA embolization for 98 cSDHs during the study period. The mean (SD) initial cSDH volume was 66.54 (34.67) mL, and the mean midline shift was 3.79 (2.85) mm. There were significant reductions in mean cSDH volume (12.1 mL, 95% CI 9.32 to 14.27 mL, P<0.001) and midline shift (0.80 mm, 95% CI 0.24 to 1.36 mm, P<0.001). In the immediate postoperative period, 22% (14/65) of patients had a>30% reduction in cSDH volume. A multivariate analysis of 36 patients found that preoperative antiplatelet and anticoagulation use was significantly associated with an expansion in volume (OR 0.028, 95% CI 0.000 to 0.405, P=0.03)., Conclusion: MMA embolization is safe and effective for the management of cSDH and is associated with significant reductions in hematoma volume and midline shift in the immediate postoperative period., Competing Interests: Competing interests: FCA and AFD serve on the editorial board of Journal of NeuroInterventional Surgery. The other authors have no personal, financial, or institutional interest in any of the drugs, materials, or devices described in this manuscript., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

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.)

Background: Flow-diverting devices (FDDs), such as the Pipeline Embolization Device, have been gaining traction for treating challenging posterior circulation aneurysms. Few previous studies have focused on using FDDs to treat aneurysms of the basilar quadrifurcation., Methods: We retrospectively reviewed the use of FDDs to treat patients with basilar quadrifurcation aneurysms. Patients were assessed for aneurysm type, previous aneurysm treatment, technical success, periprocedural complications, and long-term aneurysm occlusion., Results: 34 patients were assessed; aneurysms of the basilar apex (n=23) or superior cerebellar artery (SCA) (n=7), or both (n=1), and posterior cerebral artery (PCA) (n=3). The mean (SD) largest aneurysm dimension was 8.7 (6.1) mm (range 1.9-30.8 mm). 14 aneurysms were previously surgically clipped or endovascularly coiled. All aneurysms had a saccular morphology. Complete or near-complete occlusion was achieved in 30 of 34 patients (88%) at final angiographic follow-up, a mean (SD) of 6.6 (5.4) months (range 0-19 months) postoperatively. No patient experienced postoperative symptomatic occlusions of the SCA or PCA; 4 patients developed asymptomatic posterior communicating artery occlusions; 28 patients (82%) experienced no complications; whereas 3 (9%) experienced major complications and 3 (9%) experienced minor complications; and 1 patient died as a result of subarachnoid hemorrhage., Conclusion: Flow diversion may be a safe and effective option to treat basilar quadrifurcation aneurysms. Previously treated basilar quadrifurcation aneurysms with recurrence or residual lesion may benefit from additional treatment with an FDD. Further prospective studies should be directed toward validating these findings., Competing Interests: Competing interests: Dr Ducruet is a consultant for Penumbra, Medtronic, Stryker, Cerenovus, and Koswire. Drs Ducruet and Albuquerque serve on the editorial board of the Journal of NeuroInterventional Surgery. Content included in this article was presented as a digital poster at the American Association of Neurological Surgeons Annual Meeting, April 29–May 1, 2022, in Philadelphia, PA., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Controversy remains regarding the appropriate screening for intracranial aneurysms or for the treatment of aneurysmal subarachnoid hemorrhage (aSAH) for patients without known high-risk factors for rupture. This study aimed to assess how sex affects both aSAH presentation and outcomes for aSAH treatment., Method: A retrospective cohort study was conducted of all patients treated at a single institution for an aSAH during a 12-year period (August 1, 2007-July 31, 2019). An analysis of women with and without high-risk factors was performed, including a propensity adjustment for a poor neurologic outcome (modified Rankin Scale [mRS] score > 2) at follow-up., Results: Data from 1014 patients were analyzed (69% [n = 703] women). Women were significantly older than men (mean ± SD, 56.6 ± 14.1 years vs 53.4 ± 14.2 years, p < 0.001). A significantly lower percentage of women than men had a history of tobacco use (36.6% [n = 257] vs 46% [n = 143], p = 0.005). A significantly higher percentage of women than men had no high-risk factors for aSAH (10% [n = 70] vs 5% [n = 16], p = 0.01). The percentage of women with an mRS score > 2 at the last follow-up was significantly lower among those without high-risk factors (34%, 24/70) versus those with high-risk factors (53%, 334/633) (p = 0.004). Subsequent propensity-adjusted analysis (adjusted for age, Hunt and Hess grade, and Fisher grade) found no statistically significant difference in the odds of a poor outcome for women with or without high-risk factors for aSAH (OR = 0.7, 95% CI = 0.4-1.2, p = 0.18)., Conclusions: A higher percentage of women versus men with aSAH had no known high-risk factors for rupture, supporting more aggressive screening and management of women with unruptured aneurysms., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Austria, part of Springer Nature.)

Intraorbital arteriovenous fistulas (IOAVFs) are rare vascular pathologies that may be effectively treated with direct puncture (DP) of the venous supply and may offer a definitive and safe cure when done under ultrasound or stereotactic guidance. Here we present three new cases of DP treatment of IOAVFs, indications for safe use, and their potential complications in comparison to the existing literature on DP and other modalities.Three patients with IOAVFs were treated with DP with ultrasound guidance, stereotactic guidance, and fluoroscopy. Final digital subtraction angiography (DSA) revealed complete cure of IOAVFs. A literature review via PubMed was performed on treatments of IOAVFs since 1978.All three cases of DP resulted in successful cures with 2/3 cases resulting in complications from orbital hematoma formation. 49 total treatments including the cases herein have been documented. DP treatment constituted 5/49, conservative management 17/49, transarterial 8/49, transvenous 18/49, and surgical 3/49. Some cases received more than one mode of treatment. Transarterial and surgical managements were found to have higher complication rates than transvenous and DP.DP is a safe and effective treatment of IOAVFs that can be performed via multiple image guided methods and guarantees a definitive cure. Orbital hematomas are a potential complication of which operators should be aware., Competing Interests: Competing interests: JRM is a consultant to Stryker, PTK is a consultant for Stryker and Imperative Care. PTK has current grant awards: NIH, 1U18EB029353-01, Siemens research grant, CON30434, Joe Niekro Foundation grant, CON30914, and Medtronic research grant, ERP-2019-12070., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

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.)

Introduction: Biological medicines have been assuming an important role among the therapeutic options for several diseases, however, due to their complex production process, the products obtained from this technology have a high added value and do not reach the purchasing power of most patients, which overwhelms the budget of health systems. With the development of biosimilars, which have reduced production costs, it is expected that access to biological medicines will become broader. However, in Brazil, the criteria for determining the price of biosimilars, unlike the generic policy in the country, do not foresee a price reduction due to the reduction of development costs. Objective: To understand the impact of the current model of economic regulation on the availability and access of these products in the country, based on a comparative analysis in selected countries, and identify trends that can help to expand the availability and access to biological medicines. Method: Quantitative and qualitative study, to identify the variation between the entry prices of biological medicines in Brazil and in selected countries, as well as the differences in the economic regulation policies established in these countries. Results: The results demonstrate that the current pricing model in Brazil has generated distortions in the prices of biosimilars in the market, which, consequently, makes it difficult for the population to access this category of products, in addition to allowing unsustainable market practices for the systems of public and private health in Brazil. It was also found that most of the analyzed countries, unlike Brazil, seek to harmonize the prices of different brands of the same molecule marketed in the country and with the international market, in addition to establishing incentive policies for indication and replacement by biosimilars, which expands the participation of biosimilars in the market significantly. Conclusion: Based on the data presented, it is concluded that it is essential to build a broader political and regulatory debate on the market for biologicals and biosimilars in the country to guarantee the access of the Brazilian population to more cost-effective technologies, generate a more competitive market and consequently contribute to the financial sustainability of health systems., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Pontes, Ribeiro, Albuquerque and Leite Cotenzini.)

Background and Objectives: Preoperative embolization of arteriovenous malformations (AVMs) remains controversial. This study sought to analyze the cost-effectiveness of preoperative embolization of AVMs., Methods: Patients who underwent AVM resection at a single institute (January 1, 2015-December 31, 2020) were analyzed. Patients with preoperative embolization (embolization cohort) were compared with those without preoperative embolization (nonembolization cohort). Cost-effectiveness score (CE) was the primary outcome of interest and was determined by dividing the total 1-year cost by effectiveness, which was derived from a validated preoperative to last follow-up change in the modified Rankin Scale utility score. A lower CE signifies a more cost-effective treatment strategy., Results: Of 188 patients, 88 (47%) underwent preoperative embolization. The mean (SD) total cost was higher in the embolization group than in the nonembolization group ($117 594 [$102 295] vs $84 348 [$82 326]; P < .001). The mean (SD) CE was higher in the embolization cohort ($336 476 [$1 303 842]) than in the nonembolization cohort ($100 237 [$246 255]; P < .001). Among patients with Spetzler-Martin (SM) grade I and II AVMs, the mean (SD) CE was higher in the embolization (n = 40) than in the nonembolization (n = 72) cohort ($164 950 [$348 286] vs $69 021 [$114 938]; P = .004). Among patients with SM grade III AVMs, the mean (SD) CE was lower in the embolization (n = 33) than in the nonembolization (n = 25) cohort ($151 577 [$219 130] vs $189 195 [$446 335]; P = .006). The mean (SD) CE was not significantly different between cohorts among patients with higher-grade AVMs (embolization cohort [n = 3] vs nonembolization cohort [n = 15]: $503 639 [$776 492] vs $2 048 419 [$4 794 758]; P = .49). The mean CE for embolized SM grade III aneurysms was nonsignificant in the ruptured group; however, for the unruptured group, CE was significantly higher in the embolization cohort (n = 26; $160 871 [$240 535]) relative to the nonembolization cohort (n = 15; $108 152 [$166 446]) ( P = .006)., Conclusion: Preoperative embolization was cost-effective for patients with SM grade III AVMs but not for patients with lower-grade AVMs., (Copyright © Congress of Neurological Surgeons 2023. All rights reserved.)

Background: The timing of surgical resection is controversial when managing ruptured arteriovenous malformations (AVMs) and varies considerably among centers., Objective: To retrospectively analyze clinical outcomes and hospital costs associated with delayed treatment in a ruptured cerebral AVM patient cohort., Methods: Patients undergoing surgical treatment for a ruptured cerebral AVM (January 1, 2015-December 31, 2020) were retrospectively analyzed. Patients who underwent emergent treatment of a ruptured AVM because of acute herniation were excluded, as were those treated >180 days after rupture. Patients were stratified by the timing of surgical intervention relative to AVM rupture into early (postbleed days 1-20) and delayed (postbleed days 21-180) treatment cohorts., Results: Eighty-seven patients were identified. The early treatment cohort comprised 75 (86%) patients. The mean (SD) length of time between AVM rupture and surgical resection was 5 (5) days in the early cohort and 73 (60) days in the delayed cohort ( P < .001). The cohorts did not differ with respect to patient demographics, AVM size, Spetzler-Martin grade, frequency of preoperative embolization, or severity of clinical presentation ( P ≥ .15). Follow-up neurological status was equivalent between the cohorts ( P = .65). The associated mean health care costs were higher in the delayed treatment cohort ($241 597 [$99 363]) than in the early treatment cohort ($133 989 [$110 947]) ( P = .02). After adjustment for length of stay, each day of delayed treatment increased cost by a mean of $2465 (95% CI = $967-$3964, P = .002)., Conclusion: Early treatment of ruptured AVMs was associated with significantly lower health care costs than delayed treatment, but surgical and neurological outcomes were equivalent., (Copyright © Congress of Neurological Surgeons 2023. All rights reserved.)

Background: Mechanical thrombectomy (MT) is the standard-of-care treatment for stroke patients with emergent large vessel occlusions. Despite this, little is known about physician decision making regarding MT and prognostic accuracy., Methods: A prospective multicenter cohort study of patients undergoing MT was performed at 11 comprehensive stroke centers. The attending neurointerventionalist completed a preprocedure survey prior to arterial access and identified key decision factors and the most likely radiographic and clinical outcome at 90 days. Post hoc review was subsequently performed to document hospital course and outcome., Results: 299 patients were enrolled. Good clinical outcome (modified Rankin Scale (mRS) score of 0-2) was obtained in 38% of patients. The most frequently identified factors influencing the decision to proceed with thrombectomy were site of occlusion (81%), National Institutes of Health Stroke Scale score (74%), and perfusion imaging mismatch (43%). Premorbid mRS score determination in the hyperacute setting accurately matched retrospectively collected data from the hospital admission in only 140 patients (46.8%). Physicians correctly predicted the patient's 90 day mRS tertile (0-2, 3-4, or 5-6) and final modified Thrombolysis in Ischemic Cerebral Infarction score preprocedure in only 44.2% and 44.3% of patients, respectively. Clinicians tended to overestimate the influence of occlusion site and perfusion imaging on outcomes, while underestimating the importance of pre-morbid mRS., Conclusions: This is the first prospective study to evaluate neurointerventionalists' ability to accurately predict clinical outcome after MT. Overall, neurointerventionalists performed poorly in prognosticating patient 90 day outcomes, raising ethical questions regarding whether MT should be withheld in patients with emergent large vessel occlusions thought to have a poor prognosis., Competing Interests: Competing interests: KMF, MC, JAH, FCA, MM, and PK serve on the editorial board of JNIS., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Basilar artery (BA) fenestration aneurysm (BAFA) is a rare phenomenon commonly accompanying other aneurysms. Treatment is challenging, and few cases have been reported. This review investigated the management outcomes of BAFAs., Methods: Publication databases were searched to identify studies evaluating outcomes of endovascular treatment (EVT) and microsurgical treatment of BAFAs from inception through 2021. Outcomes (clinical, angiographic, postoperative complications, and retreatment rates) were collected and analyzed. The authors present their case of a patient treated for a BAFA., Results: Including the authors' case, 184 patients with 209 BAFAs were reported in 68 studies. Most patients (130/175; 74.3%) presented with ruptured aneurysms, most commonly involving the proximal segment of the BA. Most BAFAs were small (52/103, 50.5%) and saccular (119/143, 83.2%). Most patients underwent EVT (143/184, 77.7%); the rest underwent microsurgery. Postoperative complications after EVT occurred in 10 (8.3%) of 120 patients, with 4 of the 10 experiencing strokes. At clinical follow-up, most EVT patients (74/86, 86.0%) showed good outcomes; 3.9% (2/51) had died. Most aneurysms managed with EVT (56/73, 76.7%) showed complete occlusion at follow-up; 7.3% (8/109) were retreated. Postoperative complications occurred in 62.2% (23/37) of microsurgical patients; 5 (21.7%) of the 23 experienced strokes. All patients showed good clinical outcomes at follow-up. Most aneurysms (22/28, 78.6%) treated microsurgically showed complete occlusion at angiographic follow-up, with no retreatment required., Conclusion: BAFAs are often symptomatic; thus, treatment is challenging. By the 2000s, treatment had moved from microsurgical to endovascular modalities, with good clinical and angiographic outcomes., Competing Interests: Competing interests: FCA and AFD are on the editorial board for Journal of NeuroInterventional Surgery. No prior submissions or presentations., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Thoracic endovascular aortic repair (TEVAR) involving the aortic arch may increase the opportunity for stroke owing to disruption of cerebral circulation and embolization. In this study, a systematic meta-analysis was performed to examine the impact of proximal landing zone location on stroke and 30-day mortality after TEVAR., Methods: MEDLINE and Cochrane Library were searched for all original studies of TEVAR reporting outcomes of stroke or 30-day mortality for at least two adjacent proximal landing zones, based on the Ishimaru classification scheme. Forest plots were created using relative risks (RR) with 95% confidence intervals (CI). An I 2 of <40% was regarded as minimal heterogeneity. A P value of <.05 was considered significant., Results: Of the 57 studies examined, a total of 22,244 patients (male 73.1%, aged 71.9 ± 11.5 years) were included in the meta-analysis, with 1693 undergoing TEVAR with proximal landing zone 0, 1931 with zone 1, 5839 with zone 2, and 3089 with zone 3 and beyond. The overall risk of clinically evident stroke was 2.7% for zones ≥3, 6.6% for zone 2, 7.7% for zone 1, and 14.2% for zone 0. More proximal landing zones were associated with higher risks of stroke compared with distal (zone 2 vs ≥3: RR, 2.14; 95% CI, 1.43-3.20; P = .0002; I 2  = 56%; zone 1 vs 2: RR, 1.48; 95% CI, 1.20-1.82; P = .0002; I 2  = 0%; zone 0 vs 1: RR, 1.85; 95% CI, 1.52-2.24; P < .00001; I 2  = 0%). Mortality at 30 days was 2.9% for zones ≥3, 2.4% for zone 2, 3.7% for zone 1, and 9.3% for zone 0. Zone 0 was associated with higher mortality compared with zone 1 (RR, 2.30; 95% CI, 1.75-3.03; P < .00001; I 2  = 0%). No significant differences were found in 30-day mortality between zones 1 and 2 (P = .13) and between zone 2 and zones ≥3 (P = .87)., Conclusions: The risk of stroke from TEVAR is lowest in zone 3 and beyond, increasing significantly as the landing zone is moved proximally. Furthermore, perioperative mortality is increased with zone 0 compared with zone 1. Therefore, risk of stent grafting in the proximal arch should be weighed against alternative surgical or nonoperative options. It is anticipated that the risk of stroke will improve with further development of stent graft technology and implantation technique., (Copyright © 2023 Society for Vascular Surgery. All rights reserved.)

Background and Objectives: Basilar artery fenestration is a rare phenomenon sometimes associated with basilar artery fenestration aneurysms (BAFAs). This review investigates the natural history and management outcomes of BAFAs and describes the outcomes of BAFAs treated with embolization., Methods: A single-center database was queried for all cases of endovascular BAFA treatment. Data on complications, clinical and angiographic outcomes, and retreatment rates were collected., Results: Seventeen aneurysms across 17 patients were treated. The mean (SD) age was 56 (13) years, and 15 (88%) patients were women. Among 15 aneurysms with data available, 2 arose from the fenestration limbs and 13 from both limbs and the vertebral artery. Of 16 aneurysmal projections available, 7 projected anteriorly, 7 posteriorly, and 2 superiorly. Among 17 patients, balloon-assisted coiling was the most common treatment (n = 10), followed by primary coiling (n = 3), stent-assisted coiling (n = 2), coiling with flow diversion (n = 1), and balloon-assisted coiling and flow diversion (n = 1). Complications noted in 5 patients included hemorrhage, thromboembolism, paresthesias, vasospasm, and transient hemiparesis. Among 16 patients with postoperative results available, 12 showed favorable clinical outcomes, 3 were disabled, and 1 died. The rates of postoperative complete (Raymond-Roy Occlusion Classification 1) and incomplete (Raymond-Roy Occlusion Classification 2 and 3) occlusion among 15 patients with available data were 6 and 9, respectively., Conclusion: Endovascular management of these rare aneurysms is feasible and safe, with high rates of favorable radiographic and clinical outcomes. This series reflects a general preference toward coiling and stent-assisted coiling, although flow diversion may be considered in select cases., (Copyright © Congress of Neurological Surgeons 2023. All rights reserved.)

Background and Objectives: Arteriovenous fistulas involving the deep venous system have often been treated with microsurgery or transarterial embolization. Increasing familiarity with transvenous navigation and improved endovascular access systems may facilitate transvenous embolization (TVE) for these rare and challenging lesions., Methods: We performed a retrospective study of neurointerventional databases of 6 high-volume centers. We identified all cases of arteriovenous fistulas with deep transvenous embolizations for arteriovenous fistula. Details regarding demographics, fistula characteristics, treatment considerations, clinical outcomes, and fistula occlusion were obtained and analyzed. The meta-analysis used the same inclusion criteria., Results: Seventeen cases of TVE were identified. The most common reasons for TVE included prior treatment failure with microsurgery (n = 2) or transarterial embolization (n = 3) or inaccessible arterial pedicles (n = 4). For patients with full clinical outcome data (n = 14), 2 patients had worsened modified Rankin Scale, 8 patients had no change, and 4 were improved at a median clinical follow-up of 3.5 months. Angiographic obliteration was achieved in 15/17 cases (88.2%). In 1 case, catheterization around a sharp turn in the basal vein of Rosenthal could not be performed. In another case, despite successful TVE, there was residual lesion which was treated 1 year later by microsurgical clipping and excision., Conclusion: Transvenous approaches for embolization of deep arteriovenous fistulas have become possible with modern endovascular catheter systems and liquid embolics. These lesions can be treated safely and effectively through endovascular approaches, which may spare patients the traversal of deep structures needed for microsurgical approaches to these regions. The outcomes of TVE are comparable with published outcomes of microsurgical interruption., (Copyright © Congress of Neurological Surgeons 2023. All rights reserved.)

Background: Studies have shown an association between surgical treatment volume and improved quality metrics. This study evaluated nationwide results in carotid artery stenting (CAS) procedural readmission rates, costs, and length of stay based on hospital treatment volume., Methods: We used the Nationwide Readmissions Database for carotid stenosis from 2010 to 2015. Patients receiving CAS were matched based on demographics, illness severity, and relevant comorbidities. Patients were matched 1:1 between low- and high-volume centers using a non-parametric preprocessing matching program to adjust for parametric causal inferences. Nearest-neighbor propensity score matching was performed using logit distance., Results: Low- and high-volume centers admitted a mean (SD) of 4.68 (3.79) and 25.10 (16.86) patients undergoing CAS per hospital, respectively. Comorbidities were significantly different and initially could not be adequately matched. Because of significant differences in baseline patient population characteristics after attempted matching between low- and high-volume centers, we used propensity adjustment with multivariate analysis. Using this alternative approach, no significant differences were observed between low- and high-volume centers for the presence of any complication, postoperative stroke, postoperative myocardial infarction, and readmission at 30 days., Conclusion: In 1:1 nearest-neighbor matching with a high number of patients, our analysis did not result in well-matched cohorts for the effect of case volume on outcomes. Comparing analytical techniques for various outcomes highlights that outcome disparities may not be related to quality differences based on hospital size, but rather variability in patient populations between low- and high-volume institutions., Competing Interests: Competing interests: AFD and FCA serve on the editorial board of the Journal of NeuroInterventional Surgery. AFD is a consultant for Medtronic, Penumbra, Stryker, Cerenovus, Koswire, and Oculus., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

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.

Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Direct puncture of the superior ophthalmic vein (SOV) is an alternative approach to traversing the inferior petrosal sinus for embolization of carotid cavernous fistulas (CCFs)., Objective: To analyze direct SOV puncture for the treatment of CCFs and review the literature., Methods: All patients at a single center, treated for a CCF with direct SOV cannulation between January 1, 2000, and December 31, 2020, were retrospectively analyzed. An additional review of the literature for all case series for direct puncture of the SOV for treatment of CCF was performed., Results: During the 21-year study period, direct cannulation of the SOV for treatment of a CCF was attempted for 19 patients, with the procedure aborted for one patient because of an inability to navigate the wire into the distal aspect of the cavernous sinus. In 18 patients with direct SOV CCF treatment, 1 experienced a minor complication with an asymptomatic postoperative hemorrhage. Angiographic cure and improvement of symptoms were achieved in 17 patients with a mean (SD) follow-up of 6 (5.2) months. In the review of the literature, an additional 45 patients were reported to have direct cannulation of the SOV for CCF treatment, with angiographic cure in 43 (96%) and decreased objective visual acuity in 1 (2%)., Conclusion: Direct SOV cannulation to treat CCFs is safe and effective. Although it is typically used after other endovascular approaches have failed, SOV access for CCF treatment may be warranted as a first-line treatment for select patients., Competing Interests: Competing interests: FCA and AFD serve on the editorial board of the Journal of NeuroInterventional Surgery., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Vasospasm following aneurysmal subarachnoid hemorrhage (SAH) contributes significant morbidity and mortality after brain aneurysm rupture. However, the association between vascular territory of vasospasm and clinical outcome has not been studied. We present a hypothesis-generating study to determine whether the location of vasospasm within the intracranial circulation is associated with functional outcome after SAH., Methods: A retrospective analysis of a prospective, intention-to-treat trial for aneurysmal SAH was performed to supplement trial outcomes with in-hospital angiographic imaging and treatment variables regarding vasospasm. The location of vasospasm and the position on the vessel (distal vs proximal) were evaluated. Modified Rankin scale (mRS) outcomes were assessed at discharge and 6 months, and predictive models were constructed., Results: A total of 406 patients were included, 341 with follow-up data at 6 months. At discharge, left-sided vasospasm was associated with poor outcome (odds ratio (OR), 2.37; 95% CI, 1.25 to 4.66; P=0.01). At 6 months, anterior cerebral artery (ACA) vasospasm (OR, 3.87; 95% CI, 1.29 to 11.88; P=0.02) and basilar artery (BA) vasospasm (OR, 6.22; 95% CI, 1.54 to 27.11; P=0.01) were associated with poor outcome after adjustment. A model predicting 6-month mRS score and incorporating vasospasm variables achieved an area under the curve of 0.85 and a net improvement in reclassification of 13.2% (P<0.01) compared with a previously validated predictive model for aneurysmal SAH., Conclusions: In aneurysmal SAH, left-sided vasospasm is associated with worse discharge functional status. At 6 months, both ACA and BA vasospasm are associated with unfavorable functional status., Competing Interests: Competing interests: AFD is a consultant for Medtronic (Dublin, Ireland), Penumbra (Alameda, CA), Cerenovus (Johnson & Johnson, New Brunswick, NJ), Stryker (Kalamazoo, MI), Koswire (Flowery Branch, GA), and Oculus (Menlo Park, CA). AFD also has an ownership interest in Aneuvas Technologies, Inc. (Flagstaff, AZ). FCA and AFD are on the editorial board of Journal of NeuroInterventional Surgery., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

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.)

Background: Transradial artery access (TRA) for neurointerventional procedures is gaining widespread acceptance. However, complications that were previously rare may arise as TRA procedures increase. Here we report a series of retained catheter cases with a literature review., Methods: All patients who underwent a neurointerventional procedure during a 23-month period at a single institution were retrospectively reviewed for a retained catheter in TRA cases. In cases of retained catheters, imaging was reviewed for anatomical variances in the radial artery, and clinical and demographic case details were analyzed., Results: A total of 1386 nondiagnostic neurointerventional procedures were performed during the study period, 631 (46%) initially via TRA. The 631 TRA cases were performed for aneurysm embolization (n=221, 35%), mechanical thrombectomy (n=116, 18%), carotid stent/angioplasty (n=40, 6%), arteriovenous malformation embolization (n=38, 6%), and other reasons (n=216, 34%). Thirty-nine (6%) TRA procedures crossed over to femoral access, most commonly because the artery of interest could not be catheterized (26/39, 67%). A retained catheter was identified in five cases (1%), and one (0.2%) patient had an entrapped catheter that was recovered. All six patients with a retained or entrapped catheter had aberrant radial anatomy., Conclusion: Retained catheters for neurointerventional procedures performed via TRA are rare. However, this complication may be associated with variant radial anatomy. With the increased use of TRA for neurointerventional procedures, awareness of anatomical abnormalities that may lead to a retained catheter is necessary. We propose a simple protocol to avoid catheter entrapment, including in emergent situations such as TRA for stroke thrombectomy., Competing Interests: Competing interests: FCA and AFD serve on the editorial board of the Journal of NeuroInterventional Surgery., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Several studies have shown promising outcomes of the Woven EndoBridge (WEB) device for the treatment of wide-necked intracranial bifurcation aneurysms. This is a multicenter study attempts to explore the changes in trends and treatment outcomes over time for WEB embolization of intracranial aneurysms. The WorldWideWEB consortium is a retrospective multicenter collaboration of data from international centers spanning from January 2011 and June 2021, with no limitations on aneurysm location or rupture status. Both bifurcation and sidewall aneurysms were included. These patients were stratified based on treatment year into five treatment intervals: 2011-2015 (N = 66), 2016-2017 (N = 77), 2018 (N = 66), 2019 (N = 300), and 2020-2021 (N = 173). Patient characteristics and angiographic and clinical outcomes were compared between these time intervals. This study comprised 671 patients (median age 61.4 years; 71.2% female) with 682 intracranial aneurysms. Over time, we observed an increasing tendency to treat patients presenting with ruptured aneurysms and aneurysms with smaller neck, diameter, and dome widths. Furthermore, we observed a trend towards more off-label use of the WEB for sidewall aneurysms and increased adoption of transradial access for WEB deployment. Moreover, the proportion of patients with adequate WEB occlusion immediately and at last follow-up was significantly higher in more recent year cohorts, as well as lower rates of compaction and retreatment. Mortality and complications did not differ over time. This learning curve study suggests improved experience using the WEB for the treatment of intracranial aneurysms and has yielded higher rates of adequate occlusion over time., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: Aneurysmal subarachnoid hemorrhage (aSAH) is associated with increased blood-brain barrier permeability, disrupted tight junctions, and increased cerebral edema. Sulfonylureas are associated with reduced tight-junction disturbance and edema and improved functional outcome in aSAH animal models, but human data are scant. We analyzed neurological outcomes in aSAH patients prescribed sulfonylureas for diabetes mellitus., Methods: Patients treated for aSAH at a single institution (August 1, 2007-July 31, 2019) were retrospectively reviewed. Patients with diabetes were grouped by presence or absence of sulfonylurea therapy at hospital admission. The primary outcome was favorable neurologic status at last follow-up (modified Rankin Scale score ≤2). Variables with an unadjusted P-value of <0.20 were included in a propensity-adjusted multivariable logistic regression analysis to identify predictors of favorable outcomes., Results: Of 1013 aSAH patients analyzed, 129 (13%) had diabetes at admission, and 16 of these (12%) were receiving sulfonylureas. Fewer diabetic than nondiabetic patients had favorable outcomes (40% [52/129] vs. 51% [453/884], P = 0.03). Among diabetic patients, sulfonylurea use (OR 3.90, 95% CI 1.05-15.9, P = 0.046), Charlson Comorbidity Index <4 (OR 3.66, 95% CI 1.24-12.1, P = 0.02), and absence of delayed cerebral infarction (OR 4.09, 95% CI 1.20-15.5, P = 0.03) were associated with favorable outcomes in the multivariable analysis., Conclusions: Diabetes was strongly associated with unfavorable neurologic outcomes. An unfavorable outcome in this cohort was mitigated by sulfonylureas, supporting some preclinical evidence of a possible neuroprotective role for these medications in aSAH. These results warrant further study on dose, timing, and duration of administration in humans., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Nickel is used in many cerebral endovascular treatment devices. However, nickel hypersensitivity is the most common metal allergy, and the relative risk of treatment in these patients is unknown. This retrospective analysis identified patients with nickel or metal allergies who underwent cerebral endovascular treatment with nickel-containing devices. Seven patients with nickel and/or other metal allergies underwent treatment with 9 nickel-containing devices. None experienced periprocedural complications. No patient received treatment with corticosteroids or antihistamines. At a mean clinical follow-up for all patients of 22.8 months (range, 10.5-38.0 months), no patients had symptoms attributable to nickel allergic reactions. The mean radiographic follow-up for all patients at 18.4 months (range, 2.5-37.5 months) showed successful treatment of the targeted vascular pathologies, with no evidence of in-stent stenosis or other allergic or hypersensitivity sequelae. The treatment of cerebrovascular lesions with a nickel-containing device resulted in no adverse outcomes among these patients and was safe and effective., (© 2023 by American Journal of Neuroradiology.)