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Introduction Prevention of cardiovascular disease (CVD) is of key importance in reducing morbidity, disability and mortality worldwide. Observational studies suggest that digital health interventions can be an effective strategy to reduce cardiovascular (CV) risk. However, evidence from large randomised clinical trials is lacking.Methods and analysis The CV-PREVITAL study is a multicentre, prospective, randomised, controlled, open-label interventional trial designed to compare the effectiveness of an educational and motivational mobile health (mHealth) intervention versus usual care in reducing CV risk. The intervention aims at improving diet, physical activity, sleep quality, psycho-behavioural aspects, as well as promoting smoking cessation and adherence to pharmacological treatment for CV risk factors. The trial aims to enrol approximately 80 000 subjects without overt CVDs referring to general practitioners’ offices, community pharmacies or clinics of Scientific Institute for Research, Hospitalization and Health Care (Italian acronym IRCCS) affiliated with the Italian Cardiology Network. All participants are evaluated at baseline and after 12 months to assess the effectiveness of the intervention on short-term endpoints, namely improvement in CV risk score and reduction of major CV risk factors. Beyond the funded life of the study, a long-term (7 years) follow-up is also planned to assess the effectiveness of the intervention on the incidence of major adverse CV events. A series of ancillary studies designed to evaluate the effect of the mHealth intervention on additional risk biomarkers are also performed.Ethics and dissemination This study received ethics approval from the ethics committee of the coordinating centre (Monzino Cardiology Center; R1256/20-CCM 1319) and from all other relevant IRBs and ethics committees. Findings are disseminated through scientific meetings and peer-reviewed journals and via social media. Partners are informed about the study’s course and findings through regular meetings.Trial registration number NCT05339841.

Endovascular, endosaccular, coil embolization has emerged as an established therapy for both ruptured and unruptured cerebral aneurysms. However, many aneurysms are not cured using conventional endovascular techniques. Coil embolization often results in incomplete aneurysm occlusion or recanalization in the ensuing months after treatment. The Pipeline embolization device (PED; Chestnut Medical) represents a new generation endoluminal implant which is designed to treat aneurysms by reconstructing the diseased parent artery. Immediately after implantation, the PED functions to divert flow from the aneurysm, creating an environment conducive to thrombosis. With time, the PED is incorporated into the vessel wall as neointimal-endothelial overgrowth occurs along the construct. Ultimately, this process results in the durable complete exclusion of the aneurysm from the cerebrovasculature and a definitive endoluminal reconstruction of the diseased parent artery. [ABSTRACT FROM AUTHOR]

Background Despite the great success, the therapeutic benefits of immune checkpoint inhibitors (ICIs) in cancer immunotherapy are limited by either various resistance mechanisms or ICI-associated toxic effects including gastrointestinal toxicity. Thus, novel therapeutic strategies that provide manageable side effects to existing ICIs would enhance and expand their therapeutic efficacy and application. Due to its proven role in cancer development and immune regulation, gut microbiome has gained increasing expectation as a potential armamentarium to optimize immunotherapy with ICI. However, much has to be learned to fully harness gut microbiome for clinical applicability. Here we have assessed whether microbial metabolites working at the interface between microbes and the host immune system may optimize ICI therapy.Methods To this purpose, we have tested indole-3-carboxaldehyde (3-IAld), a microbial tryptophan catabolite known to contribute to epithelial barrier function and immune homeostasis in the gut via the aryl hydrocarbon receptor (AhR), in different murine models of ICI-induced colitis. Epithelial barrier integrity, inflammation and changes in gut microbiome composition and function were analyzed. AhR, indoleamine 2,3-dioxygenase 1, interleukin (IL)-10 and IL-22 knockout mice were used to investigate the mechanism of 3-IAld activity. The function of the microbiome changes induced by 3-IAld was evaluated on fecal microbiome transplantation (FMT). Finally, murine tumor models were used to assess the effect of 3-IAld treatment on the antitumor activity of ICI.Results On administration to mice with ICI-induced colitis, 3-IAld protected mice from intestinal damage via a dual action on both the host and the microbes. Indeed, paralleling the activation of the host AhR/IL-22-dependent pathway, 3-IAld also affected the composition and function of the microbiota such that FMT from 3-IAld-treated mice protected against ICI-induced colitis with the contribution of butyrate-producing bacteria. Importantly, while preventing intestinal damage, 3-IAld did not impair the antitumor activity of ICI.Conclusions This study provides a proof-of-concept demonstration that moving past bacterial phylogeny and focusing on bacterial metabolome may lead to a new class of discrete molecules, and that working at the interface between microbes and the host immune system may optimize ICI therapy.

Objective To summarize and classify the evidence for the use of endovascular techniques in the treatment of patients with acute ischemic stroke. Methods Recommendations previously published by the American Heart Association (AHA) (Guidelines for the early management of adults with ischemic stroke (Circulation 2007) and Scientific statement indications for the performance of intracranial endovascular neurointerventional procedures (Circulation 2009)) were vetted and used as a foundation for the current process. Building on this foundation, a critical review of the literature was performed to evaluate evidence supporting the endovascular treatment of acute ischemic stroke. The assessment was based on guidelines for evidence based medicine proposed by the Stroke Council of the AHA and the University of Oxford, Centre for Evidence Based Medicine (CEBM). Procedural safety, technical efficacy and impact on patient outcomes were specifically examined. [ABSTRACT FROM AUTHOR]

The article describes the use of the Pipeline embolization device to reconstruct the right anterior circulation in a 36-year-old male patient with a dolichoectatic internal carotid artery and middle cerebral artery and a symptomatic, large, carotid-ophthalmic segment aneurysm. Upon presentation, the patient complained of progressive vision loss in his right eye, followed by sudden severe headache. The results indicate the advantages of the Pipeline over other endovascular devices.

The article describes the use of the Neuroform stent as a diagnostic and therapeutic interventional neuroradiology procedure at a single institution. Researchers reviewed the cases of patients registered in prospectively maintained endovascular databases. The results indicate that Neuroform facilitates the endovascular treatment of complex and wide necked cerebral aneurysms.

The article describes the use of DynaCT angiographic imaging in evaluating Wingspan in-stent restenosis (ISR). High resolution DynaCT angiographic imaging of two ISR patients revealed circumferential soft tissue density material distributed with the stent as the cause of the stenosis. The results presented support the hypothesis that in-stent re-stenosis is caused by neointimal proliferation and not by vascular re-coil with stent collapse.

The authors discuss how to design randomized controlled trial (RCT) for acute ischemic stroke for mechanical thrombectomy. According to the authors, one should use the highest quality evidence-based data to generate conservative estimates for mechanical thrombectomy. The authors say that there may be several challenges in obtaining consent for a time-dependent emergency procedure, as many patients are transferred to the facility providing the thrombectomy.

An abstract of the article "Balloon Assisted Treatment of Intracranial Aneurysms: The Conglomerate Coil Mass Technique," by D. Fiorella and H. H. Woo is presented.

An abstract of the article "Impact of WASID and Wingspan on the Frequency of Intracranial Angioplasty and Stenting at a High Volume Tertiary Care Hospital," by S. I. Moskowitz, M. E. Kelly, N. Obuchowski and D. Fiorella is presented.

An abstract for the article "The utilization of the Enzo steerable microcatheter for navigation of difficult anatomy in the treatment of a traumatic ophthalmic arteryi pseudoaneurysm," by M. Kelly and D. Fiorella is presented.

An abstract for the article "Curative cerebrovascular reconstruction with the Pipeline embolization device: the emergence of definitive endovascular therapy for intracranial aneurysms," by D. Fiorella, P. Lylyk, I. Szikora et al. is presented.

An abstract for the article "Current status of the management of symptomatic intracranial atherosclerotic disease: the rationale for a randomized trial of medical therapy and intracranial stenting," by D. Fiorella, T. N. Turan, C. P. Derdeyn and M. I. Chimowitz is presented.

Background: Mechanical thrombectomy (MT) is the standard of care for acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). The SOFAST study collected clinical evidence on the safety and efficacy of the 6 French SOFIA Flow Plus aspiration catheter (SOFIA 6F) when used as first-line treatment., Methods: This was a prospective, multicenter investigation to assess the safety and efficacy of SOFIA 6F used for first-line aspiration. Anterior circulation LVO stroke patients were enrolled. The primary endpoint was the final modified Thrombolysis in Cerebral Infarction (mTICI)≥2b rate. Secondary endpoints included first-pass and first-line mTICI≥2b rates, times from arteriotomy to clot contact and mTICI≥2b, and 90-day modified Rankin Scale (mRS)≤2. First-line and final mTICI scores were adjudicated by an independent imaging core lab. Safety events were assessed by an independent clinical events adjudicator., Results: A total of 108 patients were enrolled across 12 centers from July 2020 to June 2022. Median age was 67 years, median National Institutes of Health Stroke Scale (NIHSS) was 15.5, and 56.5% of patients received intravenous thrombolytics. At the end of the procedure, 97.2%, 85.2%, and 55.6% of patients achieved mTICI≥2b, ≥2c, and 3, respectively. With SOFIA 6F first-line aspiration, 87.0%, 79.6%, and 52.8% achieved mTICI≥2b, ≥2c, and 3, respectively. After the first pass, 75.0%, 70.4%, and 50.9% achieved mTICI≥2b, ≥2c, and 3, respectively. Median times from arteriotomy to clot contact and successful revascularization were 12 and 17 min, respectively. At 90 days, 66.7% of patients achieved mRS≤2., Conclusions: First-line aspiration with SOFIA 6F is safe and effective with high revascularization rates and short procedure times., Competing Interests: Competing interests: DG: research funding from the National Institutes of Health, Focused Ultrasound Foundation, MicroVention, University of Calgary, and University of Maryland Medical Center; consultant for Navigantis. CS: research support from MicroVention, National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS), Balt, Penumbra, Medtronic, Cerenovus, Route 92, MIVI, Stryker; consultant for Medtronic, Stryker, Balt, Werfen, Viz.ai, MicroVention; shareholder for Neurotechnology Investors, REIST. DHS: consultant for Medtronic, Stryker, and Kaneka; speaker for Medtronic; proctor for Medtronic; grant support from MicroVention; advisory board for Scientia and Vasorum; stockholder of Scientia and Vasorum. GT: consultant for Dynamed, Medtronic, and Penumbra. DF: consultant for Medtronic, Cerenovus, MicroVention, Penumbra, Stryker, Balt USA, MENTICE, Neurogami, RAPID. AI, RAPID Medical, Phenox Medical, Scientia Medical, Perfuze, Vesalio; proctor for Medtronic, MicroVention; research support from MicroVention, Penumbra, Stryker, Balt USA, Siemens; advisory board on Arsenal Medical, NVMed, Perfuze; stock holder in Neurogami, Arsenal Medical, Scientia Medical, NVMed, and Perfuze., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Flow diverters carry the risk of thromboembolic complications (TEC). We tested a coating with covalently bound heparin that activates antithrombin to address TEC by locally downregulating the coagulation cascade. We hypothesized that the neuroimaging evidence of TEC would be reduced by the coating., Methods: 16 dogs were implanted with overlapping flow diverters in the basilar artery, separated into two groups: heparin-coated (n=9) and uncoated (n=7). Following implantation, high-frequency optical coherence tomography (HF-OCT) was acquired to quantify acute thrombus (AT) formation on the flow diverters. MRI was performed postoperatively and repeated at 1, 2, 3, 4, and 8 weeks, consisting of T1-weighted imaging, time-0f-flight (ToF), diffusion weighted imaging (DWI), susceptibility weighted imaging (SWI), and fluid attenuated inversion recovery (FLAIR) sequences. Neurological examinations were performed throughout the 8-week duration of the study., Results: The mean AT volume on coated devices was lower than uncoated (0.014 vs 0.018 mm 3 ); however, this was not significant (P=0.3). The mean number of foci of magnetic susceptibility artifacts (MSAs) on SWI was significantly different between the uncoated and coated groups at the 1-week follow-up (P<0.02), and remained statistically different throughout the duration of the study. The AT volume showed a direct linear correlation with the MSA count and 80% of the variance in the MSA could be explained by the AT volume (P<0.001). Pathological analysis showed evidence of ischemic injury at locations of MSA., Conclusions: Heparin-coated flow diverters significantly reduced the number of new MSAs after 1 week follow-up, showing the potential to reduce TEC., Competing Interests: Competing interests: AP: consultant for Medtronic Neurovascular, Stryker Neurovascular, Balt, Q’Apel Medical, Cerenovus, Microvention, Imperative Care, Agile, Merit, CereVasc, and Arsenal Medical; research grants from NIH, Microvention, Cerenovus, Medtronic Neurovascular, and Stryker Neurovascular; holds stocks in InNeuroCo, Agile, Perfuze, Galaxy and NTI. JMA and ABB are employees of Stryker Neurovascular. ASA: Consultant for Arsenal, Balt, Johnson and Johnson, Medtronic, Microvention, Penumbra, Scientia, Siemens, Stryker. Research support from Balt, Medtronic, Microvention, Penumbra and Siemens. Shareholder Azimuth, Bendit, Cerebrotech, Endostream, Magneto, Mentice, Neurogami, Neuros, Revbio, Scientia, Serenity, Synchron, Tulavi, Vastrax, VizAI. DF: Consultant: Medtronic, Cerenovous, Microvention, Stryker, Balt USA, MENTICE-Vascular Simulations, Neurogami, Marblehead, RAPID.AI, RAPID Medical, Qapel Medical, Arsenal Medical, Phenox Medical, Scientia Medical, Perfuze; Research Support: Microvention, Stryker, Balt USA, Siemens; Scientific Advisory Boards: Scientia Medical, NVMed, Perfuze; Holds Stock in: MENTICE-Vascular Simulations, Neurogami, Marblehead, Scientia Medical, NVMed, Perfuze. MJG: Has been a consultant on a fee-per-hour basis for Alembic LLC, Astrocyte Pharmaceuticals, BendIt Technologies, Cerenovus, Imperative Care, Jacob’s Institute, Medtronic Neurovascular, Mivi Neurosciences, phenox GMbH, Q’Apel, Route 92 Medical, Stryker Neurovascular, Stryker Sustainability Solutions, Wallaby Medical; holds stock in Imperative Care, InNeuroCo, Galaxy Therapeutics and Neurogami; and has received research support from the National Institutes of Health (NIH), the United States – Israel Binational Science Foundation, Anaconda, ApicBio, Arsenal Medical, Axovant, Balt, Cerenovus, Ceretrieve, CereVasc LLC, Cook Medical, Galaxy Therapeutics, Gentuity, Gilbert Foundation, Imperative Care, InNeuroCo, Insera, Jacob’s Institute, Magneto, MicroBot, Microvention, Medtronic Neurovascular, MIVI Neurosciences, Naglreiter MDDO, Neurogami, Philips Healthcare, Progressive Medical, Pulse Medical, Rapid Medical, Route 92 Medical, Scientia, Stryker Neurovascular, Syntheon, ThrombX Medical, Wallaby Medical, the Wyss Institute and Xtract Medical. MJG is Associate Editor of Basic Science on the JNIS Editorial Board., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Multiple studies and meta-analyses have described the technical and clinical outcomes in large cohorts of aneurysm patients treated with flow diverters (FDs). Variations in evaluation methodology complicate making comparisons among studies, hinder understanding of the device behavior, and pose an obstacle in the assessment of further advances in FD therapy., Methods: A multidisciplinary panel of neurointerventionalists, imaging experts, and neuroradiologists convened with the goal of establishing consensus recommendations for the standardization of image analyses in FD studies., Results: A standardized methodology is proposed for evaluating and reporting radiological outcomes of FD treatment of intracranial aneurysms. The recommendations include general imaging considerations for clinical studies and evaluations of longitudinal changes, such as neointimal lining and stenosis. They cover standards for classification of aneurysm location, morphology, measurements, as well as the assessment of aneurysm occlusion, wall apposition, and neck coverage. These reporting standards further define four specific braid deformation patterns: foreshortening, fish-mouthing, braid bump deformation, and braid collapse, collectively termed 'F2B2'., Conclusions: When widely applied, standardization of methods of measuring and reporting outcomes will help to harmonize the assessment of treatment outcomes in clinical studies, help facilitate communication of results among specialists, and help enable research and development to focus on specific aspects of FD techniques and technology., Competing Interests: Competing interests: JF: Research support: German Ministry of Science & Education (BMBF) and of Economy and Innovation (BMWi), German Research Foundation (DFG), European Union (EU), Hamburgische Investitions- und Förderbank (IFB), Medtronic, Microvention, Route92, Stryker. Consultant for: Acandis, Cerenovus, Medtronic, Microvention, Penumbra, Phenox, Roche, Stryker, TG Med, Tonbridge. Stockholder: Tegus Medical, Vastrax, Eppdata. DF: Medtronic – Consulting, Proctoring, Cerenovous – Consulting, Microvention – Consulting, Proctoring, Research Support, Penumbra – Consulting, Research Support, Stryker – Consulting, Research Support, Balt USA – Consulting, Research Support, Siemens – Research Support, MENTICE-Vascular Simulations – Consultant, Neurogami – Stockholder, Consultant, RAPID. AI – Consultant, RAPID Medical – Consultant, Qapel Medical –Consultant, Arsenal Medical – Consultant, Phenox Medical – Consultant, Scientia Medical – SAB, Consultant, Stockholder, NVMed – SAB, Stockholder, Perfuze – SAB, Consultant, Stockholder, Vesalio - ConsultantIS: Consulting and proctoring agreement with Medtronic & Microvention. SH: Consulting and proctoring agreement with Medtronic & Microvention. Stocks: Neuravention Inc., Vesalio Inc., Synchron Inc., Bend It Technologies, Sim & Size Inc., Borvo Medical Inc., Prometheus Inc., Piraeus Inc., Neuros Medical Inc. MJG: (1) Consultant on a fee-per-hour basis for Alembic, Astrocyte Pharmaceuticals, BendIt Technologies, Cerenovus, Imperative Care, Jacob’s Institute, Medtronic Neurovascular, Mivi Neurosciences, Phenox GMbH, Q’Apel, Route 92 Medical, Scientia, Simcerre, Stryker Neurovascular, Stryker Sustainability Solutions, Wallaby Medical; holds stock in Imperative Care, InNeuroCo, Galaxy Therapeutics, Kapto, Neurogami and Synchron; (2) Research support from the National Institutes of Health (NIH), the United States–Israel Binational Science Foundation, Anaconda, ApicBio, Arsenal Medical, Axovant, Balt, Cerenovus, Ceretrieve, CereVasc, Cook Medical, Galaxy Therapeutics, Gentuity, Gilbert Foundation, Imperative Care, InNeuroCo, Insera, Jacob’s Institute, Magneto, MicroBot, Microvention, Medtronic Neurovascular, MIVI Neurosciences, Naglreiter MDDO, Neurogami, Q’Apel, Philips Healthcare, Progressive Medical, Pulse Medical, Rapid Medical, Route 92 Medical, Scientia, Stryker Neurovascular, Syntheon, ThrombX Medical, Wallaby Medical, the Wyss Institute, Xtract Medical; and (3) Associate Editor of Basic Science on the JNIS Editorial Board., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Intracranial arterial stenting is a technique for the treatment of symptomatic stenosis. In this single-center retrospective case series we evaluated a novel low profile laser-cut stent with an antithrombogenic hydrophilic polymer coating (pEGASUS-HPC, Phenox GmbH, Bochum, Germany) for the treatment of intracranial stenosis in the setting of acute ischemic stroke and elective cases., Methods: All patients treated with pEGASUS-HPC for one or more intracranial arterial stenoses at our institution were retrospectively included. Clinical, imaging and procedural parameters as well as clinical and imaging follow-up data were collected., Results: We performed 43 interventions in 41 patients with 42 stenoses in our neurovascular center between August 2021 and February 2024. Twenty-one patients (51.2%) were female and the mean±SD age was 71±10.8 years. Thirty-seven (86.1%) procedures were performed in the setting of endovascular acute ischemic stroke treatment. Technical or procedural complications occurred in seven patients (16.3%), six in the thrombectomy group and one in the elective group. One stent-related hemorrhagic complication (subarachnoid hemorrhage) occurred in emergency cases and symptomatic intracerebral hemorrhage occurred in one patient treated in an elective setting. Overall stenosis reduction following pEGASUS-HPC stent implantation was 53.0±18.0%. On follow-up imaging, which was available for 16 patients (37.2%) after an average of 32±58.6 days, 62.5% of the stents were patent., Conclusion: Our single-center case series demonstrates the feasibility of using the pEGASUS-HPC stent system, especially in emergency situations when thrombectomy fails., Competing Interests: Competing interests: DP: Phenox – travel expenses. DF: Medtronic, Cerenovous, Microvention, Penumbra, Stryker, Balt USA, Seimens, Mentice, Neurogami, Rapid.AI, Rapid Medical, Q’apel Medical, Arsenal Medical, Phenox, Scientia, NVMed, Perfuze, Vesalio – consulting fees; Medtronic, Cerenovous, Microvention, Penumbra, Stryker, Balt USA, Q’apel Medical – speaker honoraria; Medtronic, Cerenovous, Microvention, Penumbra, Stryker, Balt USA, Seimens, Mentice, Neurogami, Rapid.AI, Rapid Medical, Q’apel Medical, Arsenal Medical, Phenox, Scientia, NVMed, Perfuze, Vesalio – travel expenses; Scientia, MENTICE, Neurogami, NVMed, Perfuze – leadership role; Scientia, Perfuze, NVMED, Mentice, Neurogami – stock options. JK: Phenox travel expenses, speaker honoraria; Phenox, Microvention – consulting fees (money paid to institution). MG: Phenox – speaker honoraria, consulting fees; Microvention – speaker honoraria, consulting fees; Balt – consulting fees; Simq GmbH – Scientific advisory board member. AS, EL, EL: none. KT-H: Bayer – speaking honoraria, advisory fees. DL: Phenox – travel expenses, speaker honoraria (money paid to institution)., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Liquid embolic agents and polyvinyl alcohol (PVA) particles have been used for the embolization of the middle meningeal artery (MMA) for the treatment of chronic subdural hematomas. However, the vascular penetration and distribution of these embolic agents have not yet been compared. The current study compares distribution of a liquid embolic agent (Squid) to PVA particles (Contour) in an in vitro model of the MMA., Methods: MMA models were embolized with Contour PVA particles 45-150 µm, Contour PVA particles 150-250 µm, and Squid-18 liquid embolic agent (n=5 each). The models were scanned and every vascular segment with embolic agent was manually marked on the images. Embolized vascular length as a percentage of control, average embolized vascular diameter, and embolization time were compared between the groups., Results: The 150-250 µm Contour particles primarily accumulated close to the microcatheter tip, yielding proximal branch occlusions. The 45-150 µm Contour particles achieved a more distal distribution, but in a patchy segmental pattern. However, the models embolized with Squid-18 had a consistently distal, near-complete and homogenous distribution. Embolized vascular length was significantly higher (76±13% vs 5±3%, P=0.0007) and average embolized vessel diameter was significantly smaller (405±25 µm vs 775±225 µm, P=0.0006) with Squid than with Contour. Embolization time with Squid was also lower (2.8±2.4 min vs 6.4±2.7 min, P=0.09)., Conclusions: Squid-18 liquid results in a considerably more consistent, distal and homogeneous pattern of embolysate distribution than Contour PVA particles in an anatomical model of the MMA tree., Competing Interests: Competing interests: SM is currently an employee of Mentice. DF and CS own stock in Mentice. DF has received travel, consulting, and research support from Balt USA and is on the Editorial Board of JNIS., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Flow-diverting stents are not currently indicated for the treatment of bifurcation aneurysms, and some case series have demonstrated low occlusion rates, possibly due to a lack in neck coverage. The ReSolv stent is a unique hybrid metal/polymer stent that can be deployed with the shelf technique in order to improve neck coverage., Methods: A Pipeline, unshelfed ReSolv, and shelfed ReSolv stent were deployed in the left-sided branch of an idealized bifurcation aneurysm model. After determining stent porosity, high-speed digital subtraction angiography runs were acquired under pulsatile flow conditions. Time-density curves were created using two region of interest (ROI) paradigms (total aneurysm and left/right), and four parameters were extracted to characterize flow diversion performance., Results: The shelfed ReSolv stent demonstrated better aneurysm outflow alterations compared to the Pipeline and unshelfed ReSolv stent when using the total aneurysm as the ROI. On the left side of the aneurysm, there was no significant difference between the shelfed ReSolv stent and the Pipeline. On the right side of the aneurysm, however, the shelfed ReSolv stent had a significantly better contrast washout profile than the unshelfed ReSolv stent and the Pipeline stent., Conclusions: The ReSolv stent with the shelf technique demonstrates the potential to improve flow diversion outcomes for bifurcation aneurysms. Further in vivo testing will help to determine whether the additional neck coverage leads to better neointimal scaffolding and long-term aneurysm occlusion., Competing Interests: Competing interests: DM and SG are employed by Fluid Biomed Inc. ME is a shareholder of Fluid Biomed Inc. DF is on the editorial board of the Journal of NeuroInterventional Surgery; has received consulting, proctoring, and/or research support from Balt USA, MicroVention, Prenumbra, and Stryker; and is a shareholder of Marblehead, Mentice Inc, Neurogami Medical Inc., NV Med, and Scientia Medical. JHW is a co-founder and shareholder of Fluid Biomed Inc, and holds patents related to the technology described in this manuscript. CS has received consulting, proctoring, and/or research support from Stryker Neurovascular, Medtronic Neurovascular, Rapid Medical, Balt USA, Siemens Healthineers, and Mentice Inc. APM received research support from Evolve2Innovate, Fluid Biomedical, and Stryker Neurovascular; is a consultant for Cerus Endovascular; is a co-founder and shareholder of Fluid Biomed Inc; and holds patents related to the technology described in this manuscript., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Stent-assisted coiling (SAC) is a well-established method for treatment of wide-necked intracranial aneurysms. In this multicenter, retrospective case series we evaluated SAC with a new low-profile, laser-cut stent with an antithrombogenic hydrophilic polymer coating (pEGASUS-HPC) for the treatment of intracranial aneurysms., Methods: Patients treated with pEGASUS-HPC SAC for one or more intracranial aneurysms were retrospectively included. Clinical, imaging, and procedural parameters as well as clinical and imaging follow-up data were recorded., Results: We treated 53 aneurysms in 52 patients in six neurovascular centers between August 2021 and November 2022. Thirty-seven patients (69.8%) were female. Mean age was 57 (±11.7) years. Twenty-nine patients were treated electively, 23 in the acute phase (22 with aneurysmal subarachnoid hemorrhage (SAH), and 1 with a partially thrombosed aneurysm causing ischemic events). One intraprocedural thromboembolic event and three postprocedural ischemic complications occurred in two (8.7 %) of the SAH patients and in one of the elective patients (3.45%). Overall aneurysm occlusion was Raymond Roy (RR) I in 36 (69.2%), RR II in 9, and RR III in 9 cases. Follow-up imaging was available for 23 patients after an average of 147.7 (±59.6) days demonstrating RR I occlusion in 22 (95.5%) and RR II in 1 patient., Conclusion: SAC with the pEGASUS-HPC stent system demonstrates rates of periprocedural safety and effectiveness that are comparable with previously reported series for stent-assisted coil embolization., Competing Interests: Competing interests: All authors: phenox GmbH organized online meetings of the centers during the initiation of the work. DL: phenox – travel expenses, speaker honoraria (money paid to institution). MH: Balt, Medtronic, Microvention, Cerenovus, Stryker, Rapid Medical, phenox – consulting fees; Penumbra – speaker honoraria; Medtronic – steering committee “Inspire” Study. FE: did not disclose competing interests. AB: none. CJM: none. DB: phenox, Acandis, Stryker, Vesalio – consulting fees; Acandis – speaker honoraria; Acandis – travel expenses. ED: none. DF: Medtronic, Cerenovous, Microvention, Penumbra, Stryker, Balt USA, Seimens, Mentice, Neurogami, Rapid.AI, Rapid Medical, Q’apel Medical, Arsenal Medical, phenox, Scientia, NVMed, Perfuze, Vesalio – consulting fees; Medtronic, Cerenovous, Microvention, Penumbra, Stryker, Balt USA, Q’apel Medical – speaker honoraria; Medtronic, Cerenovous, Microvention, Penumbra, Stryker, Balt USA, Seimens, Mentice, Neurogami, Rapid.AI, Rapid Medical, Q’apel Medical, Arsenal Medical, phenox, Scientia, NVMed, Perfuze, Vesalio – travel expenses; Scientia, MENTICE, Neurogami, NVMed, Perfuze – leadership role; Scientia, Perfuze, NVMED, Mentice, Neurogami – stock options. MG: phenox, Microvention, Balt – consulting; phenox – speaker honoraria. CP: none. LC: none. MD: none. PK: Medtronic, Stryker, Microvention – consulting fees; Stryker, Oxford Heartbeat – grants. JK: phenox – travel expenses, speaker honoraria; phenox, Microvention – consulting fees (money paid to institution). AN: none., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The aim of this study was to evaluate the overall rates of braid changes associated with flow diverter (FD) treatment for intracranial aneurysms (IAs). Additionally, we sought to provide an overview of the currently reported definitions related to these complications., Methods: A systematic search was conducted from the inception of relevant literature up to April 2023, encompassing six databases. The included studies focused on patients with IAs treated with FDs. We considered four main outcome measures as FD braid changes: (1) fish-mouthing, (2) device braid narrowing, (3) device braid collapsing, and (4) device braid deformation. The data from these studies were pooled using a random-effects model., Results: A total of 48 studies involving 3572 patients were included in the analysis. Among them, 14 studies (39%) provided definitions for fish-mouthing. However, none of the included studies offered specific definitions for device braid narrowing, collapsing, or deformation, despite reporting rates for these complications in six, five, and three studies, respectively. The pooled rates for braid changes were as follows: 3% (95% CI 2% to 4%, I 2 =27%) for fish-mouthing, 7% (95% CI 2% to 20%, I 2 =85%) for narrowing, 1% (95% CI 0% to 3%, I 2 =0%) for collapsing, and 1% (95% CI 1% to 4%, I 2 =0%) for deformation., Conclusion: The findings of this study suggest that FD treatment for IAs generally exhibits low rates of fish-mouthing, device braid narrowing, collapsing, and deformation. However, the lack of standardized definitions hinders the ability to compare device outcomes objectively, emphasizing the need for uniform definitions for FD braid changes in future prospective studies on FD., Competing Interests: Competing interests: SO-G: grants from NIH, Stryker, Medtronic, Microvention, MEthinks, IschemiaView, Viz.ai, Siemens; consulting fees from Medtronic and Stryker. HSC receives consulting fees from Medtronic and MicroVention and holds stock or stock options in Neuravention Inc, Vesalio Inc, Bend It Tech, Syncron, Prometheus Inc, Piraeus Inc, Sim Research Support: Microvention, Stryker, Balt USA, Siemens; Scientific Advisory Boards: Scientia Medical, NVMed, Perfuze; holds stock in: MENTICE-Vascular Simulations, Neurogami, Marblehead, Scientia Medical, NVMed, Perfuze. PL receives consulting fees from Medtronic, Cerevasc, and Phenox GmbH (paid to his institution); honoraria from Medtronic (paid to him); and support for attending meetings and/or travel from Cerevasc, Medtronic, and Philips (paid to him); and participates on the Cerevasc data safe monitoring board. VMP is an unpaid consultant for Siemens Healthinners Endovascular Robotics. JF reported compensation from Acandis, Cerenovus, MicroVention, Medtronic, Penumbra, Phenox, Roche, Stryker, Tonbridge and stock holdings in Eppdata GmbH and Tegus Medical outside the submitted work., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The US Woven EndoBridge Intra-saccular Therapy (WEB-IT) study is a pivotal, prospective, single arm, investigational device exemption study to evaluate the safety and effectiveness of the WEB device for the treatment of wide neck bifurcation aneurysms (WNBAs). We present complete 5 year data for the cohort of 150 patients., Methods: 150 patients with WNBAs were enrolled at 21 US and six international centers. Imaging from the index procedure, 6 month, 1 year, 3 year, and 5 year follow-up were reviewed by a core laboratory. Adverse events were reviewed and adjudicated by a clinical events adjudicator., Results: 83 patients had 5 year follow-up imaging and 123 had clinical follow-up. No ruptured (0/9) or unruptured aneurysm (0/141) rebled or bled during follow-up. No new device or procedure related adverse events or serious adverse events were reported after 1 year. At 5 years, using the LOCF method, complete occlusion was observed in 58.1% and adequate occlusion in 87.2% of patients. For patients with both 1 year and 5 year occlusion statuses available, 76.8% (63/82) of aneurysms remained stable or improved with no retreatment. After 1 year, 18 aneurysms were retreated, 11 of which were adequately occluded at 1 year, and 15 of which were retreated in the absence of any deterioration in occlusion grade., Conclusions: Five year follow-up data from the WEB-IT study demonstrated that the WEB device was safe and effective when used in the treatment of WNBAs. Aneurysm occlusion rates achieved at 1 year follow-up were durable, with rates of progressive thrombosis far exceeding rates of recurrence over time., Competing Interests: Competing interests: The US WEB IT trial was supported by Terumo/Microvention USA., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Liquid embolic agents (LEAs) such as ethylene vinyl alcohol (EVOH) are utilized for middle meningeal artery embolization (MMAE) for chronic subdural hematomas (cSDH). LEAs may be advantageous for MMAE as they are permanent and can penetrate the microvasculature of the subdural membranes. LEA surface area (SA) can quantify this penetration. The segmentation of LEA SA is not described in the literature and may be of interest in refining MMAE technique., Methods: We retrospectively collected computerized tomography (CT) scans from 74 patients (with 95 cSDH) who underwent first-line MMAE with EVOH. Non-contrast head CTs were acquired pre-embolization, immediately post-embolization and at 1-, 3-, and 6 month follow-up. A 3D-Slicer was used to segment hematoma volumes and the liquid embolic cast. We hypothesized that greater LEA SA would be correlated with greater improvements in cSDH volumetric resolution., Results: There was significant resolution in cSDH volumes over the follow-up period compared to preoperative volume (p<0.0001). The LEA SA was significantly correlated with the rate of cSDH resolution at 3 months (R 2 =0.08, p=0.03), and 6 months (R 2 =0.14, p=0.01)., Conclusions: The correlation of LEA surface area with hematoma resolution at 3-months and 6-months suggests greater LEA penetration may improve radiographic outcomes. This study uniquely provides a quantitative radiological perspective on the effect of LEA penetration on cSDH resolution., Competing Interests: Competing interests: DF has received consulting, proctoring, and research support from Medtronic Neurovascular and is on the Editorial Board of JNIS. CS has received research support from Medtronic Neurovascular and Siemens Healthineers. TK is currently an employee of Siemens Healthineers., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The benefit of mechanical thrombectomy (MT) and efficacy of different first-line MT techniques remain unclear for distal and medium vessel occlusions (DMVOs). In this systematic review, we aimed to compare the performance of three first-line MT techniques in DMVOs., Methods: The PubMed database was searched for studies examining the utility of MT in DMVOs (middle cerebral artery M2-3-4, anterior cerebral artery, and posterior cerebral artery). Studies providing data for aspiration thrombectomy (ASP), stent retriever thrombectomy (SR), and combined SR+ASP technique were included. Non-comparative studies were excluded. Safety and efficacy data were collected for each technique. The Nested Knowledge AutoLit platform was utilized for literature search, screening, and data extraction. Pooled data were presented as descriptive statistics., Results: 13 studies comprising 2422 MT procedures were identified. The overall successful recanalization rate was 77.0% (1513/1964) for DMVOs. SR+ASP had a successful recanalization rate of 83.7% (297/355), SR had a 75.6% rate (638/844), while ASP alone had a 74.2% rate (386/520). The overall functional independence rate was 51.3% (851/1659) among DMVOs. The ASP alone group had a functional independence rate of 46.9% (219/467), while functional independence rates of the SR and SR+ASP groups were 51.5% (372/723) and 61.7% (174/282), respectively. Finally, the subarachnoid hemorrhage rates were 1.8% (4/217) for the ASP group, 9.3% (26/281) for the SR group, and 11.9% (41/344) for the SR+ASP group., Conclusions: Our systematic review supports the proposition that MT is a safe and effective treatment option for DMVOs. Additionally, while the SR+ASP group had consistently high rates of clot clearance and good neurological outcomes, the SR and SR+ASP groups also had higher rates of subarachnoid hemorrhage, highlighting the need for improved DMVO treatment devices., Competing Interests: Competing interests: NH works for and holds equity in Nested Knowledge; KH works for Nested Knowledge and Superior Medical Experts; JMP is employed by and has ownership interest in Superior Medical Experts and Nested Knowledge; AM works for Superior Medical Experts; KMK works for and holds equity in Nested Knowledge and holds equity in Superior Medical Experts; DF consults for Medtronic, Cerenovus, Microvention, Stryker, Balt, RAPID.AI, RAPID Medical, Qapel Medical, Arsenal Medical, Phenox Medical, Perfuze, hold equity in MENTICE, Neurogami, Marblehead, Scientia Medical, NVMed, received research support from Microvention, Penumbra, Stryker, Balt, and Siemens; DFK consults for Medtronic, has ownership interest in Superior Medical Experts, Nested Knowledge Marblehead Medical, Conway Medical, Monarch Biosciences, Piraeus Medical, received research support from Cerenovus, Insera Therapeutics, Medtronic, Microvention, Balt, Monarch Biosciences, Brainomix, and MIVI Neuroscience; WB consults for Medtronic, has ownership interest in Superior Medical Experts, and received research support from MIVI Neuroscience., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale., Methods: PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated., Results: As per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge-Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series., Conclusions: The PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture., Trial Registration: NCT02186561., Competing Interests: Competing interests: RAH is a consultant for Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical, and Q’Apel; he is on advisory board for MiVI, eLum, Three Rivers, Shape Medical and Corindus; he has received unrestricted research grants from NIH, Interline Endowment, Microvention, Stryker, CNX; he is an investor/stockholder for InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc, Scientia, RisT, BlinkTBI, and Corindus. DKL is a consultant for Asahi, Medtronic, and Stryker; has received honoraria from Siemens, Medtronic, Stryker, and Phenox. PKN is a consultant for Medtronic, Phenox, and GmbH. AHS is a modest consultant for Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Claret Medical, Corindus, Endostream Medical, Guidepoint Global Consulting, Imperative Care, Integra, Rapid Medical, Rebound Therapeutics Corp, Silk Road Medical, StimMed, Stryker, Three Rivers Medical, VasSol, and WL Gore and Associates; he is a consultant and serves on the national PI/steering committee for Cerenovus, Medtronic, MicroVention, and Penumbra; he serves on the National PI/steering committee for the POSITIVE Trial for the Medical University of South Carolina and as DSMB Chair for the HEAT Trial for Northwest University and has ownership interest in Amnis Therapeutics, Apama Medical, BlinkTBI, Buffalo Technology Partners, Cardinal Health, Cerebrotech Medical Systems, Claret Medical, Cognition Medical, Endostream Medical Ltd, Imperative Care, International Medical Distribution Partners, Rebound Therapeutics Corp, Silk Road Medical, StimMed, Synchron, Three Rivers Medical, and Viseon. PJ serves as a consultant for Medtronic, Cerenovus, and Microvention. VMP serves as a consultant/steering committee member for Stryker, Penumbra, and Balt, and as a consultant for Medtronic and Neurovasc, and receives a research grant from Philips. ISI serves as a scientific consultant regarding trial design and conduct to Medtronic. OOZ is a consultant for Medtronic, Stryker, Penumbra, and Cerenovus. CB is a consultant for Depuy-Synthes, Bionaut labs, and Galectin Therapeutics. GPC serves as a consultant for Medtronic, Microvention-Terumo, and Stryker. MM serves as a consultant for Cerebrotech, Imperative Care, and Penumbra; receives consulting fees from Medtronic, Cerenovus, and Canon Medical; and is a member of the Journal of NeuroInterventional Surgery editorial board. CMS has received honoraria from the American Association of Neurological Surgeons and Toshiba, and has ownership interest in NTI. CG serves as a consultant, proctor, and on the Speakers’ Bureau for Medtronic and Stryker. TK is a consultant for Stryker, Cerenovus, Penumbra, and Medtronic. PT serves as a consultant for Stryker Neurovascular, Cerenovus, and Medtronic. GT serves as a consultant for Dynamed EBSCO and Microvention; and is a member of the Journal of NeuroInterventional Surgery editorial board. JFF is an equity interest holder for Fawkes Biotechnology, LLC, and Cerelux; is a consultant for Stream Biomedical, Penumbra, and Medtronic; and is a member of the Journal of NeuroInterventional Surgery editorial board. MC is a consultant for Medtronic, Stryker, Penumbra, Genentech, and GE; and a member of the Journal of NeuroInterventional Surgery editorial board. RP is a consultant for Medtronic, Stryker, and Cerenovus. PK is a consultant for Stryker Neurovascular, Medtronic, and Cerenovus; and a member of the Journal of NeuroInterventional Surgery editorial board. DFi is a consultant for Arsenal Medical, Balt USA, Cerenovous, Marblehead, Medtronic, MENTICE-Vascular Simulations, Microvention, Neurogami, Qapel Medical, RAPID Medical, RAPID.AI, Stryker, and Siemens; received research support from Balt USA, Microvention, Penumbra, Siemens, and Stryker; has received honorarium from Qapel Medicine; is a stockholder in Marblehead, MENTICE-Vascular Simulations, and Neurogami; and a member of the Journal of NeuroInterventional Surgery editorial board. DFr is a consultant and on the Speakers’ Bureau for Penumbra, Stryker Neurovascular, Genentech, MicroVention, and Codman. OD serves as a proctor for Microvention/Terumo. AMM is a cofounder, investor, and shareholder of CereVasc. ASP consults for and has received research grants from Medtronic Neurovascular, Stryker Neurovascular, and Cerenovus; serves as a consultant for Microvention, Agile, Merit, Corindus, QApel, Arsenal, and Imperative Care. DFK is president of Marblehead Medical and has patent pending in balloon catheter technologies; he has received research support from Medtronic, MicroVention, NeuroSave, Neurogami, Sequent Medical, NeuroSigma, and Insera; and serves on the Scientific Advisory Board for Triticum and Boston Scientific., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: There is conflicting evidence on the utility of intravenous (IV) alteplase in patients with emergent large vessel occlusion (ELVO) treated with mechanical thrombectomy (MT)., Methods: This was a post hoc analysis of the COMPASS: a trial of aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion. We compared clinical, procedural and angiographic outcomes of patients with and without prior IV alteplase administration., Results: In the COMPASS trial, 235 patients had presented to the hospital within the first 4 hours of stroke symptom onset and were eligible for analysis. On univariate analysis, administration of IV alteplase prior to MT was found to be significantly associated with favorable outcomes (modified Rankin scale (mRS) 0-2 at 3 months; 55.6% vs 40.0% in the MT-only group, P=0.037). However, on multivariate analysis, only baseline (pre-stroke) mRS, admission National Institutes of Health Stroke Scale (NIHSS) score and age were identified as independent predictors of favorable outcomes at 3 months. We found higher final thrombolysis in cerebral infarction (TICI) 2b/3 rates in patients without the use of alteplase prior to the aspiration first approach (100.0% vs 87.9% in IV altepase +aspiration first MT, P=0.03). In the stent retriever first group, final TICI 2b/3 rates were identical in patients with and without IV alteplase administration (87.5% and 87.5%, P=1.0)., Conclusions: Prior administration of IV alteplase may adversely affect the efficacy of aspiration, but does not seem to influence the stent retriever first approach to MT in patients with anterior circulation ELVO., Competing Interests: Competing interests: MM: Grant NIH R21NS109575. Consultant: Medtronic, Cerenovus. Stock options: Brain Q, Endostream Serenity Medical, Synchron. Assistant Editor for JNIS. MW: None. JTF: Consultant: Stryker, Penumbra, Microvention. Stocks: Cerebrotech, The Stroke Project. RDL: Consultant: Cerenovus, Stryker, Penumbra, Imperative Care, Siemens. Stock options: Synchron, Endostream, Q’Apel. Social Media Editor for JNIS. DF: Consultant: Balt USA, Penumbra, Cerenovus, Stryker, Genentech, Shape Memory Medical, Marbelhead, Medtronic, MENTICE, Neuorogami, RAPID AI, Rapid Medical, Phenox. Associate Editor for JNIS. EIL: Consultant: Penumbra, NextGen Biologics, Rapid Medical, Cognition Medical, Three Rivers Medical, Stryker, MedX, Endostream Medical. KS: Consultant: Penumbra, Canon Medical Systems, Medtronic, Jacobs Institute, Neurovascular Diagnostics. RAH: Consultant: Penumbra, Endostream, Cerebrotech, Synchron, InNeuroCo, Medtronic, Microvention, Stryker, Cerenovus; Elum, Three Rivers. KW: Consultant: Penumbra. IC: Consultant: Medtronic, Microvention, Penumbra. Stocks: Cerenovus, Serenity Medical, Cerebrotech, Three Rivers Medical, Q’apel. ATR: Consultant: Penumbra, Microvention, Stryker. DF: Consultant: Penumbra, Cerenovus, Stryker, Genentech, Shape Memory Medical, Siemens. JEDA: Consultant: Penumbra, Medtronic. MK: Consultant: Penumbra, Medtronic, Endostream. ASA: Consultant: Cerenovus, Medtronic, Microvention, Penumbra, Scientia, Siemens, Stryker. Stocks: Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Neurogami, Serenity, Synchron, Triad, Vascular Simulations. BWB: Consultant: Penumbra, Medtronic, Stryker, Cerenovus, Viz.ai, 880 Medical, Route 92, Artio Medical. JE: Consultant: Penumbra, Medtronic, Stryker, Route 92 Medical. IL: Consultant: Penumbra, Medtronic, Stryker, Microvention, InNeuroCo, Three Rivers. KMF: Associate Editor for JNIS. AT: Consultant: Cardinal Consulting, Cerenovus, Corindus, Medtronic, Siemens, 880 Medical. Stock: Cerebrotech, Endostream. Imperative Care, Three Rivers Medical, Vastrax, Shape Memory, Synchron, Serenity Medical, Blink TBI, Echovate, RIST, Apama, Q’Apel, VizAi, Early Bird Medical, Rapid Medical, Spinnaker Medical. AHS: Stocks: Adona Medical, Inc., Amnis Therapeutics, Bend IT Technologies, Ltd, BlinkTBI, Inc., Buffalo Technology Partners, Inc., Cardinal Consultants, LLC, Cerebrotech Medical Systems, Inc., Cerevatech Medical, Inc., Cognition Medical, CVAID Ltd, Endostream Medical, Ltd, Imperative Care, Inc., Instylla, Inc., International Medical Distribution Partners, Launch NY, Inc., NeuroRadial Technologies, Inc., Neurotechnology Investors, Neurovascular Diagnostics, Inc., PerFlow Medical, Ltd, Q’Apel Medical, Inc., QAS.ai, Inc., Radical Catheter Technologies, Inc., Rebound Therapeutics Corp. (purchased 2019 by Integra Lifesciences, Corp.), Rist Neurovascular, Inc. (purchased 2020 by Medtronic), Sense Diagnostics, Inc., Serenity Medical, Inc., Silk Road Medical, SongBird Therapy, Spinnaker Medical, Inc., StimMed, LLC, Synchron, Inc., Three Rivers Medical, Inc., Truvic Medical, Inc., Tulavi Therapeutics, Inc., Vastrax, LLC, VICIS, Inc., Viseon, Inc. Consultant/Advisory Board: Amnis Therapeutics, Apellis Pharmaceuticals, Inc., Boston Scientific, Canon Medical Systems USA, Inc., Cardinal Health 200, LLC, Cerebrotech Medical Systems, Inc., Cerenovus, Cerevatech Medical, Inc., Cordis, Corindus, Inc., Endostream Medical, Ltd, Imperative Care, Integra, IRRAS AB, Medtronic, MicroVention, Minnetronix Neuro, Inc., Penumbra, Q’Apel Medical, Inc., Rapid Medical, Rebound Therapeutics Corp., Serenity Medical, Inc., Silk Road Medical, StimMed, LLC, Stryker Neurovascular, Three Rivers Medical, Inc., VasSol, Viz.ai, Inc., W.L. Gore & Associates. JM: Stock options: Cerebrotech, Imperative Care, Endostream, Viseon, BlinkTBI, Serenity, Cardinal Consulting, NTI, RIST, Viz.ai, Synchron. Consultant: Imperative Care, Cerebrotech, VIseon, Endostream, Vastrax, RIST, Synchron, Viz.ai, Perflow, CVAid. Associate Editor for JNIS., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Cerebral vasospasm (CV) after aneurysmal subarachnoid hemorrhage (aSAH) is linked to worse neurological outcomes. The NeVa VS is a novel cerebral dilation device based on predicate stent retrievers. We report the results of the Vesalio NeVa VS for the Treatment of Symptomatic Cerebral Vasospasm following aSAH (VITAL) Study., Methods: This was a single-arm prospective multicenter trial to assess the safety and probable benefit of the NeVa VS device to treat CV. Patients were screened and treated if they had CV >50% on non-invasive imaging confirmed by cerebral angiography. The vessel diameters were measured before and after treatment by an independent core laboratory. The primary endpoint was ≥50% vessel diameter immediately after treatment with the NeVa VS device., Results: Thirty patients with a mean age of 52±11 years and mean Hunt-Hess grade of 3.1±0.9 were enrolled. A total of 74 vessels were treated with an average of 1.3 deployments per vessel (95 deployments total). The mean pre-treatment narrowing of the target vessel (n=74) was 65.6% with reduction of the narrowing to 29.4% after treatment. The primary endpoint was achieved in 64 of 74 vessels (86.5%). In three of 95 total deployments (3.2%), thrombus at the site of deployment was observed during the procedure without apparent neurological sequelae., Conclusions: The NeVa VS device appears to be a safe treatment to regain vessel diameter in severely narrowed intracranial arteries secondary to CV associated with aSAH. This treatment offers a new tool that allows for controlled vessel expansion to treat CV., Competing Interests: Competing interests: RG: Principal Investigator (PI) for the TIGER study (Rapid Medical), PI for the ASSIST Registry (Stryker Neurovascular), PI for the RECCLAIM II Study (Zoll), CLEAR Study (Vesalio), Clinical Events Committee (CEC) for the MIND Trial (Penumbra), Steering Committee member for MEMBRANE study Cerenovous; Shareholder for Rapid Medical and Vesalio. KW: Consultant: Cerenovus, Medtronic, Microvention, Penumbra, Stryker. DFi: JNIS Editorial Board – Deputy Editor, Medtronic – Consulting, Proctoring, Cerenovous – Consulting, Microvention – Consulting, Proctoring, Research Support, Penumbra – Research Support, Stryker – Consulting, Research Support, Balt USA – Consulting, Research Support, Siemens – Research Support, MENTICE-Vascular Simulations – Stock Holder, Consultant, Neurogami – Stock Holder, Consultant, Marblehead – Consultant, Stock Holder, RAPID.AI – Consultant, RAPID Medical – Consultant, Qapel Medical – Honorarium, Consultant, Arsenal Medical – Consultant, Phenox Medical – Consultant. DL: Consultant as imaging core lab to Cerenovus, Genentech, Medtronic, Stryker, Rapid Medical and Vesalio. DFr: Consultant/Speakers Bureau: Penumbra, Stryker; Research support: Cerenovus, Medtronic, Microvention, Penumbra, Stryker; Stock ownership: Penumbra. IL: Consultant for Medtronic, Stryker, Cerenovus. AS: Consultant for Amnis Therapeutics, Apellis Pharmaceuticals, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Cerenovous, Corindus, Endostream Medical, Imperative Care, Integra Lifesciences Corp, IRRAS, Medtronic, Microvention, Minnetronix Neuro, Northwest University-DSMB for HEAT trial, Penumbra, Perflow Medical, Q’Apel Medical, Rapid Medical, Rebound Therapeutics Corp, Serenity Medical, Silk Road Medical, StimMed, Stryker, Three Rivers Medical, VasSol, Viz.ai, W L Gore Associates; National PI/Steering Committee for Cerenovous NAPA Trial and ARISE II Trial, Medtronic SWIFT PRIME and SWIFT DIRECT Trials, Microvention FRED Trial and CONFIDENCE Study, MUSC POSITIVE Trial, Penumbra 3D Separator Trial, COMPASS Trial, INVEST Trial; Financial interests in Adona Medical, Amnis Therapeutics, Bend IT Technologies, BlinkTBI, Boston Scientific Corp (for purchase of Claret Medical), Buffalo Technology Partners, Cardinal Consultants, Cerebrotech Medical Systems, Cognition Medical, Endostream Medical, Imperative Care, Instylla, International Medical Distribution Partners, IRRAS, LaunchNY Seed Fund Management, NeuroRadial Technologies, Neurovascular Diagnostics, Perflow Medical, Q’Apel, Radical Catheter Technologies, Rebound Therapeutics Corp (Purchased 2019 by Integra Lifesciences Corp), Rist Neurovascular, Sense Diagnostics, Serenity Medical, Silk Road Medical, Spinnaker Medical, StimMed, Synchron, Three Rivers Medical, Truvic Medical, Vastrax, VICIS, Viseon, Viz.ai; Research grants as co-investigator NIH/NINDS 1RO1NS091075 Virtual intervention of aneurysms and Co-Principal Investigator NIH-NINDS R21 NS109575-01 Optimizing approaches to endovascular therapy of acute ischemic stroke. RDL: Consultant for Stryker, Cerenovus, Penumbra; Equity: Q’Apel, Synchron, Endostream. RH: Consultant for Rapid Medical, Medtronic, Stryker, Cerenovous, Balt, Phenox, Elum, MIVI; Shareholder for ThromX, Cerebrotech, Endostream, RIST, REIST, Serenity, BendIT. LE: Consulting: Medtronic, Microvention, Stryker, Scientia, VizAI, Cerenovus; Research Support: Siemens., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Evidence is growing to support minimally invasive surgical evacuation of intraparenchymal hematomas, particularly those with minimal residual hematoma volumes following evacuation. To maximize the potential for neurologic recovery, it is imperative that the trajectory for access to the hematoma minimizes disruption of normal parenchyma. Flat panel detector CT-based navigation and needle guidance software provides a platform that uses flat panel detector CT imaging obtained on the angiography table to aid reliable and safe access to the hematoma. In addition to providing a high degree of accuracy, this method also allows convenient and rapid re-imaging to assess navigation accuracy and the degree of hematoma evacuation prior to procedural completion. We provide a practical review of the syngo iGuide needle guidance software and the methodology for incorporating its use, and the software of other vendors, in a variety of minimally invasive methods for evacuation of intraparenchymal hematomas., Competing Interests: Competing interests: CH has no competing interests to report. JD, KM are employees of Siemens Medical Solutions. DF is a consultant for Arsenal Medical, Balt USA, Cerenovous, Marblehead, Medtronic, MENTICE-Vascular Simulations, Microvention, Neurogami, Qapel Medical, RAPID Medical, RAPID.AI, Stryker; received research support from Balt USA, Microvention, Penumbra, Siemens, and Stryker; has received honorarium from Qapel Medicine; is a stockholder in Marblehead, MENTICE-Vascular Simulations, and Neurogami; and a member of the Journal of NeuroInterventional Surgery editorial board. DLC has no competing interests to report. ASA is a consultant for Balt, Johnson and Johnson, Medtronic, Microvention, Penumbra, Scientia, Serenity, and Stryker; and received research support from Balt USA, Medtronic, Microvention, Penumbra, and Siemens. DD is a consultant for Imperative Care and has received research suport from Siemens., (© 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: The PerfusiOn imaging Selection of Ischemic sTroke patIents for endoVascular thErapy (POSITIVE) trial was designed to evaluate functional outcome in patients with emergent large vessel occlusion (ELVO) presenting within 0-12 hours with pre-specified bifurcated arms of early and late window presentation, who were selected for endovascular thrombectomy with non-vendor specific commercially available perfusion imaging software. Recent trials demonstrating the benefit of thrombectomy up to 16-24 hours following ELVO removed equipoise to randomize late window ELVO patients and therefore the trial was halted., Methods: Up to 200 patients were to be enrolled in this FDA-cleared, prospective, randomized, multicenter international trial to compare thrombectomy and best medical management in patients with ELVO ineligible for or refractory to treatment with IV tissue plasminogen activator (IV-tPA) selected with perfusion imaging and presenting within 0-12 hours of last seen normal. The primary outcome was 90-day clinical outcome as measured by the raw modified Rankin Scale (mRS) with scores 5 and 6 collapsed (mRS shift analysis)., Results: The POSITIVE trial suspended enrollment with the release of results from the DAWN trial and was stopped after the release of the DEFUSE 3 trial results. Thirty-three patients were enrolled (21 for medical management and 12 for thrombectomy). Twelve of the 33 patients were enrolled in the 6-12 hour cohort. Despite the early cessation, the primary outcome demonstrated statistically significant superior clinical outcomes for patients treated with thrombectomy (P=0.0060). The overall proportion of patients achieving an mRS score of 0-2 was 75% in the thrombectomy cohort and 43% in the medical management cohort (OR 4.00, 95% CI 0.84 to 19.2)., Conclusion: POSITIVE supports the already established practice of delayed thrombectomy for appropriately selected patients presenting within 0-12 hours selected by perfusion imaging from any vendor. The results of the POSITIVE trial are consistent with other thrombectomy trials. The statistically significant effect on functional improvement, despite the small number of patients, reinforces the robust benefits of thrombectomy., Clinical Trial Registration: NCT01852201., Competing Interests: Competing interests: JM is a consultant for Endostream, Viseon, Imperative Care, RIST, Synchron, Viz.ai, Perflow, CVAid, and Cerebrotech, and a shareholder in Rebound, BlinkTBI, Endostream, Viseon, Imperative Care, Serenity, Cardinal Consulting, Q'Apel, NTI, RIST, Synchron, Viz.ai, and Cerebrotech. AHS has two NIH grants as well as financial interest in Adona Medical, Amnis Therapeutics, BlinkTBI, Buffalo Technology Partners, Cardinal Consultants, Cerebrotech Medical Systems, Cognition Medical, Endostream Medical, Imperative Care, International Medical Distribution Partners, Neurovascular Diagnostics, Q’Apel Medical, Radical Catheter Technologies, Rebound Therapeutics Corp, Rist Neurovascular, Sense Diagnostics, Serenity Medical, Silk Road Medical, Spinnaker Medical, StimMed, Synchron, Three Rivers Medical, Vastrax, ICIS, and Viseon; consultant for Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Cerenovus, Corindus, Endostream Medical, Imperative Care, Integra, Medtronic, MicroVention, Minnetronix Neuro, Northwest University – DSMB Chair for HEAT Trial, Penumbra, Q’Apel Medical, Rapid Medical, Rebound Therapeutics Corp, Serenity Medical, Silk Road Medical, StimMed, Stryker, Three Rivers Medical, VasSol, and W L Gore & Associates; PI or on the Steering Committee for Cerenovus LARGE Trial and ARISE II Trial, Medtronic SWIFT PRIME and SWIFT DIRECT Trials, MicroVention FRED Trial and CONFIDENCE Study, MUSC POSITIVE Trial, Penumbra 3D Separator Trial, COMPASS Trial, and the INVEST Trial. DF has consulting agreements with Medtronic, Cerenovous, Microvention, Stryker, Balt USA, Marblehead, RAPID.AI, and RAPID Medical; research support from Cerenvous, Microvention, Penumbra, Stryker, Balt USA, and Siemens; stock holder in Vascular Simulations, Neurogami, and Marble Head; board member at Vascular Simulations; honorarium at Qapel Medical. MJA is a consultant for Stryker Neurovascular, Penumbra, and Device Proctor for Medtronic. ASA is a consultant for Balt, Johnson and Johnson, Medtronic, Microvention, Penumbra, Scientia, Siemens, Stryker; research support from Balt, Medtronic, Microvention, Penumbra, and Siemens; shareholder in Azimuth, Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Neurogami, Serenity, Synchron, Triad Medical, and Vascular Simulations. BWB is a consultant for Penumbra, Stryker, Medtronic, Cerenovus, Route 92, Artio Medical, 880 Medical, and Rapid Medical; shareholder in Penumbra (stock divested), Route 92, Artio Medical, Rapid Medical, and Marblehead. MTF has grant funding from NIH, Medtronic, Microvention, Stryker, Penumbra, EndoPhys, and Genentech; serves as a consultant for Medtronic, Stryker, Balt USA, VIZ.AI, Genentech, Cerenovus, Corindus, and EndoPhys; consultant for Medtronic, Stryker, MicroVention, Cerenovous, Balt, Phenox, SAB at eLum, Three Rivers Medical, Shape Medical, MiVI; stock holder in RIsT, Inneuro Co, Deinde, eLum, Cerebrotech, Endostream, Three Rivers Medical, BendIT, Blink TBI, Serenity, Scientia. JL has consulting agreements with Penumbra and Stryker. ASP has research grants from Medtronic, Cerenovus, and Stryker; consultant for Microvention, CereVasc, Qpel, Scientica, Arsenal Medical, Merit; stockholder in NTI, Galaxy, and InNeuroCo. ATR has consulting agreements with Stryker Neurovascular, Cerenovus and Microvention. KW is a consultant for Medtronic, Microvention, Penumbra, and Cerenovus. AT is a consultant for Cardinal Consulting, Cerebrotech, Cerenovus, Corindus Robotics, Endostream Medical, Medtronic, Siemens, Imperative Care, Three Rivers Medical, Vastrax, Shape Memory, Serenity Medical, 880 Medical, and Q’Apel; stock holder in Cerebrotech, Endostream Medical, Imperative Care, Three Rivers Medical, Vastrax, Pipe Therapeutics, Q’Apel, Shape Memory, Synchron, Serenity Medical, Blink TBI, Echovate, RIST, Apama, VIZ AI, Early Bird Medicak, Radical Medical, Spinnaker Medical; co-founder of PipeTherapeutics, Neuro Technology Investors (NTI), National Education and Research Center (NEAR), Imperative Care; on the board of BlinkTBI and provides expert testimony for Corindus Vascular Robotics., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Using data from the SMART registry, we report on periprocedural safety of the Penumbra SMART Coil System for endovascular coil embolization of saccular intracranial aneurysms., Methods: The SMART registry was a prospective, multi-center registry of site standard of care endovascular coiling procedures performed using at least 75% Penumbra SMART Coil, PC400, and/or POD coils. This subset analysis reports on the periprocedural safety outcomes of the saccular intracranial aneurysm cohort. Predictors of rupture/re-rupture or perforation (RRP), thromboembolic complications, and device- or procedure-related adverse events (AEs) were determined in univariate and multivariate analysis., Results: Between June 2016 and August 2018, 851 saccular aneurysm patients (31.0%, 264/851 ruptured) were enrolled across 66 North American centers. Clinically significant (ie, a serious adverse event) RRP occurred in 2.0% (17/851) of cases - 1.9% (5/264) for the ruptured cohort and 2.0% (12/587) for the un-ruptured cohort. Clinically significant thromboembolic events occurred in 3.1% (26/851) of cases - 5.3% (14/264) for the ruptured cohort and 2.0% (12/587) for the un-ruptured cohort. Multivariate predictors of periprocedural RRP were increased packing density and adjunctive treatment with a balloon. For periprocedural thromboembolic events, multivariate predictors were bifurcation location and ruptured status. For device- or procedure-related AEs, multivariate predictors were bifurcation location and adjunctive treatment with stent or balloon., Conclusion: The low rates of thromboembolic complications and RRP events demonstrate the adequate safety profile of the SMART Coil System to treat cerebral aneurysms in routine clinical practice., Trial Registration Number: NCT02729740., Competing Interests: Competing interests: RMS: research support – NREF, Joe Niekro Foundation, Brain Aneurysm Foundation, Bee Foundation, and National Institute of Health (R01NS111119-01A1) and (UL1TR002736, 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. Consulting – Penumbra, Abbott, Medtronic, InNeuroCo, and Cerenovus. Teaching – Penumbra, Abbott, Medtronic, InNeuroCo, and Cerenovus; MSP: other from Penumbra, during the conduct of the study; CMS: research support –Penumbra. Shareholder – Neurotechnology Investors; RD: personal fees from Penumbra, personal fees from Imperative Care, personal fees from Siemens, and personal fees from Cerenovus, outside the submitted work; DF: consultant – Balt, Marblehead, Medtronic, Stryker, Microvention, Stryker, Penumbra, and Cerenovus. Research support – Cerenovus, Medtronic, Siemens, Stryker, Microvention, and Penumbra; AJY: grants and personal fees from Penumbra, grants and personal fees from Cerenovus, grants from Medtronic, grants from Stryker, and personal fees from Genentech, outside the submitted work. Equity interest in Galaxy Therapeutics and Insera Therapeutics; AMS: consulting for Stryker, Penumbra, and Terumo. Research support Stryker, Penumbra, and Medtronic., (© 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: The Woven EndoBridge (WEB) device is approved in the USA for treatment of unruptured wide-neck bifurcation aneurysms. However, the safety and effectiveness of the WEB device in the treatment of ruptured intracranial aneurysms is not clear. We aim to evaluate the perioperative safety and effectiveness of the WEB device in patients with ruptured intracranial aneurysms., Methods: This retrospective study, conducted at eight centers in the USA, included patients with ruptured intracranial aneurysms treated with the WEB device in the setting of subarachnoid hemorrhage (SAH). Safety outcomes included intraoperative complications such as vessel perforation, thromboembolic events, and postoperative hemorrhagic or thromboembolic complications based on radiologic imaging. The primary effectiveness outcome was adequate (complete and neck remnant) aneurysm occlusion, according to the Raymond-Roy classification., Results: A total of 91 patients with 94 ruptured intracranial aneurysms were included (mean age 57.7±15.2 years; 68.1% women; 82.9% wide-necked). Aneurysms were located in the anterior communicating artery (42/94, 44.6%), middle cerebral artery (16/94, 17%), and basilar artery (15/94, 16%). Adequate occlusion was achieved in 48.8% (41/84) and 80.0% (40/50) at discharge and last follow-up (mean of 3.4 months), respectively. At discharge, procedural-related morbidity was 3.3% (3/91) and there was no procedure-related mortality. No re-rupture or delayed aneurysm rupture was observed., Conclusions: This study demonstrates the perioperative safety and effectiveness of the WEB device for the treatment of patients with ruptured intracranial aneurysms in the setting of SAH, with low periprocedural morbidity and mortality. Long-term follow-up is warranted., Competing Interests: Competing interests: ASA is a consultant for Balt, Johnson and Johnson, Leica, Medtronic, Microvention, Penumbra, Scientia, Siemens, and Stryker; receives research support from Microvention, Penumbra, and Siemens; and is a shareholder in Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Neurogami, Serenity, Synchron, Triad Medical and Vascular Simulations outside the submitted work. PJ is a consultant for Medtronic, Microvention, Balt, and Cerus. MRG and SITs are consultants to Stryker. JEDA is a consultant to Medtronic, Penumbra, and Sequent. YK is a consultant for Penumbra and for Medtronic Neurovascular. ATR is a consultant to Stryker and Cerenovus. SB is a consultant to Stryker Neurovascular and MicroVention. DF is a consultant to Balt, Marblehead, Medtronic, Stryker, Microvention, Penumbra, and Cerenovus; receives research support from Cerenovus, Medtronic, Stryker, Siemens, Microvention, and Penumbra, and royalties from Codman; and is a stockholder for Marblehead, Neurogami, and Vascular Simulations outside of the submitted work. JV is a proctor for Microvention for the WEB device. MC is a consultant to Cerenovus. AHS reports grants from Coinvestigator: NIH/NINDS 1R01NS091075 Virtual Intervention of Intracranial Aneurysms; personal fees from Adona Medical, Amnis Therapeutics, BlinkTBI, Boston Scientific Corp (for purchase of Claret Medical), Buffalo Technology Partners, Cardinal Consultants, Cerebrotech Medical Systems, Cognition Medical, Endostream Medical, Imperative Care, International Medical Distribution Partners, Neurovascular Diagnostics, Q’Apel Medical, Rebound Therapeutics Corp (purchased 2019 by Integra Lifesciences), Rist Neurovascular, Sense Diagnostics, Serenity Medical, Silk Road Medical, Spinnaker Medical, StimMed, Synchron, Three Rivers Medical, Vastrax, VICIS, Viseon; additional personal fees from Amnis Therapeutics, Canon Medical Systems USA, Cerenovus, Corindus, Integra LifeSciences, Medtronic, MicroVention, Minnetronix Neuro, Northwest University, Penumbra, Rapid Medical, Stryker, VasSol, WL Gore & Associates; consultant fees for opinion on the design of clinical trials. RAH reports conflict of interest with Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, MiVI, and Codman and is a stockholder for Neurvana, Elum, Endostream, Three Rivers Medical, Synchron, RisT, Cerebrotech, Deinde, BendIT, and InNeurCo. All the other authors have no competing interests to report., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Catheter retention and difficulty in retrieval have been observed during embolization of brain arteriovenous malformations (bAVMs) with the Onyx liquid embolic system (Onyx). The Apollo Onyx delivery microcatheter (Apollo) is a single lumen catheter designed for controlled delivery of Onyx into the neurovasculature, with a detachable distal tip to aid catheter retrieval. This study evaluates the safety of the Apollo for delivery of Onyx during embolization of bAVMs., Methods: This was a prospective, non-randomized, single-arm, multicenter, post-market study of patients with a bAVM who underwent Onyx embolization with the Apollo between May 2015 and February 2018. The primary endpoint was any catheter-related adverse event (AE) at 30 days, such as unintentional tip detachment or malfunction with clinical sequelae, or retained catheter. Procedure-related AEs (untoward medical occurrence, disease, injury, or clinical signs) and serious AEs (life threatening illness or injury, permanent physiological impairment, hospitalization, or requiring intervention) were also recorded., Results: A total of 112 patients were enrolled (mean age 44.1±17.6 years, 56.3% men), and 201 Apollo devices were used in 142 embolization procedures. The mean Spetzler-Martin grade was 2.38. The primary endpoint was not observed (0/112, 0%). The catheter tip detached during 83 (58.5%) procedures, of which 2 (2.4%) were unintentional and did not result in clinical sequelae. At 30 days, procedure related AEs occurred in 26 (23.2%) patients, and procedure-related serious AEs in 12 (10.7%). At 12 months, there were 3 (2.7%) mortalities, including 2 (1.8%) neurological deaths, none of which were device-related., Conclusion: This study demonstrates the safety of Apollo for Onyx embolization of bAVMs., Clinical Trial Registration: CNCT02378883., Competing Interests: Competing interests: JF reports grants and non-financial support from Stryker, grants and other funding from Penumbra, grants from Microvention, and equity in Cerebrotech and The Stroke Project. CAG serves on the speaker’s bureau and as a consultant and proctor for Medtronic and Stryker, and serves on the speaker’s bureau for Genentech. MM serves as a consultant for Toshiba/Canon Medical. PK serves as a consultant for Stryker Neurovascular, Medtronic, and Cerenovus. TY serves as a consultant and proctor for Medtronic. OD serves as a proctor for Microvention/Terumo. DF serves as a consultant for Balt, Marblehead Medical, Medtronic, Stryker, Microvention, Penumbra, and Cerenovus, receives research support from Cerenovus, Medtronic, Stryker, Siemens, Microvention, and Penumbra, receives royalties from Codman, and is a stockholder in Marblehead, Neurogami, and Vascular simulations outside the submitted work. RVC has received research funding from Microvention, Cerenovus, and Medtronic. AKW has received research grants from Philips Medical, serves as a consultant for Stryker and Phenox, is a stockholder in InNeuroCo, EpiEP, Neural Analytics, Rist, Analytics 4 Life, and ThrombX, and serves on the speaker’s bureau for SCENT trial presentations. ASP serves as a consultant for and has received research grants from Medtronic Neurovascular and Stryker Neurovascular. RAH serves as a consultant for Medtronic, Stryker, Codman, and Microvention, and is a stockholder in InNeuroCo. LFG holds stock in Culvert Therapeutics and NeuroCool, serves as a proctor for Medtronic Neurovascular, and participates in training other physicians in the use pipeline embolization device. MAA-S serves as a proctor for Medtronic Neurovascular, and participates in training other physicians in the use of the embolic agent Onyx and the pipeline embolization device., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Clot density (Hounsfield units, HU) and perviousness (post-contrast increase in the HU of clot) are thought to be associated with clot composition. We evaluate whether these imaging characteristics were associated with angiographic outcomes of aspiration and stent retriever thrombectomy in COMPASS: a trial of aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion., Methods: Clot density and perviousness were measured by two independent operators who were blind to all the final angiographic and clinical outcomes. The association of clot density and perviousness with the Thrombolysis In Cerebral Infarction (TICI) scale after first pass was assessed using univariate and multivariate analysis., Results: Among all patients enrolled in COMPASS, 165 were eligible for the post-hoc analysis (81 patients in the aspiration first and 84 in the stent retriever first groups). Overall mean perviousness of clot was significantly higher in patient with mTICI 2b-3 after first pass (28.6±22.9 vs 20.3±19.2, p=0.017). Mean perviousness among patients who achieved TICI 2c/3 versus TICI 2b versus TICI 0-2a in the aspiration first group varied significantly (32.6±26.1, 35.3±24.4, and 17.7±13.1, p=0.013). The association of perviousness with first pass success was not significant in the stent retriever group. Using multivariate analysis, high perviousness (defined as cut-off >27.6) was an independent predictor of TICI 2b-3 (OR 3.82, 95% CI 1.10 to 13.19; p=0.034)., Conclusions: Clot perviousness is associated with first pass angiographic success in patients treated with the aspiration first approach for thrombectomy., Competing Interests: Competing interests: MM: Grant NIH R21NS109575. Consultant; Medtronic, Canon medical, Cerenovus. Stock options: Serenity medical, Synchron, VICIS, Endostream. MW: None. JF: Consultant: Stryker, Penumbra, Microvention. Stock: Cerebrotech, The Stroke Project. RDL: Consultant: Penumbra, Cerenovus, Siemens. DF: Consultant: Penumbra, Cerenovus, Stryker, Genentech, Shape Memory Medical. EIL: 6; Consultant: Penumbra, NextGen Biologics, Rapid Medical, Cognition Medical, Three Rivers Medical, Stryker, MedX, Endostream Medical. KS Consultant: Penumbra, Canon Medical Systems, Medtronic, Jacobs Institute, Neurovascular Diagnostics. RH: Consultant: Penumbra, Endostream, Cerebrotech, Synchron, InNeuroCo, Medtronic, Microvention, Stryker, Cerenovus; Elum, Three Rivers. KW: Consultant: Penumbra. IC: Consultant: Medtronic, Microvention, Penumbra. Stock: Cerenovus, Serenity Medical, Cerebrotech, Three Rivers Medical, Q’apel. ATR: Consultant: Penumbra, Microvention, Stryker. DF: Consultant: Penumbra, Cerenovus, Stryker, Genentech, Shape Memory Medical, Siemens. JEDA: Consultant: Penumbra, Medtronic. MK: Consultant: Penumbra, Medtronic, Endostream. ASA: Consultant: Cerenovus, Medtronic, Microvention, Penumbra, Scientia, Siemens, Stryker. Stock: Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Neurogami, Serenity, Synchron, Triad, Vascular Simulations. BWB: Consultant: Penumbra, Medtronic, Stryker, Cerenovus, Viz.ai, 880 medical, Route 92, Artio Medical. JE: Consultant: Penumbra, Medtronic, Stryker, Route 92 Medical. IL: Consultant: Penumbra, Medtronic, Stryker, Microvention, InNeuroCo, Three Rivers. KF: None. AT: Consultant: Cardinal Consulting, Cerenovus, Corindus, Medtronic, Siemens, 880 Medical. Stocks: Cerebrotech, Endostream. Imperative Care, Three Rivers Medical, Vastrax, Shape Memory, Synchron, Serenity Medical, Blink TBI, Echovate, RIST, Apama, Q’Apel, VizAi, Early Bird Medical, Rapid Medical, Spinnaker Medical. AHS: Stocks: Amnis Therapeutics, Apama Medical, BlinkTBI, Inc, Buffalo Technology Partners, Inc, Cardinal Health, Cerebrotech Medical Systems, Inc, Claret Medical, Cognition Medical, Endostream Medical, Ltd, Imperative Care, International Medical Distribution Partners, Rebound Therapeutics Corp, Silk Road Medical, StimMed, Synchron, Three Rivers Medical, Inc, Viseon Spine, Inc. Consultant/Advisory Board: Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Inc, Cerenovus, Claret Medical, Corindus, Endostream Medical, Ltd, Guidepoint Global Consulting, Imperative Care, Integra, Medtronic, MicroVention. JM: Stock options: Cerebrotech, Imperative Care, Endostream, Viseon, BlinkTBI, Serenity, Cardinal Consulting, NTI, RIST, Viz.ai, Synchron. Consultant: Imperative Care, Cerebrotech, VIseon, Endostream, Vastrax, RIST, Synchron, Viz.ai, Perflow, CVAid., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Competing interests: None declared.

Competing Interests: Competing interests: DF: Medtronic – Consulting, Proctoring; Cerenovous – Consulting; Microvention – Consulting, Proctoring, Research Support; Penumbra – Research Support; Stryker – Consulting, Research Support; Balt USA – Consulting, Research Support; Siemens – Research Support; MENTICE-Vascular Simulations – Stock Holder, Consultant; Neurogami – Stock Holder, Consultant; Marblehead – Consultant, Stock Holder; RAPID.AI – Consultant; RAPID Medical – Consultant; Qapel Medical – Honorarium, Consultant; Arsenal Medical – Consultant.Consultant—MedtronicDMC member—RelievantGrant recipient—Neiman Health Policy Institute.JAH: Consultant—Medtronic; DMC member—Relievant; Grant recipient—Neiman Health Policy Institute.ASA: Consultant for Balt, J and J, Medtronic, Microvention, Penumbra, Scientia, Serenity, Stryker. Research support from Balt, Medtronic, Microvention, Penumbra, Siemens.

Background: Academic physicians aim to provide clinical and surgical care to their patients while actively contributing to a growing body of scientific literature. The coronavirus disease 2019 (COVID-19) pandemic has resulted in procedural-based specialties across the United States witnessing a sharp decline in their clinical volume and surgical cases., Objective: To assess the impact of COVID-19 on neurosurgical, stroke neurology, and neurointerventional academic productivity., Methods: The study compared the neurosurgical, stroke neurology, and neurointerventional academic output during the pandemic lockdown with the same time period in previous years. Editors from a sample of neurosurgical, stroke neurology, and neurointerventional journals provided the total number of original manuscript submissions, broken down by months, from the year 2016 to 2020. Manuscript submission was used as a surrogate metric for academic productivity., Results: 8 journals were represented. The aggregated data from all eight journals as a whole showed that a combined average increase of 42.3% was observed on original submissions for 2020. As the average yearly percent increase using the 2016-2019 data for each journal exhibited a combined average increase of 11.2%, the rise in the yearly increase for 2020 in comparison was nearly fourfold. For the same journals in the same time period, the average percent of COVID-19 related publications from January to June of 2020 was 6.87%., Conclusion: There was a momentous increase in the number of original submissions for the year 2020, and its effects were uniformly experienced across all of our represented journals., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

To assess the impact of COVID-19 on neurovascular research and deal with the challenges imposed by the pandemic., Methods: A survey-based study focused on randomized controlled trials (RCTs) and single-arm studies for acute ischemic stroke and cerebral aneurysms was developed by a group of senior neurointerventionalists and sent to sites identified through the clinical trials website (https://clinicaltrials.gov/), study sponsors, and physician investigators., Results: The survey was sent to 101 institutions, with 65 responding (64%). Stroke RCTs were being conducted at 40 (62%) sites, aneurysm RCTs at 22 (34%) sites, stroke single-arm studies at 37 (57%) sites, and aneurysm single-arm studies at 43 (66%) sites. Following COVID-19, enrollment was suspended at 51 (78%) sites-completely at 21 (32%) and partially at 30 (46%) sites. Missed trial-related clinics and imaging follow-ups and protocol deviations were reported by 27 (42%), 24 (37%), and 27 (42%) sites, respectively. Negative reimbursements were reported at 17 (26%) sites. The majority of sites, 49 (75%), had put new trials on hold. Of the coordinators, 41 (63%) worked from home and 20 (31%) reported a personal financial impact. Remote consent was possible for some studies at 34 (52%) sites and for all studies at 5 (8%) sites. At sites with suspended trials (n=51), endovascular treatment without enrollment occurred at 31 (61%) sites for stroke and 23 (45%) sites for aneurysms. A total of 277 patients with acute ischemic stroke and 184 with cerebral aneurysms were treated without consideration for trial enrollment., Conclusion: Widespread disruption of neuroendovascular trials occurred because of COVID-19. As sites resume clinical research, steps to mitigate similar challenges in the future should be considered., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The objective of this meta-analysis was to establish safety and effectiveness benchmarks for endovascular therapy of unruptured small-to-medium internal carotid artery (ICA) aneurysms using flow diverters., Methods: A systematic literature review and subsequent meta-analysis were performed using best research methods. Studies of any design with at least 10 patients treated with flow diverters for predominantly (≥90%) unruptured small/medium ICA aneurysms and ≥6 month follow-up were included. The primary effectiveness endpoint was complete aneurysm occlusion rate at 12 months. The primary safety endpoint was a composite measure of cumulative events that could indicate a stroke or neurologic death: any death, stroke, intracranial hemorrhage, or worsening on the modified Rankin Scale., Results: 41 studies (2614 patients) met eligibility criteria for the meta-analysis. The core lab adjusted complete occlusion rate was 74.9% (95% CI 69.6% to 79.8%) at 12 months for studies using any flow diverter. With an aim of generating performance goals for a US Investigational Device Exemption (IDE) study, a pre-specified analysis was conducted using only studies with flow diverters commercially available in the USA. In this cohort, 12 month complete occlusion was 74.6% (95% CI 66.8% to 81.7%). The primary safety event rate for flow diverters commercially available in the USA was 7.8% (95% CI 4.8% to 11.4%)., Conclusions: The treatment of small and medium-sized aneurysms with flow diverters is effective in achieving curative reconstruction in most cases and is associated with low rates of morbidity and mortality. This meta-analysis informs robust performance goals for evaluating new flow diverters in small/medium unruptured carotid aneurysms., Competing Interests: Competing interests: Dr Fiorella is a consultant for Balt, Marblehead, Medtronic, Stryker, Microvention, Stryker, Penumbra, and Cerenovus; receives research support from Cerenovus, Medtronic, Stryker, Siemens, Microvention, and Penumbra, and royalties from Codman; and is a stockholder for Marblehead, Neurogami, and Vascular Simulations outside of the submitted work. Mr Gache is an employee of CTI Clinical Trial & Consulting Services, which is a consultant to Cerenovus, part of Johnson & Johnson Medical Devices Companies. Ms Frame is a consultant for CTI Clinical Trial & Consulting Services, which is a consultant to Cerenovus, part of Johnson & Johnson Medical Devices Companies. Dr Arthur is a consultant for Balt, Johnson and Johnson, Leica, Medtronic, Microvention, Penumbra, Scientia, Siemens, and Stryker; receives research support from Microvention, Penumbra, and Siemens; and is a shareholder in Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Neurogami, Serenity, Synchron, Triad Medical and Vascular Simulations outside of the submitted work., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Competing Interests: Competing interests: None declared.

Wide-neck bifurcation aneurysms (WNBAs) make up 26-36% of all brain aneurysms. Intrasaccular flow disruption is an innovative technique for the treatment of WNBAs. The Woven EndoBridge (WEB) device (Sequent Medical, Aliso Viejo, California USA) is the only United States Food and Drug Administration approved intrasaccular flow disruption device. In this video article, a few cases of intracranial aneurysms treated with the WEB device are presented and various aspects of treating WNBAs with the WEB device, including aneurysm/device selection strategies, and procedural technique, are discussed (video 1)., Competing Interests: Competing interests: JP and NG report no disclosures or conflict of interests. ASA is a consultant for Balt, Johnson and Johnson, Leica, Medtronic, Microvention, Penumbra, Scientia, Siemens, and Stryker; receives research support from Microvention, Penumbra, and Siemens; and is a shareholder in Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Neurogami, Serenity, Synchron, Triad Medical and Vascular Simulations outside of the submitted work. DF is a consultant for Balt, Marblehead, Medtronic, Stryker, Microvention, Stryker, Penumbra, and Cerenovus; receives research support from Cerenovus, Medtronic, Stryker, Siemens, Microvention, and Penumbra, and royalties from Codman; and is a stockholder for Marblehead, Neurogami, and Vascular Simulations outside of the submitted work., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Competing interests: None declared.

Background and Purpose: Flow diverters are increasingly used to treat a broad category of cerebral aneurysms. We conducted an in vitro study to angiographically compare the flow diversion effect of Surpass Evolve from Stryker Neurovascular with the Pipeline Shield Embolization Device from Medtronic Neurovascular., Methods: Three copies each of three carotid aneurysm geometries were manufactured from silicone. Evolve and Pipeline flow diverters were deployed in one copy of each geometry; the third copy was used as Control. High-speed angiography was acquired under pulsatile flow in each replica, contrast concentration-time curves within the aneurysms were recorded, and the curves were quantified with six parameters. The parameters were statistically evaluated to compare the flow diversion effect of both devices., Results: The Evolve showed greater flow diversion trends in almost all intra-geometry comparisons than the Pipeline. When aggregated over the three geometries, the Evolve was statistically significantly better than the Pipeline in four of the six parameters, and about the same or better (not statistically significant) than the Pipeline in the other two parameters., Conclusions: The Evolve device demonstrated greater in vitro flow diversion effects than Pipeline. Comparative efficacy of the devices will need to be adjudicated based on clinical outcomes., Competing Interests: Competing interests: All authors have significant financial interests in Vascular Simulations, Inc. DF has received consulting, proctoring, and/or research support from both Stryker Neurovascular and Medtronic Neurovascular., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Wide-necked bifurcation aneurysms (WNBAs) make up 26-36% of all brain aneurysms. Treatments for WNBAs pose unique challenges due to the need to preserve major bifurcation vessels while achieving a durable occlusion of the aneurysm. Intrasaccular flow disruption is an innovative technique for the treatment of WNBAs. The Woven EndoBridge (WEB) device is the only United States Food and Drug Administration approved intrasaccular flow disruption device. In this review article we discuss various aspects of treating WNBAs with the WEB device, including indications for use, aneurysm/device selection strategies, antiplatelet therapy requirement, procedural technique, potential complications and bailouts, and management strategies for residual/recurrent aneurysms after initial WEB treatment., Competing Interests: Competing interests: NG reports no disclosures or conflict of interests. DH serves as a consultant for Covidien/Medtronic and Microvention outside of the submitted work and has received research support from Siemens. JD is an employee of Siemens Healthineers. LE serves as a consultant for Codman Neurovascular, Medtronic, MicroVention, Penumbra, Sequent, and Stryker outside of the submitted work. DF is a consultant for Balt, Marblehead, Medtronic, Stryker, Microvention, Stryker, Penumbra, and Cerenovus; receives research support from Cerenovus, Medtronic, Stryker, Siemens, Microvention, and Penumbra, and royalties from Codman; and is a stockholder for Marblehead, Neurogami, and Vascular Simulations outside of the submitted work. LP is a consultant for Balt, Microvention, Phenox, and Vesalio outside of the submitted work. SL is a consultant for Microvention, Medtronic, Stryker, Balt, Cerenovus, Cerus, Phenox, Neuroventures, and Oxford endovascular; and is a shareholder in Cerus endovascular outside of the submitted work. LS is a consultant for Balt, Microvention, Medtronic, Stryker and Cerenovus; receives research hospital support from Philips; and is a stockholder for Sensome and Sim & Cure outside of the submitted work. IS is a consultant for Medtronic and Sequent/Microvention outside of the published work. SC serves as consultant for Medtronic, and Sequent/MicroVention outside of the submitted work and is a stockholder in ELUM and NDI. ASA is a consultant for Balt, Johnson and Johnson, Leica, Medtronic, Microvention, Penumbra, Scientia, Siemens, and Stryker; receives research support from Microvention, Penumbra, and Siemens; and is a shareholder in Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Neurogami, Serenity, Synchron, Triad Medical and Vascular Simulations outside of the submitted work., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Competing interests: None declared.