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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.)

Larger microcatheters are being used with increasing frequency in routine neurovascular procedures. Navigating catheters safely and effectively to the target intracranial vessels can be a challenge when using conventional 0.014″ microwires. A new family of 0.024″ Aristotle 24 microwires (Scientia Vascular, West Valley City, UT) specifically designed for intracranial navigation were recently introduced. These microwires offer significant technical advantages over the standard 0.014″ microwires, including a reduced ledge gap, improved torquability and support, and overall safety. This video case series contains several illustrative cases to demonstrate the features of the novel Aristotle 24 microwire for use in endovascular neurointervention., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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.)

Objective: Flow-diverting stents with a resorbable component have significant theoretical benefits over full metal stents, although currently there are none in clinical use. In this study, the authors sought to determine the immediate flow-diversion characteristics of a novel primarily bioresorbable flow-diverting stent., Methods: Bioresorbable stents were deployed into glass tube models to determine porosity and pore density. In vitro flow diversion behavior was evaluated using high frame rate angiography under pulsatile flow conditions in a patient-specific silicone aneurysm model treated with the resorbable stent as well as the Surpass Evolve stent. In vivo flow diversion was characterized by deployment into 20 rabbit saccular aneurysm models, and grading was based on the O'Kelly-Marotta scale and the 4F-flow diversion predictive score., Results: Porosities and pore densities of the bioresorbable stent were in the flow-diverting range for all target vessel diameters. Quantified results of immediate angiography after placement of the bioresorbable stent into a silicone aneurysm model demonstrated greater flow diversion compared to the Evolve stent. Bioresorbable stent placement in saccular aneurysm models resulted in an immediate O'Kelly-Marotta grade of A3 or better and a 4F-flow diversion predictive score of 4 or better in all cases., Conclusions: The bioresorbable stent has immediate flow-diversion characteristics that are comparable to commercially available metal stents. Longer-term studies are underway to determine the ability of the resorbable fibers to act as a neointimal scaffold and result in long-term aneurysm occlusion.

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.)

The use of antiplatelets is widespread in clinical practice. However, for neurointerventional procedures, protocols for antiplatelet use are scarce and practice varies between individuals and institutions. This is further complicated by the quantity of antiplatelet agents which differ in route of administration, dosage, onset of action, efficacy and ischemic and hemorrhagic complications. Clarifying the individual characteristics for each antiplatelet agent, and their associated risks, will increasingly become relevant as the practice of mechanical thrombectomy, stenting, coiling and flow diversion procedures grows. The aim of this review is to summarize the existing literature for the use of P2Y12 inhibitors in neurointerventional procedures, examine the quality of the evidence, and highlight areas in need of further research.

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.)

The Woven Endobridge (WEB; Microvention, Aliso Viejo, California, USA) is a relatively new device which has been shown to be safe and effective for the treatment of wide necked bifurcation aneurysms in multiple prospective Good Clinical Practice studies. However, the vast majority of aneurysms included in these studies have been unruptured. The aim of this review is to summarise the current evidence available on the treatment of ruptured aneurysms with the WEB.

Background and Purpose: In certain clinical circumstances, dual-antiplatelet therapy can be problematic in patients with acute SAH. In some aneurysms, however, flow-diverting stents are the ideal therapeutic option. We report our experience with ruptured intracranial aneurysms treated with flow diverters with hydrophilic coating (p48 MW HPC and p64 MW HPC) under single-antiplatelet therapy., Materials and Methods: Patients were treated with either flow-diverter placement alone or a flow diverter and additional coiling. Due to the severity of the hemorrhage, the potential for periprocedural rehemorrhage, and the potential for additional surgical interventions, a single-antiplatelet regimen was used in all patients., Results: Thirteen aneurysms were treated in 10 patients. The median age was 62 years; 5 patients were male. All had acute SAH due to aneurysm rupture. Four blood-blister, 2 dissecting, and 7 berrylike aneurysms were treated. Seven aneurysms were adjunctively coiled. Eight of the 10 patients received a single-antiplatelet protocol of aspirin, 1 patient was treated with prasugrel only, and 1 patient was treated with tirofiban first and then switched to the aspirin single-antiplatelet protocol. One device-related complication occurred, a thrombosis of an overstented branch. All stents, however, remained open at DSA, CTA, or MRA follow-up., Conclusions: The implantation of flow diverters with reduced thrombogenicity due to hydrophilic surface coating under single-antiplatelet therapy seems to be an option in carefully selected cases of SAH due to aneurysm rupture., (© 2021 by American Journal of Neuroradiology.)

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.)

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.)

Background: Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm., Objective: To compare recurrence between the second-generation HES and bare platinum coil (BPC) in the new-generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT)., Methods: HEAT is a randomized, controlled trial that enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling. The primary endpoint was aneurysm recurrence using the Raymond-Roy scale. Secondary endpoints included minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage from target aneurysm during follow-up, aneurysm occlusion stability, and clinical outcome at final follow-up., Results: A total of 600 patients were randomized (HES, n = 297 and BPC, n = 303), including 28% with ruptured aneurysms. Recurrence occurred in 11 (4.4%) subjects in the HES arm and 44 (15.4%) subjects in the BPC arm (P = .002). While the initial occlusion rate was higher with BPC, the packing density and both major and minor recurrence rates were in favor of HES. Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms., Conclusion: Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms., (© Congress of Neurological Surgeons 2020.)

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.)

Background and Purpose: The impact of increased aneurysm packing density on angiographic outcomes has not been studied in a randomized trial. We sought to determine the potential for larger caliber coils to achieve higher packing densities and to improve the angiographic results of embolization of intracranial aneurysms at 1 year., Materials and Methods: Does Embolization with Larger Coils Lead to Better Treatment of Aneurysms (DELTA) was an investigator-initiated multicenter prospective, parallel, randomized, controlled clinical trial. Patients had 4- to 12-mm unruptured aneurysms. Treatment allocation to either 15- (experimental) or 10-caliber coils (control group) was randomized 1:1 using a Web-based platform. The primary efficacy outcome was a major recurrence or a residual aneurysm at follow-up angiography at 12 ± 2 months adjudicated by an independent core lab blinded to the treatment allocation. Secondary outcomes included indices of treatment success and standard safety outcomes. Recruitment of 564 patients was judged necessary to show a decrease in poor outcomes from 33% to 20% with 15-caliber coils., Results: Funding was interrupted and the trial was stopped after 210 patients were recruited between November 2013 and June 2017. On an intent-to-treat analysis, the primary outcome was reached in 37 patients allocated to 15-caliber coils and 36 patients allocated to 10-caliber coils (OR = 0.931; 95% CI, 0.528-1.644; P  = .885). Safety and other clinical outcomes were similar. The 15-caliber coil group had a higher mean packing density (37.0% versus 26.9%, P  = .0001). Packing density had no effect on the primary outcome when adjusted for initial angiographic results (OR = 1.001; 95% CI, 0.981-1.022; P  = .879)., Conclusions: Coiling of aneurysms randomized to 15-caliber coils achieved higher packing densities compared with 10-caliber coils, but this had no impact on the angiographic outcomes at 1 year, which were primarily driven by aneurysm size and initial angiographic results., (© 2020 by American Journal of Neuroradiology.)

Endosaccular flow disruption is an innovative method of treating wide-necked complex aneurysms. Currently four types of devices have obtained the CE mark for use within Europe. These are the Woven EndoBridge device (WEB), the Luna Aneurysm Embolization System, the Medina Embolic Device (Medtronic), and the Contour Neurovascular System. The aim of this article is to provide an overview of these devices and to summarize the evidence in the literature pertaining to the treatment of intracranial aneurysms with them., Competing Interests: Competing interests: PBh: consultant for phenox. CC: consultant for Stryker, Medtronic, Cerenovus and Microvention. MP: consultant for Medtronic, Stryker, MicroVention, Balt, Penumbra, Base Camp Vascular (share holder). N-AS: investor in Medina. PBr: consultant for Cerenovus. TA: consultant for Ablynx, Amnis Therapeutics, Anaconda, Cerenovus–Neuravi, Medtronic-Covidien, Rapid Medical. DF: consultant for Medtronic, Microvention, Penumbra, Balt, Cerenovus, Stryker; research support: Siemens, Microvention, Penumbra, Cerenovus; stockholder: Marblehead, Neurogami, Vascular Simulations; board member: Vascular Simulations. ASA: consultant for Balt, Johnson and Johnson, Leica, Medtronic, Microvention, Penumbra, Scientia, Siemens, Stryker; shareholder in Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Neurogami, Serenity, Synchron, Triad Medical, Vascular Simulations. MS: consultant for Cerenovus and Archer Research. HH: co-founder and shareholder for phenox GmbH and femtos GmbH. LP: consultant for Balt, Cerus Endovascular, MicroVention, Phenox, Vesalio, Penumbra., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Chronic subdural hematoma (cSDH) is one of the most common neurosurgical diagnoses in adults. The disease is fundamentally a disorder of the meningeal blood vessels, and options exist for the minimally invasive neuroendovascular management. We review the potential role for the endovascular management of cSDH within the context of a discussion of the epidemiology, pathophysiology, and conventional management of this disease., Competing Interests: Competing interests: ASA and DF are primary investigators for the STEM trial., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms., Methods: One-hundred and fifty patients with wide-neck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety., Results: One-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study-a delayed ipsilateral parenchymal hemorrhage-on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects., Conclusions: The prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer., Trial Registration Number: NCT02191618., Competing Interests: Competing interests: The principal investigators for the WEB-IT trial received institutional salary support for study-related activities. Investigators in the WEB-IT trial also received payment for proctoring cases within the context of the trial. 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. AM is a consultant for Microvention/Sequent, Stryker Neurovascular, and Cerus outside the submitted work. ALC is a consultant for Medtronic, Microvention, and Stryker Neurovascular outside the submitted work. IS is a consultant for Medtronic and Sequent/Microvention outside the published work. IS is a consultant for Sequent/Microvention, Stryker, Medtronic, and Cerenovus outside the submitted work. DH is a consultant for Covidien/Medtronic and Microvention outside the submitted work and has received research support from Siemens. JEDA is a consultant for Medtronic, Penumbra, and Sequent outside the submitted work. LE is a consultant for Codman Neurovascular, Medtronic, MicroVention, Penumbra, Sequent, and Stryker outside the submitted work. SC is a consultant for Medtronic and Sequent/MicroVention outside the submitted work and is a stockholder in ELUM and NDI. JVB provided core laboratory services to Sequent through Oxford University during the conduct of this study and now acts as a consultant for MicroVention and Oxford Endovascular; he is a stockholder of Oxford Endovascular outside 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 the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The LVIS stent system (LVIS and LVIS Junior) is a self-expanding, retrievable, microstent system indicated for the treatment of wide-necked cerebral aneurysms (WNAs). The present pivotal study was performed to evaluate the safety and effectiveness of this device., Methods: The US LVIS pivotal trial was a prospective, multicenter, single-arm, interventional study conducted at 21 US centers. The study enrolled 153 adults with WNAs of the anterior and posterior circulations. The study was conducted under good clinical practices and included independent adjudication of all adverse events. The primary effectiveness endpoint was defined as successful aneurysm treatment with the LVIS System as evidenced by complete (100%) aneurysm occlusion at 12 months on conventional angiography without retreatment and without significant (≥50%) stenosis of the treated artery at 12 months as determined by an independent core laboratory. The primary safety endpoint was defined as the rate of stroke or death within 30 days, or ipsilateral stroke or neurologic death with 12 months., Results: One hundred and fifty-three patients enrolled at 21 investigational sites underwent attempted LVIS-assisted coil embolization. The mean age was 58.3±10.5 years and the majority of the participants (110/153, 71.9%) were female. Fifty-seven aneurysms (57/153, 37.3%) arose from the anterior cerebral artery, 43 (43/153, 28.1%) from the internal carotid artery, 17 (17/153, 11.1%) from the middle cerebral artery, 27 (27/153, 17.6%) from the basilar artery, six (6/153,3.9 %) from the PCA, and two from the vertebral artery. A single aneurysm arose from the superior cerebellar artery. The mean aneurysm dome height was 6.0±2.2 mm and mean width 5.5±2.3 mm. Mean neck width was 4.2±1.4 mm. A total of 22 participants presented for re-treatment of a previously ruptured (>30 days prior to treatment) target aneurysm. The primary effectiveness endpoint was observed in 70.6% (108/153) in the intent to treat population (ITT). Of the evaluable participants with follow-up 12-month angiography, 79.1 % (110/139) demonstrated complete occlusion- 92.1% (128/139) in this population demonstrated ≥95% occlusion and 95% demonstrated ≥90% occlusion (132/139). Eight participants (5.2%, 8/153) had at least one primary safety event in the ITT population., Conclusion: The LVIS stent system allows safe and highly effective coil embolization of WNAs., Clinical Registration Number: NCT01793792., Competing Interests: Competing interests: The authors have the following potential conflicts with Microvention/Terumo: DF: research support, consulting; AB: speaker’s fees; AST: consulting; AHS: research support, consulting; ASA: research support, consulting; OD: proctor; DKL: research support, consulting., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Flow-diverting stents have demonstrated great promise for the treatment of cerebral aneurysms; however, clinical experience with the devices remains very preliminary. We present two cases of spontaneous delayed complications-one fatal aneurysm rupture and one symptomatic increase in aneurysm volume-following the treatment of intradural aneurysms with the Pipeline Embolization Device (PED)., Presentation/intervention: Two patients with unruptured, intradural aneurysms of the carotid artery underwent uneventful treatment with the PED (eV3, Irvine, California, USA). One patient, with a giant aneurysm of the carotid terminus, experienced worsening headache 5 days after the procedure and ultimately collapsed and became unresponsive. CT of the head demonstrated acute subarachnoid and intraventricular hemorrhage. The patient died the following day. A second patient with a large left posterior communicating artery aneurysm presented with progressive memory loss 3 months after PED reconstruction of the carotid artery. Although serial CT angiograms showed progressive thrombosis of the aneurysm to near-complete occlusion, MR of the brain demonstrated marked interval growth of the collective aneurysm-intra-aneurysmal thrombus mass with extensive edema throughout the adjacent left temporal lobe., Conclusions: Flow-diverting devices have demonstrated tremendous promise for the treatment of complex, unruptured cerebral aneurysms. However, experience with this novel approach to aneurysm treatment is preliminary and the consequences of its application within the cerebrovasculature remain incompletely defined. Mural destabilization resulting in delayed, spontaneous, aneurysm growth and/or rupture may occur in the days to weeks following the application of flow-diverting devices to treat previously unruptured intracranial aneurysms. A better understanding of the incidence and etiology of these complications is essential for this technology to be optimally applied., Competing Interests: Competing interests: Dr Fiorella is an unpaid consultant and proctor for ev3/Chestnut Medical., (© 2011, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

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., Competing Interests: Competing interests: PN is a consultant and stockholder in Chestnut Medical., (© 2009, Society of NeuroInterventional Surgery.)

Introduction: The WEB Intra-saccular Therapy (WEB-IT) trial is an investigational device exemption study to demonstrate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms. The neurovascular replicator (Vascular Simulations, Stony Brook, New York, USA) creates a physical environment that replicates patient-specific neurovascular anatomy and hemodynamic physiology, and allows devices to be implanted under fluoroscopic guidance., Objective: To report the results of a unique neurovascular replicator-based training program, which was incorporated into the WEB-IT study to optimize technical performance and patient safety., Methods: US investigators participated in a new training program that incorporated full surgical rehearsals on a neurovascular replicator. No roll-in cases were permitted within the trial. Custom replicas of patient-specific neurovascular anatomy were created for the initial cases treated at each center, as well as for cases expected to be challenging. On-site surgical rehearsals were performed before these procedures., Results: A total of 48 participating investigators at 25 US centers trained using the replicator. Sessions included centralized introductory training, on-site training, and patient-specific full surgical rehearsal. Fluoroscopy and procedure times in the WEB-IT study were not significantly different from those seen in two European trials where participating physicians had significant WEB procedure experience before study initiation., Conclusions: A new program of neurovascular-replicator-based physician training was employed within the WEB-IT study. This represents a new methodology for education and training that may be an effective means to optimize technical success and patient safety during the introduction of a new technology., Competing Interests: Competing interests: The primary Investigators for the WEB-IT trial received institutional salary support for study-related activities. Investigators in the WEB-IT trial also received payment for proctoring cases within the context of the trial. AA received personal fees from Sequent during the conduct of the study; is a consultant for Leica, Medtronic, Microvention, Penumbra, Siemens, and Stryker; receives research support from Microvention, Penumbra, and Siemens; and is a shareholder in Bendit, Cerebrotech, Serenity, and Synchron outside of the submitted work. DH received personal fees from Sequent during the conduct of the study; and serves as a consultant for Covidien outside of the submitted work. AC received personal fees from Sequent during the conduct of the study; and serves as a consultant for Medtronic, Microvention, and Stryker Neurovascular outside of the submitted work. JDA received personal fees from Sequent during the conduct of the study; and serves as consultant for Medtronic, Penumbra, and Sequent outside of the submitted work. LE received personal fees from Sequent during the conduct of the study; and serves as a consultant for Codman Neurovascular, Medtronic, MicroVention, Penumbra, Sequent, and Stryker outside of the submitted work. SC received personal fees from Sequent during the conduct of the study; and serves as consultant for Medtronic, MicroVention, Sequent outside of the submitted work. DF received personal fees from Sequent during the conduct of the study; and is a consultant for Medtronic, Stryker, Microvention, Penumbra, and Codman; receives research support from Medtronic, Microvention, Penumbra, and royalties from Codman; and is a stockholder for Vascular Simulations outside of the submitted work., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Lifestyle modification programs have improved the achievement of risk factor targets in a variety of clinical settings, including patients who have previously suffered a stroke or transient ischemic attack and those with multiple risk factors. Stenting Aggressive Medical Management for Prevention of Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) was the first vascular disease prevention trial to provide a commercially available lifestyle modification program to enhance risk factor control. We sought to determine the relationship between compliance with this program and risk factor control in SAMMPRIS., Methods: SAMMPRIS aggressive medical management included a telephonic lifestyle modification program provided free of charge to all subjects (n = 451) during their participation in the study. Subjects with fewer than 3 expected lifestyle-coaching calls were excluded from these analyses. Compliant subjects (n = 201) had  greater than or equal to 78.5% of calls (median % of completed/expected calls). Noncompliant subjects (n = 200) had less than 78.5% of calls or refused to participate. Mean risk factor values or % in-target for each risk factor was compared between compliant versus noncompliant subjects, using t tests and chi-square tests. Risk factor changes from baseline to follow-up were compared between the groups to account for baseline differences., Results: Compliant subjects had better risk factor control throughout follow-up for low-density lipoprotein, systolic blood pressure (SBP), hemoglobin A1c (HgA1c), non-high-density lipoprotein, nonsmoking, and exercise than noncompliant subjects, but there was no difference for body mass index. After adjusting for baseline differences between the groups, compliant subjects had a greater change from baseline than noncompliant subjects for SBP did at 24 months and HgA1c at 6 months., Conclusion: SAMMPRIS subjects who were compliant with the lifestyle modification program had better risk factor control during the study for almost all risk factors., (Published by Elsevier Inc.)

Introduction: Wide-necked bifurcation aneurysms (WNBAs) present unique technical challenges for both endovascular and surgical treatments which aim to achieve complete occlusion of the aneurysm without compromising the patency of the incorporated regional parent vessels. We present a meta-analysis of traditional therapies for WNBAs to provide critical benchmarks for safety and effectiveness., Methods: Following a systematic search of the literature and the application of pre-specified appropriateness criteria, 43 (including 2794 aneurysms treated) and 65 (including 5366 patients treated) references with sufficient detail were identified to include in a meta-analysis of efficacy and safety, respectively. Effectiveness endpoints of both complete and adequate occlusion were assessed. A composite safety endpoint was based upon commonly applied metrics for major adverse events. Fleiss analyses were performed for both effectiveness and safety endpoints for the entire group, and then parsed separately by treatment modality (surgical clipping (SC) or endovascular therapy (EVT)) and location (anterior or posterior circulation)., Results: Using the above methods, the core laboratory adjusted rate of complete occlusion was 46.3% (standard error 3.6%), 39.8% (3.7%), and 52.5% (9.6%) for all therapies, EVT, and SC, respectively. The rate of adequate occlusion was 59.4% (12.2%), 43.8% (5.3%), and 69.7% (14.3%) for all therapies, EVT, and SC, respectively. The rates of occurrence for pre-specified safety endpoints were 18.7% (2.9%), 21.1% (2.8%), and 24.3% (4.9%) for all therapies, EVT, and SC, respectively., Conclusions: Conventional therapies for WNBAs are associated with relatively low rates of complete occlusion and peri-procedural complications are not uncommon. As new treatment technologies are investigated, it is important that the available data regarding predicate treatments is understood., Competing Interests: Competing interests: The primary investigators received institutional salary support for the WEB-IT study, proctoring, consulting and study-related activities from Microvention Inc., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: The Woven EndoBridge (WEB) represents a novel intrasaccular therapeutic option for the treatment of intracranial wide-necked bifurcation aneurysms (WNBAs). The WEB-IT Study is a pivotal Investigational Device Exemption (IDE) study to determine the safety and effectiveness of the WEB device for the treatment of WNBAs located in the anterior and posterior intracranial circulations. We present the patient demographics, procedural characteristics, and 30-day adverse event data for the US WEB-IT study., Methods: WEB-IT is a prospective multicenter single-arm interventional study conducted at 25 US and 6 international centers. The study enrolled 150 adults with WNBAs of the anterior and posterior intracranial circulations. All patients were intended to receive a WEB device delivered via standard endovascular neurosurgical embolization techniques. The study was conducted under Good Clinical Practices and included independent adjudication effectiveness outcomes and all adverse events., Results: One hundred and fifty patients enrolled at 27 investigational sites underwent attempted treatment with the WEB. Mean age was 59 years (range 29-79) and 110 (73.3%) of the patients were female. Treated aneurysms were located at the basilar apex (n=59, 39.3%), middle cerebral artery bifurcation (n=45, 30%), anterior communicating artery (n=40, 26.7%), and internal carotid artery terminus (n=6, 4%). Average aneurysm size was 6.4 mm (range 3.6-11.4) with a mean neck size of 4.8 mm (range 2.0-8.2, mean dome to neck ratio 1.34). Nine patients presented with ruptured aneurysms. Of the enrolled patients, 98.7% were treated successfully with WEB devices. Mean±SD fluoroscopy time was 30.2±15.7 min. One primary safety event (PSE) (0.7%)-a delayed parenchymal hemorrhage 22 days after treatment-occurred between the index procedure and 30-day follow-up. In addition to the single PSE, there were seven (4.7%) minor ischemic strokes (5 resolved without sequelae and 2 had a modified Rankin Scale score of 1 at 30 days), five (2.7%) transient ischemic attacks, and two (1.3%) minor subarachnoid hemorrhages, which did not meet the prospectively established criteria for PSEs., Conclusions: The WEB device can be used to treat WNBAs with a high level of procedural safety and a high degree of technical success., Trial Registration Number: NCT02191618; Pre-results., Competing Interests: Competing interests: The primary investigators for the WEB IT trial received institutional salary support for study related activities. Investigators in the WEB IT trial also received payment for proctoring cases within the context of the trial., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Background and Purpose: Some patients are at high risk of aneurysm recurrence after endovascular treatment: patients with large aneurysms (Patients Prone to Recurrence After Endovascular Treatment PRET-1) or with aneurysms that have previously recurred after coiling (PRET-2). We aimed to establish whether the use of hydrogel coils improved efficacy outcomes compared with bare platinum coils., Materials and Methods: PRET was an investigator-led, pragmatic, multicenter, parallel, randomized (1:1) trial. Randomized allocation was performed separately for patients in PRET-1 and PRET-2, by using a Web-based platform ensuring concealed allocation. The primary outcome was a composite of a residual/recurrent aneurysm, adjudicated by a blinded core laboratory, or retreatment, intracranial bleeding, or mass effect during the 18-month follow-up. Secondary outcomes included adverse events, mortality, and morbidity (mRS > 2). The hypothesis was that hydrogel would decrease the primary outcome from 50% to 30% at 18 months, necessitating 125 patients per group (500 for PRET-1 and PRET-2)., Results: The trial was stopped once 250 patients in PRET-1 and 197 in PRET-2 had been recruited because of slow accrual. A poor primary outcome occurred in 44.4% (95% CI, 35.5%-53.2%) of those in PRET-1 allocated to platinum compared with 52.5% (95% CI, 43.4%-61.6%) of patients allocated to hydrogel (OR, 1.387; 95% CI, 0.838-2.295; P = .20) and in 49.0% (95% CI, 38.8%-59.1%) in PRET-2 allocated to platinum compared with 42.1% (95% CI, 32.0%-52.2%) allocated to hydrogel (OR, 0.959; 95% CI, 0.428-1.342; P = .34). Adverse events and morbidity were similar. There were 3.6% deaths (1.4% platinum, 5.9% hydrogel; P = .011)., Conclusions: Coiling of large and recurrent aneurysms is safe but often poorly effective according to angiographic results. Hydrogel coiling was not shown to be better than platinum., (© 2017 by American Journal of Neuroradiology.)

Background: We report a case of endovascular treatment of a complex renal artery aneurysm using the Pipeline Embolization Device, a flow diverting stent which is indicated for the treatment of large and giant cerebral aneurysms., Methods: A forty-year-old female with medically refractory hypertension and congenital agenesis of the right kidney was found to have a 2.8-cm left superior renal artery branch aneurysm. The patient was treated successfully using the Pipeline Embolization Device (Medtronic, Irvine, CA) with coil embolization of the aneurysm and of one outflow vessel., Results: On 3-year follow-up, her renal function was normal, vascular imaging showed complete occlusion of the aneurysm, and physiological remodeling of the reconstructed artery and parenchymal imaging showed no evidence of renal infarction., Conclusion: Flow diverting stents are a valuable treatment option for visceral aneurysms with complex anatomy., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Rationale: Endovascular treatment has been shown to restore blood flow effectively. Second-generation medical devices such as stent retrievers are now showing overwhelming efficacy in clinical trials, particularly in conjunction with intravenous recombinant tissue plasminogen activator., Aims and Design: This statistical analysis plan utilizing a novel, sequential approach describes a prospective, individual patient data analysis of endovascular therapy in conjunction with intravenous recombinant tissue plasminogen activator agreed upon by the Thrombectomy and Tissue Plasminogen Activator Collaborative Group., Study Outcomes: This protocol will specify the primary outcome for efficacy, as 'favorable' outcome defined by the ordinal distribution of the modified Rankin Scale measured at three-months poststroke, but with modified Rankin Scales 5 and 6 collapsed into a single category. The primary analysis will aim to answer the questions: 'what is the treatment effect of endovascular therapy with intravenous recombinant tissue plasminogen activator compared to intravenous tissue plasminogen activator alone on full scale modified Rankin Scale at 3 months?' and 'to what extent do key patient characteristics influence the treatment effect of endovascular therapy?'. Key secondary outcomes include effect of endovascular therapy on death within 90 days; analyses of modified Rankin Scale using dichotomized methods; and effects of endovascular therapy on symptomatic intracranial hemorrhage. Several secondary analyses will be considered as well as expanding patient cohorts to intravenous recombinant tissue plasminogen activator-ineligible patients, should data allow., Discussion: This collaborative meta-analysis of individual participant data from randomized trials of endovascular therapy vs. control in conjunction with intravenous thrombolysis will demonstrate the efficacy and generalizability of endovascular therapy with intravenous thrombolysis as a concomitant medication., (© 2015 World Stroke Organization.)

Introduction: The Apollo system (Penumbra Inc, Alameda, California, USA) is a low profile irrigation-aspiration system designed for the evacuation of intracranial hemorrhage., Objective: To demonstrate the feasibility of using Apollo in combination with cone beam CT guidance., Methods: Parenchymal (n=1) and mixed parenchymal-intraventricular hematomas (n=1) were created in cadaver heads using a transvascular (n=1) or transcranial (n=1) approach. Hematomas were then imaged with cone beam CT (CB-CT), and the long axis of the hematoma defined. The CB-CT data were then used to guide transcranial access to the hematoma-defining the location of the burr hole and the path to the leading edge of the hematoma. An 8F vascular sheath was then placed under live fluoroscopic guidance into the hematoma. A second CB-CT was performed to confirm localization of the sheath. The hematoma was then demarcated on the CB-CT and the Apollo wand was introduced through the 8F sheath and irrigation-aspiration was performed under (periodic) live fluoroscopic guidance. The operators manipulated the wand within the visible boundaries of the hematoma. After irrigation-aspiration, a control CB-CT was performed to document reduction in hematoma volume., Results: Transvascular and transcranial techniques were both successful in creating intracranial hematomas. Hematomas could be defined with conspicuity sufficient for localization and volumetric measurement using CB-CT. Live fluoroscopic guidance was effective in navigating a sheath into the leading aspect of a parenchymal hematoma and guiding irrigation-aspiration with the Apollo system. Irrigation-aspiration reduced the parenchymal hemorrhage volume from 14.8 to 1.7 cc in 189 s in the first case (parenchymal hemorrhage) and from 26.4 to 4.1 cc in 300 s in the second case (parenchymal and intraventricular hemorrhage)., Conclusions: The cadaver model described is a useful means of studying interventional techniques for intracranial hemorrhage. It seems feasible to use CB-CT to guide the evacuation of intraparenchymal and intraventricular hemorrhage using the Apollo system through a minimally invasive transcranial access., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background and Purpose: Flow diverters are increasingly used in the endovascular treatment of intracranial aneurysms. Our aim was to determine neurologic complication rates following Pipeline Embolization Device placement for intracranial aneurysm treatment in a real-world setting., Materials and Methods: We retrospectively evaluated all patients with intracranial aneurysms treated with the Pipeline Embolization Device between July 2008 and February 2013 in 17 centers worldwide. We defined 4 subgroups: internal carotid artery aneurysms of ≥10 mm, ICA aneurysms of <10 mm, other anterior circulation aneurysms, and posterior circulation aneurysms. Neurologic complications included spontaneous rupture, intracranial hemorrhage, ischemic stroke, permanent cranial neuropathy, and mortality. Comparisons were made with t tests or ANOVAs for continuous variables and the Pearson χ(2) or Fisher exact test for categoric variables., Results: In total, 793 patients with 906 aneurysms were included. The neurologic morbidity and mortality rate was 8.4% (67/793), highest in the posterior circulation group (16.4%, 9/55) and lowest in the ICA <10-mm group (4.8%, 14/294) (P = .01). The spontaneous rupture rate was 0.6% (5/793). The intracranial hemorrhage rate was 2.4% (19/793). Ischemic stroke rates were 4.7% (37/793), highest in patients with posterior circulation aneurysms (7.3%, 4/55) and lowest in the ICA <10-mm group (2.7%, 8/294) (P = .16). Neurologic mortality was 3.8% (30/793), highest in the posterior circulation group (10.9%, 6/55) and lowest in the anterior circulation ICA <10-mm group (1.4%, 4/294) (P < .01)., Conclusions: Aneurysm treatment with the Pipeline Embolization Device is associated with the lowest complication rates when used to treat small ICA aneurysms. Procedure-related morbidity and mortality are higher in the treatment of posterior circulation and giant aneurysms., (© 2015 by American Journal of Neuroradiology.)

Purpose: To report the initial use of a novel thrombectomy device for revascularization of below-the-knee thromboembolic occlusions encountered during proximal revascularization procedures., Case Reports: The ReVive PV Peripheral Thrombectomy Device is a non-detachable, self-expanding stent-like device recently approved for peripheral thrombectomy. Four patients (3 women; mean age 68.8 years) undergoing proximal revascularization procedures experienced embolic occlusions of all 3 trifurcation vessels in 1 patient, the tibioperoneal trunk alone in 2 cases, and the peroneal artery alone in the last patient. In all cases, the involved arteries represented the primary or sole vessel(s) providing outflow to the lower extremity. In each case, the ReVive PV device was used to successfully extract the thrombus and restore flow to the distal extremity. No complications were encountered during any of the procedures., Conclusion: The ReVive PV peripheral thrombectomy device may facilitate the safe and efficient revascularization of distal arterial embolic occlusions.

Background and Purpose: Some patients with large or recurrent aneurysms may be at increased risk of recurrence postcoiling. The Patients Prone to Recurrence after Endovascular Treatment (PRET) trial was designed to assess whether hydrogel coils were superior to platinum coils in these high-risk patients. This article reports periprocedural safety and operator-assessed angiographic results from the PRET trial., Materials and Methods: PRET was a pragmatic, multicenter, randomized controlled trial. Patients had ≥10-mm aneurysms (PRET-1) or a major recurrence after coiling of an aneurysm of any size (PRET-2). Patients were randomly allocated to hydrogel or control arms (any platinum coil) by using concealed allocation with minimization. Assist devices could be used as clinically required. Aneurysms could be unruptured or recently ruptured. Analyses were on an intent-to-treat basis., Results: Four hundred forty-seven patients were recruited (250 PRET-1; 197 PRET-2). Aneurysms were recently ruptured in 29% of PRET-1 and 4% of PRET-2 patients. Aneurysms were ≥10 mm in all PRET-1 and in 50% of PRET-2 patients. They were wide-neck (≥4 mm) in 70% and in the posterior circulation in 24% of patients. Stents were used in 28% of patients (35% in PRET-2). Coiling was successful in 98%. Adverse events occurred in 28 patients with hydrogel and 23 with platinum coils. Mortality (n=2, unrelated to treatment) and morbidity (defined as mRS>2 at 1 month) occurred in 25 patients (5.6%; 12 hydrogel, 13 platinum), related to treatment in 10 (4 hydrogel; 6 platinum) (or 2.3% of 444 treated patients). No difference was seen between hydrogel and platinum for any of the indices used to assess safety up to at least 30 days after treatment. At 1 month, 95% of patients were home with a good outcome (mRS≤2 or unchanged). Operator-assessed angiographic outcomes were satisfactory (complete occlusion or residual neck) in 339 of 447 or 76.4% of patients, with no significant difference between groups., Conclusions: Endovascular treatment of large and recurrent aneurysms can be performed safely with platinum or hydrogel coils., (© 2014 by American Journal of Neuroradiology.)

Background and Purpose: The goal of aneurysm treatment is occlusion of an aneurysm without morbidity or mortality. Using well-established, traditional endovascular techniques, this is generally achievable with a high level of safety and efficacy. These techniques involve either constructive treatment of the aneurysm (coils with or without an intravascular stent) or deconstruction (coil occlusion) of the aneurysm and the parent artery. While established as safe and efficacious, the constructive treatment of large and giant aneurysms with coils has typically been associated with relatively lower rates of complete occlusion and higher rates of recurrence. Parent artery deconstruction, though immediately efficacious in achieving complete and durable occlusion, does require occlusion of a major intracranial blood vessel and is associated with risk of stroke., Materials and Methods: Flow diversion represents a new technology that can be used to constructively treat large and giant aneurysms. Once excluded successfully, the vessel reconstruction and aneurysm occlusion appears durable. The ability to definitively reconstruct cerebral blood vessels is an attractive approach to these large and giant complex aneurysms and allows the treatment of some aneurysms which were previously not amenable to other therapies. By comparison, conventional coiling techniques have traditionally been used for endovascular treatment of large aneurysms. Large and giant aneurysms that are amenable to either flow diversion or traditional endovascular treatment will be randomized to either therapy with FDA (or appropriate regulatory body) approved devices., Results: The trial is currently enrolling and results of the data are pending the completion of enrollment and follow-up., Conclusions: This paper details the trial design of the LARGE trial, a blinded, prospective randomized trial of large anterior circulation aneurysms amenable to either traditional endovascular treatments using coils or reconstruction with flow diverters., (© 2014 by American Journal of Neuroradiology.)

Background: The development of detachable coils is one of the most pivotal developments in neurointervention, providing a tool that could be used to treat a wide variety of hemorrhagic stroke. From the original Guglielmi detachable coil, a number of different coil designs and delivery designs have evolved. This article reviews the history of commercially available detachable coils., Methods: A timeline of detachable coils was constructed and coil design philosophies were reviewed., Results: A complete list of commercially available coils is presented in a timeline format., Conclusions: Detachable coil technology continues to evolve. Advances in construction and design have yielded products which may benefit patients in terms of safety, radiation dose reduction and cost of treatment. Continued evolution is expected, irrespective of competing disruptive technologies.

Treatment of arteriovenous malformations of the central nervous system requires a multidisciplinary approach with input from vascular neurosurgeons, endovascular interventionalists, and radiation oncologists. Treatment paradigms based on a thorough understanding of the natural history of the lesion and the cumulative risks of multimodality treatment maximize the likelihood of a positive outcome. This article outlines the role of endovascular embolization in the treatment of arteriovenous malformations with specific emphasis on decision making during treatment planning. Technical considerations when treating arteriovenous malformations are discussed, including the choice of embolic agents, potential intraprocedural and periprocedural complications, and postprocedural management of patients., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Large or giant complex vertebrobasilar junction aneurysms have a dismal natural history and are often challenging to treat with standard endovascular or neurosurgical techniques., Objective: To report initial experience with endovascular treatment of these aneurysms using flow-diverting stents (FDS)., Methods: Ten patients with FDS treatment of complex vertebrobasilar junction aneurysms were collected from 4 large cerebrovascular centers. Clinical/angiographic presentation and outcome were retrospectively analyzed., Results: Of 10 aneurysms, 7 presented with brainstem compression, 2 with ischemia, and 1 with subarachnoid hemorrhage, and 3 were recurrent after stent-assisted treatments. Eight were giant. Morphology was fusiform in 5, fusiform dissecting in 1, and multilobulated saccular in 4. Six were partially thrombosed. In addition to FDS (mean number of devices, 3.9; range, 1-9), contralateral vertebral artery sacrifice and adjunctive coiling were performed in 9 and 5 of the 10 patients, respectively. At follow-up, 5 of 10 were completely occluded, 4 showed minimal residual filling, and 1 was retreated with an additional FDS. Postinterventionally, worsening mass effect and ischemic complications were seen in 2 and 4 of 10, respectively. Clinical outcome was good in 6 (modified Rankin Scale score, 0-2). Four fatalities were related to sequelae of subarachnoid hemorrhage, late FDS thrombosis, progressive mass effect, and delayed intracranial hemorrhage., Conclusion: FDS may be used to treat complex vertebrobasilar junction aneurysms with overall good angiographic outcome. A combined reconstructive/deconstructive approach appears useful to avoid endoleaks. FDS strategies, like other endovascular and neurosurgical approaches to these lesions, are associated with significant risk and therefore should be reserved for those cases in which alternative approaches either are deemed unsafe or are likely to be ineffective., Abbreviations: FDS, flow-diverting stentPED, Pipeline Embolization DeviceSAH, subarachnoid hemorrhageVA, vertebral arteryVBJ, vertebrobasilar junction.

Introduction: Treatment of wide-necked bifurcation aneurysms often poses procedural and long-term outcome challenges. The initial preclinical experience with the Pulsar Vascular Aneurysm Neck Reconstruction Device (PVANRD) in a canine bifurcation model is described., Methods: Experimental bifurcation vein pouch aneurysms were surgically created in the carotid arteries of eight dogs. Endovascular coiling of the aneurysms with assistance of the PVANRD was performed in all cases with acute performance compared with Y-stenting., Results: Twelve devices were deployed in the eight cases. Deployment of the devices was straightforward and successfully protected the parent artery and maintained patency of the bifurcation in all cases, despite the use of oversized coils., Conclusion: The PVANRD is a novel bifurcation stent that facilitates treatment of wide-necked bifurcation aneurysms compared with currently available adjunctive devices.

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.

The Gateway balloon-Wingspan stent system is the first, and currently the only "on-label" device for the treatment of symptomatic intracranial stenosis in the United States. In initial single-arm studies, investigators have indicated that this system can be used for the treatment of symptomatic intracranial atherosclerotic disease with high levels of technical success and acceptable periprocedural complication rates, which are comparable with, or better than, those reported for other endovascular techniques. Intermediate- and long-term follow-up data for patients treated with the Wingspan device remain sparse. We critically review the existing data, which characterize the risk profile and efficacy of endovascular interventions for intracranial atherosclerotic disease, as well as the available clinical evidence that could be used to select appropriate patients for treatment., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Double stenting in a Y configuration may be used to treat a subset of wide-necked aneurysms not amenable to reconstruction with a single stent., Objective: We studied the feasibility, safety, and mid-term angiographic outcome of patients treated using this technique., Methods: A retrospective review was undertaken of all coil embolizations of wide-necked aneurysms using double stents in a Y configuration., Results: Nineteen patients were identified from 2002 to 2010 (14 women, 5 men) with a mean age of 57.4 years. Stents were deployed in a Y configuration achieving complete occlusion (5/19), residual neck (5/19), and residual aneurysm filling (9/19). Angiographic follow-up was available for a mean of 16 months, and clinical follow up was available for a mean of 21.4 months. The incidence of complications at the initial treatment was 6 of 19 (31.6%), and delayed thromboembolic complications occurred in 2 of 19 (10.5%). An angiographic neck recurrence requiring retreatment developed in only 1 of the patients in whom complete occlusion was obtained with the initial treatment. Spontaneous thrombosis and complete occlusion on follow-up imaging were found in 6 patients in whom initial neck or aneurysm filling was observed. Ultimately, 12 of the aneurysms (63.2%) were completely occluded on follow-up angiography., Conclusion: Y-stent reconstruction enables the endovascular management of otherwise complex, wide-necked cerebral aneurysms and can be performed safely in experienced hands with satisfactory mid-term results, even in cases requiring retreatment.