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Objective: To evaluate the safety and effectiveness of the Flow Redirection Endoluminal Device (FRED) flow diverter in support of an application for Food and Drug Administration approval in the USA., Methods: 145 patients were enrolled in a prospective, single-arm multicenter trial. Patients with aneurysms of unfavorable morphology for traditional endovascular therapies (large, wide-necked, fusiform, etc) were included. The trial was designed to demonstrate non-inferiority in both safety and effectiveness, comparing trial results with performance goals (PGs) established from peer-reviewed published literature. The primary safety endpoint was death or major stroke (National Institutes of Health Stroke Scale score ≥4 points) within 30 days of the procedure, or any major ipsilateral stroke or neurological death within the first year. The primary effectiveness endpoint was complete occlusion of the target aneurysm with ≤50% stenosis of the parent artery at 12 months after treatment, and in which an alternative treatment of the target intracranial aneurysm had not been performed., Results: 145 patients underwent attempted placement of a FRED device, and one or more devices were placed in all 145 patients. 135/145 (93%) had a single device placed. Core laboratory adjudication deemed 106 (73.1%) of the aneurysms large or giant. A safety endpoint was experienced by 9/145 (6.2%) patients, successfully achieving the safety PG of <15%. The effectiveness PG of >46% aneurysm occlusion was also achieved, with the effectiveness endpoint being met in 80/139 (57.6%) CONCLUSION: As compared with historically derived performance benchmarks, the FRED flow diverter is both safe and effective for the treatment of appropriately selected intracranial aneurysms., Clinical Registration Number: NCT01801007., Competing Interests: Competing interests: CGM: consultant to Microvention and Medtronic OOD: proctor for FRED/Microvention. AB: consultant to Microvention and Vesalio. AHS:SNIS Board of Directors; current research grants: co-investigator: NIH/NINDS 1R01NS091075 Virtual intervention of intracranial aneurysms; role: co-principal investigator NIH-NINDS R21 NS109575-01 Optimizing approaches to endovascular therapy of acute ischemic stroke; financial interest: Adona Medical, Inc., Amnis Therapeutics, Bend IT Technologies, Ltd., BlinkTBI, Inc, Boston Scientific Corp (for purchase of Claret Medical), Buffalo Technology Partners, Inc., Cardinal Consultants, LLC, Cerebrotech Medical Systems, Inc, Cognition Medical, Endostream Medical, Ltd, Imperative Care, Inc., Instylla, Inc., International Medical Distribution Partners, IRRAS, LaunchNY Seed Fund Management, LLC, NeuroRadial Technologies, Inc., Neurovascular Diagnostics, Inc., Perflow Medical, Ltd., Q’Apel Medical, Inc., Radical Catheter Technologies, Inc., Rebound Therapeutics Corp. (purchased 2019 by Integra Lifesciences, Corp), Rist Neurovascular, Inc., Sense Diagnostics, Inc., Serenity Medical, Inc., Silk Road Medical, Spinnaker Medical, Inc., StimMed, Synchron, Three Rivers Medical, Inc., Truvic Medical, Inc, Vastrax, LLC, VICIS, Inc., Viseon, Inc., Viz.ai, Inc; consultant/advisory board: Amnis Therapeutics, Apellis Pharmaceuticals, Inc., Boston Scientific, Canon Medical Systems USA, Inc., Cerebrotech Medical Systems, Inc., Cerenovus, Corindus, Inc., Endostream Medical, Ltd, Imperative Care, Inc., Integra LifeSciences Corp., IRRAS, Medtronic, MicroVention, Minnetronix Neuro, Inc., Northwest University – Data Safety Monitoring Board chair for HEAT Trial, Penumbra, Perflow Medical, Ltd., Q’Apel Medical, Inc., Rapid Medical, Rebound Therapeutics Corp., Serenity Medical, Inc., Silk Road Medical, StimMed, Stryker, Three Rivers Medical, Inc., VasSol, Viz.ai, Inc., W.L. Gore & Associates; national PI/steering committees: Cerenovus 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;· No consulting salary arrangements. All consulting is per project and/or per hour. JC: No disclosures. JTF: SNIS Board of Directors; consultant to Microvention and Stryker. AST: consultant to Microvention, Medtronic, Viz AI, Siemens;.chief medical officer Imperative Care. YK: consultant to Microvention, Penumbra, Medtronic. PJ: consultant to Microvention, (© 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: No randomized trial of intracranial aneurysm coiling has compared long-term efficacy of polymer-modified coils to bare metal coils (BMCs). We report 5-year results comparing Matrix 2 coils to BMCs. The primary objective was to compare the rates of target aneurysm recurrence (TAR) at 12 months. Secondary objectives included angiographic outcomes at TAR or 12 months and TAR at 5 years., Methods: A total of 626 patients were randomized to BMCs or Matrix 2 coils. Detailed methods and 1-year results have been published previously., Results: Of 580 patients eligible for 5-year follow-up, 431 (74.3%) completed follow-up or reached TAR. Matrix 2 coils were non-inferior to BMCs (P=0.8) but did not confer any benefit. Core lab reported post-treatment residual aneurysm filling (Raymond III) correlated with TAR (P<0.0001) and with aneurysm hemorrhage after treatment (P<0.008). Repeat aneurysmal hemorrhage after treatment, but before hospital discharge, occurred in three patients treated for acutely ruptured aneurysms. Additionally, two patients treated for unruptured aneurysms experienced a first hemorrhage during follow-up. All five hemorrhages resulted from aneurysms with Raymond III residual aneurysm filling persisting after initial treatment. After 5 years follow-up, 2/626 (0.3%) patients are known to have had target aneurysm rupture following hospital discharge. The annualized rate of delayed hemorrhage after coiling was 2/398/5=0.001 (0.1%) per year for unruptured aneurysms and 0 for ruptured aneurysms., Conclusions: After 5 years Matrix 2 coils were non-inferior to BMCs but no benefit was demonstrated. Post-treatment residual angiographic aneurysm filling (Raymond III) is strongly associated with TAR (P<0.0001) and post-treatment aneurysmal hemorrhage (P=0.008)., Competing Interests: Competing interests: SWH: core lab services for Stryker and MicroVention Terumo (money paid to UCSF, over $5K); consulting for Microvention Terumo (money paid to Dr Hetts, under $5K). CGM: consultant for Medtronic and Microvention. JCC: consultant for Stryker. AB: consultant for Stryker, Microvention, Balt, and Phenox. AKW: research grant from Philips Medical; serves as a consultant for Stryker and Phenox; is a stockholder of InNeuroCo, EpiEP, Neural Analytics, Rist, Analytics 4 Life, and ThrombX; and is on the Speakers’ Bureau for SCENT trial (Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms) presentations. AG: consultant for Microvention and emeritus consultant at Newcastle upon Tyne Hospitals NHS Trust. CFD: chief adjudicator, Stryker EVOLVE Trial Core Angiography Lab (salary support to department)., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

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.)

Object: Despite the popularity of flow-diverting stents for the treatment of cerebral aneurysms, there is no widely accepted scale for the characterization of results. We present an outcomes-based grading scale that considers factors related to failure of flow diversion., Methods: The grading scale was developed using the results from consecutive patients at two institutions who were treated with flow diversion for a cerebral aneurysm. The initial treatment results were graded on patient, aneurysm, and treatment characteristics. A 6-point grading scale was developed based on these data., Results: One hundred and seventy-one patients were included in the patient cohort. When compared by multivariate analysis with patients without residuals, patients with aneurysm residuals were found to be older (age ≥60 years, p=0.01, OR 1.17, 95% CI 1.03 to 1.33), to have larger aneurysms (size ≥15 mm, p<0.01, OR 1.38, 95% CI 1.17 to 1.62), to have aneurysms with associated side branches (p=0.02, OR 1.17, 95% CI 1.03 to 1.33), and to have a post-treatment Raymond score of 2 or 3 (p=0.01, OR 1.28, 95% CI 1.06 to 1.56). Using the Raymond score (1-3) as the foundation for the grading scale, additional points (0 or 1) were given for the other three identified factors, creating a 6-point scale. We found that patients with residual aneurysms had statistically higher final tabulated scores (p<0.01)., Conclusions: We propose a novel straightforward outcomes-based scale to characterize results after flow diversion treatment of cerebral aneurysms. This scale may provide the basis for the common reporting of results in future studies., Competing Interests: Competing interests: PT is a consultant for Covidien and proctors physicians in the use of the PED., (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/.)

Introduction: Endovascular intervention for cervical carotid artery dissection (CAD) and vertebral artery dissection (VAD) may be indicated in specific circumstances., Objective: To review our institutional experience with endovascular treatment of cervical dissections over the past 20 years to examine indications for treatment, interventional methods, and outcomes., Methods: Retrospective review of a prospectively maintained database to identify patients with extracranial dissection who underwent endovascular intervention between January 1996 and January 2016. Demographic data and details of procedures, outcomes, and complications were extracted., Results: Of 116 patients [93 CAD, 23 VAD; mean age 44.9 years (range 5-76 years)], 104 underwent stent placement; 11, coil occlusion of the parent artery; and 1, stenting with contralateral vessel occlusion. The cohorts were well matched for age, sex, dissection etiology, and admission and follow-up modified Rankin Scale (mRS) scores. Patients with CAD had significantly more stent placements (p<0.001), failure of medical therapy (p=0.004), and interventions for enlarging pseudoaneurysms (p=0.01) or thromboembolic events (p=0.004). Patients with VAD had significantly more interventions for traumatic occlusion with recanalization (p<0.001). Dissections were spontaneous (n=67), traumatic (n=36), or iatrogenic (n=13). Traumatic dissections in patients with CAD were associated with poor admission mRS scores (p=0.01). Six of 67 (9.0%) patients with spontaneous dissection reported recent chiropractic manipulation. Mean follow-up was 3.5 years (range 1-146 months). Permanent morbidity/mortality was 3.4%, including two deaths. Over a follow-up period of 364 patient-years, 1 stroke occurred (0.27% per year). At last follow-up, 41 previously disabled patients [CAD, 31/93 (33.3%); VAD, 10/23 (43.5%)] were no longer disabled; no patient reported worsened disability., Conclusions: Patients with CAD and VAD differ significantly in presentation, indications for treatment, and treatment methods. Endovascular treatment of CAD and VAD has low procedural morbidity and is associated with a low incidence of future stroke., (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/objective: The optimal management of residual or recurrent clipped aneurysms is infrequently addressed in the literature., Methods: We reviewed our endovascular database from January 1998 to May 2016 to identify patients with clipped aneurysms undergoing subsequent endovascular treatment, evaluating treatment approach, and clinical and angiographic outcomes., Results: 60 patients underwent endovascular treatment of residual/recurrent clipped aneurysms; 7 rebled prior to endovascular therapy. Treatment was via coiling alone (n=25, 42%), stent assisted coiling (n=15, 25%), balloon assisted coiling (n=8, 13%), flow diversion (n=8, 13%), stenting alone (n=3, 5%), or flow diversion with coiling (n=1, 2%). The procedural permanent neurological morbidity and mortality rates were 3% and 2%, respectively. Over a clinical follow-up of 253.4 patient years (median 3.9 years), there was one rebleed in a patient who had declined further treatment. For 43 patients with at least 1 month of digital subtraction angiographic follow-up (median 3.4 years), complete aneurysm occlusion was seen in 79% of cases. Neck remnants were observed in 14%, and stable small dome remnants were observed in 7% of cases. In a subgroup of 18 patients with 'clip induced' narrow neck aneurysms, all domes were initially coil occluded (Raymond 1 or 2); there was no permanent procedural morbidity and no aneurysms required retreatment or recanalized over a median follow-up of 3.9 years., Conclusions: Endovascular treatment of residual or recurrent clipped aneurysms is an excellent treatment approach in well selected patients; 'clip induced' narrow neck aneurysms fare particularly well after treatment both angiographically and clinically., (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/objective: Spinal dural arteriovenous fistulas (SDAVFs) require pretreatment angiography; embolization can be performed in the same session. To validate this approach, obliteration and morbidity rates of 'endovascular-first' (embolization and microsurgery in the case of embolization failures) must be compared with rates for 'microsurgery-first' (microsurgical ligation without attempted embolization) approaches., Methods: We reviewed our institutional database (January 1998-October 2015) for SDAVFs, performing an intention-to-treat analysis comparing endovascular-first and microsurgery-first approaches., Results: A total of 71 patients underwent surgical and/or endovascular treatment for SDAVFs. All SDAVFs were ultimately occluded. Of 35 patients under consideration for an endovascular-first approach, radicular artery anatomy or anterior spinal artery embolization risk precluded attempting embolization in seven cases (20%). Among 28 patients undergoing embolization, angiographic non-opacification of the fistula was noted in 18 (64%). Fourteen patients had obliteration with excellent casting of the draining vein (50%) and did not undergo surgery. There were no significant differences in total complications (9% vs 11%; p=1.0) or permanent complications (3% vs 4%; p=1.0) after attempted endovascular and surgical treatment. Based on an intention-to-treat analysis, there were no significant differences in total complications (11% vs 14%; p=1.0), permanent complications (6% vs 3%; p=0.61), or the symptomatic resolution/improvement rate (80% vs 78%; p=1.0) between endovascular-first and microsurgery-first groups., Conclusions: Our results support attempted embolization of SDAVFs prior to consideration of microsurgery, allowing for a less invasive treatment option in the same session as diagnostic angiography., (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: With the introduction of Onyx, transarterial embolization has become the most common endovascular approach to treating dural arteriovenous fistulas (dAVFs), often via the middle meningeal or occipital arteries. The ascending pharyngeal artery (APA) is a less frequently explored transarterial route because of its small caliber, potential anastomoses to the internal carotid and vertebral arteries, and vital supply to lower cranial nerves., Objective: To review our institutional experience and highlight the prevalence of APA supply to dAVFs and cases where it is a safe and effective pedicle for embolization., Methods: We reviewed our endovascular database (January 1, 1996 to March 1, 2016) for cranial dAVFs, evaluating dAVF characteristics and embolization results for those treated transarterially via the APA., Results: Of 267 endovascularly treated dAVFs, 68 had APA supply (25%). Of these 68 dAVFs, embolization was carried out via this pedicle in 8 (12%) and 7 were ultimately occluded. No complications, including post-treatment cranial neuropathies or radiographic evidence of non-target embolization, were found. For 5 dAVFs, the APA was selected as the initial pedicle for embolization (two marginal sinus, one distal sigmoid, one cavernous, one tentorial). In four of these five cases, dAVF occlusion was achieved via the initial APA feeding artery pedicle. In one case, near-complete, stagnant occlusion was achieved after APA embolization; complete occlusion was achieved after adjunctive embolization of a single additional middle meningeal artery pedicle. In three other cases of complex transverse/sigmoid dAVFs, the APA was used after multiple attempts via middle meningeal and occipital artery pedicles. Occlusion was not achieved transarterially; two of these three dAVFs were ultimately occluded transvenously., Conclusions: In rare, select cases, the APA is an excellent route for transarterial embolization of cranial dAVFs., (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/.)

Patients with cavernous carotid fistulas (CCFs) can present with pituitary hypoperfusion and hypopituitarism; however, there are no previous reports of pituitary or hormonal abnormalities developing after CCF embolisation in an asymptomatic patient. We describe a patient with no hormonal abnormalities who developed syndrome of inappropriate antidiuretic hormone (SIADH) secretion after CCF embolisation. The patient had bilateral indirect CCFs, which were completely embolised via a transvenous approach, and was neurologically stable postoperatively and discharged. In the subsequent 2 weeks the patient was readmitted twice for acute hyponatraemia and a tonic-clonic seizure. Laboratory studies revealed severe SIADH. Clinical status and sodium levels improved after treatment. One year later the patient was weaned off all medications and remained neurologically stable. SIADH may be a delayed phenomenon after CCF embolisation. Given the proximity of embolised vessels to the pituitary's vascular supply, CCF treatment may result in flow disturbance, ischaemia and hormonal abnormalities., (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: Reported rates of in-stent restenosis after carotid artery stenting (CAS) vary, and restenosis risk factors are poorly understood. We evaluated restenosis rates and risk factors, and compared patients with 'hostile-neck' carotids (a history of ipsilateral neck surgery or irradiation) and atherosclerotic lesions., Methods: Demographic, clinical, and radiological characteristics of patients undergoing cervical CAS between 1995 and 2010 with at least 1 month of follow-up were reviewed. Patients with substantial (≥50%) radiographic restenosis were compared with those without significant restenosis to identify restenosis risk factors., Results: The analysis included 121 patients with 133 stented vessels; 91 (68.4%) lesions were symptomatic. Indications for stent placement included hostile-neck lesions, substantial surgical comorbidities, inclusion in a randomized carotid stenting trial, acute carotid occlusion, tandem stenosis, large pseudoaneurysm, high carotid bifurcation, and contralateral laryngeal nerve palsy. Procedures were technically successful in all but one lesion (99.2%). Perioperative stroke occurred in four cases (3.0%). Mean follow-up was 38 months (range 1-204 months), during which 23 vessels (17.3%) developed restenosis. Hostile-neck carotids (n=57) comprised 42.9% of all vessels treated and were responsible for 15 of 23 restenosis cases, resulting in a significantly higher restenosis rate than that of primary atherosclerotic lesions (26.3% vs 10.5%, p=0.017). By univariate analysis, the presence of calcified plaque was significantly associated with the incidence of in-stent restenosis (p=0.02)., Conclusions: Restenosis rates after carotid angioplasty and stenting are low. Patients with a history of ipsilateral neck surgery or irradiation are at higher risk for substantial radiographic and symptomatic restenosis., (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: Standard pretreatment with dual antiplatelet medication (DAPM) was compared with a standalone intraprocedural abciximab bolus for the prevention of thromboembolic and hemorrhagic events during endovascular stenting of unruptured intracranial aneurysms., Materials and Methods: We treated 94 patients with 99 aneurysms with intracranial stenting (with or without coiling). Patients were either pretreated with DAPM daily for ≥3 days before stenting (pretreatment group) or received an abciximab bolus during or immediately after stent placement followed by postoperative DAPM (abciximab group), at the treating physician's discretion. Twenty patients underwent immediate postoperative MRI. Demographic, clinical, and radiological information and periprocedural complications were recorded., Results: There were 52 procedures in the pretreatment group and 47 in the abciximab group. More flow-diverting stents were placed in the pretreatment group than in the abciximab group (45 vs 23, p<0.001), and the aneurysm diameter was larger (11.2±6.7 vs 8.3±4.7 mm, p=0.01). There were 11 thrombotic and 7 access site complications, with no significant difference between the groups (p>0.99 and p=0.12, respectively). There were no intracranial hemorrhages. In patients with postoperative MRI, there was no difference in the presence of diffusion-restricted lesions between groups (p=0.20). Multivariate analysis of a composite of any complication did not show significant associations with aneurysm or patient variables in either group., Conclusions: Standalone intraprocedural abciximab bolus was not associated with an increased rate of complications compared with pretreatment with DAPM for unruptured intracranial aneurysm stenting., (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: The goal of preoperative embolization of spinal tumors is to improve surgical outcomes by diminishing the vascular supply to the tumor to reduce intraoperative blood loss and operative time., Objective: To report our institutional experience with spinal tumor embolization and review the present literature., Methods: Clinical records from January 1, 2001 to December 31, 2012 were reviewed and analyzed. Angiograms were used to calculate the percentage reduction in tumor vascularity, and relevant clinical and operative data were collected and analyzed., Results: Thirty-seven patients underwent preoperative spinal tumor embolization (24 metastatic and 13 primary lesions) and were included in the study. One complication resulted in transient lower extremity weakness and was attributed to post-embolization swelling, which fully resolved after surgical resection. The transient neurological complication rate was 1/37 (3%) and the permanent rate was 0/37 (0%). The average surgical estimated blood loss (EBL) was 1946 mL (100-7000 mL) and the average operative time was 330 min (range 164-841 min). After embolization, tumor blush was reduced by 83% on average. Average pre- and postoperative modified Rankin Scale scores were 2.10 and 1.36, respectively (p=0.03). Cases in which tumor blush was decreased by ≥90% (classes 1 or 2) after embolization had significantly less operative blood loss than those cases in which <90% (classes 3 or 4) was achieved (mean EBL 1391 vs 2296 mL, respectively, p=0.05)., Conclusions: Spinal tumor embolization is a safe procedure, is associated with few complications, and may improve surgical outcomes by limiting intraoperative blood loss and reducing operative time., (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: The effect of dural venous sinus stenting has been investigated for the treatment of idiopathic intracranial hypertension (IIH) but the effect of stenting on the long-term patency of the cortical draining veins, especially the vein of Labbé (VOL), remains unknown., Methods: We reviewed our database of 38 patients with IIH with 41 stented dural venous sinuses between October 2006 and December 2014. Demographic, clinical, and radiological data were reviewed. Follow-up catheter angiographic data were included when available., Results: Stent placement spanned the ostium of the VOL in 35 patients (92.1%), with no immediate effect on the drainage of the VOL. Follow-up angiography (mean 35.1 months, range 1.7-80.7 months) was available in 24 patients, 21 of whom had stents spanning the VOL ostium. The VOL remained patent without occlusion or drainage alteration in all 21 patients. There were no immediate or long-term intracranial complications., Conclusions: Dural venous sinus stenting for patients with IIH does not affect the immediate or long-term patency of the VOL and is not associated with intracranial complications., (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: Use of the Pipeline embolization device (PED) in the posterior circulation is of some controversy., Objective: Recent publications have described adverse outcomes associated with the PED for vertebral and/or basilar artery pathology. We assessed our results in the treatment of this challenging subset of aneurysms after Food and Drug Administration (FDA) approval., Methods: We prospectively reviewed our series of PED cases in this cohort. Patients were assessed for aneurysm type, technical success, periprocedural complications, and aneurysm obliteration., Results: Since FDA approval, 17 patients with posterior circulation aneurysms were treated with the PED. These included aneurysms of the vertebral artery (V4) segments (n=8), basilar trunk (n=6), basilar apex (n=2), and cervical vertebral artery (n=1). Two patients had a prior subarachnoid hemorrhage. All of the aneurysms treated were either saccular, had a saccular component, or were dissecting in nature. No dolichoectatic aneurysms were treated. Technical success was achieved in all patients. One complication (1/17 patients; 5.9%), a parenchymal hematoma after ventriculostomy replacement, resulted in permanent disability. Angiographic follow-up has been obtained to date in 14 of the 17 patients and shows complete or near-complete (>90%) obliteration in all cases., Conclusions: Patient selection is essential for safe and effective PED treatment of posterior circulation aneurysms. The PED is equally effective in achieving aneurysm obliteration with an acceptable risk profile as it is in the anterior circulation. Dolichoectatic aneurysms were not included in this treatment cohort. PED may be a preferable alternative to open surgical treatment of posterior circulation aneurysms., (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: The Pipeline Embolization Device (PED) has become an important tool in the treatment of complex cerebrovascular pathology since it was approved by the Food and Drug Administration in April 2011., Objective: To determine the overall complication rate (permanent and transient) associated with the use of this new device from a single institution., Methods: We retrospectively examined a prospectively maintained database of our patients treated with the PED since its availability to the current time. 126 patients (24 men, 102 women; age range 14-83 years, mean 59.8 years) were treated for a total of 137 intracranial aneurysms, one cervical internal carotid artery dissection, one cervical vertebral artery dissection, and one carotid-cavernous fistula with a total of 217 PEDs (1.72 PED/patient)., Results: A total of 40 complications were experienced by 33 patients in our cohort. Four complications (4/126, 3.2%) in four patients were permanent, resulting in three deaths and one permanent disability. The other 36 complications (28.6%) occurred in 29 patients, all of whom went on to recover completely. The total complication rate associated with the use of the PED was 31.7% (40/126)., Conclusions: Despite a low rate of permanent complications associated with the PED in this series, the total complication rate was high. This finding supports the conclusion that this device should be reserved for the most challenging aneurysms. Patients should be advised of this higher rate of transient periprocedural complications., Trial Registration Number: IRB#:14BN027 Q7., (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.)

Introduction: Reports of the limitations and feasibility of balloon remodeling for treatment of complex anterior communicating artery (ACoA) aneurysms are scarce., Methods: Ninety-nine patients were treated with balloon-assisted coil embolization for ACoA aneurysms between August 2004 and October 2012. Records were reviewed for aneurysm characteristics, balloon trajectory (vessel and side), bilateral access, treatment-related complications, and aneurysm recurrence determined by magnetic resonance angiography (MRA). Morphological outcomes following treatment were categorized into Raymond class I, II, or III., Results: Fifty-three aneurysms (53.5%) were unruptured and 46 (46.4%) were ruptured. Aneurysmal occlusion (Raymond I or II) was achieved in 89 patients (89.9%); three (3.0%) were incompletely embolized and treatment was aborted in six (6.1%). Balloon trajectories were from the A1 to either the ipsilateral or contralateral A2. In 17 cases (17.2%), bilateral A1 access was used to achieve balloon protection of the contralateral A2. In four cases (4.0%), balloon remodeling was aborted due to technical difficulty. There were 15 (15.2%) treatment-related complications; five (5.1%) were intraoperative ruptures, one of which resulted in a neurological deficit and another in death. All other complications were clinically silent, producing a permanent complication rate of 2.0%. Mean radiographic follow-up was 2.5 years, and six patients (6.1%) were retreated for recurrence or known remnant., Conclusions: Balloon remodeling should be considered for broad-based complex ACoA aneurysms. This technique provides a high rate of aneurysm occlusion with an acceptable complication profile, and avoids the need for dual antiplatelet therapy. The balloon trajectory will depend on aneurysm morphology and bilateral access may be useful in selected cases., (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: Clinical outcomes of methamphetamine users with aneurysmal subarachnoid hemorrhage (aSAH) are unknown., Objective: To analyze differences in presentation, in-hospital morbidity, and outcomes between methamphetamine users and non-users., Methods: All 472 patients included in the Barrow Ruptured Aneurysm Trial from 2003 to 2007 were reviewed. Patients with 1- and 3-year follow-up were included in this analysis (n=398). Methamphetamine users were identified as patients who provided a history of methamphetamine use on admission or tested positive on urine toxicology testing. Methamphetamine users were compared with non-users using univariate analysis. Outcomes were then analyzed using multivariate logistic regression models for demographic characteristics, medical comorbidities, radiographic and clinical presentation, and vasospasm., Results: Thirty-one patients (7.8%) were identified as methamphetamine users in this cohort. Methamphetamine users were younger than non-users (mean age 42.8 vs 55 years, p<0.001). In multivariate logistic regression models, methamphetamine use was an independent predictor of poor Glasgow Outcome Scale score at both 1 year (OR=5.02; 95% CI 1.03 to 24.48; p<0.05) and 3 years (OR=7.18; 95% CI 1.73 to 29.87; p=0.007). Other independent predictors in this model included older age, clinical vasospasm, diabetes, and aneurysm size. Cocaine and tobacco use were not significantly associated with poor outcome in our cohort. Methamphetamine use was not significantly associated with vasospasm, higher Fisher or Hunt and Hess grade, or intraparenchymal hemorrhage/intraventricular hemorrhage., Conclusions: Methamphetamine users have significantly worse outcomes at 1 and 3 years following aSAH. Further analysis is necessary to understand the pathological response associated with methamphetamine use in this setting., (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: Flow-diverting stents represent a substantial advancement in the treatment of cerebral aneurysms. They can, however, be associated with unique complications that may require management through adjunctive techniques., Objective: To present a technical report of a salvage technique used to realign a prolapsed Pipeline Embolization Device (PED) during the treatment of a giant internal carotid artery (ICA) aneurysm., Methods: A patient in his late 70s with an incidental giant supraclinoid ICA aneurysm presented for endovascular consideration. Treatment was planned using the PED. Following placement of the device there were two focal areas of incomplete expansion and balloon angioplasty was performed. This manipulation resulted in foreshortening of the distal aspect of the PED which caused the device to prolapse into the aneurysm. After multiple unsuccessful attempts to regain distal access, a salvage technique was attempted in which a balloon was inflated in the middle cerebral artery and, by applying traction, the PED was realigned with the parent artery., Results: After the PED was realigned, direct distal catheter access was achieved and a second Pipeline device was deployed, successfully covering the aneurysm neck with resultant flow stasis. The patient had no postoperative issues and was discharged 2 days later without deficit., Conclusions: The balloon-anchoring technique was successfully used to realign a PED that had prolapsed into a giant ICA aneurysm. This maneuver prevented potentially disastrous complications and allowed the satisfactory completion of the aneurysm embolization. This represents a useful salvage technique that should be considered when encountering a prolapsed stent., (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/objective: Transarterial infusion of Onyx is now widely used in the treatment of arteriovenous malformations (AVMs) and dural arteriovenous fistulas (DAVFs). Transvenous Onyx embolization is rarely performed, and usually in cases of carotid cavernous fistulas. We describe a novel technique of transvenous Onyx embolization in the treatment of three high risk DAVFs and one vein of Galen (VOG) AVM., Methods: Cases were evaluated with specific attention to technical caveats, clinical indications, and complications. Patients were treated during 2011-2012 by two operators (FCA and CGM). Standard transfemoral venous approaches were employed in order to obtain access into the draining venous system in all cases., Results: Four female patients, aged 5 months to 68 years, were treated. Two patients, one presenting with headache and the other with a bruit, demonstrated high risk DAVFs involving the transverse-sigmoid sinuses. One patient, who was asymptomatic, manifested a high risk ethmoidal DAVF that was discovered incidentally during treatment of a basilar aneurysm. The final patient presented with symptoms of a pineal region mass and was found to have a VOG AVM. In all cases, a microcatheter was navigated through the draining venous pouch and into the ostium of an arterial feeder. A single Onyx infusion from this position filled multiple arterial feeders and resulted in cures in the first three patients and a significant reduction in AVM nidus in the fourth patient. No complications occurred., Conclusions: Transvenous Onyx infusion into a single arterial feeder can produce retrograde embolization of numerous other arterial feeders supplying high risk DAVFs and complex cerebral AVMs. This technique appears to be safe and potentially curative in select cases.

Background: Recent reports suggest that placement of a venous sinus stent improves symptoms in selected patients with idiopathic intracranial hypertension (IIH). We report our evaluation of the long-term patency of venous stents placed for IIH., Methods: We retrospectively reviewed our clinical database for 30 patients (mean age 33±10 years) with IIH who underwent placement of 36 venous sinus stents between October 2006 and December 2012. Relevant clinical, demographic and radiographic data were extracted after review of these records. All patients underwent retrograde venography to confirm a >50% stenosis and a trans-stenosis pressure gradient. Follow-up catheter angiography was performed beginning 3 months after the procedure., Results: Follow-up imaging was available for 23 (77%) of the 30 patients (mean 23 months). For seven patients, angiographic follow-up of >2 years (mean 45 months) was available. All stents remained patent with mild (<25%) in-stent stenosis observed in four patients. In five patients, however, we observed a narrowing of the sinus proximal to the stent. Although no patient underwent repeat stent placement for persistent or recurrent symptoms, cerebrospinal fluid diversion was performed in five cases., Conclusions: Venous sinus stent placement has emerged as a promising treatment option for the subgroup of patients with IIH with a pressure gradient across a stenotic venous sinus. We observed long-term patency of all stents placed in this patient population. Further prospective investigation is necessary to improve our understanding of the phenomenon of sinus narrowing upstream of a patent stent and to establish definitively the long-term clinical efficacy of venous sinus stent placement for IIH.

Spinal arteriovenous malformations (sAVMs) are rare vascular lesions whose natural history remains incompletely defined. Several classification schemes for sAVMs have evolved based on an improved understanding of the anatomic characteristics as well as pathophysiologic behavior of these arteriovenous shunts. Advances in endovascular technology have inspired the adoption of interventional techniques both as stand-alone treatment and as part of a multi-modality management paradigm for sAVMs. Further refinements in liquid embolic agents as well as improved microcatheter navigability will contribute to an ever-expanding role for endovascular intervention in the management of these lesions.

Background: The Pipeline embolization device has been used successfully to treat intracranial aneurysms with difficult morphologies. However, the need for dual antiplatelet therapy has limited its use after subarachnoid hemorrhage., Case Report: A 42-year-old woman with a ruptured dissecting aneurysm of her dominant vertebral artery (V4) was successfully treated by Pipeline embolization with preservation of flow through a covered posterior inferior cerebellar artery. This strategy preserved endovascular access for the treatment of severe posterior circulation vasospasm. She was a non-responder to thienopyridine agents and was thus maintained on aspirin and heparin, which was transitioned to warfarin following ventricular drain removal. The aneurysm remains angiographically obliterated at 6 months. Despite a moribund presentation and an extended hospitalization, she has made a remarkable neurological recovery., Conclusions: Pipeline embolization may be used to treat a ruptured dissecting aneurysm in selected cases where parent vessel preservation is paramount.

Background: Cerebral venous sinus thrombosis (CVT) is an uncommon cause of stroke that is usually treated medically with intravenous heparin therapy followed by long-term anticoagulation therapy. A series of patients with CVT who underwent rheolytic thrombectomy with the AngioJet as a first-line adjunctive treatment in addition to standard anticoagulation therapy is presented., Methods: Prospectively maintained endovascular databases at two institutions were retrospectively reviewed. The available clinical and imaging data were compiled at each institution and combined for analysis., Results: Over 18 months, 13 patients (seven women and six men; age range 17-73 years, median age 45 years) with CVT were treated with rheolytic thrombectomy. Immediate (partial or complete) recanalization of the thrombosed intracranial sinuses was achieved in all patients. At a median radiographic follow-up of 7 months there was continued patency of all recanalized sinuses. Clinical follow-up was available on nine patients: modified Rankin score of 0 in four patients, 1 in three patients and 6 in two patients., Conclusion: This series demonstrates the feasibility of performing mechanical thrombectomy as a first-line treatment for acute CVT. This technique facilitates the prompt restoration of intracranial venous outflow, which may result in rapid neurological and symptomatic improvement.

These guidelines were developed by consensus of a multidisciplinary panel of specialists interested in the evaluation and treatment of patients with arteriovenous malformations (AVMs) of the CNS. The reporting criteria described will serve as a template for trial design and for clinical investigators who wish to report on endovascular therapy of cerebral AVMs. Direct comparison of various treatment paradigms is important to standardization of care, maximization of good treatment outcomes, assessment of new methods and technologies.

Introduction: Coccidioidomycosis is secondary to infection with fungal species Coccidioides immitis or Coccidioides posadasii. One consequence of extrapulmonary coccidioidomycosis dissemination is meningitis, which is associated with high rates of morbidity and mortality if left untreated. Intracranial vasospasm, although rarely described, can occur and may be a result of vasculitic or subacute fibrotic changes. We describe a case of successful percutaneous transluminal angioplasty (PTA) in a patient with severe vasospasm related to coccidioidal meningitis. This is the first report of this endovascular treatment used to treat coccidioidal vasospasm., Clinical Presentation: A patient with a history of pulmonary coccidioidomycosis presented with acute confusion, blurry vision and headache. Serology confirmed basilar meningitis and magnetic resonance angiography demonstrated severe symptomatic vasospasm., Intervention: Emergent cerebral angiography confirmed severe vasospasm in the right middle cerebral artery and moderate vasospasm in the left middle cerebral artery. Successful PTA was performed under general anesthesia. The patient demonstrated postprocedural angiographic and clinical improvement., Conclusion: We report the first case of successful PTA performed to treat vasospasm related to coccidioidal meningitis. When vasospasm is clinically symptomatic, PTA is a safe and feasible procedure.

Introduction: Traditional endovascular treatment of cranial dural arteriovenous fistulas (DAVFs) consists of a transarterial approach with n-butylcyanoacrylate (nBCA) or a transvenous approach with coil embolization. The advent of Onyx in the endovascular arsenal potentially offers a high probability of obliteration of these vascular lesions through a purely transarterial route., Methods: A retrospective review of the Barrow Neurological Institute endovascular database between October 2005 and November 2009 highlighted 50 patients with 63 cranial DAVFs that were treated with transarterial Onyx, with and without adjuvant embolysates, for a total of 76 embolization procedures. Hospital records, cerebral angiography and other diagnostic imaging and clinical visits were reviewed., Results: At a median follow-up of 5 months (range 0-25 months), complete angiographic cure was obtained in 41 patients with 50 (79%) DAVFs after transarterial embolization using Onyx combined with other embolysates. When Onyx was used as the sole embolic agent, 32 of 37 DAVFs (87%) in 29 (of 33) patients achieved angiographic cure. Subgroup analysis showed that by using the middle meningeal artery (MMA) as a conduit for primary Onyx embolization, angiographic cures were achieved in 27 of the 37 DAVFs (73%). Periprocedural complications occurred in six (7.9%) sessions in one patients (8%). Only one patient had a permanent complication (2%) with unimproved cranial nerve palsies., Conclusion: Transarterial Onyx embolization of cranial DAVFs, particularly using the MMA as a conduit, is a safe and effective curative therapy.

A patient with a giant partially thrombosed basilar apex aneurysm was treated with balloon-assisted coil embolization. At the conclusion of the embolization, an Enterprise stent was placed from the upper basilar artery to the left P1 segment. Follow-up angiography 4 months later showed that the distal stent had pulled out of the posterior cerebral artery and was in the coil mass within the aneurysm. Angiography clearly showed that the stent had migrated down the basilar artery and that the artery was now kinked proximal to the stent. Nonetheless, the left posterior cerebral artery and the basilar artery were still widely patent. This is the first documented case in which a stent 'compacted' into a completed coiled aneurysm in a delayed fashion.

Introduction: This report details experience with the Neuroform stent, with an emphasis on evolving treatment strategies, complication rates and treatment durability., Methods: All patients undergoing Neuroform stent assisted aneurysm treatment were registered in prospectively maintained endovascular databases at two institutions., Results: 284 patients with 302 aneurysms underwent aneurysm treatment with Neuroform during a 42-month study period. Imaging follow-up was available for 166 of 286 saccular aneurysms which were treated with stents and coils (average interval 12.9 months). 80 demonstrated progressive thrombosis (48.2%), 40 were unchanged (24.1%) and 46 (27.7%) demonstrated re-canalization, 25 (15.1%) of which were major recanalizations requiring retreatment. The vast majority of recanalizations and retreatments were observed in large or giant aneurysms. A cumulative total of 25 ischemic strokes (8.8%) and eight neurovascular deaths (2.8%) were recorded in these patients. Ten of these strokes were associated with transient deficits which went on to complete resolution by the time of discharge or at the initial clinical follow-up, yielding a significant stroke rate of 5.3%. Delayed (>48 h) complications, including four deaths-related to stroke (n=2, 6 days and 8 weeks post-procedure) and spontaneous parenchymal hemorrhages (n=2)-represent events which are a direct consequence of stenting and likely would not have been encountered in the context of standard non-stent supported embolization techniques., Conclusion: Neuroform facilitates the endovascular treatment of complex and wide necked cerebral aneurysms. However, complete occlusion at angiographic follow-up remains uncommon and is observed in only one-third of patients. Delayed complications (>48 h) represent an important component of the overall complications associated with Neuroform assisted aneurysm embolization.

Introduction: The management of unruptured intracranial aneurysms in the elderly remains controversial. Treatment risks are thought to be higher in this group. Large series assessing endovascular treatment of unruptured intracranial aneurysms in the elderly are lacking. Our single center endovascular experience in treating unruptured intracranial aneurysms in the elderly is presented., Methods: 77 patients, 70 years or older, were referred to the endovascular neurosurgery service for treatment of an unruptured intracranial aneurysm between February 2000 and May 2008. Hospital records, operative reports, angiograms and radiology reports were reviewed and analyzed retrospectively., Results: 99 aneurysms were treated in 77 patients in 102 procedures. Mean patient age was 75±4 years, and the average aneurysm size was 11±7 mm. Adjuvant techniques were used in 66% of cases. Endovascular procedures included coiling alone (32%), balloon assisted coiling (19%), stent assisted coiling (37%), balloon assisted stent and coiling (8%), stent only (1%) and glue (2%). The permanent morbidity and mortality rates were 1% and 3%, respectively. Four adverse events were attributed to the patient's age. Posterior circulation aneurysms were associated with more adverse events (41%) than anterior circulation aneurysms (14%). Endovascular treatments using adjuvant techniques were associated with a higher complication rate than coiling alone., Conclusions: With only a 4% permanent rate of neurological morbidity and mortality, endovascular treatment of unruptured aneurysms can be performed safely in the elderly. Age should not be the limiting factor when considering endovascular therapy.

Introduction: We present the use of the Pipeline embolization device (PED) to achieve reconstruction of the right anterior circulation in a patient with a dolichoectatic internal carotid artery (ICA) and middle cerebral artery (MCA) and an associated symptomatic, large, carotid-ophthalmic segment aneurysm., Clinical Presentation: A 36-year-old man presented with progressive right eye vision loss followed by sudden severe headache. Subsequent neuroimaging revealed a large right carotid-ophthalmic segment aneurysm and diffuse ectasia of the supraclinoid ICA and proximal MCA. A coil embolization of the aneurysm was performed without stent support. Over the next year, the patient experienced increasing headache and progressive bitemporal vision loss. Serial MRI showed progressive coil compaction and recanalization of the aneurysm., Treatment: The right anterior circulation was reconstructed with a total of six PEDs that extended from the distal M1 segment of the MCA proximally into the distal cavernous segment of the ICA. Follow-up angiography at 1 and 4 months demonstrated progressive complete occlusion of the aneurysm and a reorganization of blood flow to the anterior cerebral and anterior choroidal arteries. MRI and radiographic imaging provided evidence of progressive contraction of the intra-aneurysmal thrombus. The patient's headaches resolved and serial visual field examinations have demonstrated gradual improvement after treatment., Conclusion: Extensive cerebrovascular reconstructions that are not possible using commercially available endovascular devices can be achieved with Pipeline. The safety, efficacy and long term implications of such reconstructions are currently being defined.

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.

Stroke is the third leading cause of death in the USA, Canada, Europe, and Japan. According to the American Heart Association and the American Stroke Association, there are now 750,000 new strokes that occur each year, resulting in 200,000 deaths, or 1 of every 16 deaths, per year in the USA alone. Endovascular therapy for patients with acute ischemic stroke is an area of intense investigation. The American Stroke Association has given a qualified endorsement of intra-arterial thrombolysis in selected patients. Intra-arterial thrombolysis has been studied in two randomized trials and numerous case series. Although two devices have been granted FDA approval with an indication for mechanical stroke thrombectomy, none of these thrombectomy devices has demonstrated efficacy for the improvement of patient outcomes. The purpose of the present document is to define what constitutes adequate training to perform neuroendovascular procedures in patients with acute ischemic stroke and what performance standards should be adopted to assess outcomes. These guidelines have been written and approved by multiple neuroscience societies which historically have been directly involved in the medical, surgical and endovascular care of patients with acute stroke. The participating member organizations of the Neurovascular Coalition involved in the writing and endorsement of this document are the Society of NeuroInterventional Surgery, the American Academy of Neurology, the American Association of Neurological Surgeons/Congress of Neurological Surgeons Cerebrovascular Section, and the Society of Vascular & Interventional Neurology.