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BackgroundThe pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale.MethodsPREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated.ResultsAs per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge–Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series.ConclusionsThe PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture.Trial registrationNCT02186561.

The last 10 years have seen a major shift in management of large vessel ischemic stroke with changes towards ever-expanding use of reperfusion therapies (intravenous thrombolysis and mechanical thrombectomy). These strategies ‘open the door’ to acute therapeutics for ischemic tissue, and we should investigate novel therapeutic approaches to enhance survival of recently reperfused brain. Key insights into new approaches have been provided through translational research models and preclinical paradigms, and through detailed research on ischemic mechanisms. Additional recent clinical trials offer exciting salvos into this new strategy of pairing reperfusion with neuroprotective therapy. This pairing strategy can be employed using drugs that have shown neuroprotective efficacy; neurointerventionalists can administer these during or immediately after reperfusion therapy. This represents a crucial moment when we emphasize reperfusion, and have the technological capability along with the clinical trial experience to lead the way in multiprong approaches to stroke treatment.

BackgroundStent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results.ObjectiveTo present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs.MethodsThe ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis >50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee.ResultsThe ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2±10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively.ConclusionsIn the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance.Trial registration numberhttps://clinicaltrials.gov/ct2/show/NCT02340585.

BackgroundWhile mechanical thrombectomy (MT) is the standard of care for large vessel occlusion strokes, the optimal management of tandem occlusions (TO) remains uncertain. We aimed to determine the current practice patterns among stroke physicians involved in the treatment of TO during MT.MethodsWe distributed an online survey to neurovascular practitioners (stroke neurologists, neurointerventionalists, neurosurgeons, and radiologists), members of professional societies. After 2 months the site was closed and data were extracted and analyzed. We divided respondents into acute stenting and delayed treatment groups and responses were compared between the two groups.ResultsWe received 220 responses from North America (48%), Latin America (28%), Asia (15%), Europe (5%), and Africa (4%). Preferred timing for cervical revascularization varied among respondents; 51% preferred treatment in a subsequent procedure during the same hospitalization whereas 39% preferred to treat during MT. Angioplasty and stenting (41%) was the preferred technique, followed by balloon angioplasty and local aspiration (38%). The risk of intracerebral hemorrhage was the most compelling reason for not stenting acutely (68%). There were no significant differences among practice characteristics and timing groups. Most practitioners (70%) agreed that there is equipoise regarding the optimal endovascular treatment of cervical lesions in TO; hence, 77% would participate in a randomized controlled trial.ConclusionsThe PICASSO survey demonstrates multiple areas of uncertainty regarding the medical and endovascular management of TOs. Experts acknowledged the need for further evidence and their willingness to participate in a randomized controlled trial to evaluate the best treatment for the cervical TO lesion.

To assess the impact of COVID-19 on neurovascular research and deal with the challenges imposed by the pandemic.MethodsA survey-based study focused on randomized controlled trials (RCTs) and single-arm studies for acute ischemic stroke and cerebral aneurysms was developed by a group of senior neurointerventionalists and sent to sites identified through the clinical trials website (https://clinicaltrials.gov/), study sponsors, and physician investigators.ResultsThe survey was sent to 101 institutions, with 65 responding (64%). Stroke RCTs were being conducted at 40 (62%) sites, aneurysm RCTs at 22 (34%) sites, stroke single-arm studies at 37 (57%) sites, and aneurysm single-arm studies at 43 (66%) sites. Following COVID-19, enrollment was suspended at 51 (78%) sites—completely at 21 (32%) and partially at 30 (46%) sites. Missed trial-related clinics and imaging follow-ups and protocol deviations were reported by 27 (42%), 24 (37%), and 27 (42%) sites, respectively. Negative reimbursements were reported at 17 (26%) sites. The majority of sites, 49 (75%), had put new trials on hold. Of the coordinators, 41 (63%) worked from home and 20 (31%) reported a personal financial impact. Remote consent was possible for some studies at 34 (52%) sites and for all studies at 5 (8%) sites. At sites with suspended trials (n=51), endovascular treatment without enrollment occurred at 31 (61%) sites for stroke and 23 (45%) sites for aneurysms. A total of 277 patients with acute ischemic stroke and 184 with cerebral aneurysms were treated without consideration for trial enrollment.ConclusionWidespread disruption of neuroendovascular trials occurred because of COVID-19. As sites resume clinical research, steps to mitigate similar challenges in the future should be considered.

The purpose of this publication is to provide a comprehensive review on the techniques and tools used for vascular access in neurointerventional procedures. Using published literature, we reviewed data on access methods, sites, tools, and techniques for neurointerventions. Recommendations are provided based on quality of data/levels of evidence and, where appropriate, expert consensus. While tools and techniques continue to be developed, current literature and experience supports certain principles regarding vascular access for neurointerventional procedures.

BackgroundPreliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications.ObjectiveTo evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms.MethodsPREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death.ResultsA total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured ConclusionsTreatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications.Trial registrationNCT02186561.

Cerebral venous thrombosis (CVT) is a rare condition accounting for

BackgroundBurnout takes a heavy toll on healthcare providers. We sought to assess the prevalence and risk factors for burnout among neurointerventional (NI) non-physician procedural staff (nurses and technologists) given increasing thrombectomy demands.MethodsA 41-question online survey containing questions including the Maslach Burnout Inventory-Human Services Survey for Medical Personnel was distributed to NI nurses and radiology technologists at 20 US endovascular capable stroke centers.Results244 responses were received (64% response rate). Median (IQR) composite scores for emotional exhaustion were 25 (15–35), depersonalization 6 (2–11), and personal accomplishment 39 (35–43). Fifty-one percent of respondents met established criteria for burnout. There was no significant relationship between hospital thrombectomy volume, call frequency, call cases covered, or length of commute. On multiple logistic regression analysis, feeling under-appreciated by hospital leadership (OR 4.1; PConclusionsThis survey of US NI non-physician procedural staff demonstrates a self-reported burnout prevalence of 51%. This was driven more by interaction with leadership and physician staff than by thrombectomy procedural volume and stroke call. Attrition among NI non-physician procedural staff is high.

Pediatric spinal vascular malformations are rare entities that typically present with symptoms from their effect on surrounding structures. Here we report a unique case of lumbar spinal dural/perimedullary arteriovenous fistula (AVF) that presented with intraventricular hemorrhage and hydrocephalus. The previously healthy child presented with lethargy and headache, and initial imaging revealed only ventriculomegaly with trace intraventricular blood. His mental status improved with CSF diversion via an external ventricular drain. Further workup revealed a spinal AVF that was treated via endovascular embolization. His course was complicated by vasospasm requiring endovascular treatment and he eventually required ventriculoperitoneal shunt placement. He made a full recovery and has returned to his normal activities. This is a unique case of spinal AVF presentation and highlights the importance of considering imaging of the entire neuroaxis during workup for hydrocephalus.

Stroke is the leading cause of adult disability in North America and is the fifth most common cause of death.1 ,2 The natural history of patients with acute ischemic stroke and occlusion of a major intracranial vessel such as the internal carotid artery (ICA), middle cerebral artery (MCA), or basilar artery is dismal, with high rates of mortality and low rates of disability-free survival.3 ,4 We introduce the term ‘Emergent Large Vessel Occlusion (ELVO)’ to describe this clinical scenario. Among acute ischemic stroke, ELVO accounts for the greatest proportion of patients with long-term disability. For the past two decades the use of endovascular therapy has been performed in many centers across the world. The therapies have spanned from infusion of thrombolytic agents5 ,6 to mechanical embolectomy with the introduction of first-generation devices,7 ,8 aspiration-based embolectomy techniques,9 ,10 and the use of stent-retriever based procedures.11 ,12 However, these embolectomy trials were single-arm trials demonstrating safety of the procedure and technique or superiority over another, without direct comparison with standard medical therapy alone. In the past 3 years, several major trials have been published comparing endovascular therapy with standard medical therapy alone. The purpose of this document is to summarize the results of these trials and synthesize the level of evidence supporting the use of embolectomy in patients with ELVO. This document was prepared by the Standards and Guidelines Committee of the Society of NeuroInterventional Surgery, a multidisciplinary society representing the leaders in the field of endovascular therapy for neurovascular disease. The strength of the evidence supporting each recommendation was summarized using a scale previously described by the American Heart Association. ### Role of intravenous thrombolysis In 1996 the FDA approved the use of recombinant tissue plasminogen activator (tPA) for the treatment of acute ischemic stroke …

Every year almost 800 000 people in the USA suffer a new or recurrent stroke, and stroke is the third leading cause of death with over 140 000 deaths in the USA in 1995.1 Additionally, stroke is a leading cause of long-term disability with an estimated cost of $68.9 billion in 2009. The relationship between carotid artery disease and stroke was first described by Fisher in 1951,2 and it is estimated that about one-third of ischemic strokes are due to carotid artery thromboembolic disease.3 ,4 Several trials have established carotid endarterectomy (CEA) as an excellent surgical technique for revascularization and prevention of future stroke, with a reasonable safety profile. Over the last 10–15 years, carotid artery stenting has been studied as an alternative and potentially less invasive revascularization method. Early trials of carotid artery stenting struggled with high complication rates but, as experience has grown and techniques improved, more recent trials have shown complication rates comparable to CEA. The goals of this document are to suggest standards of practice for patients treated with carotid artery angioplasty and stenting (CAS) and to provide a reporting framework for series of patients treated with CAS. Our evidence-based treatment recommendations were assessed according to criteria published by the American Heart Association/American Stroke Association (AHA/ASA) and the University of Oxford's Center for Evidence Based Medicine (CEBM). The development of treatment guidelines for CAS is facilitated by several large clinical trials that have already investigated surgical treatment for extracranial carotid stenosis as well as trials that have compared CAS with the established surgical treatment (CEA). In addition to this standards document, we would also recommend previously published guidelines for the use of CAS.5 Note that this document is not addressing the use of angioplasty with or without stenting in the setting of acute ischemic …

Background Symptomatic intracranial atherosclerotic disease (ICAD) worldwide represents one of the most prevalent causes of stroke. When severe, studies show that it has a very high risk for recurrent stroke, highlighting the need for effective preventative strategies. The mainstay of treatment has been medical therapy and is of critical importance in all patients with this disease. Endovascular therapy is also a possible therapeutic option but much remains to be defined in terms of best techniques and patient selection. This guideline will serve as recommendations for diagnosis

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.

Objective Tracheotomy and percutaneous endoscopic gastrostomy (PEG) are sometimes performed in critically ill hemorrhagic stroke patients in order to avoid complications associated with prolonged intubation and nasogastric feeding. However, there is a paucity of information regarding the optimal timing of these procedures. In this study, we aimed to evaluate the role of early tracheotomy and PEG in hemorrhagic stroke patients. Methods A series of patients treated at University of Kentucky for hemorrhagic stroke between June 1, 2011 and June 1, 2015 was retrospectively reviewed. Data regarding diagnosis, demographics, comorbidities, treatment, hospital course, and performance of tracheotomy and/or PEG were collected and then analyzed using logistic regression and multiple linear regression. Results Of 366 hemorrhagic stroke patients, 75 underwent tracheotomy and 86 received PEG. Factors significantly associated with tracheotomy and PEG included patient age (p Conclusions Hemorrhagic stroke is a devastating neurovascular event that requires prompt intervention and vigilant management. Our study identified patient risk factors that may suggest candidacy for tracheotomy and PEG. Additionally, we found that timing of PEG may shape a patient’s hospital course. Complication rates related to tracheostomy and PEG in this population were minimal. In conclusion, this retrospective data set supports some benefit to early PEG placement in this population, and justifies the need for further prospective study. Disclosures M. McCann: None. J. Fraser: None.

Background Moyamoya disease is characterized by progressive narrowing of the internal carotid artery (ICA). Symptomatic patients typically undergo cerebrovascular intervention via extracranial–intracranial (EC–IC) bypass, most often with the use of the superficial temporal artery. This case of Moyamoya disease is of particular interest as the patient presented with a unilateral atherosclerotic external carotid artery (ECA) stenosis after EC–IC bypass that eliminated the benefit of his original surgery, resulting in a symptomatic presentation. Clinical presentation A 53-year-old man presenting with Moyamoya disease and known left ICA occlusion had received a bilateral encephaloduroarteriosynangiosis (EDAS) bypass 10 years previously. He re-presented complaining of right-sided tingling, weakness, and numbness radiating up the arm. CT angiography indicated significant stenosis of the left ECA. ECA angioplasty and stenting with a distal protection device resulted in resolution of his symptoms. Conclusions This case illustrates that a patient presenting with Moyamoya disease and concurrent symptomatic ECA stenosis post-EDAS can be effectively and safely treated with ECA stenting.

Objective The Scepter C™ balloon occlusion catheter (Microvention, Tustin CA) is an endovascular device designed with a polyurethane balloon that elongates with inflation to allow it to conform to the lumen of the target vessel. The device has a double lumen, allowing passage over a 0.014-inch guidewire, and/or passage of Onyx embolisation distal to the balloon. We reviewed our initial use of this device as a conduit for liquid embolisation of vascular malformations as compared to the Marathon™ microcatheter (ev3, Plymouth, MN) alone, outlining indications for and outcomes with use. Methods We performed a retrospective review of patients who underwent Onyx embolisation of an arterovenous malformation or a dural A-V fistula from October 2011 to February 2013 at the University of Kentucky Hospital. Results 14 Scepter C™ devices were used in 8 patients over the course of 10 endovascular interventions. We compared this to 8 patients treated with 11 embolisations over the course of 9 interventions without balloon assistance. Technical success was achieved in 13/14 (93%) deployments of the balloon. There were no complications related to Scepter C™ use. Scepter C™ permitted distal navigation, while facilitating faster Onyx injection with more extensive and distal casting. This led to a trend of decreased fluoro time per embolisation with Scepter C™, though not statistically significant (23.0 ± 8.8 min vs 34.0 ± 10.4 min). There were no cases of Onyx fixation of the device in the parent artery; no significant tension was required to remove the device after Onyx injection. This represents a significantly different experience from the typically used Onyx microcatheter (Marathon), which carries a known risk of tip-adhesion to the Onyx cast. We detail technical nuances used to maximise the benefits of the Scepter C™ for such applications. Conclusions The Scepter C balloon catheter has, thus far, proven to be a safe and effective device for the endovascular treatment of vascular malformations through Onyx embolisation. A larger prospective study should be undertaken to ascertain any potential advantages or disadvantages compared to the current standard delivery catheters. Disclosures S. Grupke: None. A. Alhajeri: None. J. Fraser: None.