Aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion (COMPASS): a multicentre, randomised, open label, blinded outcome, non-inferiority trial.

BACKGROUND: Stent retriever thrombectomy of large-vessel occlusion results in better outcomes than medical therapy alone. Alternative thrombectomy strategies, particularly a direct aspiration as first pass technique, while promising, have not been rigorously assessed for clinical efficacy in randomised trials. We designed COMPASS to assess whether patients treated with aspiration as first pass have non-inferior functional outcomes to those treated with a stent retriever as first line. METHODS: We did a multicentre, randomised, open label, blinded outcome, core lab adjudicated non-inferiority trial at 15 sites (ten hospitals and four specialty clinics in the USA and one hospital in Canada). Eligible participants were patients presenting with acute ischaemic stroke from anterior circulation large-vessel occlusion within 6 h of onset and an Alberta Stroke Program Early CT Score of greater than 6. We randomly assigned participants (1:1) via a central web-based system without stratification to either direct aspiration first pass or stent retriever first line thrombectomy. Those assessing primary outcomes via clinical examinations were masked to group assignment as they were not involved in the procedures. Physicians were allowed to use adjunctive technology as was consistent with their standard of care. The null hypothesis for this study was that patients treated with aspiration as first pass achieve inferior outcomes compared with those treated with a stent retriever first line approach. The primary outcome was non-inferiority of clinical functional outcome at 90 days as measured by the percentage of patients achieving a modified Rankin Scale score of 0-2, analysed by intent to treat; non-inferiority was established with a margin of 0·15. All randomly assigned patients were included in the safety analyses. This trial is registered at ClinicalTrials.gov, number: NCT02466893. FINDINGS: Between June 1, 2015, and July 5, 2017, we assigned 270 patients to treatment: 134 to aspiration first pass and 136 to stent retriever first line. A modified Rankin score of 0-2 at 90 days was achieved by 69 patients (52%; 95% CI 43·8-60·3) in the aspiration group and 67 patients (50%; 41·6-57·4) in the stent retriever group, showing that aspiration as first pass was non-inferior to stent retriever first line (pnon-inferiority=0·0014). Intracranial haemorrhage occurred in 48 (36%) of 134 in the aspiration first pass group, and 46 (34%) of 135 in the stent retriever first line group. All-cause mortality at 3 months occurred in 30 patients (22%) in both groups. INTERPRETATION: A direct aspiration as first pass thrombectomy conferred non-inferior functional outcome at 90 days compared with stent retriever first line thrombectomy. This study supports the use of direct aspiration as an alternative to stent retriever as first-line therapy for stroke thrombectomy. FUNDING: Penumbra.

Direct Aspiration versus Stent Retriever Thrombectomy for Acute Stroke: A Systematic Review and Meta-Analysis in 9127 Patients.

BACKGROUND: The two most common approaches to thrombectomy of emergent large vessel occlusion (direct aspiration and primary stent retriever thrombectomy) have been extensively studied; however, the detailed benefit and risk comparison is largely unknown. OBJECTIVE: To conduct a systematic review and meta-analysis to compare radiographic and clinical outcomes between the use of primary stent retrievers and direct aspiration in management of acute ischemic stroke. METHODS: PubMed database was searched for studies between September 1, 2012 and December 31, 2017 with acute ischemic stroke patients. RESULTS: We identified 64 studies with 6875 patients in the primary stent retriever group and 25 studies with 2252 patients in the aspiration group. Primary aspiration alone, without the need of rescue stent retriever devices within the aspiration cohort, was performed in 65% of 2252 patients. There was no difference in the distribution of emergent large vessel occlusion based on occlusion site, age, baseline National Institutes of Health Stroke Scale, or the use of intravenous tPA (P = .19, .051, .23, and .093, respectively). Successful recanalization rates, defined as thrombolysis in cerebral Infarction 2b/3, were significantly higher in the aspiration group than the primary stent retriever group (89% versus 80%, P < .0001). No significant difference in good clinical outcome, defined as modified Rankin scale 0-2 (aspiration 52% versus stent 48%, P = .13), symptomatic intracerebral hemorrhage (aspiration 5.6% versus stent 7.2%, P = .07), and mortality at 3 months (aspiration 15% versus stent 19%, P = .10). CONCLUSIONS: Both aspiration-first (including the subsequent use of stent retriever) and primary stent retriever thrombectomy approaches are equally effective in achieving good clinical outcomes. Our study suggests that direct aspiration with or without subsequent use of stent retriever is a safe and effective alternative to primary stent retriever in acute ischemic stroke.

ASPECTS (Alberta Stroke Program Early CT Score) Measurement Using Hounsfield Unit Values When Selecting Patients for Stroke Thrombectomy.

BACKGROUND AND PURPOSE: The ASPECTS (Alberta Stroke Program Early CT Score) is a quantitate score that measures the extent of early ischemic changes. Our aim was to investigate how measurement of ASPECTS using Hounsfield unit (HU) values on initial noncontrast head computerized tomography (CT) correlates with the extent of final infarct on follow-up imaging. METHODS: Cases of acute stroke from the middle cerebral artery M1 occlusion in which complete recanalization (TICI [Thrombolysis in Cerebral Infarction] 3) was achieved were included for analysis. Using HU ratio (HU affected/HU control hemisphere) and HU difference (HU control-HU affected hemisphere) values, ASPECTS was measured on initial CT imaging and correlated with final ASPECTS at 24 hours. The study cohort consisted of 41 patients with acute stroke from the M1 occlusion. The mean time from stroke symptoms onset to baseline head CT imaging was 264 minutes and from CT to TICI 3 recanalization was 142 minutes. RESULTS: HU ratio within the 0.94 to 0.96 ranges showed the highest correlation coefficient and lowest mean and median errors with the final ASPECTS. The difference of 2.0 HU between the 2 hemispheres demonstrated the higher correlation coefficient (r=0.71; P<0.0001) and the lowest mean and median absolute errors (1.4 and 1, respectively). CONCLUSIONS: We established a simple algorithm for rapid and accurate assessment of ASPECTS on baseline CT imaging to predict the extent of final stroke in patients with emergent large vessel occlusion who undergo endovascular revascularization.

Training Standards in Neuroendovascular Surgery: Program Accreditation and Practitioner Certification.

BACKGROUND AND PURPOSE: Neuroendovascular surgery is a medical subspecialty that uses minimally invasive catheter-based technology and radiological imaging to diagnose and treat diseases of the central nervous system, head, neck, spine, and their vasculature. To perform these procedures, the practitioner needs an extensive knowledge of the anatomy of the nervous system, vasculature, and pathological conditions that affect their physiology. A working knowledge of radiation biology and safety is essential. Similarly, a sufficient volume of clinical and interventional experience, first as a trainee and then as a practitioner, is required so that these treatments can be delivered safely and effectively. METHODS: This document has been prepared under the aegis of the Society of Neurological Surgeons and its Committee for Advanced Subspecialty Training in conjunction with the Joint Section of Cerebrovascular Surgery for the American Association of Neurological Surgeons and Congress of Neurological Surgeons, the Society of NeuroInterventional Surgery, and the Society of Vascular and Interventional Neurology. RESULTS: The material herein outlines the requirements for institutional accreditation of training programs in neuroendovascular surgery, as well as those needed to obtain individual subspecialty certification, as agreed on by Committee for Advanced Subspecialty Training, the Society of Neurological Surgeons, and the aforementioned Societies. This document also clarifies the pathway to certification through an advanced practice track mechanism for those current practitioners of this subspecialty who trained before Committee for Advanced Subspecialty Training standards were formulated. CONCLUSIONS: Representing neuroendovascular surgery physicians from neurosurgery, neuroradiology, and neurology, the above mentioned societies seek to standardize neuroendovascular surgery training to ensure the highest quality delivery of this subspecialty within the United States.

High-Resolution Magnetic Resonance Imaging Evidence for Intracranial Vessel Wall Inflammation Following Endovascular Thrombectomy.

Intracranial high-resolution vessel wall magnetic resonance imaging evidence of vessel wall inflammation is present following stent retriever manipulation but absent following aspiration thrombectomy. This is presented in a case of rotatory vertebral artery compression causing multiple posterior circulation infarctions requiring multiple separate aspiration and stent retriever thrombectomies.

Clinical and Procedural Predictors of Outcomes From the Endovascular Treatment of Posterior Circulation Strokes.

BACKGROUND AND PURPOSE: Patients with posterior circulation strokes have been excluded from recent randomized endovascular stroke trials. We reviewed the recent multicenter experience with endovascular treatment of posterior circulation strokes to identify the clinical, radiographic, and procedural predictors of successful recanalization and good neurological outcomes. METHODS: We performed a multicenter retrospective analysis of consecutive patients with posterior circulation strokes, who underwent thrombectomy with stent retrievers or primary aspiration thrombectomy (including A Direct Aspiration First Pass Technique [ADAPT] approach). We correlated clinical and radiographic outcomes with demographic, clinical, and technical characteristics. RESULTS: A total of 100 patients were included in the final analysis (mean age, 63.5±14.2 years; mean admission National Institutes of Health Stroke Scale score, 19.2±8.2). Favorable clinical outcome at 3 months (modified Rankin Scale score ≤2) was achieved in 35% of patients. Successful recanalization and shorter time from stroke onset to the start of the procedure were significant predictors of favorable clinical outcome at 90 days. Stent retriever and aspiration thrombectomy as primary treatment approaches showed comparable procedural and clinical outcomes. None of the baseline advanced imaging modalities (magnetic resonance imaging, computed tomographic perfusion, or computed tomography angiography assessment of collaterals) showed superiority in selecting patients for thrombectomy. CONCLUSIONS: Time to the start of the procedure is an important predictor of clinical success after thrombectomy in patients with posterior circulation strokes. Both stent retriever and aspiration thrombectomy as primary treatment approaches are effective in achieving successful recanalization.

Safety and feasibility of the Wahoo Hybrid Access System, a dual-mode guide catheter, in a range of neuroendovascular procedures.

BACKGROUND: There is a clinical need for a guide catheter with combined stability and navigability, which can be used in a biaxial system for neuroendovascular procedures in place of triaxial systems. OBJECTIVE: To assess the safety and feasibility of the Q'Apel Medical Wahoo Hybrid Access System, a dual-mode 0.072″ internal diameter guide catheter, in a range of neuroendovascular procedures. METHODS: We performed a retrospective analysis of consecutive cases from a high-volume tertiary center in which the Wahoo Hybrid Access System was used as the guide catheter. Characteristics of the patients, vascular lesions, procedure, and procedural complications were assessed. RESULTS: A total of 102 patients were included for analysis. Vascular lesions were in the anterior circulation in 90 of 102 (88%), and posterior circulation in 12 of 102 (12%). Eighty-four cases were ruptured or unruptured aneurysm embolization procedures, the majority being balloon-assisted coiling (42%) and flow diversion (42%). All cases, including flow diversion, were performed as a biaxial system. There were no instances of prolapse of the catheter beyond the arterial segment in which it was initially placed. The procedure was able to be performed to completion in 101 of 102 (99%) cases. Thromboembolic complications occurred in 5 of 102 (5%); causality in two cases was unrelated to the guide catheter, and three were indeterminate. CONCLUSIONS: The Wahoo guide catheter is safe and feasible when used in a variety of neuroendovascular procedures. It can accommodate a range of devices, can be safely navigated into distal vasculature, and provides support for a range of procedures, including those which traditionally require triaxial support.

Safety and efficacy of eptifibatide in acute ischemic stroke requiring extracranial carotid artery stenting.

BACKGROUND: The antiplatelet management in acute ischemic stroke requiring carotid artery stenting is heterogenous, with no clear guidelines to direct management. OBJECTIVE: To evaluate the safety and efficacy of an intravenous eptifibatide protocol in the management of acute ischemic stroke requiring emergent carotid artery stenting. METHODS: We performed a retrospective analysis of consecutive patients who underwent carotid artery stenting for acute ischemic stroke at a high-volume tertiary neuroscience center, who were managed with an intravenous eptifibatide protocol. The protocol consists of an intravenous loading eptifibatide bolus (180 mcg/kg) at the time of stenting, followed by a maintenance infusion of 1 mcg/kg/min, then oral or nasogastric loading of dual antiplatelet agents. RESULTS: 80 patients were included for analysis. Median presenting NIHSS was 17. Sixty-six patients (83%) had a tandem intracranial occlusion. Six (7.5%) patients developed symptomatic intracranial hemorrhage (sICH). Those who received intravenous thrombolysis were not more likely to develop sICH (10% vs 5%, p = 0.40). Those patients with a presenting ASPECTS <8 were significantly more likely to develop sICH than those with ASPECTS 8-10 (25% vs 3%, p = 0.004). CONCLUSIONS: Eptifibatide may have a role in the management of acute stroke requiring carotid stenting. Caution may be required in those with established infarct on presentation imaging.

Predictors of early neurologic deterioration (END) following stroke thrombectomy.

BACKGROUND: Early neurologic deterioration (END) following ischemic stroke is a serious event and is associated with poor outcomes. However, the incidence and predictors of END after stroke thrombectomy for emergent large vessel occlusion are largely unknown. METHODS: The baseline characteristics of patients enrolled in the COMPASS trial (NCT02466893) were analyzed. The primary outcome was worsening of ≥4 National Institutes of Health Stroke Scale (NIHSS) points 24 hours post thrombectomy (4+ END24) and the secondary outcome was deterioration of ≥2 points (2+ END24). RESULTS: Among 270 patients, 27 (10%) developed 4+ END24 and 42 (16%) had 2+ END24. Those with 4+ END24 were older (76.4±12.9 vs 70.9±12.9 years; p=0.04), had a higher prevalence of hypertension (96% vs 69%; p=0.003), diabetes (41% vs 27%; p=0.13) and higher pretreatment systolic blood pressure (SBP) (170.4±32.6 vs 157.6±28.1 mmHg; p=0.03). More 4+ END24 patients had failed reperfusion: Thrombolysis in Cerebral Infarction ≤2a (26% vs 8%; p=0.003). In unadjusted analysis, older patients and those with hypertension, diabetes, elevated SBP and failed reperfusion had higher odds of 4+ END24. In adjusted analysis, age increase by 5 years led to an increase in 4+ END24 of 28%, diabetes increased odds of 2.6 and failed reperfusion increased odds of 4.5. In the multivariable analysis for the secondary outcome, age (OR 1.33; 95% CI 1.109 to 1.593), diabetes (OR 2.7; 95% CI 1.247 to 5.764) and failed reperfusion (OR 7.2; 95% CI 0.055 to 0.349) were also significant predictors of 2+ END24. CONCLUSIONS: Older patients with acute ischemic stroke who have a history of diabetes or hypertension, with elevated pretreatment SBP and failed reperfusion are at a higher risk of END following stroke thrombectomy for emergent large vessel occlusion.

Stroke thrombectomy volume, rather than stroke center accreditation status of hospitals, is associated with mortality and discharge disposition.

BACKGROUND: Few studies have explored the association between stroke thrombectomy (ST) volume and hospital accreditation with clinical outcomes. OBJECTIVE: To assess the association of ST case volume and accreditation status with in-hospital mortality and home discharge disposition using the national Medicare Provider Analysis and Review (MEDPAR) database. METHODS: Rates of hospital mortality, home discharge disposition, and hospital stay were compared between accredited and non-accredited hospitals using 2017-2018 MEDPAR data. The association of annual ST case volume with mortality and home disposition was determined using Pearson's correlation. Median rate of mortality and number of ST cases at hospitals within the central quartiles were estimated. RESULTS: A total of 29 355 cases were performed over 2 years at 847 US centers. Of these, 354 were accredited. There were no significant differences between accredited and non-accredited centers for hospital mortality (14.8% vs 14.5%, p=0.34) and home discharge (12.1% vs 12.0%, p=0.78). A significant positive correlation was observed between thrombectomy volume and home discharge (r=0.88; 95% CI 0.58 to 0.97, p=0.001). A significant negative relationship was found between thrombectomy volume and mortality (r=-0.86; 95% CI -0.97 to -0.49, p=0.002). Within the central quartiles, the median number of ST cases at hospitals with mortality was 24/year, and the median number of ST cases at hospitals with home discharge rate was 23/year. CONCLUSION: A higher volume of ST cases was associated with lower mortality and higher home discharge rate. No significant differences in mortality and discharge disposition were found between accredited and non-accredited hospitals.

Diagnostic imaging of vascular anomalies.

Congenital vascular anomalies are complex hereditary lesions with distinct clinical presentation, imaging, course, and treatment. We present a relevant review of the classification, pathophysiology, clinical presentation, and imaging characteristics that will allow for adequate diagnosis and understanding of these lesions.

Walrus large bore guide catheter impact on recanalization first pass effect and outcomes: the WICkED study.

BACKGROUND: The use of a balloon-guide catheter (BGC) in acute stroke treatment has been widely adopted after demonstrating optimized procedure metrics and outcomes. Initial technical constraints of previous devices included catheter stiffness and smaller inner diameters. We aim to evaluate the performance and safety of the Walrus BGC, a variable stiffness catheter with a large bore 0.087 inch inner diameter (ID), via the the WICkED study (Walrus Large Bore guide Catheter Impact on reCanalization first pass Effect anD outcomes). METHODS: This is a retrospective, site adjudicated, multicenter study on consecutive patients with large vessel occlusion treated with the Walrus BGC. Baseline characteristics, procedural outcomes and functional outcomes were analyzed. RESULTS: A total of 338 patients met the inclusion criteria. The Walrus was successfully tracked into distal vasculature and allowed therapeutic device delivery in all but 3 cases (0.9%). Large aspiration catheters ≥0.070 inch ID were used in 71.9% of cases. Stent retriever thrombectomy was used as the first-line modality in 59.2% and thromboaspiration in 40.8% of cases. The successful recanalization rate (modified treatment in cerebral ischemia (mTICI) 2b/3) was 94.4%, with 64.8% of the patients achieving mTICI 2b/3 after the first pass. The Walrus-related adverse event rate was 0.6%, corresponding to two vessel dissections. Functional independence was 50% (126/252) and mortality 25% (63/252). Unfavorable outcomes were more likely in older patients, who had unsuccessful reperfusion, longer procedure times, and a higher mean number of passes. CONCLUSION: In acute ischemic stroke patients presenting with large vessel occlusion, the Walrus BGC demonstrated excellent navigability and safety profile, allowed the accommodation of leading large bore aspiration catheters, and demonstrated high vessel recanalization rates.

Comparative study of intracranial access in thrombectomy using next generation 0.088 inch guide catheter technology.

BACKGROUND: Most conventional 0.088 inch guide catheters cannot safely navigate intracranial vasculature. The objective of this study is to evaluate the safety of stroke thrombectomy using a novel 0.088 inch guide catheter designed for intracranial navigation. METHODS: This is a multicenter retrospective study, which included patients over 18 years old who underwent thrombectomy for anterior circulation large vessel occlusions. Technical outcomes for patients treated using the TracStar Large Distal Platform (TracStar LDP) or earlier generation TRX LDP were compared with a matched cohort of patients treated with other commonly used guide catheters. The primary outcome measure was device-related complications. Secondary outcome measures included guide catheter failure and time between groin puncture and clot engagement. RESULTS: Each study arm included 45 patients. The TracStar group was non-inferior to the control group with regard to device-related complications (6.8% vs 8.9%), and the average time to clot engagement was 8.89 min shorter (14.29 vs 23.18 min; p=0.0017). There were no statistically significant differences with regard to other technical outcomes, including time to recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2B). The TracStar was successfully advanced into the intracranial internal carotid artery in 33 cases (73.33%); in three cases (6.67%), it was swapped for an alternate catheter. Successful reperfusion (mTICI 2B-3) was achieved in 95.56% of cases. Ninety-day follow-up data were available for 86.67% of patients, among whom 46.15% had an modified Rankin Score of 0-2%, and 10.26% were deceased. CONCLUSIONS: Tracstar LDP is safe for use during stroke thrombectomy and was associated with decreased time to clot engagement. Intracranial access was regularly achieved.

Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial.

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.

POSITIVE: Perfusion imaging selection of ischemic stroke patients for endovascular therapy.

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.

Intravenous alteplase has different effects on the efficacy of aspiration and stent retriever thrombectomy: analysis of the COMPASS trial.

BACKGROUND: There is conflicting evidence on the utility of intravenous (IV) alteplase in patients with emergent large vessel occlusion (ELVO) treated with mechanical thrombectomy (MT). METHODS: This was a post hoc analysis of the COMPASS: a trial of aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion. We compared clinical, procedural and angiographic outcomes of patients with and without prior IV alteplase administration. RESULTS: In the COMPASS trial, 235 patients had presented to the hospital within the first 4 hours of stroke symptom onset and were eligible for analysis. On univariate analysis, administration of IV alteplase prior to MT was found to be significantly associated with favorable outcomes (modified Rankin scale (mRS) 0-2 at 3 months; 55.6% vs 40.0% in the MT-only group, P=0.037). However, on multivariate analysis, only baseline (pre-stroke) mRS, admission National Institutes of Health Stroke Scale (NIHSS) score and age were identified as independent predictors of favorable outcomes at 3 months. We found higher final thrombolysis in cerebral infarction (TICI) 2b/3 rates in patients without the use of alteplase prior to the aspiration first approach (100.0% vs 87.9% in IV altepase +aspiration first MT, P=0.03). In the stent retriever first group, final TICI 2b/3 rates were identical in patients with and without IV alteplase administration (87.5% and 87.5%, P=1.0). CONCLUSIONS: Prior administration of IV alteplase may adversely affect the efficacy of aspiration, but does not seem to influence the stent retriever first approach to MT in patients with anterior circulation ELVO.

Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomes.

BACKGROUND: Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results. OBJECTIVE: To present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs. METHODS: The 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. RESULTS: The 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. CONCLUSIONS: In the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585.

U.S. Wingspan Registry: 12-month follow-up results.

BACKGROUND AND PURPOSE: The purpose of this study is to present 12-month follow-up results for a series of patients undergoing percutaneous transluminal angioplasty and stenting with the Gateway-Wingspan stenting system (Boston Scientific) for the treatment of symptomatic intracranial atherostenosis. METHODS: Clinical and angiographic follow-up results were recorded for patients from 5 participating institutions. Primary end points were stroke or death within 30 days of the stenting procedure or ipsilateral stroke after 30 days. RESULTS: During a 21-month study period, 158 patients with 168 intracranial atherostenotic lesions (50% to 99%) were treated with the Gateway-Wingspan system. The average follow-up duration was 14.2 months with 143 patients having at least 3 months of clinical follow-up and 110 having at least 12 months. The cumulative rate of the primary end point was 15.7% for all patients and 13.9% for patients with high-grade (70% to 99%) stenosis. Of 13 ipsilateral strokes occurring after 30 days, 3 resulted in death. Of these strokes, 76.9% (10 of 13) occurred within the first 6 months of the stenting procedure and no events were recorded after 12 months. An additional 9 patients experienced ipsilateral transient ischemic attack after 30 days. Most postprocedural events (86%) could be attributed to interruption of antiplatelet medications (n=6), in-stent restenosis (n=12), or both (n=1). In 3 patients, the events were of uncertain etiology. CONCLUSIONS: After successful Wingspan percutaneous transluminal angioplasty and stenting, some patients continued to experience ipsilateral ischemic events. Most of these ischemic events occurred within 6 months of the procedure and were associated with the interruption of antiplatelet therapy or in-stent restenosis.

Aspiration Thrombectomy: 2-Dimensional Operative Video.

Acute ischemic stroke is one of the leading causes of disability and mortality worldwide. There have been significant improvements to the treatment of acute ischemic stroke over the past 5 yr, specifically related to strokes caused by large vessel occlusions. Stent retrievers with and without local aspiration and direct aspiration alone have all been demonstrated as viable treatment options for this patient population. This case represents the surgical technique for direct aspiration for the treatment of large vessel occlusion. A 76-yr-old man presented with right-sided weakness and aphasia. His last known normal was 5 h ago. His NIHSS (National Institutes of Health Stroke Scale) was 18. The noncontrast computed tomography (CT) did not show a significant infarct burden and ASPECTS (Alberta Stroke Program Early CT Score) of 9. CT angiogram demonstrated a left M1 occlusion. The patient was not a candidate for tissue plasminogen activator (tPA) because of time to presentation; however, the patient was deemed to be a candidate for emergent thrombectomy. Consent was obtained per institutional guidelines for the emergent procedure and the video recording. The video demonstrates a direct aspiration thrombectomy technique for the treatment of stroke. The patient successfully underwent direct aspiration thrombectomy with a TICI 3 (thrombolysis in cerebral infarction) recanalization.

Efficacy of beveled tip aspiration catheter in mechanical thrombectomy for acute ischemic stroke.

BACKGROUND: Direct aspiration thrombectomy techniques use large bore aspiration catheters for mechanical thrombectomy. Several aspiration catheters are now available. We report a bench top exploration of a novel beveled tip catheter and our experience in treating large vessel occlusions (LVOs) using next-generation aspiration catheters. METHODS: A retrospective analysis from a prospectively maintained database comparing the bevel shaped tip aspiration catheter versus non-beveled tip catheters was performed. Patient demographics, periprocedural metrics, and discharge and 90-day modified Rankin Scale (mRS) scores were collected. Patients were divided into two groups based on which aspiration catheter was used. RESULTS: Our data showed no significant difference in age, gender, IV tissue plasminogen activator administration, admission NIH Stroke Scale score, baseline mRS, or LVO location between the beveled tip and flat tip groups. With the beveled tip, Thrombolysis in Cerebral Infarction (TICI) 2C or better recanalization was more frequent overall (93.2% vs 74.2%, p=0.017), stent retriever usage was lower (9.1% vs 29%, p=0.024), and patients had lower mRS on discharge (median 3 vs 4, p<0.001) and at 90 days (median 2 vs 4, p=0.008). CONCLUSION: Patients who underwent mechanical thrombectomy with the beveled tip catheter had a higher proportion of TICI 2C or better and had a significantly lower mRS score on discharge and at 90 days.