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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.

BackgroundThere is conflicting evidence on the utility of intravenous (IV) alteplase in patients with emergent large vessel occlusion (ELVO) treated with mechanical thrombectomy (MT).MethodsThis 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.ResultsIn 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).ConclusionsPrior 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.

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.

BackgroundClot density (Hounsfield units, HU) and perviousness (post-contrast increase in the HU of clot) are thought to be associated with clot composition. We evaluate whether these imaging characteristics were associated with angiographic outcomes of aspiration and stent retriever thrombectomy in COMPASS: a trial of aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion.MethodsClot density and perviousness were measured by two independent operators who were blind to all the final angiographic and clinical outcomes. The association of clot density and perviousness with the Thrombolysis In Cerebral Infarction (TICI) scale after first pass was assessed using univariate and multivariate analysis.ResultsAmong all patients enrolled in COMPASS, 165 were eligible for the post-hoc analysis (81 patients in the aspiration first and 84 in the stent retriever first groups). Overall mean perviousness of clot was significantly higher in patient with mTICI 2b-3 after first pass (28.6±22.9 vs 20.3±19.2, p=0.017). Mean perviousness among patients who achieved TICI 2c/3 versus TICI 2b versus TICI 0-2a in the aspiration first group varied significantly (32.6±26.1, 35.3±24.4, and 17.7±13.1, p=0.013). The association of perviousness with first pass success was not significant in the stent retriever group. Using multivariate analysis, high perviousness (defined as cut-off >27.6) was an independent predictor of TICI 2b-3 (OR 3.82, 95% CI 1.10 to 13.19; p=0.034).ConclusionsClot perviousness is associated with first pass angiographic success in patients treated with the aspiration first approach for thrombectomy.

Objective Cerebral venous thrombosis (CVT) is a rare type of stroke whose pathophysiology differs from arterial stroke. CVT is treated with systemic anticoagulant therapy even in the setting of intracerebral hemorrhage. Patients who do not respond adequately may require decompressive surgery. The study objective was to examine the timing of anticoagulation in patients with CVT who require decompressive surgery through systematic literature review and consecutive case series. Methods A review of the literature was performed through PubMed using key word search to identify case series and cohort studies examining timing of anticoagulation following decompressive surgery. Our case series included 4 patients who had decompressive surgery for hemorrhagic CVT between 1 January, 2015 and 31 December, 2016 at our comprehensive stroke center. Results The literature review summarizes 243 patients from 15 studies whose timing of anticoagulation varied. The review suggests anticoagulation can be safely resumed at 48 hours postoperatively based on larger series and as early as 12 hours in smaller series, especially when delivered as a half or prophylactic dose. In our case series, timing of anticoagulation varied slightly but was started or resumed within 38–44 hours postoperatively in 3 patients and was started at the time of decompressive surgery without interruption in 1 patient. No patient had worsening hemorrhage or new hemorrhage while 2 patients rethrombosed. Conclusions Despite the lack of high-quality studies, this systematic review of patients with CVT requiring decompressive surgery indicates that anticoagulation can be safely initiated or resumed around 24–48 hours postoperatively; our series supports the existing literature.

Introduction: Neutrophil-lymphocyte ratios (NLRs) can be used to assess inflammatory status, with higher NLRs indicating inflammation and physiologic stress. NLRs after ischemic stroke have been shown to predict both short- and long-term outcomes. Methods: This was a retrospective study of adult patients admitted to a high-volume stroke center in 1/1/2018-12/31/2020 for ischemic stroke who underwent endovascular therapy (ET). The primary outcomes were successful reperfusion (TICI score ≥2B), favorable discharge NIH Stroke Scale/Score (NIHSS≤4), and favorable discharge and 3-month modified Rankin Scale (mRS≤2) scores. The primary predictor was neutrophil-lymphocyte ratio (NLR), measured at admission and throughout the hospital stay, as well as change in NLR between admission and post-ET. Logistic regression and generalized estimating equations assessed associations between NLRs and the outcomes. Results: The study included 131 patients, with a median admission NIHSS of 13 and median discharge NIHSS of 1. Almost all patients (94%) achieved successful reperfusion, and only 2 (1.5%) developed symptomatic ICH. The median discharge mRS was 3, and the median 3-month mRS was 2. The median admission NLR was 6.5 (range 0.8-18.0), and the median NLR change (admission to first post-ET) was 0.0 (range -13.8 to 12.0). Each 1-unit increase in admission NLR was associated with a 19% decreased odds of successful perfusion, 16% decreased odds of favorable discharge NIHSS, 15% decreased odds of favorable discharge mRS, and 14% decreased odds of favorable 3-month mRS. Higher post-ET NLRs on various days were also associated with decreased odds of favorable outcomes (Table 1). Conclusions: Admission and select follow-up NLRs were predictive of successful reperfusion and condition at discharge and at 3-months post-discharge in this patient population. These results show that NLRs, a readily available biomarker, can identify individuals at risk for poor outcomes after ET.

Introduction Endovascular management of wide-necked bifurcation aneurysms poses a therapeutic challenge as coiling often requires the use of multiple adjunctive stent constructs to achieve successful embolization without compromising parent vessel integrity. The Neuroform Atlas Stent System is a novel low-profile, intraluminal remodeling device. The study aims to investigate the safety and efficacy of the Y-configuration constructs with the ATLAS stent for aneurysm coil embolization. Methods Patients undergoing Y-stent assisted coil embolization in the ATLAS IDE trial (Investigational Device Exemption) were identified. The primary efficacy end point was complete aneurysm occlusion (Raymond-Roy class 1) on 12-month angiography, in the absence of retreatment or parent artery stenosis (>50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent Imaging Core Laboratory and the Clinical Events Committee. Result A total of 60 patients of were identified. The mean age was 59 and 28.3% were men. The median aneurysm size was 6.7mm with a median neck size of 4.3 mm. Aneurysm locations were as follows: basilar apex (56.7%), basilar trunk (3.3%), anterior communicating artery (20%), anterior cerebral artery (3.3%), internal cerebral artery (3.3%) and middle cerebral artery (13.3%). The composite primary efficacy end point of complete aneurysm occlusion (Raymond-Roy 1) without parent artery stenosis or aneurysm retreatment was achieved in 81.1% of patients. Overall, 1.7% (1/60) of patients experienced a primary safety end point of major ipsilateral stroke or neurological death. Conclusions In the ATLAS IDE aneurysm cohort premarket approval study, the Neuroform Atlas stent with adjunctive Y-stent coiling met the primary end points and demonstrated high rates of long-term complete aneurysm occlusion at 12 months, with low rates of morbidity. Disclosures A. Jadhav: None. S. Desai: None. R. Hanel: None. D. Frei: None. A. Khaldi: None. S. Hetts: None. O. Zaidat: None. B. Jankowitz: None.

BackgroundCerebral vasospasm (CV) after aneurysmal subarachnoid hemorrhage (aSAH) is linked to worse neurological outcomes. The NeVa VS is a novel cerebral dilation device based on predicate stent retrievers. We report the results of the Vesalio NeVa VS for the Treatment of Symptomatic Cerebral Vasospasm following aSAH (VITAL) Study.MethodsThis was a single-arm prospective multicenter trial to assess the safety and probable benefit of the NeVa VS device to treat CV. Patients were screened and treated if they had CV >50% on non-invasive imaging confirmed by cerebral angiography. The vessel diameters were measured before and after treatment by an independent core laboratory. The primary endpoint was ≥50% vessel diameter immediately after treatment with the NeVa VS device.ResultsThirty patients with a mean age of 52±11 years and mean Hunt–Hess grade of 3.1±0.9 were enrolled. A total of 74 vessels were treated with an average of 1.3 deployments per vessel (95 deployments total). The mean pre-treatment narrowing of the target vessel (n=74) was 65.6% with reduction of the narrowing to 29.4% after treatment. The primary endpoint was achieved in 64 of 74 vessels (86.5%). In three of 95 total deployments (3.2%), thrombus at the site of deployment was observed during the procedure without apparent neurological sequelae.ConclusionsThe NeVa VS device appears to be a safe treatment to regain vessel diameter in severely narrowed intracranial arteries secondary to CV associated with aSAH. This treatment offers a new tool that allows for controlled vessel expansion to treat CV.

Summary 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 (p non-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.

Background and objectiveStent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial.MethodThe Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (>50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints.Results30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4±11.8 years and 24/30 patients (80%) were women. The mean aneurysm size was 5.3±1.7 mm and the dome:neck ratio was 1.1±0.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26/30 patients (86.7%, 95% CI 69.3% to 96.2%) compared with 25/27 patients (92.6%, 95% CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths.ConclusionThe Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort.Clinical trial.gov registration numberNCT0234058;Results

BackgroundIt is not clear whether the COVID-19 pandemic and subsequent Society of Neurointerventional Surgery (SNIS) recommendations affected hospital stroke metrics.MethodsThis retrospective cohort study compared stroke patients admitted to a comprehensive stroke center during the COVID-19 pandemic April 1 2020 to June 30 2020 (COVID-19) to patients admitted April 1 2019 to June 30 2019. We examined stroke admission volume and acute stroke treatment use.ResultsThere were 637 stroke admissions, 52% in 2019 and 48% during COVID-19, with similar median admissions per day (4 vs 3, P=0.21). The proportion of admissions by stroke type was comparable (ischemic, P=0.69; hemorrhagic, P=0.39; transient ischemic stroke, P=0.10). Acute stroke treatment was similar in 2019 to COVID-19: tPA prior to arrival (18% vs, 18%, P=0.89), tPA treatment on arrival (6% vs 7%, P=0.85), and endovascular therapy (endovascular therapy (ET), 22% vs 25%, P=0.54). The door to needle time was also similar, P=0.12, however, the median time from arrival to groin puncture was significantly longer during COVID-19 (38 vs 43 min, P=0.002). A significantly higher proportion of patients receiving ET were intubated during COVID-19 due to SNIS guideline implementation (45% vs 96%, PConclusionsThe COVID-19 pandemic did not significantly affect stroke admission volume or acute stroke treatment utilization. Outcomes were not affected by implementing SNIS guidelines. Although there was a statistical increase in time to groin puncture for ET, it was not clinically meaningful. These results suggest hospitals managing patients efficiently can implement practices in response to COVID-19 without impacting outcomes.

Background Imaging clot characteristics such as clot density and perviousness (the latter is defined as a difference in regional clot density values between computed tomography angiography (CTA) and non-contrast CT [NCCT]), can be used as an imaging marker characterizing red blood cell and fibrin composition of the clot serving. We aimed to examine whether clot density and perviousness were associated with angiographic outcomes of aspiration and stent retriever thrombectomy in the COMPASS Trial: a Direct Aspiration First Pass Technique trial. Methods Clot density (Hounsfield units, HU) and perviousness were measured by two operators who were blind to all the final angiographic and clinical outcomes except for the knowledge of stroke laterality. NCCT and CTA images were co-registered to accurately localize clot on both imaging modalities. The values were then matched with angiographic and clinical outcome data of the first pass for each randomization arm. Univariate and multivariate analysis was carried out to assess the association of clot density and perviousness using SPSS version 25. Results Of the original 270 patients included in the COMPASS trial, 165 were eligible for the post-hoc analysis (81 patients in the aspiration first and 84 in the stent retriever first groups). There was no difference between the groups in regards to gender distribution, age, laterality and side of large vessel occlusion, smoking status of patients, and comorbidities. There was also no difference between the aspiration and stent retriever first randomization groups in regards to baseline clot Hounsfield units (HU) on NCCT (49.9 ±8.2 vs. 47.8 ±8.7, P=0.11), and perviousness (26.84 ±21.8 vs. 22.8 ±19.9, P=0.20). For the aspiration first group, there was a difference in mean perviousness values among patients who achieved TICI 2c-3 vs. TICI 2b vs. TICI 0–2a (33.1 ±26, 35.9 ±25.1, and 19.0 ±14.2, respectively; P=0.016). There was no difference between clot HU density on NCCT among these 3 groups (48.8 ±8.5, 50.1 ±7.2, and 51.0 ±8.4, P=0.56). In the stent retriever first group, there was no difference in perviousness or HU density of clot in patients with TICI 2c/3, TICI 2b or TICI 0–2a after first pass (perviousness 21.6 ±17.0, 22.4 ±18.04 and 22.6 ±22.9, P=0.97; HU on NCCT 48.7 ±9.1, 49.7 ±6.5 and 46.7 ±9.0, P=0.47).In multivariate analysis using a model that included use of intravenous tPA, balloon guide catheter use, onset to groin puncture and age, perviousness of more than 10 was the only independent factor predictive of successful recanalization (defined as TICI 2b-3) after first pass in the aspiration first group with odds ratio of 3.4 (95% CI 1.0 -12.0). We did not find any significant predictors of successful reperfusion (TICI 2b-3) after first pass in the stent retriever first group. Conclusions Clot perviousness values are associated with first pass angiographic success in patients treated with the aspiration first approach for thrombectomy. Additional research is needed to determine if clot perviousness may be used to identify patients who are more likely to have successful recanalization with aspiration when deciding between aspiration versus stent retriever first approaches. Disclosures M. Mokin: 1; C; NIH R21NS109575. 2; C; Medtronic, Canon medical, Cerenovus. 4; C; Serenity medical, Synchron, VICIS, Endostream. M. Waqas: None. J. Fifi: 1; C; Stryker, Penumbra, Microvention. 4; C; Cerebrotech, The Stroke Project. R. De Leacy: 1; C; Penumbra. 6; C; Cerenovus, Siemens. D. Fiorella: 1; C; Penumbra, Cerenovus, Stryker. 6; C; Genentech, Shape Memory Medical. E. Gu: None. E. Levy: 6; C; Penumbra, NextGen Biologics, Rapid Medical, Cognition Medical, Three Rivers Medical, Stryker, MedX, Endostream Medical. K. Snyder: 6; C; Penumbra, Canon Medical Systems, Medtronic, Jacobs Institute; and other from Neurovascular Diagnostics. R. Hanel: 6; C; Penumbra, Endostream, Cerebrotech, Synchron, InNeuroCo, Medtronic, Microvention, Stryker, Cerenovus; Elum, Three Rivers. A. Aghaebrahim: None. K. Woodward: 6; C; Penumbra. H. Hixson: 6; C; Penumbra. M. Chaudry: 6; C; Penumbra, Pulsar Vascular, Medtronic, Microvention, Codman, Blockade. A. Spiotta: 6; C; Penumbra, Pulsar Vascular, Stryker, Microvention. A. Rai: 6; C; Penumbra, Microvention, Stryker. D. Frei: 6; C; Penumbra, Cerenovus, Stryker, Genentech, Shape Memory Medical, Siemens. J. Delgado Almandoz: 6; C; Penumbra, Medtronic. M. Kelly: 6; C; Penumbra, Medtronic, Endostream. A. Arthur: 6; C; Penumbra. B. Baxter: 6; C; Penumbra, Medtronic, Stryker, Viz, and 880 Medical. J. English: 6; C; Penumbra, Medtronic, Stryker, Route 92 Medical. I. Linfante: 6; C; Penumbra, Medtronic, Stryker, Microvention, InNeuroCo, andThree Rivers. K. Fargen: 6; C; Penumbra and Cerebrotech. A. Turk III: 6; C; Penumbra, Pulsar Vascular, Codman, Microvention, Medtronic, Blockade. A. Siddiqui: 6; C; Amnis Therapeutics, Serenity Medical, Silk Road Medical, Rebound Therapeutics, Penumbra Medtronic, Three Rivers Medical, Microvention, Imperative Care, Cerenovus, Endostream Medical, StimMed, Claret M. J. Mocco: 6; C; Penumbra, Cerebrotech, Rebound Therapeutics, TSP, Lazarus Effect, Medina, Pulsar Vascular, Blockade.

BACKGROUND Heterogeneous effect of endovascular aneurysm therapy has been observed across different anatomic locations. There is a paucity of data for stent-assisted coiling of middle cerebral artery (MCA) aneurysms. OBJECTIVE To present the results of the MCA aneurysm group from the Neuroform Atlas (Stryker Neurovascular) investigational device exemption (IDE) trial. METHODS The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of wide-neck aneurysms (neck ≥ 4 mm or dome-to-neck ratio

Supplemental Digital Content is available in the text., Background and Purpose: Stent-assisted coil embolization using the new generation Neuroform Atlas Stent System has shown promising safety and efficacy. The primary study results of the anterior circulation aneurysm cohort of the treatment of wide-neck, saccular, intracranial, aneurysms with the Neuroform Atlas Stent System (ATLAS trial [Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms With the Neuroform Atlas Stent System]) are presented. Methods: ATLAS IDE trial (Investigational Device Exemption) is a prospective, multicenter, single-arm, open-label study of wide-neck (neck ≥4 mm or dome-to-neck ratio 50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent Imaging Core Laboratory and the Clinical Events Committee. Results: A total of 182 patients with wide-neck anterior circulation aneurysms at 25 US centers were enrolled. The mean age was 60.3±11.4 years, 73.1% (133/182) women, and 80.8% (147/182) white. Mean aneurysm size was 6.1±2.2 mm, mean neck width was 4.1±1.2 mm, and mean dome-to-neck ratio was 1.2±0.3. The most frequent aneurysm locations were the anterior communicating artery (64/182, 35.2%), internal carotid artery ophthalmic artery segment (29/182, 15.9%), and middle cerebral artery bifurcation (27/182, 14.8%). Stents were placed in the anticipated anatomic location in all patients. The study met both primary safety and efficacy end points. The composite primary efficacy end point of complete aneurysm occlusion (Raymond-Roy 1) without parent artery stenosis or aneurysm retreatment was achieved in 84.7% (95% CI, 78.6%–90.9%) of patients. Overall, 4.4% (8/182, 95% CI, 1.9%–8.5%) of patients experienced a primary safety end point of major ipsilateral stroke or neurological death. Conclusions: In the ATLAS IDE anterior circulation aneurysm cohort premarket approval study, the Neuroform Atlas stent with adjunctive coiling met the primary end points and demonstrated high rates of long-term complete aneurysm occlusion at 12 months, with 100% technical success and

Introduction: Mechanisms for the hospital identification of patients with suspected large vessel occlusions (LVO) vary widely based on referring and receiving stroke center resources. We compared processes for identifying patients with suspected LVO who may be candidates for endovascular therapy (EVT) at non-EVT hospitals and the criteria for interfacility transport to Comprehensive Stroke Centers (CSC) for potential EVT. Methods: Data were obtained from 4 CSC which serve distinct geographic regions, ranging from rural to urban environments, over a continuous 12 month period of time beginning year 2018. Patients transferred from all referring hospitals to these facilities were considered regardless of hospital affiliations (n=2213). Geographic description, imaging modalities and form of emergent neurologic consultation available and utilized, rates of stroke transfers for EVT, and rates of final EVT were recorded. Results: The process for identifying a patient with a likely LVO appropriate for interfacility transfer varied greatly by referring and receiving hospital (table). The intensity of referring hospital evaluation ranged from complete multimodal CT imaging and either onsite or video telestroke consultation with access to neuroimaging to simple noncontrast CT and telephone consultation. Rates of transfer and eventual EVT varied across the centers. Further details of the form of stroke expertise, penumbral imaging criteria, unique geographic variances, criteria for transfer, and final utilization of EVT will be presented. Conclusions: Optimal interfacility transfer procedures are essential to ensure patients with LVO are considered in a timely fashion, and that over triage does not overwhelm receiving CSC. We found significant process variations in identifying EVT candidates for interfacility transfer. Providing examples of multiple best practices allows for other centers to identify potential solutions for their unique circumstances.

ObjectiveIn this multicenter study, we sought to evaluate comparative safety and efficacy of combined IV thrombolysis (IVT) and mechanical thrombectomy (MT) vs direct MT in emergent large vessel occlusion (ELVO) patients.MethodsConsecutive ELVO patients treated with MT at 6 high-volume endovascular centers were evaluated. Standard safety and efficacy outcomes (successful reperfusion [modified Thrombolysis in Cerebral Infarction IIb/III], functional independence [FI] [modified Rankin Scale (mRS) score of 0–2 at 3 months], favorable functional outcome [mRS of 0–1 at 3 months], functional improvement [mRS shift by 1-point decrease in mRS score]) were compared between patients who underwent combined IVT and MT vs MT alone. Additional propensity score–matched analyses were performed.ResultsA total of 292 and 277 patients were treated with combination therapy and direct MT, respectively. The combination therapy group had greater functional improvement (p = 0.037) at 3 months. After propensity score matching, 104 patients in the direct MT group were matched to 208 patients in the combination therapy group. IVT pretreatment was independently (p < 0.05) associated with higher odds of FI (odds ratio [OR] 1.75; 95% confidence interval [CI] 1.02–2.99) and functional improvement (common OR 1.64; 95% CI 1.05–2.56). Combination therapy was independently (p < 0.05) related to lower likelihood of 3-month mortality (0.50; 95% CI 0.26–0.96).ConclusionsThis observational study provides preliminary evidence that IVT pretreatment may improve outcomes in ELVO patients treated with MT. The question of the potential effect of IVT on ELVO patients treated with MT should be addressed with a randomized controlled trial.Classification of evidenceThis study provides Class III evidence that for stroke patients with emergent large vessel occlusion, combined IVT and MT is superior to direct MT in improving functional outcomes.

BACKGROUND AND PURPOSE: The safety and efficacy of endovascular therapy for large-artery stroke in the extended time window is not yet well-established. We performed a subgroup analysis on subjects enrolled within an extended time window in the Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) trial. MATERIALS AND METHODS: Fifty-nine of 315 subjects (33 in the intervention group and 26 in the control group) were randomized in the ESCAPE trial between 5.5 and 12 hours after last seen healthy (likely to have groin puncture administered 6 hours after that). Treatment effect sizes for all relevant outcomes (90-day mRS shift, mRS 0–2, mRS 0–1, and 24-hour NIHSS scores and intracerebral hemorrhage) were reported using unadjusted and adjusted analyses. RESULTS: There was no evidence of treatment heterogeneity between subjects in the early and late windows. Treatment effect favoring intervention was seen across all clinical outcomes in the extended time window (absolute risk difference of 19.3% for mRS 0–2 at 90 days). There were more asymptomatic intracerebral hemorrhage events within the intervention arm (48.5% versus 11.5%, P = .004) but no difference in symptomatic intracerebral hemorrhage. CONCLUSIONS: Patients with an extended time window could potentially benefit from endovascular treatment. Ongoing randomized controlled trials using imaging to identify late presenters with favorable brain physiology will help cement the paradigm of using time windows to select the population for acute imaging and imaging to select individual patients for therapy.

Background To determine the clinical outcomes of perimesencephalic subarachnoid hemorrhages based on the computed tomography (CT) bleeding patterns. Methods This retrospective cohort study included: (1) patients (≥18 years) admitted to a comprehensive stroke center (January 2015-May 2018), (2) with angiography-negative, nontraumatic subarachnoid hemorrhage in a perimesencephalic or diffuse bleeding pattern, and (3) had CT imaging performed in ≤ 72 hours of symptom onset. Patients were stratified by location of bleeding on CT: Peri-1: focal prepontine hemorrhage; Peri-2: prepontine with suprasellar cistern +/- intraventricular extension; and diffuse. Results Of the 39 patients included, 13 were Peri-1, 11 were Peri-2, and 15 were diffuse. The majority were male (n = 26), with a mean (standard deviation) age of 55.3 (11.3) years, who often presented with headache (n = 37) and nausea (n = 28). Overall, patients in Peri-1 were significantly less likely to have hydrocephalus compared to Peri-2 and dSAH (P= .003), and 4 patients required an external ventricular drain. Five patients developed symptomatic vasospasm. Patients in Peri-1, compared to Peri-2 and diffuse, had a significantly shorter median neuro critical care unit length of stay (LOS) and hospital LOS. Most patients (n = 35) had a discharge modified Rankin Score between 0 and 2 with no significant differences found between groups. Conclusion These data suggest that patients with the best clinical course were those in Peri-1, followed by Peri-2, and then diffuse. Because these patients often present with similar clinical signs, stratifying by hemorrhage pattern may help clinicians predict which patients with perimesencephalic subarachnoid hemorrhage develop complications.

Background: Our level 1 stroke center has developed a standardized protocol, which has allowed us to achieve a median door-to-recanalization time of less than 60 minutes. In order to achieve such rapid recanalization rates, the neuro-interventional team is called in to meet the stroke patient upon their arrival to the hospital. We will describe our protocol for achieving rapid recanalization, and we will discuss the cost. Methods: For the last 18 months, while performing more than 300 thrombectomies, we have achieved a median door-to-recanalization time of < 60 minutes. Standardized protocols have contributed to this rapid time metric, but the most important contribution to time savings was calling in the neuro-interventional team to meet the patient upon their arrival to the emergency room. The neuro-interventional team called in to meet the patient includes: 1 RN, 2 technologists, 1 anesthesiologist and 1 neurointerventional surgeon. We will analyze time metrics, the percent of neuro-interventional stroke alerts that proceed to thrombectomy and the personnel costs for this protocol in this consecutive cohort of patients. Results: From 1/1/2017 – 3/31/2018, there were 1162 ELVO activations of the neuro-interventional team. Of these alerts, 314 proceeded to thrombectomy, equal to a 27% rate of thrombectomy. This rate was 21% during weekday working hours, 43% after 5 PM on weekdays, and 29% on weekends. If a thrombectomy is not performed, the RN and technologists are each paid 2 hours of overtime pay. Not counting hours lost in daytime productivity, physician time, and hours of lost sleep, there were more than 5000 hours paid to the RNs and technologists for these alerts that did not proceed to thrombectomy, totaling > $200,000.00 in overtime pay. The median time from patient arrival to recanalization was 52 minutes. The median time from door to groin puncture was 34.5 minutes, and from groin puncture to recanalization was 17.5 minutes. Conclusion: Rapid and safe revascularization helps achieve the best clinical outcomes in ELVO patients, and our stroke systems of care need to be streamlined to achieve these rapid time metrics, but it comes at a cost. Cost benefit analysis suggests in house neurointerventional teams may be needed to take care of these patients best.

Background: Given the overwhelming evidence for the benefit of stent-retriever thrombectomy, a future trial of primary aspiration thrombectomy (PAT) against best medical therapy (BMT) alone has become unethical and impractical. Therefore, alternative approaches are needed to further investigate the impact of PAT in the outcomes in large vessel occlusion (LVO) strokes. The aim of this project is to assess the effectiveness of PAT plus BMT (including IV t-PA if indicated) compared to BMT alone in patients with anterior circulation LVO strokes. Methods: A systematic search of the medical literature and trial registries (EMBASE, Pubmed Medline, Cochrane trial registry, clinical trials.gov and ISRCTN) was conducted to trace randomized clinical trials (RCT) that evaluated PAT as a first treatment approach for LVO strokes. Four prospective RCTs employing aspiration thrombectomy as a primary treatment modality in one arm were identified: THERAPY (n=108; 55 PAT), Penumbra 3D Stent-Retriever (n=198; 100 PAT), ASTER (n=381; 192 PAT) and COMPASS (n=270; 134 PAT). Data from the PAT arms from these four RCTs and controls from the MR CLEAN (n=500; 267 controls) and THERAPY (53 controls) trials will be pooled. Treatment effect on the primary outcome (90-day mRS ordinal shift analysis) will be analyzed with multivariable ordinal regression analysis in the propensity matched dataset, after adjusting for remaining differences in distribution of baseline prognostic factors, to increase power. Adjustments will be made for age, sex, baseline NIHSS, collateral score, pre-treatment ASPECTS, admission glucose levels, time from stroke onset to qualifying imaging. The effect will be expressed as an adjusted common odds ratio, with 95% confidence interval. Treatment effects for secondary outcomes will be estimated in a similar approach, with the appropriate regression method. Results: The data will be analyzed by an independent statistical group (Erasmus MC, University Medical Center Rotterdam, the Netherlands). The results will be available and reported at the time of the ISC 2019. Conclusion: This pooled data project will provide unique and high-level evidence concerning the effect of aspiration thrombectomy on functional outcome after acute ischemic stroke.

The overwhelming benefit of endovascular therapy in patients with large-vessel occlusions suggests that more patients will be screened than treated. Some of those patients will be evaluated first at primary stroke centers; this type of evaluation calls for standardizing the imaging approach to minimize delays in assessing, transferring, and treating these patients. Here, we propose that CT angiography (performed at the same time as head CT) should be the minimum imaging approach for all patients with stroke with suspected large-vessel occlusion presenting to primary stroke centers. We discuss some of the implications of this approach and how to facilitate them.

Intra-arterial therapy (IAT) is most effective when performed rapidly after ischemic stroke onset. However, there are limited performance benchmarks in IAT and there is a scarcity of information on how to structure an effective IAT protocol and its impact on time to treatment. The objective of our study was to detail a standardized IAT protocol, and to assess its influence on time to treatment in ischemic stroke.This was a retrospective observational study over 4 years at a comprehensive stroke center. A standardized IAT protocol was implemented in June 2013 that included pre-notifying the stroke team before hospital arrival, defining clinician roles, processing tasks in parallel, and standardizing IAT procedures. Three time metrics were examined and reported as median (IQR) minutes: arrival to CT imaging, CT to groin puncture, and puncture to recanalization. We compared these metrics in patients admitted before implementation (January 2012-May 2013) to patients admitted after (June 2013-December 2015) using Wilcoxon Mann-Whitney tests.380 patients were included. After the protocol was implemented, there were significant reductions in time from arrival to CT (17 (14-21) vs 13 (11-19) min, p0.001), CT to puncture (46 (30-82) vs 31 (23-54) min, p0.001), and puncture to recanalization (65 (33-90) vs 37 (22-65) min, p0.001). 60% of time was saved during puncture to recanalization. Significant reductions in time were observed during both normal working hours and off-hours.Implementation of a standardized protocol resulted in a significant reduction in time to recanalization for patients with an ischemic stroke. A standardized IAT protocol decreases time to recanalization when team roles are clearly defined, tasks are processed in parallel, and procedures are standardized.

ObjectiveThe safety and efficacy of intra-arterial treatment (IAT) in patients with acute ischemic stroke (AIS) due to cervical artery dissection (CeAD) has not been formally studied. The purpose of this study was twofold: first, describe a large series with CeAD treated with IAT; second, analyze outcomes with CeAD receiving IAT versus (a) CeAD not treated with IAT, (b) CeAD receiving intravenous thrombolysis (IVT) alone, and (c) non-CeAD mechanism of AIS receiving IAT.DesignDemographics, clinical characteristics, treatment, and outcomes were summarized for all CeAD patients treated with IAT from January 2010 to May 2015. Outcomes included favorable 90 day modified Rankin Scale (mRS) score of 0–2, symptomatic intracerebral hemorrhage (sICH), recanalization (Thrombolysis in Cerebral Infarction 2b-3), procedural complications, and mortality. Outcomes were analyzed with χ2 tests and multivariate logistic regression.ResultsThere were 161 patients with CeAD: 24 were treated with IAT and comprised our target population. Dissections were more common in the internal carotid (n=18) than in the vertebral arteries (n=6). All but one patient had intracranial embolus. IAT techniques included thrombectomy (n=19), IA thrombolysis (n=17), stent (n=14), and angioplasty (n=7). Outcomes included favorable 90 day mRS score of 0–2 in 63%, 4 deaths, 1 sICH, and 3 procedural complications. After adjustment, favorable mRS in our target population was similar to comparison populations: (a) in CeAD, IAT versus no IAT (OR 0.62, p=0.56); (b) In CeAD, IAT versus IVT alone (OR 1.32, p=0.79); and (c) IAT in CeAD versus non-CeAD mechanism of AIS (OR 0.58, p=0.34).ConclusionsIAT is a valid alternative therapeutic option for AIS caused by CeAD due to the low complication rate and excellent outcomes observed in this study.

Background— The Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) trial used innovative imaging and aggressive target time metrics to demonstrate the benefit of endovascular treatment in patients with acute ischemic stroke. We analyze the impact of time on clinical outcome and the effect of patient, hospital, and health system characteristics on workflow within the trial. Methods and Results— Relationship between outcome (modified Rankin Scale) and interval times was modeled by using logistic regression. Association between time intervals (stroke onset to arrival in endovascular-capable hospital, to qualifying computed tomography, to groin puncture, and to reperfusion) and patient, hospital, and health system characteristics were modeled by using negative binomial regression. Every 30-minute increase in computed tomography-to-reperfusion time reduced the probability of achieving a functionally independent outcome (90-day modified Rankin Scale 0–2) by 8.3% ( P =0.006). Symptom onset-to-imaging time was not associated with outcome ( P >0.05). Onset-to-endovascular hospital arrival time was 42% (34 minutes) longer among patients receiving intravenous alteplase at the referring hospital (drip and ship) versus direct transfer (mothership). Computed tomography-to-groin puncture time was 15% (8 minutes) shorter among patients presenting during work hours versus off hours, 41% (24 minutes) shorter in drip-ship patients versus mothership, and 43% (22 minutes) longer when general anesthesia was administered. The use of a balloon guide catheter during endovascular procedures shortened puncture-to-reperfusion time by 21% (8 minutes). Conclusions— Imaging-to-reperfusion time is a significant predictor of outcome in the ESCAPE trial. Inefficiencies in triaging, off-hour presentation, intravenous alteplase administration, use of general anesthesia, and endovascular techniques offer major opportunities for improvement in workflow. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01778335.

Acute ischemic stroke remains a major public health concern, with low national treatment rates for the condition, demonstrating a disconnection between the evidence of treatment benefit and delivery of this treatment. Intravenous thrombolysis and endovascular thrombectomy are both strongly evidence supported and exquisitely time sensitive therapies. The mismatch between the distribution and incidence of stroke presentations and the availability of specialist care significantly affects access to care. Telestroke, the use of telemedicine for stroke, aims to surmount this hurdle by distributing stroke expertise more effectively, through video consultation with and examination of patients in locations removed from specialist care. This is the second of a two part review, and is focused on the challenges telestroke faces for wider adoption. It further details the anticipated evolution of this novel therapeutic platform, and the potential roles it holds in stroke prevention, ambulance based care, rehabilitation, and research.

Six recent trials and a patient-level meta-analysis have demonstrated the superiority of endovascular therapy (EVT) compared with standard care (including intravenous alteplase) among patients with large-artery anterior circulation strokes.1–7 The absolute benefit of EVT was substantial in these trials, and EVT now requires careful implementation and optimization in real-world settings to provide all eligible patients with this new standard of care. Parallel rather than serial workflow, with team members having well-defined roles, is a crucial element in providing rapid and effective delivery of acute stroke care.8 There is little or no literature on the division of labor or the expected role for each individual in this setting, and existing stroke guidelines do not elaborate on this issue. Although each system may require customization, it is clear is that there must be physician leadership outside of the angiography suite, a physician in addition to the neurointerventionalist (who is most commonly a radiologist, but who may be a neurosurgeon or neurologist) in the angiography suite, and a physician to coordinate care between the other stroke team members throughout the periprocedural period. We suggest that it is necessary to designate a physician to fulfill these roles during the EVT process, and we have termed herein the individual fulfilling this role the stroke physician. The stroke physician must work in close collaboration with the neurointerventionalist to optimize the speed, efficiency, and safety of EVT, elements which are critical to enhancing patient outcomes. A proposed division of physician roles is shown in Table, with emphasis on parallel rather than serial workflow. The administration of intravenous alteplase is ideally performed under the guidance of a stroke physician with specialized training in stroke care. This is most often a neurologist but may also be an emergency physician, geriatrician, internist, or family physician, …

The Thrombolysis in Cerebral Infarction (TICI) grading system was first described by Higashida in 20031 and later modified.2 More recently a 2C grade (near complete, >90%) has been adopted widely (table 1).3 However, this grading system is based on the assumption that the emergent large vessel occlusion (ELVO) involves the M1 segment (or carotid terminus) and loses relevance when this is not the case. Consider a superior division M2 occlusion, for example. Assuming codominant M2 divisions, from the onset of the procedure the TICI grade would be a 2B: an endpoint indicating successful recanalization in the historical literature. If partial M2 recanalization was achieved it may still be graded as a 2B at the conclusion, rendering it impossible to decipher if progress had been made. An alternative approach would be to grade the M2 occlusion a ‘target vessel TICI’ 0. In this manner, at the procedure conclusion, whether it remained a 0 or if it were recanalized …

Introduction Smart Coils are novel generation of embolic coils comprised of complex and WAVE shape properties with varying levels of softness to promote dense packing and durable long-term occlusion. We report results from interim analysis on utility of the Penumbra Smart Coil System in the treatment of a variety of intracranial vascular lesions, such as aneurysms and other abnormalities. Methods SMART registry is a prospective and multi-center registry assessing treatment of intracranial aneurysms and other malformations. Procedures must implant at least 75% Smart, PC400, or POD coils to meet the registry criteria. SMART registry endpoints include retreatment through one-year follow-up, procedural device-related serious adverse events (SAE), occlusion status at immediate post-procedure, and at one- year follow-up. Results The interim analysis from the first 500 consecutive subjects enrolled includes cerebral aneurysms (90.6%, 451/498), of which 31.0% were ruptured; arteriovenous malformations (1.4%); fistulae (4.6%); and other lesions (3.4%). At presentation, 70.8% of subjects were female, and the mean age was 60.0±13.3 years. The primary lesion locations are ACA (23.1%), ICA (37.6%), MCA (11.8%), posterior circulation (19.3%), and other locations (8.2%). Aneurysms were small (87.7%), large (12.1%), and giant (0.2%), with 64.2% (265/413) having a wide neck. The coil deployment time is defined as the time from the first coil deployed until the last coil detached. The median time of coil deployment is 16.0 min (IQR 8.0–32.0) and the median time of fluoroscopic exposure is 36.5 min (IQR 24.0–56.0). The mean number of coils deployed was 5.9±5.9. Stent-assisted coiling was performed in 29.8% of patients, whereas balloon-assisted coiling was performed on 19.4% of patients. The median packing density for all aneurysms was 29.5% (IQR 21.4–38.3). For all subjects, adequate occlusion at immediate post-procedure was achieved for 97.6% (483/495). In aneurysm subjects, class I and II Raymond Roy Occlusion was 79.7% (354/444) at immediate post-procedure, and 88.6% (124/140) at one year follow-up. The retreatment rate through one year follow-up was 3.8% (6/157). Procedural device-related SAE were observed in 3.2% subjects (16/500). Mortality within 24 hours of intervention was reported in 0.4% (2/496), and after 24 hours in 11.4% (21/185); no deaths were device-related. One-year follow-up data collection is ongoing. Conclusion Initial results suggest that Smart Coil achieves adequate embolization in variety of neurovascular lesions. Disclosures D. Frei: 2; C; Penumbra Inc. K. Liu: None. C. Schirmer: None. B. Bohnstedt: None. R. Bellon: None. R. DeLeacy: None. D. Fiorella: None. A. Spiotta: 2; C; Penumbra Inc.

Introduction Wide-necked bifurcating aneurysms remain a significant challenge for endovascular treatment. Therefore, the Barrel VRD was designed to specifically address wide-neck bifurcating anatomy with a bulging center that has two ‘hinge’ segments to allow excellent apposition across the aneurysm neck. Materials and methods The Barrel IDE Study was an FDA approved, Prospective, Multi-Center, Single-Arm Study of the Barrel Vascular Reconstruction Device (VRD) for Adjunctive Treatment to Embolic Coils for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms of Middle Cerebral and Basilar Arteries. The primary effectiveness endpoint was the percentage of Barrel VRD treated aneurysms achieving Raymond Grade I (100% occlusion) at one year, in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture. The primary safety endpoint was the incidence of neurological death or major ipsilateral stroke at any time during the follow-up period. Results The BARREL IDE Study enrolled a total of 138 patients. The mean aneurysm neck size was 4.8±1.4 mm with aneurysm neck size up to 7.9 mm and dome/neck ratio of 1.3±0.4. The 12 month primary effectiveness endpoint was achieved in 63% of patients. The primary safety endpoint occurred in 3.9% (5/127) of subjects. Comprehensive final results of the Barrel IDE Study will be presented at the SNIS annual meeting. Conclusion The BARREL IDE Study demonstrates the safety and efficacy of an important new technology to treat challenging wide-neck, intracranial, bifurcation/branching aneurysms of Middle Cerebral and Basilar Arteries. Disclosures J. Mocco: 1; C; Medtronic. 2; C; TSP, Rebound Therapeutics, Viseon, Pulsar, Cerebrotech, Endostream, Vastrax. 4; C; Cerebrotech, TSP, Endostream, Apama, Rebound, Viseon, Neurvana, Cardinal Consulting, Blink TBI, Serenity, NTI. 5; C; Mount Sinai. 6; C; INVEST Study (Co-PI), COMPASS Study (Co-PI), THERAPY Study (PI), FEAT Study (PI), POSITIVE Study (Co-PI), BARREL Study (PI). S. Tateshima: 1; C; Medtronic. 2; C; Medtronic, Stryker, Cerenovus, Balt USA, Spartan Micro, NeuroVasc Technologies, ReBound Therapeutic, Century Medical, Walk Vascular, Python Vascular. 4; C; Balt USA, ReBound Therapeutic, Viseon Spine, Python Vascular, NeuroVasc Technologies, Spartan Micro. 5; C; University of California Los Angeles. 6; C; NAPA Study, Steering Committee, ARTISSE Trial Steering Committee, NeuroVasc Versi Study in Canada, DSMB Chair. D. Frei: 2; C; Cerenovus, Stryker, Penumbra, Genentech. 4; C; Penumbra. 5; C; RIA Radiology Imaging Associates. 6; C; Enterprise Stent IDE Trail (PI). A. Siddiqui: 2; C; Apama Medical, Cardinal Health, Cerenovus, Large Trial, ARISE II Trial, Claret Medical, Imperative Care, Integra, International Medical Distribution Partners, Medtronic, Microvention, Penumbra, 3D Separator Trial, COMPASS Trial, INVEST Trial, Rapid Medical, Rebound Therapeutics, Silk Road Medical, StimMed. 4; C; Amnis Therapeutics, BlinkTBI, Inc, Boston Scientific, Cerenovus, Claret Medical, Cognition Medical, Corindus, Inc., Guidepoint Global Consulting, Integra, StimMed. 6; C; Buffalo Technology Partners, Inc., Canon Medical Systems USA, Inc., Cerebrotech Medical Systems, Inc., Endostream Medical, Ltd., Guidepoint Global Consulting, Integra, Medtronic, Silk Road Medical.

Background In order to maximize clinical outcomes in patients with acute ischemic stroke related to ELVO (Emergent Large Vessel Occlusion), safe and rapid recanalization is necessary. Our level 1 stroke center has developed a standardized protocol which has allowed us to achieve a median door-to-recanalization time of less than 60 min. In order to achieve such rapid recanalization rates, the neuro-interventional team is called in to meet the stroke patient upon their arrival to the hospital. We will describe our protocol for achieving rapid recanalization, and we will discuss the cost. Methods For the last 18 months, while treating more than 300 patients, we have achieved a median door-to-recanalization time of Results From 1/1/2017 – 3/31/2018, there were 1162 ELVO activations of the neuro-interventional team. Of these alerts, 314 proceeded to thrombectomy, equal to a 27% rate of thrombectomy. This rate was 21% during weekday working hours, 43% after 5 PM on weekedays, and 29% on weekends. If a thrombectomy is not performed, the RN and technologists are each paid 2 hours of overtime pay. Not counting hours lost in daytime productivity, physician time, and hours of lost sleep, there were more than 5000 hours paid to the RNs and technologists for these alerts that did not proceed to thrombectomy, totaling > $200,000.00 in overtime pay. The median time from patient arrival to recanalization was 52 min. The median time from door to groin puncture was 34.5 min, and from groin puncture to recanalization was 17.5 min. Conclusion Rapid and safe revascularization helps achieve the best clinical outcomes in ELVO patients, and our stroke systems of care need to be streamlined to achieve these rapid time metrics, but it comes at a cost. Cost benefit analysis suggests in house neurointerventional teams may be needed to take care of these patients best. Disclosures D. Frei: 1; C; Ceranovus, Stryker, Medtronic, Siemens, Microvention, Penumbra. 2; C; Ceranovus, Stryker, Penumbra, Genentech. 3; C; Ceranovus, Stryker, Penumbra, Genentech. 4; C; Penumbra. B. Atchie: None. I. Kaminsky: None. R. Bellon: None. D. Wilson: None.

This is truly a remarkable time for both patients and physicians treating acute ischemic stroke. Patients suffering from an emergent large vessel occlusion (ELVO) have more hope for recovery than ever before. Stroke surgeons are now equipped with safe and effective treatment methods for ELVO patients, backed with overwhelming level 1A evidence. The pool of patients who may receive a benefit from thrombectomy is expanding as patient selection, thrombectomy techniques, and stroke systems of care are further optimized. The refinement of strategies for thrombectomy has revolutionized our technical approach as stroke surgeons. Gone are the days when thrombectomy procedures would routinely take 2 hours, with less than half of cases achieving successful recanalization. These prolonged procedures often involved progressively more aggressive attempts with multiple devices and, often, the most difficult decision was when to throw in the towel and abort the case in the hopes of avoiding a complication. The current mindset is entirely different. We start the thrombectomy procedure with the evidence-based expectation that it will be a success. While the drive and motivation of those caring for ELVO patients has not changed, the attitude has drastically improved from defeatist to positive. As the latest data from the COMPASS trial have demonstrated, both aspiration and stent-trievers can be …

Importance The treatment effects of individual mechanical thrombectomy devices in large-vessel acute ischemic stroke (AIS) remain unclear. Objective To determine whether the novel 3-dimensional (3-D) stent retriever used in conjunction with an aspiration-based mechanical thrombectomy device (Penumbra System; Penumbra) is noninferior to aspiration-based thrombectomy alone in AIS. Design, Setting, and Participants This randomized, noninferiority clinical trial enrolled patients at 25 North American centers from May 19, 2012, through November 19, 2015, with follow-up for 90 days. Adjudicators of the primary end points were masked to treatment allocation. Patients with large-vessel intracranial occlusion AIS presenting with a National Institutes of Health Stroke Scale (NIHSS) score of at least 8 within 8 hours of onset underwent 1:1 randomization to 3-D stent retriever with aspiration or aspiration alone. The primary analyses were conducted in the intention-to-treat population. Interventions Mechanical thrombectomy using intracranial aspiration with or without the 3-D stent retriever. Main Outcomes and Measures The primary effectiveness end point was the rate of a modified Thrombolysis in Cerebral Infarction (mTICI) grade of 2 to 3 with a 15% noninferiority margin. Device- and procedure-related serious adverse events at 24 hours were the primary safety end points. Results Of 8082 patients screened, 198 patients were enrolled (111 women [56.1%] and 87 men [43.9%]; mean [SD] age, 66.9 [13.0] years) and randomized, including 98 in the 3-D stent retriever with aspiration group and 100 in the aspiration alone group; an additional 238 patients were eligible but not enrolled. The median baseline NIHSS score was 18.0 (interquartile range, 14.0-23.0). Eighty-two of 94 patients in the 3-D stent retriever and aspiration group (87.2%) had an mTICI grade of 2 to 3 compared with 79 of 96 in the aspiration alone group (82.3%; difference, 4.9%; 90% CI, −3.6% to 13.5%). None of the other measures were significantly different between the 2 groups. Device-related serious adverse events were reported by 4 of 98 patients in the 3-D stent retriever with aspiration group (4.1%) vs 5 of 100 patients in the aspiration only group (5.0%); procedure-related serious adverse events, 10 of 98 (10.2%) vs 14 of 100 (14.0%). A 90-day modified Rankin Scale score of 0 to 2 was reported by 39 of 86 patients in the 3-D stent retriever with aspiration group (45.3%) vs 44 of 96 patients in the aspiration only group (45.8%). Conclusions and Relevance The present study provides class 1 evidence for the noninferiority of the 3-D stent retriever with aspiration vs aspiration alone in AIS. Future trials should evaluate whether these results can be generalized to other stent retrievers. Trial Registration clinicaltrials.gov Identifier:NCT01584609

ESCAPE is a prospective, multicenter, randomized clinical trial that will enroll subjects with the following main inclusion criteria: less than 12 h from symptom onset, age > 18, baseline NIHSS >5, ASPECTS score of >5 and CTA evidence of carotid T/L or M1 segment MCA occlusion, and at least moderate collaterals by CTA. The trial will determine if endovascular treatment will result in higher rates of favorable outcome compared with standard medical therapy alone. Patient populations that are eligible include those receiving IV tPA, tPA ineligible and unwitnessed onset or wake up strokes with 12 h of last seen normal. The primary end-point, based on intention-to-treat criteria is the distribution of modified Rankin Scale scores at 90 days assessed using a proportional odds model. The projected maximum sample size is 500 subjects. Randomization is stratified under a minimization process using age, gender, baseline NIHSS, baseline ASPECTS (8–10 vs. 6–7), IV tPA treatment and occlusion location (ICA vs. MCA) as covariates. The study will have one formal interim analysis after 300 subjects have been accrued. Secondary end-points at 90 days include the following: mRS 0–1; mRS 0–2; Barthel 95–100, EuroQOL and a cognitive battery. Safety outcomes are symptomatic ICH, major bleeding, contrast nephropathy, total radiation dose, malignant MCA infarction, hemicraniectomy and mortality at 90 days.

Background Cerebral venous thrombosis is a rare cause of stroke that poses diagnostic, therapeutic, and prognostic challenges. Mainstay treatment is systemic anticoagulation, but endovascular treatment is increasingly advocated. Our objectives were to describe the epidemiology, treatment, and prognosis of 152 patients with cerebral venous thrombosis. Methods and Results This was a retrospective study of consecutive cerebral venous thrombosis cases from 2006 to 2013 at a comprehensive stroke center through hospital discharge. Predictors of full recovery (modified Rankin Scale scores 0–1) were analyzed with multiple logistic regression and presented as adjusted odds ratios ( AORs ) with 95% confidence intervals ( CIs ). The population was young (average age: 42 years), majority female (69%), and commonly presenting with cerebral edema (63%), and 72% were transferred in. All patients received systemic anticoagulation; 49% (n=73) required endovascular treatment. Reasons for requiring endovascular treatment included cerebral edema, herniation, or hemorrhagic infarct (n=38); neurologic decline (n=17); rethrombosis, persistent occlusion, or clot propagation (n=10); extensive clot burden (n=7); and persistent headache despite anticoagulation (n=1). There were 7 (10%) procedural complications. Recanalization was successful (61%), partial (30%), and unsuccessful (9%). Overall, 60% fully recovered. Positive predictors of full recovery included hormonal etiology, particularly for patients who were transferred in ( AOR : 7.06 [95% CI, 2.27–21.96], interaction P =0.03) and who had migraine history ( AOR : 4.87 [95% CI, 1.01–23.50], P =0.05), whereas negative predictors of full recovery were cerebral edema ( AOR : 0.11 [95% CI, 0.04–0.34], P AOR : 0.28 [95% CI, 0.09–0.96], P =0.04). Conclusions As one of the largest cohort studies, our findings suggest that cerebral edema, history of migraine, and hormonal etiology were prognostic and that endovascular treatment might be a safe and effective treatment for cerebral venous thrombosis when conventional management is inadequate.

Background and Purpose— In the ESCAPE trial (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times), patients with large vessel occlusions and small infarct cores identified with computed tomography (CT)/CT angiography were randomized to endovascular therapy or standard of care. CT perfusion (CTP) was obtained in some cases but was not used to select patients. We tested the hypothesis that patients with penumbral CTP patterns have higher rates of good clinical outcome. Methods— All CTP data acquired in ESCAPE patients were analyzed centrally using a semiautomated perfusion threshold-based approach. A penumbral pattern was defined as an infarct core 15 mL, and a total hypoperfused volume:core volume ratio of >1.8. The primary outcome was good functional outcome at 90 days (modified Rankin Scale score, 0–2). Results— CTP was acquired in 138 of 316 ESCAPE patients. Penumbral patterns were present in 116 of 128 (90.6%) of patients with interpretable CTP data. The rate of good functional outcome in penumbral pattern patients (53 of 114; 46%) was higher than that in nonpenumbral patients (2 of 12; 17%; P =0.041). In penumbral patients, endovascular therapy increased the likelihood of a good clinical outcome (34 of 58; 57%) compared with those in the control group (19 of 58; 33%; odds ratio, 2.68; 95% confidence interval, 1.25–5.76; P =0.011). Only 3 of 12 nonpenumbral patients were randomized to the endovascular group, preventing an analysis of treatment effect. Conclusions— The majority of patients with CTP imaging in the ESCAPE trial had penumbral patterns, which were associated with better outcomes overall. Patients with penumbra treated with endovascular therapy had the greatest odds of good functional outcome. Nonpenumbral patients were much less likely to achieve good outcomes.

BACKGROUND Mechanical thrombectomy (MT) is the current standard of care for acute ischemic stroke (AIS) patients with emergent large-vessel occlusions (ELVO). Successful reperfusion of ELVO is traditionally defined by modified Thrombolysis in Cerebral Infarction (mTICI) grades of 2b or 3. OBJECTIVE To evaluate the comparative safety and efficacy of mTICI 2b and mTICI 3 reperfusion in AIS patients treated with MT. METHODS Consecutive ELVO patients who underwent MT at 6 high-volume centers were included in this analysis. Standard safety (3-mo mortality, symptomatic intracranial hemorrhage [sICH]) and efficacy (absolute and relative reduction in NIHSS-scores during hospitalization, functional-improvement [shift analysis in mRS-scores], and functional-independence [mRS-scores of 0-2] at 3-mo) were compared between patients who had mTICI 2b and mTICI 3 reperfusion post MT. RESULTS A total of 416 ELVO patients achieved successful reperfusion with mTICI 2b (n = 216) and mTICI 3 (n = 200) following MT. The mTICI 3 group had significantly (P < .05) greater absolute (11 vs 9 points) and relative (77% vs 63%) reduction in NIHSS-scores during hospitalization, lower sICH (6% vs 12%), and higher 3-mo functional-independence (55% vs 44%) rates. Successful reperfusion with mTICI 3 was independently (P < .05) associated with greater absolute and relative reduction in NIHSS-scores during hospitalization as well as higher odds of 3-mo functional improvement (common odds ratios: 1.67; 95% confidence interval: 1.10-2.56) and functional independence (odds ratio: 2.08; 95% confidence interval: 1.22-3.53) in multivariable regression models adjusting for confounders. CONCLUSION Successful reperfusion with mTICI 3 was associated with greater neurological improvement during hospitalization and better 3-mo functional outcomes in comparison to mTICI 2b reperfusion.

BackgroundTandem occlusions of the extracranial carotid and intracranial carotid or middle cerebral artery have a particularly poor prognosis without treatment. Several management strategies have been used with no clear consensus recommendations. We examined subjects with tandem occlusions enrolled in the ESCAPE trial and their outcomes.MethodsData are from the ESCAPE trial. Additional data were sought on interventions for each subject.ResultsThere were 54 (17%) subjects with tandem extracranial and intracranial occlusions. Patients in the endovascular treatment arm (n=30) were more likely to be younger (median age 66 years, pConclusionsTandem occlusions occurred in one-sixth of patients and were treated highly variably within the ESCAPE trial. While outcomes were similar, the best method to treat the carotid artery in patients with tandem occlusion awaits further randomized data.Trial registration numberNCT01778335.

Purpose It is well established that endovascular thrombectomy (EVT) benefits patients with acute ischemic stroke (AIS). Nevertheless, although ~30% of patients with large infarct volume regain functional independence at 90 days, it remains controversial whether this particular cohort should be treated. The purpose of this study was to determine predictors of functional independence in a large infarct AIS patient cohort treated with EVT. Materials and methods Patients treated with the Penumbra System were pooled from five, multicenter trials (PIVOTAL, PICS, RetroSTART, START, Separator 3D). Of the 957 pooled AIS patients, data from 614 met study criteria and were subjected to multivariate analyses to identify factors which predict functional independence (90 day mRS 0–2) in the Penumbra System ASPECTS 0–6 cohort. These data were subsequently compared to an ASPECTS 0–6 natural history cohort. Results The rate of 90 day functional independence was 27.1% and 7.9% in the EVT ASPECTS 0–6 cohort compared to the natural history cohort, respectively (p=0.0002). Amongst the ASPECTS 0–6 EVT patients, the mortality rate was 34.8% compared to 23.6% in the ASPECTS 0–6 natural history cohort (p=0.084). The rate of symptomatic intracranial hemorrhage (sICH) was 14.2% in the ASPECTS 0–6 EVT patient population compared to 3.4% in the ASPECTS 0–6 natural history cohort (p=0.0077). Among the ASPECTS 0–6 patient population treated with mechanical thrombectomy, age (p=0.0048) and NIHSS at admission (p=0.0198) were significantly associated with functional independence at 90 days. The results of these analyses are depicted in Tables 1 and 2. Conclusions The present analysis indicates that large infarct volume patients who present with predictors of 90 day functional independence should be considered for endovascular treatment. These results have significant implications for the decision to treat in this AIS stroke cohort. Disclosures D. Frei: 2; C; Penumbra, Inc.. 4; C; Penumbra, Inc.. R. Nogueira: None. A. Siddiqui: 6; C; Penumbra, Inc. J. Wagner: 3; C; Genentech. 6; C; Penumbra, Inc.. O. Zaidat: None. A. Yoo: 1; C; Penumbra, Inc.. 2; C; Neuravi.

Introduction Endovascular therapy for cerebral aneurysms has increasingly been adopted as a viable treatment strategy for its minimally invasive but effective approach. This rising adoption has been correlated with an evolution in coil technology, including the recently FDA-cleared SMART Coil. In contrast to traditional bare metal coils, which have historically been designed with a uniform degree of softness, SMART Coils are designed with transitional softness, allowing the coil to become progressively softer as it is deployed. This mitigates catheter kickback while enabling the coil to pack more tightly and achieve greater packing density. Herein, we present our initial technical experience on aneurysm obliteration with SMART Coils. Methods Following IRB approval, a retrospective review was conducted at 2 centers to identify consecutive patients presenting with cerebral aneurysms wherein at least 1 SMART Coil was employed as intervention. Patient characteristics, procedural metrics, angiographic outcome, and procedural outcome data were captured to evaluate the safety and efficacy of the use of SMART Coils. Adverse events were classified as major or minor, depending upon whether additional intervention was needed (major). Occlusion outcome was graded using the Raymond Roy Occlusion Classification, in which Class I was complete obliteration, and Class III denotes residual aneurysm. Results Between July 2015 and January 2016, 59 patients were identified wherein embolization was performed with at least 1 SMART Coil; 44% presented with ruptured aneurysms. The mean aneurysm size was 5.9±2×4.5±2 mm, with an average neck diameter of 3.4±1 mm. In total, 54.2% of patients were treated exclusively with SMART Coils while the remainder used various framing or finishing coils. Balloon-assisted coiling was employed in 33.9%, and stent-assisted coiling in 47.5% of all cases. More specifically, in patients wherein SMART Coils were used exclusively, 34.4% were treated with balloon assistance, and 43.4% employed stent-assisted coiling. In the remaining patients, these rates were 77.8% and 51.9%, respectively, for balloon and stent-assisted coiling. Minor adverse events occurred in 10.1%, and included thrombus formation along the coil mass (n=4), thrombus formation within the stent (n=2), and coil prolapse (n=2); none resulted in sequelae. No major adverse events observed. On average, 6.4 ±4 coils were deployed per aneurysm, with a mean fluoroscopy time of 48.5±22 min. Occlusion outcomes included Class I in 33.9%, Class II in 37.3% and Class III in 28.8%. No rebleeds have been observed. Conclusion The progressive design of SMART Coils offered appreciable clinical advantages during deployment. In addition, SMART demonstrated satisfactory safety and efficacy outcomes in treatment of a wide variety aneurysms, both ruptured and unruptured. Disclosures A. Spiotta: 1; C; Penumbra, Inc.. 2; C; Penumbra, Inc. 4; C; Penumbra, Inc. K. Fargen: None. J. Lena: 2; C; Penumbra, Inc. I. Chaudry: 1; C; Penumbra, Inc. 4; C; Penumbra, Inc. R. Turner: 1; C; Penumbra, Inc. 4; C; Penumbra, Inc. A. Turk: 1; C; Penumbra, Inc. 4; C; Penumbra, Inc.. D. Huddle: None. L. David: None. R. Bellon: None. D. Frei: 2; C; Penumbra, Inc., Codman, Microvention, Stryker, Siemens, Codman, Microvention, Stryker, Siemens. 4; C; Penumbra, Inc.

Background Mechanical thrombectomy (MT) for acute ischemic stroke (AIS) patients with emergent large-vessel occlusions (ELVO) has become the standard of care. A recent meta-analysis of the 5 randomized trials demonstrated that 46% of patients in the intervention arm achieved mRS of 0–2 at 3 months. Considering the fact that significant numbers of patients still have residual disability at three months despite MT, it is important to consider other modifiable variables that might improve functional outcomes in patients with ELVO. Successful reperfusion post MT is the strongest modified predictor of the outcome. Thrombolysis in cerebral infarction (TICI) grades are current standard of care for assessment of degree of reperfusion post MT. Recently conducted trials defined both TICI 2b and 3 grades as successful reperfusion. In this multicenter study we sought to evaluate if there are any differences in safety and effectiveness outcomes between ELVO patients who achieved TICI 2b and those who achieved TICI 3 reperfusion post MT. Methods We conducted an observational study on consecutive AIS patients with ELVO who underwent MT at 6 high-volume endovascular centers. Standard safety (3 month mortality, symptomatic intracranial hemorrhage) and effectiveness (3 month functional independence: modified Rankin Scale scores of 0–2) outcomes were compared between patients who had TICI 2b and TICI 3 reperfusion post MT. Results The sample consisted of 583 patients with ELVO who underwent MT. A total of 416 patients achieved successful reperfusion (TICI 2b or 3) post MT. TICI 2b reperfusion was achieved in 216 (52%) patients [mean age 64±15, Male 50%, median NIHSS: 16 (IQR 12–20)], while 200 patients (48%) achieved TICI 3 reperfusion post MT [mean age 66±14, Male, 48%, median NIHSS 16 (IQR: 13–20)]. TICI 2b and TICI 3 reperfusion groups did not differ in terms of intravenous thrombolysis pretreatment (51% vs 56%, p=0.425), median onset to groin puncture time [minutes, median (IQR); 223 (157–318) vs 240 (176–311), p=0.850], median groin puncture to recanalization time [minutes, median (IQR); 38 (23–62 vs 41 (26–57), p=0.282) and 3 months mortality (22% vs 19%, p=0.523). TICI 3 reperfusion group had lower median discharge NIHSS [median (IQR) 3 (1–7) vs 5 (2-12), p=0.029), lower rates of symptomatic intracranial hemorrhage (6% vs 12%, p=0.035) and higher rates of functional independence at 3 months (55% vs 44%, p=0.050) compared to TICI 2b reperfusion group. In multivariate model after adjustment for potential confounders, TICI 3 reperfusion group was associated with greater neurological improvement during hospitalization (OR 1.009; 95% CI: 1.002–1.016, p=0.024), lower rates of sICH (OR 0.28; 95% CI: 0.10–0.78, p=0.027) and tended to have higher rates of 3 months functional independence (OR 1.80; 95% CI; 1.01–3.21, p=0.054) compared to TICI 2b group. Conclusions TICI 3 reperfusion appears to be associated with better early outcomes in comparison to TICI 2b reperfusion in ELVO Patients treated with MT. Future clinical trials involving ELVO patients should differentiate between these reperfusion groups in terms of safety and effectiveness outcomes. Disclosures N. Goyal: None. G. Tsivgoulis: None. D. Frei: None. A. Turk: None. B. Baxter: None. M. Froehler: None. J. Mocco None. M. Ishfaq: None. D. Hoit: None. J. Chang: None. L. Elijovich: None. D. Loy: None. R. Turner: None. J. Mascitelli: None. K. Espaillat: None. A. Alexandrov: None. A. Arthur: None.

Introduction Various thrombectomy devices promise high rates of recanalization and reduction of disability. A recent meta-analysis of the Solitaire device demonstrated its utility as safe and effective in revascularization of large vessel occlusions. The present analysis seeks to determine if good clinical outcome can similarly be achieved by the 3D Revascularization Device for patients with small score infarcts (ASPECTS 8-10). Methods The 3D trial sought to evaluate the safety and efficacy of the 3D Revascularization Device as compared to the Penumbra System alone in acute stroke intervention. Subjects meeting the per protocol study criteria and presenting with small core infarcts were included in the present analysis. Notwithstanding similarities in baseline characteristics between the 3D ASPECTS 8–10 patients compared to the Campbell cohort (Table I), only patients with small core infarcts were considered for the present analysis. Study outcome on the reduction of disability, defined as mRS 0-2 at 90 days, were compared with the Campbell Solitaire meta-analysis. Results In total, 105 of 198 patients met the study criteria. While ASPECTS 8-10 data could not be determined for the Campbell cohort, the median NIHSS (3D: 17 [IQR 12–21] vs Campbell: 17 [IQR 13–20] and ASPECTS (3D: 9 [IQR 8–10] vs 9 [IQR 7–10] scores were similar. Reduction of disability (mRS 0-2) data for available trials within the Campbell meta-analysis was extrapolated to evaluated to yield a weighted outcome of 57.7% at 90 days for ASPECTS 8–10 patients treated with the Solitaire device (Table II). Similarly, patients treated with the 3D Revascularization Device demonstrated comparable clinical outcomes, mRS 0–2 in 52.5% (figure 1). Conclusion Utility of the 3D Revascularization Device with the Penumbra System can achieve favorable long term clinical outcome similar to the use of Solitaire. Disclosures: A. Siddiqui: 2; C; Codman, Medtronic, Guide Point Global Consulting, Penumbra, Stryker, Microvention, W. L. Gore & Associates, Three Rivers Medical, Inc., Corindus, Inc., Amnis Therapeutics, Ltd.,CereVasc, LLC. D. Frei: 2; C; Penumbra, Inc., Codman, Microvention, Stryker, Siemens. 4; C; Penumbra, Inc. A. Yoo: 1; C; Neuravi, Inc., Penumbra, Inc.. J. Kirmani: None. O. Zaidat: 2; C; Penumbra, Inc.. D. Lopes: None. A. Turk: 1; C; Penumbra, Inc., Microvention, Stryker, Covidien, Medina Medical. D. Heck: 1; C; Penumbra, Inc.. 2; C; Stryker. B. Mason: None. D. Haussen: None. E. Levy: None. S. Mehta: None. M. Lazzaro: None. M. Chen: None. A. Dorfler: 1; C; Penumbra, Inc.. C. Derdeyn: None. L. Schwamm: None. D. Langer: None. R. Nogueira: None.

Recent trials have proven the benefits of endovascular treatment for patients with stroke from emergent large vessel occlusions (ELVOs).1–5 Optimal management of these patients involves attention to pre-procedural, intra-procedural, and post-procedural elements. However, many of the ideal treatment approaches following endovascular stroke therapy remain controversial. This document synthesizes current recommendations from the best available evidence to provide guidance in the post-procedural management of a patient undergoing stroke thrombectomy. This document was constructed by the Standards and Guidelines Committee of the Society for NeuroInterventional Surgery, a multidisciplinary committee composed of practitioners with backgrounds including neuroradiology, vascular neurosurgery, stroke neurology, and neurocritical care. We reviewed electronic databases for publications related to the management of acute stroke patients post-procedure, using both broad and narrow search terms. We subsequently evaluated those results for papers with randomized clinical results, which were given the highest priority. The remaining papers were assessed on the basis of individual methodology, and recommendations were made based on the data available. In the absence of supporting adequate clinical trial evidence, the committee made consensus recommendations. Each recommendation is graded, where possible, with a level of evidence utilizing the American Heart Association/American Stroke Association grading system.6 This document represents one of a continuum related to acute stroke intervention, including other documents on prehospital management, training standards for thrombectomy, and management of ELVO patients.7–9 ### Post-thrombectomy care environment ELVO patients require careful monitoring in a stroke unit or intensive care unit. Stroke units provide dedicated, specialized, multidisciplinary inpatient care for ELVO patients. Patients treated in this environment are more likely to survive, regain independence, and return home than those receiving less organized service.10 Stroke units are characterized by protocol guided care, adherence to guidelines, and coordination of care provided by various services.11–14 Furthermore, a dedicated stroke unit is preferable to a mobile consultative …

Introduction: A recent meta-analysis of four randomized controlled trials (RCTs) concluded that mechanical thrombectomy using Solitaire for large vessel ischemic stroke was effective with significantly reduced disability. Hypothesis: Our hypothesis was that treatment with the Penumbra Aspiration System and the novel 3D Stent Retriever would demonstrate similar angiographic and functional outcomes compared to use of Solitaire. Methods: The 3D trial was a RCT to compare the safety and effectiveness of the 3D Stent Retriever when used with the Penumbra Aspiration System (3D/PS) compared to the PS alone. Inclusion criteria for the 3D RCT included presentation with NIH Stroke Scale ≥ 8 and refractory to or not eligible for IV rtPA. Analysis compared reperfusion to mTICI 2b or 3 and functional independence (mRS 0-2 at 90 days) in a 3D Trial cohort with ASPECTS 8-10 vs the meta-analysis data reported by Campbell et al ( Stroke 2016). Results: One hundred four (104) of 198 patients met analysis criteria. Baseline ASPECTS (median [IQR]) were similar between the 3D Trial ASPECTS 8-10 cohort (3D/PS, PS, combined: 9 [8,10]) and Campbell group (9 [7,10]). Substantial reperfusion (mTICI 2b or 3) was experienced in 84.6% (44/52) of 3D/PS and 75.0% (39/52) of PS alone cases, similar to the Campbell group (76.6%). When both arms were pooled, results (79.8%) were also similar to Campbell. With regards to functional independence, both 3D cohorts and pooled trial results showed similar rates compared with Campbell (Figure). Conclusions: The novel 3D Stent Retriever + Penumbra System and the Penumbra Aspiration System alone showed similar reperfusion and functional outcomes compared to Solitaire.

Introduction: Patients with mild acute ischemic strokes (NIHSS ≤7, AISs) have been excluded from intra-arterial therapy (IAT) trials, limiting our understanding of their outcomes after IAT. Mild AIS with large vessel occlusions (LVOs) represent a fragile subset of mild AISs. Despite a low NIHSS, these patients can have a sudden failure of collateral circulation and deteriorate rapidly, resulting in significant disability. The objective of this study was to compare patient outcomes between those with mild AIS and LVO who did and did not received IAT. Methods: We included all adults (≥18) with a mild AIS due to an LVO admitted over 6.5 years to a high-volume comprehensive stroke center. Patients were excluded for any contraindication to IAT (n=240). Comparison groups were IAT vs. no therapy. Outcomes were sICH, in-hospital mortality, discharge mRS ≤2, and an improvement in NIHSS at discharge (>2 vs ≤2). Fisher’s, chi-squared, and logistic regression compared outcomes between groups. Results: There were 75 patients included in the study (Table 1). Overall 21% received treatment, and a majority of patients were 55-79 years, presented with hypertension and hyperlipidemia, and arrived within 4.5h from symptom onset. 7 patients also received IV-tPA. The IAT group had a significantly larger proportion of males, and hypo-mild strokes (NIHSS 4-7). There was one sICH in the no therapy group, and overall few deaths (Table 1). There was no significant difference between groups in improvement in NIHSS, and after adjusting for admission NIHSS, there was no significant difference in favorable discharge mRS. There were no IAT procedure complications. Conclusions: It remains to be seen whether IAT is beneficial in patients with mild AIS and LVO. Future, interventional, multi-center studies are needed to definitively determine the efficacy of IAT. Though these data come from a small patient population, they offer an insight into the potential safety of IAT in a fragile stroke population.

Background: Recent recommendations for mechanical thrombectomy (MT) of acute ischemic stroke (AIS) patients with emergent large-vessel occlusions (ELVO) appropriately award top tier evidence (TTE) to the same selective criteria that were employed in recent clinical trials. We sought to evaluate the safety and efficacy of MT in AIS patients with ELVO who fail TTE criteria in a prospective multi-center study. Methods: Data on consecutive AIS patients with ELVO who underwent mechanical thrombectomy were collected from 6 high-volume endovascular centers. Standard safety and efficacy outcomes were compared between patients meeting and failing TTE criteria. Results: TTE criteria for MT were fulfilled in 349 (60%) cases (mean age 63±18 years; 47% men; median admission NIHSS-score 17 points, interquartile range 14-21), whereas 234 (40%) patients did not meet TTE criteria (mean age 62±19 years; 53% men; median admission NIHSS-score 16 points, interquartile range 9-21). (Table 1) The two most common reasons for failing TTE criteria were location of intracranial occlusion (n=144) and treatment window (n=108). In multivariate logistic regression models adjusting for potential confounders cases failing TTE criteria had similar safety (three-month mortality and symptomatic intracranial hemorrhage) and efficacy (three-month functional independence) outcomes with patients meeting TTE. Location of occlusion and proposed time-window according to TTE was also not related to any safety or efficacy outcome. (Table 2) Conclusions: Approximately 40% of AIS patients with ELVO offered MT do not fulfill TTE criteria for MT. Our multi-center experience indicates that MT may be offered to these patients with similar safety and efficacy to ELVO cases meeting TTE. Evidence-based medicine requires that health care providers understand published data and how those data might apply to a given patient’s treatment options. In a changing treatment environment this is a dynamic process.

Introduction: The relative treatment effects for a stent retriever when used as an adjunct to aspiration versus aspiration alone remain unclear. The aim of this study was to demonstrate the safety and efficacy of the Penumbra stent retriever, 3D, when used in conjunction with the Penumbra Aspiration System (3D/PS), was non-inferior to the Penumbra Aspiration System (PS) alone. It remains controversial if a Per Protocol (PP) or an Intent-To-Treat (ITT) analysis is more appropriate for this study design. Hypothesis: PP and ITT analyses are comparable for a non-inferiority design trial. Materials and Methods: Patients presenting with symptoms of ischemic stroke within 8 hours of onset who had evidence of a LVO (diameter ≥2.5mm) and a NIH Stroke Scale ≥8 were assigned 1:1 to either treatment group. The primary endpoint for effectiveness was angiographic revascularization of the occluded target vessel at immediate post-procedure where the 3D/PS is non-inferior to PS by no more than 15%. Key secondary endpoints were 90 day functional independence as defined by a modified Rankin score 0-2, all-cause mortality and the incidence of symptomatic intracerebral hemorrhage. A Core Laboratory assessed imaging data. Results: The trial was terminated in June 2016 after the DSMB voted unanimously that recruiting additional subjects was judged to be both not feasible and unable to alter conclusions. A total of 198 patients were randomized at 25 sites: 98 to the 3D/PS and 100 to the PS alone group. The results indicate the 3D/PS was non-inferior to the PS alone in safety and effectiveness (difference in TICI 2-3=2.6%, 95%CI -5.8 to 11%). PP and ITT analyses showed similar results (Table). Conclusion: This is the first Class 1 evidence showing the similarity in safety and effectiveness of a stent retriever when used as an adjunct to aspiration versus aspiration alone in acute stroke from LVO. Both PP and ITT analyses showed similar results.