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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.

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 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

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.

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.

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, …

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.

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

Vertebroplasty and kyphoplasty are minimally invasive image-guided procedures that involve the injection of cement (typically polymethylmethacrylate (PMMA)) into a vertebral body. Kyphoplasty involves inflation of a balloon tamp to create a cavity within the vertebral body into which cement is subsequently injected. The majority of these vertebral augmentation procedures are performed to relieve back pain from osteoporotic or cancer-related vertebral compression fractures and to reinforce the vertebral body with neoplasm or vascular tumor. The primary goal of vertebroplasty and kyphoplasty is to reduce back pain and to improve patient's functional status, and the secondary goal is stabilization of a vertebra weakened by fracture or neoplasia. ### Osteoporotic vertebral fractures Osteoporosis is a common disease that causes significant morbidity and incurs a significant healthcare cost to the community. The major osteoporotic fractures involve the hip, vertebra, proximal humerus and distal forearm; the lifetime osteoporotic fracture risk at age 50 is approximately one in two women and one in five men.1 The lifetime incidence of symptomatic osteoporotic vertebral fractures in women at age 50 is estimated at 10–15%1; once a vertebral fracture occurs, there is a 20% risk of another vertebral fracture within 12 months.2 Most osteoporotic vertebral compression fractures are asymptomatic or result in minimal pain; only a third of vertebral fractures result in medical attention.3 Conservative medical therapy is therefore appropriate for the vast majority of vertebral compression fractures since most acute back pain symptoms are mild and subside over a period of 6–8 weeks as the fracture heals. The goals of conservative therapy are pain reduction (with analgesics and/or bed rest), improvement in functional status (with orthotic devices and physical therapy) and prevention of future fractures (with vitamin D, calcium supplementation and antiresorptive agents). However, conservative treatment for those with severe pain or limitation of function is not benign. It …

Purpose In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. It is intended that these benchmarks be used in a quality assurance program to assess and improve processes and outcomes in acute stroke revascularization. Materials and Methods Members of the writing group were appointed by the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society of Cardiac Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology. The writing group reviewed the relevant literature from 1986 through February 2012 to create an evidence table summarizing processes and outcomes of care. Performance metrics and thresholds were then created by consensus. The guideline was approved by the sponsoring societies. It is intended that this guideline be fully updated in 3 years. Results In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. These include process measures of time to imaging, arterial puncture, and revascularization and measures of clinical outcome up to 90 days. Conclusions Quality improvement guidelines are provided for endovascular acute ischemic stroke revascularization procedures. © 2013 Wiley Periodicals, Inc.

BackgroundWhile mechanical thrombectomy (MT) has become the standard of care for patients with acute ischemic stroke (AIS) with emergent large-vessel occlusions (ELVO), recently published guidelines appropriately award top-tier evidence to the same selective criteria that were employed in completed clinical trials. We sought to evaluate the safety and effectiveness of MT in patients with AIS with ELVO who do not meet top-tier evidence criteria (TTEC).MethodsWe conducted an observational study on consecutive patients with AIS with ELVO who underwent MT at six high-volume endovascular centers. Standard safety outcomes (3-month mortality, symptomatic intracranial hemorrhage) and effectiveness outcomes (3-month functional independence: modified Rankin Scale scores of 0–2) were compared between patients meeting and failing TTEC.ResultsThe sample consisted of 349 (60%) controls fulfilling TTEC and 234 (40%) non-TTEC patients. Control patients meeting TTEC for MT tended to have higher functional independence rates at 3 months (47% vs 39%; p=0.055), while the rates of symptomatic intracerebral hemorrhage (sICH) were similar (9%) in both groups (p=0.983). In multivariable logistic regression models, adherence to TTEC for MT was not independently related to any safety outcome (sICH: OR 0.71, 95% CI 0.30 to 1.68, p=0.434; 3-month mortality: OR 1.27, 95% CI 0.69 to 2.33, p=0.448) or effectiveness outcome (3-month functional independence: OR 0.81, 95% CI 0.48 to 1.37, p=0.434; 3-month functional improvement: OR 0.73, 95% CI 0.48 to 1.11, p=0.138) after adjusting for potential confounders.ConclusionsApproximately 40% of patients with AIS with ELVO offered MT do not fulfill TTEC for MT. Patients who did not meet TTEC had high rates of good clinical outcome and low complication rates.

Background and Purpose— The goal of reperfusion therapy in acute ischemic stroke is to limit brain infarction. The objective of this study was to investigate whether the beneficial effect of endovascular treatment on functional outcome could be explained by a reduction in post-treatment infarct volume. Methods— The Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) trial was a multicenter randomized open-label trial with blinded outcome evaluation. Among 315 enrolled subjects (endovascular treatment n=165; control n=150), 314 subject’s infarct volumes at 24 to 48 hours on magnetic resonance imaging (n=254) or computed tomography (n=60) were measured. Post-treatment infarct volumes were compared by treatment assignment and recanalization/reperfusion status. Appropriate statistical models were used to assess relationship between baseline clinical and imaging variables, post-treatment infarct volume, and functional status at 90 days (modified Rankin Scale). Results— Median post-treatment infarct volume in all subjects was 21 mL (interquartile range =65 mL), in the intervention arm, 15.5 mL (interquartile range =41.5 mL), and in the control arm, 33.5 mL (interquartile range =84 mL; P P P P P P >0.05). Post-treatment infarct volume ( P P Conclusions— These results support the primary results of the ESCAPE trial and show that the biological underpinning of the success of endovascular therapy is a reduction in infarct volume. 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 first of a detailed two part review, and explores the growth and current practice of telestroke, including the specific role it plays in the assessment and management of patients after emergent large vessel occlusion.

Background and Purpose— Endovascular mechanical thrombectomy may be used during acute ischemic stroke due to large vessel intracranial occlusion. First-generation MERCI devices achieved recanalization rates of 48% and, when coupled with intraarterial thrombolytic drugs, recanalization rates of 60% have been reported. Enhancements in embolectomy device design may improve recanalization rates. Methods— Multi MERCI was an international, multicenter, prospective, single-arm trial of thrombectomy in patients with large vessel stroke treated within 8 hours of symptom onset. Patients with persistent large vessel occlusion after IV tissue plasminogen activator treatment were included. Once the newer generation (L5 Retriever) device became available, investigators were instructed to use the L5 Retriever to open vessels and could subsequently use older generation devices and/or intraarterial tissue plasminogen activator. Primary outcome was recanalization of the target vessel. Results— One hundred sixty-four patients received thrombectomy and 131 were initially treated with the L5 Retriever. Mean age±SD was 68±16 years, and baseline median (interquartile range) National Institutes of Health Stroke Scale score was 19 (15 to 23). Treatment with the L5 Retriever resulted in successful recanalization in 75 of 131 (57.3%) treatable vessels and in 91 of 131 (69.5%) after adjunctive therapy (intraarterial tissue plasminogen activator, mechanical). Overall, favorable clinical outcomes (modified Rankin Scale 0 to 2) occurred in 36% and mortality was 34%; both outcomes were significantly related to vascular recanalization. Symptomatic intracerebral hemorrhage occurred in 16 patients (9.8%); 4 (2.4%) of these were parenchymal hematoma type II. Clinically significant procedural complications occurred in 9 (5.5%) patients. Conclusions— Higher rates of recanalization were associated with a newer generation thrombectomy device compared with first-generation devices, but these differences did not achieve statistical significance. Mortality trended lower and the proportion of good clinical outcomes trended higher, consistent with better recanalization.

ObjectiveTo summarize the current literature regarding the initial hospital management of patients with acute ischemic stroke (AIS) secondary to emergent large vessel occlusion (ELVO), and to offer recommendations designed to decrease the time to endovascular treatment (EVT) for appropriately selected patients with stroke.MethodsUsing guidelines for evidenced-based medicine proposed by the Stroke Council of the American Heart Association, a critical review of all available medical literature supporting best initial medical management of patients with AIS secondary to ELVO was performed. The purpose was to identify processes of care that most expeditiously determine the eligibility of a patient with an acute stroke for interventions including intravenous fibrinolysis with recombinant tissue plasminogen activator (IV tPA) and EVT using mechanical embolectomy.ResultsThis review identifies four elements that are required to achieve timely revascularization in ELVO. (1) In addition to non-contrast CT (NCCT) brain scan, CT angiography should be performed in all patients who meet an institutional threshold for clinical stroke severity. The use of any advanced imaging beyond NCCT should not delay the administration of IV tPA in eligible patients. (2) Activation of the neurointerventional team should occur as soon as possible, based on either confirmation of large vessel occlusion or a prespecified clinical severity threshold. (3) Additional imaging techniques, particularly those intended to physiologically select patients for EVT (CT perfusion and diffusion–perfusion mismatch imaging), may provide additional value, but should not delay EVT. (4) Routine use of general anesthesia during EVT procedures, should be avoided if possible. These workflow recommendations apply to both primary and comprehensive stroke centers and should be tailored to meet the needs of individual institutions.ConclusionsPatients with ELVO are at risk for severe neurologic morbidity and mortality. To achieve the best possible clinical outcomes stroke centers must optimize their triage strategies. Strategies that provide patients with ELVO with the fastest access to reperfusion depend upon detail-oriented process improvement.

Background: Clinical trials confirmed the safety and efficacy of intra-arterial therapy (IAT) in the management of ischemic stroke. At a community hospital, we compared outcomes in patients aged ≥80 and patients in the age range 55-79 years receiving IAT following ischemic stroke. Methods: Data were retrospectively abstracted for ischemic stroke patients ≥55 years treated with IAT at an urban comprehensive stroke center between 2010 and 2013. Baseline demographics, incidence of symptomatic intracranial hemorrhage (sICH), in-hospital mortality, discharge modified Rankin scale (mRS) score (favorable ≤2) and improvement in National Institutes of Health Stroke Scale Score (NIHSS; decreased score at discharge) were compared between patients in the age range 55-79 and patients ≥80 years. Data were analyzed using univariate analyses and multivariate logistic regression. Results: IAT was performed in 239 patients with ischemic stroke; 63 (26.4%) were ≥80 years. When compared to patients aged 55-79, the elderly patients were more often female and non-smokers, with a history of atrial fibrillation. No differences were observed in those ≥80 years compared to patients in the age range 55-79 years for sICH (10 vs. 5%, p = 0.23), mortality (24 vs. 18%, p = 0.28), favorable discharge mRS score (13 vs. 19%, p = 0.27), or improvement in NIHSS (83 vs. 92%, p = 0.10). The nonsignificant association of age with the outcomes persisted after adjusting for covariates and when analyzing the subset of patients who received IAT only. Conclusions: These findings suggest that in a cohort not subject to the criteria of a clinical trial, age ≥80 years should not be a contraindication to IAT.

To use baseline computed tomographic (CT) angiography to analyze imaging and clinical end points in an Interventional Management of Stroke III cohort to identify patients who would benefit from endovascular stroke therapy.The primary clinical end point was 90-day dichotomized modified Rankin Scale (mRS) score. Secondary end points were 90-day mRS score distribution and 24-hour recanalization. Prespecified subgroup was baseline proximal occlusions (internal carotid, M1, or basilar arteries). Exploratory analyses were subsets with any occlusion and specific sites of occlusion (two-sided α = .01).Of 656 subjects, 306 (47%) underwent baseline CT angiography or magnetic resonance angiography. Of 306, 282 (92%) had arterial occlusions. At baseline CT angiography, proximal occlusions (n = 220) demonstrated no difference in primary outcome (41.3% [62 of 150] endovascular vs 38% [27 of 70] intravenous [IV] tissue-plasminogen activator [tPA]; relative risk, 1.07 [99% confidence interval: 0.67, 1.70]; P = .70); however, 24-hour recanalization rate was higher for endovascular treatment (n = 167; 84.3% [97 of 115] endovascular vs 56% [29 of 52] IV tPA; P.001). Exploratory subgroup analysis for any occlusion at baseline CT angiography did not demonstrate significant differences between endovascular and IV tPA arms for primary outcome (44.7% [85 of 190] vs 38% [35 of 92], P = .29), although ordinal shift analysis of full mRS distribution demonstrated a trend toward more favorable outcome (P = .011). Carotid T- or L-type occlusion (terminal internal carotid artery [ICA] with M1 middle cerebral artery and/or A1 anterior cerebral artery involvement) or tandem (extracranial or intracranial) ICA and M1 occlusion subgroup also showed a trend favoring endovascular treatment over IV tPA alone for primary outcome (26% [12 of 46] vs 4% [one of 23], P = .047).Significant differences were identified between treatment arms for 24-hour recanalization in proximal occlusions; carotid T- or L-type and tandem ICA and M1 occlusions showed greater recanalization and a trend toward better outcome with endovascular treatment. Vascular imaging should be mandated in future endovascular trials to identify such occlusions. Online supplemental material is available for this article.

Objective Flexible large lumen aspiration catheters and stent retrievers have recently become available in the USA for the revascularization of large vessel occlusions presenting within the context of acute ischemic stroke (AIS). We describe a multicenter experience using a combined aspiration and stent retrieval technique for thrombectomy. Design A retrospective analysis to identify patients receiving combined manual aspiration and stent retrieval for treatment of AIS between August 2012 and April 2013 at six high volume stroke centers was conducted. Outcome variables, including recanalization rate, post-treatment National Institutes of Health Stroke Scale (NIHSS) score, symptomatic intracranial hemorrhage, discharge 90 day modified Rankin Scale (mRS) score, and mortality were evaluated. Results 105 patients were found that met the inclusion criteria for this retrospective study. Successful recanalization (Thrombolysis in Cerebral Infarction score 2B) was achieved in 92 (88%) of these patients. 44% of patients had favorable (mRS score 0–2) outcomes at 90 days. There were five (4.8%) symptomatic intracerebral hemorrhages and three procedure related deaths (2.9%). Conclusions Mechanical thrombectomy utilizing combined manual aspiration with a stent retriever is an effective and safe strategy for endovascular recanalization of large vessel occlusions presenting within the context of AIS.

Although improvements in thrombectomy devices, stroke management and patient selection in clinical trials over the last two decades have occurred in concert with increasingly greater angiographic recanalization rates, clinical outcomes have remained largely unchanged.1 For example, recently completed prospective trials using Stentriever technology have reported successful recanalization or reperfusion in upwards of 90% of enrolled patients, yet the percentage of patients with a good outcome at 90 days remains at only 35–55%.2–4 The association between adequate recanalization and good functional outcome has been well-documented in a number of studies.5–12 Furthermore, those making a dramatic recovery, defined as a decrease in the NIH Stroke Scale (NIHSS) score to ≤3 within 24 h, are more likely to have had early or more complete recanalization.13 However, the definition of ‘successful’ or adequate recanalization/reperfusion as an angiographic endpoint for treatment effect in such trials has become increasingly varied and confusing. The different grading scales and non-standardized definitions of successful thrombectomy reported in published stroke trials have made direct comparison of results difficult. In fact, some authors have called for increasing standardization of reporting among the stroke community using angiographic reperfusion to enhance generalizability.14 ,15 In this paper we review the current grading systems for recanalization/reperfusion, discuss the current controversies in grading systems and the need for standardization of recanalization and reperfusion in trial reporting. Finally, we offer a revised grading system that accounts for less than perfect but clearly excellent reperfusion within its scale. There are a number of proposed scales for documenting the degree of revascularization after acute stroke intervention. These include the Thrombolysis In Myocardial Infarction scale (TIMI)16 recanalization, TIMI reperfusion, Thrombolysis In Cerebral Infarction scale (TICI),17 the modified TICI scale,18 the Mori reperfusion scale19 and the Qureshi score,20 among others. These scales …

Importance Endovascular thrombectomy with second-generation devices is beneficial for patients with ischemic stroke due to intracranial large-vessel occlusions. Delineation of the association of treatment time with outcomes would help to guide implementation. Objective To characterize the period in which endovascular thrombectomy is associated with benefit, and the extent to which treatment delay is related to functional outcomes, mortality, and symptomatic intracranial hemorrhage. Design, Setting, and Patients Demographic, clinical, and brain imaging data as well as functional and radiologic outcomes were pooled from randomized phase 3 trials involving stent retrievers or other second-generation devices in a peer-reviewed publication (by July 1, 2016). The identified 5 trials enrolled patients at 89 international sites. Exposures Endovascular thrombectomy plus medical therapy vs medical therapy alone; time to treatment. Main Outcomes and Measures The primary outcome was degree of disability (mRS range, 0-6; lower scores indicating less disability) at 3 months, analyzed with the common odds ratio (cOR) to detect ordinal shift in the distribution of disability over the range of the mRS; secondary outcomes included functional independence at 3 months, mortality by 3 months, and symptomatic hemorrhagic transformation. Results Among all 1287 patients (endovascular thrombectomy + medical therapy [n = 634]; medical therapy alone [n = 653]) enrolled in the 5 trials (mean age, 66.5 years [SD, 13.1]; women, 47.0%), time from symptom onset to randomization was 196 minutes (IQR, 142 to 267). Among the endovascular group, symptom onset to arterial puncture was 238 minutes (IQR, 180 to 302) and symptom onset to reperfusion was 286 minutes (IQR, 215 to 363). At 90 days, the mean mRS score was 2.9 (95% CI, 2.7 to 3.1) in the endovascular group and 3.6 (95% CI, 3.5 to 3.8) in the medical therapy group. The odds of better disability outcomes at 90 days (mRS scale distribution) with the endovascular group declined with longer time from symptom onset to arterial puncture: cOR at 3 hours, 2.79 (95% CI, 1.96 to 3.98), absolute risk difference (ARD) for lower disability scores, 39.2%; cOR at 6 hours, 1.98 (95% CI, 1.30 to 3.00), ARD, 30.2%; cOR at 8 hours,1.57 (95% CI, 0.86 to 2.88), ARD, 15.7%; retaining statistical significance through 7 hours and 18 minutes. Among 390 patients who achieved substantial reperfusion with endovascular thrombectomy, each 1-hour delay to reperfusion was associated with a less favorable degree of disability (cOR, 0.84 [95% CI, 0.76 to 0.93]; ARD, −6.7%) and less functional independence (OR, 0.81 [95% CI, 0.71 to 0.92], ARD, −5.2% [95% CI, −8.3% to −2.1%]), but no change in mortality (OR, 1.12 [95% CI, 0.93 to 1.34]; ARD, 1.5% [95% CI, −0.9% to 4.2%]). Conclusions and Relevance In this individual patient data meta-analysis of patients with large-vessel ischemic stroke, earlier treatment with endovascular thrombectomy + medical therapy compared with medical therapy alone was associated with lower degrees of disability at 3 months. Benefit became nonsignificant after 7.3 hours.

Guidelines have been established for the management of acute ischemic stroke; however, specific recommendations for endovascular revascularization therapy are lacking. Burgeoning investigation of endovascular revascularization therapies for acute ischemic stroke, rapid device development, and a diverse training background of the providers performing the procedures underscore the need for practice recommendations. This review provides a concise summary of the Society of Vascular and Interventional Neurology endovascular acute ischemic stroke roundtable meeting. This document was developed to review current clinical efficacy of pharmacologic and mechanical revascularization therapy, selection criteria, periprocedure management, and endovascular time metrics and to highlight current practice patterns. It therefore provides an outline for the future development of multisociety guidelines and recommendations to improve patient selection, procedural management, and organizational strategies for revascularization therapies in acute ischemic stroke.

Medical devices, developed through physician and industry partnerships, have helped to revolutionize the treatment of disease spanning most medical disciplines. This includes such entities as deep brain stimulation implants for Parkinson's disease, knee replacements for osteoarthritis, coil embolization technologies for intracranial aneurysms and implantable cardiac defibrillators for life-threatening arrhythmias. These remarkable products have undeniably led to increased patient longevity and improved quality of life. Such marvels of modern medicine, however, do not come without cost, to either the consumer or the manufacturer. Recent estimates suggest that the annual expenditures on medical devices in the USA approximates $95–150 billion, which represents almost one-half to three-quarters of the $200 billion spent on such devices across the world and about 6% of our total national health expenditures.1 ,2 Development of new technologies requires considerable investment from companies in terms of research and development costs, manufacturing and marketing, as well as a rigorous approval process through the Food and Drug Administration (FDA). All-in-all, the price of innovation is monumental for those invested in advancing medicine through cutting edge technologies. Recently, there has been a push among lobbyists representing device manufacturers to streamline the lengthy FDA approval process,3 arguing that the USA will lose its ability to compete globally due to the excessive costs and delays in obtaining FDA approval. However, in direct contrast to any effort to ‘streamline’ the approval process, the oversight of device innovation and the approval process has been criticized recently due to several notable device ‘failures’ that have been linked to patient harm. These devices were approved for use through FDA humanitarian device exemption (HDE) or 510(k) processes, which do not require randomized controlled trial evidence demonstrating safety and effectiveness prior to …

Successful endovascular therapy for acute ischemic stroke (AIS) requires optimal patient selection and effective tools, and also the rapid delivery of treatment from the time of symptom onset. Time to treatment for patients with AIS remains, arguably, the most important modifiable factor in improving outcomes. Although intravenous tissue plasminogen activator (tPA) administration has been extended to 4.5 h,1 ,2 fewer than one-third of eligible patients receive it within the target door to needle (DTN) time of 60 min.3 This failure to achieve benchmark times has led to ‘Target: Stroke’, a national quality improvement initiative of the American Heart Association/American Stroke Association which aims to increase the timeliness of intravenous tPA administration. Over the past 20 years, tremendous efforts in developing primary stroke centers and implementing strategies based on the development of these centers have led to a dramatic reduction in DTN times, but there is much room for improvement. Studies in myocardial infarction (MI) have shown the critical importance of time in improving outcome for patients undergoing percutaneous coronary intervention (PCI). In a large meta-analysis of 27 MI trials,4 a strong relationship between PCI-related time delay and benefits from primary angioplasty was observed in high-risk patients (r=–0.50, β= –0.075 (95% CI –0.189 to 0.04)), with 131 min as the equipoint between PCI and medical therapies. Moreover, for every 10 min reduction in time to PCI, MI mortality was also reduced.4 In a prospective PCI trial investigating the relationship between time and outcome, patients randomized

Background and purposeThe purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application.MethodsA retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events. Results were compared with those of the Penumbra pivotal trial.ResultsA total of 157 vessels were treated. Mean baseline values at enrollment were: age 65 years, NIHSS score 16. After use of the Penumbra system, 87% of the treated vessels were revascularized to TIMI 2 (54%) or 3 (33%) as compared with 82% reported in the Pivotal trial. Nine procedural serious adverse events were reported in 157 patients (5.7%). All-cause mortality was 20% (32/157), and 41% had a mRS of ≤2 at 90-day follow-up as compared with only 25% in the Pivotal trial. Patients who were successfully revascularized by the Penumbra system had significantly better outcomes than those who were not.ConclusionInitial post-market experience of the Penumbra system revealed that the revascularization rate and safety profile of the device are comparable to those reported in the Pivotal trial. However, the proportion of patients who had good functional outcome was higher than expected.