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Background A considerable proportion of stroke patients have unfavorable outcomes despite substantial reperfusion during mechanical thrombectomy for large vessel occlusion. This study aimed to determine predictors of unfavorable outcomes despite substantial reperfusion (modified thrombolysis in cerebral infarction score of ≥2b). Methods We conducted a post hoc analysis of Analysis of Revascularization in Ischemic Stroke With EmboTrap, a prospective, multicenter study on the efficacy of the EmboTrap revascularization device. We included patients with anterior large vessel occlusion, substantial reperfusion within three passes, and 3-month follow-up. Univariate and multivariate logistic regression analyses were performed to determine independent predictors of dependency or death (modified Rankin Score 3–6) at 90 days. Results Of the 176 patients included in the study, 124 (70.45%) achieved modified Rankin Score of 0–2 at 90 days and 52 (29.6%) had modified Rankin Score of 3–6. On univariate analysis, patient age and initial National Institutes of Health Stroke Scale score were significantly higher in the modified Rankin Score of 3–6 groups (71.4 ± 11.3 years vs. 66.0 ± 13.1 years, 0.01; 18.9 ± 4.13 vs. 14.6 ± 4.36, p Conclusion More severe initial neurologic deficit and higher number of passes in patients with substantial reperfusion were independent predictors of dependency or death. These findings highlight a reduction in the number of passes required to achieve reperfusion as a therapeutic target to improve the outcome after thrombectomy.

Introduction: EXCELLENT (NCT03685578) is a global prospective, multicenter, real-world registry of mechanical thrombectomy for stroke with the EmboTrap device as first line treatment which includes clot collection and analysis. Aim of the study: To report the rates of clinical outcomes and clot characteristics associated with first pass reperfusion in EXCELLENT. Methods: Per pass angiographic outcomes assessed by an independent core lab were available in 984 subjects Analysis of clot from 538 cases was performed by independent central labs blinded to clinical data. 90-day mRS assessment was blinded to subject data. Results: First pass reperfusion of mTICI 2b-3 (63.2%) and 2c-3 (38.3%) was significantly predictive of mRS 0-2 or ≤pre-stroke (p=0.011 and p=0.016) but not all-cause mortality at 90 days (p=0.080 and p=0.123, respectively). Further, mTICI 2c-3 in one pass was associated with a higher rate of mRS 0-2 or ≤pre-stroke vs. mTICI 2c-3 reperfusion in >1 pass, (55.5% and 45.1%, respectively, p=0.013) and a rate of all-cause mortality at 90 days of 14.6% vs. 19.8% (p=0.097). Full patient characteristics and clinical outcomes are shown in Table 1. Notable clot composition findings included: RBC (%, mean±SD): mTICI 2c-3, 1 pass 47.69±22.25, mTICI 2c-3, >1 pass 43.86±19.05, (p=0.088); fibrin: mTICI 2c-3, 1 pass 23.20±13.80, mTICI 2c-3 >1 pass 25.40 ± 13.52 (p=0.131); von Willebrand factor (VWF): mTICI2c-3, 1 pass 16.09±14.62, mTICI 2c-3, >1 pass 19.42±17.15 (p=0.038). Conclusions: First pass reperfusion in the EXCELLENT registry was associated with better clinical outcomes at 90 days. Clots retrieved with first pass reperfusion had higher RBC and lower fibrin and VWF content compared to those who achieved reperfusion at greater than one pass.

Importance: Clinical trials focusing on new mechanical thrombectomy (MT) technologies have been typically single-arm studies using historical comparison data to determine the safety and efficacy of the novel device. To date, there has not been a contemporaneous prospective, randomized, controlled study comparing standard to newer designed stent-retrievers. Objective: To evaluate the safety and efficacy of the pRESET (phenox Ltd) compared to the Solitaire (Medtronic Corp) thrombectomy devices in the treatment of large vessel occlusion strokes (LVOS). Methods: Multicenter, prospective, randomized, open-label, blinded endpoint, core lab adjudicated, non-inferiority trial that enrolled 340 patients from October 2019 to February 2022 across 19 US & 5 German sites. Patients aged ≥ 18 years with either anterior or posterior circulation LVOS were included up to 8 hours after symptom onset. Patients were randomly assigned in a 1:1 ratio to either pRESET or Solitaire for the first three device passes.The Primary Endpoint was the proportion of patients achieving a modified Rankin Scale score of 0-2, analyzed by intent to treat with a non-inferiority margin of 0.125 based on the lower bound 95% Confidence Interval. The Primary Safety Endpoint was the proportion of subjects with device- or procedure-related symptomatic intracerebral hemorrhage at 24 (-8/+12) hours as per the SITS-MOST criteria. Secondary Outcome Measures included the rates of (1) Successful Revascularization (defined as expanded Thrombolysis in Cerebrovascular Infarction [eTICI] ≥2b50 ≤3 passes of the assigned device; (2) eTICI ≥2c following the first pass of the assigned device; (3) 90-day mortality and (4) Distribution of 90-day mRS across the entire spectrum of disability (ordinal shift). Results: The study database was locked in August 2022. The analysis is ongoing and the final results will be presented at the 2023 International Stroke Conference. Conclusions and Relevance: PROST is the first randomized clinical trial aiming to compare a novel versus an established stent-retriever technology, establishing a new scientific benchmark for stroke device trials. (ClinicalTrials.gov: NCT03994822).

Background and Purpose: The Tigertriever is a novel, radially adjustable, fully visible, stentriever that permits the operator to align radial expansion with target vessel diameters. This multicenter trial compared the Tigertriever’s effectiveness and safety compared with established stent retrievers. Methods: Single arm, prospective, multicenter trial comparing the Tigertriever to efficacy and safety performance goals derived from outcomes in 6 recent pivotal studies evaluating the Solitaire and Trevo stent-retriever devices with a lead-in and a main-study phase. Patients were enrolled if they had acute ischemic stroke with National Institutes of Health Stroke Scale score ≥8 due to large vessel occlusion within 8 hours of onset. The primary efficacy end point was successful reperfusion, defined as core laboratory-adjudicated modified Thrombolysis in Cerebral Ischemia score 2b-3 within 3 passes of the Tigertriever. The primary safety end point was a composite of 90-day all-cause mortality and symptomatic intracranial hemorrhage. Secondary efficacy end points included 3-month good clinical outcome (modified Rankin Scale score 0–2) and first-pass successful reperfusion. Results: Between May 2018 and March 2020, 160 patients (43 lead-in, 117 main phase) at 17 centers were enrolled and treated with the Tigertriever. The primary efficacy end point was achieved in 84.6% in the main-study phase group compared with the 63.4% performance goal and the 73.4% historical rate (noninferiority P P P =0.004; superiority P =0.57). Good clinical outcome was achieved in 58% at 90 days. Conclusions: The Tigertriever device was shown to be highly effective and safe compared with Trevo and Solitaire devices to remove thrombus in patients with large-vessel occlusive stroke eligible for mechanical thrombectomy. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03474549.

Increasing evidence supports the effectiveness of venous sinus stenting (VSS) with favorable outcomes, safety, and expenses compared with shunting for idiopathic intracranial hypertension. Yet, no evidence is available regarding optimal postoperative recovery, which has increasing importance with the burdens on health care imposed by the coronavirus disease 2019 pandemic. We examined adverse events and costs after VSS and propose an optimal recovery pathway to maximize patient safety and reduce stress on health care resources.A retrospective review was undertaken of elective VSS operations performed from May 2008 to August 2021 at a single institution. Primary data included hospital length of stay, intensive care unit (ICU) length of stay, adverse events, need for ICU interventions, and hospital costs.Fifty-three patients (98.1% female) met the inclusion criteria. Of these patients, 51 (96.2%) were discharged on postoperative day (POD) 1 and 2 patients were discharged on POD 2. Both patients discharged on POD 2 remained because of groin hematomas from femoral artery access. There were no major complications or care that required an ICU. Eight patients (15.1%) were lateralized to other ICUs or remained in a postanesthesia care unit because the neurosciences ICU was above capacity. Total estimated cost for initial recovery day in a neurosciences ICU room was $2361 versus $882 for a neurosurgery/neurology ward room. In our cohort, ward convalescence would save an estimated $79,866 for bed placement alone and increase ICU bed availability.Our findings reaffirm the safety of VSS. These patients should recover on a neurosurgery/neurology ward, which would save health care costs and increase ICU bed availability.

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

BACKGROUND Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm. OBJECTIVE To compare recurrence between the second-generation HES and bare platinum coil (BPC) in the new-generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT). METHODS HEAT is a randomized, controlled trial that enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling. The primary endpoint was aneurysm recurrence using the Raymond-Roy scale. Secondary endpoints included minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage from target aneurysm during follow-up, aneurysm occlusion stability, and clinical outcome at final follow-up. RESULTS A total of 600 patients were randomized (HES, n = 297 and BPC, n = 303), including 28% with ruptured aneurysms. Recurrence occurred in 11 (4.4%) subjects in the HES arm and 44 (15.4%) subjects in the BPC arm (P = .002). While the initial occlusion rate was higher with BPC, the packing density and both major and minor recurrence rates were in favor of HES. Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms. CONCLUSION Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms. VIDEO ABSTRACT

Introduction EXCELLENT (NCT03685578) is a prospective, single-arm, multicenter, real-world international registry of mechanical thrombectomy (MT) for stroke with the EmboTrap device as first line treatment. The study entails thrombus analysis of specimens collected with each MT pass. Aim of the Study To compare rates of mRS 0–2 at 90 days and clot characteristics in subjects with and without first pass effect (FPE). Methods FPE was defined as mTICI 2c/3 after one pass and non-FPE as mTICI 2c/3 after >1 pass as adjudicated by an independent core lab. Clot analysis was performed by independent central labs blinded to clinical data. mRS at 90 days was scored by investigators blinded to procedural data. Results Overall mTICI2c/3 rates were 63.7% (326/512). FPE was achieved in 37.1% (190/512) and non-FPE in 26.6% (136/512) subjects. 90 day mRS 0–2 or equal to pre-stroke was achieved in 47.2% (75/159) with FPE and in 42.1% (51/121) non-FPE patients. All-cause 90-day mortality was 19.1% (34/178) in subjects with FPE and 26.4% (34/129) in subjects with non-FPE. Major thrombus components (mean% ±SD) were as follows: RBC: FPE 45.88±20.54, non-FPE 39.08±18.23, and first pass mTICI Conclusions The high rate of ‘real-world’ FPE observed in EXCELLENT was associated with improved clinical outcomes. Clots retrieved with FPE had higher RBC and lower fibrin content compared to non FPE and to first pass mTICI Disclosure EXCELLENT is sponsored by Cerenovus. Dr. Jovin is a consultant for Neuravi, Codman Neurovascular, Stryker (PI DAWN; unpaid), Fundacio Ictus (PI REVASCAT; unpaid), and holds stock in Anaconda, Silk Road, and Blockade Medical.

Background and Purpose— Mechanical thrombectomy (MT) devices have led to improved reperfusion and clinical outcomes in acute ischemic stroke patients with emergent large vessel occlusions; however, less than one-third of patients achieve complete reperfusion. Use of intraarterial thrombolysis in the context of MT may provide an opportunity to enhance these results. Here, we evaluate the use of intraarterial rtPA (recombinant tissue-type plasminogen activator) as rescue therapy (RT) after failed MT in the North American Solitaire Stent-Retriever Acute Stroke registry. Methods— The North American Solitaire Stent-Retriever Acute Stroke registry recruited sites within North America to submit data on acute ischemic stroke patients treated with the Solitaire device. After restricting the population of 354 patients to use of RT and anterior emergent large vessel occlusions, we compared patients who were treated with and without intraarterial rtPA after failed MT. Results— A total of 37 and 44 patients was in the intraarterial rtPA RT and the no intraarterial rtPA RT groups, respectively. Revascularization success (modified Thrombolysis in Cerebral Infarction ≥2b) was achieved in more intraarterial rtPA RT patients (61.2% versus 46.6%; P =0.13) with faster times to recanalization (100±85 versus 164±235 minutes; P =0.36) but was not statistically significant. The rate of symptomatic intracranial hemorrhage (13.9% versus 6.8%; P =0.29) and mortality (42.9% versus 44.7%; P =0.87) were similar between the groups. Good functional outcome (modified Rankin Scale score of ≤2) was numerically higher in intraarterial rtPA patients (22.9% versus 18.4%; P =0.64). Further restriction of the RT population to M1 occlusions only and time of onset to groin puncture ≤8 hours, resulted in significantly higher successful revascularization rates in the intraarterial rtPA RT cohort (77.8% versus 38.9%; P =0.02). Conclusions— Intraarterial rtPA as RT demonstrated a similar safety and clinical outcome profile, with higher reperfusion rates achieved in patients with M1 occlusions. Prospective studies are needed to delineate the role of intraarterial thrombolysis in MT.

Background and Purpose— Mechanical thrombectomy has been shown to improve clinical outcomes in patients with acute ischemic stroke. However, the impact of balloon guide catheter (BGC) use is not well established. Methods— STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter study of patients with large vessel occlusion treated with the Solitaire stent retriever as first-line therapy. In this study, an independent core laboratory, blinded to the clinical outcomes, reviewed all procedures and angiographic data to classify procedural technique, target clot location, recanalization after each pass, and determine the number of stent retriever passes. The primary clinical end point was functional independence (modified Rankin Scale, 0–2) at 3 months as determined on-site, and the angiographic end point was first-pass effect (FPE) success rate from a single device attempt (modified Thrombolysis in Cerebral Infarction, ≥2c) as determined by a core laboratory. Achieving modified FPE (modified Thrombolysis in Cerebral Infarction, ≥2b) was also assessed. Comparisons of clinical outcomes were made between groups and adjusted for baseline and procedural characteristics. All participating centers received institutional review board approval from their respective institutions. Results— Adjunctive technique groups included BGC (n=445), distal access catheter (n=238), and conventional guide catheter (n=62). The BGC group had a higher rate of FPE following first pass (212/443 [48%]) versus conventional guide catheter (16/62 [26%]; P =0.001) and distal access catheter (83/235 [35%]; P =0.002). Similarly, the BGC group had a higher rate of modified FPE (294/443 [66%]) versus conventional guide catheter (26/62 [42%]; P P =0.003). The BGC group achieved the highest rate of functional independence (253/415 [61%]) versus conventional guide catheter (23/55 [42%]; P =0.007) and distal access catheter (113/218 [52%]; P =0.027). Final revascularization and mortality rates did not differ across the groups. Conclusions— BGC use was an independent predictor of FPE, modified FPE, and functional independence, suggesting that its routine use may improve the rates of early revascularization success and good clinical outcomes. Clinical Trial Registration— URL: https://www.clinicaltrials.gov . Unique identifier: NCT02239640.

Tenecteplase (TNK) is more fibrin specific and has longer activity duration than Alteplase (ALT). Compared to ALT, recent acute stroke treatment studies have found TNK at doses up to 0.4mg/kg to have equivalent safety and efficacy. A major advantage of TNK is that it is given as a five second bolus without the need for a 60 minutes infusion. The 2018 AHA/ASA guidelines suggest that TNK may be considered as an alternative to ALT. In January 2019 we switched to TNK for our first line acute stroke treatment at our institution. Methods: Following AHA/ASA plus ECAS3 < 4.5 hour stroke thrombolytic treatment guidelines, we treated consecutive patients with TNK 0.25mg/kg max 25mg at our main “hub” hospital in 2019. We compared these results to patients we treated with ALT in 2019 using telestroke at our 10 “satellite” hospitals. Safety was assessed by SICH on CT at 24 hours. For LVO patients early vessel opening was accessed by angiogram, and clinical success was determined by three month Modified Rankin Score (MR 0-1). Results: We have successfully treated 22 patients with TNK: Baseline median NIH was 9 (2-20); with a mean treatment time of 148±58 minutes. There were no systemic bleeding or mortality events and 0% SICH occurred. 19/22 patients had initial LVO on presentation with 9/19 (47%) having early vessel opening post TNK prior to thrombectomy. 14/22 (64%) of patients had excellent recovery (MR 0-1) at three months. During the same time we also treated 76 patients with Alteplase: Median BL NIHSS of 14 (2-27) (P = 0.001) with 0% SICH, 5% mortality and 30% MR 0-1 (P = 0.02 worse compared to TNK). Conclusion: We successfully changed to TNK as our preferred stroke thrombolytic and our initial experience with it has been very favorable. We are currently in the process of switching to TNK at several of our spoke hospital sites. TNK should be considered as an alternative to Altepase especially at sites that need to transfer patients for thrombectomy.

Introduction: Red blood cell (RBC) rich vs fibrin rich clots have different mechanical properties and greater knowledge about clot composition in the context of clinical, imaging, and procedural factors in mechanical thrombectomy (MT) may help with procedural optimization. The EXCELLENT Registry (NCT03685578) is a prospective, global, multi-center, observational registry of EmboTrap as the first line MT device for large vessel occlusion (LVO). We present an interim analysis of clot collected per pass in the registry. Methods: Five hundred thirty-three clot specimens from 376 subjects were collected by 20 sites and sent for analysis by independent Central Labs under standardized protocol. Analysis was interrupted by COVID-19, but the labs were fully operational as of June 2020 and on track to deliver results for 300 subjects in Q4. At the time of abstract submission, composition data for 234 clots from 163 subjects was available. All available data will be presented at the time of the conference. Results: Cardioembolic etiology (n=100) was associated with lower RBC (40.2 vs 47.2%) and higher fibrin content (31.7 vs 26.7%) compared to large artery disease (n=12). Hyperdense/vessel susceptibility sign (78+, 24-, per independent imaging core lab) corresponded to higher mean RBC content (44.4 vs 34.9%). Treatment with IV tPA (60+, 91-) had no clear impact on clot composition (42.3 vs 40.6% RBC; 30.4 vs 30.0% fibrin). Notably, clots retrieved with the first 2 passes of were more RBC rich (42.1 vs 28.0%) and clots retrieved in higher passes had a higher average fibrin content (35.5 vs 29.6%) suggesting that higher fibrin content leads to greater refractoriness. Conclusions: Clot density/susceptibility on baseline imaging, stroke etiology and number of thrombectomy passes were associated with differential clot composition. These findings may have potential implications for the development of better MT strategies.

Background: EXCELLENT (NCT03685578) is a large, prospective, single-arm, multicenter, international registry of mechanical thrombectomy (MT) with EmboTrap as the first attempted device in routine clinical practice. The study collects per pass data on procedural and technical details that are based on interventionalists’ preference, providing an opportunity to assess current practices in MT across multiple international high-volume stroke centers. Methods: Subjects treated according to standard of care were eligible for inclusion in the study if EmboTrap was used in the first MT pass. Interim analysis focusing on procedural details and per pass clot retrieval technique was performed based on 689 subjects enrolled by 79 physicians across 26 international sites (US, Belgium, Germany, France) between Sept 2018 and Jul 2020. Results: Mean #passes was 2.1 (median=1, max=10), 50.3% subjects had only 1 pass and 84.8% had 3 or fewer. Per pass use of stent retriever, aspiration, balloon guide, intermediate catheter and long sheath catheter, along with technique details (e.g. incubation time, device positioning, co-aspiration) are summarized in Table 1. Rates and reasons for device changes are also given. Conclusion: Interim analysis of the ongoing EXCELLENT registry informs on current practice patterns in MT. This is the first report of detailed per pass clot retrieval strategies in a large international multicenter cohort.

Introduction: Patients with proximal (M1) and more distal occlusions (M2) of the middle cerebral artery (MCA) from the ARISE II Study were assessed in order to determine risks and efficacy of revascularization with the EmboTrap device, which has a 5 mm diameter, in small vessels. Methods: Data from the ARISE II Study concerning MCA occlusions were separated into 2 groups: M1 occlusion and M2 occlusion (proximal, median, distal segment). From the ARISE II Study, inclusion criteria were NIHSS score ≥ 8 and ≤ 25, ASPECT ≥ 6. Comparison of the 2 groups was performed in order to evaluate M2 revascularization with EmboTrap device. Results: M1 occlusion was present in 126 patients and M2 occlusions in 57 patients. M2 occlusions were distal in 35.1%. Substantial reperfusion within 3 passes (TICI 2b-3) was similar for both target locations, 79.3% for M1 and 78.9% for M2 (P=0.29). First pass substantial reperfusion was also similar, 43.6% for M1 versus 40.3% for M2 (p=0.75). Symptomatic intracranial hemorrhage was observed in 4.7% of patients in M1 and 3.5% in M2 (p=0.66). Functional independence at 90 days (mRS 0-2) was achieved in 67.5% of patients with M1 occlusions and 70.2% with M2 occlusions (p=0.320). Conclusions: Revascularization of the M2 segment of MCA with a 3 or 4 mm-stent retriever was previously evaluated and was considered safe and efficient. In this study, we analyzed patients with M2 occlusions and treated with a 5 mm stent retriever EmboTrap that showed similar efficacy and safety compared to M1 occlusions. Use of the same device for proximal and more distal occlusions can have economic and technical advantages.

BackgroundThe benefit of endovascular thrombectomy for acute ischemic stroke with M2 segment middle cerebral artery occlusion remains controversial, with uncertainty and paucity of data specific to this population.ObjectiveTo compare outcomes between M1 and M2 occlusions in the Analysis of Revascularization in Ischemic Stroke with EmboTrap (ARISE II) trial.MethodsWe performed a prespecified analysis of the ARISE II trial with the primary outcome of 90-day modified Rankin Scale score of 0–2, which we termed good outcome. Secondary outcomes included reperfusion rates and major adverse events. The primary predictor was M2 occlusion, which we compared with M1 occlusion.ResultsWe included 183 patients, of whom 126 (69%) had M1 occlusion and 57 (31%) had M2 occlusion. There was no difference in the reperfusion rates or adverse events between M2 and M1 occlusions. The rate of good outcome was not different in M2 versus M1 occlusions (70.2% vs 69.7%, p=0.946). In a logistic regression model adjusted for age, sex, and baseline National Institutes of Health Stroke Scale score, M2 occlusions did not have a significantly different odds of good outcome compared with M1 occlusions (OR 0.94, 95% CI 0.47 to 1.88, p=0.87).ConclusionIn ARISE II, M2 occlusions achieved a 70.2% rate of good outcome at 90 days, which is above published rates for untreated M2 occlusions and superior to prior reports of M2 occlusions treated with endovascular thrombectomy. We also report similar rates of good outcome, successful reperfusion, death, and other adverse events when comparing the M1 and M2 occlusions.

BackgroundFirst-pass effect (FPE), restoring complete or near complete reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2c-3) in a single pass, is an independent predictor for good functional outcomes in the endovascular treatment of acute ischemic stroke. The economic implications of achieving FPE have not been assessed.ObjectiveTo assess the economic impact of achieving complete or near complete reperfusion after the first pass.MethodsPost hoc analyses were conducted using ARISE II study data. The target population consisted of patients in whom mTICI 2c–3 was achieved, stratified into two groups: (1) mTICI 2c–3 achieved after the first pass (FPE group) or (2) after multiple passes (non-FPE group). Baseline characteristics, clinical outcomes, and healthcare resource use were compared between groups. Costs from peer-reviewed literature were applied to assess cost consequences from the perspectives of the United States (USA), France, Germany, Italy, Spain, Sweden, and United Kingdom (UK).ResultsAmong patients who achieved mTICI 2c–3 (n=172), FPE was achieved in 53% (n=91). A higher proportion of patients in the FPE group reached good functional outcomes (90-day modified Rankin Scale score 0–2 80.46% vs 61.04%, pConclusionsFPE resulted in improved clinical outcomes, translating into lower healthcare resource use and lower estimated costs.

Background and Purpose— In acute ischemic stroke, fast and complete recanalization of the occluded vessel is associated with improved outcomes. We describe a novel measure for newer generation devices: the first pass effect (FPE). FPE is defined as achieving a complete recanalization with a single thrombectomy device pass. Methods— The North American Solitaire Acute Stroke Registry database was used to identify a FPE subgroup. Their baseline features and clinical outcomes were compared with non-FPE patients. Clinical outcome measures included 90-days modified Rankin Scale score, National Institutes of Health Stroke Scale score, mortality, and symptomatic intracranial hemorrhage. Multivariate analyses were performed to determine whether FPE independently resulted in improved outcomes and to identify predictors of FPE. Results— A total of 354 acute ischemic stroke patients underwent thrombectomy in the North American Solitaire Acute Stroke registry. FPE was achieved in 89 out of 354 (25.1%). More middle cerebral artery occlusions (64% versus 52.5%) and fewer internal carotid artery occlusions (10.1% versus 27.7%) were present in the FPE group. Balloon guide catheters were used more frequently with FPE (64.0% versus 34.7%). Median time to revascularization was significantly faster in the FPE group (median 34 versus 60 minutes; P =0.0003). FPE was an independent predictor of good clinical outcome (modified Rankin Scale score ≤2 was seen in 61.3% in FPE versus 35.3% in non-FPE cohort; P =0.013; odds ratio, 1.7; 95% confidence interval, 1.1–2.7). The independent predictors of achieving FPE were use of balloon guide catheters and non-internal carotid artery terminus occlusion. Conclusions— The achievement of complete revascularization from a single Solitaire thrombectomy device pass (FPE) is associated with significantly higher rates of good clinical outcome. The FPE is more frequently associated with the use of balloon guide catheters and less likely to be achieved with internal carotid artery terminus occlusion.

Supplemental Digital Content is available in the text., Background: Endovascular treatment with mechanical thrombectomy (MT) is beneficial for patients with acute stroke suffering a large-vessel occlusion, although treatment efficacy is highly time-dependent. We hypothesized that interhospital transfer to endovascular-capable centers would result in treatment delays and worse clinical outcomes compared with direct presentation. Methods: STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter, observational, single-arm study of real-world MT for acute stroke because of anterior-circulation large-vessel occlusion performed at 55 sites over 2 years, including 1000 patients with severe stroke and treated within 8 hours. Patients underwent MT with or without intravenous tissue plasminogen activator and were admitted to endovascular-capable centers via either interhospital transfer or direct presentation. The primary clinical outcome was functional independence (modified Rankin Score 0–2) at 90 days. We assessed (1) real-world time metrics of stroke care delivery, (2) outcome differences between direct and transfer patients undergoing MT, and (3) the potential impact of local hospital bypass. Results: A total of 984 patients were analyzed. Median onset-to-revascularization time was 202.0 minutes for direct versus 311.5 minutes for transfer patients (P

Background and Purpose— Mechanical thrombectomy with stent retrievers has become standard of care for treatment of acute ischemic stroke patients because of large vessel occlusion. The STRATIS registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) aimed to assess whether similar process timelines, technical, and functional outcomes could be achieved in a large real world cohort as in the randomized trials. Methods— STRATIS was designed to prospectively enroll patients treated in the United States with a Solitaire Revascularization Device and Mindframe Capture Low Profile Revascularization Device within 8 hours from symptom onset. The STRATIS cohort was compared with the interventional cohort of a previously published SEER patient-level meta-analysis. Results— A total of 984 patients treated at 55 sites were analyzed. The mean National Institutes of Health Stroke Scale score was 17.3. Intravenous tissue-type plasminogen activator was administered in 64.0%. The median time from onset to arrival in the enrolling hospital, door to puncture, and puncture to reperfusion were 138, 72, and 36 minutes, respectively. The Core lab–adjudicated modified Thrombolysis in Cerebral Infarction ≥2b was achieved in 87.9% of patients. At 90 days, 56.5% achieved a modified Rankin Scale score of 0 to 2, all-cause mortality was 14.4%, and 1.4% suffered a symptomatic intracranial hemorrhage. The median time from emergency medical services scene arrival to puncture was 152 minutes, and each hour delay in this interval was associated with a 5.5% absolute decline in the likelihood of achieving modified Rankin Scale score 0 to 2. Conclusions— This largest-to-date Solitaire registry documents that the results of the randomized trials can be reproduced in the community. The decrease of clinical benefit over time warrants optimization of the system of care. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT02239640.

Introduction The first pass effect (FPE), a measure of thrombectomy device’s ability to restore near or complete revascularization (modified Thrombolysis in Cerebral Ischemia [mTICI] ≥2c) in a single pass, may be considered as a benchmark for thrombectomy devices in the treatment of acute ischemic stroke. While the FPE has been shown to be an independent predictor of good functional outcomes (modified Rankin Scale [mRS] ≤2) and is associated with reduced 90-day mortality, the economic impact of achieving the FPE has not been assessed. Methodology Data were obtained from the EMBOTRAP II device, ARISE-II (n=227) study. FPE was defined as complete revascularization (mTICI ≥2c) after the first pass of the EMBOTRAP II device. Patients who did not achieve complete revascularization within the ARISE-II population were excluded from the analysis. Healthcare resources included total hospital length of stay (LOS), days in the intensive care unit (ICU), standard bed days, and procedural device use (stent retrievers and aspiration devices). Costs from the literature, in 2018 USD, were applied to healthcare resources. Results In ARISE-II, 76% of patients (n=172) achieved complete revascularization; among these patients, 53% achieved the FPE. Among patients that achieved complete revascularization, baseline characteristics were well-balanced between patients that did or did not achieve the FPE. A significantly higher percentage of patients that achieved the FPE had good functional outcomes vs. those that did not achieve the FPE (80.5% vs. 61.0%, p=0.006). Healthcare resource use was lower among patients that achieved the FPE. While patients that achieved the FPE required only a single EMBOTRAP II device, 35% of the patients that did not achieve the FPE required both the EMBOTRAP II device and an additional device to achieve complete revascularization. Patients that achieved the FPE had a significantly shorter LOS (6.1 vs. 9.5 days, p=0.004) and fewer days spent in a standard bed (3.1 vs. 6.1, p=0.004) vs. those that did not achieve the FPE. Overall, the reduction in healthcare resource use associated with achieving the FPE led to estimated per-patient cost-savings of $6,355 (table 1). In the absence of cost data reported in ARISE-II, costs for healthcare resource use were obtained from the literature, which may not be generalizable across settings and is a limitation of this analysis. Additionally, this analysis did not include all components of health resource use that may impact costs (e.g., procedure time, surgical evacuation for symptomatic intracranial hemorrhage [sICH]). Conclusion Among patients with final complete reperfusion (mTICI≥2c), achieving the FPE may lead to per-patient cost-savings of $6,355 due to reductions in procedural and in-patient healthcare resource use. Disclosure O. Zaidat: 1; C; Cerenovus, Stryker, Medtronic, Penumbra, Genentech. 2; C; Stryker, Cerenovus, Penumbra, Medtronic. J. Saver: 2; C; Cerenovus, Stryker, Medtronic, Rapid Medical. 4; C; Rapid Medical. 5; C; University of California. H. Mattle: 1; C; Neuravi/Cerenovus. 2; C; Neuravi/Cerenovus. 3; C; Neuravi/Cerenovus. H. Bozorgchami: 2; C; Cerenovus, Stryker, Coherex. A. Narata: None. A. Yoo: 1; C; Cerenovus, Stryker, Medtronic, Penumbra, Genentech. 2; C; Cerenovus, Genentech, Zoll Circulation. 4; C; Insera Therapeutics. M. Ribo: 1; C; Stryker, Medtronic. 2; C; Cerenovus, Stryker, Medtronic, Anaconda Biomed. 4; C; Anaconda Biomed. C. Crivera: 4; C; Johnson & Johnson. 5; C; Johnson & Johnson. H. Cameron: 5; C; Cornerstone Research Group, contracted by Cerenovus. T. Andersson: 2; C; Cerenovus, Anaconda, Medtronic, Rapid Medical, Ablynx, Amnis Therapeutics.

Background A significantly large number of patients with emergent large vessel occlusion (ELVO) fail to achieve favorable outcomes despite successful recanalization. Why some patients do not achieve functional independence despite successful revascularization is an important question. There is a paucity of prospective data on the predictors of unfavorable outcomes despite successful recanalization during mechanical thrombectomy for ELVO. Objective This study was performed to determine the predictors of unfavorable outcomes in patients receiving successful recanalization (modified thrombolysis in cerebral infarct, mTICI grade ≥2b) in a prospective multicenter cohort of patients with ELVO. Methods This was a secondary analysis of data collected from ARISE II study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). ARISE II was a prospective, multicenter single arm study on the efficacy of EmboTrap Revascularization Device. Patients who achieved mTICI score of 2b or greater within 3 passes were included in this study. Patients with incomplete follow up were excluded from the study. A univariate and multivariate logistic regression was performed to determine the independent predictors of unfavorable outcomes at 90 days (defined as mRS 3–6). The variables tested as predictors included age, gender, collateral grade, ASPECTS, mode of transfer, National health institute stroke scale (NIHSS) score, use of intravenous tissue plasminogen activator, number of passes, clot location, final mTICI and symptomatic intracranial hemorrhage (sICH). Odds ratio (OR) with 95% confidence interval (CI) were reported. Results One hundred seventy six patients were included in this secondary analysis of ARISE II data. Unfavorable outcomes (mRS=3–6) at 3 months were seen in 52 (29.6%) patients. Females constituted 54.88% of total population. Mean age was 67.15 years. Mean NIHSS score was 15.85±4.71. M1 was the most common site of occlusion with 54.55% followed by M2 (25.0%) and ICA (15.91%). Delay from stroke onset to the deployment of stent retriever was 3.97±1.44 hours. Ninety (51.14%) patients required a single pass. On univariate logistic regression analysis age, ASPECTS, collateral grade, time from stroke onset to the deployment of stent retriever, duration of procedure, NIHSS score, and sICH were found to be significant predictors of unfavorable outcomes. On multivariate analysis collateral grade (OR, 0.24, 95% CI 0.06–0.94, p value 0.04), NIHSS score (OR 1.28, 95% CI 1.15–1.43, p value Conclusion Collateral grade, NIHSS score at presentation, and number of passes are independent predictors of unfavorable outcomes at 90 days. Disclosures A. Siddiqui: 1; C; Co-investigator NIH/NINDS 1R01NS091075. 2; C; Canon Medical System US, Boston Scientific, Amnis Therapeutics, Cerebrotech Medical Systems, Silk Road, Corindus Inc., Blockade Medical, Guidepoint Global Consulting, Imperative Care, Integra LifeSciences Corp, Medtronic, MicroVention, Q’Apel Medical Inc, Rapid Medical, Rebound Therapeutics Corp., Serenity Medical Inc, Silk Road Medical, StimMed, Stryker, Three Rivers Medical, VasSol, W.L. Gore & Associates. M. Waqas: None. T. Andersson: 2; C; Neuravi, Ablynx, Amnis Therapeutics, Medtronic, Rapid Medical, Stryker. J. Saver: 1; C; Medtronic-Abbott, Neuravi. H. Mattle: None. H. Bozorgchami: None. R. Chapot: None. A. Narata: None. A. Yoo: 1; C; Penumbra, Neuravi, Cerenovus. M. Ribo: None. O. Zaidat: 2; C; Stryker, Medtronic, Neuravi, Penumbra.

Introduction Swift and complete revascularization in large vessel occlusion (LVO) stroke is associated with better functional outcomes. First pass effect (FPE), achievement of TICI 2C/3 revascularization on the first pass, is a new metric of technical success of endovascular thrombectomy (EVT). We aim to identify predictors of FPE and TICI 3 revascularization in the ARISE II study. Methods Anterior circulation LVO [ACLVO-internal carotid (ICA) and middle cerebral artery (MCA-M1)] strokes from the ARISE II study were used for this analysis. Core-lab adjudicated TICI scores after the first pass of EmboTrap were collected. FPE and modified FPE (mFPE) were defined as first pass achievement of TICI 2C/3 and TICI ≥2B, respectively. Demographic, clinical and radiographic parameters were analyzed. Multivariable logistic regression was performed to identify predictors. Results A total of 161 ACLVOs underwent thrombectomy in the ARISE II study. Mean age was 67 ±13 years and 43% (n=69) were male. Mean NIHSS and median ASPECTS were 16 ±5 and 10, respectively. While FPE was achieved in 37% (n=59), mFPE was seen 43% (n=69) patients. Multivariable logistic regression was performed using age, sex, use of IV-tpA, BMI, NIHSS, vascular risk factors, ASPECTS, collateral status (ASITN), occlusion location and use of balloon-guided catheter as variables. While absence of ICA occlusion (p=0.07, OR-8.6, 0.8–90) can predict FPE, there were no independent predictors of mFPE. Independent predictors of TICI 3 after 3 passes include use of balloon guide catheter (p=0.01, OR-0.033, 0.003–0.535) and higher ASITN score(p=0.04, OR-10.2, 1–100). Conclusion Absence of internal carotid artery occlusion predicts FPE and the use of balloon guide catheter and favorable collaterals predicts complete revascularization. These results support the consideration of routine BGC use with the Embotrap device to achieve complete revascularization. Disclosures A. Jadhav: None. S. Desai: None. D. Liebeskind: None. A. Yoo: None. H. Bozorgchami: None. M. Ribo: None. J. L: None. H. Mattle: None. T. Andersson: None. O. Zaidat: None.

Background and Purpose- Mechanical thrombectomy (MT) devices have led to improved reperfusion and clinical outcomes in acute ischemic stroke patients with emergent large vessel occlusions; however, less than one-third of patients achieve complete reperfusion. Use of intraarterial thrombolysis in the context of MT may provide an opportunity to enhance these results. Here, we evaluate the use of intraarterial rtPA (recombinant tissue-type plasminogen activator) as rescue therapy (RT) after failed MT in the North American Solitaire Stent-Retriever Acute Stroke registry. Methods- The North American Solitaire Stent-Retriever Acute Stroke registry recruited sites within North America to submit data on acute ischemic stroke patients treated with the Solitaire device. After restricting the population of 354 patients to use of RT and anterior emergent large vessel occlusions, we compared patients who were treated with and without intraarterial rtPA after failed MT. Results- A total of 37 and 44 patients was in the intraarterial rtPA RT and the no intraarterial rtPA RT groups, respectively. Revascularization success (modified Thrombolysis in Cerebral Infarction ≥2b) was achieved in more intraarterial rtPA RT patients (61.2% versus 46.6%; P=0.13) with faster times to recanalization (100±85 versus 164±235 minutes; P=0.36) but was not statistically significant. The rate of symptomatic intracranial hemorrhage (13.9% versus 6.8%; P=0.29) and mortality (42.9% versus 44.7%; P=0.87) were similar between the groups. Good functional outcome (modified Rankin Scale score of ≤2) was numerically higher in intraarterial rtPA patients (22.9% versus 18.4%; P=0.64). Further restriction of the RT population to M1 occlusions only and time of onset to groin puncture ≤8 hours, resulted in significantly higher successful revascularization rates in the intraarterial rtPA RT cohort (77.8% versus 38.9%; P=0.02). Conclusions- Intraarterial rtPA as RT demonstrated a similar safety and clinical outcome profile, with higher reperfusion rates achieved in patients with M1 occlusions. Prospective studies are needed to delineate the role of intraarterial thrombolysis in MT.

Background: Recent studies report an approximately 90% rate of TICI 2b-3 reperfusion. With little room for further improvement, the resulting ceiling effect will limit the utility of this angiographic endpoint in future studies. We aimed to identify a more optimal definition of angiographic success along two dimensions: 1) the extent of tissue reperfusion and 2) the speed of revascularization. Methods: Data from the ARISE II study was used for this analysis. Core-lab adjudicated TICI scores (inclusive of 2c) after the first pass of EmboTrap and the final TICI scores after all interventions were collected. Receiver-operating characteristic (ROC) analyses were used to compare first pass and final TICI 2b-3, TICI 2c-3, and TICI 3 endpoints for the optimal prediction of 90-day mRS 0-2, 24-hour NIHSS improvement of ≥8 points, and 90-day mortality. The optimal procedural time from groin puncture to substantial reperfusion (TICI ≥2b) was also determined using ROC analysis. Results: Of 218 ARISE II subjects with anterior circulation occlusions, 201 (92.2%) had substantial reperfusion at the end of the procedure (final TICI 2b-3): 38 (17.4%) final TICI 2b, 52 (23.9%) final TICI 2c, and 111 (50.9%) final TICI 3. Substantial reperfusion after the first pass (first pass TICI 2b-3) was seen in 109 (50%) subjects. In 101 of these 109 (92.7%) cases, the first pass TICI score matched the final TICI score. The median procedural time from groin puncture to achieving TICI ≥2b was 29 minutes (interquartile range [IQR] 22.75-45 minutes) in the subjects who had first pass TICI 2b-3 versus 60 minutes (IQR 44.5-85 minutes) in those who did not (P Conclusion: First pass TICI 2b-3 is the optimal angiographic endpoint for predicting clinical and safety outcomes in ARISE II.

Background: The severity and duration of ischemia determine the extent of injury in acute ischemic stroke (AIS). Rapid reperfusion in endovascular therapy is therefore linked with good outcomes, yet the chronology of reperfusion with subsequent device passes has not been fully explored. We tested whether the sequence of reperfusion after each interventional step or mTICI chronology, influences subsequent imaging and clinical outcomes after endovascular therapy for AIS. Methods: ARISE II dataset of clinical and angiography variables was analyzed to determine the relationship between sequential mTICI reperfusion scores with 90-day mRS outcomes. mTICI was scored at baseline and after each device pass. A Mantel-Haenszel chi-square p-value was calculated to measure the correlation between the total number of passes required and the mRS score at 90 days. Results: Core lab adjudicated mTICI scores on routine angiography injections were available in 227/227 (100%) of treated ARISE II subjects (age 68.0 ± 13.0, 54.2% women, mean baseline NIHSS 15.8 ± 5) and 90±30 day mRS scores were available for 217. The number of passes was highly correlated with mRS (p Conclusions: mTICI chronology, or reperfusion at each procedural stage, varies in endovascular treatment of AIS and demonstrates an important link with outcomes.

Background and Purpose— EmboTrap is a novel stent retriever designed to achieve rapid and substantial flow restoration in acute ischemic stroke secondary to large-vessel occlusions. Here, we evaluated EmboTrap’s safety and efficacy compared with established stent retrievers. Methods— ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) was a single-arm, prospective, multicenter study, comparing the EmboTrap device to a composite performance goal criterion derived using a Bayesian meta-analysis from the pivotal SWIFT (Solitaire device) and TREVO 2 (Trevo device) trials. Patients at 11 US and 8 European sites were eligible for inclusion if they had large-vessel occlusions and moderate-to-severe neurological deficits within 8 hours of symptom onset. The primary efficacy end point was achievement of modified Thrombolysis in Cerebral Ischemia (mTICI) reperfusion scores of ≥2b within 3 EmboTrap passes as adjudicated by the core laboratory. The primary safety end point was a composite of symptomatic intracerebral hemorrhage and serious adverse device effects. Secondary end points included functional independence (modified Rankin Scale, 0–2) and all-cause mortality at 90 days. Results— Between October 2015 and February 2017, 227 patients were enrolled and treated with the EmboTrap device. The primary efficacy end point (mTICI ≥2b within 3 passes) was achieved in 80.2% (95% confidence interval, 74%–85% versus 56% performance goal criterion; P value, Conclusions— The EmboTrap stent-retriever mechanical thrombectomy device demonstrated high rates of substantial reperfusion and functional independence in patients with acute ischemic stroke secondary to large-vessel occlusions. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT02488915.

Background: Various techniques are used to enhance the results of mechanical thrombectomy with stent-retrievers, including proximal arrest with balloon guide catheter (BGC), conventional large bore proximal catheter (CGC), or in combination with local aspiration through a large-bore catheter positioned at the clot interface (Aspiration-Retriever Technique for Stroke [ARTS]). We evaluated the impact of ARTS in the North American Solitaire Acute Stroke (NASA) registry. Summary: Data on the use of the aspiration technique were available for 285 anterior circulation patients, of which 29 underwent ARTS technique, 131 CGC, and 125 BGC. Baseline demographics were comparable, except that ARTS patients are less likely to have hypertension or atrial fibrillation. The ARTS group had more ICA occlusions (41.4 vs. 22% in the BGC, p = 0.04 and 26% in CGC, p = 0.1) and less MCA/M1 occlusions (44.8 vs. 68% in BGC and 62% in CGC). Time from arterial puncture to reperfusion or end of procedure with ARTS was shorter than with CGC (54 vs. 91 min, p = 0.001) and was comparable to the BGC time (54 vs. 67, p = 0.11). Final degree of reperfusion was comparable among the groups (TICI [modified Thrombolysis in Cerebral Infarction] score 2b or higher was 72 vs. 70% for CGC vs. 78% for BGC). Procedural complications, mortality, and good clinical outcome at 90 days were similar between the groups. Key Messages: The ARTS mechanical thrombectomy in acute ischemic stroke patients appears to yield better results as compared to the use of CGCs with no significant difference when compared to BGC. This early ARTS technique NASA registry data are limited by the earlier generation distal large bore catheters and small sample size. Future studies should focus on the comparison of ARTS and BGC techniques.

Background and Aims: Balloon Guide Catheter (BGC) use during thrombectomy treatment in Stroke patients has been reported to have positive effects on revascularization, procedural characteristics, and clinical outcomes. We evaluate the use of BGC in an open-label large prospective TREVO Retriever Registry of real world patients to determine predictors of good ‘clinical’ outcomes. Method: Consecutive Trevo Registry patients that had Balloon Guide Catheter (BGC) used during their thrombectomy procedure were identified; a subset of patients who fulfilled the criteria (ICA and/or MCA-M1/M2 occlusion with pre-morbid mRS 0-1, TLSW ≤6 hrs) within the cohort were also identified. Multivariate analysis was performed to identify the predictors of good outcomes in BGC thrombectomy patients. Results: A total of 1031 BGC treated Trevo Registry patients (overall enrolled, n=2010) qualified for analysis, of which 605 patients fulfilling the subset criteria were identified. The mean age of BGC/stent retriever patients was 67.5 with a median (IQR) baseline NIHSS of 15(11-19). Occlusion location of the BCG group was ICA -20.4%, M1- 57.1%, M2/M3-20.3%, and Posterior 1.8%. In the overall BGC cohort, the median (IQR) time to treatment was (4.2 (3.0,6.5)- hrs.) with conscious/local sedation used in 63.4% and general anesthesia used in 37.3% of cases. The median number of passes with Trevo stent retriever was 1 and revascularization (mTICI ≥ b) was achieved in 92.8% of cases. The sICH rate was low at 1.9% (20/1031) with a low rate of vessel perforation (0.2%). At 90 days post stroke, 56.0% of patients achieved functional independence (mRS 0-2) with 63.7% of the subset of “guidline “ BGC patients achieving functional independence at 90 days. Multivariate logistic regression showed age (aOR 0.97 [0.96, 0.99] P Conclusion: Data from Trevo Registry demonstrate the use of BGC in thrombectomy procedure is safe, and leads to a reduction of disability in ischemic stroke patients.

Background and Purpose— Failure to recanalize predicts mortality in acute ischemic stroke. In the North American Solitaire Acute Stroke registry, we investigated parameters associated with mortality in successfully recanalized patients. Methods— Logistic regression was used to evaluate baseline characteristics and recanalization parameters for association with 90-day mortality. A multivariable model was developed based on backward selection with retention criteria of P P ≤0.10), then refit to minimize the number of excluded cases (missing data). Results— Successfully recanalized patients had lower mortality (25.2% [59/234] versus 46.9% [38/81] P P =0.205). However, mortality was significantly higher in patients with symptomatic intracranial hemorrhage (72% [23/32] versus 26% [73/281]; P P P c index=0.72), proximal occlusion, initial National Institutes of Health Stroke Scale≥18, and use of rescue therapy remained significant independent predictors of 90-day mortality. Conclusions— Failure to recanalize and presence of symptomatic intracranial hemorrhage resulted in increased mortality. Despite successful recanalization, proximal occlusion, high National Institutes of Health Stroke Scale, and need for rescue therapy were predictors of mortality.

Background and Purpose— The Solitaire With the Intention for Thrombectomy (SWIFT) and thrombectomy revascularization of large vessel occlusions in acute ischemic stroke (TREVO 2) trial results demonstrated improved recanalization rates with mechanical thrombectomy; however, outcomes in the elderly population remain poorly understood. Here, we report the effect of age on clinical and angiographic outcome within the North American Solitaire-FR Stent-Retriever Acute Stroke (NASA) Registry. Methods— The NASA Registry recruited sites to submit data on consecutive patients treated with Solitaire-FR. Influence of age on clinical and angiographic outcomes was assessed by dichotomizing the cohort into ≤80 and >80 years of age. Results— Three hundred fifty-four patients underwent treatment in 24 centers; 276 patients were ≤80 years and 78 were >80 years of age. Mean age in the ≤80 and >80 cohorts was 62.2±13.2 and 85.2±3.8 years, respectively. Of patients >80 years, 27.3% had a 90-day modified Rankin Score ≤2 versus 45.4% ≤80 years ( P =0.02). Mortality was 43.9% and 27.3% in the >80 and ≤80 years cohorts, respectively ( P =0.01). There was no significant difference in time to revascularization, revascularization success, or symptomatic intracranial hemorrhage between the groups. Multivariate analysis showed age >80 years as an independent predictor of poor clinical outcome and mortality. Within the >80 cohort, National Institutes of Health Stroke Scale (NIHSS), revascularization rate, rescue therapy use, and symptomatic intracranial hemorrhage were independent predictors of mortality. Conclusion— Greater than 80 years of age is predictive of poor clinical outcome and increased mortality compared with younger patients in the NASA registry. However, intravenous tissue-type plasminogen activator use, lower NIHSS, and shorter revascularization time are associated with better outcomes. Further studies are needed to understand the endovascular therapy role in this cohort compared with medical therapy.

Although clinical trials have investigated thrombolytic therapies such as streptokinase, urokinase, and desmoteplase in acute ischemic stroke treatment, only trials assessing intravenous (IV) tissue plasminogen activator (tPA) and intraarterial prourokinase were successful in showing efficacy. Since a confirmatory trial with prourokinase was not performed, it has not been approved for treatment and IV tPA remains the standard of care. Advances in fluoroscopic imaging led to additional research in endovascular therapies as performing interventional cerebrovascular procedures became more feasible. After years of device development, enhanced acute stroke imaging, and improvements in systems of care, endovascular therapy has now shown efficacy in acute stroke treatment in randomized trials as well. Trials have shown the efficacy of stent retrievers compared to medical therapy alone in patients with anterior circulation large vessel occlusions. This has resulted in a paradigm shift in the management of acute ischemic stroke.

Background and Purpose— Previous work that predated the availability of the safer stent-retriever devices has suggested that general anesthesia (GA) may have a negative impact on outcomes in patients with acute ischemic stroke undergoing endovascular therapy. Methods— We reviewed demographic, clinical, procedural (GA versus local anesthesia [LA], etc), and site-adjudicated angiographic and clinical outcomes data from consecutive patients treated with the Solitaire FR device in the investigator-initiated North American SOLITAIRE Stent-Retriever Acute Stroke (NASA) Registry. The primary outcomes were 90-day modified Rankin Scale, mortality, and symptomatic intracranial hemorrhage. Results— A total of 281 patients from 18 centers were enrolled. GA was used in 69.8% (196/281) of patients. Baseline demographic and procedural factors were comparable between the LA and GA groups, except the former demonstrated longer time-to-groin puncture (395.4±254 versus 337.4±208 min; P =0.04), lower National Institutes of Health Stroke Scale (NIHSS; 16.2±5.8 versus 18.8±6.9; P =0.002), lower balloon-guide catheter usage (22.4% versus 49.2%; P =0.0001), and longer fluoroscopy times (39.5±33 versus 28±22.8 min; P =0.008). Recanalization (thrombolysis in cerebral infarction ≥2b; 72.94% versus 73.6%; P =0.9) and rate of symptomatic intracranial hemorrhage (7.1% versus 11.2%; P =0.4) were similar but modified Rankin Scale ≤2 was achieved in more LA patients, 52.6% versus 35.6% (odds ratio, 1.4 [1.1–1.8]; P =0.01). In multivariate analysis, hypertension, NIHSS, unsuccessful revascularization, and GA use (odds ratio, 3.3 [1.6–7.1]; P =0.001) were associated with death. When only anterior circulation and elective GA patients were included, there was a persistent difference in good outcomes in favor of LA patients (50.7% versus 35.5%; odds ratio, 1.3 [1.01–1.6]; P =0.04). Conclusions— The NASA Registry has demonstrated that clinical outcomes and survival are significantly better in patients treated with LA, without increased symptomatic intracranial hemorrhage risk. Future trials should prospectively evaluate the effect of GA on outcomes.

Background: The Interventional Management of Stroke III (IMS-III) trial demonstrated no benefit for intravenous recombinant tissue plasminogen activator (IV rt-PA) followed by endovascular therapy versus IV rt-PA alone. However, IMS-III mostly included earlier generation devices. The recent thrombectomy trials have incorporated the stent-retriever technology, but their generalizability remains unknown. Methods: The North American Solitaire Acute Stroke (NASA) registry recruited patients treated with the Solitaire FR™ device between March 2012 and February 2013. The NASA-IMS-III-Like Group (NILG baseline NIHSS score ≥10 who received IV rt-PA) was compared to the IV rt-PA and IV + intra-arterial (IA)-IMS-III groups and the MR CLEAN, ESCAPE, SWIFT Prime, and REVASCAT trial controls to assess the stent-retriever treatment in the ‘real-world' setting. The NILG was also compared to non-IV rt-PA NASA patients to evaluate the impact of IV rt-PA on thrombectomy. Results: A total of 136 of the 354 NASA patients fulfilled criteria for the NILG. Baseline characteristics were well balanced across groups. Time from onset to puncture was higher in NILG than IV+IA-IMS-III patients (274 ± 112 vs. 208 ± 47 min, p < 0.0001). Occlusions involving the intracranial ICA, MCA-M1, or basilar arteries were more common in NILG than IV+IA-IMS-III patients (91.2 vs. 47.2%, p < 0.00001). Modified thrombolysis in cerebral infarction ≥2b reperfusion was higher in NILG than IV+IA-IMS-III patients (74.3 vs. 39.6%, p < 0.00001). A 90-day modified Rankin Scale score ≤2 was more frequent in the NILG than IV+IA-IMS-III patients (51.9 vs. 40.8%, p = 0.03) and MR CLEAN (51.9 vs. 19.1%, p < 0.00001), ESCAPE (51.9 vs. 29.3%, p = 0.0002), SWIFT Prime (51.9 vs. 35.5%, p = 0.02), and REVASCAT (51.9 vs. 28.2%, p = 0.0003) controls. Symptomatic intracranial hemorrhage definitions varied across the different studies with rates ranging from 2.7% (ESCAPE) to 11.9% (NILG). The NILG 90-day mortality (24.4%) was higher than in SWIFT Prime but comparable to all other groups. IV rt-PA was an independent predictor of good outcome in NASA (OR = 2.3, 95% CI 1.2-4.7). Conclusion: Our results support the ‘real-world' applicability of the recent thrombectomy trials.

BackgroundTime to reperfusion following endovascular treatment (ET) predicts outcomes after acute ischemic stroke (AIS).ObjectiveTo assess the time–outcome relationship within reperfusion grades in the North American Solitaire Acute Stroke registry.MethodsWe identified patients given ET for anterior circulation ischemic stroke within 8 h from onset and in whom reperfusion was achieved. Together with clinical and outcome data, site-adjudicated modified Thrombolysis in Cerebral Ischemia (TICI) was recorded. We assessed the impact of time to reperfusion (onset to procedure completion time) on good outcome (modified Rankin Scale 0–2 at 3 months) in patients who achieved TICI 2 or higher reperfusion in multivariable models. We further assessed this relationship within strata of reperfusion grades. A pResultsIndependent predictors of good outcome at 3 months among those achieving TICI ≥2a reperfusion (n=188) were initial National Institutes of Health Stroke Scale score (adjusted OR=0.90, 95% CI 0.85 to 0.95), symptomatic hemorrhage (adj. OR=0.16, 95% CI 0.05 to 0.60), TICI grade (TICI 3: adj. OR=11.52, 95% CI 3.34 to 39.77; TICI 2b: adj. OR=5.14, 95% CI 1.61 to 16.39), and time to reperfusion per 30 min interval (adj. OR=0.91, 95% CI 0.82 to 0.99). There was an interaction between final TICI grade and 30 min time to reperfusion intervals (p=0.001) such that the effect of time was strongest in TICI 2a patients.ConclusionsTime to reperfusion was a strong predictor of outcome following ET for AIS. However, the effect varied by TICI grade such that its greatest effect was in those achieving TICI 2a reperfusion.

Background: Time to reperfusion following endovascular treatment (ET) strongly predicts outcomes after acute ischemic stroke (AIS). However, the impact of time may vary depending on the grade of reperfusion. We sought to assess time-outcome relationship within grades of reperfusion in the North American Solitaire Acute Stroke (NASA) registry. Methods: The investigator-initiated NASA registry recruited 24 clinical sites within North America to submit demographic, clinical, site-adjudicated angiographic, and clinical outcome data on consecutive patients treated with the Solitaire Flow Restoration device. We identified patients treated with anterior circulation ischemic stroke treated within 8 hours. The modified Thrombolysis in Cerebral Ischemia (TICI) was used wherein TICI 2 was divided in TICI 2a (< 50% reperfusion) and TICI 2b (> 50% reperfusion). We assessed the impact of time to reperfusion (onset to procedure completion time) on good outcome (modified Rankin Scale 0-2 at 3 months) in those who achieved at least TICI 2a reperfusion, independent of other relevant covariates using logistic regression analysis. We further assessed this relationship within strata of reperfusion grade. Results: Among 265 eligible patients, 209 (78.9%) had complete data (mean age 68.4 years, median NIHSS score 18). Reperfusion grade was as follows: TICI 3: 35.4%; TICI 2b: 39.7%, TICI 2a: 14.8%; TICI 0-1: 10.0%. Independent predictors of outcome at 3 months among those achieving TICI 2-3 reperfusion were: initial NIHSS score, intravenous tissue plasminogen activator use, symptomatic hemorrhage, and time to reperfusion. For each 30 minutes, the adjusted OR for time to reperfusion was 0.874 (95% CI 0.797-958). There was a significant interaction between final TICI grade and 30-minute time to reperfusion intervals (P=0.001) such that the effect of time was strongest in TICI 2a patients. Conclusions: Time to reperfusion is a strong predictor of outcome following ET for AIS with 13% decreased odds of good outcome per 30-minute delay in achieving TICI 2-3 reperfusion. However, the effect varied by TICI grade such that its greatest effect was in those achieving TICI 2a reperfusion.

International audience; BACKGROUND AND PURPOSE:Flow diverters are increasingly used in the endovascular treatment of intracranial aneurysms. Our aim was to determine neurologic complication rates following Pipeline Embolization Device placement for intracranial aneurysm treatment in a real-world setting.MATERIALS AND METHODS:We retrospectively evaluated all patients with intracranial aneurysms treated with the Pipeline Embolization Device between July 2008 and February 2013 in 17 centers worldwide. We defined 4 subgroups: internal carotid artery aneurysms of ≥10 mm, ICA aneurysms of

Tensin is a focal adhesion molecule that binds to actin filaments and participates in signaling pathways. In this study, we have characterized a previously undocumented tensin family member, tensin2/KIAA 1075. Human tensin2 cDNA encodes a 1,285-aa sequence that shares extensive homology with tensin1 at its amino- and carboxyl-terminal ends, which include the actin-binding domain, the Src homology 2 (SH2) domain, and the phosphotyrosine binding (PTB) domain. Analysis of the genomic structures of tensin1 and tensin2 further confirmed that they represent a single gene family. Examination of tensin2 mRNA distribution revealed that heart, kidney, skeletal muscle, and liver were tissues of high expression. The endogenous and recombinant tensin2 were expressed as a 170-kDa protein in NIH 3T3 cells. The subcellular localization of tensin2 was determined by transfection of green fluorescence protein (GFP)–tensin2 fusion construct. The results indicated that tensin2 is also localized to focal adhesions. Finally, functional analysis of tensin genes has demonstrated that expression of tensin genes is able to promote cell migration on fibronectin, indicating that the tensin family plays a role in regulating cell motility.

Background and Purpose— Efficient and timely recanalization is an important goal in acute stroke endovascular therapy. Several studies demonstrated improved recanalization and clinical outcomes with the stent retriever devices compared with the Merci device. The goal of this study was to evaluate the role of the balloon guide catheter (BGC) and recanalization success in a substudy of the North American Solitaire Acute Stroke (NASA) registry. Methods— The investigator-initiated NASA registry recruited 24 clinical sites within North America to submit demographic, clinical, site-adjudicated angiographic, and clinical outcome data on consecutive patients treated with the Solitaire Flow Restoration device. BGC use was at the discretion of the treating physicians. Results— There were 354 patients included in the NASA registry. BGC data were reported in 338 of 354 patients in this subanalysis, of which 149 (44%) had placement of a BGC. Mean age was 67.3±15.2 years, and median National Institutes of Health Stroke Scale score was 18. Patients with BGC had more hypertension (82.4% versus 72.5%; P =0.05), atrial fibrillation (50.3% versus 32.8%; P =0.001), and were more commonly administered tissue plasminogen activator (51.6% versus 38.8%; P =0.02) compared with patients without BGC. Time from symptom onset to groin puncture and number of passes were similar between the 2 groups. Procedure time was shorter in patients with BGC (120±28.5 versus 161±35.6 minutes; P =0.02), and less adjunctive therapy was used in patients with BGC (20% versus 28.6%; P =0.05). Thrombolysis in cerebral infarction 3 reperfusion scores were higher in patients with BGC (53.7% versus 32.5%; P P =0.002) and good clinical outcome at 3 months were superior in patients with BGC compared with patients without (51.6% versus 35.8%; P =0.02). Multivariate analysis demonstrated that the use of BGC was an independent predictor of good clinical outcome (odds ratio, 2.5; 95% confidence interval, 1.2–4.9). Conclusions— Use of a BGC with the Solitaire Flow Restoration device resulted in superior revascularization results, faster procedure times, decreased need for adjunctive therapy, and improved clinical outcome.

BackgroundLimited post-marketing data exist on the use of the Solitaire FR device in clinical practice. The North American Solitaire Stent Retriever Acute Stroke (NASA) registry aimed to assess the real world performance of the Solitaire FR device in contrast with the results from the SWIFT (Solitaire with the Intention for Thrombectomy) and TREVO 2 (Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischemic stroke) trials.MethodsThe investigator initiated NASA registry recruited North American sites to submit retrospective angiographic and clinical outcome data on consecutive acute ischemic stroke (AIS) patients treated with the Solitaire FR between March 2012 and February 2013. The primary outcome was a Thrombolysis in Myocardial Ischemia (TIMI) score of ≥2 or a Treatment in Cerebral Infarction (TICI) score of ≥2a. Secondary outcomes were 90 day modified Rankin Scale (mRS) score, mortality, and symptomatic intracranial hemorrhage.Results354 patients underwent treatment for AIS using the Solitaire FR device in 24 centers. Mean time from onset to groin puncture was 363.4±239 min, mean fluoroscopy time was 32.9±25.7 min, and mean procedure time was 100.9±57.8 min. Recanalization outcome: TIMI ≥2 rate of 83.3% (315/354) and TICI ≥2a rate of 87.5% (310/354) compared with the operator reported TIMI ≥2 rate of 83% in SWIFT and TICI ≥2a rate of 85% in TREVO 2. Clinical outcome: 42% (132/315) of NASA patients demonstrated a 90 day mRS ≤2 compared with 37% (SWIFT) and 40% (TREVO 2). 90 day mortality was 30.2% (95/315) versus 17.2% (SWIFT) and 29% (TREVO 2).ConclusionsThe NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.

Introduction: Stent-assisted coil embolization facilitates the treatment of wide-necked aneurysms. In-stent stenosis, although rare, may lead to stroke by occlusion of the parent artery or by thromboembolism. To our knowledge, the risk factors for in-stent stenosis in this context have not yet been investigated. Hypothesis: We hypothesized that cardiovascular risk factors and vessel size would be associated with in-stent stenosis. Methods: Consecutive patients undergoing stent-assisted coil embolization at our institution using the Neuroform stent (Stryker, Kalamazoo, MI, USA) were identified by billing records. Medical comorbidities were extracted retrospectively from patient charts. In-stent stenosis on last angiogram and vessel size (dichotomized into Results: A total of 224 unruptured aneurysms were treated with stent assisted-coil embolization between 2003 and 2010 utilizing the Neuroform stent. Follow-up catheter angiography was available in 196/224 (87.5%) at mean of 19 mos in those with in-stent stenosis and 24 mos in those without. In-stent stenosis occurred in 8/196 (4.1%). Mean age was 59 in those with in-stent stenosis and 62 in those without. The prevalence of cardiovascular risk factors in the groups with and without stenosis were as follows: diabetes 25% (2/8) vs. 6.9% (13/188), hypertension 42.6% (80/188) vs. 50% (4/8), hyperlipidemia 13% (1/8) vs. 5.9% (11/188), coronary artery disease 13% (1/8) vs. 3.7% (7), and smoking 38% (3/8) vs. 39% (75/188). Vessel size was Conclusions: The overall risk of in-stent stenosis in patients undergoing stent-assisted coil embolization was relatively low. Although cardiovascular comorbidities were numerically more common in patients with in-stent stenosis, the differences between the two groups were not statistically significant.

Background Recanalization of the occluded artery is a powerful predictor of good outcome in acute ischemic stroke secondary to large artery occlusions. Mechanical thrombectomy with stent-trievers results in higher recanalization rates and better outcomes compared to previous devices. However, despite successful recanalization rates (Treatment in Cerebral Infarction, TICI, score ≥ 2b) between 70 and 90%, good clinical outcomes assessed by modified Rankin Scale (mRS ≥ 2 is present in 40–50% of patients. We aimed to evaluate predictors of poor outcomes (mRS ≥ 2) despite successful recanalization (TICI ≥ 2b) in the acute stroke patients treated with the Solitaire device of the North American Solitaire Stent Retriever Acute Stroke (NASA) registry. Methods The NASA registry is a multicenter, non-sponsored, physician-conducted, post-marketing registry on the use of SOLITAIRE FR device in 354 acute, large vessels, ischemic stroke patients. Logistic regression was used to evaluate patient characteristics and treatment parameters for association with 90-day mRS score of 0–2 (good outcome) versus 3–6 (poor outcome) within patients who were recanalised successfully (Thrombolysis in Cerebral Infarction or TICI score 2b-3). Univariate tests were followed by development of a multivariable model based on stepwise selection with entry and retention criteria of p Results Out of 354 patients, 256 (72.3%) were successfully recanalised (TICI ≥ 2b). Based on 90-day mRS score for 234 of these patients, there were 116 (49.6%) with mRS ≥2. Univariate analysis identified increased risk of mRS ≥2 for each of the following: age ≥ 80 years (upper quartile of data), occlusion site other than M1/M2, NIH Stroke Scale (NIHSS) score ≥ 18 (median), history of diabetes mellitus (DM), TICI = 2b, use of rescue therapy, not using a balloon-guided catheter (BCG) or intravenous tissue plasminogen activator (IV t-PA), and time to recanalization > 30 min (all p ≤ 0.05). Three or more passes was marginally significant (p = 0.097). In multivariable analysis, age ≥80 years, site other than M1/M2, initial NIHSS ≥18, DM, absence of IVtPA, use of rescue therapy and three or more passes were significant independent predictors of poor 90-day outcome in a model with good predictive power (c-index = 0.80). Conclusions Age, occlusion site, high NIHSS, diabetes, not receiving IVtPA, use of rescue therapy and three or more passes, were associated with poor 90-day outcome despite successful recanalization. Disclosures I. Linfante: None. G. Dabus: None. A. Starosciak: None. A. Castonguay: None. R. Gupta: None. C. Sun: None. C. Martin: None. W. Holloway: None. N. Mueller-Kronast: None. J. English: None. T. Malisch: None. F. Marden: None. H. Bozorgchami: None. A. Xavier: None. A. Rai: None. M. Froehler: None. A. Badruddin: None. T. Nguyen: None. M. Taqi: None. M. Abraham: None. V. Janardhan: None. H. Shaltoni: None. R. Novakovic: None. A. Yoo: None. O. Zaidat: None.

Background Advances in acute ischemic stroke mechanical thrombectomy devices have led to increased expectations of their safety and efficacy results. Objective To describe a new measure for the newer generation stroke thrombectomy devices, the First Pass Effect (FPE), defined as achieving thrombolysis in cerebral ischemia (TICI) score of 3 from the first pass, without the use of rescue therapy. In addition, a second objective was to assess if achieving TICI2b only with FP (FPE-TICI2b only) yielded similar results as FPE-TICI3 or non-FPE-TICI3 or non-FPE-TICI2b. The influence of FPE on clinical outcome, and its frequency and predictors was evaluated in the North American Solitaire Acute stroke (NASA) registry. Methods The FPE group was identified from the NASA multicenter registry database. Baseline features and clinical outcomeswere compared between the FPE group and the rest of the cohort. Subsequently, two multivariate analyzes were performed to identify if FPE is an independent predictor of clinical outcome and to identify the predictors of FPE. Furthermore, we assessed the difference between FPE and achieving other revascularization grades such as non-FPE-TICI3, FPE-TICI2b, and non-FPE-TICI2b scores. Clinical outcomes were mRS0–2 at 90 days, NIH stroke severity scale, mortality, and symptomatic intracranial hemorrhage (sICH). Results A total of 354 patients from 24 US centers were included in the NASA registry. The FPE was achieved in 89/354 (25.1%). Baseline demographics were comparable between FPE and the rest of the cohort, except that the FPE population had less octogenarians (34.6% vs. 65.4%), more woman (60.7% vs. 47.2%), and more Caucasians (83% vs. 71.2%). Baseline NIHSS and time from onset to groin puncture did not differ among the two groups. Angiographic features demonstrated more MCA occlusion (64% vs. 52.7%) and less ICA occlusion (10.1% vs. 27.7%) in the FPE group. Technical factors associated with FPE were limited to BGC use (64.8% vs. 36.8%), with no difference with use of IV-tPA, IA-tPA, or General Anesthesia. Multivariate analysis demonstrated use of BGC, no ICA occlusion, MCA occlusion, female gender, and white race as independent predictors of FPE. Clinical outcome measured with mRS 0–2 at 90 days was seen in 61.3%, 52.4%, 44.7%, and 39.1% with FPE-TICI3, FPE-TICI 2b, non-FPE-TICI3, and non-FPE-TICI2b, respectively. sICH was seen less frequently in FPE (5.6%,11.6%, 9.6%, and 12.9% in FPE-TICI3, FPE-TICI2b, non-FPE-TICI3,and non-FPE-TICI2b, respectively). Ninety days mortality was 16.3%, 31.0%, 27.7%, and 29.7% with FPE-TICI3, FPE-TICI2b, non-FPE-TICI3, and non-FPE-TICI2b, respectively. Conclusions The First Pass Effect was seen in 25.1% of NASA post-marketing registry patients and is the most powerful predictor of clinical outcome with best safety results. FPE is more commonly seen in white patients, MCA occlusion, and balloon guide catheter use; however, ICA terminus occlusion seems to be resistant to FPE. The FPE may also be related to gender, race, and age. Further research is needed to better understand the FPE and to guide future technical advances. Disclosures O. Zaidat: 1; C; Covidien, Stryker. 2; C; Covidien, Stryker. A. Castonguay: None. R. Gupta: None. C. Sun: None. C. Martin: None. W. Holloway: None. N. Mueller-Kronast: None. J. English: None. I. Linfante: None. G. Dabus: None. T. Malisch: None. F. Marden: None. H. Bozorgchami: None. A. Xavier: None. A. Rai: None. M. Froehler: None. A. Badruddin: None. T. Nguyen: None. M. Taqi: None. M. Abraham: None. V. Janardhan: None. H. Shaltoni: None. R. Novakovic: None. A. Yoo: None. A. Abou-Chebl: None. P. Chen: None. G. Britz: None. R. Kaushal: None. A. Nanda: None. R. Nogueira: None.

Study objective We determine whether all patients with pain or tenderness to the left lower ribs after blunt traumatic injury require abdominal computed tomography (CT) scanning for the detection of splenic injury. Methods This was a prospective, observational cohort of all blunt-trauma patients who had pain or tenderness to the left lower ribs and presented to the emergency department (ED) of a Level I trauma center. Patients were enrolled if they had a Glasgow Coma Scale (GCS) score greater than 13 and pain or tenderness to the left lower ribs (ribs 7 to 12). Patients with pain or tenderness to the left lower ribs were considered to have pleuritic pain if the pain increased with inspiration or cough. All hemodynamically stable patients underwent abdominal CT scanning for detection of intraabdominal injuries. Data forms collecting information on the medical history and physical examination of all patients were completed before radiographic imaging. Patients with left lower rib pain or tenderness were considered to have "isolated" left lower rib injury if they were without all of the following: ED or out-of-hospital systolic blood pressure less than 90 mm Hg, abdominal or flank tenderness, pelvic or femur fractures, and gross hematuria. Results Eight hundred seventy-five patients had left lower rib pain or tenderness, 63 (7.2%; 95% confidence interval [CI] 5.6% to 9.1%) patients had splenic injuries, and 20 (2.3%; 95% CI 1.4% to 3.5%) patients had left renal injuries. Five hundred seventy-four patients had additional indications for abdominal imaging, leaving 301 patients with "isolated" left lower rib injury. Of the 301 patients, 9 (3.0%; 95% CI 1.4% to 5.6%) had splenic injuries. All 9 patients had a pleuritic component to their rib tenderness, and 3 (33%) patients underwent splenectomy. Conclusion A small but important percentage of patients with pain or tenderness to the left lower ribs has splenic injuries. All patients with splenic injury had pleuritic pain.

Background In light of the negative results of three randomised trials for endovascular acute ischemic stroke therapy, proper patient selection has become a critical area of focus for endovascular therapy. The Stroke Prognostication using Age and NIH Stroke Scale (SPAN) index, a score that combines age and NIHSS, demonstrated that SPAN-100 positive patients did not benefit from IV-tPA. Here, we sought to evaluate the predictive value of SPAN index in a real-life cohort of patients undergoing endovascular therapy. Method Using data from the investigator-initiated, multicenter North American Solitaire Stent-Retriever Acute Stroke (NASA) Registry, the SPAN index was calculated for each patient (age plus NIHSS). A cohort of SPAN-100 positive (SPAN ≥ 100) patients was identified and compared to SPAN-100 negative (SPAN Results Of 354 patients in the NASA Registry, 308 had available baseline NIHSS scores and 90-day mRS scores. 68/354 (22.1%) patients were SPAN-100 positive. Mean age of patients that were SPAN-100 positive was 83.9 ± 5.6 years vs. 62.8 ± 13.3 years in the SPAN-100 negative cohort (p = Conclusion Analysis of the NASA Registry demonstrated that SPAN-100 positive is significantly associated with worse clinical outcome and higher mortality rate at 90 days compared to SPAN-100 negative patients. SPAN-100 was shown as an independent predictor of clinical outcome and may be useful tool in the selection of patients for endovascular therapy. Disclosures A. Castonguay: None. O. Zaidat: 1; C; Stryker Neurovascular, Covidien Neurovascular. 2; C; Covidien Neurovascular. R. Novakovic: None. R. Gupta: None. C. Sun: None. C. Martin: None. W. Holloway: None. N. Mueller-Kronast: None. J. English: None. I. Linfante: None. G. Dabus: None. T. Malisch: None. F. Marden: None. H. Bozorgchami: None. A. Xavier: None. A. Rai: None. M. Froehler: None. A. Badruddin: None. T. Nguyen: None. M. Taqi: None. M. Abraham: None. V. Janardhan: None. H. Shaltoni: None. A. Yoo: None. A. Abou-Chebl: None.

Introduction Efficient and timely recanalisation is an important goal in acute stroke endovascular therapy. Several studies have shown improved recanalisation and clinical outcomes with the Stentriever devices compared to the MERCI device. The goal of this study was to evaluate the role of the balloon guide catheter and recanalisation success in a sub-study of the North American Solitaire Stent-Retriever Acute Stroke Registry (NASA). Methods The investigator-initiated NASA Registry recruited 24 clinical sites in North America to submit demographic, clinical, site-adjudicated angiographic and clinical outcome data on consecutive patients treated with the Solitaire FR device (Covidien). Balloon guide catheter was used at the discretion of the treating physicians. Results There were 354 patients included in this study. Data of BGC use was not reported in 16 patients, leaving 338 patients in this sub-analysis, of which 149 (44%) had placement of the BGC. Mean age was 67.3+15.2 years and median NIHSS was 18. Patients with BGC had more hypertension (82% vs 73%; p=0.05), atrial fibrillation (51% vs 33%; p=0.001) and were more commonly administered tPA (51% vs 39%; p=0.02) compared to patients without BGC. Time from symptom onset to groin puncture and number of passes were similar between the two groups. Procedure time was shorter in patients with BGC (120 vs 161 minutes, p=0.02) and less rescue therapy was used in patients with BGC (20% vs 28.6%, p=0.05). TICI 2b/3, TICI 3 recanalisation was higher in patients with BGC compared to patients without (TICI 2b/3: 75% vs 70%; TICI 3 53% vs 32.5% p>0.001). Distal emboli and emboli in new territory were similar between the two groups. Discharge NIHSS (mean 12 vs 17.5; p=0.002) and good clinical outcome at 3 months were superior in patients with BGC compared to patients without (51.6% vs 35.8%; p=0.02). In multivariate analysis, initial NIHSS, use of general anaesthesia and BGC were independent predictors of good clinical outcome. Conclusion Use of a balloon guide catheter with the Solitaire Stent retriever in acute ischaemic stroke results in superior recanalisation results, faster procedure time, decreased need for rescue therapy, and improved clinical outcome. Disclosures T. Nguyen: 2; C; Penumbra, THERAPY Trial DSMB/ CEC. T. Malisch: None. A. Castonguay: None. R. Gupta: None. C. Sun: None. C. Martin: None. W. Holloway: None. N. Mueller-Kronast: None. I. Linfante: None. G. Dabus: None. F. Marden: None. H. Bozorgchami: None. A. Xavier: None. A. Rai: None. A. Badruddin: None. M. Taqi: None. M. Abraham: None. H. Shaltoni: None. V. Janardhan: None. A. Abou Chebl: None. P. Chen: None. A. Yoo: None. R. Nogueira: None. A. Norbash: None. O. Zaidat: None.

Introduction/Purpose The recent results of the SWIFT and TREVO-2 trials demonstrated better recanalisation and efficacy rates with mechanical thrombectomy; however, its efficacy in the elderly population is poorly understood. Here, we report the effect of age on clinical and angiographic outcome within the North American SOLITAIRE-FR Stent-Retriever Acute Stroke (NASA) Registry. Methods The investigator-initiated NASA Registry recruited sites within North America to submit data on consecutive patients treated with Solitaire-FR. Good clinical outcome was defined as a 90-day mRS ≤2. Successful recanalisation was defined as TIMI ≥2. SICH was defined as any parenchymal haematoma, SAH, or IVH associated with a worsening of the NIHSS score by 4 or more within 24 hours. Age influence on outcomes was assessed by comparing the means between outcomes and dichotomising the age into ≤80 or ≥80 years of age. A standard medical care cohort was not available for comparison in this study. Results 343 patients underwent treatment using the SOLITAIRE-FR device in 24 centres. The mean age for those with good clinical outcome at 90 days was 64.9 ± 15 versus 69.2 ± 14.4 years (P=0.02). Only 26.6% (17/64) of patients >80 years of age had a 90-day mRS ≤ 2 versus 45.3% (111/245) of those ≤80 years of age (p=0.007, OR 1.34, 95%CI 1.2-1.6). Mortality was 42.2% (27/64) and 27.4% (67/245) in the >80 and ≤80 age groups, respectively. No difference in good outcome or mortality between female and males was observed in this population (90-day mRS≤ 2 was 41.3% (62/150) with mortality of 28% (42/150) versus 42.1% (69/164) with mortality of 32.3% (53/164) in females and males, respectively). Multivariate logistic regression analysis (adjusting for age, sex, race, baseline-NIHSS, occlusion site, initial BP, time from symptoms onset to groin puncture, and revascularisation), showed age, baseline-NIHSS, initial systolic blood pressure and revascularisation status as an independent predictors of both good outcome and mortality. Conclusions In the NASA registry, patients >80 years of age who were treated with the Solitaire-FR device demonstrated a significantly lower rate of good clinical outcome and increased mortality at 90-days, compared to the those in the ≤ 80 years of age group. Disclosures A. Castonguay: None. R. Gupta: None. R. Nogueira: None. C. Martin: None. W. Holloway: None. N. Mueller-Kronast: None. T. Malisch: None. F. Marden: None. H. Bozorgchami: None. A. Xavier: None. A. Rai: None. A. Badruddin: None. M. Taqi: None. I. Linfante: None. G. Dabus: None. M. Abraham: None. H. Shaltoni: None. V. Janardhan: None. T. Nguyen: None. A. Abou-Chebl: None. P. Chen: None. A. Yoo: None. G. Britz: None. A. Nanda: None. O. Zaidat: None.

Introduction/Purpose IMS3 demonstrated no significant difference between treatment with IV-rtPA alone or IV-rtPA plus IA therapy. However, the trial included only earlier generations of thrombectomy devices and did not evaluate the efficacy of newer devices. Here, we present data on an “IMS-III-Like group” from The North American SOLITAIRE Acute Stroke (NASA) Registry, a repository database of the newer generation Solitaire Stent-retriever. An exploratory analysis was performed to compare these results to the IMS3 IV and IV/IA groups. Materials and Methods The investigator-initiated NASA Registry recruited sites to submit data on consecutive patients treated with Solitaire-FR. A cohort similar to the IMS-III IV-rtPA+Solitaire-FR population (NASA-IMS3 Matched Group (NIMG)) was identified and compared to the recently published results of the IMS3 IV and IV/IA groups. Good clinical outcome was defined as a 90-day mRS ≤2. Successful recanalisation was defined as TIMI ≥2. SICH was defined as any parenchymal haematoma, SAH, or IVH associated with a worsening of the NIHSS score by 4 or more within 24 hours. Results 354 acute ischaemic stroke patients were enrolled in the NASA Registry from 24 centres. The cohorts were comprised of: 156 NIMG versus 434 and 222 in the IMS3 IV/IA and IV only groups, respectively. Baseline demographics were similar between cohorts: Median age 70 (NIMG); 69 (IMS3 IV/IA); 70 (IMS3 IV). Initial median NIHSS was higher in NIMG (19) compared to the IMS3 IV/IA (17) and IMS3 IV groups (18). mTICI > 2b rate was 69.9% in NIMG versus 39.6% in the IMS III IV/IA. Interestingly, mTICI 3 rate was 41% in NIMG vs 2.2% in the IMS III IV/IA group. The 90-day mRS outcome was available in 88.5% (138/156) of NIMG patients. A good outcome of mRS?2 was demonstrated in 51.5% (71/138), compared to 40.8% (169/415) in IMS3 IV/IA and 38.7% (83/215) in IM3 IV alone groups. 90-day mortality was 24.6% in NIMG versus 19.1% and 21.6% in IMS3 IV/IA and IV alone groups, respectively. Conclusion In the NASA registry, the NASA-IMS3 Matched Group (NIMG) demonstrated a higher rate of good clinical outcome (51.5%) compared to the IMS3 IV/IA (40.8%) and IV alone (34.6%) groups. Disclosures R. Nogueira: None. A. Castonguay: None. R. Gupta: None. C. Sun: None. C. Martin: None. W. Holloway: None. N. Mueller-Kronast: None. J. English: None. I. Linfante: None. G. Dabus: None. T. Malisch: None. H. Bozorgchami: None. A. Xavier: None. A. Rai: None. M. Froehler: None. A. Badruddin: None. T. Nguyen: None. M. Taqi: None. M. Abraham: None. V. Janardhan: None. H. Shaltoni: None. A. Yoo: None. A. Abou-Chebl: None. P. Chen: None. O. Zaidat: None.