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Background Large vessel recanalization (LVR) before endovascular therapy (EVT) for acute large vessel ischemic strokes is a poorly understood phenomenon. Better understanding of predictors for LVR is important for optimizing stroke triage and patient selection for bridging thrombolysis. Methods In this retrospective cohort study, consecutive patients presenting to a comprehensive stroke center for EVT treatment were identified from 2018 to 2022. Demographic information, clinical characteristics, intravenous thrombolysis (IVT) use, and LVR before EVT were recorded. Factors independently associated with different rates of LVR were identified, and a prediction model for LVR was constructed. Results 640 patients were identified. 57 (8.9%) patients had LVR before EVT. A minority (36.4%) of LVR patients had significant improvements in National Institutes of Health Stroke Scale. Independent predictors for LVR were identified and used to construct the 8-point HALT score: hyperlipidemia (1 point), atrial fibrillation (1 point), location of vascular occlusion (internal carotid: 0 points, M1: 1 point, M2: 2 points, vertebral/basilar: 3 points), and thrombolysis at least 1.5 hours before angiography (3 points). The HALT score had an area under the receiver-operating curve (AUC) of 0.85 (95% CI 0.81 to 0.90, P<0.001) for predicting LVR. LVR before EVT occurred in only 1 of 302 patients (0.3%) with low (0-2) HALT scores. Conclusions IVT at least 1.5 hours before angiography, site of vascular occlusion, atrial fibrillation, and hyperlipidemia are independent predictors for LVR. The 8-point HALT score proposed in this study may be a valuable tool for predicting LVR before EVT. [ABSTRACT FROM AUTHOR]

Background Elevated International Normalized Ratio (INR) is a marker of coagulopathy, but its impact on outcomes following mechanical thrombectomy (MT) in patients with stroke is unclear. This study investigates the impact of mild INR elevations on clinical outcomes following MT. Methods In this retrospective cohort study, consecutive patients with stroke treated with MT were identified from 2015 to 2020 at a Comprehensive Stroke Center. Demographic information, past medical history, INR, National Institutes of Health Stroke Scale score, use of tissue plasminogen activator, and last known normal to arteriotomy time were recorded. Outcome measures included modified Thrombolysis in Cerebral Infarction (mTICI) score, modified Rankin Scale (mRS) score at 90 days, and intracerebral hemorrhage (ICH). Patients were divided into two groups: normal INR (0.8-1.1) and mildly elevated INR (1.2-1.7). Results A total of 489 patients were included for analysis, of which 349 had normal INR and 140 had mildly elevated INR. After multivariable adjustments, mildly elevated INR was associated with lower odds of excellent outcomes (mRS 0-1, OR 0.24, p=0.009), lower odds of functional independence (mRS 0-2, OR 0.38, p=0.038), and higher odds of 90-day mortality (OR 3.45, p=0.018). Elevated INR was not associated with a higher likelihood of ICH, and there were no differences in rates of HI1, HI2, PH1, or PH2 hemorrhagic transformations; however, elevated INR was associated with significantly higher odds of 90-day mortality in patients with ICH (OR 6.22, p=0.024). This effect size was larger than in patients without ICH (OR 3.38, p<0.001). Conclusion In patients with stroke treated with MT, mildly elevated INR is associated with worse clinical outcomes after recanalization and may worsen the mortality risk of hemorrhagic transformations. [ABSTRACT FROM AUTHOR]

Background High levels of platelet inhibition have been associated with hemorrhagic complications following Pipeline embolization of intracranial aneurysms. We therefore titrate clopidogrel dosing to maintain a moderate level of platelet inhibition using the VerifyNow P2Y12 assay. However, many patients demonstrate dramatic increases in platelet inhibition following treatment despite being on a consistent antiplatelet regimen. We therefore elected to explore the incidence of this phenomenon and possible predisposing factors. Methods All successful Pipeline aneurysm treatments performed at our institution from 2011 to 2019 with moderate procedure-day platelet inhibition levels as indicated by a VerifyNow PRU of 60-235 were included. Patients who received glycoprotein IIb/IIIa inhibitors and those treated for ruptured/symptomatic lesions were excluded. The incidence of excessive platelet inhibition defined by a PRU<60 within 8 weeks of treatment was noted. Multivariable logistic regression was performed to determined independent predictors of the phenomenon. Results Some 190 treatments were performed in 178 qualifying patients. A post-procedure PRU <60 occurred following 79% of treatments, documented on average after 8.5 (range 1-47) days. A higher procedure day hematocrit level (P=0.003, OR 1.09, 95% CI 1.029 to 1.152) was an independent predictor of reaching a PRU <60, while intra-procedural midazolam exposure (P=0.044, OR 0.44, 95% CI 0.201 to 0.980) and a higher procedure-day PRU (P=0.047, OR 0.99, 95% CI 0.982 to 1.000) were associated with a reduced odds. Time-since-procedure and hematocrit levels were associated with excessive platelet inhibition when excluding patients who initially demonstrated hyperresponse. Conclusion Elevations in platelet inhibition were frequently observed following flow diversion with Pipeline. [ABSTRACT FROM AUTHOR]

Background The utility of using the VerifyNow P2Y12 platelet inhibition assay in patients undergoing Pipeline embolization of intracranial aneurysms remains controversial. As we have routinely employed the assay for patients undergoing flow diversion, we elected to explore the relationship between P2Y12 hyporesponse as indicated by a P2Y12 Reaction Units (PRU) value >200 and treatment outcomes, including intraprocedural platelet aggregation and ischemic complications. Methods All successful intracranial aneurysm Pipeline treatments performed at our institution from November 2011 to May 2019 were included. The rate of P2Y12 hyporesponse and treatment outcomes were evaluated. Multivariable logistic regression was utilized to determine independent predictors of treatment outcomes. Results 333 qualifying treatments were performed in 297 patients. Clopidogrel hyporesponse was initially noted in 24%, falling to 17% by day-of-procedure by dose titration. A glycoprotein (GP) IIb/IIIa inhibitor was administered prophylactically in 3% of cases for persistent, profound hyporesponse. 27 (8.1%) patients developed acute platelet aggregation; only 6 demonstrated day-of-procedure P2Y12 hyporesponse. Day-of-procedure hyporesponse was not associated with intraprocedural platelet aggregation or ischemic complications. Greater Pipeline embolization device (PED) diameter was associated with a reduced odds of platelet aggregation (OR 0.38, 95% CI 0.17 to 0.85; p=0.019). Antiplatelet non- compliance (OR 25.20, 95% CI 3.86 to 164.61; p=0.001) and treatment of posterior circulation aneurysms (OR 5.23, 95% CI 1.22 to 22.33; p=0.026) were the only independent predictors of ischemic complications. Conclusions P2Y12 hyporesponse was not associated with acute platelet aggregation or ischemic complications in our patients undergoing Pipeline embolization of intracranial aneurysms, possibly due to aggressive management of the hyporesponse using clopidogrel dose titration and/or GP IIb/IIIa inhibitor administration. [ABSTRACT FROM AUTHOR]

Background There is a paucity of data regarding mechanical thrombectomy (MT) in distal arterial occlusions (DAO). We aim to evaluate the safety and efficacy of MT in patients with DAO and compare their outcomes with proximal arterial occlusion (PAO) strokes. Methods The Trevo Registry was a prospective openlabel MT registry including 2008 patients from 76 sites across 12 countries. Patients were categorized into: PAO: intracranial ICA, and MCA--M1; and DAO: MCA--M2, MCA--M3, ACA, and PCA. Baseline and outcome variables were compared across the PAO vs DAO patients with pre-morbid mRS 0--2. Results Among 407 DAOs including 350 (86.0%) M2, 25 (6.1%) M3, 10 (2.5%) ACA, and 22 (5.4%) PCA occlusions, there were 376 DAO with pre-morbid mRS 0--2 which were compared with 1268 PAO patients. The median baseline NIHSS score was lower in DAO (13 [8--18] vs 16 [12--20], P<0.001). There were no differences in terms of age, sex, IV-tPA use, co-morbidities, or time to treatment across DAO vs PAO. The rates of post-procedure reperfusion, symptomatic intracranial hemorrhage (sICH), and 90-mortality were comparable between both groups. DAO showed significantly higher rates of 90-day mRS 0--2 (68.3% vs 56.5%, P<0.001). After adjustment for potential confounders, the level of arterial occlusion was not associated with the chances of excellent outcome (DAO for 90-day mRS 0--1: OR; 1.18, 95% CI [0.90 to 1.54], P=0.225), successful reperfusion or SICH. However, DAO patients were more likely to be functionally independent (mRS 0--2: OR; 1.45, 95% CI [1,09 to 1.92], P=0.01) or dead (OR; 1.54, 95% CI [1.06 to 2.27], P=0.02) at 90 days. Conclusion Endovascular therapy in DAO appears to result in a comparable safety and technical success profile as in PAO. The potential benefits of DAO thrombectomy should be investigated in future randomized trials. [ABSTRACT FROM AUTHOR]

Background: Mechanical thrombectomy (MT) is the standard of care for acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). The SOFAST study collected clinical evidence on the safety and efficacy of the 6 French SOFIA Flow Plus aspiration catheter (SOFIA 6F) when used as first-line treatment., Methods: This was a prospective, multicenter investigation to assess the safety and efficacy of SOFIA 6F used for first-line aspiration. Anterior circulation LVO stroke patients were enrolled. The primary endpoint was the final modified Thrombolysis in Cerebral Infarction (mTICI)≥2b rate. Secondary endpoints included first-pass and first-line mTICI≥2b rates, times from arteriotomy to clot contact and mTICI≥2b, and 90-day modified Rankin Scale (mRS)≤2. First-line and final mTICI scores were adjudicated by an independent imaging core lab. Safety events were assessed by an independent clinical events adjudicator., Results: A total of 108 patients were enrolled across 12 centers from July 2020 to June 2022. Median age was 67 years, median National Institutes of Health Stroke Scale (NIHSS) was 15.5, and 56.5% of patients received intravenous thrombolytics. At the end of the procedure, 97.2%, 85.2%, and 55.6% of patients achieved mTICI≥2b, ≥2c, and 3, respectively. With SOFIA 6F first-line aspiration, 87.0%, 79.6%, and 52.8% achieved mTICI≥2b, ≥2c, and 3, respectively. After the first pass, 75.0%, 70.4%, and 50.9% achieved mTICI≥2b, ≥2c, and 3, respectively. Median times from arteriotomy to clot contact and successful revascularization were 12 and 17 min, respectively. At 90 days, 66.7% of patients achieved mRS≤2., Conclusions: First-line aspiration with SOFIA 6F is safe and effective with high revascularization rates and short procedure times., Competing Interests: Competing interests: DG: research funding from the National Institutes of Health, Focused Ultrasound Foundation, MicroVention, University of Calgary, and University of Maryland Medical Center; consultant for Navigantis. CS: research support from MicroVention, National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS), Balt, Penumbra, Medtronic, Cerenovus, Route 92, MIVI, Stryker; consultant for Medtronic, Stryker, Balt, Werfen, Viz.ai, MicroVention; shareholder for Neurotechnology Investors, REIST. DHS: consultant for Medtronic, Stryker, and Kaneka; speaker for Medtronic; proctor for Medtronic; grant support from MicroVention; advisory board for Scientia and Vasorum; stockholder of Scientia and Vasorum. GT: consultant for Dynamed, Medtronic, and Penumbra. DF: consultant for Medtronic, Cerenovus, MicroVention, Penumbra, Stryker, Balt USA, MENTICE, Neurogami, RAPID. AI, RAPID Medical, Phenox Medical, Scientia Medical, Perfuze, Vesalio; proctor for Medtronic, MicroVention; research support from MicroVention, Penumbra, Stryker, Balt USA, Siemens; advisory board on Arsenal Medical, NVMed, Perfuze; stock holder in Neurogami, Arsenal Medical, Scientia Medical, NVMed, and Perfuze., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval., Objective: To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device., Methods: Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a -10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0-2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH)., Results: From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12-20). In the primary analysis population (n=107), eTICI 2b-3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b-3 was observed in 73.8% (79/107), with first pass eTICI 2b67-3 in 69.2% (74/107) and eTICI 2c-3 in 48.6% (52/107). Median number of passes was 1 (IQR 1-2). Final eTICI 2b-3 rate was 99.1% (106/107); final eTICI 2b67-3 rate was 91.6% (98/107); final eTICI 2c-3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0-2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139)., Conclusions: The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal., Trial Registration Number: NCT04514562., Competing Interests: Competing interests: AJY: consultant: Penumbra, Cerenovus, Vesalio, Zoll Circulation, Philips Neurovascular; individual stocks/stock options: Nicolab; ownership interest: Insera Therapeutics, Galaxy Therapeutics; research funding (principal investigator (PI) or named investigator): Medtronic, Cerenovus, Penumbra, Stryker, Genentech. LS: consultant: Balt, Medtronic, Microvention, Stryker; research funding (PI or named investigator): Philips. AH: consultant: Medtronic, Microvention, Stryker, Penumbra, Cerenovus, Genentech, GE Healthcare, Scientia, Balt, Viz.ai, Insera therapeutics, Proximie, NeuroVasc, NovaSignal, Vesalio, Rapid Medical, Imperative Care. AS: consultant: Microvention, Stryker, Vesalio. AHS: consultant: Amnis Therapeutics, Apellis Pharmaceuticals, Inc., Boston Scientific, Canon Medical Systems USA, Inc., Cardinal Health 200, LLC, Cerebrotech Medical Systems, Inc., Cerenovus, Cerevatech Medical, Inc; inidividual stocks/stock options: Adona Medical, Inc., Amnis Therapeutics, Bend IT Technologies, Ltd., BlinkTBI, Inc, Borvo Medical, Inc., Cerebrotech Medical Systems, Inc., Cerevatech Medical, Inc., Cognition Medical, Collavidence, I; other; Cerenovus EXCELLENT and ARISE II Trial; Medtronic SWIFT PRIME, VANTAGE, EMBOLISE and SWIFT DIRECT Trials; MicroVention FRED Trial; CONFIDENCE Study; MUSC POSITIVE Trial; Penumbra 3D Separator Trial, Research Funding (PI or named investigator); co-investigator for NIH - 1R01EB030092-01, Project Title: High speed angiography at 1000 frames per second; Mentor for Brain Aneurysm Foundation Carol W. Harvey Chair of Research, Sharon Epperson Chai. SG: Consultant; Stryker, Microvention, Medtronic. TRM: Advisor; Carpl AI. MTF: advisor; Cerenovus; research funding (PI or named investigator): Medtronic Neurovascular; researcher: Stryker Neurovascular, Cerenovus, Rapid Medical. DCH: consultant; Stryker Neurovascular, Cerenovus, Chiesi USA, Brainomix, Poseydon Medical; individual stocks/stock options: VizAI and Motif; other: Jacobs Institute/Medtronic, Vesalio., Frontiers in Neurology. MIC: advisor: Celt/Vasorum; consultant: Microvention, Medtronic, Imperative Care, Q'Apel; individual stocks/stock options: Imperative Care, Celt/Vasorum, Synchron, Endostream, Cerebrotech, Q'Apel, RIST, Three Rivers Medical, Neuolutions, Radical Medical, Tulavi, viseon, VMT, Vastrax, Serenity Medical. MF: consultant: Cerenovus, Balt, Jacobs Institute, Kai Medical, Oculus; research funding (PI or named investigator): Vesalio, Genentech, Siemens. MS: consultant: Vesalio., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Elevated International Normalized Ratio (INR) is a marker of coagulopathy, but its impact on outcomes following mechanical thrombectomy (MT) in patients with stroke is unclear. This study investigates the impact of mild INR elevations on clinical outcomes following MT., Methods: In this retrospective cohort study, consecutive patients with stroke treated with MT were identified from 2015 to 2020 at a Comprehensive Stroke Center. Demographic information, past medical history, INR, National Institutes of Health Stroke Scale score, use of tissue plasminogen activator, and last known normal to arteriotomy time were recorded. Outcome measures included modified Thrombolysis in Cerebral Infarction (mTICI) score, modified Rankin Scale (mRS) score at 90 days, and intracerebral hemorrhage (ICH). Patients were divided into two groups: normal INR (0.8-1.1) and mildly elevated INR (1.2-1.7)., Results: A total of 489 patients were included for analysis, of which 349 had normal INR and 140 had mildly elevated INR. After multivariable adjustments, mildly elevated INR was associated with lower odds of excellent outcomes (mRS 0-1, OR 0.24, p=0.009), lower odds of functional independence (mRS 0-2, OR 0.38, p=0.038), and higher odds of 90-day mortality (OR 3.45, p=0.018). Elevated INR was not associated with a higher likelihood of ICH, and there were no differences in rates of HI1, HI2, PH1, or PH2 hemorrhagic transformations; however, elevated INR was associated with significantly higher odds of 90-day mortality in patients with ICH (OR 6.22, p=0.024). This effect size was larger than in patients without ICH (OR 3.38, p<0.001)., Conclusion: In patients with stroke treated with MT, mildly elevated INR is associated with worse clinical outcomes after recanalization and may worsen the mortality risk of hemorrhagic transformations., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)