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

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

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

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

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

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

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

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

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

OBJECTIVE: To evaluate the safety and effectiveness of the Flow Redirection Endoluminal Device (FRED) flow diverter in support of an application for Food and Drug Administration approval in the USA. METHODS: 145 patients were enrolled in a prospective, single-arm multicenter trial. Patients with aneurysms of unfavorable morphology for traditional endovascular therapies (large, wide-necked, fusiform, etc) were included. The trial was designed to demonstrate non-inferiority in both safety and effectiveness, comparing trial results with performance goals (PGs) established from peer-reviewed published literature. The primary safety endpoint was death or major stroke (National Institutes of Health Stroke Scale score ≥4 points) within 30 days of the procedure, or any major ipsilateral stroke or neurological death within the first year. The primary effectiveness endpoint was complete occlusion of the target aneurysm with ≤50% stenosis of the parent artery at 12 months after treatment, and in which an alternative treatment of the target intracranial aneurysm had not been performed. RESULTS: 145 patients underwent attempted placement of a FRED device, and one or more devices were placed in all 145 patients. 135/145 (93%) had a single device placed. Core laboratory adjudication deemed 106 (73.1%) of the aneurysms large or giant. A safety endpoint was experienced by 9/145 (6.2%) patients, successfully achieving the safety PG of <15%. The effectiveness PG of >46% aneurysm occlusion was also achieved, with the effectiveness endpoint being met in 80/139 (57.6%) CONCLUSION: As compared with historically derived performance benchmarks, the FRED flow diverter is both safe and effective for the treatment of appropriately selected intracranial aneurysms. CLINICAL REGISTRATION NUMBER: NCT01801007.

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

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

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

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

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

BACKGROUND: Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results. OBJECTIVE: To present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs. METHODS: The ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis >50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee. RESULTS: The ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2±10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively. CONCLUSIONS: In the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585.

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

BACKGROUND: The PerfusiOn imaging Selection of Ischemic sTroke patIents for endoVascular thErapy (POSITIVE) trial was designed to evaluate functional outcome in patients with emergent large vessel occlusion (ELVO) presenting within 0-12 hours with pre-specified bifurcated arms of early and late window presentation, who were selected for endovascular thrombectomy with non-vendor specific commercially available perfusion imaging software. Recent trials demonstrating the benefit of thrombectomy up to 16-24 hours following ELVO removed equipoise to randomize late window ELVO patients and therefore the trial was halted. METHODS: Up to 200 patients were to be enrolled in this FDA-cleared, prospective, randomized, multicenter international trial to compare thrombectomy and best medical management in patients with ELVO ineligible for or refractory to treatment with IV tissue plasminogen activator (IV-tPA) selected with perfusion imaging and presenting within 0-12 hours of last seen normal. The primary outcome was 90-day clinical outcome as measured by the raw modified Rankin Scale (mRS) with scores 5 and 6 collapsed (mRS shift analysis). RESULTS: The POSITIVE trial suspended enrollment with the release of results from the DAWN trial and was stopped after the release of the DEFUSE 3 trial results. Thirty-three patients were enrolled (21 for medical management and 12 for thrombectomy). Twelve of the 33 patients were enrolled in the 6-12 hour cohort. Despite the early cessation, the primary outcome demonstrated statistically significant superior clinical outcomes for patients treated with thrombectomy (P=0.0060). The overall proportion of patients achieving an mRS score of 0-2 was 75% in the thrombectomy cohort and 43% in the medical management cohort (OR 4.00, 95% CI 0.84 to 19.2). CONCLUSION: POSITIVE supports the already established practice of delayed thrombectomy for appropriately selected patients presenting within 0-12 hours selected by perfusion imaging from any vendor. The results of the POSITIVE trial are consistent with other thrombectomy trials. The statistically significant effect on functional improvement, despite the small number of patients, reinforces the robust benefits of thrombectomy. CLINICAL TRIAL REGISTRATION: NCT01852201.

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

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

Assessment of Optimal Patient Selection for Endovascular Thrombectomy Beyond 6 Hours After Symptom Onset: A Pooled Analysis of the AURORA Database.

Importance: The optimal imaging approach for identifying patients who may benefit from endovascular thrombectomy (EVT) beyond 6 hours after they were last known well is unclear. Six randomized clinical trials (RCTs) have evaluated the efficacy of EVT vs standard medical care among patients with ischemic stroke. Objective: To assess the benefits of EVT among patients with 3 baseline imaging profiles using a pooled analysis of RCTs. Data Sources: The AURORA (Analysis of Pooled Data from Randomized Studies of Thrombectomy More Than 6 Hours After Last Known Well) Collaboration pooled patient-level data from the included clinical trials. Study Selection: An online database search identified RCTs of endovascular stroke therapy published between January 1, 2010, and March 1, 2021, that recruited patients with ischemic stroke who were randomized between 6 and 24 hours after they were last known well. Data Extraction/Synthesis: Data from the final locked database of each study were provided. Data were pooled, and analyses were performed using mixed-effects modeling with fixed effects for parameters of interest. Main Outcomes and Measures: The primary outcome was reduction in disability measured by the modified Rankin Scale at 90 days. An evaluation was also performed to examine whether the therapeutic response differed based on imaging profile among patients who received treatment based on the time they were last known well. Treatment benefits were assessed among a clinical mismatch subgroup, a target perfusion mismatch subgroup, and an undetermined profile subgroup. The primary end point was assessed among these subgroups and during 3 treatment intervals (tercile 1, 360-574 minutes [6.0-9.5 hours]; tercile 2, 575-762 minutes [9.6-12.7 hours]; and tercile 3, 763-1440 minutes [12.8-24.0 hours]). Results: Among 505 eligible patients, 266 (mean [SD] age, 68.4 [13.8] years; 146 women [54.9%]) were assigned to the EVT group and 239 (mean [SD] age, 68.7 [13.7] years; 126 men [52.7%]) were assigned to the control group. Among 295 patients in the clinical mismatch subgroup and 359 patients in the target perfusion mismatch subgroup, EVT was associated with reductions in disability at 90 days vs no EVT (clinical mismatch subgroup, odds ratio [OR], 3.57; 95% CI, 2.29-5.57; P < .001; target perfusion mismatch subgroup, OR, 3.13; 95% CI, 2.10-4.66; P = .001). Statistically significant benefits were observed in all 3 terciles for both subgroups, with the highest OR observed for tercile 3 (clinical mismatch subgroup, OR, 4.95; 95% CI, 2.20-11.16; P < .001; target perfusion mismatch subgroup, OR, 5.01; 95% CI, 2.37-10.60; P < .001). A total of 132 patients (26.1%) had an undetermined imaging profile and no significant treatment benefit (OR, 1.59; 95% CI, 0.82-3.06; P = .17). The interaction between treatment effects for the clinical and target perfusion mismatch subgroups vs the undetermined profile subgroup was significant (OR, 2.28; 95% CI, 1.11-4.70; P = .03). Conclusions and Relevance: In this study, EVT was associated with similar benefit among patients in the clinical mismatch and target perfusion mismatch subgroups during the 6- to 24-hour treatment interval. These findings support EVT as a treatment for patients meeting the criteria for either of the imaging mismatch profiles within the 6- to 24-hour interval.

Aspiration Thrombectomy: 2-Dimensional Operative Video.

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

Clot perviousness is associated with first pass success of aspiration thrombectomy in the COMPASS trial.

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

Five-year results of randomized bioactive versus bare metal coils in the treatment of intracranial aneurysms: the Matrix and Platinum Science (MAPS) Trial.

BACKGROUND: No randomized trial of intracranial aneurysm coiling has compared long-term efficacy of polymer-modified coils to bare metal coils (BMCs). We report 5-year results comparing Matrix2 coils to BMCs. The primary objective was to compare the rates of target aneurysm recurrence (TAR) at 12 months. Secondary objectives included angiographic outcomes at TAR or 12 months and TAR at 5 years. METHODS: A total of 626 patients were randomized to BMCs or Matrix2 coils. Detailed methods and 1-year results have been published previously. RESULTS: Of 580 patients eligible for 5-year follow-up, 431 (74.3%) completed follow-up or reached TAR. Matrix2 coils were non-inferior to BMCs (P=0.8) but did not confer any benefit. Core lab reported post-treatment residual aneurysm filling (Raymond III) correlated with TAR (P<0.0001) and with aneurysm hemorrhage after treatment (P<0.008). Repeat aneurysmal hemorrhage after treatment, but before hospital discharge, occurred in three patients treated for acutely ruptured aneurysms. Additionally, two patients treated for unruptured aneurysms experienced a first hemorrhage during follow-up. All five hemorrhages resulted from aneurysms with Raymond III residual aneurysm filling persisting after initial treatment. After 5 years follow-up, 2/626 (0.3%) patients are known to have had target aneurysm rupture following hospital discharge. The annualized rate of delayed hemorrhage after coiling was 2/398/5=0.001 (0.1%) per year for unruptured aneurysms and 0 for ruptured aneurysms. CONCLUSIONS: After 5 years Matrix2 coils were non-inferior to BMCs but no benefit was demonstrated. Post-treatment residual angiographic aneurysm filling (Raymond III) is strongly associated with TAR (P<0.0001) and post-treatment aneurysmal hemorrhage (P=0.008).

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

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

First-in-human, robotic-assisted neuroendovascular intervention.

Robotic-assisted technology has been used as a tool to enhance open and minimally invasive surgeries as well as percutaneous coronary and peripheral vascular interventions. It offers many potential benefits, including increased procedural and technical accuracy as well as reduced radiation dose during fluoroscopic procedures. It also offers the potential for truly "remote" procedures. Despite these benefits, robotic technology has not yet been used in the neuroendovascular field, aside from diagnostic cerebral angiography. Here, we report the first robotic-assisted, therapeutic, neuroendovascular intervention performed in a human. This was a stent-assisted coiling procedure to treat a large basilar aneurysm. All intracranial steps, including stent placement and coil deployment, were performed with assistance from the CorPath© GRX Robotic System (Corindus, a Siemens Healthineers Company, Waltham, MA, USA). This represents a major milestone in the treatment of neurovascular disease and opens the doors for the development of remote robotic neuroendovascular procedures.

Lessons Learned Over More than 500 Stroke Thrombectomies Using ADAPT With Increasing Aspiration Catheter Size.

BACKGROUND: Endovascular thrombectomy is currently the standard of care for acute ischemic stroke (AIS). Although earlier trials on endovascular thrombectomy were performed using stent retrievers, recently completed the contact aspiration vs stent retriever for successful revascularization (ASTER) and a comparison of direct aspiration versus stent retriever as a first approach (COMPASS) trials have shown the noninferiority of direct aspiration. OBJECTIVE: To report the largest experience with ADAPT thrombectomy and compare the impact of advancement in reperfusion catheter technologies on outcomes. METHODS: We reviewed a retrospective database of AIS patients who underwent ADAPT thrombectomy between January 2013 and November 2017 at the Medical University of South Carolina. Demographics and baseline characteristics, technical variables, and radiological and clinical outcomes were reviewed. RESULTS: Among 510 patients (mean age: 67.7, 50.6% females), successful recanalization at first pass was achieved in 61.8%, and with aspiration only in 77.5%. Mean procedure time was 27.4 min, and the rate of good outcomes (mRS 0-2) at 90 d was 42.9%. The rate of recanalization with aspiration only was significantly higher, and procedure time was significantly lower in patients treated with larger catheters (ACE 064 and ACE 068) compared to smaller catheters (5 MAX and ACE, P < .05). There were no differences in complication rates or postoperative parenchymal hemorrhage across groups (P > .05); however, use of ACE 068 was an independent predictor of good outcomes at 90 d on multivariate regression analysis (odds ratio = 1.6, P < .05). CONCLUSION: Refinement of ADAPT thrombectomy by incorporating reperfusion catheters with higher inner diameters and thus higher aspiration forces is associated with better outcomes, shorter procedure times, and lower likelihood of using additional devices without impacting complication rates.

Stent-assisted coiling of cerebral aneurysms: multi-center analysis of radiographic and clinical outcomes in 659 patients.

INTRODUCTION: The endovascular stent-assisted coiling approach for the treatment of cerebral aneurysms is evolving rapidly with the availability of new stent devices. It remains unknown how each type of stent affects the safety and efficacy of the stent-coiling procedure. METHODS: This study compared the outcomes of endovascular coiling of cerebral aneurysms using Neuroform (NEU), Enterprise (EP), and Low-profile Visualized Intraluminal Support (LVIS) stents. Patient characteristics, treatment details and angiographic results using the Raymond-Roy grade scale (RRGS), and procedural complications were analyzed in our study. RESULTS: Our study included 659 patients with 670 cerebral aneurysms treated with stent-assisted coiling (NEU, n=182; EP, n=158; LVIS, n=330) that were retrospectively collected from six academic centers. Patient characteristics included mean age 56.3±12.1 years old, female prevalence 73.9%, and aneurysm rupture on initial presentation of 18.8%. We found differences in complete occlusion on baseline imaging, defined as RRGS I, among the three stents: LVIS 64.4%, 210/326; NEU 56.2%, 95/169; EP 47.6%, 68/143; P=0.008. The difference of complete occlusion on 10.5 months (mean) and 8 months (median) angiographic follow-up remained significant: LVIS 84%, 251/299; NEU 78%, 117/150; EP 67%, 83/123; P=0.004. There were 7% (47/670) intra-procedural complications and 11.5% (73/632) post-procedural-related complications in our cohort. Furthermore, procedure-related complications were higher in the braided-stents vs laser-cut, P=0.002. CONCLUSIONS: There was a great variability in techniques and choice of stent type for stent-assisted coiling among the participating centers. The type of stent was associated with immediate and long-term angiographic outcomes. Randomized prospective trials comparing the different types of stents are warranted.

An international multicenter retrospective study to survey the landscape of thrombectomy in the treatment of anterior circulation acute ischemic stroke: outcomes with respect to age.

BACKGROUND: Thrombectomy is an efficacious treatment for acute ischemic stroke (AIS). However, relatively few studies to date have specifically examined the impact and clinical implications of age on outcomes for thrombectomy in anterior AIS. OBJECTIVE: To provide a snapshot of patient metrics and outcomes with respect to age following thrombectomy for anterior AIS to supplement the current body of data for predictors of clinical outcomes in a real-world setting. METHODS: Data were collected for 20 consecutive patients with AIS treated with thrombectomy at 15 high-volume stroke centers across North America between 2015 and 2016. Patients with anterior occlusions were dichotomized based on whether they were older or younger than 80 years. Ordinal logistic regression analyzed how clinical variables impacted disability using 90-day modified Rankin Scale (mRS) scores. RESULTS: Adequate revascularization (TICI ≥2B) was achieved in 92.3% of patients aged <80 years with an average 1.7±0.1 passes taken with the primary technique and in 88.0% of patients aged ≥80 years with an average 1.7±0.2 passes. Despite similar baseline characteristics, mRS scores were significantly higher in older patients postoperatively and at 90 days after intervention. Age was a significant predictor of 90-day mRS across the study population. CONCLUSION: This analysis affirms age is a significant determinant of 90-day mRS scores following thrombectomy for large vessel anterior AIS. Further investigation into risks faced by elderly patients during thrombectomy may provide actionable information to help refine patient selection and improve outcomes.

'Real-world' comparison of first-line direct aspiration and stent retriever mechanical thrombectomy for the treatment of acute ischemic stroke in the anterior circulation: a multicenter international retrospective study.

BACKGROUND: Thrombectomy for anterior large vessel occlusion less than 24 hours since last known well is now standard of care. Certain aspects of clinical trials may limit generalizability to 'real-world' practice. OBJECTIVE: To compare revascularization rates and outcomes for direct aspiration (ADAPT) and stent retriever thrombectomy following anterior acute ischemic stroke (AIS) in a real-life setting. METHODS: Data from the most recent 20 consecutive patients with AIS treated with mechanical thrombectomy between 2015 and 2016 were collected from 15 high-volume stroke centers across North America for a total of 300 cases. Patients with proximal anterior large vessel occlusions were dichotomized by primary treatment technique. Ordinal logistic regression assessed the effects of clinical variables on patient disability using 90-day modified Rankin Scale (mRS) scores. RESULTS: Adequate revascularization (Thrombolysis in Cerebral Infarction ≥2b) was ultimately achieved in 91.2% of first-line direct aspiration (ADAPT) cases with an average of 1.9±1.9 passes and in 87.5% of stent retriever cases with an average of 1.7±1.0 passes. Time from groin puncture to revascularization was shorter for ADAPT cases. The mean 90-day mRS score for both groups was 3.0±2.4. Number of passes using primary technique, and postintervention intracranial hemorrhage, were significant predictors of 90-day mRS scores after ADAPT, while age and preprocedure mRS score were predictive of outcomes following first-line stent retriever. CONCLUSIONS: Our data show similar adequate revascularization rates and 90-day functional outcomes for first-line direct aspiration and stent retrievers for anterior large vessel occlusion in a real-world setting. These results support the findings of other prospective trials evaluating the two techniques.