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OBJECTIVE Flow-diverting stents with a resorbable component have significant theoretical benefits over full metal stents, although currently there are none in clinical use. In this study, the authors sought to determine the immediate flow-diversion characteristics of a novel primarily bioresorbable flow-diverting stent. METHODS Bioresorbable stents were deployed into glass tube models to determine porosity and pore density. In vitro flow diversion behavior was evaluated using high frame rate angiography under pulsatile flow conditions in a patient-specific silicone aneurysm model treated with the resorbable stent as well as the Surpass Evolve stent. In vivo flow diversion was characterized by deployment into 20 rabbit saccular aneurysm models, and grading was based on the O’Kelly-Marotta scale and the 4F-flow diversion predictive score. RESULTS Porosities and pore densities of the bioresorbable stent were in the flow-diverting range for all target vessel diameters. Quantified results of immediate angiography after placement of the bioresorbable stent into a silicone aneurysm model demonstrated greater flow diversion compared to the Evolve stent. Bioresorbable stent placement in saccular aneurysm models resulted in an immediate O’Kelly-Marotta grade of A3 or better and a 4F-flow diversion predictive score of 4 or better in all cases. CONCLUSIONS The bioresorbable stent has immediate flow-diversion characteristics that are comparable to commercially available metal stents. Longer-term studies are underway to determine the ability of the resorbable fibers to act as a neointimal scaffold and result in long-term aneurysm occlusion.

BackgroundThe pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale.MethodsPREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated.ResultsAs per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge–Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series.ConclusionsThe PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture.Trial registrationNCT02186561.

Background: Mobile stroke units (MSU) were developed as a tool to facilitate rapid delivery of acute stroke treatments and improving patient functional outcomes. Currently, there is limited data on the functional outcomes of patients receiving acute stroke treatments after being transported by MSU. In 2019, Stony Brook University Hospital (SBUH) implemented 2 mobile stroke units to assist with rapid delivery of acute stroke treatments. We sought to compare the long-term functional outcomes of patients who received acute stroke treatment after transport by our MSU versus conventional transportation prior to MSU implementation. Methods: This is a retrospective study of patients who received either tissue plasminogen activator (t-PA) and/or thrombectomy between the years 2017-2020 (n=316). Patients were separated into two groups; Either receiving care via MSU to SBUH (n=107) or receiving care after arrival/transfer to SBUH via conventional transportation (n=165). Time interval from door to t-PA administration and door to groin puncture were measured. T test for independent samples were used to measure differences in time among both groups. Long term functional outcomes were measured using modified Rankin Scale (mRS) at 90 days. Patients were trichotomized into three outcome groups, mRS 0-1, 2-4, and 5-6. Chi square was used to analyze differences among the outcome groups. Results: The MSU patients had a significantly shorter Door to TPA time than the control group: (28 min±22 min vs. 63 min ±40 min respectively, t=4.770, 74 df, P2 =9.770, 2df, p Conclusions: MSU transported patients had shorter door to t-PA and thrombectomy times compared to patients using traditional EMS transfer system in Suffolk County. This improvement translated into more favorable long-term patient outcomes as seen with more MSU patients with lower 90 day mRS.

Background: A major limiting factor of favorable outcomes among patients with emergent large vessel occlusions (ELVO) is delay in transfer to a comprehensive stroke center (CSC). Stony Brook University Hospital (SBUH) is one of two CSCs in Suffolk County, serving approximately 1.5 million patients over 912 square miles. In 2019, SBUH implemented 2 mobile stroke units in strategic locations within Suffolk County to facilitate rapid delivery of acute stroke treatments. With the capability of performing computed tomography angiography (CTA) in addition to non-contrasted head CT, SBUH MSU offers an opportunity to rapidly triage patients to necessary CSCs. We sought to compare functional outcomes of patients receiving thrombectomies following transport by MSU versus conventional EMS and hospital transfers. Methods: A retrospective study was conducted that included patients eligible to receive mechanical thrombectomy from 2017 to 2020. Patients who had pre-morbid modified Rankin scale (mRs) greater than 0, transient ischemic events, subarachnoid hemorrhage, intraparenchymal hemorrhage, or strokes post-hospital arrival were excluded. A total of 77 patients were included, 37 of whom received care by MSU and 40 by EMS or transfers. Time interval from Door-to-Needle time was measured. T-test for independent samples was used to measure differences in time among both groups. Functional outcomes were measured using mRS at discharge. Patients were trichotomized into three outcome groups, mRS 0-1, 2-4, and 5-6. Chi square was used to analyze differences among the outcome groups Results: MSU patients had a significantly shorter Door-to-Needle time than the EMS patients: (69± 64 min vs. 115 ± 65 min respectively, t=3.319, 78.155df, P2 =7.716, 2df, p Conclusions: CTA can be performed on MSUs to detect ELVOs in the field and achieve prompt triage of these patients to CSCs, thereby reducing time to thrombectomy and improving short-term functional outcomes.

Objective The Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System (SMART) is the largest prospective, multicenter, postmarket registry established to gather real-world experience on Penumbra (Alameda, USA) SMART COIL System, PC400, and POD embolization coils. The goal of this study is to report the technical success and efficacy of SMART COIL System coils in treating saccular intracranial aneurysms. Methods This subgroup analysis from the SMART registry included patients with saccular intracranial aneurysms treated using ≥75% SMART COIL System or PC400 coils. Baseline and procedural data, angiographic data, and clinical outcomes were collected. Predictors of catheter kickout, packing density, and postprocedural angiographic outcome were analyzed using multivariable regression models in saccular aneurysm cases. Results Between June 2016 and August 2018, the SMART registry enrolled 995 patients at 68 sites, of which 851 of 995 (85.5%) were treated for saccular aneurysms (mean age, 59.9 years). Aneurysms had a mean size of 6.8 mm, were wide neck in 63.1%, and ruptured in 31.0% of patients. Mean aneurysm packing density was 32.3%. Postprocedural Raymond-Roy Occlusion Classification (RROC) I–II was achieved in 80.3% of patients; smaller aneurysms, non–wide-neck aneurysms, and high packing density were predictive of RROC I–II. Overall, mean fluoroscopic time was 43.4 minutes, rate of reaccess attempts because of catheter kickout was 6.2%, and mean procedure time was 83.2 minutes. Conclusions SMART COIL System coils achieved good technical success and adequate occlusion in treating saccular intracranial aneurysms in a real-world setting.

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

BackgroundThe benefit of mechanical thrombectomy (MT) and efficacy of different first-line MT techniques remain unclear for distal and medium vessel occlusions (DMVOs). In this systematic review, we aimed to compare the performance of three first-line MT techniques in DMVOs.MethodsThe PubMed database was searched for studies examining the utility of MT in DMVOs (middle cerebral artery M2-3-4, anterior cerebral artery, and posterior cerebral artery). Studies providing data for aspiration thrombectomy (ASP), stent retriever thrombectomy (SR), and combined SR+ASP technique were included. Non-comparative studies were excluded. Safety and efficacy data were collected for each technique. The Nested Knowledge AutoLit platform was utilized for literature search, screening, and data extraction. Pooled data were presented as descriptive statistics.Results13 studies comprising 2422 MT procedures were identified. The overall successful recanalization rate was 77.0% (1513/1964) for DMVOs. SR+ASP had a successful recanalization rate of 83.7% (297/355), SR had a 75.6% rate (638/844), while ASP alone had a 74.2% rate (386/520). The overall functional independence rate was 51.3% (851/1659) among DMVOs. The ASP alone group had a functional independence rate of 46.9% (219/467), while functional independence rates of the SR and SR+ASP groups were 51.5% (372/723) and 61.7% (174/282), respectively. Finally, the subarachnoid hemorrhage rates were 1.8% (4/217) for the ASP group, 9.3% (26/281) for the SR group, and 11.9% (41/344) for the SR+ASP group.ConclusionsOur systematic review supports the proposition that MT is a safe and effective treatment option for DMVOs. Additionally, while the SR+ASP group had consistently high rates of clot clearance and good neurological outcomes, the SR and SR+ASP groups also had higher rates of subarachnoid hemorrhage, highlighting the need for improved DMVO treatment devices.

Antiplatelet therapies are commonly used in neurointerventional procedures. However, specific guidelines for their use in these settings is lacking and it can often be difficult to balance the potential risks and benefits of these medications. Considering the continued growth and adoption of neurointerventional procedures, it is crucial to understand the properties of these agents in order to use them safely. Large-scale clinical trials are still needed to clarify many of these aspects for this emerging field. However, the existing literature already provides insight into which antiplatelet drugs are of benefit to the neurointerventionalist as well as their associated risks of ischemic and hemorrhagic complications. Hence, this review focuses on the applications of GPIIb/IIIA inhibitors to neurointerventional procedures.

The use of antiplatelets is widespread in clinical practice. However, for neurointerventional procedures, protocols for antiplatelet use are scarce and practice varies between individuals and institutions. This is further complicated by the quantity of antiplatelet agents which differ in route of administration, dosage, onset of action, efficacy and ischemic and hemorrhagic complications. Clarifying the individual characteristics for each antiplatelet agent, and their associated risks, will increasingly become relevant as the practice of mechanical thrombectomy, stenting, coiling and flow diversion procedures grows. The aim of this review is to summarize the existing literature for the use of P2Y12 inhibitors in neurointerventional procedures, examine the quality of the evidence, and highlight areas in need of further research.

BackgroundFlow-diverting stents are not currently indicated for the treatment of bifurcation aneurysms, and some case series have demonstrated low occlusion rates, possibly due to a lack in neck coverage. The ReSolv stent is a unique hybrid metal/polymer stent that can be deployed with the shelf technique in order to improve neck coverage.MethodsA Pipeline, unshelfed ReSolv, and shelfed ReSolv stent were deployed in the left-sided branch of an idealized bifurcation aneurysm model. After determining stent porosity, high-speed digital subtraction angiography runs were acquired under pulsatile flow conditions. Time–density curves were created using two region of interest (ROI) paradigms (total aneurysm and left/right), and four parameters were extracted to characterize flow diversion performance.ResultsThe shelfed ReSolv stent demonstrated better aneurysm outflow alterations compared to the Pipeline and unshelfed ReSolv stent when using the total aneurysm as the ROI. On the left side of the aneurysm, there was no significant difference between the shelfed ReSolv stent and the Pipeline. On the right side of the aneurysm, however, the shelfed ReSolv stent had a significantly better contrast washout profile than the unshelfed ReSolv stent and the Pipeline stent.ConclusionsThe ReSolv stent with the shelf technique demonstrates the potential to improve flow diversion outcomes for bifurcation aneurysms. Further in vivo testing will help to determine whether the additional neck coverage leads to better neointimal scaffolding and long-term aneurysm occlusion.

BackgroundLiquid embolic agents and polyvinyl alcohol (PVA) particles have been used for the embolization of the middle meningeal artery (MMA) for the treatment of chronic subdural hematomas. However, the vascular penetration and distribution of these embolic agents have not yet been compared. The current study compares distribution of a liquid embolic agent (Squid) to PVA particles (Contour) in an in vitro model of the MMA.MethodsMMA models were embolized with Contour PVA particles 45–150 µm, Contour PVA particles 150–250 µm, and Squid-18 liquid embolic agent (n=5 each). The models were scanned and every vascular segment with embolic agent was manually marked on the images. Embolized vascular length as a percentage of control, average embolized vascular diameter, and embolization time were compared between the groups.ResultsThe 150–250 µm Contour particles primarily accumulated close to the microcatheter tip, yielding proximal branch occlusions. The 45–150 µm Contour particles achieved a more distal distribution, but in a patchy segmental pattern. However, the models embolized with Squid-18 had a consistently distal, near-complete and homogenous distribution. Embolized vascular length was significantly higher (76±13% vs 5±3%, P=0.0007) and average embolized vessel diameter was significantly smaller (405±25 µm vs 775±225 µm, P=0.0006) with Squid than with Contour. Embolization time with Squid was also lower (2.8±2.4 min vs 6.4±2.7 min, P=0.09).ConclusionsSquid-18 liquid results in a considerably more consistent, distal and homogeneous pattern of embolysate distribution than Contour PVA particles in an anatomical model of the MMA tree.

Background Neurointerventionalists use in-vitro vascular models to train for worst-case scenarios and test new devices in a simulated use environment to predict clinical performance. According to the Food and Drug Administration (FDA), any neurovascular navigation device should be able to successfully navigate two 360-degree turns and two 180-degree turns at the distal portion of the anatomical model. Here, we present a device benchmarking vascular model that complies with FDA recommendations. Methods Our vascular model was assembled from quantitative characterization of 49 patients who underwent CT angiography either for acute ischemic stroke caused by large vessel occlusion or for aneurysm treatment. Following complete characterization of these data, the vascular segments were 3D reconstructed from CT angiograms of 6 selected patients that presented with challenging anatomy. The curvature and total rotational angle were calculated for each segment and the anatomical parts that complied with FDA recommendations were fused together into a single in-vitro model. Results The model was constructed containing two common carotid branches arising from a type two aortic arch and the dimensions of the overall model exceeded the recommendations of the FDA. Two experienced neurointerventionalists tested the model for navigation difficulty using several devices on an in-vitro perfusion system and concluded that the model provided a realistic, challenging scenario. Conclusions This model provides a first prototype designed according to FDA recommendations of cumulative angle while also integrating an aggregation of actual patient-specific anatomy. The availability of this clinically relevant benchmark model presents a potential standardized approach for neurovascular device testing.

Background During diagnostic cerebral angiography, the contrast bolus injected into a vessel can cause substantial changes in baseline pressures and flows. One potential, and serious complication is the re-rupture of aneurysms due to these injections. The goals of this in vitro study were to evaluate the effect of injection conditions on intraneurysmal pressure changes during angiography. Methods A silicone replica of a complete circle of Willis model with ophthalmic, anterior communicating, and basilar tip aneurysms was connected to a physiologically accurate flow pump. Contrast injections were performed under different conditions (carotid or vertebral vessel imaging, catheter diameter, injection rate, injection time, and arterial blood flow rate) and the pressure in each aneurysm was recorded before and during each injection. The effect of injection conditions on percentage increase in aneurysm pressures was statistically assessed. Additionally, the effect of the distance between the aneurysm and the catheter-tip on aneurysmal pressures was assessed. Results Mean intraneurysmal pressures during injection (84.5 ± 10.8 mmHg) were significantly higher than pre-injection pressures (80.4 ± 10.6 mmHg, p Conclusions Increasing contrast injection rates and decreasing catheter diameters are correlated to intraneurysmal pressure increases during angiography irrespective of the distance to the catheter tip. Future in vivo studies are required to confirm these findings and determine whether the amplitude of pressure increases with commonly used injection rates can be clinically detrimental.

BackgroundCatheter retention and difficulty in retrieval have been observed during embolization of brain arteriovenous malformations (bAVMs) with the Onyx liquid embolic system (Onyx). The Apollo Onyx delivery microcatheter (Apollo) is a single lumen catheter designed for controlled delivery of Onyx into the neurovasculature, with a detachable distal tip to aid catheter retrieval. This study evaluates the safety of the Apollo for delivery of Onyx during embolization of bAVMs.MethodsThis was a prospective, non-randomized, single-arm, multicenter, post-market study of patients with a bAVM who underwent Onyx embolization with the Apollo between May 2015 and February 2018. The primary endpoint was any catheter-related adverse event (AE) at 30 days, such as unintentional tip detachment or malfunction with clinical sequelae, or retained catheter. Procedure-related AEs (untoward medical occurrence, disease, injury, or clinical signs) and serious AEs (life threatening illness or injury, permanent physiological impairment, hospitalization, or requiring intervention) were also recorded.ResultsA total of 112 patients were enrolled (mean age 44.1±17.6 years, 56.3% men), and 201 Apollo devices were used in 142 embolization procedures. The mean Spetzler–Martin grade was 2.38. The primary endpoint was not observed (0/112, 0%). The catheter tip detached during 83 (58.5%) procedures, of which 2 (2.4%) were unintentional and did not result in clinical sequelae. At 30 days, procedure related AEs occurred in 26 (23.2%) patients, and procedure-related serious AEs in 12 (10.7%). At 12 months, there were 3 (2.7%) mortalities, including 2 (1.8%) neurological deaths, none of which were device-related.ConclusionThis study demonstrates the safety of Apollo for Onyx embolization of bAVMs.Clinical trial registrationCNCT02378883.

BackgroundThe Woven EndoBridge (WEB) device is approved in the USA for treatment of unruptured wide-neck bifurcation aneurysms. However, the safety and effectiveness of the WEB device in the treatment of ruptured intracranial aneurysms is not clear. We aim to evaluate the perioperative safety and effectiveness of the WEB device in patients with ruptured intracranial aneurysms.MethodsThis retrospective study, conducted at eight centers in the USA, included patients with ruptured intracranial aneurysms treated with the WEB device in the setting of subarachnoid hemorrhage (SAH). Safety outcomes included intraoperative complications such as vessel perforation, thromboembolic events, and postoperative hemorrhagic or thromboembolic complications based on radiologic imaging. The primary effectiveness outcome was adequate (complete and neck remnant) aneurysm occlusion, according to the Raymond–Roy classification.ResultsA total of 91 patients with 94 ruptured intracranial aneurysms were included (mean age 57.7±15.2 years; 68.1% women; 82.9% wide-necked). Aneurysms were located in the anterior communicating artery (42/94, 44.6%), middle cerebral artery (16/94, 17%), and basilar artery (15/94, 16%). Adequate occlusion was achieved in 48.8% (41/84) and 80.0% (40/50) at discharge and last follow-up (mean of 3.4 months), respectively. At discharge, procedural-related morbidity was 3.3% (3/91) and there was no procedure-related mortality. No re-rupture or delayed aneurysm rupture was observed.ConclusionsThis study demonstrates the perioperative safety and effectiveness of the WEB device for the treatment of patients with ruptured intracranial aneurysms in the setting of SAH, with low periprocedural morbidity and mortality. Long-term follow-up is warranted.

Evidence is growing to support minimally invasive surgical evacuation of intraparenchymal hematomas, particularly those with minimal residual hematoma volumes following evacuation. To maximize the potential for neurologic recovery, it is imperative that the trajectory for access to the hematoma minimizes disruption of normal parenchyma. Flat panel detector CT-based navigation and needle guidance software provides a platform that uses flat panel detector CT imaging obtained on the angiography table to aid reliable and safe access to the hematoma. In addition to providing a high degree of accuracy, this method also allows convenient and rapid re-imaging to assess navigation accuracy and the degree of hematoma evacuation prior to procedural completion. We provide a practical review of the syngo iGuide needle guidance software and the methodology for incorporating its use, and the software of other vendors, in a variety of minimally invasive methods for evacuation of intraparenchymal hematomas.

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

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

BackgroundThe objective of this meta-analysis was to establish safety and effectiveness benchmarks for endovascular therapy of unruptured small-to-medium internal carotid artery (ICA) aneurysms using flow diverters.MethodsA systematic literature review and subsequent meta-analysis were performed using best research methods. Studies of any design with at least 10 patients treated with flow diverters for predominantly (≥90%) unruptured small/medium ICA aneurysms and ≥6 month follow-up were included. The primary effectiveness endpoint was complete aneurysm occlusion rate at 12 months. The primary safety endpoint was a composite measure of cumulative events that could indicate a stroke or neurologic death: any death, stroke, intracranial hemorrhage, or worsening on the modified Rankin Scale.Results41 studies (2614 patients) met eligibility criteria for the meta-analysis. The core lab adjusted complete occlusion rate was 74.9% (95% CI 69.6% to 79.8%) at 12 months for studies using any flow diverter. With an aim of generating performance goals for a US Investigational Device Exemption (IDE) study, a pre-specified analysis was conducted using only studies with flow diverters commercially available in the USA. In this cohort, 12 month complete occlusion was 74.6% (95% CI 66.8% to 81.7%). The primary safety event rate for flow diverters commercially available in the USA was 7.8% (95% CI 4.8% to 11.4%).ConclusionsThe treatment of small and medium-sized aneurysms with flow diverters is effective in achieving curative reconstruction in most cases and is associated with low rates of morbidity and mortality. This meta-analysis informs robust performance goals for evaluating new flow diverters in small/medium unruptured carotid aneurysms.

Wide-necked bifurcation aneurysms (WNBAs) make up 26–36% of all brain aneurysms. Treatments for WNBAs pose unique challenges due to the need to preserve major bifurcation vessels while achieving a durable occlusion of the aneurysm. Intrasaccular flow disruption is an innovative technique for the treatment of WNBAs. The Woven EndoBridge (WEB) device is the only United States Food and Drug Administration approved intrasaccular flow disruption device. In this review article we discuss various aspects of treating WNBAs with the WEB device, including indications for use, aneurysm/device selection strategies, antiplatelet therapy requirement, procedural technique, potential complications and bailouts, and management strategies for residual/recurrent aneurysms after initial WEB treatment.

Background and Purpose: Pattern of infarct due to ICAS (e.g. borderzone) may predict recurrent stroke risk. We sought to describe the patterns of index and recurrent infarcts in patients enrolled in the medical arm of the SAMMPRIS Trial (Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis). Methods: - Patients enrolled in the medical management arm of the SAMMPRIS trial with infarct as the qualifying event who had CT or MRI, or those with a recurrent infarct in the territory of the symptomatic artery during follow up were included. Infarct pattern for both the index infarct and any recurrent infarct in the territory was determined using criteria defined in prior SAMMPRIS publications as borderzone, MCA artery core, and perforator for anterior circulation and cerebellar, perforator and distal for posterior circulation (see figure for examples). Infarct pattern was adjudicated independently by 2 reviewers, with a 3 rd reviewer as tiebreaker. Results: - Among the 142 patients who had index infarcts in the anterior circulation (n=101) and posterior (n=41) circulation, the patterns were: 53 (37.3%) borderzone, 24 (16.9%) MCA core, 35 (24.6%) perforator, 13 (9.2%) distal, and 17 (12%) cerebellar. Among the 31 who had recurrent infarct in the territory, the patterns were: 10 (32.3%) borderzone, 6 (19.4%) MCA core, 6 (19.4%) perforator, 4 (12.9%) distal, 1 (3.2%) cerebellar, and 4 (12.9%) were missing imaging. Of the recurrent infarcts in territory, 21 had both index infarct and recurrent infarct in territory adjudications, with 11 demonstrating the same pattern of infarct for both events (7 borderzone, 2 core, 2 perforator). Conclusions: - The majority of patients with stroke due to severe symptomatic intracranial stenosis demonstrated borderzone pattern of infarct for index and recurrent infarcts. Ongoing analyses of this dataset will determine the association between pattern of index stroke and risk of recurrent stroke.

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

Introduced into the human population in December 2019, the zoonotic novel β-coronavirus spread rapidly. Labeled Coronavirus Disease 2019 (COVID-19) by the World Health Organization (WHO), the infection reached pandemic proportions by March 11, 2020. At the time of writing this commentary, globally our way of life is transforming. Hospitals are no exception, with mobilization into an emergency mode including halting all non-urgent elective procedures and clinic visits. The Centers for Disease Control and Prevention (CDC) and the WHO are currently recommending aggressive measures to prevent viral transmission. For healthcare workers, aside from standard precautions like using personal protective equipment (PPE) and handwashing, these bodies are strongly encouraging the practice of ‘social distancing’ (SD) and ‘self-quarantine’ (SQ) for those with suspected or proven infections. In essence, SD means avoiding crowds, closing schools, canceling all social events and meetings, and maintaining a 6-foot distance between individuals. SQ refers to isolating oneself for 2 weeks without any social contact to avoid transmission. These efforts will be critical to mitigating covid-19 spread, as they may ‘flatten the curve’ of new and serious cases and prevent the healthcare system from being overwhelmed. Healthcare workers are on the front line, and doctors, nurses, and hospital staff are at highest risk of contracting the virus. As cases become ubiquitous throughout the healthcare system, many staff will become secondarily infected and will require medical treatment and SQ. As the volume of infected personnel increases, many services will need to operate on a skeleton crew. If infection breaches a critical threshold, some emergency services may cease to be possible. The greatest potential impact will be on mechanical thrombectomy (MT) in acute ischemic stroke. MT for emergent large vessel occlusion (ELVO) represents one of the most impactful and effective emergent interventions in medicine,1 markedly reducing morbidity and mortality. MT is …

IntroductionThe 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.MethodsThis 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.ResultsOur 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.ConclusionsThere 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.

BackgroundPreliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications.ObjectiveTo evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms.MethodsPREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death.ResultsA total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured ConclusionsTreatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications.Trial registrationNCT02186561.

Background The recent growth of neuro-endovascular treatment has rekindled interest in the use of angiographic techniques for flow assessment. Aneurysm treatment with flow diverters is particularly amenable to such analysis. We analyze contrast time–density curves — recorded within aneurysms before (pre) and immediately after (post) flow diverter implantation to estimate six-month treatment outcomes. Methods Fifty-six patients with 65 aneurysms were treated with flow diverters at two institutions. A region of interest was drawn around the aneurysm perimeter in image sequences taken both pre and post angiography, and the temporal variation in grayscale intensity within the aneurysm (time–density curve) was recorded. Eleven parameters were quantified from each time–density curve. Aneurysm occlusion status was recorded six months post treatment. The change in parameters from pre to post treatment was statistically evaluated between aneurysm occluded and non-occluded groups. Results Of the 11 parameters, eight were significantly different before and immediately after flow diversion. Considering the entire data set, none of the parameters was statistically different between the occluded and non-occluded groups. However, subgroup analyses showed that four variables were significantly different between the aneurysm occluded and non-occluded groups. The sensitivity of these variables to predict aneurysm occlusion at six months ranged from 60% to 89%, while the specificity ranged from 55% to 70%. Conclusions Device-induced intra-aneurysmal flow alterations quantified by simple aneurysmal time–density curves can potentially be used to predict long-term outcomes of flow diversion. Large multi-center studies will be required to confirm these findings. Patient-to-patient variability in coagulation may need to be incorporated for clinically relevant predictive values.

BackgroundThrombectomy 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.ObjectiveTo 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.MethodsData 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.ResultsAdequate revascularization (TICI ≥2B) was achieved in 92.3% of patients aged ConclusionThis 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.

Summary Background Stent retriever thrombectomy of large-vessel occlusion results in better outcomes than medical therapy alone. Alternative thrombectomy strategies, particularly a direct aspiration as first pass technique, while promising, have not been rigorously assessed for clinical efficacy in randomised trials. We designed COMPASS to assess whether patients treated with aspiration as first pass have non-inferior functional outcomes to those treated with a stent retriever as first line. Methods We did a multicentre, randomised, open label, blinded outcome, core lab adjudicated non-inferiority trial at 15 sites (ten hospitals and four specialty clinics in the USA and one hospital in Canada). Eligible participants were patients presenting with acute ischaemic stroke from anterior circulation large-vessel occlusion within 6 h of onset and an Alberta Stroke Program Early CT Score of greater than 6. We randomly assigned participants (1:1) via a central web-based system without stratification to either direct aspiration first pass or stent retriever first line thrombectomy. Those assessing primary outcomes via clinical examinations were masked to group assignment as they were not involved in the procedures. Physicians were allowed to use adjunctive technology as was consistent with their standard of care. The null hypothesis for this study was that patients treated with aspiration as first pass achieve inferior outcomes compared with those treated with a stent retriever first line approach. The primary outcome was non-inferiority of clinical functional outcome at 90 days as measured by the percentage of patients achieving a modified Rankin Scale score of 0–2, analysed by intent to treat; non-inferiority was established with a margin of 0·15. All randomly assigned patients were included in the safety analyses. This trial is registered at ClinicalTrials.gov, number: NCT02466893. Findings Between June 1, 2015, and July 5, 2017, we assigned 270 patients to treatment: 134 to aspiration first pass and 136 to stent retriever first line. A modified Rankin score of 0–2 at 90 days was achieved by 69 patients (52%; 95% CI 43·8–60·3) in the aspiration group and 67 patients (50%; 41·6–57·4) in the stent retriever group, showing that aspiration as first pass was non-inferior to stent retriever first line (p non-inferiority =0·0014). Intracranial haemorrhage occurred in 48 (36%) of 134 in the aspiration first pass group, and 46 (34%) of 135 in the stent retriever first line group. All-cause mortality at 3 months occurred in 30 patients (22%) in both groups. Interpretation A direct aspiration as first pass thrombectomy conferred non-inferior functional outcome at 90 days compared with stent retriever first line thrombectomy. This study supports the use of direct aspiration as an alternative to stent retriever as first-line therapy for stroke thrombectomy. Funding Penumbra.

Chronic subdural hematoma (cSDH) is one of the most common neurosurgical diagnoses in adults. The disease is fundamentally a disorder of the meningeal blood vessels, and options exist for the minimally invasive neuroendovascular management. We review the potential role for the endovascular management of cSDH within the context of a discussion of the epidemiology, pathophysiology, and conventional management of this disease.

BackgroundWe conducted a case-control study to assess the relative safety and efficacy of minimally invasive endoscopic surgery (MIS) for clot evacuation in patients with basal-ganglia intracerebral hemorrhage (ICH).MethodsWe evaluated consecutive patients with acute basal-ganglia ICH at a single center over a 42-month period. Patients received either best medical management according to established guidelines (controls) or MIS (cases). The following outcomes were compared before and after propensity-score matching (PSM): in-hospital mortality; discharge National Institutes of Health Stroke Scale score; discharge disposition; and modified Rankin Scale scores at discharge and at 3 months.ResultsAmong 224 ICH patients, 19 (8.5%) underwent MIS (mean age, 50.9±10.9; 26.3% female, median ICH volume, 40 (IQR, 25–51)). The interventional cohort was younger with higher ICH volume and stroke severity compared with the medically managed cohort. After PSM, 18 MIS patients were matched to 54 medically managed individuals. The two cohorts did not differ in any of the baseline characteristics. The median ICH volume at 24 hours was lower in the intervention group (40 cm3 (IQR, 25–50) vs 15 cm3 (IQR, 5–20); PConclusionsMinimally invasive endoscopic hematoma evacuation was associated with lower rates of in-hospital mortality in patients with spontaneous basal-ganglia ICH. These findings support a randomized controlled trial of MIS versus medical management for ICH.

Introduction: Penumbra SMART COIL® (SMART) System is a novel generation embolic coil with varying stiffness. The study purpose was to report real-world usage of the SMART System in patients with intracranial aneurysms (ICA) and non-aneurysm vascular lesions.Materials and Methods: The SMART Registry is a post-market, prospective, multicenter registry requiring ≥75% Penumbra Coils, including SMART, PC400, and/or POD coils. The primary efficacy endpoint was retreatment rate at 1-year and the primary safety endpoint was the procedural device-related serious adverse event rate.Results: Between June 2016 and August 2018, 995 patients (mean age 59.6 years, 72.1% female) were enrolled at 68 sites in the U.S. and Canada. Target lesions were intracranial aneurysms in 91.0% of patients; 63.5% were wide-neck and 31.8% were ruptured. Adjunctive devices were used in 55.2% of patients. Mean packing density was 32.3%. Procedural device-related serious adverse events occurred in 2.6% of patients. The rate of immediate post-procedure adequate occlusion was 97.1% in aneurysms and the rate of complete occlusion was 85.2% in non-aneurysms. At 1-year, the retreatment rate was 6.8%, Raymond Roy Occlusion Classification (RROC) I or II was 90.0% for aneurysms, and Modified Rankin Scale (mRS) 0-2 was achieved in 83.1% of all patients. Predictors of 1-year for RROC III or retreatment (incomplete occlusion) were rupture status (P < 0.0001), balloon-assisted coiling (P = 0.0354), aneurysm size (P = 0.0071), and RROC III immediate post-procedure (P = 0.0086) in a model that also included bifurcation aneurysm (P = 0.7788). Predictors of aneurysm retreatment at 1-year was rupture status (P < 0.0001).Conclusions: Lesions treated with SMART System coils achieved low long-term retreatment rates.Clinical Trial Registration:https://www.clinicaltrials.gov/, identifier NCT02729740.

Introduction: We report the durability of treatment with SMART COIL System at one-year in patients with ruptured aneurysms enrolled in the SMART registry. Materials and Methods: The SMART Registry is a prospective, multi-center registry study. Procedures must employ ≥75% of the SMART, PC400, or POD coils to meet registry criteria. Patients with ruptured aneurysms presenting prior to the procedure were included in this analysis. SMART Registry endpoints include retreatment rates at one year, procedural device-related serious adverse events (SAE), and the ability to achieve adequate occlusion at immediate post-procedure. Results: Of the 905 enrolled patients with aneurysms, 31.8% (288/905) of patients had ruptured aneurysms (74.0% female; mean age 58.0 ± 13.5 years). Ruptured aneurysms were small (10 to 25 mm) in 14.6% (42/288), giant (>25) in 0.3% (1/288), and the mean size was 6.9 mm (SD 3.5 ). Hunt and Hess grade ≥3 was reported in 43.8% (123/281) of patients. The anterior cerebral artery had 33.7% (97/288) of all ruptured aneurysms and the internal carotid artery had 30.6% (88/288). Stent-assisted coiling and balloon-assisted coiling were performed in 7.6% (22/288) and 31.3% (90/288) of patients, respectively. Mean packing density for ruptured aneurysms was 33.4% (SD 20.9). In patients with ruptured aneurysms, retreatment rate at one year was 16.5% (33/200). Procedural device-related SAEs were observed in 3.1% subjects (9/288). Raymond Class I or II was observed in 84.6% (242/286) at immediate post-procedure and in 84.3% (161/191) at one year. The multivariate analysis showed that neck width ≥4 mm (OR 2.56, 95% CI 1.21-5.44, P=0.0144) and male gender (OR 2.17 95% CI 1.05-4.49, P=0.0376) were predictors of Raymond Class III or retreatment at one year. Conclusion: This analysis suggests that the SMART COIL System achieves adequate embolization and retreatment rates in ruptured aneurysms at one year.

BackgroundThe 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.MethodsUp 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).ResultsThe 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).ConclusionPOSITIVE 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 registrationNCT01852201

While recent major trials have demonstrated the efficacy of thrombectomy for the treatment of emergent large vessel occlusion (ELVO), major technical aspects of the endovascular procedure used to achieve revascularization vary significantly. Balloon-guide catheters (BGCs) were initially brought into use as a means of temporarily arresting antegrade flow to improve the ability of the operator to extract clot from the intracranial vessels. In addition, BGCs limit embolization to new territories (ENT), as during the clot extraction, portions of the thrombus may break off and travel distally, potentially resulting in re-occlusion of the target artery or occlusion of previously unaffected vessels. For proximal internal carotid (and sometimes middle cerebral) artery occlusions, BGCs can serve as a standalone mechanism for thrombectomy when coupled with aspiration. This concept of “remote aspiration,” in which the inflated BGC arrests flow and then direct aspiration of the BGC functions to reverse flow, is a technically straightforward technique, which, when effective, results in prompt and efficient revascularization without the need of and potential risks associated with distal intracranial catheter manipulation.

Larger microcatheters are being used with increasing frequency in routine neurovascular procedures. Navigating catheters safely and effectively to the target intracranial vessels can be a challenge when using conventional 0.014″ microwires. A new family of 0.024″ Aristotle 24 microwires (Scientia Vascular, West Valley City, UT) specifically designed for intracranial navigation were recently introduced. These microwires offer significant technical advantages over the standard 0.014″ microwires, including a reduced ledge gap, improved torquability and support, and overall safety. This video case series contains several illustrative cases to demonstrate the features of the novel Aristotle 24 microwire for use in endovascular neurointervention.

“Failure is success in progress,” is one of Albert Einstein’s quotes, emphasizing the importance of recognizing one’s own limitations. The devices we use in our daily neurointerventional practice are constantly undergoing changes and improvements, as well as the techniques and approaches we apply to treat a wide range of cerebrovascular pathologies. Yet, we continue to judge procedural success or failure based on the visual feedback—the approach that has remained fundamentally the same since the introduction of the digital subtraction angiography technique. The Thrombolysis in Cerebral Infarction (TICI) scoring system is the uniform 'currency' we all use every day; it tells us when the thrombectomy procedure is completed or whether additional device passes are required, it is used by the regulatory agencies to evaluate device safety, and it allows us to compare trial results and determine if the 'next best thing' truly achieves superior and faster reperfusion rates, as claimed by the authors.1 It is not surprising therefore that the TICI scale has quickly found its way in the social media arena, with endless posts announcing first pass TICI 3 results greatly surpassing the clinical trial data or with claims of new devices’ 'superiority'. Dmytriw et al compared post-intervention Twitter reported thrombectomy outcomes with the Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke (HERMES) individual patient meta-analysis and showed a striking (over 20%) difference in the …

BackgroundUsing data from the SMART registry, we report on periprocedural safety of the Penumbra SMART Coil System for endovascular coil embolization of saccular intracranial aneurysms.MethodsThe SMART registry was a prospective, multi-center registry of site standard of care endovascular coiling procedures performed using at least 75% Penumbra SMART Coil, PC400, and/or POD coils. This subset analysis reports on the periprocedural safety outcomes of the saccular intracranial aneurysm cohort. Predictors of rupture/re-rupture or perforation (RRP), thromboembolic complications, and device- or procedure-related adverse events (AEs) were determined in univariate and multivariate analysis.ResultsBetween June 2016 and August 2018, 851 saccular aneurysm patients (31.0%, 264/851 ruptured) were enrolled across 66 North American centers. Clinically significant (ie, a serious adverse event) RRP occurred in 2.0% (17/851) of cases – 1.9% (5/264) for the ruptured cohort and 2.0% (12/587) for the un-ruptured cohort. Clinically significant thromboembolic events occurred in 3.1% (26/851) of cases – 5.3% (14/264) for the ruptured cohort and 2.0% (12/587) for the un-ruptured cohort. Multivariate predictors of periprocedural RRP were increased packing density and adjunctive treatment with a balloon. For periprocedural thromboembolic events, multivariate predictors were bifurcation location and ruptured status. For device- or procedure-related AEs, multivariate predictors were bifurcation location and adjunctive treatment with stent or balloon.ConclusionThe low rates of thromboembolic complications and RRP events demonstrate the adequate safety profile of the SMART Coil System to treat cerebral aneurysms in routine clinical practice.Trial registration numberNCT02729740.

BACKGROUND AND PURPOSE: In certain clinical circumstances, dual-antiplatelet therapy can be problematic in patients with acute SAH. In some aneurysms, however, flow-diverting stents are the ideal therapeutic option. We report our experience with ruptured intracranial aneurysms treated with flow diverters with hydrophilic coating (p48 MW HPC and p64 MW HPC) under single-antiplatelet therapy. MATERIALS AND METHODS: Patients were treated with either flow-diverter placement alone or a flow diverter and additional coiling. Due to the severity of the hemorrhage, the potential for periprocedural rehemorrhage, and the potential for additional surgical interventions, a single-antiplatelet regimen was used in all patients. RESULTS: Thirteen aneurysms were treated in 10 patients. The median age was 62 years; 5 patients were male. All had acute SAH due to aneurysm rupture. Four blood-blister, 2 dissecting, and 7 berrylike aneurysms were treated. Seven aneurysms were adjunctively coiled. Eight of the 10 patients received a single-antiplatelet protocol of aspirin, 1 patient was treated with prasugrel only, and 1 patient was treated with tirofiban first and then switched to the aspirin single-antiplatelet protocol. One device-related complication occurred, a thrombosis of an overstented branch. All stents, however, remained open at DSA, CTA, or MRA follow-up. CONCLUSIONS: The implantation of flow diverters with reduced thrombogenicity due to hydrophilic surface coating under single-antiplatelet therapy seems to be an option in carefully selected cases of SAH due to aneurysm rupture.

BackgroundAcademic physicians aim to provide clinical and surgical care to their patients while actively contributing to a growing body of scientific literature. The coronavirus disease 2019 (COVID-19) pandemic has resulted in procedural-based specialties across the United States witnessing a sharp decline in their clinical volume and surgical cases.ObjectiveTo assess the impact of COVID-19 on neurosurgical, stroke neurology, and neurointerventional academic productivity.MethodsThe study compared the neurosurgical, stroke neurology, and neurointerventional academic output during the pandemic lockdown with the same time period in previous years. Editors from a sample of neurosurgical, stroke neurology, and neurointerventional journals provided the total number of original manuscript submissions, broken down by months, from the year 2016 to 2020. Manuscript submission was used as a surrogate metric for academic productivity.Results8 journals were represented. The aggregated data from all eight journals as a whole showed that a combined average increase of 42.3% was observed on original submissions for 2020. As the average yearly percent increase using the 2016–2019 data for each journal exhibited a combined average increase of 11.2%, the rise in the yearly increase for 2020 in comparison was nearly fourfold. For the same journals in the same time period, the average percent of COVID-19 related publications from January to June of 2020 was 6.87%.ConclusionThere was a momentous increase in the number of original submissions for the year 2020, and its effects were uniformly experienced across all of our represented journals.

Introduction The Penumbra SMART COIL® System includes a novel generation of embolic coils comprising complex and WAVE shape properties with varying levels of softness to promote dense packing and durable long-term occlusion. We present the final analysis of 997 patients at 68 U.S./Canada sites with up to 1-yr follow-up in the SMART registry to assess the utility of the SMART COIL System in the treatment of intracranial aneurysms and other malformations. Materials and Methods The SMART registry is a prospective, multi-center registry assessing the embolization of neurovascular lesions using the Penumbra SMART COIL System. Procedures must employ ≥75% of SMART, PC400, or POD coils to meet inclusion criteria. SMART registry endpoints included retreatment rates through 1-yr (±6-mo) follow-up, procedural device-related serious adverse events (SAE), and the ability to achieve adequate occlusion at immediate post-procedure. Results This analysis of 997 patients (72.1% female; mean age 59.6±13.0 yr) included cerebral aneurysms (91.0%, 907/997); arteriovenous malformations (1.1%); fistulae (4.1%); and other lesions (3.8%). Aneurysms, of which 31.8% were ruptured, were small (≤10 mm) in 85.3% (774/907) of patients, large (>10 mm to 25 mm) in 14.4% (131/907), and giant (>25 mm) in 0.2% (2/907); 63.5% (555/874) of patients had wide-neck aneurysms (dome-to-neck ratio For all lesions, median coil deployment time, defined as the time from the first coil deployed until the last coil detached, was 16.0 min (IQR 8.0–32.0), and median time of fluoroscopic exposure was 37.0 min (IQR 24.0–56.0). Stent-assisted coiling was performed in 5.7% of patients, and balloon-assisted coiling was performed in 18.7% of patients. Median packing density (calculated for aneurysms only) was 29.1% [IQR 21.0–38.8]. For aneurysms, Raymond Occlusion Class (RROC) I and II was achieved in 79.7% (719/902) of cases at immediate post-procedure and in 90.1% (643/714) at 1-yr follow-up, with a recanalization rate of 12.8% (91/710) and a retreatment rate of 7.1% (52/733). In multivariate models, a large or giant aneurysm size (odds ratio [OR]=2.45, p=0.0030), balloon-assisted coiling (OR=1.84, p=0.0195), ruptured aneurysm status (OR=3.91, p For non-aneurysm lesions, complete angiographic occlusion was achieved in 85.2% (23/27) of lesions post-procedure, with a recanalization rate of 6.1% (3/49) and a retreatment rate of 1.9% (1/53) at 1-yr follow-up. Overall, procedural device-related serious adverse events (SAE) were observed in 2.6% (26/997) of subjects. Conclusion The final results of the SMART Registry, a prospective registry with 997 subjects, demonstrate that the SMART COIL System achieves safe and adequate embolization in a wide variety of neurovascular lesions with low retreatment rates over 1 yr. Large aneurysm size and balloon-assisted coiling were predictive of incomplete occlusion at 1-yr and retreatment through 1-yr follow-up. Disclosures A. Spiotta: None. M. Park: None. R. Bellon: None. B. Bohnstedt: None. C. Schirmer: None. R. DeLeacy: None. D. Fiorella: None. B. Woodward: None. B. Baxter: None. S. Kale: None. O. Zaidat: None. P. Sunenshine: None. A. Yoo: None. M. Kabbani: None. K. Liu: None. R. Starke: None. A. Reeves: None. K. Snyder: None. T. Sivapatham: None. T. Dumont: None.