Volumetric microscopy of cerebral arteries with a miniaturized optical coherence tomography imaging probe.

Endovascular interventions are increasingly becoming the preferred approach for treating strokes and cerebral artery diseases. These procedures rely on sophisticated angiographical imaging guidance, which encounters challenges because of limited contrast and spatial resolution. Achieving a more precise visualization of the underlying arterial pathology and neurovascular implants is crucial for accurate procedural decision-making. In a human study involving 32 patients, we introduced the clinical application of a miniaturized endovascular neuro optical coherence tomography (nOCT) imaging probe. This technology was designed to navigate the tortuous paths of the cerebrovascular circulation and to offer high-resolution imaging in situ. The nOCT probe is compatible with standard neurovascular microcatheters, integrating with the procedural workflow used in clinical routine. Equipped with a miniaturized optical fiber and a distal lens, the probe illuminates the tissue and collects the backscattered, near-infrared light. While rotating the fiber and the lens at high speed, the probe is rapidly retracted, creating a spiral-shaped light pattern to comprehensively capture the arterial wall and implanted devices. Using nOCT, we demonstrated volumetric microscopy of cerebral arteries in patients undergoing endovascular procedures. We imaged the anterior and posterior circulation of the brain, including distal segments of the internal carotid and middle-cerebral arteries, as well as the vertebral, basilar, and posterior cerebral arteries. We captured a broad spectrum of neurovascular pathologies, such as brain aneurysms, ischemic stroke, arterial stenoses, dissections, and intracranial atherosclerotic disease. nOCT offered artifact-free, high-resolution visualizations of intracranial artery pathology and neurovascular devices.

Novel, braided, self-expandable stent designed for the treatment of pulsatile tinnitus caused by intracranial venous stenosis: first-in-human experience and long-term outcomes.

BACKGROUND: Pulsatile tinnitus (PT) can be a disabling clinical condition, which may be caused by a sigmoid/transverse sinus stenosis (STSS). Intracranial venous stenting with off-label carotid or peripheral venous stents has been used successfully to treat this condition. We present the results of a cohort of patients presenting with PT treated with a novel, dedicated, braided stent for the endovascular treatment of STSS. METHODS: Twelve patients presenting with PT and associated STSS were treated at our institution (December 2022-June 2023). All clinical and procedural variables were prospectively collected. We used the Tinnitus Function Index (TFI) and the Tinnitus Handicap Inventory (THI) scores to assess the impact of PT on quality of life before and after the treatment (mean follow-up: 10.3 months). RESULTS: Twelve women (mean age: 44±16.5 years) presenting with PT and STSS were treated. Mean pretreatment TFI/THI scores were 78.8/77. The BosStent was successfully deployed in all patients. We experienced no intraprocedural/postoperative complications. Intra-stent angioplasty was performed in three cases. All patients reported a complete resolution of PT symptoms within 1 month and remained stable and PT-free at the last follow-up (mean posttreatment TFI/THI score: 7.1/5, p<0001). CONCLUSIONS: The BosStent was successfully used in a cohort of patients with PT without any intraprocedural complications. All the patients experienced a complete resolution of PT symptoms after 1 month, which was stable during the follow-up period. Further studies with larger populations will be necessary to investigate the safety and effectiveness of this novel stent for the treatment of PT with STSS.

Can micro-guidewire advancement forces predict clot consistency and location to assist the first-line technique for mechanical thrombectomy?

BACKGROUND: The identification of specific clot characteristics before mechanical thrombectomy (MTB) might allow the selection of the most effective first-line technique, thus potentially improving the procedural outcome. We aimed to evaluate if the microwire push forces could extrapolate information on clot consistency and extension before MTB, based on clot mechanical properties. METHODS: We measured in vitro the forces exerted on the proximal extremity of the guidewire during the advancement and retrieval of the guidewire through clot analogs of different compositions. In addition, we analyzed the forces exerted on the guidewire to extrapolate information about the location of the proximal and distal extremities of the clot analogs. RESULTS: The maximum forces recorded during the whole penetration phase were significantly different for hard and soft clots (median values, 55.6 mN vs 15.4 mN, respectively; P<0.0001). The maximum slope of the force curves recorded during the advancement of the guidewire for the first 3 s of penetration also significantly differentiated soft from hard clot analogs (7.6 mN/s vs 23.9 mN/s, respectively; P<0.0001). In addition, the qualitative analysis of the shape of the force curves obtained during the advancement and retrieval of the guidewire showed a good potential for the identification of the proximal and distal edges of the clot analogs. CONCLUSION: Our results demonstrated that it was possible to differentiate between soft and hard clot analogs. Furthermore, force measurements could give important information about the location of the clot extremities. Such an approach might support the selection of the first-line MTB technique, with the potential to improve the outcome.

Safety and effectiveness assessment of the surpass evolve (SEASE): a post-market international multicenter study.

BACKGROUND: Flow diverters are the first-line treatment for specific intracranial aneurysms (iA). Surpass Evolve (SE) is a new-generation 64-wire flow diverter with a high braid angle. Current literature on the SE is limited. We aimed to report the first international real-world experience evaluating the safety and effectiveness of the SE. METHODS: The Safety and Effectiveness Assessment of the Surpass Evolve (SEASE) was a multicenter retrospective international post-marketing cohort study including consecutive patients treated with SE for iAs between 2020 and 2022. Demographic, clinical, and angiographic data were collected. Primary effectiveness was independent core lab adjudicated complete occlusion rates (Raymond-Roy Class 1) at last follow-up. Primary safety were major ischemic/hemorrhagic events and mortality. RESULTS: In total, 305 patients with 332 aneurysms underwent SE implantation. The patients had a median age of 59 [50-67] years, and 256 (83.9%) were female. The baseline modified Rankin scale score was 0-2 in 291 patients (96.7%). Most aneurysms were unruptured (285, 93.4%) and saccular (309, 93.1%). Previous treatment was present in 76 (22.9%) patients. The median aneurysm size was 5.1 [3.4-9.0] mm, and the median neck width was 3.6 [2.7-5.1] mm. Most aneurysms were in the internal carotid artery C6 ophthalmic segment (126, 38.0%), followed by the communicating segment (58, 17.5%). At median 10.2 [6.4-12.9] months follow-up, 233 (73.0%) aneurysms achieved complete occlusion. After adjusting for confounders, complete occlusion remained consistent. Major stroke and procedure-related mortality were reported in 6 (2%) and 2 (0.7%) cases, respectively. CONCLUSION: These results demonstrate that SE has a consistently high effectiveness and favorable safety for the treatment of iAs.

The feasibility of mechanical thrombectomy versus medical management for acute stroke with a large ischemic territory.

BACKGROUND: Mechanical thrombectomy (MT) for acute ischemic stroke is generally avoided when the expected infarction is large (defined as an Alberta Stroke Program Early CT Score of <6). OBJECTIVE: To perform a meta-analysis of recent trials comparing MT with best medical management (BMM) for treatment of acute ischemic stroke with large infarction territory, and then to determine the cost-effectiveness associated with those treatments. METHODS: A meta-analysis of the RESCUE-Japan, SELECT2, and ANGEL-ASPECT trials was conducted using R Studio. Statistical analysis employed the weighted average normal method for calculating mean differences from medians in continuous variables and the risk ratio for categorical variables. TreeAge software was used to construct a cost-effectiveness analysis model comparing MT with BMM in the treatment of ischemic stroke with large infarction territory. RESULTS: The meta-analysis showed significantly better functional outcomes, with higher rates of patients achieving a modified Rankin Scale score of 0-3 at 90 days with MT as compared with BMM. In the base-case analysis using a lifetime horizon, MT led to a greater gain in quality-adjusted life-years (QALYs) of 3.46 at a lower cost of US$339 202 in comparison with BMM, which led to the gain of 2.41 QALYs at a cost of US$361 896. The incremental cost-effectiveness ratio was US$-21 660, indicating that MT was the dominant treatment at a willingness-to-pay of US$70 000. CONCLUSIONS: This study shows that, besides having a better functional outcome at 90-days' follow-up, MT was more cost-effective than BMM, when accounting for healthcare cost associated with treatment outcome.

Clinical uncertainty in large vessel occlusion ischemic stroke: does automated perfusion imaging make a difference? An intra-rater and inter-rater agreement study.

BACKGROUND: Limited research exists regarding the impact of neuroimaging on endovascular thrombectomy (EVT) decisions for late-window cases of large vessel occlusion (LVO) stroke. OBJECTIVE: T0 assess whether perfusion CT imaging: (1) alters the proportion of recommendations for EVT, and (2) enhances the reliability of EVT decision-making compared with non-contrast CT and CT angiography. METHODS: We conducted a survey using 30 patients drawn from an institutional database of 3144 acute stroke cases. These were presented to 29 Canadian physicians with and without perfusion imaging. We used non-overlapping 95% confidence intervals and difference in agreement classification as criteria to suggest a difference between the Gwet AC1 statistics (κG). RESULTS: The percentage of EVT recommendations differed by 1.1% with or without perfusion imaging. Individual decisions changed in 21.4% of cases (11.3% against EVT and 10.1% in favor). Inter-rater agreement (κG) among the 29 raters was similar between non-perfusion and perfusion CT neuroimaging (κG=0.487; 95% CI 0.327 to 0.647 and κG=0.552; 95% CI 0.430 to 0.675). The 95% CIs overlapped with moderate agreement in both. Intra-rater agreement exhibited overlapping 95% CIs for all 28 raters. κG was either substantial or excellent (0.81-1) for 71.4% (20/28) of raters in both groups. CONCLUSIONS: Despite the minimal difference in overall EVT recommendations with either neuroimaging protocol one in five decisions changed with perfusion imaging. Regarding agreement we found that the use of automated CT perfusion images does not significantly impact the reliability of EVT decisions for patients with late-window LVO.

Carotid stenting for symptomatic carotid artery web: Multicenter experience.

OBJECTIVE: Carotid artery webs are an underappreciated cause of recurrent ischemic stroke, and may represent a significant portion of cryptogenic stroke. Evidence-based guidelines for the management of symptomatic carotid webs do not exist. The goal of this study is to audit our local experience for patients with symptomatic carotid artery webs undergoing carotid stenting as a treatment option, along with describing the hypothesized dynamic physiology of carotid webs. METHODS: All patients undergoing stenting for symptomatic carotid artery web at two comprehensive regional stroke centers with high endovascular thrombectomy volume from January 1, 2012 to March 1, 2021 were included. The modified Rankin Scale (mRS) score was used to define functional outcome at 3 months after stenting. RESULTS: Fourteen consecutive patients with symptomatic carotid artery webs underwent stenting. Twelve patients were female (86%), with a median age of 54 (IQR, 48-64) years across all patients. Stroke was the qualifying event in 12 (86%) patients and TIA in 2. Eleven patients (11/14, 79%) achieved a mRS score of 0-2 at 90 days, 2 (14%) were mRS 3-5, and one patient was lost to follow-up. The median follow-up was 12 months (IQR, 10-12). There was no recurrent stroke or TIA like symptoms in any patients. CONCLUSIONS: Carotid stenting appears to be safe at preventing recurrent stroke/TIA with a median follow-up of 12 months in this retrospective multicenter observational study.

Safety and Efficacy of Flow Diverters for Treatment of Unruptured Anterior Communicating Artery Aneurysms: Retrospective Multicenter Study.

BACKGROUND: The anterior communicating artery (AComm) region is the most common site of intracranial aneurysms, with increased rupture risk compared with other locations. Overall, flow diverters present as a safe and efficacious treatment for intracranial aneurysms, but there is paucity of data for their use in the treatment of unruptured AComm aneurysms. We present the largest multicentric analysis evaluating the outcomes of flow diverters in AComm aneurysm treatment. METHODS: Databases from 10 centers were retrospectively reviewed for unruptured AComm aneurysms treated with flow diverters. Demographics, clinical presentation, radiographic characteristics, procedural complications, and outcomes were assessed. RESULTS: A total of 144 patients harboring 147 AComm aneurysms were treated between January 2012 and December 2021. Seventy-four were women (51.4%) and median age was 60 (IQR 50-67) years. All were unruptured AComm aneurysms. Half of the cohort had similar anterior cerebral artery sizes (51.4%). The most common morphology was saccular (94.6%), with a branch involvement in 32.7% of cases. Median vessel diameter was 2.4 mm, and the Pipeline Flex was the most prevalent device (32.7%). Median follow-up time was 17 months, with complete occlusion in 86.4% at the last follow-up. Functional independence (modified Rankin Scale score 0-2) was reported in 95.1%. Intraprocedural complications occurred in 5.6%, and postoperative complications were noted in 9.7% of cases. Combined major complication and mortality rate was 2.1%. CONCLUSIONS: Our study suggests that flow diverters are a useful treatment for AComm aneurysms. Mid-term results indicated favorable aneurysm occlusion with a good safety profile. Additional prospective studies with longer follow-up periods and independent adjudication are warranted to better assess these results.

Sensitivity of hostile hemodynamics to aneurysm geometry via unsupervised shape interpolation.

BACKGROUND AND OBJECTIVE: Vessel geometry and hemodynamics are intrinsically linked, whereby geometry determines hemodynamics, and hemodynamics influence vascular remodeling. Both have been used for testing clinical outcomes, but geometry/morphology generally has less uncertainty than hemodynamics derived from medical image-based computational fluid dynamics (CFD). To provide clinical utility, CFD-based hemodynamic parameters must be robust to modeling errors and/or uncertainties, but must also provide useful information not more-easily extracted from shape alone. The objective of this study was to methodically assess the response of hemodynamic parameters to gradual changes in shape created using an unsupervised 3D shape interpolation method. METHODS: We trained the neural network NeuroMorph on 3 patient-derived intracranial aneurysm surfaces (labelled A, B, C), and then generated 3 distinct morph sequences (A→B, B→C, C→A) each containing 10 interpolated surfaces. From high-fidelity CFD simulation of these, we calculated a variety of common reduced hemodynamic parameters, including many previously associated with aneurysm rupture, and analyzed their responses to changes in shape, and their correlations. RESULTS: The interpolated surfaces demonstrate complex, gradual changes in branch angles, vessel diameters, and aneurysm morphology. CFD simulation showed gradual changes in aneurysm jetting characteristics and wall-shear stress (WSS) patterns, but demonstrated a range of responses from the reduced hemodynamic parameters. Spatially and temporally averaged parameters including time-averaged WSS, time-averaged velocity, and low-shear area (LSA) showed low variation across all morph sequences, while parameters of flow complexity such as oscillatory shear, spectral broadening, and spectral bandedness indices showed high variation between slightly-altered neighboring surfaces. Correlation analysis revealed a great deal of mutual information with easier-to-measure shape-based parameters. CONCLUSIONS: In the absence of large clinical datasets, unsupervised shape interpolation provides an ideal laboratory for exploring the delicate balance between robustness and sensitivity of nominal hemodynamic predictors of aneurysm rupture. Parameters like time-averaged WSS and LSA that are highly "robust" may, as a result, be effectively redundant to morphological predictors, whereas more sensitive parameters may be too uncertain for practical clinical use. Understanding these sensitivities may help identify parameters that are capable of providing added value to rupture risk assessment.

Diagnosis and endovascular management of vasospasm after aneurysmal subarachnoid hemorrhage - survey of real-life practices.

BACKGROUND: Vasospasm and delayed cerebral ischemia (DCI) are the leading causes of morbidity and mortality after intracranial aneurysmal subarachnoid hemorrhage (aSAH). Vasospasm detection, prevention and management, especially endovascular management varies from center to center and lacks standardization. We aimed to evaluate this variability via an international survey of how neurointerventionalists approach vasospasm diagnosis and endovascular management. METHODS: We designed an anonymous online survey with 100 questions to evaluate practice patterns between December 2021 and September 2022. We contacted endovascular neurosurgeons, neuroradiologists and neurologists via email and via two professional societies - the Society of NeuroInterventional Surgery (SNIS) and the European Society of Minimally Invasive Neurological Therapy (ESMINT). We recorded the physicians' responses to the survey questions. RESULTS: A total of 201 physicians (25% [50/201] USA and 75% non-USA) completed the survey over 10 months, 42% had >7 years of experience, 92% were male, median age was 40 (IQR 35-46). Both high-volume and low-volume centers were represented. Daily transcranial Doppler was the most common screening method (75%) for vasospasm. In cases of symptomatic vasospasm despite optimal medical management, endovascular treatment was directly considered by 58% of physicians. The most common reason to initiate endovascular treatment was clinical deficits associated with proven vasospasm/DCI in 89%. The choice of endovascular treatment and its efficacy was highly variable. Nimodipine was the most common first-line intra-arterial therapy (40%). Mechanical angioplasty was considered the most effective endovascular treatment by 65% of neurointerventionalists. CONCLUSION: Our study highlights the considerable heterogeneity among the neurointerventional community regarding vasospasm diagnosis and endovascular management. Randomized trials and guidelines are needed to improve standard of care, determine optimal management approaches and track outcomes.

Flow Diverter Performance in Aneurysms Arising From the Posterior Communicating Artery: A Systematic Review and Meta-Analysis.

BACKGROUND: Flow diverters (FDs) have demonstrated a safe and effective profile. However, the use of FDs for posterior communicating artery (PComA) aneurysms remains controversial. OBJECTIVE: To evaluate the safety and effectiveness of FDs for PComA aneurysms using a systematic review and meta-analysis of the literature. METHODS: We performed a systematic search from inception until June 2022 for flow diversion in PComA aneurysms. Primary effectiveness was the rate of complete aneurysm occlusion defined by Raymond-Roy class 1. Primary safety outcomes were treatment-related ischemic/hemorrhagic (composite) events causing morbidity and mortality. Secondary safety was PComA patency at follow-up. Random-effects meta-analyses were used to calculate proportions, and statistical heterogeneity was assessed. RESULTS: A total of 13 studies with 397 patients harboring 403 aneurysms were included. Mean age was 48 years, and the mean aneurysm size was 5.3 mm. Most aneurysms were unruptured (65%). Complete occlusion at final follow-up was 73% (CI 66%-79%), and adjunctive coils were used in 10% of aneurysms. Retreatment rate was 2% (CI 0%-9%). The primary safety composite outcome was 4% (CI 3%-7%), and mortality was 1%. PComA patency at final follow-up was 76% (CI 57%-89%). Subgroup analysis, patients with fetal PComAs had a lower complete occlusion rate (42% fetal PComA vs 77%, psubgroupdifference = <.01). CONCLUSION: The performance of FDs in PComA aneurysms is comparable with outcomes found in other subtypes of supraclinoid aneurysms. Effectiveness was acceptable and safety favorable. However, effectiveness was suboptimal in patients with fetal-type PComAs; alternative treatments should be considered in these cases.

A Rational Approach to Meshing Cerebral Venous Geometries for High-Fidelity Computational Fluid Dynamics.

Computational fluid dynamics (CFD) of cerebral venous flows has become popular owing to the possibility of using local hemodynamics and hemoacoustics to help diagnose and plan treatments for venous diseases of the brain. Lumen geometries in low-pressure cerebral veins are different from those in cerebral arteries, often exhibiting fenestrations and flattened or triangular cross section, in addition to constrictions and expansions. These can challenge conventional size-based volume meshing strategies, and the ability to resolve nonlaminar flows. Here we present a novel strategy leveraging estimation of length scales that could be present if flow were to become transitional or turbulent. Starting from the lumen geometry and flow rate boundary conditions, centerlines are used to determine local hydraulic diameters and cross-sectional mean velocities, from which flow length scales are approximated using conventional definitions of local Kolmogorov and Taylor microscales. By inspection of these scales, a user specifies minimum and maximum mesh edge lengths, which are then distributed along the model in proportion to the approximated local Taylor length scales. We demonstrate in three representative cases that this strategy avoids some of the pitfalls of conventional size-based strategies. An exemplary CFD mesh-refinement study shows convergence of high-frequency flow instabilities even starting from relatively coarse edge lengths near the lower bounds of the approximated Taylor length scales. Rational consideration of the length scales in a possibly nonlaminar flow may thus provide a useful and replicable baseline for denovo meshing of complicated or unfamiliar venous lumen geometries.

Aneurysm Neck Overestimation has a Relatively Modest Impact on Simulated Hemodynamics.

INTRODUCTION: Overestimation of intracranial aneurysm neck width by 3D angiography is a recognized clinical problem, and has long been a concern for image-based computational fluid dynamics (CFD). Recently, it was demonstrated that neck overestimation in 3D rotational angiography (3DRA) could be corrected via segmentation with upsampled resolution and gradient enhancement (SURGE). Our aim was to leverage this approach to determine whether and how neck overestimation actually impacts CFD-derived hemodynamics. MATERIALS AND METHODS: A subset of 17 cases having the largest neck errors from a consecutive clinical sample of 60 was segmented from 3DRA using both standard watershed and SURGE methods. High-fidelity, pulsatile CFD was performed, and a variety of scalar hemodynamic parameters that have been associated with aneurysm growth and/or rupture status were derived. RESULTS: With a few exceptions, flow and wall shear stress (WSS) patterns were qualitatively similar between neck-overestimated and corrected models. Sac-averaged WSS values were significantly lower after neck correction (p = 0.0005) but were highly correlated with their neck-overestimated counterparts (R2 = 0.98). Jet impingement was significantly more concentrated in the neck-corrected vs. -uncorrected models (p = 0.0011), and only moderately correlated (R2 = 0.61). Parameters quantifying velocity or WSS fluctuations were not significantly different after neck correction, but this reflected their poorer correlations (R2 < 0.4). Nevertheless, for all hemodynamic parameters, median absolute differences were < 26%, and no parameter had more than 5/17 cases with absolute differences > 50%. CONCLUSION: Differences in hemodynamics due to neck width overestimation were found to be at most equal to, and often less than, those reported for other sources of error/uncertainty in intracranial aneurysm CFD, such as solver settings or assumed inflow rates.

Improving visualization of three-dimensional aneurysm features via segmentation with upsampled resolution and gradient enhancement (SURGE).

BACKGROUND: Intracranial aneurysm neck width tends to be overestimated when measured with three-dimensional rotational angiography (3DRA) compared with two-dimensional digital subtraction angiography (2D-DSA), owing to high curvature at the neck. This may affect morphological and hemodynamic analysis in support of treatment planning. We present and validate a method for extracting high curvature features, such as aneurysm ostia, during segmentation of 3DRA images. METHODS: In our novel SURGE (segmentation with upsampled resolution and gradient enhancement) approach, the gradient of an upsampled image is sharpened before gradient-based watershed segmentation. Neck measurements were performed for both standard and SURGE segmentations of 3DRA for 60 consecutive patients and compared with those from 2D-DSA. Those segmentations were also qualitatively compared for surface topology and morphology. RESULTS: Compared with the standard watershed method, SURGE reduced neck measurement error relative to 2D-DSA by >60%: median error was 0.49 mm versus 0.17 mm for SURGE, which is less than the average pixel resolution (~0.33 mm) of the 3DRA dataset. SURGE reduced neck width overestimations >1 mm from 13/60 to 5/60 cases. Relative to 2D-DSA, standard segmentations were overestimated by 16% and 93% at median and 95th percentiles, respectively, compared with only 6% and 37%, respectively, for SURGE. CONCLUSION: SURGE provides operators with high-level control of the image gradient, allowing recovery of high-curvature features such as aneurysm ostia from 3DRA where conventional algorithms may fail. Compared with standard segmentation and tedious manual editing, SURGE provides a faster, easier, and more objective method for assessing aneurysm ostia and morphology.

Motion artifact correction for cone beam CT stroke imaging: a prospective series.

BACKGROUND: Imaging assessment for acute ischemic stroke (AIS) patients in the angiosuite using cone beam CT (CBCT) has created increased interest since endovascular treatment became the first line therapy for proximal vessel occlusions. One of the main challenges of CBCT imaging in AIS patients is degraded image quality due to motion artifacts. This study aims to evaluate the prevalence of motion artifacts in CBCT stroke imaging and the effectiveness of a novel motion artifact correction algorithm for image quality improvement. METHODS: Patients presenting with acute stroke symptoms and considered for endovascular treatment were included in the study. CBCT scans were performed using the angiosuite X-ray system. All CBCT scans were post-processed using a motion artifact correction algorithm. Motion artifacts were scored before and after processing using a 4-point scale. RESULTS: We prospectively included 310 CBCT scans from acute stroke patients. 51% (n=159/310) of scans had motion artifacts, with 24% being moderate to severe. The post-processing algorithm improved motion artifacts in 91% of scans with motion (n=144/159), restoring clinical diagnostic capability in 34%. Overall, 76% of the scans were sufficient for clinical decision-making before correction, which improved to 93% (n=289/310) after post-processing with our algorithm. CONCLUSIONS: Our results demonstrate that CBCT motion artifacts are significantly reduced using a novel post-processing algorithm, which improved brain CBCT image quality and diagnostic assessment for stroke. This is an important step on the road towards a direct-to-angio approach for endovascular thrombectomy (EVT) treatment.

Sex Differences in Functional Outcomes Following Endovascular Treatment for Acute Ischemic Stroke.

BACKGROUND: Sex disparities have been reported across many aspects of acute ischemic stroke (AIS) care; however, there is a relative paucity of research examining sex differences in outcomes following endovascular treatment (EVT). Some studies report worse functional independence for females following EVT. Few, if any of these studies account for differences in age, baseline function, and comorbidity burden. This retrospective cohort study aimed to assess for sex differences in functional outcomes following EVT by comparing 90-day modified Rankin Scale (mRS) of males and females while controlling for baseline function and comorbidity burden. METHODS: Baseline demographic and clinical data, and stroke severity were compared for 230 consecutive patients undergoing EVT for AIS between October 2014 and July 2019 at a tertiary stroke centre in Toronto, Canada. Effect of sex on likelihood of functional independence post-EVT was assessed using regression analysis with and without correction for age, baseline mRS, and Charlson Comorbidity Index (CCI). RESULTS: Females undergoing EVT for AIS were older (75 ± 13 vs. 66 ± 15, p < 0.0001), with worse clinical and functional baselines. Unadjusted, males were more functionally independent (90-day mRS < 3) [OR = 1.831, 95%CI 1.082-3.098]. After controlling for age, baseline mRS and CCI, there was no difference between groups [OR 1.21, 95%CI 0.61-2.37]. CONCLUSIONS: This study provides evidence that prior findings of sex disparities in function after EVT may be accounted for by differences in age, baseline clinical status and functional independence between males and females when a comprehensive measure of comorbidity burden is utilized.

Thrombectomy alone versus intravenous alteplase plus thrombectomy in patients with stroke: an open-label, blinded-outcome, randomised non-inferiority trial.

BACKGROUND: Whether thrombectomy alone is equally as effective as intravenous alteplase plus thrombectomy remains controversial. We aimed to determine whether thrombectomy alone would be non-inferior to intravenous alteplase plus thrombectomy in patients presenting with acute ischaemic stroke. METHODS: In this multicentre, randomised, open-label, blinded-outcome trial in Europe and Canada, we recruited patients with stroke due to large vessel occlusion confirmed with CT or magnetic resonance angiography admitted to endovascular centres. Patients were randomly assigned (1:1) via a centralised web server using a deterministic minimisation method to receive stent-retriever thrombectomy alone or intravenous alteplase plus stent-retriever thrombectomy. In both groups, thrombectomy was initiated as fast as possible with any commercially available Solitaire stent-retriever revascularisation device (Medtronic, Irvine, CA, USA). In the combined treatment group, intravenous alteplase (0·9 mg/kg bodyweight, maximum dose 90 mg per patient) was administered as early as possible after randomisation for 60 min with 10% of the calculated dose given as an initial bolus. Personnel assessing the primary outcome were masked to group allocation; patients and treating physicians were not. The primary binary outcome was a score of 2 or less on the modified Rankin scale at 90 days. We assessed the non-inferiority of thrombectomy alone versus intravenous alteplase plus thrombectomy in all randomly assigned and consenting patients using the one-sided lower 95% confidence limit of the Mantel-Haenszel risk difference, with a prespecified non-inferiority margin of 12%. The main safety endpoint was symptomatic intracranial haemorrhage assessed in all randomly assigned and consenting participants. This trial is registered with ClinicalTrials.gov, NCT03192332, and is closed to new participants. FINDINGS: Between Nov 29, 2017, and May 7, 2021, 5215 patients were screened and 423 were randomly assigned, of whom 408 (201 thrombectomy alone, 207 intravenous alteplase plus thrombectomy) were included in the primary efficacy analysis. A modified Rankin scale score of 0-2 at 90 days was reached by 114 (57%) of 201 patients assigned to thrombectomy alone and 135 (65%) of 207 patients assigned to intravenous alteplase plus thrombectomy (adjusted risk difference -7·3%, 95% CI -16·6 to 2·1, lower limit of one-sided 95% CI -15·1%, crossing the non-inferiority margin of -12%). Symptomatic intracranial haemorrhage occurred in five (2%) of 201 patients undergoing thrombectomy alone and seven (3%) of 202 patients receiving intravenous alteplase plus thrombectomy (risk difference -1·0%, 95% CI -4·8 to 2·7). Successful reperfusion was less common in patients assigned to thrombectomy alone (182 [91%] of 201 vs 199 [96%] of 207, risk difference -5·1%, 95% CI -10·2 to 0·0, p=0·047). INTERPRETATION: Thrombectomy alone was not shown to be non-inferior to intravenous alteplase plus thrombectomy and resulted in decreased reperfusion rates. These results do not support omitting intravenous alteplase before thrombectomy in eligible patients. FUNDING: Medtronic and University Hospital Bern.

Silk Vista Baby for the Treatment of Complex Posterior Inferior Cerebellar Artery Aneurysms.

BACKGROUND: Treatment of small-caliber vessel lesions using flow diverters remains challenging because of vasculature's narrow luminal diameter and tortuosity. This in turn makes navigation and delivery of conventional devices with standard microcatheters more difficult. The Silk Vista Baby (SVB, Balt) flow diversion device was designed for ease of use in vessels with a smaller diameter, distal lesions, and 0.017 ″ microcatheter delivery systems. OBJECTIVE: To report the outcomes of the SVB device on the treatment of posterior inferior cerebellar artery (PICA) aneurysms. METHODS: Databases from different centers were retrospectively reviewed for PICA aneurysms treated with SVB. Demographic information, clinical presentation, radiographic characteristics, procedural complications, and immediate postprocedure outcomes were obtained. RESULTS: Fourteen patients harboring 15 true PICA aneurysms were treated between January 2019 and June 2021. Nine were female (n = 9/14; 64.2%), and the mean age was 51 ± 14.9 years. Most patients had previously ruptured aneurysms, treated by another endovascular technique. Six aneurysms were located distally (n = 6/15; 40%). The mean neck size was 3 mm (SD 1.35, range 2.5-5 mm), whereas the mean PICA diameter was 1.6 mm (SD 0.26, range 1.5-1.7 mm). The mean length of follow-up was 6 months (SD 8.28, range 4.5-16 months). Treatment-related adverse events included 1 case of transient hypoesthesia. Two additional events were reported, but adjudicated as unrelated to the procedure. Complete occlusion, measured as Raymond-Roy class I, was achieved in all cases. CONCLUSION: The SVB device was safely and effectively used in the treatment of PICA aneurysms. The smaller delivery system profile reduces the risk of procedure complications and creates new treatment options for distal lesions.

Patient outcomes after treatment of brain aneurysm in small diameter vessels with the silk vista baby flow diverter: A systematic review.

BACKGROUND: The Silk Vista Baby (SVB, BALT) is a first-in-class flow-diverter device delivered using a 0.017" microcatheter, designed for the treatment of intracranial aneurysms, including those in small diameter vessels. This study reports a systematic literature review (SLR) to evaluate the safety and efficacy of using SVB to treat intracranial aneurysms in vessels less than 3.5 mm in diameter. METHODS: We performed a PRISMA-compliant SLR to evaluate the outcomes of SVB in the treatment of aneurysms in small intracranial vessels. Primary outcomes were occlusion status and major stroke, and secondary outcomes included all-cause mortality, procedure-related neurologic death, and post-operative aneurysm rupture. Data were expressed as descriptive statistics only. RESULTS: A total of four studies, including 163 patients with 173 intracranial aneurysms, were included. The most common aneurysm locations were the anterior cerebral artery (24.9% [43/173]), the middle cerebral artery (24.3% [42/173]), and the anterior communicating artery (23.1% [40/173]). Parent artery diameter ranged from 0.9 mm to 3.6 mm, and 29% were acutely or previously ruptured aneurysms. Overall, complete or near-complete occlusion was 72.1% on early-term follow-up. Mortality rate among the studies was 2.5%, with 3 instances adjudicated as neurologic deaths (1.8%). Major stroke was noted in 1.2% of cases, and branch occlusion or stent thrombus formation in 5.5%. CONCLUSION: Our review suggests that SVB is a safe and effective treatment for intracranial aneurysms in small vessels. Further prospective and comparative studies with patient outcome data specific to aneurysm location are needed to confirm the safety and efficacy of SVB.