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.

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.

Thrombectomy With the pRESET vs Solitaire Stent Retrievers as First-Line Large Vessel Occlusion Stroke Treatment: A Randomized Clinical Trial.

Importance: Stent retriever-based thrombectomy is highly beneficial in large vessel occlusion (LVO) strokes. Many stent retriever designs are currently available, but comparison of these technologies in well-conducted studies is lacking. Objective: To determine whether thrombectomy for LVO stroke with the pRESET stent retriever is noninferior to treatment with the Solitaire stent retriever. Design, Setting, and Participants: This study was a multicenter, prospective, randomized, controlled, open-label, adaptive, noninferiority trial with blinded primary end point evaluation. Between October 2019 and February 2022, multicenter participation occurred across 19 research hospitals and/or universities in the US and 5 in Germany. Patients with LVO stroke were enrolled and included up to 8 hours after symptom onset. Interventions: Patients underwent 1:1 randomization to thrombectomy with the pRESET or Solitaire stent retriever. Main Outcomes and Measures: The primary outcome was the difference in the rate of 90-day functional independence across the 2 devices, using a -12.5% noninferiority margin for the lower bound of the 1-sided 95% CI of the difference between pRESET and Solitaire retrievers. Results: Of 340 randomized patients, 170 (50.0%) were female, and the median (IQR) age was 73.0 (64.0-82.0) years. The study procedure was completed in 322 of the 340 randomized patients. The primary end point of 90-day functional independence was achieved by 95 patients (54.9%; 95% CI, 48.7-61.1) in the pRESET group and in 96 (57.5%; 95% CI, 51.2-63.8) in the Solitaire group (absolute difference, -2.57%; 95% CI, -11.42 to 6.28). As the lower bound of the 95% CI was greater than -12.5%, the pRESET retriever was deemed noninferior to the Solitaire retriever. The noninferiority of pRESET over Solitaire was also observed in the secondary clinical end point (90-day shift in modified Rankin Scale score) and in both angiographic end points (Expanded Treatment in Cerebral Infarction [eTICI] score of 2b50 or greater within 3 passes: 146 of 173 [84.4%] vs 149 of 167 [89.2%]; absolute difference, -4.83%; 95% CI, -10.84 to 1.19; eTICI of 2c or greater following the first pass: 76 of 173 [43.7%] vs 74 of 167 [44.3%]; absolute difference, -0.63%; 95% CI, -9.48 to 8.21). Symptomatic intracranial hemorrhage occurred in 0 patients in the pRESET group and 2 (1.2%) in the Solitaire group. Mortality occurred in 25 (14.5%) in the pRESET group and in 24 (14.4%) in the Solitaire group at 90 days. Findings of the per-protocol and as-treated analyses were in concordance with findings of the intention-to-treat analysis. Conclusions and Relevance: In this study, among patients with LVO stroke, thrombectomy with the pRESET stent retriever was noninferior to thrombectomy with the Solitaire stent retriever. Findings suggest that pRESET offers a safe and effective option for flow restoration and disability reduction in patients with LVO stroke.

Primary results from the CLEAR study of a novel stent retriever with drop zone technology.

BACKGROUND: Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval. OBJECTIVE: To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device. METHODS: Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a -10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0-2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH). RESULTS: From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12-20). In the primary analysis population (n=107), eTICI 2b-3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b-3 was observed in 73.8% (79/107), with first pass eTICI 2b67-3 in 69.2% (74/107) and eTICI 2c-3 in 48.6% (52/107). Median number of passes was 1 (IQR 1-2). Final eTICI 2b-3 rate was 99.1% (106/107); final eTICI 2b67-3 rate was 91.6% (98/107); final eTICI 2c-3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0-2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139). CONCLUSIONS: The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal. TRIAL REGISTRATION NUMBER: NCT04514562.

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.

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.

Sonolucent Cranioplasty in Extracranial to Intracranial Bypass Surgery: Early Multicenter Experience of 44 Cases.

BACKGROUND: The new sonolucent cranioplasty implant (clear polymethyl methacrylate, PMMA) adds functionality besides surgical reconstruction. One possible application uses the transcranioplasty ultrasound (TCUS) technique after PMMA cranioplasty to assess graft patency of extracranial-intracranial (EC-IC) bypass procedures. OBJECTIVE: To report our early multicenter experience. METHODS: This is a multicenter analysis of consecutive EC-IC bypass patients from 5 US centers (2019-2022) with closure postbypass using PMMA implant. RESULTS: Forty-four patients (median age 53 years, 68.2% females) were included. The most common indication for bypass was Moyamoya disease/syndrome (77.3%), and superficial temporal artery to middle cerebral artery bypass was the most common procedure (79.5%). Pretreatment modified Rankin Scales of 0 and 1 to 2 were noted in 11.4% and 59.1% of patients, respectively. Intraoperative imaging for bypass patency involved a combination of modalities; Doppler was the most used modality (90.9%) followed by indocyanine green and catheter angiography (86.4% and 61.4%, respectively). Qualitative TCUS assessment of graft patency was feasible in all cases. Postoperative inpatient TCUS confirmation of bypass patency was recorded in 56.8% of the cases, and outpatient TCUS surveillance was recorded in 47.7%. There were no cases of bypass failure necessitating retreatment. Similarly, no implant-related complications were encountered in the cohort. Major complications requiring additional surgery occurred in 2 patients (4.6%) including epidural hematoma requiring evacuation (2.3%) and postoperative surgical site infection (2.3%) that was believed to be unrelated to the implant. CONCLUSION: This multicenter study supports safety and feasibility of using sonolucent PMMA implant in EC-IC bypass surgery with the goal of monitoring bypass patency using TCUS.

Technical Challenges in Endovascular Treatment of Ruptured Aneurysm in a Patient with Body Mass Index >100.

BACKGROUND: Morbid obesity can pose unique challenges in the endovascular treatment of cerebrovascular diseases, particularly in the management of ruptured aneurysms. CASE DESCRIPTION: This technical report discusses the challenges faced during the treatment of a ruptured aneurysm in a morbidly obese patient with a body mass index of 101. The technical adaptations used included the utilization of Dyna CT for routine imaging, vacuum assist devices for patient transfer, and a transradial approach to avoid groin complications. The technical adaptations used in the management of the ruptured aneurysm in the morbidly obese patient were effective in overcoming the challenges posed by the patient's obesity. CONCLUSION: This technical report and literature review can serve as a guide for physicians treating morbidly obese patients with cerebrovascular diseases. Utilization of advanced technology and innovative approaches can aid in overcoming the challenges posed by obesity and improving patient outcomes.

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification.

BACKGROUND: The 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. METHODS: PREMIER (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. RESULTS: As 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. CONCLUSIONS: The 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 REGISTRATION: NCT02186561.

Evaluation of time-resolved whole brain flat panel detector perfusion imaging using RAPID ANGIO in patients with acute stroke: comparison with CT perfusion imaging.

BACKGROUND: In contrast to conventional CT perfusion (CTP) imaging, flat panel detector CT perfusion (FD-CTP) imaging can be acquired directly in the angiosuite. OBJECTIVE: To evaluate time-resolved whole brain FD-CTP imaging and assess clinically important qualitative and quantitative perfusion parameters in correlation with previously acquired conventional CTP using the new RAPID for ANGIO software. METHODS: We included patients with internal carotid artery occlusions and M1 or M2 occlusions from six centers. All patients underwent mechanical thrombectomy (MT) with preinterventional conventional CTP and FD-CTP imaging. Quantitative performance was determined by comparing volumes of infarct core, penumbral tissue, and mismatch. Eligibility for MT according to the perfusion imaging criteria of DEFUSE 3 was determined for each case from both conventional CTP and FD-CTP imaging. RESULTS: A total of 20 patients were included in the final analysis. Conventional relative cerebral blood flow (rCBF) <30% and FD-CTP rCBF <45% showed good correlation (R2=0.84). Comparisons of conventional CTP Tmax >6 s versus FD-CTP Tmax >6 s and CTP mismatch versus FD-CTP mismatch showed more variability (R2=0.57, and R2=0.33, respectively). Based on FD-CTP, 16/20 (80%) patients met the inclusion criteria for MT according to the DEFUSE 3 perfusion criteria, in contrast to 18/20 (90%) patients based on conventional CTP. The vessel occlusion could be correctly extrapolated from the hypoperfusion in 18/20 cases (90%). CONCLUSIONS: In our multicenter study, time-resolved whole brain FD-CTP was technically feasible, and qualitative and quantitative perfusion results correlated with those obtained with conventional CTP.

Collateral Capacity Assessment : Robustness and Interobserver Agreement of Two Grading Scales and Agreement with Quantitative Scoring.

BACKGROUND AND PURPOSE: Intracranial collateral capacity is conducive to imply parenchymal perfusion of affected territory after acute vessel occlusion. The Tan collateral score is commonly used to assess the intracranial collateral capacity; however, this score is coarsely grained and interobserver agreement is low, which reduces prognostic value and clinical utility. We introduce and evaluate an alternative extended Tan score based on the conventional Tan scale and assess the agreement with a quantitative score. METHODS: We included 100 consecutive patients with a proven acute single large vessel occlusion of the proximal anterior circulation. Collaterals were graded with the conventional and extended Tan score and an automated quantitative score. The extended Tan score is a finer 6­scale manual score based on the conventional 4­point Tan scale. The quantitative score is calculated by an automatic software package (StrokeViewer). Interobserver agreement of the manual scores was assessed with the weighted kappa. The Spearman correlation coefficient was calculated to determine the agreement between the manual and automated collateral scores. RESULTS: The interobserver agreement was higher for the extended score than for the conventional score with a weighted kappa of 0.70 and 0.65, respectively. For the extended and conventional score, the Spearman correlation coefficient for the agreement with the automated score was 0.78 and 0.76, respectively. CONCLUSION: Because of the good interobserver agreement and good agreement with quantitative assessment, the extended collateral score is a strong candidate to improve prognostic value of collateral assessment and implementation in clinical practice.

Treatment of giant intracranial aneurysms using the Pipeline flow-diverting stent: Long-term results from the International Retrospective Study of the Pipeline Embolization Device (IntrePED) study.

BACKGROUND: Traditional endovascular treatments of giant intracranial aneurysms are associated with high rates of complications and retreatment. Our objective was to examine the safety and long-term efficacy of the Pipeline Embolization Device for treatment of these aneurysms. METHODS: This retrospective study using the IntrePED database included all patients with giant intracranial aneurysms treated with the Pipeline device between July 2008 and February 2013. Efficacy outcomes were stratified by using the Raymond-Roy Occlusion Classification. Predefined safety outcomes included spontaneous rupture of the target aneurysm; ipsilateral intracranial hemorrhage; ischemic stroke; parent artery stenosis; and sustained cranial neuropathy. RESULTS: Sixty-six embolizations were performed to treat 63 giant intracranial aneurysms (including 2 ruptured): 49 (77.8%) in the anterior and 14 (22.2%) in the posterior circulation. The median follow-up was 22.4 (0.1-60.5) months. Class I angiographic occlusion was achieved in 72.0% (36/50). The neurological morbidity/mortality rate was 23.8% (15/63), with higher rates in the posterior circulation than in the anterior circulation (22.4% vs. 28.6%). Among seven deaths, five had neurological causes. The procedure-related neurological morbidity and mortality rates were 22.7% (15/66) and 7.6% (5/66), respectively. The spontaneous rupture rate was 4.5% (3/66). Two spontaneous ruptures (1 death), 4/4 postprocedural intracranial hemorrhages, and 6/9 ischemic events occurred within 30 days. In-stent stenosis and new-onset cranial neuropathy were not observed during the angiographic follow-up period. CONCLUSIONS: Although procedure-related neurological morbidity/mortality rates were not insignificant, this study confirms the feasibility and long-term efficacy of the Pipeline Embolization Device to treat giant intracranial aneurysms.

International controlled study of revascularization and outcomes following COVID-positive mechanical thrombectomy.

BACKGROUND AND PURPOSE: Previous studies suggest that mechanisms and outcomes in patients with COVID-19-associated stroke differ from those in patients with non-COVID-19-associated strokes, but there is limited comparative evidence focusing on these populations. The aim of this study, therefore, was to determine if a significant association exists between COVID-19 status with revascularization and functional outcomes following thrombectomy for large vessel occlusion (LVO), after adjustment for potential confounding factors. METHODS: A cross-sectional, international multicenter retrospective study was conducted in consecutively admitted COVID-19 patients with concomitant acute LVO, compared to a control group without COVID-19. Data collected included age, gender, comorbidities, clinical characteristics, details of the involved vessels, procedural technique, and various outcomes. A multivariable-adjusted analysis was conducted. RESULTS: In this cohort of 697 patients with acute LVO, 302 had COVID-19 while 395 patients did not. There was a significant difference (p < 0.001) in the mean age (in years) and gender of patients, with younger patients and more males in the COVID-19 group. In terms of favorable revascularization (modified Thrombolysis in Cerebral Infarction [mTICI] grade 3), COVID-19 was associated with lower odds of complete revascularization (odds ratio 0.33, 95% confidence interval [CI] 0.23-0.48; p < 0.001), which persisted on multivariable modeling with adjustment for other predictors (adjusted odds ratio 0.30, 95% CI 0.12-0.77; p = 0.012). Moreover, endovascular complications, in-hospital mortality, and length of hospital stay were significantly higher among COVID-19 patients (p < 0.001). CONCLUSION: COVID-19 was an independent predictor of incomplete revascularization and poor functional outcome in patients with stroke due to LVO. Furthermore, COVID-19 patients with LVO were more often younger and had higher morbidity/mortality rates.

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.

Characteristics of a COVID-19 Cohort With Large Vessel Occlusion: A Multicenter International Study.

BACKGROUND: The mechanisms and outcomes in coronavirus disease (COVID-19)-associated stroke are unique from those of non-COVID-19 stroke. OBJECTIVE: To describe the efficacy and outcomes of acute revascularization of large vessel occlusion (LVO) in the setting of COVID-19 in an international cohort. METHODS: We conducted an international multicenter retrospective study of consecutively admitted patients with COVID-19 with concomitant acute LVO across 50 comprehensive stroke centers. Our control group constituted historical controls of patients presenting with LVO and receiving a mechanical thrombectomy between January 2018 and December 2020. RESULTS: The total cohort was 575 patients with acute LVO; 194 patients had COVID-19 while 381 patients did not. Patients in the COVID-19 group were younger (62.5 vs 71.2; P < .001) and lacked vascular risk factors (49, 25.3% vs 54, 14.2%; P = .001). Modified thrombolysis in cerebral infarction 3 revascularization was less common in the COVID-19 group (74, 39.2% vs 252, 67.2%; P < .001). Poor functional outcome at discharge (defined as modified Ranklin Scale 3-6) was more common in the COVID-19 group (150, 79.8% vs 132, 66.7%; P = .004). COVID-19 was independently associated with a lower likelihood of achieving modified thrombolysis in cerebral infarction 3 (odds ratio [OR]: 0.4, 95% CI: 0.2-0.7; P < .001) and unfavorable outcomes (OR: 2.5, 95% CI: 1.4-4.5; P = .002). CONCLUSION: COVID-19 was an independent predictor of incomplete revascularization and poor outcomes in patients with stroke due to LVO. Patients with COVID-19 with LVO were younger, had fewer cerebrovascular risk factors, and suffered from higher morbidity/mortality rates.

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

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

Predictors of incomplete aneurysm occlusion after treatment with the Pipeline Embolization Device: PREMIER trial 1 year analysis.

BACKGROUND: Flow diverters have revolutionized the treatment of intracranial aneurysms. Nevertheless, some aneurysms fail to occlude with flow diversion. The Prospective Study on Embolization of Intracranial Aneurysms with the Pipeline Device (PREMIER) was a prospective, multicenter and single-arm trial of small and medium wide-necked unruptured aneurysms. In the current study, we evaluate the predictors of treatment failure in the PREMIER cohort. METHODS: We analyzed PREMIER patients who had incomplete occlusion (Raymond-Roy >1) at 1 year angiographic follow-up and compared them with those who achieved Raymond-Roy 1, aiming to identify predictors of treatment failure. RESULTS: 25 aneurysms demonstrated incomplete occlusion at 1 year. There was a median reduction of 0.9 mm (IQR 0.41-2.43) in maximum diameter between pre-procedure and 1 year measurements, with no aneurysmal hemorrhage. Patients with incomplete occlusion were significantly older than those with complete occlusion (p=0.011). Smoking (p=0.045) and C6 segment location (p=0.005) were significantly associated with complete occlusion, while location at V4 (p=0.01) and C7 (p=0.007) and involvement of a side branch (p<0.001) were significantly associated with incomplete occlusion. In multivariable logistic regression, significant predictors of incomplete occlusion were non-smoker status (adjusted OR 4.49, 95% CI 1.11 to 18.09; p=0.03) and side branch involvement (adjusted OR 11.68, 95% CI 3.84 to 35.50; p<0.0001), while C6 location had reduced odds of incomplete occlusion (adjusted OR 0.29, 95% CI 0.10 to 0.84; p=0.02). CONCLUSIONS: The results of our study are consistent with previous retrospective series and warrant consideration for technique adaptations to achieve higher occlusion rates. Further follow-up is needed to assess progression of aneurysm occlusion and clinical behavior in these cases.

Automated Final Lesion Segmentation in Posterior Circulation Acute Ischemic Stroke Using Deep Learning.

Final lesion volume (FLV) is a surrogate outcome measure in anterior circulation stroke (ACS). In posterior circulation stroke (PCS), this relation is plausibly understudied due to a lack of methods that automatically quantify FLV. The applicability of deep learning approaches to PCS is limited due to its lower incidence compared to ACS. We evaluated strategies to develop a convolutional neural network (CNN) for PCS lesion segmentation by using image data from both ACS and PCS patients. We included follow-up non-contrast computed tomography scans of 1018 patients with ACS and 107 patients with PCS. To assess whether an ACS lesion segmentation generalizes to PCS, a CNN was trained on ACS data (ACS-CNN). Second, to evaluate the performance of only including PCS patients, a CNN was trained on PCS data. Third, to evaluate the performance when combining the datasets, a CNN was trained on both datasets. Finally, to evaluate the performance of transfer learning, the ACS-CNN was fine-tuned using PCS patients. The transfer learning strategy outperformed the other strategies in volume agreement with an intra-class correlation of 0.88 (95% CI: 0.83-0.92) vs. 0.55 to 0.83 and a lesion detection rate of 87% vs. 41-77 for the other strategies. Hence, transfer learning improved the FLV quantification and detection rate of PCS lesions compared to the other strategies.