Trial of Endovascular Thrombectomy for Large Ischemic Strokes.

BACKGROUND: Trials of the efficacy and safety of endovascular thrombectomy in patients with large ischemic strokes have been carried out in limited populations. METHODS: We performed a prospective, randomized, open-label, adaptive, international trial involving patients with stroke due to occlusion of the internal carotid artery or the first segment of the middle cerebral artery to assess endovascular thrombectomy within 24 hours after onset. Patients had a large ischemic-core volume, defined as an Alberta Stroke Program Early Computed Tomography Score of 3 to 5 (range, 0 to 10, with lower scores indicating larger infarction) or a core volume of at least 50 ml on computed tomography perfusion or diffusion-weighted magnetic resonance imaging. Patients were assigned in a 1:1 ratio to endovascular thrombectomy plus medical care or to medical care alone. The primary outcome was the modified Rankin scale score at 90 days (range, 0 to 6, with higher scores indicating greater disability). Functional independence was a secondary outcome. RESULTS: The trial was stopped early for efficacy; 178 patients had been assigned to the thrombectomy group and 174 to the medical-care group. The generalized odds ratio for a shift in the distribution of modified Rankin scale scores toward better outcomes in favor of thrombectomy was 1.51 (95% confidence interval [CI], 1.20 to 1.89; P<0.001). A total of 20% of the patients in the thrombectomy group and 7% in the medical-care group had functional independence (relative risk, 2.97; 95% CI, 1.60 to 5.51). Mortality was similar in the two groups. In the thrombectomy group, arterial access-site complications occurred in 5 patients, dissection in 10, cerebral-vessel perforation in 7, and transient vasospasm in 11. Symptomatic intracranial hemorrhage occurred in 1 patient in the thrombectomy group and in 2 in the medical-care group. CONCLUSIONS: Among patients with large ischemic strokes, endovascular thrombectomy resulted in better functional outcomes than medical care but was associated with vascular complications. Cerebral hemorrhages were infrequent in both groups. (Funded by Stryker Neurovascular; SELECT2 ClinicalTrials.gov number, NCT03876457.).

Endovascular thrombectomy plus medical care versus medical care alone for large ischaemic stroke: 1-year outcomes of the SELECT2 trial.

BACKGROUND: Multiple randomised trials have shown efficacy and safety of endovascular thrombectomy in patients with large ischaemic stroke. The aim of this study was to evaluate long-term (ie, at 1 year) evidence of benefit of thrombectomy for these patients. METHODS: SELECT2 was a phase 3, open-label, international, randomised controlled trial with blinded endpoint assessment, conducted at 31 hospitals in the USA, Canada, Spain, Switzerland, Australia, and New Zealand. Patients aged 18-85 years with ischaemic stroke due to proximal occlusion of the internal carotid artery or of the first segment of the middle cerebral artery, showing large ischaemic core on non-contrast CT (Alberta Stroke Program Early Computed Tomographic Score of 3-5 [range 0-10, with lower values indicating larger infarctions]) or measuring 50 mL or more on CT perfusion and MRI, were randomly assigned, within 24 h of ischaemic stroke onset, to thrombectomy plus medical care or to medical care alone. The primary outcome for this analysis was the ordinal modified Rankin Scale (range 0-6, with higher scores indicating greater disability) at 1-year follow-up in an intention-to-treat population. The trial is registered at ClinicalTrials.gov (NCT03876457) and is completed. FINDINGS: The trial was terminated early for efficacy at the 90-day follow-up after 352 patients had been randomly assigned (178 to thrombectomy and 174 to medical care only) between Oct 11, 2019, and Sept 9, 2022. Thrombectomy significantly improved the 1-year modified Rankin Scale score distribution versus medical care alone (Wilcoxon-Mann-Whitney probability of superiority 0·59 [95% CI 0·53-0·64]; p=0·0019; generalised odds ratio 1·43 [95% CI 1·14-1·78]). At the 1-year follow-up, 77 (45%) of 170 patients receiving thrombectomy had died, compared with 83 (52%) of 159 patients receiving medical care only (1-year mortality relative risk 0·89 [95% CI 0·71-1·11]). INTERPRETATION: In patients with ischaemic stroke due to a proximal occlusion and large core, thrombectomy plus medical care provided a significant functional outcome benefit compared with medical care alone at 1-year follow-up. FUNDING: Stryker Neurovascular.

Anticoagulation Use and Endovascular Thrombectomy in Patients with Large Core Stroke: A Secondary Analysis of the SELECT2 Trial.

Endovascular thrombectomy (EVT) safety and efficacy in patients with large core infarcts receiving oral anticoagulants (OAC) are unknown. In the SELECT2 trial (NCT03876457), 29 of 180 (16%; vitamin K antagonists 15, direct OACs 14) EVT, and 18 of 172 (10%; vitamin K antagonists 3, direct OACs 15) medical management (MM) patients reported OAC use at baseline. EVT was not associated with better clinical outcomes in the OAC group (EVT 6 [4-6] vs MM 5 [4-6], adjusted generalized odds ratio 0.89 [0.53-1.50]), but demonstrated significantly better outcomes in patients without OAC (EVT 4 [3-6] vs MM 5 [4-6], adjusted generalized odds ratio 1.87 [1.45-2.40], p = 0.02). The OAC group had higher comorbidities, including atrial fibrillation (70% vs 17%), congestive heart failure (28% vs 10%), and hypertension (87% vs 72%), suggesting increased frailty. However, the results were consistent after adjustment for these comorbidities, and was similar regardless of the type of OACs used. Whereas any hemorrhage rates were higher in the OAC group receiving EVT (86% in OAC vs 70% in no OAC), no parenchymal hemorrhage or symptomatic intracranial hemorrhage were observed with OAC use in both the EVT and MM arms. Although we did not find evidence that the effect was due to excess hemorrhage or confounded by underlying cardiac disease or older age, OAC use alone should not exclude patients from receiving EVT. Baseline comorbidities and ischemic injury extent should be considered while making individualized treatment decisions. ANN NEUROL 2024.

Direct Versus Indirect Revascularization for Moyamoya: a Large Multicenter Study.

BACKGROUND: Moyamoya is a chronic occlusive cerebrovascular disease of unknown etiology causing neovascularization of the lenticulostriate collaterals at the base of the brain. Although revascularization surgery is the most effective treatment for moyamoya, there is still no consensus on the best surgical treatment modality as different studies provide different outcomes. OBJECTIVE: In this large case series, we compare the outcomes of direct (DR) and indirect revascularisation (IR) and compare our results to the literature in order to reflect on the best revascularization modality for moyamoya. METHODS: We conducted a multicenter retrospective study in accordance with the Strengthening the Reporting of Observational studies in Epidemiology guidelines of moyamoya affected hemispheres treated with DR and IR surgeries across 13 academic institutions predominantly in North America. All patients who underwent surgical revascularization of their moyamoya-affected hemispheres were included in the study. The primary outcome of the study was the rate of symptomatic strokes. RESULTS: The rates of symptomatic strokes across 515 disease-affected hemispheres were comparable between the two cohorts (11.6% in the DR cohort vs 9.6% in the IR cohort, OR 1.238 (95% CI 0.651 to 2.354), p=0.514). The rate of total perioperative strokes was slightly higher in the DR cohort (6.1% for DR vs 2.0% for IR, OR 3.129 (95% CI 0.991 to 9.875), p=0.052). The rate of total follow-up strokes was slightly higher in the IR cohort (8.1% vs 6.6%, OR 0.799 (95% CI 0.374 to 1.709) p=0.563). CONCLUSION: Since both modalities showed comparable rates of overall total strokes, both modalities of revascularization can be performed depending on the patient's risk assessment.

Endovascular therapy versus best medical management in distal medium middle cerebral artery acute ischaemic stroke: a multinational multicentre propensity score-matched study.

BACKGROUND: The efficacy of endovascular treatment (EVT) in acute ischaemic stroke due to distal medium vessel occlusion (DMVO) remains uncertain. Our study aimed to evaluate the safety and efficacy of EVT compared with the best medical management (BMM) in DMVO. METHODS: In this prospectively collected, retrospectively reviewed, multicentre cohort study, we analysed data from the Multicentre Analysis of primary Distal medium vessel occlusions: effect of Mechanical Thrombectomy registry. Patients with acute ischaemic stroke due to DMVO in the M2, M3 and M4 segments who underwent EVT or received BMM were included. Primary outcome measures comprised 10 co-primary endpoints, including functional independence (mRS 0-2), excellent outcome (mRS 0-1), mortality (mRS 6) and haemorrhagic complications. Propensity score matching was employed to balance the cohorts. RESULTS: Among 2125 patients included in the primary analysis, 1713 received EVT and 412 received BMM. After propensity score matching, each group comprised 391 patients. At 90 days, no significant difference was observed in achieving mRS 0-2 between EVT and BMM (adjusted OR 1.00, 95% CI 0.67 to 1.50, p>0.99). However, EVT was associated with higher rates of symptomatic intracerebral haemorrhage (8.4% vs 3.0%, adjusted OR 3.56, 95% CI 1.69 to 7.48, p<0.001) and any intracranial haemorrhage (37% vs 19%, adjusted OR 2.61, 95% CI 1.81 to 3.78, p<0.001). Mortality rates were similar between groups (13% in both, adjusted OR 1.48, 95% CI 0.87 to 2.51, p=0.15). CONCLUSION: Our findings suggest that while EVT does not significantly improve functional outcomes compared with BMM in DMVO, it is associated with higher risks of haemorrhagic complications. These results support a cautious approach to the use of EVT in DMVO and highlight the need for further prospective randomised trials to refine treatment strategies.

The negative impact of treatment delays on the long-term neurological outcomes of spinal dural arteriovenous fistulas: a longitudinal cohort study.

OBJECTIVE: Dural arteriovenous fistulas are rare vascular malformations that affect the brain and spinal cord. Spinal dural arteriovenous fistulas (sdAVFs) are the most frequently encountered vascular malformation affecting the spinal cord. The object of this study was to evaluate the impact of treatment delays on the long-term neurological outcomes of either open surgical or interventional treatment of sdAVFs. METHODS: In this retrospective, population-based cohort study, the authors examined consecutive patients with diagnosed sdAVFs at a tertiary care center between 2005 and 2020. Patients were assessed using the Aminoff-Logue disability scale (ALS) at various time points including symptom onset, primary care visit, first specialist outpatient visit, as well as both short and long-term follow-ups. The postoperative long-term ALS gait and bladder grades constituted the primary outcomes of the study. RESULTS: Among the 34 patients included in the study, the median age was 65 years, and there was a male predominance (71%). Most lesions were in the lumbar region (47%). Significant worsening in ALS gait and bladder grades was observed preoperatively, followed by postoperative improvements (p < 0.05). There was no difference in outcomes between surgical and endovascular treatments. Older age (OR 1.10, 95% CI 1.03-1.17, p = 0.007), worse preoperative ALS gait grades (OR 5.12, 95% CI 2.18-12.4, p < 0.001), and longer time from first specialist outpatient visit to first treatment (OR 1.00, 95% CI 1.00-1.01, p = 0.040) were independently associated with worse long-term gait outcomes. Only the preoperative ALS bladder score was a predictor of worse long-term bladder function (OR 92.7, 95% CI 28.0-306.7, p < 0.001). CONCLUSIONS: Both surgical and endovascular treatments for sdAVFs led to significant neurological improvements. However, treatment delays were associated with less favorable long-term outcomes. Prompt diagnosis and early intervention prior to symptom progression may enhance recovery and help to preserve neurological function.

Comparison between endovascular and surgical treatment of spinal dural arteriovenous fistulas: a single-center cohort and systematic review.

OBJECTIVE: With recent advancements in minimally invasive techniques, endovascular embolization has gained popularity as a first-line treatment option for spinal dural arteriovenous fistulas (sDAVFs). The authors present their institution's case series of sDAVFs treated endovascularly and surgically, and they performed a systemic review to assess the outcomes of both modalities of treatment. METHODS: The authors conducted a retrospective observational study of 24 consecutive patients with sDAVFs treated between 2013 and 2023. The primary outcome was the rate of occlusion, which was compared between the surgically and endovascularly treated sDAVFs. They also conducted a systemic review of all the literature comparing outcomes of endovascular and surgical treatment of sDAVFs. RESULTS: A total of 24 patients with 24 sDAVFs were studied. The mean patient age was 63.8 ± 15.5 years, and the majority of patients were male (n = 19, 79.2%). Of the 24 patients, 8 (33.3%) received endovascular treatment, 15 (62.5%) received surgical treatment, and 1 (4.2%) patient received both. Complete occlusion at first follow-up was higher in the surgical cohort but did not achieve statistical significance (66.7% vs 25%, p = 0.52). Recurrence was higher in the endovascular cohort (37.5% vs 13.3%, p = 0.3), while the rate of postprocedural complications was higher in the surgical cohort (13.3% vs 0%, p = 0.52); however, neither of these differences was statistically significant. CONCLUSIONS: Endovascular embolization in the management of sDAVFs is an alternative treatment to surgery, whose long-term efficacy is still under investigation. These findings suggest overall comparable outcomes between endovascular and open surgical treatment of sDAVFs. Future studies are needed to determine the role of endovascular embolization in the overall management of sDAVFs.

Comparison of the transarterial, transvenous, and superior ophthalmic vein approaches in the treatment of indirect carotid-cavernous fistulas.

OBJECTIVE: Indirect carotid-cavernous fistulas (CCFs) are abnormal arteriovenous shunting lesions with a highly variable clinical presentation that depends on the drainage pattern. Based on venous drainage, treatment can be either transarterial (TA) or transvenous (TV). The aim of this study was to compare the outcomes of indirect CCF embolization via the TA, TV, and direct superior ophthalmic vein (SOV) approaches. METHODS: The authors conducted a retrospective analysis of 74 patients admitted to their institution from 2010 to 2023 with the diagnosis of 77 indirect CCFs as confirmed on digital subtraction angiography. RESULTS: A total of 74 patients with 77 indirect CCFs were included in this study. Embolization was performed via the TA approach in 4 cases, the TV approach in 50 cases, and the SOV in 23 cases. At the end of the procedure, complete occlusion was achieved in 76 (98.7%) cases. The rate of complete occlusion at the end of the procedure and at last radiological follow-up was significantly higher in the SOV and TV cohorts than in the TA cohort. The rate of recurrence was highest in the TA cohort (25% for TA vs 5.3% for TV vs 0% for SOV, p = 0.68). CONCLUSIONS: The rate of immediate complete occlusion was higher in the TV and SOV cohorts than in the TA cohort while the rate of complete occlusion at final follow-up was highest in the SOV cohort. The SOV approach was significantly associated with higher rates of postoperative complications. Indirect CCFs require careful examination of the fistulous point and the venous drainage to provide the most effective patient-tailored approach.

Complex intracranial aneurysms: a DELPHI study to define associated characteristics.

PURPOSE: Intracranial aneurysms present significant health risks, as their rupture leads to subarachnoid haemorrhage, which in turn has high morbidity and mortality rates. There are several elements affecting the complexity of an intracranial aneurysm. However, criteria for defining a complex intracranial aneurysm (CIA) in open surgery and endovascular treatment could differ, and actually there is no consensus on the definition of a "complex" aneurysm. This DELPHI study aims to assess consensus on variables defining a CIA. METHODS: An international panel of 50 members, representing various specialties, was recruited to define CIAs through a three-round Delphi process. The panelists participated in surveys with Likert scale responses and open-ended questions. Consensus criteria were established to determine CIA variables, and statistical analysis evaluated consensus and stability. RESULTS: In open surgery, CIAs were defined by fusiform or blister-like shape, dissecting aetiology, giant size (≥ 25 mm), broad neck encasing parent arteries, extensive neck surface, wall calcification, intraluminal thrombus, collateral branch from the sac, location (AICA, SCA, basilar), vasospasm context, and planned bypass (EC-IC or IC-IC). For endovascular treatment, CIAs included giant size, very wide neck (dome/neck ratio ≤ 1:1), and collateral branch from the sac. CONCLUSIONS: The definition of aneurysm complexity varies by treatment modality. Since elements related to complexity differ between open surgery and endovascular treatment, these consensus criteria of CIAs could even guide in selecting the best treatment approach.

Balloon-mounting stent versus balloon angioplasty for intracranial arterial stenosis: A systematic review and meta-analysis.

BACKGROUND: Intracranial artery atherosclerotic stenosis (ICAS) is a major cause of stroke, especially in Asian countries. Current treatment options, including balloon-mounted stent (BMS) and balloon angioplasty (BA), lack sufficient evidence to determine a preferred approach. This systematic review and meta-analysis aimed to compare the efficacy and safety of BMS and BA in treating ICAS. METHODS: Following PRISMA 2020 guidelines, we conducted a comprehensive search in PubMed, Web of Science, and Scopus up to December 1, 2023. Eligible studies compared BMS with BA in patients diagnosed with ICAS. Primary outcomes included the success rate and occurrence of stroke (ischemic or hemorrhagic). Secondary outcomes were perforator occlusion, in-stent thrombosis, death, and restenosis. Statistical analysis was conducted using R software version 4.3.1, employing a random-effects model. RESULTS: Five high-quality studies involving 707 patients (515 males, 192 females) were included. BMS had a significantly higher success rate compared to BA (Risk Ratio [RR]: 1.13; CI: 1.03 to 1.24, p < 0.01; I2 = 14 %). The overall risk for stroke (ischemic and hemorrhagic) was significantly higher in BMS (RR: 2.97; CI: 1.32 to 6.67, p < 0.01; I2 = 0 %). However, no significant difference was found between BMS and BA regarding ischemic stroke (RR: 2.33; CI: 0.80 to 6.74, p = 0.12; I2 = 0 %). Additionally, no significant differences were observed in terms of perforator occlusion, in-stent thrombosis, dissection, minor and major strokes, and mortality rates. BMS was associated with a lower risk of restenosis (RR: 0.31; 95 % CI: 0.12 to 0.83, p = 0.02; I2 = 0 %). CONCLUSION: Our results indicate that BMS might be associated with higher success and lower restenosis rates than BA in the treatment of ICAS but with an increased overall risk of stroke. No significant differences were observed in ischemic stroke, perforator occlusion, in-stent thrombosis, dissection, minor and major strokes, and mortality rates. The choice of treatment should consider these findings, alongside the technical challenges and desired angiographic outcomes. Future randomized controlled trials are necessary to further elucidate these results.

The effect of institutional case volume on post-operative outcomes after endarterectomy and stenting for symptomatic carotid stenosis.

OBJECTIVE: To investigate the effects of yearly institutional case volume for carotid endarterectomy (CEA) and stenting (CAS) among symptomatic carotid stenosis patients on the rates of postoperative stroke and inpatient mortality. MATERIALS AND METHODS: Patients with prior stroke ("symptomatic") undergoing CEA or CAS during an inpatient stay were identified from the National Inpatient Sample for years 2012-2015. The primary variable was volume of CEA or CAS performed annually by each institution. The primary outcome was a composite variable for in-hospital death or postoperative stroke. RESULTS: A total of 5,628 patients with symptomatic carotid stenosis underwent CEA, while 245 underwent CAS. In the symptomatic CEA population, 519 (9.2 %) patients experienced postoperative stroke or mortality, and were more likely to be treated at centers with a lower yearly institutional volume (median 10 [IQR 5-15] versus 10 [7-20] cases, p < 0.001). In the symptomatic CAS population, 32 (13.1 %) patients experienced stroke or mortality, and these patients were also more likely to undergo treatment at hospitals with a lower yearly institutional volume (median 5 [IQR 5-7] versus 5 [5-10] cases, p = 0.044). Thresholds for yearly institutional volume found differences in adverse outcome between 0-9, 10-29, and ≥30 cases/year (11.7 % vs 8.4 % vs 6.0 %, p < 0.001) for CEA, and differences in postoperative stroke between 0-9 and ≥10 cases/year for CAS (11.0 % vs 1.4 %, p = 0.028). CONCLUSIONS: Hospitals performing higher volumes of CEA or CAS have fewer postoperative strokes. The threshold reported herein is ≥30 CEA procedures or ≥10 CAS procedures annually for appreciably improved outcomes.

Comparative Outcomes of Mechanical Thrombectomy in Acute Ischemic Stroke Patients with ASPECTS 2-3 vs. 4-5.

BACKGROUND: The influence of Alberta Stroke Program Early CT Score (ASPECTS) on outcomes following mechanical thrombectomy (MT) for acute ischemic stroke (AIS) patients with low ASPECTS remains unknown. In this study, we compared the outcomes of AIS patients treated with MT for large vessel occlusion (LVO) categorized by ASPECTS value. METHODS: We conducted a retrospective analysis involving 305 patients with AIS caused by LVO, defined as the occlusion of the internal carotid artery and/or the M1 segments of the middle cerebral artery, stratified into two groups: ASPECTS 2-3 and 4-5. The primary outcome was favorable outcome defined as a 90-day modified Rankin Scale (mRS) score of 0-3. Secondary outcomes were 90-day mRS 0-2, 90-day mortality, any intracerebral hemorrhage (ICH), and symptomatic ICH (sICH). We performed multivariable logistic regression analysis to evaluate the impact of ASPECTS 2-3 vs. 4-5 on outcomes. RESULTS: Fifty-nine patients (19.3%) had ASPECTS 2-3 and 246 (80.7%) had ASPECTS 4-5. Favorable outcomes showed no significant difference between the two groups (adjusted odds ratio [aOR]= 1.13, 95% confidence interval [CI]: 0.52-2.41, p=0.80). There were also no significant differences in 90-day mRS 0-2 (aOR= 1.65, 95% CI: 0.66-3.99, p=0.30), 90-day mortality (aOR= 1.14, 95% CI: 0.58-2.20, p=0.70), any ICH (aOR= 0.54, 95% CI: 0.28-1.00, p=0.06), and sICH (aOR= 0.70, 95% CI: 0.27-1.63, p = 0.40) between the groups. CONCLUSIONS: AIS patients with LVO undergoing MT with ASPECTS 2-3 had similar outcomes compared to ASPECTS 4-5.

Comparative outcomes of middle meningeal artery embolization with statins versus embolization alone in the treatment of chronic subdural hematoma: a systematic review and meta-analysis.

Chronic subdural hematoma (cSDH) is common among the elderly, with surgical evacuation as a prevalent treatment, facing recurrence rates up to 30%. Recently, middle meningeal artery embolization (MMAE) has emerged as a promising approach, offering reduced treatment failures and recurrence rates. Additionally, statins, known for their anti-inflammatory properties, have been considered as a potential adjunctive or sole treatment for cSDH. However, the combination of MMAE with statins remains understudied. This systematic review and meta-analysis aims to evaluate the comparative outcomes of MMAE with statins versus MMAE alone in the treatment of cSDH. A comprehensive systematic search of the PubMed, Web of Science, and SCOPUS databases was conducted. Inclusion criteria were: studies published in English between the dates of inception of each database and August 2023, studies comparing the treatment of cSDH with either MMAE + statin or MMAE alone were included. Main outcome measures were complete resolution of the hematoma at follow-up and the recurrence rates. Two studies comprising 715 patients were included; 408 patients underwent MMAE + statin; and 307 underwent MMAE alone. MMAE + statin was not significantly superior to MMAE alone in achieving complete resolution of the hematoma at follow-up (RR: 0.99; CI: 0.91 to 1.07, P = 0.84), nor was it a significant difference in rates of recurrence (RR: 1.35; CI: 0.83 to 2.17, P = 0.21) between the two groups. MMAE + statin did not demonstrate significant superiority over MMAE alone for achieving complete resolution and decreasing the recurrence rates in cSDH patients. Further research with larger, randomized studies may be required to fully elucidate the potential synergistic effects of MMAE and statins in this patient population.

Safety and efficacy of the Pipeline Flex embolization device with Shield Technology for the acute treatment of ruptured internal carotid artery pseudoaneurysms: a multi-institution case series.

OBJECTIVE: Ruptured blister, dissecting, and iatrogenic pseudoaneurysms are rare pathologies that pose significant challenges from a treatment standpoint. Endovascular treatment via flow diversion represents an increasingly popular option; however, drawbacks include the requirement for dual antiplatelet therapy and the potential for thromboembolic complications, particularly acute complications in the ruptured setting. The Pipeline Flex embolization device with Shield Technology (PED-Shield) offers reduced material thrombogenicity, which may aid in the treatment of ruptured internal carotid artery pseudoaneurysms. METHODS: The authors conducted a multi-institution, retrospective case series to determine the safety and efficacy of PED-Shield for the treatment of ruptured blister, dissecting, and iatrogenic pseudoaneurysms of the internal carotid artery. Clinical, radiographic, treatment, and outcomes data were collected. RESULTS: Thirty-three patients were included in the final analysis. Seventeen underwent placement of a single device, and 16 underwent placement of two devices. No thromboembolic complications occurred. Four patients were maintained on aspirin alone, and all others were treated with long-term dual antiplatelet therapy. Among patients with 3-month follow-up, 93.8% had a modified Rankin Scale score of 0-2. Complete occlusion at follow-up was observed in 82.6% of patients. CONCLUSIONS: PED-Shield represents a new option for the treatment of ruptured blister, dissecting, and iatrogenic pseudoaneurysms of the internal carotid artery. The reduced material thrombogenicity appeared to improve the safety of the PED-Shield device, as this series demonstrated no thromboembolic complications even among patients treated with only single antiplatelet therapy. The efficacy of PED-Shield reported in this series, particularly with placement of two devices, demonstrates its potential as a first-line treatment option for these pathologies.

Repeat Flow Diversion for Cerebral Aneurysms Failing Prior Flow Diversion: Safety and Feasibility From Multicenter Experience.

BACKGROUND: Aneurysmal persistence after flow diversion (FD) occurs in 5% to 25% of aneurysms, which may necessitate retreatment. There are limited data on safety/efficacy of repeat FD-a frequently utilized strategy in such cases. METHODS: A series of consecutive patients undergoing FD retreatment from 15 centers were reviewed (2011-2019), with inclusion criteria of repeat FD for the same aneurysm at least 6 months after initial treatment, with minimum of 6 months post-retreatment imaging. The primary outcome was aneurysmal occlusion, and secondary outcome was safety. A multivariable logistic regression model was constructed to identify predictors of incomplete occlusion (90%-99% and <90% occlusion) versus complete occlusion (100%) after retreatment. RESULTS: Ninety-five patients (median age, 57 years; 81% women) harboring 95 aneurysms underwent 198 treatment procedures. Majority of aneurysms were unruptured (87.4%), saccular (74.7%), and located in the internal carotid artery (79%; median size, 9 mm). Median elapsed time between the first and second treatment was 12.2 months. Last available follow-up was at median 12.8 months after retreatment, and median 30.6 months after the initial treatment, showing complete occlusion in 46.2% and near-complete occlusion (90%-99%) in 20.4% of aneurysms. There was no difference in ischemic complications following initial treatment and retreatment (4.2% versus 4.2%; P>0.99). On multivariable regression, fusiform morphology had higher nonocclusion odds after retreatment (odds ratio [OR], 7.2 [95% CI, 1.97-20.8]). Family history of aneurysms was associated with lower odds of nonocclusion (OR, 0.18 [95% CI, 0.04-0.78]). Likewise, positive smoking history was associated with lower odds of nonocclusion (OR, 0.29 [95% CI, 0.1-0.86]). History of hypertension trended toward incomplete occlusion (OR, 3.10 [95% CI, 0.98-6.3]), similar to incorporated branch into aneurysms (OR, 2.78 [95% CI, 0.98-6.8]). CONCLUSIONS: Repeat FD for persistent aneurysms carries a reasonable success/safety profile. Satisfactory occlusion (100% and 90%-99% occlusion) was encountered in two-thirds of patients, with similar complications between the initial and subsequent retreatments. Fusiform morphology was the strongest predictor of retreatment failure.

Quantification of hematoma and perihematomal edema volumes in intracerebral hemorrhage study: Design considerations in an artificial intelligence validation (QUANTUM) study.

BACKGROUND: Hematoma and perihematomal edema volumes are important radiographic markers in spontaneous intracerebral hemorrhage. Accurate, reliable, and efficient quantification of these volumes will be paramount to their utility as measures of treatment effect in future clinical studies. Both manual and semi-automated quantification methods of hematoma and perihematomal edema volumetry are time-consuming and susceptible to inter-rater variability. Efforts are now underway to develop a fully automated algorithm that can replace them. A (QUANTUM) study to establish inter-quantification method measurement equivalency, which deviates from the traditional use of measures of agreement and a comparison hypothesis testing paradigm to indirectly infer quantification method measurement equivalence, is described in this article. The Quantification of Hematoma and Perihematomal Edema Volumes in Intracerebral Hemorrhage study aims to determine whether a fully automated quantification method and a semi-automated quantification method for quantification of hematoma and perihematomal edema volumes are equivalent to the hematoma and perihematomal edema volumes of the manual quantification method. METHODS/DESIGN: Hematoma and perihematomal edema volumes of supratentorial intracerebral hemorrhage on 252 computed tomography scans will be prospectively quantified in random order by six raters using the fully automated, semi-automated, and manual quantification methods. Primary outcome measures for hematoma and perihematomal edema volumes will be quantified via computed tomography scan on admission (<24 h from symptom onset) and on day 3 (72 ± 12 h from symptom onset), respectively. Equivalence hypothesis testing will be conducted to determine if the hematoma and perihematomal edema volume measurements of the fully automated and semi-automated quantification methods are within 7.5% of the hematoma and perihematomal edema volume measurements of the manual quantification reference method. DISCUSSION: By allowing direct equivalence hypothesis testing, the Quantification of Hematoma and Perihematomal Edema Volumes in Intracerebral Hemorrhage study offers advantages over radiology validation studies which utilize measures of agreement to indirectly infer measurement equivalence and studies which mistakenly try to infer measurement equivalence based on the failure of a comparison two-sided null hypothesis test to reach the significance level for rejection. The equivalence hypothesis testing paradigm applied to artificial intelligence application validation is relatively uncharted and warrants further investigation. The challenges encountered in the design of this study may influence future studies seeking to translate artificial intelligence medical technology into clinical practice.

Intra-procedural complications, success rate, and need for retreatment of endovascular treatments in anterior communicating artery aneurysms: a systematic review and meta-analysis.

In recent years, intracranial aneurysms have been widely treated with endovascular methods. The anterior communicating artery (Acom) is the most common site of intracranial aneurysms. Despite its effectiveness, endovascular interventions can be associated with various intra-procedural and post-procedural complications. A systematic review of the literature was performed through PubMed, Embase, Scopus, and Web of Sciences databases up to March 18, 2022. The pooled rates of intra-procedural complications, mortality, procedure-related morbidities, the immediate and late aneurysm occlusion, and also the necessity for retreatment were calculated by applying random-effects models. A total of 41 articles with 4583 patients were included in the meta-analysis. The pooled rate of overall intra-procedural complications was 9.6% (95% CI: 7.7 to 11.8%). The initial rupture status and also type of EVT procedure did not affect the overall complication rate. The pooled rate of intra-procedural thrombosis, aneurysm rupture, coil prolapse, and early aneurysm rebleeding were 6.1% (95% CI: 4.5 to 8.2%); 4.2% (95% CI: 3.4 to 5.2%), 4.7% (95% CI: 3.2 to 6.7%), and 2.2% (95% CI: 1.5 to 3.2%), respectively. Our analysis showed that intra-procedural mortality occurred in 1.7% (95% CI: 1.1 to 2.5%) and procedure-related permanent morbidities in 3.3% (95% CI: 2.3 to 4.7%) of patients. Endovascular methods achieved complete and near to complete aneurysm occlusion (Raymond-Roy occlusion classification 1 and 2) in 89.2% (95% CI: 86.4 to 92.5%) of cases post-procedure, and 9.5% (95% CI: 7.3 to 12.4%) of patients needed retreatment due to recanalization in follow-ups. Endovascular treatment can serve as an acceptable method for Acom aneurysms. However, improved endovascular treatment equipment and new techniques provide more satisfactory outcomes for complicated cases.

Predictors of aneurysm occlusion following treatment with the WEB device: systematic review and case series.

The Woven EndoBridge (WEB) device is becoming increasingly popular for treatment of wide-neck aneurysms. As experience with this device grows, it is important to identify factors associated with occlusion following WEB treatment to guide decision making and screen patients at high risk for recurrence. The aim of this study was to identify factors associated with adequate aneurysm occlusion following WEB device treatment in the neurosurgical literature and in our case series. A systematic review of the present literature was conducted to identify studies related to the prediction of WEB device occlusion. In addition, a retrospective review of our institutional data for patients treated with the WEB device was performed. Demographics, aneurysm characteristics, procedural variables, and 6-month follow-up angiographic outcomes were recorded. Seven articles totaling 450 patients with 456 aneurysms fit our criteria. Factors in the literature associated with inadequate occlusion included larger size, increased neck width, partial intrasaccular thrombosis, irregular shape, and tobacco use. Our retrospective review identified 43 patients with 45 aneurysms. A total of 91.1% of our patients achieved adequate occlusion at a mean follow-up time of 7.32 months. Increasing degree of contrast stasis after WEB placement on the post-deployment angiogram was significantly associated with adequate occlusion on follow-up angiogram (p = 0.005) and with Raymond-Roy classification (p = 0.048), but not with retreatment (p = 0.617). In our systematic review and case series totaling 450 patients with 456 aneurysms, contrast stasis on post-deployment angiogram was identified as a predictor of adequate aneurysm occlusion, while morphological characteristics such as larger size and wide neck negatively impact occlusion.

Robot-assisted carotid artery stenting: outcomes, safety, and operational learning curve.

OBJECTIVE: Over the past 2 decades, robots have been increasingly used in surgeries to help overcome human limitations and perform precise and accurate tasks. Endovascular robots were pioneered in interventional cardiology, however, the CorPath GRX was recently approved by the FDA for peripheral vascular and extracranial interventions. The authors aimed to evaluate the operational learning curve for robot-assisted carotid artery stenting over a period of 19 months at a single institution. METHODS: A retrospective analysis of a prospectively maintained database was conducted, and 14 consecutive patients who underwent robot-assisted carotid artery stenting from December 2019 to June 2021 were identified. The metrics for proficiency were the total fluoroscopy and procedure times, contrast volume used, and radiation dose. To evaluate operator progress, the patients were divided into 3 groups of 5, 4, and 5 patients based on the study period. RESULTS: A total of 14 patients were included. All patients received balloon angioplasty and stent placement. The median degree of stenosis was 95%. Ten patients (71%) were treated via the transradial approach and 4 patients (29%) via the transfemoral approach, with no procedural complications. The median contrast volume used was 80 mL, and the median radiation dose was 38,978.5 mGy/cm2. The overall median fluoroscopy and procedure times were 24.6 minutes and 70.5 minutes, respectively. Subgroup analysis showed a significant decrease in these times, from 32 minutes and 86 minutes, respectively, in group 1 to 21.9 minutes and 62 minutes, respectively, in group 3 (p = 0.002 and p = 0.008, respectively). CONCLUSIONS: Robot-assisted carotid artery stenting was found to be safe and effective, and the learning curve for robotic procedures was overcome within a short period of time at a high-volume cerebrovascular center.

Mechanical Thrombectomy in Patients Presenting with NIHSS Score <6: A Safety and Efficacy Analysis.

BACKGROUND AND OBJECTIVES: Groundbreaking trials have shown the tremendous efficacy of mechanical thrombectomy for large vessel occlusions. Currently, mechanical thrombectomy is limited to patients with NIHSS scores ≥6. We investigated the feasibility and safety of MT in patients presenting with NIHSS scores <6. MATERIALS AND METHODS: A retrospective review of patient who presented with acute ischemic stroke due to large vessel occlusion with an NIHSS score <6 between 2015 - 2021. The patients were then divided into two groups: those who received mechanical thrombectomy and those who did not. RESULTS: Among 83 patients, 41 received a mechanical thrombectomy while 42 received medical treatment only. The mean age in the mechanical thrombectomy group was 66 years versus 60 years in the medical group (p = 0.06). Risk factors for stroke did not differ significantly between both groups. 14 patients (34.1%) in the mechanical thrombectomy group and 20 (47.6%) in the medical group received tissue plasminogen activator. No significant difference in clinical improvement (NIHSS) at discharge (p=0.85) or the mRS score at 90 days (p = 0.15) was noted. Mechanical thrombectomy was associated with smaller infarct size (p=0.04) and decreased mortality (p=0.03). CONCLUSIONS: Mechanical thrombectomy is safe and effective for patients who present with large vessel occlusions and low initial NIHSS scores. Therefore, the decision to offer the patient mechanical thrombectomy or not should not be decided by NIHSS score alone. Rather, the decision should be multifactorial with the aim of maximizing the patients' outcomes.