Abstract Background and aims Stroke patients with tandem carotid lesions constitute about 15-20% of patients undergoing endovascular thrombectomy (EVT). However, the optimal treatment of acute stroke in these patients remains uncertain with regards to addressing the ICA lesion during EVT or not. Methods To determine if acute cervical ICA stenting in addition to intracranial thrombectomy is superior to intracranial thrombectomy alone without acute cervical ICA stenting with regards to functional outcome at 90 days. Results EASI-TOC is an ongoing Canadian, pragmatic Phase III, multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) controlled trial. It will enroll 458 adult tandem patients undergoing EVT and randomize them (1:1) to either undergo acute ICA stenting during EVT (either before or after intracranial thrombectomy, as per clinician judgement) or undergo intracranial thrombectomy alone without ICA stenting. Conclusions The primary outcome is the proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days and primary analysis will be by intention-to-treat. Our primary hypothesis assumes a greater proportion of patients with 90-day mRS 0-2 in the stenting group versus the no stenting group (55% versus 40%). Safety outcomes will include symptomatic intracerebral hemorrhage, procedural complications and death. Conflict of interest
Background: The Treatment Of Brain Arteriovenous malformations Study is a pragmatic study comprising 2 randomized trials and prospective registries of patients with brain arteriovenous malformations (AVMs). We report the results of the stereotactic radiosurgery (SRS) registry. Methods: TOBAS uses an algorithm integrating clinical judgment and randomization. When SRS was selected as the preferred curative modality and randomized allocation of SRS versus observation was judged unreasonable, patients were included in the SRS registry (with/without pre-SRS embolization). The primary outcome was modified Rankin Scale > 2 at last follow-up. Secondary outcomes included serious adverse events, AVM rupture, radiation-induced changes, and magnetic resonance angiographic results at 3 years. Analyses were intent-to-treat. Results: From June 2014 to May 2021, 1010 patients were recruited; 105 (10.4%) were offered participation in the SRS registry. After exclusions, 94 patients were analyzed; most had ruptured (n = 64/94 [68%]), small AVMs (0-3 cm) (84 [89%]), within eloquent brain (57 [61%]). Pre-SRS embolization was performed in 19 (20%); 4 were cured and 3 had endovascular complications, leaving 87/94 (93%) patients who received SRS. The median SRS dose was 22 Gy (interquartile range: 20-24). During a mean follow-up of 51 months, the primary outcome (modified Rankin Scale > 2) occurred in 7/94 (7%; 95% confidence interval [CI]: 4%-15%), with serious adverse events in 16/94 (17%; 95% CI: 11%-26%), including AVM rupture in 5/94 (5%; 95% CI: 2%-12%), and symptomatic radiation-induced changes in 6/87 (7%; 95% CI: 3%-14%). Three-year imaging follow-up, available in 79/94 (84%) confirmed AVM occlusion in 51/79 (65%; 95% CI: 54%-74%) or 54% (95% CI: 44%-64%) of all patients. Conclusions: In this prospective registry, radiosurgery with or without embolization was relatively safe, but of moderate efficacy, with 3-year AVM occlusion in 54%-65% patients.
BACKGROUND:Patients with stroke due to symptomatic intracranial occlusion and concurrent symptomatic high-grade cervical internal carotid artery (ICA) stenosis (≥70%) or occlusion constitute 15%-20% of patients undergoing EVT. The optimal management of the cervical ICA in these tandem lesions remains unknown. We hypothesise that acute carotid artery stenting in addition to EVT will improve functional outcomes when compared with EVT alone. STUDY DESIGN:Endovascular Acute Stroke Intervention-Tandem Occlusion (EASI-TOC) is a multicentre, prospective, randomised, open-label, blinded end-point (PROBE) controlled trial. Adult patients with a disabling acute anterior circulation stroke (intracranial carotid, M1 or M2 segment occlusion) and salvageable brain tissue who undergo EVT within 24 h of onset, are eligible for enrolment if they have an angiographically confirmed atherosclerotic carotid tandem lesion. Patients are randomised 1:1 to acute carotid stenting or no stenting during EVT. STUDY ENDPOINTS:The primary outcome is the proportion of patients achieving a favourable functional outcome (mRS 0-2) at 90 days. Secondary outcomes include 12-month mRS, recanalisation, the 90-day rate of recurrent ipsilateral stroke or retinal ischaemia, the proportion of patients with ICA thrombosis, 90-day Montreal Cognitive Assessment score and quality of life. Safety outcomes include any ICH, sICH, all-cause mortality and procedural complications. SUMMARY:Endovascular Acute Stroke Intervention-Tandem Occlusion is a pragmatic trial addressing a critical gap in the acute management of patients with tandem carotid lesions by evaluating whether acute carotid stenting provides a functional benefit over no stenting in patients undergoing EVT. TRIAL REGISTRATION:ClinicalTrials.gov NCT04261478.
BACKGROUND:The Alberta Stroke Program Early CT Score (ASPECTS) and CT angiography (CTA) Collateral Score (CS) are routinely used to estimate ischemic core burden and collateral status in acute ischemic stroke due to large vessel occlusion, but suffer from limited reliability. Whether automated CT perfusion (CTP) maps improve scoring consistency remains unclear. OBJECTIVES:To assess the reliability of these scores on non-contrast computed tomography (NCCT) and CTA among numerous raters, with and without access to automated perfusion maps, and their correlations with endovascular thrombectomy (EVT) decisions. METHODS:Twenty-nine clinicians independently rated 60 imaging cases from 30 late-window stroke patients with large vessel occlusion, each presented twice: once using NCCT and CTA alone ('non-CTP cases'), and once with the addition of perfusion maps ('CTP cases'). Twenty-eight raters (97%) completed the survey twice. Inter- and intra-reliability was assessed using Gwet's AC1/2 coefficients (κG). Correlations with EVT decisions were evaluated using Cramer V. RESULTS:Inter-rater reliability for ASPECTS was substantial and similar between non-CTP (κG = 0.65, 95% CI: 0.53 to 0.78) and CTP cases (κG = 0.64, 95% CI: 0.51 to 0.77). CS showed an almost perfect reliability in both scenarios (κG= 0.82 and 0.83). Intra-rater agreement was at least substantial. Dichotomizing ASPECTS as 0-2/3-10 improved reliability to almost perfect. ASPECTS strongly correlated with EVT decisions (V=0.80), whereas CS showed moderate correlation (V=0.56), both remaining similar with the addition of CTP (V=0.75 and 0.54, respectively). CONCLUSION:Automated perfusion imaging did not improve the reliability of ASPECTS or CS. Strong reliability was achieved with NCCT and CTA alone.
OBJECTIVE Many patients recruited in the Treatment of Brain Arteriovenous Malformations Study (TOBAS) are managed conservatively. The aim of this study was to monitor what happened to those patients. METHODS TOBAS comprises two randomized controlled trials and multiple prospective registries. All patients with brain arteriovenous malformations (AVMs) can participate. This report concerns patients selected for conservative management. The primary trial outcome measure is related death or dependency (modified Rankin Scale [mRS] score > 2) at 10 years. Secondary outcomes include intracranial hemorrhages, nonhemorrhagic neurological events, and serious adverse events (SAEs). For this report, outcome results are presented using patient-years, Kaplan-Meier survival curves, and Cox log-rank tests. There was no blinding. RESULTS From June 2014 to May 2021, 1010 patients were recruited, of whom 498 (49%) were proposed the prospective observation registry. After exclusions, 434 (87%) patients remained for analysis. The majority of patients had unruptured AVMs (378/434 [87%]), of which 195 (52%) were low grade (Spetzler-Martin grade I or II). During a mean follow-up period of 3.2 years (total 1368 patient-years), the primary outcome occurred in 23 of 434 (5%) patients, corresponding to an incidence of 1.7 (95% CI 1.1-2.5) per 100 patient-years. For unruptured AVMs the incidence was 1.1 (95% CI 0.7-1.9) per 100 patient-years, and for low-grade unruptured AVMs it was 0.6 (95% CI 0.2-1.7) per 100 patient-years. Poor outcomes were more frequent in patients with a history of rupture (HR 5.6 [95% CI 2.4-13.0], p < 0.001), infratentorial AVMs (HR 2.9 [95% CI 1.1-7.3], p = 0.027), and age >= 55 years (HR 3.2 [95% CI 1.4-7.6], p = 0.007). Major intracranial hemorrhage occurred in 35 of 434 (8%) patients (incidence of 2.6 [95% CI 1.9-3.6] per 100 patient-years; 2.0 [95% CI 1.3-2.9] per 100 patient-years for unruptured AVMs and 1.3 [95% CI 0.6-2.6] per 100 patient-years for low-grade unruptured AVMs). Major AVM hemorrhages were more frequent in ruptured (HR 4.4 [95% CI 2.1-8.9], p < 0.001), large (HR 2.6 [95% CI 1.1-6.6], p = 0.039), and high-grade (HR 2.5 [95% CI 1.2-5.3], p = 0.013) AVMs and those with deep venous drainage (HR 2.1 [95% CI 1.1-4.2], p = 0.032). SAEs occurred in 48 of 434 (11%) patients (incidence of 3.6 [95% CI 2.7-4.8] per 100 patient-years). For unruptured AVMs the incidence was 2.8 (95% CI 2.0-4.0) per 100 patient-years, and for low-grade unruptured AVMs it was 1.8 (95% CI 1.0-3.2) per 100 patient-years. CONCLUSIONS Nearly half of TOBAS participants were observed. Rates of untoward neurological events were within expected boundaries.
Background and Purpose In the ESCAPE-NA1 (Efficacy and Safety of Nerinetide for the Treatment of Acute Ischaemic Stroke) trial, treatment with nerinetide was associated with improved outcomes in patients who did not receive intravenous alteplase. We compared the effect of nerinetide on clinical outcomes in patients without concurrent intravenous alteplase treatment within different patient subgroups. Methods ESCAPE-NA1 was a multicenter randomized trial in which acute stroke patients with baseline Alberta Stroke Program Early CT Score (ASPECTS) >4 undergoing endovascular treatment (EVT) were randomized to intravenous nerinetide or placebo. The primary outcome was independence (modified Rankin Scale [mRS] score 0-2) at 90 days. We assessed baseline, clinical, and imaging variables as predictors of outcome and for evidence of treatment effect modification. We constructed two multivariable models using variables known prior to randomization and variables known immediately post-EVT procedure to provide adjusted estimates of effect. We assessed for evidence of treatment effect modification using multiplicative interaction terms within each model. Results Four hundred forty-six patients were included in the analysis. Clinical outcomes were better in patients randomized to the nerinetide arm (mRS 0-2: 59.4% vs. 49.8%). There was possible treatment effect modification by ASPECTS score; patients with ASPECTS 8-10 showed a larger treatment effect compared to those with lower ASPECTS score. Younger age, lower NIHSS score, lower baseline serum glucose, absence of atrial fibrillation at baseline, higher ASPECTS score, middle cerebral artery (vs. internal carotid artery) occlusion, use of conscious or no sedation (vs. general anesthesia), and faster treatment were all predictors of favorable outcome. Conclusion Patients in the nerinetide arm who were not treated with concurrent alteplase showed improved clinical outcomes and the treatment effect was larger among patients with favorable ASPECTS profiles.
Magnetic resonance angiography (MRA) is a commonly used non-invasive imaging modality for the follow-up of treated intracranial aneurysms. The 3-category Montreal classification system is widely used to evaluate treatment outcomes, including aneurysms treated with Woven EndoBridge (WEB) devices or coils. This study aimed to assess the reliability and clinical implications of the Montreal scale for aneurysms imaged with MRA. An electronic portfolio of 60 aneurysms (30 treated with WEB devices and 30 with coils) was evaluated by 30 raters from diverse clinical backgrounds. Raters graded aneurysm occlusion using the Montreal classification system and provided management recommendations (delayed follow-up, close follow-up, or re-treatment). Twenty-three raters completed a second evaluation of permuted cases after one month. Reliability was assessed using Gwet’s AC2 (κG) coefficients, and the correlation between occlusion grade and management recommendation was analyzed with Cramer’s V. Inter-rater agreement for occlusion grades was substantial (κG = 0.70; 95
OBJECTIVE:Many patients with ruptured intracranial aneurysms (RIAs) underrepresented or excluded from previous randomized controlled trials (RCTs) comparing surgery with endovascular treatment (EVT) are still considered for surgical clipping, but the best management of these patients remains unknown. METHODS:The International Subarachnoid Aneurysm Trial-2 was a randomized trial comparing surgical versus EVT of RIAs considered for surgical clipping, despite the results of previous RCTs, and also eligible for EVT. The primary endpoint was death or dependency according to the modified Rankin Scale score (mRS score > 2) at 1 year. Secondary endpoints included 1-year angiographic results and length of hospital stay. The primary hypothesis was that endovascular management would decrease the number of poor outcomes (mRS score > 2) from 30% to 23%, necessitating 1896 patients. The trial was interrupted after 10 years because of slow recruitment. Primary analysis was by intent-to-treat. There was no blinding. RESULTS:From November 2012 to December 2022, 270 patients were recruited at 6 North American and European centers. After exclusions, 263 patients were randomly allocated to receive surgery (n = 133) or EVT (n = 130). There were 12 crossovers (9 from surgery to EVT). The primary outcome was reached in 40 of 133 surgical patients (30%, 95% CI 23%-38%) compared with 35 of 130 EVT patients (27%, 95% CI 20%-35%) (p = 0.572). Residual aneurysms at 1 year were less frequent with surgery (10/118 [8%, 95% CI 5%-15%]) than EVT (22/109 [20%, 95% CI 14%-29%]) (p = 0.015). Additional procedures (ventricular drainage and decompressive craniotomy, p < 0.05) and hospitalization > 20 days were more frequent in the surgery group (69/133 [52%, 95% CI 43%-60%]) than in the EVT group (38/130 [29%, 95% CI 22%-38%]) (p < 0.001). CONCLUSIONS:This prematurely interrupted trial showed more frequent additional procedures and longer hospitalizations but better 1-year angiographic results with surgery. The primary clinical outcome, death or dependency at 1 year, was similar for EVT and surgery.
BACKGROUND:Transvenous embolization (TVE) is a new treatment of brain arteriovenous malformations (AVMs). The safety and efficacy of TVE have not been compared with transarterial embolization (TAE). The primary hypothesis of this trial was that TVE would increase the proportion of AVM occlusion from 40% to 80%. METHODS:The TATAM (Transvenous Approach for the Treatment of Cerebral AVMs) was an investigator-initiated, multicenter, prospective, phase 2, open-label, controlled randomized trial comparing TVE versus TAE alone (1:1). Patients with symptomatic or asymptomatic AVMs considered curable with 2 endovascular sessions were reviewed by a case selection committee. Participating centers were experienced (>20 cases) or proctored by experts. The primary outcome was complete occlusion of the AVM, confirmed by catheter angiography at 3 to 6 months. There was no blinding. Primary analyses were intent-to-treat. RESULTS:From May 2019 to April 2023, 77 patients were recruited in 7 French and 2 Canadian centers. After exclusions, results from 69 patients were analyzed; 35 were allocated TVE and 34 TAE. The mean age of participants was 43.3 years; 29 of 69 (42%) were female. There were 2 crossovers. The primary outcome was reached in 29 of 35 patients with TVE (83% [95% CI, 67%-92%]) compared with 20 of 34 patients allocated TAE (59% [95% CI, 42%-74%]; P=0.036). Poor outcomes (modified Rankin Scale score >2 at 3-6 months) occurred in 7 of 35 patients with TVE (20% [95% CI, 10%-36%]) and 9 of 34 patients with TAE (27% [95% CI, 15%-43%]; P=0.578) and related serious adverse events in 12 of 35 patients with TVE (34% [95% CI, 21%-51%]) and 14 of 34 patients with TAE (41% [95% CI, 26%-58%]; P=0.624). CONCLUSIONS:TVE was more effective than TAE in terms of angiographic results at 3 to 6 months. Morbidity was similar but high for both groups. More studies are needed to determine the role of curative embolization in managing patients with brain AVM. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03691870.
BACKGROUND AND OBJECTIVES:There is uncertainty about whether patients with an anterior circulation large vessel occlusion (LVO) and a low NIH Stroke Scale (NIHSS) score (≤5) benefit from endovascular therapy (EVT) in the late time window (6-24 hours). We compared the clinical outcomes of these patients receiving EVT with those receiving medical management (MM). METHODS:The CT for Late Endovascular Reperfusion multinational cohort study was conducted at 66 sites across 10 countries from January 2014 to May 2022. This subanalysis included consecutive patients with late-window stroke due to an anterior circulation LVO, defined as occlusion of the internal carotid artery or proximal middle cerebral artery (M1/M2 segments), and a baseline NIHSS score ≤5 who received EVT or MM alone. The primary end point was a 90-day ordinal shift in the modified Rankin Scale (mRS) score. Secondary outcomes were 90-day excellent outcome (defined as mRS scores 0-1 or return to baseline mRS score in patients with a prestroke mRS score >1) and favorable outcome (defined as mRS scores 0-2 or return to baseline mRS score in patients with prestroke mRS score >2). Safety outcomes were symptomatic intracranial hemorrhage and 90-day mortality. We used ordinal and binary logistic regression models to test for outcome differences. RESULTS:Among 5,098 patients, 318 patients were included (median [interquartile range] age 67 [56-76] years; 149 [46.9%] were female; baseline NIHSS score was 4 [2-5]). A total of 202 patients (63.5%) received EVT and 116 MM (36.5%). There was no difference in favorable 90-day ordinal mRS score shift (adjusted common odds ratio [OR] 0.77, 95% CI 0.45-1.32), excellent outcome (adjusted OR 0.86, 95% CI 0.49-1.50), or favorable outcome (adjusted OR 0.72, 95% CI 0.35-1.50) in the EVT group compared with MM. Symptomatic intracranial hemorrhage risk (adjusted OR 3.40, 95% CI 0.84-13.73) and mortality at 90 days (adjusted OR 2.44, 95% CI 0.60-10.02) were not statistically different between treatment groups. DISCUSSION:In patients with an anterior LVO and low NIHSS score in the 6-24-hour time window, there was no statistical difference in disability outcomes or intracranial bleeding risk between patients treated with EVT compared with MM. The retrospective and observational design limits our findings. Ongoing randomized controlled trials will provide further insight. CLASSIFICATION OF EVIDENCE:This study provides Class III evidence that in adult patients with anterior circulation LVO and low NIHSS score (≤5) presenting in the late time window (6-24 hours), EVT does not improve clinical outcome vs MM. TRIAL REGISTRATION:This study was registered at clinicaltrials.gov under NCT04096248.
BACKGROUND AND PURPOSE:Flow diversion (FD) has expanded beyond initial indications (proximal carotid artery aneurysms) to include distal circulation aneurysms (on the anterior, middle, or posterior cerebral arteries). Our objective was to examine results obtained from aneurysms in these locations in the Flow Diversion in Intracranial Aneurysm Treatment Trial (FIAT), which compared FD with alternative standard management options (ASMO). MATERIALS AND METHODS:FIAT was an all-inclusive parallel-group 1:1 randomized study comparing FD with 1 of 4 ASMOs (coiling +/- stenting, parent vessel occlusion [PVO], clipping, or observation, prespecified by clinical judgment). The primary safety outcome was death or dependency (mRS >2) at 3 months. The composite primary outcome was "treatment failure," defined as initial failure to treat the aneurysm; aneurysm rupture or retreatment during follow-up; death or dependency (mRS >2); or angiographic residual aneurysm adjudicated by an independent core laboratory at 12 months. This subgroup analysis was not prespecified, and there was no blinding. RESULTS:Of the 323 patients in FIAT, 46 (14%) with distal circulation aneurysms were randomly allocated: 23 to FD and 23 to ASMO (coiling +/- stenting 16 patients; PVO, 1 patient; clipping, 3 patients; and observation, 3 patients). Death or dependency at 3 months occurred in 1 patient (allocated ASMO). Treatment failures occurred in 6/23 FD-treated patients (26.1%; 95% CI, 12.6%-46.5%) compared with 11/22 patients treated with ASMO (50.0%; 95% CI, 30.7%-69.3%) (risk ratio = 0.52 [0.23-1.17]; P = .13). Serious adverse events were similar. CONCLUSIONS:Distal circulation aneurysms treated with FDs in FIAT showed an encouraging trend, but this analysis was underpowered. Further randomized trials are needed.
BACKGROUND:It remains unclear whether outcomes of patients treated with endovascular thrombectomy with large-vessel occlusion and unwitnessed onset of stroke differ from those with witnessed onset in the extended time window. METHODS:We enrolled patients with anterior circulation large-vessel occlusion (internal carotid artery, M1, or M2 segment of the middle cerebral artery) undergoing endovascular thrombectomy within 6 to 24 hours from the time last seen well, from 2014 to 2022, at 66 sites in Europe, North America, and Asia. Patients with a prestroke modified Rankin Scale score of >3 or age <18 were excluded. We categorized patients by onset mode as witnessed or unwitnessed. The primary outcome was the modified Rankin Scale shift at 90 days. Secondary outcomes were functional independence, a composite of functional independence or return of Rankin to prestroke level, symptomatic intracranial hemorrhage, mortality, and a composite of severe disability or mortality at 90 days. We applied inverse probability of treatment weighting to compare outcomes between the groups. RESULTS:Of 5098 patients assessed for eligibility, we included 2073, of whom 1760 (84.9%) had unwitnessed onset, and 313 (15.1%) were witnessed. In the univariate comparison (before inverse probability of treatment weighting), 38.8% of the unwitnessed and 45.7% of the witnessed patients achieved functional independence (P=0.022). Mortality was 21.6% among unwitnessed and 22.0% among witnessed (P=0.847), and symptomatic intracranial hemorrhage rates were 6.6% and 5.8%, respectively (P=0.623). The primary outcome (modified Rankin Scale shift) showed no difference comparing unwitnessed to witnessed patients (odds ratio, 1.35 [95% CI, 0.82-2.20]; P=0.235) in the inverse probability of treatment weighting. Unwitnessed patients were more likely to achieve functional independence or return of Rankin (1.53 [1.01-2.33]; P=0.045). Other secondary outcomes did not differ between the witnessed and unwitnessed patients. CONCLUSIONS:In the extended time window, unwitnessed patients with large-vessel occlusion undergoing endovascular thrombectomy have at least the same likelihood of favorable outcomes as witnessed patients. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT04096248.
Angiographic results are commonly used to evaluate and compare the treatment of aneurysms. We sought to determine and compare the reliability and clinical implications of a commonly used 3-point angiographic outcome scale for aneurysms treated with WEB or endovascular coils. An electronic portfolio of 60 aneurysms (30 treated with WEB devices and 30 with coils) was evaluated by 32 raters of various training backgrounds, who were asked to grade angiographic results and provide management recommendations (delayed follow-up, close follow-up, or re-treatment). Twenty-five raters performed a second evaluation of permuted cases at least a month later. Agreement was analyzed with Gwet’s AC2 (κG) reliability coefficients and the relationship between angiographic grade and management recommendation using Cramer’s V. Inter-rater agreement was substantial for occlusion grade (κG = 0.78; 95
BACKGROUND:There is uncertainty about whether patients with M2 occlusion benefit from endovascular therapy (EVT) in the late (6-24-hour) time window. We evaluated the clinical outcomes of patients with M2 occlusion selected for EVT compared with those who received medical management (MM) in the late window. METHODS:This multinational cohort study was conducted at 66 sites across 10 countries (January 2014 to May 2022). We included consecutive patients with late-window stroke due to M2 occlusion, baseline National Institutes of Health Stroke Scale score of ≥5, and premorbid modified Rankin Scale score of ≤2 who received EVT or MM alone. The primary end point was 90-day ordinal shift in the modified Rankin Scale score. Safety end points were symptomatic intracranial hemorrhage and 90-day mortality. Differences in outcomes were determined using inverse probability of treatment weighting-adjusted logistic regression models. RESULTS:Among 5098 patients, 496 met inclusion criteria (median [interquartile range] age, 74 years [62-81 years]; baseline National Institutes of Health Stroke Scale score, 12 [8-17]), of whom 394 (79.4%) received EVT and 102 (20.6%) MM. In inverse probability of treatment weighting adjusted analyses, there was no favorable 90-day ordinal modified Rankin Scale shift (odds ratio, 1.39 [95% CI, 0.92-2.12]) and no difference of functional independence rates (modified Rankin Scale score of 0-2; odds ratio, 1.72 [95% CI, 0.93-3.15]) with EVT compared with MM. Moreover, symptomatic intracranial hemorrhage risk (odds ratio, 3.46 [95% CI, 0.50-23.92]) and 90-day mortality (odds ratio, 1.11 [95% CI, 0.66-1.87]) were not statistically different between treatment groups. CONCLUSIONS:In patients with M2 occlusion in the 6- to 24-hour time window, there was no difference in disability outcomes or symptomatic intracranial hemorrhage risk between patients treated with EVT compared with MM. Results of ongoing randomized trials will provide further insight. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT04096248.
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 (kappa G).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 (kappa G) among the 29 raters was similar between non-perfusion and perfusion CT neuroimaging (kappa G=0.487; 95% CI 0.327 to 0.647 and kappa G=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. kappa G 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.
Introduction: The benefit of endovascular therapy (EVT) among stroke patients with large ischemic core (ASPECTS 0–5) in the extended time window outside of trial settings remains unclear. We analyzed the effect of EVT among these stroke patients in real-world settings. Patients and methods: The CT for Late Endovascular Reperfusion (CLEAR) study recruited patients from 66 centers in 10 countries between 01/2014 and 05/2022. The extended time-window was defined as 6–24 h from last-seen-well to treatment. The primary outcome was shift of the 3-month modified Rankin scale (mRS) score. Safety outcomes included symptomatic intracranial hemorrhage (sICH) and mortality. Outcomes were analyzed with ordinal and logistic regressions. Results: Among 5098 screened patients, 2451 were included in the analysis (median age 73, 55% women). Of patients with ASPECTS 0–5 ( n = 310), receiving EVT ( n = 209/310) was associated with lower 3-month mRS when compared to medical management (median 4 IQR 3–6 vs 6 IQR 4–6; aOR 0.4, 95% CI 0.2–0.7). Patients undergoing EVT had higher sICH (11.2% vs 4.0%; aOR 4.1, 95% CI 1.2–18.8) and lower mortality (31.6% vs 58.4%, aOR 0.4; 95% CI 0.2–0.9) compared to medically managed patients. The relative benefit of EVT was comparable between patients with ASPECTS 0 and 5 and 6–10 in the extended time window (interaction aOR 0.9; 95% CI 0.5–1.7). Conclusion: In the extended time window, patients with ASPECTS 0–5 may have preserved relative treatment benefit of EVT compared to patients with ASPECTS 6–10. These findings are in line with recent trials showing benefit of EVT among real-world patients with large ischemic core in the extended time window. Trial registration number: clinicaltrials.gov; Unique identifier: NCT04096248
Background and purpose: To evaluate the reliability and accuracy of nonaneurysmal perimesencephalic subarachnoid hemorrhage (NAPSAH) on Noncontrast Head CT (NCCT) between numerous raters. Materials and methods: 45 NCCT of adult patients with SAH who also had a catheter angiography (CA) were independently evaluated by 48 diverse raters; 45 raters performed a second assessment one month later. For each case, raters were asked: 1) whether they judged the bleeding pattern to be perimesencephalic; 2) whether there was blood anterior to brainstem; 3) complete filling of the anterior interhemispheric fissure (AIF); 4) extension to the lateral part of the sylvian fissure (LSF); 5) frank intraventricular hemorrhage; 6) whether in the hypothetical presence of a negative CT angiogram they would still recommend CA. An automatic NAPSAH diagnosis was also generated by combining responses to questions 2 -5. Reliability was estimated using Gwet 's AC1 ( K G ), and the relationship between the NCCT diagnosis of NAPSAH and the recommendation to perform CA using Cramer 's V test. Multi -rater accuracy of NCCT in predicting negative CA was explored. Results: Inter -rater reliability for the presence of NAPSAH was moderate ( K G = 0.58; 95%CI: 0.47, 0.69), but improved to substantial when automatically generated ( K G = 0.70; 95%CI: 0.59, 0.81). The most reliable criteria were the absence of AIF filling ( K G = 0.79) and extension to LSF ( K G = 0.79). Mean intra-rater reliability was substantial ( K G = 0.65). NAPSAH weakly correlated with CA decision ( V = 0.50). Mean sensitivity and specificity were 58% (95%CI: 44%, 71%) and 83 % (95%CI: 72 %, 94%), respectively. Conclusion: NAPSAH remains a diagnosis of exclusion. The NCCT diagnosis was moderately reliable and its impact on clinical decisions modest. (c) 2024 The Authors. Published by Elsevier Masson SAS. This is an open access article under the CC BY -NC -ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
The flow diverter is a self-expandable braided stent that has helped improve the effectiveness of cerebral aneurysm treatment during the last decade. The flow diverter's efficiency heavily relies on proper decision-making during the pre-operative phase, which is currently based on static measurements that fail to account for vessel or tissue deformation. In the context of providing realistic measurements, a biomechanical computational method is designed to aid physicians in predicting patient-specific treatment outcomes. The method integrates virtual and analytical treatment models, validated against experimental mechanical tests, and two patient treatment outcomes. In the case of both patients, deployed stent length was one of the validated result parameters, which displayed an error inferior to 1.5% for the virtual and analytical models. These results indicated both models' accuracy. However, the analytical model provided more accurate results with a 0.3% error while requiring a lower computational cost for length prediction. This computational method can offer designing and testing platforms for predicting possible intervention-related complications, patient-specific medical device designs, and pre-operative planning to automate interventional procedures.
Flow diverters revolutionized the treatment of intracranial aneurysms. However, the flow diverter procedure requires intense training to optimize sizing and delivery and prevent potential complications. A better understanding of the medical devices' biomechanical interaction with patient anatomy is necessary to optimize device selection and prevent possible complications. We propose a virtual treatment model to evaluate the contact pressure between the flow diverter and vascular wall at the preoperative planning phase. The current model can simulate flow diverter devices deployment on patient-specific vascular anatomy and analyzed forces. For the present case, the radial force rate at the distal portion of the deployed stent was 0.74 N/mm, compared with 0.50 N/mm at the proximal part. The result indicates a correlation of radial force with lumen diameter and shape. Additionally, the current study offers an analytical treatment model to evaluate the metal coverage ratio. Utilizing these models can also apply to other self-expanding braided stents.
BACKGROUND:The association between sex and outcome after endovascular thrombectomy of acute ischemic stroke is unclear. The aim of this study was to compare the clinical and safety outcomes between men and women treated with endovascular thrombectomy in the late 6-to-24-hour window period.METHODS:This multicenter, retrospective observational cohort study included consecutive patients who underwent endovascular thrombectomy of anterior circulation stroke in the late window from 66 clinical sites in 10 countries from January 2014 to May 2022. The primary outcome was the 90-day ordinal modified Rankin Scale score. Secondary outcomes included 90-day functional independence (FI), return of Rankin (RoR) to prestroke baseline, FI or RoR, symptomatic intracranial hemorrhage, and mortality. Multivariable and inverse probability of treatment weighting methods were used. We explored the interaction of sex with baseline characteristics on the outcomes ordinal modified Rankin Scale and FI or RoR.RESULTS:Of 1932 patients, 1055 were women and 877 were men. Women were older (77 versus 69 years), had higher rates of atrial fibrillation, hypertension, and greater prestroke disability, but there was no difference in baseline National Institutes of Health Stroke Scale score. Inverse probability of treatment weighting analysis showed no difference between women and men in ordinal modified Rankin Scale (odds ratio, 0.98 [95% CI, 0.79-1.21]), FI or RoR (odds ratio, 0.98 [95% CI, 0.78-1.22]), severe disability or mortality (odds ratio, 0.99 [95% CI, 0.80-1.23]). The multivariable analysis of the above end points was concordant. There were no interactions between baseline characteristics and sex on the outcomes of ordinal modified Rankin Scale and FI or RoR.CONCLUSIONs:In late presenting patients with anterior circulation stroke treated with endovascular thrombectomy in the 6 to 24-hour window, there was no difference in clinical or safety outcomes between men and women.