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Background The RESILIENT trial demonstrated the clinical benefit of mechanical thrombectomy in patients presenting acute ischemic stroke secondary to anterior circulation large vessel occlusion in Brazil. Aims This economic evaluation aims to assess the cost-utility of mechanical thrombectomy in the RESILIENT trial from a public healthcare perspective. Methods A cost-utility analysis was applied to compare mechanical thrombectomy plus standard medical care (n = 78) vs. standard medical care alone (n = 73), from a subset sample of the RESILIENT trial (151 of 221 patients). Real-world direct costs were considered, and utilities were imputed according to the Utility-Weighted modified Rankin Score. A Markov model was structured, and probabilistic and deterministic sensitivity analyses were performed to evaluate the robustness of results. Results The incremental costs and quality-adjusted life years gained with mechanical thrombectomy plus standard medical care were estimated at Int$ 7440 and 1.04, respectively, compared to standard medical care alone, yielding an incremental cost-effectiveness ratio of Int$ 7153 per quality-adjusted life year. The deterministic sensitivity analysis demonstrated that mRS-6 costs of the first year most affected the incremental cost-effectiveness ratio. After 1000 simulations, most of results were below the cost-effective threshold. Conclusions The intervention's clear long-term benefits offset the initially higher costs of mechanical thrombectomy in the Brazilian public healthcare system. Such therapy is likely to be cost-effective and these results were crucial to incorporate mechanical thrombectomy in the Brazilian public stroke centers.

Background Identification of large vessel occlusion (LVO) is critical to the management of acute ischemic stroke and prerequisite to endovascular therapy in recent trials. Increasing volumes and data complexity compel the development of fast, reliable, and automated tools for LVO detection to facilitate acute imaging triage. Purpose To investigate the performance of an anterior circulation LVO detection platform in a large mixed sample of individuals with and without LVO at cerebrovascular CT angiography (CTA). Materials and Methods In this retrospective analysis, CTA data from recent cerebrovascular trials (CRISP [

BackgroundWhile mechanical thrombectomy (MT) is the standard of care for large vessel occlusion strokes, the optimal management of tandem occlusions (TO) remains uncertain. We aimed to determine the current practice patterns among stroke physicians involved in the treatment of TO during MT.MethodsWe distributed an online survey to neurovascular practitioners (stroke neurologists, neurointerventionalists, neurosurgeons, and radiologists), members of professional societies. After 2 months the site was closed and data were extracted and analyzed. We divided respondents into acute stenting and delayed treatment groups and responses were compared between the two groups.ResultsWe received 220 responses from North America (48%), Latin America (28%), Asia (15%), Europe (5%), and Africa (4%). Preferred timing for cervical revascularization varied among respondents; 51% preferred treatment in a subsequent procedure during the same hospitalization whereas 39% preferred to treat during MT. Angioplasty and stenting (41%) was the preferred technique, followed by balloon angioplasty and local aspiration (38%). The risk of intracerebral hemorrhage was the most compelling reason for not stenting acutely (68%). There were no significant differences among practice characteristics and timing groups. Most practitioners (70%) agreed that there is equipoise regarding the optimal endovascular treatment of cervical lesions in TO; hence, 77% would participate in a randomized controlled trial.ConclusionsThe PICASSO survey demonstrates multiple areas of uncertainty regarding the medical and endovascular management of TOs. Experts acknowledged the need for further evidence and their willingness to participate in a randomized controlled trial to evaluate the best treatment for the cervical TO lesion.

Randomized trials involving patients with stroke have established that outcomes are improved with the use of thrombectomy for large-vessel occlusion. These trials were performed in high-resource countries and have had limited effects on medical practice in low- and middle-income countries.We studied the safety and efficacy of thrombectomy in the public health system of Brazil. In 12 public hospitals, patients with a proximal intracranial occlusion in the anterior circulation that could be treated within 8 hours after the onset of stroke symptoms were randomly assigned in a 1:1 ratio to receive standard care plus mechanical thrombectomy (thrombectomy group) or standard care alone (control group). The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days.A total of 300 patients were enrolled, including 79 who had undergone thrombectomy during an open-label roll-in period. Approximately 70% in the two groups received intravenous alteplase. The trial was stopped early because of efficacy when 221 of a planned 690 patients had undergone randomization (111 to the thrombectomy group and 110 to the control group). The common odds ratio for a better distribution of scores on the modified Rankin scale at 90 days was 2.28 (95% confidence interval [CI], 1.41 to 3.69; P = 0.001), favoring thrombectomy. The percentage of patients with a score on the modified Rankin scale of 0 to 2, signifying an absence of or minor neurologic deficit, was 35.1% in the thrombectomy group and 20.0% in the control group (difference, 15.1 percentage points; 95% CI, 2.6 to 27.6). Asymptomatic intracranial hemorrhage occurred in 51.4% of the patients in the thrombectomy group and 24.5% of those in the control group; symptomatic intracranial hemorrhage occurred in 4.5% of the patients in each group.In this randomized trial conducted in the public health care system of Brazil, endovascular treatment within 8 hours after the onset of stroke symptoms in conjunction with standard care resulted in better functional outcomes at 90 days than standard care alone. (Funded by the Brazilian Ministry of Health; RESILIENT ClinicalTrials.gov number, NCT02216643.).

IntroductionStroke is a leading cause of adult death and disability. Although acute ischemic stroke (AIS) in pregnancy is rare, it has devastating consequences on the life of the mother and fetus. Pregnancy was an exclusion criterion in endovascular thrombectomy (EVT) trials and so there are no evidence-based treatment recommendations in this subgroup. The objective of this study was to evaluate the safety and feasibility of mechanical thrombectomy in large vessel occlusion (LVO) stroke in pregnancy.MethodsPatients with AIS due to LVO treated with EVT during pregnancy between 2000 and 2019 were identified at seven tertiary care centers. After IRB approval, retrospective analysis of prospectively maintained stroke/endovascular databases was performed.ResultsA total of seven subjects were identified. The average age was 33.2 years (range 25–38 years) and the average initial National Institutes of Health Stroke Scale (NIHSS) score at presentation was 15 (range 9–28). Three patients received IV tissue plasminogen activator. Techniques of EVT included stent retriever thrombectomy, stent retriever-assisted continuous aspiration, direct contact aspiration, and multimodal techniques including a rescue balloon mounted coronary stent placement. While one patient was noted to have petechial hemorrhage, no individuals developed parenchymal hematoma. Mean discharge NIHSS score was 1.7 (range 0–5).ConclusionEVT is a safe and effective treatment for acute stroke secondary to LVO in this series of pregnant patients. While EVT for acute stroke is standard of care in select patient populations, our study suggests that treatment should be considered in the gravid population.

Introduction: Stroke is one of the leading causes of death in Latin America, a region with countless gaps to be addressed to decrease its burden. In 2018, at the first Latin American Stroke Ministerial Meeting, stroke physician and healthcare manager representatives from 13 countries signed the Declaration of Gramado with the priorities to improve the region, with the commitment to implement all evidence-based strategies for stroke care. The second meeting in March 2020 reviewed the achievements in 2 years and discussed new objectives. This paper will review the 2-year advances and future plans of the Latin American alliance for stroke.Method: In March 2020, a survey based on the Declaration of Gramado items was sent to the neurologists participants of the Stroke Ministerial Meetings. The results were confirmed with representatives of the Ministries of Health and leaders from the countries at the second Latin American Stroke Ministerial Meeting.Results: In 2 years, public stroke awareness initiatives increased from 25 to 75% of countries. All countries have started programs to encourage physical activity, and there has been an increase in the number of countries that implement, at least partially, strategies to identify and treat hypertension, diabetes, and lifestyle risk factors. Programs to identify and treat dyslipidemia and atrial fibrillation still remained poor. The number of stroke centers increased from 322 to 448, all of them providing intravenous thrombolysis, with an increase in countries with stroke units. All countries have mechanical thrombectomy, but mostly restricted to a few private hospitals. Pre-hospital organization remains limited. The utilization of telemedicine has increased but is restricted to a few hospitals and is not widely available throughout the country. Patients have late, if any, access to rehabilitation after hospital discharge.Conclusion: The initiative to collaborate, exchange experiences, and unite societies and governments to improve stroke care in Latin America has yielded good results. Important advances have been made in the region in terms of increasing the number of acute stroke care services, implementing reperfusion treatments and creating programs for the detection and treatment of risk factors. We hope that this approach can reduce inequalities in stroke care in Latin America and serves as a model for other under-resourced environments.

Background: Identification of large vessel occlusion (LVO) is paramount in the urgent evaluation of acute ischemic stroke (AIS). Emergent interpretation of large and high-complexity data sets, however, may impose strains upon imaging and clinical workflows, motivating development of fast and accurate computer-aided approaches to facilitate LVO detection in the emergency setting. This study investigates the performance of a fully automated LVO detection platform in a mixed cohort of stroke subjects with and without LVO on head and neck CT angiography (CTA). Methods: CTA from two cerebrovascular trials were enriched with cases from eleven global sites. Imaging and clinical variables were balanced between populations including in LVO positivity and across demographic and imaging environments to the extent achievable. Independent and fully blinded review for intracranial ICA or MCA M1 LVO was performed by two subspecialty neuroradiologists. A novel, user-independent imaging analysis application ( RAPID-LVO , iSchemaview inc) was used to predict LVO presence, location, and overall performance relative to reader consensus. Any discordance between readers was adjudicated by a blinded tertiary reader with subspecialty training. Sensitivity, specificity, and receiver-operating characteristics were determined by an independent statistician. Performance thresholds were set a priori, including a lower bound of the 95% CI of sensitivity and specificity of ≥0.8 at mean times-to-notification Results: 217 CTA (median age 65.5, 53% male, 109 LVO(+)) were included. Lower confidence limits of sensitivity and specificity exceeded 90% (sensitivity 0.963, 95% CI 0.909-0.986; specificity 0.981, 95% CI 0.935-0.995), surpassing pre-specified performance benchmarks. Subgroup analyses revealed no decrement in performance relative to subject age or sex, vendor systems, or location of the examination within or outside the United States. The area under the receiver operating characteristics curve was 0.99 (95% CI: 0.971-0.999) and average time-to-notification was 3.18 minutes. Conclusion: RAPID-LVO offers fast, highly accurate, and fully user-independent large vessel occlusion detection across all tested clinical and imaging environments.

Background RESILIENT is a prospective, multicenter, randomized phase III trial to test the safety, efficacy, and cost-effectiveness of mechanical thrombectomy as compared to medical treatment alone in patients treated under the less than ideal conditions typically found in the public healthcare system of a developing country. Methods Subjects must fulfill the following main inclusion criteria: symptom onset ≤8 h, age ≥18 years, baseline NIHSS ≥8, evidence of intracranial ICA or proximal MCA (M1 segment) occlusion, ASPECTS ≥6 on CT or >5 on DWI-MRI and be either ineligible for or unresponsive to intravenous alteplase. The primary end-point is the distribution of disability levels (on the modified Rankin Scale, mRS) at 90 days under the intention-to-treat principle. Randomization Randomization is performed under a minimization process using age, baseline NIHSS, intravenous alteplase use, occlusion site and center. Design The trial is designed with an expectation of a 10% difference in the proportion of favorable outcome (mRS 0–2 at 90 days) common odds ratio of 1.615. Primary outcome Projected sample size is 690 subjects with pre-planned interim analyses at 174, 346, and 518 subjects. Secondary outcomes Secondary end-points include: 90-day functional independence (mRS ≤2), mRS shift stratified for treatment with IV rt-PA at 90 days, infarct volume on 24 h CT or MRI, early dramatic response (NIHSS 0–2 or improvement ≥8 points) at 24 h, vessel recanalization evaluated by CTA or MRA at 24 h, and the post-procedure rate of successful reperfusion (defined as a modified Treatment in Cerebral Infarction 2b or greater). Safety variables are mortality at 90 days, symptomatic intracranial hemorrhage at 24 h and procedure-related complications.

BackgroundDuring the COVID-19 pandemic, decreased volumes of stroke admissions and mechanical thrombectomy were reported. The study’s objective was to examine whether subarachnoid haemorrhage (SAH) hospitalisations and ruptured aneurysm coiling interventions demonstrated similar declines.MethodsWe conducted a cross-sectional, retrospective, observational study across 6 continents, 37 countries and 140 comprehensive stroke centres. Patients with the diagnosis of SAH, aneurysmal SAH, ruptured aneurysm coiling interventions and COVID-19 were identified by prospective aneurysm databases or by International Classification of Diseases, 10th Revision, codes. The 3-month cumulative volume, monthly volumes for SAH hospitalisations and ruptured aneurysm coiling procedures were compared for the period before (1 year and immediately before) and during the pandemic, defined as 1 March–31 May 2020. The prior 1-year control period (1 March–31 May 2019) was obtained to account for seasonal variation.FindingsThere was a significant decline in SAH hospitalisations, with 2044 admissions in the 3 months immediately before and 1585 admissions during the pandemic, representing a relative decline of 22.5% (95% CI −24.3% to −20.7%, pInterpretationThere was a relative decrease in the volume of SAH hospitalisations, aneurysmal SAH hospitalisations and ruptured aneurysm embolisations during the COVID-19 pandemic. These findings in SAH are consistent with a decrease in other emergencies, such as stroke and myocardial infarction.

Background: Malignant infarction of the middle cerebral artery (MCA) occurs in a subgroup of patients with ischemic stroke and early decompressive craniectomy (DC) is one of its treatments. Objective: To investigate the functional outcome of patients with malignant ischemic stroke treated with decompressive craniectomy at a neurological emergency center in Northeastern Brazil. Methods: Prospective cohort study, in which 25 patients were divided into two groups: those undergoing surgical treatment with DC and those who continued to receive standard conservative treatment (CT). Functionality was assessed using the modified Rankin Scale (mRS), at follow-up after six months. Results: A favorable outcome (mRS≤3) was observed in 37.5% of the DC patients and 29.4% of CT patients (p=0.42). Fewer patients who underwent surgical treatment died (25%), compared to those treated conservatively (52.8%); however, with no statistical significance. Nonetheless, the proportion of patients with moderate to severe disability (mRS 4‒5) was higher in the surgical group (37.5%) than in the non-surgical group (17.7%). Conclusion: In absolute values, superiority in the effectiveness of DC over CT was perceived, showing that the reduction in mortality was at the expense of increased disability. RESUMO Introdução: O infarto maligno da artéria cerebral média (ACM) ocorre em um subgrupo de pacientes com acidente vascular cerebral (AVC) isquêmico e a craniectomia descompressiva (CD) precoce é um de seus tratamentos. Objetivo: Investigar o desfecho funcional de pacientes com acidente vascular cerebral isquêmico maligno submetidos à craniectomia descompressiva em um centro de emergência neurológica do nordeste do Brasil. Métodos: Nesta coorte prospectiva, os pacientes foram divididos em dois grupos: aqueles submetidos a tratamento cirúrgico com craniectomia descompressiva (CD) e aqueles que mantiveram tratamento conservador (TC) padrão. A funcionalidade foi avaliada por meio da Escala de Rankin modificada (ERm) ao final de seis meses de seguimento. Resultados: Evidenciou-se desfecho favorável (ERm≤3) em 37,5% dos pacientes craniectomizados e em 29,4% dos pacientes não craniectomizados (p=0,42). A mortalidade foi menor no grupo de pacientes que se submeteram a tratamento cirúrgico (25%) do que entre aqueles tratados conservadoramente (52,8%), porém sem significância estatística. Por outro lado, a proporção de pacientes com incapacidade moderada a grave (ERm 4‒5) foi maior no grupo cirúrgico (37,5%) do que no grupo não cirúrgico (17,7%). Conclusão: Em valores absolutos, percebeu-se superioridade na eficácia do tratamento cirúrgico sobre o conservador, mostrando que a redução de mortalidade se dá à custa de aumento da incapacidade funcional.

BACKGROUND AND PURPOSE: Intracranial hemorrhage (ICH) is an important event that is diagnosed on head NCCT. Increased NCCT utilization in busy hospitals may limit timely identification of ICH. RAPID ICH is an automated hybrid 2D–3D convolutional neural network application designed to detect ICH that may allow for expedited ICH diagnosis. We determined the accuracy of RAPID ICH for ICH detection and ICH volumetric quantification on NCCT. MATERIALS AND METHODS: NCCT scans were evaluated for ICH by RAPID ICH. Consensus detection of ICH by 3 neuroradiology experts was used as the criterion standard for RAPID ICH comparison. ICH volume was also automatically determined by RAPID ICH in patients with intraparenchymal or intraventricular hemorrhage and compared with manually segmented ICH volumes by a single neuroradiology expert. ICH detection accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and positive and negative likelihood ratios by RAPID ICH were determined. RESULTS: We included 308 studies. RAPID ICH correctly identified 151/158 ICH cases and 143/150 ICH-negative cases, which resulted in high sensitivity (0.956, CI: 0.911–0.978), specificity (0.953, CI: 0.907–0.977), positive predictive value (0.956, CI: 0.911-0.978), and negative predictive value (0.953, CI: 0.907–0.977) for ICH detection. The positive likelihood ratio (20.479, CI 9.928–42.245) and negative likelihood ratio (0.046, CI 0.023–0.096) for ICH detection were similarly favorable. RAPID ICH volumetric quantification for intraparenchymal and intraventricular hemorrhages strongly correlated with expert manual segmentation (correlation coefficient r = 0.983); the median absolute error was 3 mL. CONCLUSIONS: RAPID ICH is highly accurate in the detection of ICH and in the volumetric quantification of intraparenchymal and intraventricular hemorrhages.

Introduction: Although the 2019 severe acute respiratory syndrome coronavirus 2 infection (SARS-CoV-2, COVID-19) pandemic poses new challenges to the healthcare system to provide support for thousands of patients, there is special concern about common medical emergencies, such as stroke, that will continue to occur and will require adequate treatment. The allocation of both material and human resources to fight the pandemic cannot overshadow the care for acute stroke, a time-sensitive emergency that with an inefficient treatment will further increase mortality and long-term disability. Objective: This paper summarizes the recommendations from the Scientific Department on Cerebrovascular Diseases of the Brazilian Academy of Neurology, the Brazilian Society of Cerebrovascular Diseases and the Brazilian Society of Neuroradiology for management of acute stroke and urgent neuro-interventional procedures during the COVID-19 pandemic, including proper use of screening tools, personal protective equipment (for patients and health professionals), and patient allocation.

Background and purpose: RESILIENT Trial was the first study in a developing country to demonstrate the benefit of mechanical thrombectomy (MT) in acute stroke patients. This economic evaluation aimed to access the cost-utility of MT under the perspective of the Brazilian Public Healthcare System. Methods: Analysis was based on a subset sample of the original study (151 of 221 patients) from 4 hospitals. We compared costs and utilities between MT plus standard care (n=78) vs. standard care alone (n=73). Direct medical costs were considered, and utilities were inputted according to each patient’s Utility-Weighted modified Rankin Score (UW-mRS). First-year survival was obtained from trial follow-up and modelled for a life-time horizon adjusted by National Mortality Data. Direct medical costs were converted to I$ using Purchasing Power Parity (PPP). A discount rate of 5% was used. Incremental cost-effectiveness ratio (ICER) is expressed in cost (I$) per Quality-Adjusted Life Year (QALY). Results: RESILIENT trial was stopped on its first interim analysis because of early efficacy. The incremental costs and QALYs gained with MT were estimated at I$ 8,369 and 0.75, respectively, compared with standard medical care, yielding an incremental cost-effectiveness ratio (ICER) of I$ 7,256 per QALY. Conclusion: The initially higher costs of MT were offset by the clear benefit of the intervention. RESILIENT trial demonstrated that such therapy is likely to be cost-effective despite the economical constraints in the Brazilian healthcare system.

Background: Decompressive hemicraniectomy (DH) is a level IA therapy for malignant middle cerebral artery (MCA) infarction. However, randomized trials were performed in high income countries with better access to post-stroke care and rehabilitation services. We aimed to assess long term functional outcome and the associated prognostic factors of patients undergoing DH in Brazil. Methods: From January 2013 and July 2018, all patients undergoing DH for malignant MCA infarction in a single comprehensive stroke center were retrospectively identified. Outcomes were the modified Rankin Scale (mRS) (dichotomized as ≤ 4 vs. > 4) and mortality at follow-up. The mRS at follow-up was collected prospectively by telephone using a validated structured interview. Logistic regression analysis was performed to assess independent predictors of outcome. Results: Eighty patients who underwent DH for malignant MCA infarction were identified. Age ranged from 16 to 78 years (median 48 years, IQR 42 - 54,7 years), 46 (57.6%) were males and median time from stroke onset to hemicraniectomy was 30.75 hours (IQR 17.8-46.0). Hospital discharge mRS ≤ 3 and ≤ 4 was observed in 5 (6.2%) and 74 (92,5%) patients respectively. Follow-up information was available for 65 (81.2%) patients. At follow-up (raging from 1.1 to 5.6 years), mRS ≤ 4 was observed in 23 (35.3%) patients. In binary logistic regression analysis, age (OR 1.09, 95% CI 1.02 - 1.17, p=0.01), and right MCA infarction (OR 16.70, 95% CI 1.8-152.30, p=0.01) were independently associated with a worse functional outcome at follow-up. Admission NIHSS (OR 1.0 ,95% CI 0.8-1.3, p=0.45), IV rt-PA (OR 0.5, 95% CI 0.08-3.00, p=0.46) or time of hemicraniectomy (OR 1.00, 95% CI 1.00 - 1.00, p=0.94) were not associated with functional outcome at follow-up. Mortality was 26% (N=21) at hospital discharge and 46% (N=30) at follow-up. Conclusion: The large effect size of DH for malignant MCA infarction is significantly diminished in the population of patients treated under the less than ideal conditions typically found in the public healthcare system of a developing country. Poor access to post-stroke care and rehabilitation services might be possible reasons for the results observed.

Background: Mechanical thrombectomy (MT) in addition to intravenous thrombolysis (IVT) is now the recommended treatment for acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). The positive trials also demonstrated that MT alone among patients ineligible for IVT is an effective therapy for AIS. Whether MT alone is as effective, worse, or better than pretreatment with IVT before MT among IVT-eligible AIS patients with LVO is debatable. We aimed to assess the effect of IVT on the clinical outcome of MT in the RESILIENT trial. Methods: RESILIENT was a randomized, prospective, multicenter, controlled trial evaluating the safety, efficacy, and cost-effectiveness of thrombectomy versus medical treatment alone. A total of 221 patient were enrolled. The trial showed a strong benefit to thrombectomy (90-day mRS ordinal shift, OR 95%CI). All eligible patients received intravenous tPA within the 4.5-hour-window. The primary end-point was the common odds ratio (cOR) of mRs at 90 days (shift analysis) and the main secondary endpoint was the rate of functional independence (mRS 0-2) at 90 days. Ordinal logistic and binary regression analyses with the use of intravenous tPA as an interaction term were performed with adjustments for potential confounders including age, baseline NIHSS score, occlusion site, IV tPA use and ASPECTS. A p value < 0.05 was considered statistically significant. Results: Among 221 randomized patients (median NIHSS, 18 IQR [14-21]), 155 (70%) were treated with IV tPA. The frequency of good recanalization (TICI 2b> ) and of hemorrhagic transformation was not affected by IVT. There was no significant difference in the treatment effect size across patients who received intravenous tPA versus those who did not in terms of overall functional disability (ordinal mRS shift: aOR: 2.63, 95%CI [1.48-4.69] vs. 1.54, 95%CI [0.63-3.74]; p=0.42) or functional independence (mRS 0-2: aOR: 3.06, 95%CI [1.37-6.48] vs. 1.71 95%CI [0.55-5.33], p=0.40) at 90 days. Conclusions: The large effect size of MT on LVO outcomes was not significantly affected by IVT. Further studies directly evaluating the role of IVT before MT are of utmost importance.

Introduction: In randomized clinical trials, central adjudication is frequently used for study outcomes. However, stroke trials have historically used site-derived Rankin scale assessments as primary outcome. Hypothesis: A central adjudication of Rankin scale assessment is at least as accurate as site-derived assessment. Methods: We studied acute stroke survivors from the RESILIENT study, where primary outcome was the consensus Rankin scale rating of two blinded central adjudicators who independently watched video recordings of a 90-day post-stroke structured patient and/or family interview. We compared agreement rates (weighted kappa statistics) between both central adjudicators with that between the blinded site investigator and the consensus reading between central adjudicators. Results: Trial randomized 221 patients to thrombectomy or medical treatment alone. At 90 days, 161 (73%) survived and 142/161 (88%) had quality video recordings for central adjudicators. Median (interquartile range) Rankin scores were similarly 3 (2-4) for each central rater and for the site investigators. Agreement rates between central adjudicators was 79.6% (kappa=0.94, p Conclusions: Central blinded Rankin scale outcome assessment is feasible and is at least as good as site investigator assessments. For open-label trials with blinded clinical outcome assessment, central adjudication of video-recorded interviews provides safer blinding and accountability.

Background: Despite evidence supporting the overall efficacy of mechanical thrombectomy (MT) in acute ischemic stroke (AIS) due to large vessel occlusion (LVO) of the anterior circulation, it is unclear whether the treatment effect of MT differs by sex in different populations. We assessed the impact of sex differences in the treatment effect of MT in the RESILIENT trial. Methods: RESILIENT was a prospective, multicenter, randomized phase III trial that was designed to assess the safety, efficacy, and cost-effectiveness of mechanical thrombectomy as compared to medical treatment alone in patients treated under the less than ideal conditions typically found in the public healthcare system of a developing country. Results: Among 221 patients enrolled in the trial, 104 (47,1%) were female. Baseline characteristics were well balanced between sexes, except for a higher prevalence of hypertension (76% vs. 57.4%; p=0.004) and diabetes (34.3% vs. 21.7%; p=0.039) and a lower frequency of alcohol abuse (4% vs. 28.9%; p=0.001) in females. After adjustment for baseline characteristics, we found a significant interaction (p=0.026) between sex and the effect of MT with a lower efficacy of MT for functional independency at 90 days among women (aOR=1.13;95%CI:0.42-3.02) compared to men (aOR=4.78; 95%CI:1.88-12.15). Conclusions: In our study population of patients with AIS caused by LVO of the anterior circulation, women were less likely to benefit from MT than men. Further studies are necessary to investigate these findings.

Background: The RESILIENT randomized trial of endovascular therapy for anterior circulation stroke within 8 hours of symptom onset excluded subjects with poor collaterals. We analyzed the relationship of CTA collateral grade with respect to subsequent infarct growth over 24 hours, with and without revascularization. Methods: The independent RESILIENT imaging and angiography core lab scored baseline CTA Tan collateral grade (0-3) and CT ASPECTS scores at baseline and 24 hours in both arms. ASITN collateral grade (0-4) was adjudicated prior to revascularization in the interventional arm. Descriptive statistics, univariate, multivariate and ANOVA related CTA collateral grade with 24-hour infarct growth. Results: 210/221 (95%) subjects (median age 67 (53-76) years; 48% women) in RESILIENT had baseline single-phase CTA available to the core lab evaluation. CTA collateral grade was complete (grade 3) in 106 (50.5%), grade 2 (50-99%) in 68 (32.4%), grade 1 (1-49%) in 36 (17.1%), with no collaterals in 0. The extent of collaterals was more robust in the medical arm (55.0% grade 3, 31.4% grade 2, 13.3% grade 1) compared to the interventional arm (45.7% grade 3, 33.3% grade 2, 21.0% grade 1), although this finding was not statistically significant (p=0.11). In the interventional arm, the extent of CTA collaterals had a strong correlation with ASITN grade (ρ=0.59, p Conclusions: In RESILIENT, CTA collateral grade was linked with higher ASPECTS and less infarct growth over 24 hours. Despite more robust collaterals in the medical arm, greater infarct growth occurred without revascularization or endovascular therapy.

Background: Randomized trials performed in high income countries have shown similar effects of mechanical thrombectomy (MT) in elderly and non-elderly patients with large vessel ischemic strokes (LVO). We aimed to assess the effect of age on the clinical outcome of MT in RESILIENT (a randomized, prospective, multicenter, controlled, phase III, clinical trial with blinded outcome assessment performed in Brazil designed to assess the safety, efficacy, and cost-effectiveness of mechanical thrombectomy as compared to medical treatment alone). Methods: Patients were classified as elderly and non-elderly (≤ 70 vs. > 70 years). The end-points were the common odds ratio (cOR) of mRs (shift analysis) and the frequency of functional independence (mRS 0-2) at 90 days. Ordinal logistic regression analysis (unadjusted and adjusted for important potential confounders) with age group as an interaction term were performed. A p value < 0.05 was considered statistically significant. Results: Among 221 randomized patients (117- 52.9% males), 89 (40.2%) were classified as elderly. Age had an important effect modification of MT on the mRS shift analysis (elderly - cOR 1.20 95% CI [0.57-2.51] vs. non-elderly cOR 3.9, 95% CI [1.65-5.80], p-interaction = 0.003) and on the frequency of functional independence at 90 days (elderly - OR 0.92 95% CI [0.33 - 2.59] vs. non-elderly OR 3.56, 95% CI [1.64 - 7.75], p-interaction = 0.04). A similar effect modification was observed after adjusting for IV rt-PA, occlusion site, baseline NIHSS and ASPECTS on the mRS shift analysis (elderly - cOR 1.34, 95% CI [0.63 - 2.86] vs. non-elderly cOR 3.26, 95% CI [1.73 - 6.13], p-interaction = 0.06) and on the frequency of functional independence at 90 days (elderly - OR 1.08 95% CI [0.36 - 3.21] vs. non-elderly OR 4.26, 95% CI [1.85 - 9.82], p-interaction = 0.04) . Conclusion: The large effect size of MT on LVO outcomes is significantly diminished in the elderly population of patients treated under the less than ideal conditions typically found in the public healthcare system of a developing country.

Background: CT perfusion has been increasingly used as a selection tool in acute reperfusion therapies. However, it remains unknown whether its use is associated with a higher treatment benefit in patients undergoing thrombectomy. We sought to evaluate the interaction between imaging selection modalities and treatment effect in the RESILIENT Trial. Methods: RESILIENT was a randomized, prospective, multicenter, controlled trial evaluating the safety, efficacy, and cost-effectiveness of thrombectomy versus medical treatment alone in Brazil. A total of 221 patient were enrolled. The trial showed a strong benefit of thrombectomy (90-day mRS ordinal shift, OR 2.28 95%CI [1.41-3.70]; p=0.001). Key imaging selection criteria included ASPECTS ≥6 on non-contrast CT (NCCT) and the exclusion of malignant collateral profile on CT angiography. The use of automated CT perfusion software (RAPID, IschemaView) was optional but was made available in some centers with the pre-specified plan to compare imaging selection modalities. The primary end-point was the common odds ratio (cOR) of mRs at 90 days (shift analysis) and the main secondary endpoint was the rate of functional independence (mRS 0-2) at 90 days. Ordinal logistic and binary regression analyses with imaging selection modality (NCCT versus CTP) as an interaction term were performed with adjustments for potential confounders including age, baseline NIHSS score, occlusion site, IV tPA use and ASPECTS. A p value < 0.05 was considered statistically significant. Results: CTP was performed in 41% of the thrombectomy group and 45% in the control group. There was no significant difference in the treatment effect size for patients selected on the basis of NCCT and CTA only versus those submitted to CTP in terms of overall functional disability (ordinal mRS shift: aOR: 2.87, 95%CI [1.47-5.61] vs. 2.10, 95%CI [1.01-4.36]; p=0.390) or functional independence (mRS 0-2: aOR: 3.16, 95%CI [1.32-7.57] vs. 2.54 95%CI [0.86-7.49], p=0.40) at 90 days. Conclusion: In a randomized clinical trial of thrombectomy within 8 hours of stroke onset, there was no evidence of difference in the treatment effect size across patients selected with NCCT and CTA alone versus automated CT perfusion software.

BackgroundDespite advancements in stroke treatment, refractory clots are relatively common, prompting the exploration of alternative techniques. Bifurcation occlusions pose specific intraprocedural challenges, occasionally dealt with by two stentrievers deployed in Y-configuration. Previous studies have portrayed this strategy as feasible, yet little is known about its safety and efficacy, and how to best select retrievers.ObjectiveTo determine whether device selection influences the efficacy and safety of Y-stentrieving.MethodsWe performed a multicentric, retrospective analysis of patients undergoing Y-stentrieving rescue for bifurcation occlusions. Demographics, devices, procedural metrics, neurological severity, reperfusion, disability, and safety were assessed.ResultsY-configuration stents were used as a rescue maneuver after 2.16±1.5 failed attempts with other techniques in 20 patients. Successful reperfusion (modified Thrombolysis in Cerebral Infarction score 2b–3) was achieved in 70% of patients after the first Y-stentrieving attempt. The first stentriever more often had a larger diameter (5.15±0.92 vs 3.67±0.57 mm, p=0.017) and longer length (33.12±5.78 vs 20.67±1.15 mm, p=0.002) in successfully reperfused cases. Also, the diameter of the first device was associated with both any parenchymal (6.0 vs 4.71±0.99 mm, p=0.045) and symptomatic (6.0 vs 4.86±1.02 mm, pConclusionY-stentrieving is an effective and safe bail-out strategy for refractory bifurcation clots. Longer stents may promote better angiographic outcomes, whereas avoidance of disproportionately large retrievers may mitigate intracranial hemorrhage. Future studies should account for these factors when evaluating alternative stentriever techniques.

Stroke is the second cause of death in most developing countries, and approximately 10% of cases are people younger than 45 years old. Several studies have shown that stroke units, timely use of intravenous tissue plasminogen activator (IV-tPA), and mechanical thrombectomy (MT) for selected patients are not only indicated but also cost-effective in the treatment of acute ischemic stroke (AIS). Although most studies have been conducted in developed countries, over 80% of all stroke deaths in the world occur in developing countries. In this chapter, we provide an assessment of the status of stroke care and the use of MT to treat AIS in low- and medium-income countries.

Made available in DSpace on 2018-11-28T03:37:26Z (GMT). No. of bitstreams: 0 Previous issue date: 2017-01-01. Added 1 bitstream(s) on 2019-10-09T18:27:35Z : No. of bitstreams: 1 S0004-282X2017000100050.pdf: 155772 bytes, checksum: c55550248854584f7b2472bcb06a538a (MD5) Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) Brazilian Ministry of Health (Decit/SCTIE/MS) These guidelines are the result of a joint effort from writing groups of the Brazilian Stroke Society, the Scientific Department of Cerebrovascular Diseases of the Brazilian Academy of Neurology, the Brazilian Stroke Network and the Brazilian Society of Diagnostic and Therapeutic Neuroradiology. Members from these groups participated in web-based discussion forums with predefined themes, followed by videoconference meetings in which controversies and position statements were discussed, leading to a consensus. This guidelines focuses on the implications of the recent clinical trials on endovascular therapy for acute ischemic stroke due to proximal arterial occlusions, and the final text aims to guide health care providers, health care managers and public health authorities in managing patients with this condition in Brazil. Univ Sao Paulo, Fac Med Ribeirao Preto, Ribeirao Preto, SP, Brazil Hosp Clin Porto Alegre, Porto Alegre, RS, Brazil Emory Univ, Sch Med, Grady Mem Hosp, Marcus Stroke & Neurosci Ctr, Atlanta, GA USA Univ Fed Sao Paulo, Sao Paulo, SP, Brazil Hosp Base Brasilia, Brasilia, DF, Brazil Univ Sao Paulo, Fac Med, Sao Paulo, SP, Brazil Univ Estadual Paulista, Fac Med Botucatu, Botucatu, SP, Brazil Hosp Pro Cardiaco, Rio De Janeiro, RJ, Brazil Univ Fed Minas Gerais, Belo Horizonte, MG, Brazil Univ Fed Fluminense, Niteroi, RJ, Brazil Inst Dor Pesquisa & Ensino, Rio De Janeiro, RJ, Brazil Hosp Municipal Sao Jose, Div Neurol, Joinville, SC, Brazil Hosp Geral Fortaleza, Fortaleza, Ceara, Brazil Hosp Restauracao, Recife, PE, Brazil Hosp Sirio Libanes, Sao Paulo, SP, Brazil Univ Fed Bahia, Salvador, BA, Brazil Santa Casa Sao Paulo, Fac Ciencias Med, Sao Paulo, SP, Brazil Hosp Israelita Albert Einstein, Sao Paulo, SP, Brazil Univ Estadual Paulista, Fac Med Botucatu, Botucatu, SP, Brazil CNPq: 402388/2013-5 CNPq: 467322/2014-7

Our purpose was to evaluate the postoperative aneurysm occlusion volume and clinical results of treating unruptured intracranial aneurysm using three-dimensional (3D) coils. Over a 2-year period 62 aneurysms (39 with a neckor =4 mm, 23 with a neck4 mm) in 62 patients in five participating centres were treated. The procedure consisted, firstly, of framing the aneurysm with one or more spherical 3D coils, and secondly, of filling it with two-dimensional (2D) helical coils. Anatomical and clinical results were evaluated by univariate analysis. Multivariate analysis was used to identify independent predictors of these results. For neck sizesor =4 and4 mm, angiographic occlusion was complete in 31 (79%) and 16 (70%) aneurysms, respectively; the mean percentage of occlusion volume was 31.4% and 29.5%, respectively, and postoperative morbidity was 3% and 4%, respectively, with no significant differences between the two groups. There were no deaths. However, occlusion volume correlated with sac size (P = 0.037) and sac-to-neck ratio1.5 (P = 0.073), except when three or more 3D coils per aneurysm were used (P = 0.516 and P = 0.308, respectively). Occlusion volume correlated with the number of 3D coils per aneurysm (P0.001) and was an independent predictor of angiographic complete occlusion (P = 0.002). The use of the largest number of 3D coils per aneurysm was safe and may improve the postoperative volume and angiographic occlusion of aneurysms with a neck4 mm, provided the sac-to-neck ratio isor =1.5.

We report a case of cerebral fat embolism which occurred in a 33-year-old man after a diaphyseal femoral fracture without cranial traumatism. The initial examination showed an incomplete picture of coma with tetrapyramidal syndrome and cutaneomucous purpura. There was no respiratory damage. We present a magnetic resonance spectroscopy analysis of the cerebral lesions observed in the initial phase of the embolism, as well as follow-up, which has strengthened the clinical and imaging features for the diagnosis.

Spinal involvement is a common presentation of multiple myeloma (MM); however, the cervical spine is the least common site of myelomatous involvement. Few studies evaluate the results of percutaneous vertebroplasty (PV) in the treatment of MM of the spine. The purpose of this series is to report on the use of PV in the treatment of MM of the cervical spine and to review the literature.From January 1994 to October 2007, four patients (three men and one woman; mean age, 45 years) who underwent five PV for painful MM in the cervical spine were retrospectively reviewed. The pain was estimated by the patient on a verbal analogic scale. Clinical follow-up was available for all patients (mean, 27.5 months; range, 1-96 months).The mean volume of cement injected per vertebral body was 2.3 +/- 0.8 mL (range, 1.0-4.0 mL) with a mean vertebral filling of 55.0 +/- 12.0% (range, 40.0-75.0%). Analgesic efficacy was achieved in all patients. One patient had a spinal instability due to a progression of spinal deformity noted on follow-up radiographs, without clinical symptoms. Cement leakage was detected in three (60%) of the five treated vertebrae. There was no clinical complication.The present series suggests that PV for MM of the cervical spine is safe and effective for pain control; nonetheless, the detrimental impact of the disease on bone quality should prompt close radiological follow-up after PV owing to the risk of spinal instability.