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Introduction The benefits of mechanical thrombectomy in the treatment of patients with acute stroke due to large vessel occlusions (LVOs) have been extensively demonstrated by randomized trials and registries in developed countries. However, data on thrombectomy outside controlled trials are scarce in developing countries. The aim of this study was to assess the safety and efficacy, and to investigate the predictors for good and poor outcomes of thrombectomy for treatment of AIS due to anterior circulation LVOs in Brazil. Materials and Methods This was a single center registry of thrombectomy in the treatment of stroke caused by anterior circulation LVOs. Between 2011 and 2019, a total of 565 patients were included. Results the mean baseline NIHSS score on admission was 17.2. The average baseline ASPECTS was 8, and 91.0% of patients scored ≥6. Half of the patients received intravenous thrombolysis. The mean time from symptom onset to arterial puncture was 296.4 minutes. The mean procedure time was 61.4 minutes. The rates of the main outcomes were recanalization (TICI 2b-3) 85.6%, symptomatic intracranial hemorrhage (sICH) 8,1%, good clinical outcome (mRS=0-2) 43,5%, and mortality 22.1% at three months. Conclusions This study demonstrates the efficacy and safety of mechanical thrombectomy for treatment of patients with AIS of the anterior circulation in real-life conditions under limited facilities and resources. The results of the present study were relatively similar to those of large trials and population registers of developed countries.

The image-guided gastrostomy techniques, as transoral and transabdominal, can be performed when there is a failure of the endoscopic procedure or in some specific clinical scenarios. This pictorial essay intends to show the percutaneous gastrostomy techniques, indications, technical approaches, post-procedure care, and complications.As técnicas de gastrostomia guiadas por imagem, por via transoral e transabdominal podem ser realizadas quando há falha na técnica endoscópica ou em cenários clínicos em que a endoscopia não pode ser realizada. Este ensaio iconográfico pretende mostrar as técnicas de gastrostomia percutânea, suas indicações, aspectos técnicos, cuidados pós-procedimento e complicações.

Objective: Total aneurysm occlusion is crucial for the prevention of rebleeding of a ruptured aneurysm or to avoid rupture of an unruptured lesion. Both surgical and endovascular embolization fail to achieve complete aneurysm occlusion in all the cases. The objective of the study was to establish the safety and efficacy of endovascular treatment for previously clipped residual or recurrent aneurysms.Methods: This was an observational, retrospective study of patients harboring incompletely occluded intracranial aneurysms after clipping who underwent endovascular treatment. Patients were treated using 4 different techniques: (1) simple coiling, (2) balloon remodeling, (3) stent-assisted coiling, and (4) flow diversion. Analyses were performed to identify predictors of total aneurysm occlusion, recanalization and complications.Results: Between May 2010 and September 2018, 70 patients harboring incompletely occluded intracranial aneurysms after clipping met the inclusion criteria in 5 centers. The mean residual aneurysm size was 7.5 mm. Fifty-nine aneurysms were unruptured. Total aneurysm occlusion was achieved in 75.3% of the aneurysms after 1 year. All aneurysms treated with flow diversion revealed complete occlusion according to control angiography. Recanalization was observed in 14.5%. Permanent morbidity and mortality occurred in 2.9% and 1.4% of the patients, respectively.Conclusions: Endovascular treatment of recurrent or residual aneurysms after surgical clipping was safe and efficacious. Flow diversion seems to be associated with better anatomical results. A more rigid study, a larger group of patients, and longterm follow-up are required to provide stronger conclusions about the best approach for residual clipped aneurysms.

Background Abdominoperineal excision (APE)-related hemorrhage can be challenging due to difficult access to pelvic organs and the risk of massive blood loss. The objective of the present study was to demonstrate the use of preoperative embolization (PE) as a strategy for blood preservation in a patient with a large low rectal tumor with a high risk of bleeding, scheduled for APE. Case summary A 56-year-old man presented to our institution with a one-year history of anal bleeding and rectal tenesmus. The patient was diagnosed with bulky adenocarcinoma limited to the rectum. As the patient refused any clinical treatment, surgery without previous neoadjuvant chemoradiation was indicated. The patient underwent a tumor embolization procedure, two days before surgery performed via the right common femoral artery. The tumor was successfully devascularized and no major bleeding was noted during APE. Postoperative recovery was uneventful and a one-year follow-up showed no signs of recurrence. Conclusion Therapeutic tumor embolization may play a role in bloodless surgeries and increase surgical and oncologic prognoses. We describe a patient with a bulky low rectal tumor who successfully underwent preoperative embolization and bloodless abdominoperineal resection.

BACKGROUND AND PURPOSE: Treatment of dural arteriovenous fistulas can be performed by transarterial or transvenous accesses. For those fistulas located at a dural sinus wall, obliteration of the sinus might lead to a substantial risk of complications if the occluded sinus impairs normal venous drainage. For those fistulas with direct leptomeningeal venous drainage, navigation to reach the arteriovenous shunting point of a leptomeningeal vein is usually technically demanding. We report the outcomes of patients with dural AVFs treated by transarterial injection of liquid embolic agents assisted by transarterial double-lumen balloon catheters and/or transvenous balloon catheters. MATERIALS AND METHODS: This was a retrospective, 3-center study including patients with dural AVFs treated with a balloon-assisted technique in at least 1 treatment session. Angiographic follow-up was performed at 6 months. Clinical assessment was performed at admission and discharge and was reassessed at 30-day and 6-month follow-ups. RESULTS: Forty-one patients with 43 dural AVFs were treated. Thirty-four fistulas were located at a dural sinus wall. Treatment was performed using only a transarterial approach in 42 fistulas. Only 1 session was needed for complete obliteration of the fistula in 86% of the patients. Immediate complete angiographic occlusion was achieved in 39 fistulas. Of the 41 controlled fistulas, 40 (97.6%) were completely occluded at 6 months. Thirty-nine fistulas (95.1%) were cured without any report of major neurologic events or death during follow-up. CONCLUSIONS: Transarterial balloon-assisted treatment of dural AVFs with or without transvenous balloon protection was shown to be safe and effective.

Purpose We aimed to evaluate the effectiveness and safety of n-butyl cyanoacrylate (n-BCA) in the context of the transarterial embolization (TAE) of abdominal wall hemorrhage in an urgent scenario. Methods A retrospective study of cases admitted from January 2008 to December 2017 in the emergency unit of our institution revealed 11 patients with abdominal wall hemorrhage who underwent digital subtraction angiography and TAE with n-BCA. We analyzed the sex, age, hemorrhagic risk factors, etiology, embolized vessel, technical success (no rebleeding in the embolized area), clinical success (hemoglobin level control and hemodynamic stability after the procedure), complications inherent to the procedure, and clinical outcome (mortality in 30 days). Results The mean age was 63.4 years (52-83 years), with a predominance of the female sex (64%). The majority (91%) of patients presented hemorrhagic risk factors (chronic hepatopathy and anticoagulation drug usage). Spontaneous hemorrhage was present in 18% of patients, and the other 82% had an iatrogenic etiology. Technical success was achieved in 100% of the patients, which required the embolization of inferior epigastric artery in 10 patients (91%), circumflex iliac artery in 2 (18%), and superior epigastric artery in 1 (9%). Five patients were hemodynamically unstable, and despite achieving technical success, 4 (36%) died in less than 30 days due to decompensation of their clinical comorbidities caused by the acute phase. There were no complications inherent to the procedures. Conclusion The present study concludes that TAE with n-BCA is a safe and effective treatment for abdominal wall hemorrhage in an urgent scenario, with high rates of technical and clinical success.

Purpose An increasing number of polytraumatized patient presenting with active abdominal pelvic bleeding (APB) have been treated by endovascular selective embolization. However, reports on evaluate the efficacy, safety and complications caused by this technique have been limited. The aim of this study was to assess the safety and efficacy of embolization of APB using N-butyl cyanoacrylate glue (NBCA). Materials and methods Single center retrospective study, that included consecutive 47 patients presenting with traumatic APB treated by embolization with NBCA between January 2013 and June 2019. The efficacy endpoint was defined as the absence of contrast extravasation immediately after procedure and clinical stabilization in the following 24 h after procedure. Clinical stabilization was defined as no rebleeding after embolization or the need for a surgical approach until the patient is discharged. Safety endpoint were any technical or clinical complications related to the embolization procedure. Results The mean age of patients was 38.6 years (3–81), with a predominance of males (87.2%). The major causal factor of APB being involvement in a car accident, accounting for 68% of cases. Of the 47 cases, 29.8% presented pelvic trauma and the remaining (70.2%) presented abdominal trauma. The efficacy rate was 100%, while no complications related to the procedure were observed. The mortality rate was 14.8% (7/47) due to neurologic decompensation and other clinical causes. Conclusion Endovascular embolization of traumatic abdominopelvic bleedings appear to be a highly safe and effective treatment, while avoiding emergent exploratory open surgeries.

Introduction The benefits of thrombectomy for occlusion of M2 segments remain controversial. The aim of this study is to assess thrombectomy’s efficacy and safety in patients with M2 segment occlusion and associations between occlusion sites and anatomic variations of M1 division. Materials and methods A prospective series of 30 patients with acute ischemic stroke (AIS) resulting from M2 segment occlusion of the middle cerebral artery (MCA) who underwent thrombectomy was analyzed. The primary endpoint was assessed by the Extended Treatment in Cerebral Infarction scale (eTICI). The secondary endpoints were the incidence of symptomatic hemorrhagic transformation (sICH), mortality and good functional outcome at three months. Results The mean patient age was 69.2 years. The mean National Institutes Health Stroke Scale score (NIHSS) upon hospital admission was 16. The recanalization rates were eTICI 2b/3 in 90% and 2c/3 in 60% of the patients. Total recanalization of the M2 branch was achieved in 53% of patients. sICH incidence was 6.6%, the mortality rate was 30%, and a good functional outcome (mRS ≤2) was observed in 50% of the patients. Twenty-seven patients (90%) had a dominant M2 branch and all were occluded. Regarding the site of M2 occlusions, 74% of patients had proximal M2 occlusions. Conclusions Thrombectomy appears to be a safe and effective method for the treatment of acute M2 segment occlusions of the MCA. Most of the cases had a dominant M2 branch, and all of them were occluded. Larger studies are needed to verify the benefits of thrombectomy for different settings of M2 occlusions.

Purpose We aimed to evaluate the safety and feasibility of the embolization of peripheral arteriovenous malformation (AVM) with non-adhesive liquid agents (NALA) injected by dual-lumen balloons (DLB). Methods We conducted a multicenter retrospective study between January 2017 and June 2019, including patients with peripheral AVM embolized with NALA by DLB. Fourteen patients were included. The AVM classification, technical and clinical success were evaluated, as were nidus size, liquid agent used, volume and time of injection in DLB, complications, follow-up and need of surgical intervention. Results The mean age of the patients was 37±22.5 years (range, 6-82 years). The mean nidus size was 5.2±2.4 cm (range, 3.0-12.0 cm). By Schobinger classification, 11 AVMs were classified in stage 3 and 3 AVMs were classified in stage 2. By Cho's classification, 2 AVMs were in stage II, 4 AVMs were in stage I, 4 AVMs were in stage IIIa and 4 AVMs were in stage IIIb. Onyx was used in 11 patients (78.6%), while Squid, PHIL, and both Onyx and Squid were used in one patient each (7.1%). Seven patients (50%) required one session of embolization, 4 patients (28.6%) required two, 2 patients (14.3%) required three and 1 patient (7.1%) required four sessions. Complete nidus exclusion was achieved in 11 patients (78.6%), optimal clinical response in 12 patients (85.7%). Four patients (28.6%) exhibited minor complications, all controlled. No major complications were seen. Four patients underwent surgical intervention (28.6%). Conclusion The embolization of peripheral AVM with NALA in DLB appears to be safe and feasible, achieving high rates of technical and clinical success.

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 Assessment of the impact of the thrombectomy learning curve on clinical outcomes is essential for developing healthcare system protocols. Aims The aim of this study was to assess the effect of thrombectomy case volume on procedural and clinical outcomes in a Brazilian registry. Methods A total of 645 patients with acute ischemic stroke treated by thrombectomy were included in the analysis. Patients were divided into two groups regarding the period of treatment: the early period group and the late period group. Results In the adjusted analysis, treatment in the late period was an independent predictor of recanalization (odds ratio 1.91, 95% CI 1.28–2.86) and excellent neurologic outcomes at three months (odds ratio 1.77, 95% CI 1.04–3.01). Treatment in the late period had no significant association with mortality (odds ratio 0.88, 95% CI 0.55–1.41). Conclusions An increase in thrombectomy case volume for the treatment of AIS over time was an independent predictor of recanalization and excellent neurologic outcome.

Background Acute basilar artery occlusion is a devastating life-threatening condition. Early recanalization is the therapeutic goal in patients with acute ischemic stroke. Despite the high rates of recanalization achieved with modern devices for basilar occlusions, many patients have had poor clinical outcomes. This study aimed to assess the predictors of good and poor outcomes among patients with basilar artery occlusion treated with thrombectomy. Methods A consecutive registry of 80 patients was included in this retrospective study. The primary end point was to access variables associated with neurologic outcomes defined by a modified Rankin Scale (mRS) score of 0–2, symptomatic intracranial hemorrhage (sICH), and mortality at 3 months follow-up. Results Recanalization was achieved in 86.2%, and the sICH rate was 8.7%. A good neurologic outcome (mRS score 0–2) was observed in 26.2% and a moderate outcome (mRS score 0–3) in 32.5% of patients. The mortality was 38.7% at 3 months follow-up. Conclusions After thrombectomy for posterior circulation strokes, young patients, V4–proximal basilar occlusion, (high) baseline posterior circulation Alberta Stroke Program Early CT Score, and complete recanalization were independent predictors of good neurologic outcomes. Failure to recanalize was strongly related to sICH and mortality. In addition, diabetes, atrial fibrillation, and baseline National Institutes of Health Stroke Scale scores ≥10 had an independent association with mortality. This study contributes to the knowledge required to optimize recanalization treatments for posterior circulation strokes and may help to improve future clinical studies.

A 46-year-old female patient presented symptoms of complete right oculomotor nerve palsy without proptosis. Orbital magnetic resonance (MR) imaging showed no abnormalities (). 3D time-of-flight MR angiography revealed high signal intensity in the right cavernous sinus (). This isolated finding has a 10-15% rate of false-positive in the diagnosis of dural arteriovenous fistula (DAVF). Additional 4D-dynamic contrast-enhanced MR angiography evidenced an early asymmetric enhancement of bilateral cavernous sinus, mainly on the right, draining downward through the inferior petrous sinus (),,,. [...]

Purpose We aimed to evaluate ultrasound-guided distal radial artery (DRA) access to perform abdominopelvic endovascular procedures. Methods A prospective, observational study was carried out in a single center between December 2017 and February 2019. Forty-two abdominopelvic endovascular procedures were performed by the same operator in 37 patients with DRA access using a 5 F sheath. Most patients were male (67.6%) with a mean age of 62.0±11.4 years (age range, 27.6-82.8 years). Patient characteristics, including Barbeau's test classification, radial and ulnar sizes and technical success, were evaluated. Patients with a DRA smaller than 1.7 mm could not be safely punctured and were not included. Results Procedures included chemoembolization of hepatocellular carcinoma in 35 cases (83.3%), embolization of hepatic metastasis in neuroendocrine tumors in 4 cases (9.5%) and other embolization procedures in 3 cases (7.1%). The mean diameters of the DRA, proximal radial artery and proximal ulnar artery were 2.31, 2.63, and 2.09 mm, respectively. Out of 42 DRA puncture attempts, 97.6% (41/42) were successfully performed. There were no postoperative complications related to the access site, such as pain, palsy, paresthesia, occlusion, finger ischemia, bleeding, hematoma, and pseudoaneurysm. Transient forearm discomfort was reported in 7.1% of patients (3/42); one occurrence was associated with kinking rectification, and two occurrences were attributed to small arteries and/or vasospasm. Conclusion Ultrasound-guided DRA access seems to be feasible and safe to perform in abdominopelvic endovascular procedures in patients with a DRA considered amenable to be safely punctured, with high technical success rates.

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.

Intracranial arteriovenous malformations (AVMs) cause hemorrhage, and the role of draining vein diameters in rupture risk is controversial. The aims of the present study were to investigate the variables related with intracranial AVM rupture and to examine the association of draining vein diameters and AVM hemorrhage. Two hundred three patients were included in this study, of which 117 (57%) had unruptured AVMs, and 86 (43%) had ruptured AVMs. In an adjusted (multivariate) analysis, the variables significantly associated with AVM hemorrhagic presentation were age (OR per year increase 0.97, 95%CI 0.95–0.99, p = 0.007), a deep nidus compared with superficial nidus (OR 3.21, 95%CI 1.13–9.06, p = 0.028), the nidus diameter (OR per each mm increase 0.95, 95%CI 0.92–0.97, p

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: 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.