Abstract BACKGROUND: Primary hyperhidrosis is a condition characterized by excessive sweating, inconsistent with the needs for thermoregulation. OBJECTIVE: To assess the effectiveness and the change in the quality of life of patients undergoing bilateral VATS (video-assisted thoracoscopic sympathectomy) for treatment of hyperhidrosis, in a large case series. DESIGN AND SETTING: Cohort study conducted in a tertiary hospital specializing in hyperhidrosis located in São Paulo, Brazil. METHODS: A total of 2,431 patients who underwent surgery consisting of bilateral video-assisted thoracoscopic sympathectomy between January 2000 and February 2017 were retrospectively assessed in an outpatient clinic specializing in hyperhidrosis. The patients underwent clinical and quality of life assessments on two occasions: firstly, prior to surgery, and subsequently, one month after the operation. The presence or absence of compensatory hyperhidrosis (CH) and general satisfaction after the first postoperative month were also evaluated. RESULTS: All the patients operated had poor or very poor quality of life before surgery. In the postoperative period, an improvement in the quality of life was observed in more than 90% of the patients. Only 10.7% of the patients did not present CH, and severe CH occurred in 22.1% of the patients in this sample. CONCLUSION: Bilateral VATS is a therapeutic method that decreases the degree of sweating more than 90% of patients with palmar and axillary hyperhidrosis. It improves the quality of life for more than 90% of the patients, at the expense of development of CH in approximately 90% of the patients, but not intensely.

Abstract Introduction: Hemodynamic Depression (HD) characterized by hypotension and bradycardia is a complication of carotid surgery due to direct autonomic stimulation in the carotid sinus. The authors believe the incidence of HD is high and possibly related to major cardiac complications. Methods: Analysis of patient records during admissions for carotid surgery between January 2014 and December 2018 in two hospitals. HD was defined as bradycardia or hypotension in the first 24 postoperative hours. Bradycardia was defined as heart rate < 50bpm; hypotension as systolic blood pressure < 90 mmHg, continuous use of vasopressors, or a drop in SBP > 20% compared to preoperative values. Myocardial infarction, stroke, and cardiovascular death were defined as adverse events. Results: Overall, 237 carotid surgeries (178 endarterectomies, 59 angioplasties) were studied, and the global incidence of HD was 54.4% (hypotension in 50.2%, bradycardia in 11.0%, and hypotension and bradycardia in 6.8%). The independent predictors of HD were asymptomatic carotid stenosis (OR = 1.824; 95% CI 1.014 −3.280; p = 0.045), endovascular surgery (OR = 3.319; 95% CI 1.675−6.576; p = 0.001) and intraoperative hypotension or bradycardia (OR = 2.144; 95% CI 1.222−3.762; p = 0.008). Hypotension requiring continuous vasopressor infusion was the only factor independently associated with adverse cardiovascular events (OR = 5.504; 95% CI 1.729-17.529; p = 0.004). Discussion/conclusion: Incidence of Hemodynamic Depression after carotid surgery is high and independently associated with surgical technique, symptomatic repercussion of the carotid stenosis, and intraoperative hypotension or bradycardia. Hypotension requiring the continuous infusion of vasopressors was independently associated with the occurrence of MACE.

OBJECTIVES: Remarkable changes in the epidemiology of abdominal aortic aneurysm (AAA) have occurred in many countries during last few decades, which have also affected Brazilian mortality concurrently. This study aimed to investigate mortality trends related to AAA mortality in Brazil from 2000 to 2016. METHODS: Annual AAA mortality data was extracted from the public databases of the Mortality Information System, and processed by the Multiple Cause Tabulator. RESULTS: In Brazil, 2000 through 2016, AAA occurred in 69,513 overall deaths; in 79.6% as underlying and in 20.4% as an associated cause of death, corresponding to rates respectively of 2.45, 1.95 and 0.50 deaths per 100,000 population; 65.4% male and 34.6% female; 60.6% in the Southeast region. The mean ages at death were 71.141 years overall, and 70.385 years and 72.573 years for men and women, respectively. Ruptured AAA occurred in 64.3% of the deaths where AAA was an underlying cause, and in 18.0% of the deaths where AAA was an associated cause. The standardized rates increased during 2000-2008, followed by a decrease during 2008-2016, resulting in an average annual percent change decline of -0.2 (confidence interval [CI], -0.5 to 0.2) for the entire 2000-2016 period. As associated causes, shock (39.2%), hemorrhages (33.0%), and hypertensive diseases (26.7%) prevailed with ruptured aneurysms, while hypertensive diseases (29.4%) were associated with unruptured aneurysms. A significant seasonal variation, highest during autumn and followed by in winter, was observed in the overall ruptured and unruptured AAA deaths. CONCLUSIONS: This study highlights the need to accurately document epidemiologic trends related to AAA in Brazil. We demonstrate the burden of AAA on mortality in older individuals, and our results may assist with effective planning of mortality prevention and control in patients with AAA.

OBJECTIVES: Studies have identified correlations between the psychological characteristics of individuals with primary hyperhidrosis (HH), the degree of sweating, and the quality of life (QoL). This study aimed to evaluate the prevalence of anxiety and depression symptoms in patients with HH before and after oxybutynin treatment. METHODS: Data were collected from 81 patients. Palmar or axillary HH was the most frequent complaint (84.0%). All patients were evaluated before the medication was prescribed and after five weeks of treatment. The Beck Depression Inventory and Beck Anxiety Inventory were used to evaluate depression and anxiety. RESULTS: Improvement in HH occurred in 58 patients (71.6%), but there was no improvement in 23 patients (28.4%). The QoL before treatment in all patients was either “poor” or “very poor.” Patients who experienced improvement in sweating rates also experienced a greater improvement in QoL than patients who did not experience improvement in sweating at the main site (87.9% vs. 34.7%) (p<0.001). A total of 19.7% of patients showed an improvement in their level of depression, and a total of 46.9% of patients exhibited improvements in their level of anxiety. A significant correlation was observed between sweating and anxiety (p=0.015). CONCLUSION: Patients with HH who experienced improvements in sweating immediately after treatment with oxybutynin exhibited small improvements in their levels of depression and significant improvements in their levels of anxiety and QoL.

Resumo Fundamento: Aumentos nos níveis de atividade física diária são recomendados para pacientes com doença arterial periférica (DAP). No entanto, apesar dessa recomendação, pouco se sabe sobre os padrões de atividade física dos pacientes com DAP. Objetivo: Descrever os padrões de atividade física de pacientes com DAP sintomática. Métodos: Este estudo transversal incluiu 174 pacientes com DAP com sintomas de claudicação intermitente. Os pacientes foram submetidos a avaliações clínicas, hemodinâmicas e funcionais. A atividade física foi objetivamente medida por um acelerômetro, e o tempo gasto em atividades sedentárias, de baixa intensidade, de alta intensidade e atividade física moderada-a-vigorosa (AFMV) foi obtido. A análise descritiva foi realizada para resumir os dados dos pacientes e a regressão logística binária foi utilizada para testar as associações brutas e ajustadas entre a adesão à recomendação de atividade física e os fatores sociodemográficos e clínicos. Para todas as análises estatísticas, a significância foi estabelecida em p < 0,05. Resultados: Os pacientes gastaram em média 640 ± 121 min/dia, 269 ± 94 min / dia, 36 ± 27 min/dia e 15 ± 16 min/dia em atividades sedentárias, de baixa intensidade, alta intensidade e AFMV, respectivamente. A prevalência de pacientes que atingiram as recomendações de atividade física foi de 3,4%. Após ajuste para fatores de confusão, observou-se associação inversa significativa entre adesão à recomendação de atividade física e idade (OR = 0,925; p = 0,004), enquanto tempo de doença, ITB e distância total de caminhada não se associaram a esse critério de adesão (p> 0,05). Conclusão: Os padrões de atividade física dos pacientes com DAP são caracterizados por uma grande quantidade de tempo gasto em comportamentos sedentários e um baixo envolvimento na AFMV. Pacientes mais jovens, independentemente dos fatores clínicos e funcionais, apresentaram maior probabilidade de atender às recomendações atuais de atividade física.

Abstract Background: Increases in daily physical activity levels is recommended for patients with peripheral artery disease (PAD). However, despite this recommendation, little is known about the physical activity patterns of PAD patients. Objective: To describe the physical activity patterns of patients with symptomatic peripheral artery (PAD) disease. Methods: This cross-sectional study included 174 PAD patients with intermittent claudication symptoms. Patients were submitted to clinical, hemodynamic and functional evaluations. Physical activity was objectively measured by an accelerometer, and the time spent in sedentary, low-light, high-light and moderate-vigorous physical activities (MVPA) were obtained. Descriptive analysis was performed to summarize patient data and binary logistic regression was used to test the crude and adjusted associations between adherence to physical activity recommendation and sociodemographic and clinical factors. For all the statistical analyses, significance was accepted at p < 0.05. Results: Patients spent in average of 640 ± 121 min/day, 269 ± 94 min/day, 36 ± 27 min/day and 15 ± 16 min/day in sedentary, low-light, high-light and MVPA, respectively. The prevalence of patients who achieved physical activity recommendations was 3.4%. After adjustment for confounders, a significant inverse association was observed between adherence to physical activity recommendation and age (OR = 0.925; p = 0.004), while time of disease, ankle brachial index and total walking distance were not associated with this adherence criteria (p > 0.05). Conclusion: The patterns of physical activity of PAD patients are characterized by a large amount of time spent in sedentary behaviors and a low engagement in MVPA. Younger patients, regardless of the clinical and functional factors, were more likely to meet the current physical activity recommendations.

RESUMO Introdução: Em Portugal estima-se que cerca de 20.000 indivíduos sejam portadores de estoma, com todas as alterações associadas que podem comprometer a sua Qualidade de Vida (QdV). Objectivos: Avaliar a QdV de doentes ostomizados de acordo com o sexo, idade, tipo de cirurgia, doença primária, duração e tipo de estoma. Materiais e métodos: Foram incluídos todos os avaliados na consulta de Estomatoterapia entre Janeiro e Maio de 2017. A avaliação da QdV foi efetuada com recurso ao Questionário de QdV Stoma care. Avaliaram-se quatro domínios: autoestima e autoimagem (SeSi); relação com família e amigos (FF) relação com sono e cansaço e inseguranças relacionada com funcionamento do dispositivo (DeF). Resultados: Doentes com urostomia apresentaram Scores Total, SeSi e FF, significativamente superior a doentes com colostomia e ileostomia. Relativamente ao score SeSi, os doentes com idade igual ou superior a 70 anos e doença maligna apresentaram scores significativamente maiores que os mais jovens e com doenças benignas, respectivamente. Quanto ao score FF verificou-se que doentes com causas malignas apresentaram scores significativamente superiores aos com causas benignas. Conclusões: Doente ileostomizados e colostomizados apresenta QdV significativamente inferior aos doentes com urostomia, sobretudo devido ao impacto nas relações sociais, auto-estima e auto-imagem.

ABSTRACT Introduction: In Portugal around 20,000 individuals are ostomized, with all the associated changes in patients' everyday life that can compromise their Quality of Life (QoL). Objectives: Assess and compare QoL of a group of ostomized patients according to sex, age group, type of surgery, primary disease, stoma duration and stoma type. Material and methods: Ostomized patients observed in Stomatherapy department in between January 1st and May 30th 2017 was enrolled. QoL was assessed using the questionnaire Stoma Care QoL Questionnaire). Four domains were evaluated: Self-esteem and Self-image - SeSi Score; relation with Family and Friends - FF Score; relation with Sleep and Fatigue - SF score and ostomy Device Functioning insecurities - DeF score. Results: Urostomy patients had significantly higher Total Scores, SeSi and FF scores than colostomy and ileostomy patients. Regarding SeSi Score, patients aged 70 years old or more and malignant diseases presented significantly higher scores than their younger counterparts and benign causes, respectively. FF Score document that patients with malignant diseases have significantly higher scores than patients with benign diseases. Conclusions: Ileostomy and colostomy patients have a significantly lower QoL than urostomy patients mostly because of its impact on social relations and self-esteem and self-image.

Abstract: Background: The present paper aims to study the prevalence of the various manifestations of hyperhidrosis in patients who sought treatment in a specialized ambulatory in the state of São Paulo. Objectives: Opposite to previous studies, this paper studies the different combinations of sweating sites, not being restricted to the main complaint site of the patients, but taking into consideration secondary complaints patients may present. Methods: This was a retrospective approach of a database containing more than 1200 patients in which were mapped: combination of sweating sites, age of onset, age spectrum, mean age, body mass index and gender of patients. Patients were categorized into four groups based on their main sweating site - palmar, plantar, axillary and facial. Results: We concluded that hyperhidrosis appears frequently in more than one site, being the main complaint that affects the most patients palmar hyperhidrosis, which appears early in the patients during adolescence. When there are two sites of sweating, the most frequent combination is palmar + plantar, and when there are three sites of sweating the most frequent combinations are palmar + plantar + axillary and axillary + palmar + plantar. Study limitations: This research has casuistics limited to a single care service for patients with hyperhidrosis. Conclusion: It is necessary to keep in mind that the disease manifests itself mainly in more than one location, with different intensities in each of the patients, generating a significant impairment of their quality of life.

Resumo O acesso ao sistema venoso, seja para coleta de amostras de sangue ou para infusão de soluções, é de vital importância para o diagnóstico e tratamento de pacientes com as mais variadas condições clínicas. Desde que Harvey, em 1616, descreveu o sistema circulatório a partir de estudos em animais e que Sir Christopher Wren, 4 décadas depois, realizou a primeira infusão endovenosa em seres vivos, a evolução na técnica de acesso e nos dispositivos para infusão tem sido constante. Merece destaque a criação dos cateteres de longa duração na década de 1970, em especial os totalmente implantáveis, que revolucionaram o tratamento do câncer, aumentando a segurança e o conforto dos pacientes oncológicos. Este artigo tem como objetivo a revisão de dados históricos relativos ao acesso vascular e a discussão da técnica de implante e das principais complicações associadas ao procedimento de colocação e ao uso dos cateteres totalmente implantáveis.

Abstract Access to the venous system is of vital importance for diagnosis and treatment of patients with the most varied range of clinical conditions, whether for taking blood samples or for infusion of solutions. In 1616, Harvey described the circulatory system on the basis of studies in animals and 4 decades later Sir Christopher Wren conducted the first intravenous infusions in living beings. Since then there has been constant evolution in access technique and infusion devices. Of particular note is the creation of long-term catheters in the 1970s, particularly totally implantable devices, which revolutionized cancer treatment, increasing both safety and comfort for oncology patients. The objectives of this article are to review historical data on vascular access and discuss the implantation technique and the main complications associated with procedures for placement and use of totally implantable venous access devices.

RESUMO Objetivo: Descrever as diferenças de achados entre a angiofluoresceinografia (FA) e a angiografia digital com indocianina verde (ICG) em pacientes com coriorretinopatia serosa central crônica (CSC), incluindo imagens de tomografia de coerência óptica (OCT). Métodos: Série de casos em que 10 pacientes consecutivos com CSC crônica submetidos à avaliação multimodal, que incluiu FA, ICG e OCT (Spectralis HRA-OCT, Heidelberg Engineering, Heidelberg; Germany). Os pacientes foram avaliados quanto às mudanças como hiperfluorescências (causadas por aumento da transmissão da fluorescência coroidal normal, impregnação ou "pooling") e hipofluorescências (causadas pelo bloqueio ou defeito de enchimento vascular) nas fases precoce (4 minutos), intermediárias (4-8 minutos) e tardias (acima de 8 minutos) da angiografia e comparadas aos achados de OCT. Resultados: Sete dos 10 pacientes (19 olhos) eram homens, média (± DP) de idade dos pacientes foi de 50,7 ± 8,4 anos, e doença bilateral estava presente em nove dos 10 pacientes. Áreas de descontinuação ou atenuação da camada do epitélio pigmentado da retina (EPR), hiporreflectivas no OCT e hiperfluorescência por defeito em janela na FA e ICG ocorreram em locais coincidentes durante as mesmas fases do exame. Em áreas de descolamento seroso ou do EPR, o padrão de hiperfluorescência também foi semelhante em relação à FA e à ICG. No entanto, a ICG demonstrou áreas de hiperfluorescência secundária a hiperpermeabilidade coriocapilar sem mudança correspondente na FA em 12(70%) dos 19 olhos. Este achado da ICG ficou mais evidente nas fases precoces e intermediárias dos exames e não houve mudança evidente na arquitetura da retina no OCT nessas regiões de alteração de hiperpermeabilidade da coroide. Conclusão: Em pacientes com CSC crônica, a ICG pode revelar anormalidades da coróide não evidentes na FA. Esta informação pode ajudar a aperfeiçoar o moni to ramento e tratamento da CSC.

ABSTRACT Purpose: To examine differences between fluorescein angiography (FA) and indocyanine green angiography (ICG) findings in patients with chronic central serous chorioretinopathy (CSC), comparing these with optical coherence tomography (OCT) findings. Methods: Ten consecutive patients with chronic CSC (19 eyes; 7 men; mean age, 50.7 ± 8.4 years) underwent multimodal evaluation that included FA, ICG, and OCT (Spectralis HRA-OCT, Heidelberg Engineering, Heidelberg, Germany). Changes such as hyperfluorescence (caused by increased transmission of the normal choroidal fluorescence, staining, or "pooling") and hypofluorescence (caused by a blockage or vascular filling defect) were evaluated in the early (4 min), middle (4-8 min) and late (>8 min) angiography phases and compared to OCT findings. Results: Bilateral disease was present in nine of the 10 patients. Areas of discontinuation or attenuation of the hyporeflective layer of the retinal pigment epithelium (RPE) on OCT were observed at the same locations as hyperfluorescent angiography window defects on FA and ICG within examination phases. In areas of serous or RPE detachment, the hyperfluorescence pattern was similar on FA and ICG. However, ICG demonstrated areas of hyperfluorescence secondary to choriocapillaris hyperpermeability, with no corresponding change on FA in 12 (70%) of the 19 eyes. This finding was more evident in the middle and late phases of the examinations and there was no evident change in retinal architecture on OCT in these hyperpermeable choroidal regions. Conclusion: In patients with chronic CSC, ICG may reveal choroidal abnormalities that are not evident on FA. This finding may help optimize the monitoring and treatment of CSC.

RESUMO Objetivos: Avastin® (bevacizumabe) é um anticorpo monoclonal inibidor do fator de crescimento endotelial de vasos (VEGF) utilizado "off-label" por meio de administração intravítrea para o tratamento de doenças oculares. A sua aplicação clínica associada ao custo-benefício do medicamento gerou uma demanda para seu fracionamento em frascos de dose única para utilização pela via intraocular. No entanto, a segurança do fracionamento do anticorpo em frascos de dose única ainda é alvo de discussão. Neste trabalho, a estabilidade e a eficácia do Avastin® fracionado em frascos ou ampolas de vidro de dose unitária por farmácias de manipulação do mercado foram avaliadas. Métodos: As técnicas de eletroforese em gel de poliacrilamida (PAGE), cromatografia por exclusão de tamanho (SEC), espalhamento dinâmico da luz (DLS) e turbidimetria foram empregadas para avaliar a formação de agregados de diferentes tamanhos. Alterações na atividade biológica do bevacizumabe foram estudadas utilizando ELISA. Resultados: Amostras referência e do bevacizumabe fracionado apresentaram resultados semelhantes quando analisado por gel de poliacrilamida. Por cromatografia por exclusão de tamanho, um pequeno aumento na quantidade de agregados de alta massa molar seguido de uma redução nos monômeros do bevacizumabe foram observados para as amostras das três farmácias de manipulação quando comparado ao referência. A comparação dos cromatogramas mostrou uma quantidade de redução do monômero inferior a 1% para todas as amostras fracionadas. Por espalhamento dinâmico da luz e turbidimetria, não foram detectados agregados de proteína na faixa de tamanho de micrômetro e nanômetro. No ensaio de eficácia, o bevacizumabe fracionado preservou sua função biológica pois apresentou menos de 3% de perda na capacidade de ligação ao VEGF quando comparado ao referência. Conclusão: Este estudo sugere que o bevacizumabe se mantem estável após fracionamento em ampolas e frascos de vidro de dose unitária pois não foram observadas agregação e/ou fragmentação de proteínas e perda de atividade biológica em quan tidades significativas.

ABSTRACT Purpose: Avastin® (bevacizumab) is an anti-vascular endothelial growth factor (VEGF) monoclonal antibody given as an off-label drug by intravitreal administration for treatment of ocular diseases. The drug's clinical application and its cost-benefit profile has generated demand for its division into single-use vials to meet the low volume and low-cost doses necessary for intraocular administration. However, the safety of compounding the drug in single-use vials is still under discussion. In this study, the stability and efficacy of Avastin® repacked in individual single-use glass vials and glass ampoules by external compounding pharmacies were evaluated. Methods: Polyacrylamide gel electrophoresis (PAGE), size-exclusion chromatography (SEC), dynamic light scattering (DLS), and turbidimetry were selected to detect the formation of aggregates of various sizes. Changes in bevacizumab biological efficacy were investigated by using an enzyme-linked immunosorbent assay (ELISA). Results: Repacked and reference bevacizumab showed similar results when analyzed by PAGE. By SEC, a slight increase in high molecular weight aggregates and a reduction in bevacizumab monomers were observed in the products of the three compounding pharmacies relative to those in the reference bevacizumab. A comparison of repacked and reference SEC chromatograms showed that the mean monomer loss was ≤1% for all compounding pharmacies. Protein aggregates in the nanometer- and micrometer-size ranges were not detected by DLS and turbidimetry. In the efficacy assay, the biological function of repacked bevacizumab was preserved, with <3% loss of VEGF binding capacity relative to that of the reference. Conclusion: The results showed that bevacizumab remained stable after compounding in ampoules and single-use glass vials; no significant aggregation, fragmentation, or loss of biological activity was observed.

RESUMO Objetivo: a avaliação de pacientes com hiperidrose (HH) pode ser realizada, entre outras maneiras, por questionários e escalas. O Hyperhidrosis Disease Severity Scale (HDSS) tem sido utilizado como uma forma simples e rápida. Embora o HDSS seja utilizado em outros idiomas, ainda não foi traduzido para o português, limitando sua utilização em pacientes brasileiros. O objetivo deste estudo foi traduzir o HDSS para o português e validá-lo em uma amostra brasileira. Método duzentos e noventa (290) pacientes brasileiros (69% mulheres, idade média de 28,7±9,6 anos e IMC médio de 22,4±3.9 kg/m2) com HH foram avaliados pelo HDSS, pelo Questionário de Qualidade de Vida (QQV) e pelo Questionário de Evolução da Sudorese (QES) antes e após 5 semanas de tratamento com oxibutinina. Para a validação de constructo do HDSS, foi realizada a associação entre seus resultados com os dos outros dois questionários. Para analisar a sua sensibilidade, foi realizada a análise do efeito pré e pós-tratamento com oxibutinina. Além disso, foi analisada a sua reprodutibilidade em uma subamostra, na qual a escala foi aplicada novamente após 7 dias da primeira consulta. Resultados observamos correlação estatística entre o HDSS e o QQV e entre o HDSS e o QES antes do tratamento e após 5 semanas. O HDSS demonstrou ser reprodutível e sensível em relação ao efeito do tratamento. Conclusão a versão em português da escala HDSS apresentou validade e reprodutibilidade em amostra brasileira e pode ser utilizada como instrumento na assistência à saúde de pacientes com HH.

SUMMARY Introduction The evaluation of patients with hyperhidrosis (HH) can be accomplished, among other ways, through questionnaires and scales. The Hyperhidrosis Disease Severity Scale (HDSS) has been used as a simple and quick tool to perform this evaluation. Although HDSS has been well established in several languages, it has not been translated into Portuguese, restricting its specific use for Brazilian patients. The aim of this study was to translate HDSS into Portuguese and validate it in a sample of Brazilian subjects. Method 290 Brazilian patients (69% women, with a mean age of 28.7±9.6 years and BMI 22.4±3.9 kg/m2) diagnosed with HH were evaluated using HDSS, Quality of Life Questionnaire (QLQ) and Sweating Evolution Questionnaire (SEQ) before and after a five-week oxybutynin treatment. Regarding validation, an association between HDSS results and two other questionnaires was performed. To analyze HDSS sensitivity, evaluation of effects pre- and post-treatment with oxybutynin was conducted. Furthermore, HDSS reproducibility was analyzed in a subsample in which the scale was applied again after 7 days of the first follow-up appointment. Results There was statistical correlation between HDSS and QLQ and between HDSS and SEQ before treatment and after 5 weeks. Additionally, HDSS was reproducible and sensitive to clinical changes after the treatment period. Conclusion The Portuguese version of HDSS has been validated and shown to be reproducible in a Brazilian sample. Therefore it can be used as a tool to improve medical assistance in patients with HH.

OBJECTIVES: To analyze angiotomographic parameters of juxtarenal aneurysms to assess the applicability of an endograft model to patients and to create in vitro and in vivo models to assess the new endograft. METHODS: A total of 49 patients with juxtarenal aneurysms were submitted to angiotomographic evaluation, and parameters such as the aortic diameter, the length of the neck, and the angulations of the celiac trunk, superior mesenteric artery and renal arteries; the distances between them; and anatomic variations were analyzed. Based on these parameters, an endograft model was developed and tested in a newly created in vitro model of juxtarenal aneurysm. An experimental model of juxtarenal aneurysm was then established in six pigs weighing 50-60 kg to assess the new endograft model. RESULTS: The angiotomographic parameters of juxtarenal aneurysm measured in this study were similar to those reported in the literature and allowed the development of an endograft based on the hourglass concept, which was applicable to 85.8% of the patients. The in vitro model of juxtarenal aneurysm evidenced good radiopacity and functionality and permitted adjustments in the new device and technical improvements in the procedures for treating these aneurysms. In addition, the porcine model of juxtarenal aneurysm was successfully created in all six animals using a bovine pericardial patch, and use of the new endograft in three pilot procedures evidenced its feasibility. CONCLUSIONS: The Hourglass endograft was rendered applicable to treatment of the majority of patients with juxtarenal aneurysms simply by changing its diameter. Moreover, the new in vitro and in vivo models were shown to be effective for assessing both the presented endograft and experiments assessing the endovascular treatment of juxtarenal aneurysms.

Objetivos: comparar a eficácia biológica da enoxaparina genérica (HeptronTM) versus enoxaparina Sanofi-Aventis na profilaxia e no tratamento da trombose venosa profunda (TVP) de membros inferiores em ensaio prospectivo, randomizado e não cego. Método: pacientes com diagnóstico de TVP de membros inferiores (grupo terapêutico, n = 57) e pacientes com indicação de profilaxia de tromboembolismo venoso (TEV), após cirurgias vasculares de grande porte ou amputações maiores (grupo profilático, n = 57), foram randomizados para receber a enoxaparina sob teste (HeptronTM) ou a droga padrão-ouro (Sanofi-Aventis). A atividade da enoxaparina foi mensurada pela análise diária da atividade antifator-Xa no pico de concentração plasmática das drogas. Foram coletados dados de ocorrência ou progressão de TVP/TEV, eventos adversos graves e sangramentos graves; e foram utilizados para a análise de eficácia e segurança clínica como objetivos secundários. Resultados: grupo terapêutico: 25 pacientes receberam enoxaparina genérica, e 32, a droga padrão-ouro (via subcutânea, 1 mg/kg, a cada 12 horas). Os percentuais médios de atividade antifator-Xa dentro dos limites terapêuticos foram de 62 ± 35,4% e 67,5 ± 24,7%, respectivamente (p = 0,035, para não inferioridade). Nenhum paciente apresentou progressão da TVP, embolia pulmonar clinicamente detectável ou sangramentos maiores. Grupo profilático: trinta pacientes receberam enoxaparina genérica, e 27, a droga padrão-ouro (via subcutânea, 40 mg/dia). Os percentuais médios de atividade antifator-Xa dentro dos limites terapêuticos foram de 77,9 ± 30.9% e 77,8 ± 32,9%, respectivamente (p = 0,009, para não inferioridade). Nenhum paciente desenvolveu TVP ou apresentou sangramentos maiores. Conclusão: enoxaparinas genéricas e de marca apresentaram respostas semelhantes em estudos in vivo, quando medidas pela atividade do anti-fator Xa, assim como eficácia clínica e dados de segurança similares.

Objectives: to compare the biological efficacy of generic enoxaparin (HeptronTM) versus branded Sanofi-Aventis enoxaparin for prophylaxis and treatment of lower-extremity deep venous thrombosis (DVT) in a prospective, randomized, open-label study. Methods: patients with diagnosed lower-extremity DVT (therapeutic branch, n=57) and patients requiring venous thromboembolism (VTE) prophylaxis after arterial vascular surgery or major lower-extremity amputations (prophylactic branch, n=57) were randomized to receive generic or branded enoxaparin for up to seven days. Enoxaparin activity was measured by estimating blood anti-factor Xa levels at the peak plasma concentration. As secondary outcomes, development or progression of VTE events, major adverse events and major bleeding events were considered for efficacy and safety comparisons. Results: DVT therapy: twenty-five patients received generic enoxaparin while 32 received branded enoxaparin (subcutaneous, 1 mg/kg BID). Mean percentages of anti-factor Xa levels within the target ranges were 62 ± 35.4% and 67.5 ± 24.7%, respectively (p= .035 for non-inferiority). No patient presented DVT progression, clinically detectable pulmonary embolism, or major bleeding events in any subgroup. DVT prophylaxis: Thirty patients received generic enoxaparin and 27 received branded enoxaparin (subcutaneous, 40 mg/day). Mean percentages of anti-factor Xa levels within the target ranges were 77.9 ± 30.9% and 77.8 ± 32.9%, respectively (p = .009 for non-inferiority). There were no cases of VTE or major bleeding events in any subgroup. Conclusion: generic and branded enoxaparins exhibited similar in vivo responses as measured by the anti-factor Xa activity, as well as similar clinical efficacy and safety outcomes.

OBJECTIVE: The purpose of this study was to evaluate the effectiveness of contrast-enhanced ultrasound with a second-generation contrast agent in distinguishing between occlusion and pseudo-occlusion of the cervical internal carotid artery, comparing it with that of conventional Doppler ultrasound and the gold standard, computed tomography angiography. METHOD: Between June 2006 and June 2012, we screened 72 symptomatic vascular surgery outpatients at a public hospital. Among those patients, 78 cervical internal carotid arteries were previously classified as occluded by Doppler ultrasound (without contrast). The patients were examined again with Doppler ultrasound, as well as with contrast-enhanced ultrasound and computed tomography angiography. The diagnosis was based on the presence or absence of flow. RESULTS: Among the 78 cervical internal carotid arteries identified as occluded by Doppler ultrasound, occlusion was confirmed by computed tomography angiography in only 57 (73.1%), compared with 59 (77.5%) for which occlusion was confirmed by contrast-enhanced ultrasound (p>0.5 vs. computed tomography angiography). Comparing contrast-enhanced ultrasound with Doppler ultrasound, we found that the proportion of cervical internal carotid arteries classified as occluded was 24.4% higher when the latter was used (p<0.001). CONCLUSIONS: We conclude that, in making the differential diagnosis between occlusion and pseudo-occlusion of the cervical internal carotid artery, contrast-enhanced ultrasound with a second-generation contrast agent is significantly more effective than conventional Doppler ultrasound and is equally as effective as the gold standard (computed tomography angiography). Our findings suggest that contrast-enhanced ultrasound could replace computed tomography angiography in this regard.