In der vorliegenden Arbeit werden die Ergebnisse von Stent Implantationen bei Kindern mit angeborenen Herzfehlern an der Humboldt Universität zu Berlin, Charité vorgestellt. Zwischen 1994 und 2001 wurden bei 103 Patienten 146/149 Stents erfolgreich in 115 Gefäßstenosen oder Ductus arteriosus implantiert. Das Alter der Patienten bei der Implantation lag zwischen einem Tag und 34 Jahren (ein erwachsener Patient), im Mittel 4 Jahre, Median 1,1 Jahre; das Körpergewicht lag zwischen 1,75 kg und 75 kg, im Mittel 14,4 kg bei einem Median von 7,5 kg. Von den 149 Stents wurden 39,5% in periphere Pulmonalarterienstenosen, 17,5% in Aortenisthmusstenosen, 28,5% in den Ductus arteriosus, 8,5% in Systemvenenstenosen und 6% in Pulmonalvenenstenosen. 40% der 146 erfolgreich implantierten Stents wurden palliativ, 60% kurativ implantiert. Während eines Nachbeobachtungszeitraumes von einem Monat bis 7,5 Jahren, im Mittel 2,14 Jahren, wurden 60 der implantierten Stents insgesamt 79 mal redilatiert. 15 dieser Stents zweimal und 4 dreimal. Der häufigste Grund für eine Redilatation war das Körperwachstum der Patienten (58%). In-Stent Restenosen aufgrund von Intima-Proliferation führten in 25,5% zu einer Redilatation, die übrigen 16,5% Restenosen wurden durch Kompression von außen verursacht. Bei der vorliegenden Studie zeigte sich, dass die Stent-Implantation nicht nur eine effektive Methode zur Behandlung von Gefäßstenosen bei Patienten mit angeborenen Herzfehlern ist. Vielmehr gilt sie bei dem vorgestellten Patientengut als: 1. Vorbereitung, Erleichterung oder Ermöglichung von korrigierenden Operationen bei Neugeborenen durch palliativen Stent Einsatz in den Ductus arteriosus, Aortenisthmusstenosen oder in interventionell eröffnete rechtsventrikuläre Ausflußtrakte; 2. Vermeidung komplexer chirurgischer Eingriffe durch Stent Implantationen in native Aortenisthmusstenosen oder in den Ductus arteriosus bei Patienten mit kritischer Pulmonalstenose oder- atresie mit intaktem Ventrikelseptum; 3. Verbesserung post-operativer Ergebnisse und damit Verbesserung der langfristigen Prognose durch Beseitigung post-operativer Restenosen, zum Beispiel peripherer Pulmonalstenosen nach operativer Korrektur einer Fallotschen Tetralogie. Darüber hinaus lassen sich mit Hilfe von Stents komplexe chirurgisch/interventionelle Therapiestrategien, zum Beispiel dem Etablieren einer Fontanzirkulation, verwirklichen. Da in den meisten Fällen ein lebenslanger Verbleib der Stents geplant war wurden ausschließlich ballonexpandierbare Stents implantiert. Diese können, dem Alter und dem Körperwachstum der Patienten entsprechend durch Redilatation angepaßt werden. Diese limitierten Langzeit-Ergebnisse erscheinen diesbezüglich vielversprechend. Dagegen sind die Ursachen der In-Stent Restenosen aufgrund von Intima-Proliferation, die bei einigen Kindern gefunden wurden, noch nicht verstanden und bedürfen weiterer Untersuchungen. Eine Limitation der vorgestellten Methode besteht in der Stent-Technologie. Derzeit stehen keine Stents zur Verfügung, die im Neugeborenenalter implantiert werden können und bis zum Abschluß des Größenwachstums der Patienten eine gefäßstützende Funktion gewährleisten. Neue Stent-Technologien sind daher für den kurativen Einsatz bei Neugeborenen und kleinen Säuglingen erforderlich und werden in dieser Arbeit im Tiermodel vorgestellt. Zwei unterschiedliche neu Stents, die von zwei unabhängigen Herstellern entwickelt wurden, können durch eine Miniaturisierung der Einführungssysteme im Neugeborenenalter eingesetzt werden und ermöglichen eine Erweiterung der gestenteten Gefäßdurchmesser von minimal 4 Millimeter auf über 20 Millimeter. Weitere chronische Untersuchungen im Tiermodel sind notwendig bevor diese neuen Stent-Technologien in die klinische Erprobung bei Neugeborenen mit angeborenen Herzfehlern eingeführt werden können. / This study reports on stent implantation in paediatric patients with congenital heart disease at the department of paediatric cardiology, Humboldt university of Berlin, Charité. Between 1994 and 2001 146/149 stents were successfully implanted in 115 lesions or arterial ducts of 103 patients. The age of the patients ranged between 1 day and 34 years (one adult patient), mean 4 years, median 1.1 years; the bodyweight was measured between 1.75 kg and 75 kg, mean 14.4 kg, median 7.5 kg. The stent were implanted into different lesions: 39.5% in peripheral pulmonary artery stenoses, 17.5% in coarctation, 28.5% in the arterial duct, 8.5% in systemic vein stenoses and 6% in pulmonary vein stenoses. The implantations were performed for palliativ reasons in 40% or as a definite treatment in 60%. During a follow up period between 1 months and 7.5 years, mean 2.14 years 79 repeat dilations were performed on 60 stents, 15 stents twice and 4 stents three times. The most common reason for repeat intervention were dilation according to patients growth (58%). In-stent restenoses due to intimal hyperplasia were noted in 25.5% and 16.5% restenoses occurred due to compression from surrounding structures. The results of this study demonstrated stent-implantation not only as an effective method for treatment of vessel stenosis in young patients with congenital heart diseases. In addition 1. palliative stenting of the arterial duct, critical coarctation or right ventricular outflow tract obstruction in neonates improves surgical outcome or increases operability. 2. stent implantation can be an attractive alternative to complex surgery i.e. the establishment of Fontan circulation as part of a combined surgical/interventional concept 3. postoperative stenting of restenosis improves surgical results and reduces mortality and morbidity by reduction of the individual number of surgical procedures. Balloon expandable stents were used exclusively as the vast majority were considered to treat vessel stenosis for a lifelong period. The limited experiences on long-term follow-up are encouraging concerning the possibility of repeat dilation according to patients growth. However, the mechanisms of in-stent restenosis are not fully understand. For long-term treatment of vessel stenosis in neonates and small infants the conventional stent technology was found as a major limitation. New stent-designs are necessary. The report encloses two different new stent-technologies in animal studies. Miniaturised stents and delivery systems developed by two different companies are demonstrated. An additional advantage of the new stent designs is the broad variability of the stent diameters. After the initial implantation with a minimum diameter of 4 millimetres those stents can be dilated to a maximum diameter of more than 20 millimetres. Further investigations are necessary to demonstrate the efficacy of the new stent designs in different lesions of human neonates.

Introdução e objetivo: A avaliação da gravidade da neoplasia em pacientes com câncer de próstata tem como propósito identificar e tratar somente os pacientes com doença clinicamente significativa. Os parâmetros clínicos e histopatológicos tradicionalmente utilizados na estratificação de risco classificam erroneamente uma parcela importante dos pacientes. O objetivo deste estudo foi avaliar o papel da ressonância nuclear multiparamétrica de próstata (RNMMP) e da biópsia transretal realizada com fusão de imagem e estimativa visual na estratificação precoce dos pacientes em vigilância ativa. Métodos: Foram incluídos prospectivamente pacientes com câncer de próstata de baixo risco candidatos a vigilância ativa: biópsia inicial convencional com no mínimo 12 fragmentos; escore de Gleason <= 6; PSA sérico <= 10,0; <= 3 fragmentos positivos; <= 50% de acometimento de cada fragmento; toque T1c ou T2a. Todos os pacientes foram submetidos à RNMMP e biópsia confirmatória: biópsia aleatória sistemática e biópsia guiada com fusão de imagem (ultrassom e RNMMP) e analisada por método cognitivo de estimativa visual. As regiões suspeitas para câncer foram definidas e classificadas utilizando-se a escala PI-RADS (Prostate Imaging Reporting and Data System). Definimos reclassificação na biópsia confirmatória como aparecimento de escore de Gleason >= 7, > 3 fragmentos positivos ou >= 50% de envolvimento de qualquer fragmento. A performance da RNMMP em prever os resultados da biópsia confirmatória foi estudada. Análise uni e multivariada mediante regressão logística avaliou a relação entre idade, PSA, densidade de PSA, número de fragmentos positivos na biópsia inicial e o escore da RNMMP e a chance de reclassificação na biópsia confirmatória. Resultados: Cento e cinco pacientes estiveram disponíveis para análise final. Quarenta e dois (40%) pacientes apresentaram PI-RADS 1,2 ou 3 e 63 (60%) PI-RADS 4 ou 5. No geral, 87 pacientes foram submetidos à biópsia guiada com fusão. A taxa de reclassificação entre pacientes com PI-RADS 1,2,3,4 e 5 foi de 0%, 23.1%, 9.1%, 74.5% e 100%, respectivamente. No geral, a sensibilidade, especificidade, valor preditivo positivo (VPP) e valor preditivos negativo (VPN) da RNMMP para predição de reclassificação foi de 92.5%, 76%, 81% e 90.5%, respectivamente. Daqueles reclassificados, 47 (44.8%) tinham escore de Gleason >= 7 e 11 apresentavam (10.4%) >= 3 fragmentos positivos e >= 50% de envolvimento de qualquer fragmento individualmente. Na análise multivariada, somente a densidade de PSA e a RNMMP permaneceram como fatores preditivos significativos para reclassificação (p < 0,05). Na tabulação cruzada a biópsia aleatória sistemática teria deixado de classificar corretamente 15 pacientes com câncer significativo detectados pela biópsia com fusão de imagem. Por outro lado, a biópsia aleatória sistemática detectou cinco casos de câncer significante que não teriam sido identificados pela biopsia de fusão de imagem isoladamente. Conclusões: A RNMMP é uma ferramenta importante na predição da taxa de reclassificação da gravidade da neoplasia de próstata em pacientes candidatos à vigilância ativa submetidos à biopsia confirmatória. A taxa de reclassificação na biopsia confirmatória é particularmente alta no grupo de pacientes com lesões PI-RADS grau 4-5. Apesar da utilidade da biópsia com fusão de imagem, recomenda-se a manutenção da prática de se retirar fragmentos sistemáticos aleatórios quando da realização da biópsia confirmatória para maximizar a detecção de neoplasia de comportamento agressivo / Introduction and objective: The goal of prostate cancer (PCa) risk stratification is to identify and treat only men with clinically significant disease. Clinical and pathologic parameters currently used to stratify PCa risk misclassify a significant amount of patients. The objective of this study was to evaluate the role of multiparametric magnetic resonance imaging of the prostate (mpMRI) and transrectal guided biopsy with visual estimation (TRUS-Bx) in early risk stratification of patients with prostate cancer on active surveillance. Methods: Study subjects were prospectively enrolled including patients with low risk, low-grade, localized PCa: Gleason <= 6, T1c-T2a, PSA <=10 ng/ml, no more than 3 positive cores and <= 50% involvement of single cores. They were followed with subsequent mp-MRI and confirmatory biopsy (CB): standard biopsy (SB) and visual estimation-guided TRUS-Bx. Cancer-suspicious regions (CSRs) were defined using Prostate Imaging Reporting And Data System (PIRADS) scores. Reclassification occurred if CB confirmed Gleason >= 7, > 3 positive fragments or >= 50% involvement of any core. The performance of mp- MRI on predicting CB results was assessed. Univariate and multivariate logistic regression were performed to study relationships between age, PSA, PSA density, number of positive cores in the initial biopsy and mpMRI grade on CB reclassification. Results: 105 patients were available for analysis. 42 (40%) patients had PIRADS 1,2 or 3 lesions and 63 (60%) had only grades 4 or 5 lesions. Overall, 87 patients underwent visual estimation TRUS-Bx. Reclassification among patients with PI-RADS 1,2,3,4 and 5 was 0%, 23.1%, 9.1%, 74.5% and 100%, respectively. Overall, mpMRI sensitivity, specificity, PPV and NPV for disease reclassification were 92.5%, 76%, 81% and 90.5%, respectively. Of men reclassified 47 (44.8%) were upstaged because of Gleason >= 7, 11 (10.4%) because of >= 3 positive fragments plus >= 50% involvement. On multivariate analysis, only PSA density and mpMRI remained significant for reclassification (p < 0,05). On cross-tabulation SB would have missed 15 significant cases detected by targeted biopsy. On the other hand SB detected 5 cases of significant cancer not detected by targeted biopsy alone. Conclusions: Multiparametric magnetic resonance imaging is a significant tool for predicting cancer severity reclassification on CBx among AS candidates. The reclassification rate on CBx is particularly high in the group of patients who have PI-RADS grades 4 or 5 lesions. Despite the usefulness of visual-guided biopsy, it still remains highly recommended to retrieve standard fragments during CBx in order to avoid missing significant tumors

INTRODUÇÃO: Durante procedimentos endovasculares, estão presentes os riscos relacionados ao uso dos contrastes iodados, tais como a nefropatia por contraste, uma vez que é fundamental o emprego de um meio de contraste para a obtenção das imagens radiológicas vasculares. A injeção intravascular de gás CO2 purificado é reconhecidamente uma alternativa relativamente mais segura ao contraste iodado, contudo, seu manuseio artesanal pode também trazer dificuldades técnicas e riscos aos pacientes. Para contemplar estas questões, foi desenvolvido o protótipo de um injetor intravascular de CO2 medicinal, microprocessado, dedicado à obtenção de imagens angiográficas. OBJETIVOS: Realizar os testes de viabilidade técnica inicial do protótipo em modelo in vivo. MÉTODOS: Realizar a angioplastia da artéria renal esquerda de 10 porcos, divididos em 2 grupos: Grupo 1 (n=5) injeção de contraste iodado, Grupo 2 (n=5) injeção de CO2 através do protótipo. Monitorização clínica e laboratorial dos animais no pré, intra e pós-operatório, com exames de função renal na véspera e 48h após os procedimentos e 3 gasometrias arteriais seriadas no intra-operatório. Observação clínica foi mantida por 48h no pós- operatório. RESULTADOS: Os procedimentos de angioplastia com CO2 foram realizados com sucesso técnico de 100%, sem necessidade de complementação com injeção de contraste iodado no Grupo 2. Não foram identificadas falhas no protótipo em funcionamento. Não foram identificadas alterações clínicas ou radiológicas sugestivas de contaminação por ar ambiente do sistema de CO2 e nem alterações laboratoriais nos animais. As imagens angiográficas obtidas no Grupo 2 foram consideradas, numa avaliação subjetiva, relativamente inferiores às imagens obtidas no Grupo 1. DISCUSSÃO: A qualidade inferior de imagem no Grupo 2 pode ser atribuída ao equipamento de fluoroscopia utilizado, com software desatualizado em relação aos equipamentos atuais, que incluem pré-configurações para angiografia com CO2; no entanto, ainda assim todos os procedimentos propostos no Grupo 2 foram realizados com sucesso técnico, o que nos leva a classificar as imagens deste grupo 2 como satisfatórias. O manuseio do aparelho mostrou-se ágil e eficiente, com a programação dos parâmetros sendo realizada com facilidade através do visor \"touch screen\", comparativamente superior ao método artesanal de injeção de CO2 com seringas em selo d\'água. CONCLUSÕES: O protótipo do aparelho injetor intravascular de CO2 funcionou de forma adequada durante os testes e as imagens obtidas permitiram a compleição com sucesso dos procedimentos. Portanto, os resultados positivos obtidos sugerem que o equipamento é tecnicamente viável / INTRODUCTION: During endovascular procedures, several risks related to iodinated contrast media are taken, such as Contrast Induced Nephropathy, since these are fundamental to obtain radiological vascular images under fluoroscopy. Intravascular medical grade CO2 injection is a widely accepted and relatively safer alternative to iodinated contrast, but its handling and manual delivery system could as well bring risks to patients, such as room air injection. To address these problems, we developed a prototype for a micro processed intravascular medicinal CO2 injector, dedicated to help obtain angiographic images. OBJECTIVES: To perform the in vivo Early Feasibility Clinical Studies of the prototype. METHODS: Perform a left renal artery angioplasty of 10 pigs, divided in 2 groups: Group 1 (n=5) injection of iodinated contrast and Group 2 (n=5) injection of CO2 with the prototype. Clinical and laboratorial data were measured pre, peri and post-operatively, by pre-operative and 48h post- operative creatinine tests and 3 peri-operative serial arterial blood gas analysis. Animais were kept under clinical observation for 48h after procedures. RESUL TS: Angioplasty procedures had 100% technical success in both groups, without the need of extra imaging with iodinated contrast in Group 2. There were no technical failures with the prototype. There were no identifiable clinical or radiological signs of room air intravascular injections. Ali laboratorial measurements were under normal value ranges. Angiography images obtained in Group 2 were subjectively considered inferior to images from Group 1. DISCUSSION: The inferior image quality in Group 2 could be attributed to the employed fluoroscopy equipment, since its software is not up to date to current equipment, which includes a dedicated CO2 angiography preset. Nevertheless, ali procedures in Group 2 were successful, and images in this group were therefore considered satisfactory. Handling of the prototype proved to be user friendly, since ali injection parameters are performed through a touch screen panel, much superior from previous authors experience with manual saline submerged syringe filling before intravascular injection. CONCLUSIONS: The intravascular CO2 injector prototype worked properly during the tests and the obtained images allowed successful procedures without unexpected complications, in consonance with previous positive in vitro results. Therefore, the study results suggest the positive early technical feasibility of the device

La littérature concernant l’obésité semble apporter de nombreuses connaissances quant à la mise en œuvre des dispositifs de lutte contre l’obésité mais également dans celle de la pratique d’activité physique (AP). Cependant, certains éléments comme les modalités de structuration de l’AP restent encore à approfondir. Ces travaux de recherche menés sous forme de recherche-action font appel à la fois aux données de terrain mais aussi à celles de la littérature. Complétés par un encadrement pluridisciplinaire en sciences de la vie et sciences humaines, pour répondre au caractère multidimensionnel de l’obésité, l’ensemble de cette organisation en fait son originalité.Cette recherche permet de mesurer les bénéfices d’un dispositif de terrain expérimental construit en ayant pris en compte à la fois les préconisations ou recommandations des politiques publiques (Programme National Nutrition Santé ou encore Plan Obésité) ainsi que celles émanant de la littérature. Nous nous sommes plus particulièrement intéressés aux bénéfices liés aux paramètres morphologiques des personnes puis nous avons aussi noté les changements opérés dans le profil d’activité physique et des comportements sédentaires. Enfin, nous avons tenté de comprendre les éléments semblant interférer ou au contraire aider le processus de perte de poids, à travers l'étude des interactions entre les variables d'activité physique, anthropométriques, de qualité de vie et de bien-être psychologique dans le cadre du programme d'AP proposé au long cours, mais aussi l'effet de la perte de poids et de la modification du profil d'activité sur la qualité de vie et le bien-être psychologique des participantes.Ces travaux de recherche ont permis d’apporter des éléments quant à la mise en œuvre pour la prise en charge de ce public atteint d’obésité en mettant à disposition des professionnels du secteur de nombreuses connaissances scientifiques et pratiques. Ils démontrent également l’intérêt et la complémentarité de la recherche de terrain / Literature about obesity seems to bring knowledge regarding the implementation of measures to fight obesity but also in physical practice. However, some elements like the conditions of structuration of the physical practice still should be examined further. This research studies conducted under in the form of action research rely on ground data but also on literature. What makes the organization different is the use of a multidisciplinary framework in life sciences and human sciences to answer the multidimensional nature of obesity. This research allows to see / gauge the profits of such a measure of experimental ground built on both recommendations of public policies - Programme National Nutrition Santé or Plan Obésité (National Program of Health and Nutrition or Plan on obesity) – and literature. We focused particularly on profits linked to the morphological aspect of people. Then we noted the changes operated in the physical activity pattern and in sedentary behaviors. Finally, we tried to understand the conditions that seem to interfere or on the contrary help the process of weight loss through the study of interactions between the variables of physical activity, anthropometrics, quality of life and well-being psychologic of the participants. Those research studies have allowed to provide conditions about the management of that public suffering from obesity by providing sector professionals of many scientific and practical knowledge. They demonstrate also the interest and the complementarity of field work

Made available in DSpace on 2016-04-28T20:39:08Z (GMT). No. of bitstreams: 1 texto_completo3.pdf: 437756 bytes, checksum: 000cd4f1e1f27ff25af272ad5c43aad1 (MD5) Previous issue date: 2006-03-22 / Pontificia Universidade de São Paulo / The goal of this dissertation is to reflect about the school visit, a procedure that is part of the interventional psychodiagnosis of children within the existential phenomenological approach. The challenge of this work is to start with a familiar phenomenon, already known by the author, the school visit, and then, return to it, but now by analyzing the details of this resource that make possible a wider comprehension of the child and of the parents in the psychodiagnosis process. Theoretical bases about the school universe intercalated with some short cases attended by the author, as well as a clinical case, make it possible to emphasize the importance of the school visit in the psychodiagnosis process. School has a meaningful value in the child s life, because it is within this new social group, composed of different human relationships, that the child composes a new meaningful network. An understanding of the child s relationships with the teacher, classmates and other school professionals enlarges the psychological understanding of the child. The relationship between the parents and the school, and the expectations that they reveal about the institution, expands the psychologist s understanding of the family dynamic. The learning approaches, the physical areas and interlocution spaces are also considered in this work, because they reveal important aspects of the child and the parents / O objetivo desta dissertação é refletir sobre a visita escolar, procedimento que faz parte do psicodiagnóstico infantil interventivo de base fenomenológico-existencial. O desafio desse trabalho é partir de um fenômeno familiar e já conhecido pela autora, a visita escolar, e retornar ao mesmo ponto agora apreendendo as especificidades deste recurso que permite ampliar a compreensão da criança e dos pais no processo de psicodiagnóstico. Fundamentos teóricos sobre o universo escolar intercalados com vinhetas de casos atendidos pela autora, assim como um caso clínico, deram condições de enfatizar a importância da visita escolar no processo de psicodiagnóstico. A escola tem uma importância significativa na vida da criança, pois é nesse novo grupo social, composto por diversas relações humanas que ela constitui uma nova rede de significados. A compreensão das relações de uma criança com os professores, colegas e outros profissionais da escola ampliam o olhar do psicólogo sobre ela. A relação dos pais com a escola e a expectativa que estes revelam sobre a instituição ampliam também o entendimento que o psicólogo tem da dinâmica familiar. As abordagens de ensino, o espaço físico e o de interlocução também são consideradas neste trabalho, pois revelam aspectos importantes da criança e de seus pais

ABMA (aller bien pour mieux apprendre) est un dispositif de promotion de la santé en milieu scolaire élaboré à partir des données de la littérature internationale. Il a été expérimenté dans 19 établissements volontaires de l'académie de Lyon. Le dispositif a pour objectif de rendre l'établissement promoteur de santé. Les établissements bénéficient d'un accompagnement par un référent académique, de formations et de conseils méthodologiques. C'est un dispositif expérimental innovant élaboré dans le cadre du fonctionnement académique. Il s'appuie sur une démarche de projet construite avec les équipes d'établissement. Le dispositif de recherche est celui d'une recherche-intervention et repose sur une co-construction avec les établissements et les personnels académiques afin d'obtenir des données probantes sur l'approche globale de la santé en milieu scolaire. L'évaluation de processus a été mise en place dès le début de l'expérimentation. La question de recherche porte sur l'analyse des freins et des leviers pour intégrer ce type de dispositif au système éducatif français. La méthode d'évaluation est mixte, qualitative et quantitative et fait appel à des entretiens semi-directifs, à une analyse documentaire et des données quantitatives. Les variables indépendantes renvoient aux caractéristiques de l'établissement, aux résultats scolaires et au climat scolaire. Les variables dépendantes renvoient au niveau et à la qualité d'implantation du dispositif dans l'établissement. Les résultats confirment l'importance d'un accompagnement méthodologique des établissements et montrent que l'implantation du dispositif au niveau académique est essentielle dans ce type de démarche, d'abord centré sur les établissements / ABMA (increased well-being for better learning) is a health promoting school program based on international literature on the concept of health promoting schools. The planning and implementation of the health promotion program ABMA was constructed in the Lyon school board in 19 pilot schools. The program goal is to guide a school to become a health promoting school. The project is within the framework of interventional research. Our study consisted of identifying the enabling and inhibiting factors in the implementation of a health promotion program in the French education system. Evaluation methods are mixed: quantitative, but primarily qualitative. Independent variables correspond to individual characteristics of the school, to academic performance and to school climate. The dependent variables correspond to the level and quality of implementation of the program as well as the support process in the school. The results highlight the importance of the support process and show that the implication of the school board is essential for the long-term success. For schools, the main facilitating factors for global health promotion development are the involvement of the principal, regular communication to the entire educational community, a good initial evaluation of current conditions and individualized support

INTRODUÇÃO: Durante procedimentos endovasculares, estão presentes os riscos relacionados ao uso dos contrastes iodados, tais como a nefropatia por contraste, uma vez que é fundamental o emprego de um meio de contraste para a obtenção das imagens radiológicas vasculares. A injeção intravascular de gás CO2 purificado é reconhecidamente uma alternativa relativamente mais segura ao contraste iodado, contudo, seu manuseio artesanal pode também trazer dificuldades técnicas e riscos aos pacientes. Para contemplar estas questões, foi desenvolvido o protótipo de um injetor intravascular de CO2 medicinal, microprocessado, dedicado à obtenção de imagens angiográficas. OBJETIVOS: Realizar os testes de viabilidade técnica inicial do protótipo em modelo in vivo. MÉTODOS: Realizar a angioplastia da artéria renal esquerda de 10 porcos, divididos em 2 grupos: Grupo 1 (n=5) injeção de contraste iodado, Grupo 2 (n=5) injeção de CO2 através do protótipo. Monitorização clínica e laboratorial dos animais no pré, intra e pós-operatório, com exames de função renal na véspera e 48h após os procedimentos e 3 gasometrias arteriais seriadas no intra-operatório. Observação clínica foi mantida por 48h no pós- operatório. RESULTADOS: Os procedimentos de angioplastia com CO2 foram realizados com sucesso técnico de 100%, sem necessidade de complementação com injeção de contraste iodado no Grupo 2. Não foram identificadas falhas no protótipo em funcionamento. Não foram identificadas alterações clínicas ou radiológicas sugestivas de contaminação por ar ambiente do sistema de CO2 e nem alterações laboratoriais nos animais. As imagens angiográficas obtidas no Grupo 2 foram consideradas, numa avaliação subjetiva, relativamente inferiores às imagens obtidas no Grupo 1. DISCUSSÃO: A qualidade inferior de imagem no Grupo 2 pode ser atribuída ao equipamento de fluoroscopia utilizado, com software desatualizado em relação aos equipamentos atuais, que incluem pré-configurações para angiografia com CO2; no entanto, ainda assim todos os procedimentos propostos no Grupo 2 foram realizados com sucesso técnico, o que nos leva a classificar as imagens deste grupo 2 como satisfatórias. O manuseio do aparelho mostrou-se ágil e eficiente, com a programação dos parâmetros sendo realizada com facilidade através do visor \"touch screen\", comparativamente superior ao método artesanal de injeção de CO2 com seringas em selo d\'água. CONCLUSÕES: O protótipo do aparelho injetor intravascular de CO2 funcionou de forma adequada durante os testes e as imagens obtidas permitiram a compleição com sucesso dos procedimentos. Portanto, os resultados positivos obtidos sugerem que o equipamento é tecnicamente viável / INTRODUCTION: During endovascular procedures, several risks related to iodinated contrast media are taken, such as Contrast Induced Nephropathy, since these are fundamental to obtain radiological vascular images under fluoroscopy. Intravascular medical grade CO2 injection is a widely accepted and relatively safer alternative to iodinated contrast, but its handling and manual delivery system could as well bring risks to patients, such as room air injection. To address these problems, we developed a prototype for a micro processed intravascular medicinal CO2 injector, dedicated to help obtain angiographic images. OBJECTIVES: To perform the in vivo Early Feasibility Clinical Studies of the prototype. METHODS: Perform a left renal artery angioplasty of 10 pigs, divided in 2 groups: Group 1 (n=5) injection of iodinated contrast and Group 2 (n=5) injection of CO2 with the prototype. Clinical and laboratorial data were measured pre, peri and post-operatively, by pre-operative and 48h post- operative creatinine tests and 3 peri-operative serial arterial blood gas analysis. Animais were kept under clinical observation for 48h after procedures. RESUL TS: Angioplasty procedures had 100% technical success in both groups, without the need of extra imaging with iodinated contrast in Group 2. There were no technical failures with the prototype. There were no identifiable clinical or radiological signs of room air intravascular injections. Ali laboratorial measurements were under normal value ranges. Angiography images obtained in Group 2 were subjectively considered inferior to images from Group 1. DISCUSSION: The inferior image quality in Group 2 could be attributed to the employed fluoroscopy equipment, since its software is not up to date to current equipment, which includes a dedicated CO2 angiography preset. Nevertheless, ali procedures in Group 2 were successful, and images in this group were therefore considered satisfactory. Handling of the prototype proved to be user friendly, since ali injection parameters are performed through a touch screen panel, much superior from previous authors experience with manual saline submerged syringe filling before intravascular injection. CONCLUSIONS: The intravascular CO2 injector prototype worked properly during the tests and the obtained images allowed successful procedures without unexpected complications, in consonance with previous positive in vitro results. Therefore, the study results suggest the positive early technical feasibility of the device

Introdução e objetivo: A avaliação da gravidade da neoplasia em pacientes com câncer de próstata tem como propósito identificar e tratar somente os pacientes com doença clinicamente significativa. Os parâmetros clínicos e histopatológicos tradicionalmente utilizados na estratificação de risco classificam erroneamente uma parcela importante dos pacientes. O objetivo deste estudo foi avaliar o papel da ressonância nuclear multiparamétrica de próstata (RNMMP) e da biópsia transretal realizada com fusão de imagem e estimativa visual na estratificação precoce dos pacientes em vigilância ativa. Métodos: Foram incluídos prospectivamente pacientes com câncer de próstata de baixo risco candidatos a vigilância ativa: biópsia inicial convencional com no mínimo 12 fragmentos; escore de Gleason <= 6; PSA sérico <= 10,0; <= 3 fragmentos positivos; <= 50% de acometimento de cada fragmento; toque T1c ou T2a. Todos os pacientes foram submetidos à RNMMP e biópsia confirmatória: biópsia aleatória sistemática e biópsia guiada com fusão de imagem (ultrassom e RNMMP) e analisada por método cognitivo de estimativa visual. As regiões suspeitas para câncer foram definidas e classificadas utilizando-se a escala PI-RADS (Prostate Imaging Reporting and Data System). Definimos reclassificação na biópsia confirmatória como aparecimento de escore de Gleason >= 7, > 3 fragmentos positivos ou >= 50% de envolvimento de qualquer fragmento. A performance da RNMMP em prever os resultados da biópsia confirmatória foi estudada. Análise uni e multivariada mediante regressão logística avaliou a relação entre idade, PSA, densidade de PSA, número de fragmentos positivos na biópsia inicial e o escore da RNMMP e a chance de reclassificação na biópsia confirmatória. Resultados: Cento e cinco pacientes estiveram disponíveis para análise final. Quarenta e dois (40%) pacientes apresentaram PI-RADS 1,2 ou 3 e 63 (60%) PI-RADS 4 ou 5. No geral, 87 pacientes foram submetidos à biópsia guiada com fusão. A taxa de reclassificação entre pacientes com PI-RADS 1,2,3,4 e 5 foi de 0%, 23.1%, 9.1%, 74.5% e 100%, respectivamente. No geral, a sensibilidade, especificidade, valor preditivo positivo (VPP) e valor preditivos negativo (VPN) da RNMMP para predição de reclassificação foi de 92.5%, 76%, 81% e 90.5%, respectivamente. Daqueles reclassificados, 47 (44.8%) tinham escore de Gleason >= 7 e 11 apresentavam (10.4%) >= 3 fragmentos positivos e >= 50% de envolvimento de qualquer fragmento individualmente. Na análise multivariada, somente a densidade de PSA e a RNMMP permaneceram como fatores preditivos significativos para reclassificação (p < 0,05). Na tabulação cruzada a biópsia aleatória sistemática teria deixado de classificar corretamente 15 pacientes com câncer significativo detectados pela biópsia com fusão de imagem. Por outro lado, a biópsia aleatória sistemática detectou cinco casos de câncer significante que não teriam sido identificados pela biopsia de fusão de imagem isoladamente. Conclusões: A RNMMP é uma ferramenta importante na predição da taxa de reclassificação da gravidade da neoplasia de próstata em pacientes candidatos à vigilância ativa submetidos à biopsia confirmatória. A taxa de reclassificação na biopsia confirmatória é particularmente alta no grupo de pacientes com lesões PI-RADS grau 4-5. Apesar da utilidade da biópsia com fusão de imagem, recomenda-se a manutenção da prática de se retirar fragmentos sistemáticos aleatórios quando da realização da biópsia confirmatória para maximizar a detecção de neoplasia de comportamento agressivo / Introduction and objective: The goal of prostate cancer (PCa) risk stratification is to identify and treat only men with clinically significant disease. Clinical and pathologic parameters currently used to stratify PCa risk misclassify a significant amount of patients. The objective of this study was to evaluate the role of multiparametric magnetic resonance imaging of the prostate (mpMRI) and transrectal guided biopsy with visual estimation (TRUS-Bx) in early risk stratification of patients with prostate cancer on active surveillance. Methods: Study subjects were prospectively enrolled including patients with low risk, low-grade, localized PCa: Gleason <= 6, T1c-T2a, PSA <=10 ng/ml, no more than 3 positive cores and <= 50% involvement of single cores. They were followed with subsequent mp-MRI and confirmatory biopsy (CB): standard biopsy (SB) and visual estimation-guided TRUS-Bx. Cancer-suspicious regions (CSRs) were defined using Prostate Imaging Reporting And Data System (PIRADS) scores. Reclassification occurred if CB confirmed Gleason >= 7, > 3 positive fragments or >= 50% involvement of any core. The performance of mp- MRI on predicting CB results was assessed. Univariate and multivariate logistic regression were performed to study relationships between age, PSA, PSA density, number of positive cores in the initial biopsy and mpMRI grade on CB reclassification. Results: 105 patients were available for analysis. 42 (40%) patients had PIRADS 1,2 or 3 lesions and 63 (60%) had only grades 4 or 5 lesions. Overall, 87 patients underwent visual estimation TRUS-Bx. Reclassification among patients with PI-RADS 1,2,3,4 and 5 was 0%, 23.1%, 9.1%, 74.5% and 100%, respectively. Overall, mpMRI sensitivity, specificity, PPV and NPV for disease reclassification were 92.5%, 76%, 81% and 90.5%, respectively. Of men reclassified 47 (44.8%) were upstaged because of Gleason >= 7, 11 (10.4%) because of >= 3 positive fragments plus >= 50% involvement. On multivariate analysis, only PSA density and mpMRI remained significant for reclassification (p < 0,05). On cross-tabulation SB would have missed 15 significant cases detected by targeted biopsy. On the other hand SB detected 5 cases of significant cancer not detected by targeted biopsy alone. Conclusions: Multiparametric magnetic resonance imaging is a significant tool for predicting cancer severity reclassification on CBx among AS candidates. The reclassification rate on CBx is particularly high in the group of patients who have PI-RADS grades 4 or 5 lesions. Despite the usefulness of visual-guided biopsy, it still remains highly recommended to retrieve standard fragments during CBx in order to avoid missing significant tumors

Magnetic Resonance Imaging (MRI) provides unique advantages such as superior soft tissue contrast, true multiplanar imaging, variable contrast mechanisms, measurement of temperature changes, perfusion and diffusion, and no ionizing radiation. Despite considerable research efforts in the field of interventional MRI, numerous challenges remain including restricted access to the patient, high acoustic noise and a shortage of MRI-safe devices. Novel methods and devices are presented in this thesis with the primary objective of enabling effective MRI-guided interventions, particularly abdominal needle and common catheter-based endovascular interventions. Firstly, a set of MRI-safe devices (guidewires, micro guidewires, catheters and micro catheters) were developed with passive or inductively coupling resonant markers for MRI visualisation. Secondly, a method was implemented for wireless tracking and dynamic guidance of instruments. Thirdly, a framework of technologies was developed for in-room display, wireless MRI remote control and multi-user communication along with a dedicated user interface and imaging protocol. These implementations were assessed in regards to MRI-safety, performance and usability and evaluated for MRI-guided liver biopsies, balloon angioplasty procedures and also for mechanical thrombolysis. Flow phantoms, Thiel soft-embalmed human cadavers with partially re-established perfusion and a porcine model were used for in vitro, ex vivo and in vivo validation, respectively. The results demonstrate that these interventions are experimentally feasible and practical when using the presented developments: automated device tracking and equipment designed for MRI-guided interventions streamlined procedural workflow. Specifically, it was shown that fast and accurate needle placements along complex trajectories were feasible using a wireless interactive display and control device with a dedicated user interface for interventions. Moreover, safe and efficacious balloon angioplasties of the iliac artery were practical using the described framework of technologies along with a dedicated MRI protocol. Finally, it was demonstrated that these developments could be adapted and applied to MRI-guided endovascular mechanical thrombolysis of the middle cerebral artery. The technologies, described in this thesis have been shown to overcome many of the present limitations and should therefore be useful for enabling MRI-guided interventions while not further constraining the operating physician in an already complex environment. Nevertheless, it is acknowledged that many crucial issues remain to be solved in the field of iMRI and in the context of the presented research. In particular further device optimisations, improvements of the tracking implementation along with further in vivo evaluations are required before moving towards clinical evaluation. This thesis sets the groundwork for moving ahead with the eventual clinical realisation of optimised MRI-guided interventions.

Orientador: Diana Rodrigues Pina / Resumo: A Radiologia Intervencionista (RI) é a área da medicina que proporciona as maiores exposições ocupacionais. Os valores de dose aos quais os intervencionistas são expostos são difíceis de padronizar. Nesta pesquisa apresentamos uma avaliação completa das exposições ocupacionais e determinamos a eficiência de distintos métodos de dosimetria pessoal utilizados na RI. Essa pesquisa foi abordada em 2 etapas, conforme descrito a seguir: A primeira etapa se baseou em caracterizar as exposições ocupacionais em diferentes modalidades de procedimentos de RI vascular para duas categorias de profissionais e estimar o número de procedimentos anuais que cada profissional pode realizar sem exceder os limites de dose. Foi avaliada a exposição ocupacional, através de dosimetria termoluminescente, em diferentes partes do corpo (cristalino, tireoide, tórax, abdômen, pés e mãos) de duas categorias de intervencionistas (principais e assistentes) em três modalidades diferentes de procedimentos de RI vascular. As maiores doses equivalentes foram encontradas para as mão de ambos os profissionais, podendo chegar a aproximadamente 9 mSv em um único procedimento. Algumas regiões dos profissionais em alguns procedimentos podem receber, durante o ano, níveis de doses perigosamente perto dos limites anuais. Dosímetros posicionados no tórax podem subestimar as doses para outras regiões do corpo, especialmente abdômen, extremidades e cristalinos. Na segunda etapa foram avaliadas as eficiências de 6 diferent... (Resumo completo, clicar acesso eletrônico abaixo) / Abstract: Interventional Radiology (IR) is the area of medicine that provides the largest occupational exposures. The dose values to which interventionists are exposed are difficult to standardize. In this research we present a complete evaluation of occupational exposures and determine the efficiency of different personal dosimetry methods used in IR. This research was performed in 2 stages, as described below: The first step was to characterize the occupational exposures in different modalities of vascular IR procedures for two categories of professionals. We also estimated the number of annual procedures that each professional can perform without exceeding the dose limits. Occupational exposures were evaluated in different body parts (crystalline, thyroid, thorax, abdomen, feet and hands) by two interventional categories (primary and assistants) in three different modalities of vascular IR procedures. The highest equivalent doses were found for the hands of both professionals, reaching approximately 9 mSv in a single procedure. Some regions of professionals in some procedures may receive dose levels during the year dangerously close to annual limits. Dosimeters positioned in the chest may underestimate the doses to other regions of the body, especially the abdomen, extremities and crystalline. The second stage, we evaluated the efficiencies of 6 different personal dosimetry methodologies used internationally to estimate the effective dose received by interventional professionals. An... (Complete abstract click electronic access below) / Mestre