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

L’implantation valvulaire (mise en place d’une stent-valve percutanée), pulmonaire ou aortique, est une procédure récente en plein (et rapide) développement. Cette procédure prometteuse, possède plusieurs écueils parmi lesquels, l’altération du matériel implanté lors de son déploiement. L’implantation valvulaire dans les voies pulmonaires dilatées, est une autre limite de la procédure. Dans notre travail, nous avons étudié le traumatisme valvulaire lié au déploiement des prothèses. Ensuite, nous avons évalué un nouveau dispositif de réduction du calibre de la voie pulmonaire, afin d’en élargir les indications ultérieurement.Nous avons donc dans un premier temps comparé 2 types de stent-valves, l’un expansible par ballon et l’autre auto-expansible. La comparaison a porté sur l’occurrence de lésions valvulaires lors du sertissage et du déploiement de ces 2 types de prothèses. Nous avons pu montrer la présence de lésions des feuillets péricardiques de ces prothèses, induites par la compression des dispositifs. Par ailleurs, la présence de lésions histologiques plus marquées avec les valves expansibles par ballon, suggère aussi un rôle de l’expansion de ces prothèses dans la genèse des lésions valvulaires post-déploiement. Nous n’avons pas constaté d’altérations des propriétés mécaniques du tissu valvulaire induites par la compression et le déploiement des feuillets.Dans une autre partie de notre travail, nous avons mis au point un modèle d’élargissement de la voie pulmonaire, associé à la création d’une insuffisance pulmonaire sévère. Nous avons pu montrer que la réduction du calibre de la voie d’éjection pulmonaire était possible avec notre réducteur, par voie endovasculaire ou transventriculaire droite. Il n’a pas été observé de migration ou de fracture du stent de ces prothèses 2 mois après la procédure. Si le modèle d’élargissement de la voie pulmonaire est intéressant pour évaluer les réducteurs et la faisabilité de leur implantation, un suivit à plus long terme est nécessaire avant d’envisager une implantation chez l’homme. Enfin, l’altération des feuillets induite par le maniement des prothèses, est un phénomène à prendre en considération. Il nécessite, compte tenu de son impact potentiel sur la durabilité des prothèses, une investigation plus approfondie. / Percutaneous valve implantation (PVI) is a new with fast growing expansion procedure. Nevertheless, this promising technic has some reefs. Impairment of the implanted device at deployment is one of them. Valvular implantation in dilated right ventricular outflow tract (RVOT) is another limit of the procedure. In our work, we studied the valvular traumatism after prosthesis deployment. Subsequently, we evaluated a new device for RVOT size reduction, in order to widen PVI indications.Firstly, We compared 2 types of valved-stent (VS) (balloon expandable and self-expandable). We compared the occurrence of valvular leaflets injury after crimping and deployment of both types of prosthesis. We showed the occurrence of pericardial leaflet injuries, induced by devices crimping. Otherwise, the presence of sharp histologic lesions with balloon expandable VS, suggests a prosthesis expansion role, in genesis of valvular injuries, as well. We couldn’t show any impairment of valvular tissue mechanical properties after leaflets crimping and deployment. In another part of our work, experimental asymmetric enlargement of the RVOT with creation of severe pulmonary regurgitation, were performed in an ovine model. Size reduction of the enlarged RVOT and PVI were successfully achieved through an endovascular and right transventricular access. Valve function was satisfactory in all correctly implanted VS (one case of inversion). No migration or fractures of the size reducer or VS were seen before animal sacrifice, after 2 months follow-up. Since feasibility of RVOT enlargement and RVOT reduction has been demonstrated, a long-term study is necessary before considering a human implantation. At last but not least, deterioration on valvular leaflets after prosthesis handling is an effect to consider. Taking into account its potential impact on prosthesis durability, it requires further deep investigations.

A ruptura do aneurisma da aorta abdominal está entre as principais causas de óbito. A alta morbi-mortalidade associada à ruptura e tratamento dos aneurismas representa um grande desafio aos médicos e um alto risco aos pacientes. Apesar dos modelos experimentais serem úteis para compreendermos, treinarmos, testar novos métodos diagnósticos e terapêuticos para esta doença, os modelos existentes até o momento ainda não são os ideais. Nos modelos existentes, os animais são muito pequenos e não representam a doença nos humanos, ou o procedimento envolve laparotomia, ou o comportamento do aneurisma criado não é semelhante ao de um aneurisma verdadeiro. Desenvolvemos, a partir de uma abordagem minimamente invasiva, um método eficiente de induzirmos a formação de um aneurisma verdadeiro na aorta abdominal infrarrenal de porcos Large White. Os animais foram submetidos a indução química a partir de uma aplicação por via endovascular de cloreto de cálcio a 25% ou elastase pancreática suína. Os animais controles foram submetidos a tratamento com soro fisiológico (NaCl 0,9%). Todos os animais foram submetidos à mesma técnica operatória, sob anestesia geral. Os animais foram acompanhados com exames ultrassonográficos com Doppler semanalmente, e as aortas colhidas para testes biomecânicos e análise histológica após 4 semanas. Apesar das aortas tratadas com elastase apresentarem apenas dilatação, estudos de imagens, histológicos e biomecânicos mostraram que as aortas tratadas com cloreto de cálcio evoluíram para aneurismas verdadeiros, com comportamento biomecânico semelhante ao dos aneurismas de humanos. Estes resultados/achados indicam que a abordagem endovascular para a indução de aneurisma é factível e não ocasiona uma fibrose retroperitoneal / Abdominal aortic aneurysms rupture are among the main causes of death. The high morbidity and mortality associated with aneurysm rupture and repair represents a challenge for surgeons and high risk for patients. Although experimental models are useful to understand, train, and develop new treatment and diagnostic methods for this disease, animal models developed to date are far from ideal. Animals are either too small and do not represent the pathology of humans, or the procedures employ laparotomy, or the aortic behavior does not resemble that of a true aneurysm. We developed a novel, less invasive and effective method to induce true aortic aneurysms in Large White pigs. Animals were submitted to an endovascular chemical induction using either calcium chloride (25%) or swine pancreatic elastase. Controls were exposed to saline solution. All animals were operated on using the same surgical technique under general anesthesia. They were followed weekly with ultrasound examinations and at 4 weeks the aorta was harvested. Although elastase induced only arterial dilation, imaging, histological, and biomechanical studies of the aorta revealed the formation of true aneurysms in animals exposed to calcium chloride. Aneurysms in the latter group had biomechanical failure properties similar to those of human aneurysms. These findings indicate that the endovascular approach is viable and does not cause retroperitoneal fibrosis

INTRODUÇÃO: As imagens de lesões hiperdensas encontradas em exames de tomografia (TC) de crânio após o tratamento endovascular do acidente vascular cerebral isquêmico (AVCi) agudo têm sido correlacionadas ao risco de transformação hemorrágica após o AVC. Entretanto, a correlação entre as lesões hiperdensas e a área cerebral infartada é desconhecida. O objetivo deste estudo é determinar a correlação entre as lesões hiperdensas encontradas em TC de crânio realizadas logo após tratamento endovascular do AVCi agudo e a área de AVC isquêmico. MATERIAIS E MÉTODOS: Foram coletados retrospectivamente dados radiológicos de pacientes com AVCi agudo por oclusão de grandes vasos da circulação anterior submetidos ao tratamento endovascular. Foram analisadas imagens de TC de crânio nas primeiras 24 horas e até 21 dias após o tratamento. As áreas hiperdensas foram classificadas utilizando o escore ASPECTS e comparadas com as áreas de AVC isquêmico final pelo mesmo escore. As imagens foram analisadas independentemente por dois avaliadores, sendo que um terceiro avaliador analisou os casos discordantes. A concordância entre avaliadores (CCI) e os valores de sensibilidade, especificidade, preditivos positivo e negativos e acurácia foram calculados. RESULTADOS: Lesões hiperdensas foram encontradas em 71 dos 93 (76,34%) pacientes com AVC isquêmico de circulação anterior. As áreas captantes de contraste corresponderam às áreas de AVC final segundo o escore ASPECTS (CCI=0,58 [0,40 0,71]). Os valores para cada região individual foram avaliados e a sensibilidade variou de 58,3% a 96,9%, a especificidade de 42,9% a 95,6%, os valores preditivos positivos de 71,4% a 97,7%, os valores preditivos negativos de 53,8% a 79,5% e os valores de acurácia de 0,68 a 0,91. Os maiores valores de sensibilidade foram encontrados para os núcleos lentiforme (96,9%) e caudado (80,4%) e para a cápsula interna (87,5%) e os menores para os córtices M1 (58,3%) e M6 (66,7%). CONCLUSÕES: A aplicação do escore ASPECTS para avaliação das imagens de tomografia de crânio após o tratamento endovascular do AVCi agudo que apresentam captação de contraste, demonstrou ser uma ferramenta útil para a predição da área final de infarto cerebral. A predição foi maior na região profunda e menor nos córtices cerebrais, provavelmente devido maior circulação colateral cortical. Além disso, o método se mostrou reprodutível e de fácil utilização. / INTRODUCTION: The hyperdense lesions images found in head computed tomography (CT) scan after endovascular treatment have been correlated to risk of hemorrhagic transformation after stroke. However, the correlation between hyperdense lesions and the infarcted brain area is unknown. The aim of this study is to determine the correlation between the hyperdense lesions found on CT scan performed after endovacular treatment of acute stroke and final ischemic stroke area. MATERIALS AND METHODS: It was collected radiological data of patients with acute ischemic stroke by occlusion of large vessels in the anterior circulation were treated with endovascular treatment. Head CT scan were evaluated in the first 24 hours and by 21 days after treatment. The hyperdense areas were rated using the ASPECTS score and compared with final ischemic stroke by the same score. The images were analyzed independently by two reviewers, and a third evaluator examined the discordant cases. The interrater agreement (ICC) and the sensitivity, specificity, positive and negative predictive values and accuracy were calculated. RESULTS: hyperdense lesions were found in 71 of 93 (76.34%) patients with ischemic stroke of anterior circulation. The contrast iodineaccumulating areas corresponded to the final stroke areas (ICC = 0.58 [0.40 to 0.71]) as the ASPECTS score. The values for each individual region were evaluated and the sensitivity ranged from 58.3% to 96.9%, specificity of 42.9% to 95.6%, the positive predictive value of 71.4% to 97, 7%, the negative predictive value of 53.8% to 79.5% and the accuracy of values from 0.68 to 0.91. The higher sensitivity found for lenticular nuclei (96.9%) and caudate (80.4%) and the internal capsule (87.5%) and lower for M1 (58.3%) and M6 (66.7%) cortices. CONCLUSIONS: The use of the ASPECTS score for evaluation of CT head scan after endovascular treatment of acute ischemic stroke images that exhibit contrast enhancement proved to be a useful tool for predicting the final ischemic stroke area. The prediction was higher in the deep region and lower in the cerebral cortex, probably because the cortical collateral circulation. Futhermore, these method was reproducible and easy to use.

Dados de grandes estudos sobre a ocorrência de complicações vasculares pós-procedimentos percutâneos realizados em laboratórios de hemodinâmica são vastos na literatura. Contudo, a avaliação dos resultados clínicos dos pacientes após intervenções de enfermagem visando minimizá-las ou evitá-las ainda são incipientes na prática, com registros pouco objetivos e sistemáticos. Nesta perspectiva, a Nursing Outcomes Classification (NOC), que é uma classificação de resultados sensíveis às intervenções de enfermagem, possibilita o desenvolvimento de instrumentos com indicadores clínicos passíveis de serem medidos durante a avaliação clínica do enfermeiro. Todavia, essa classificação ainda carece de resultados que contemplem a diversidade de situações enfrentadas pelos pacientes na prática clínica. Nessa perspectiva, o presente estudo objetivou desenvolver um novo Resultado de Enfermagem em consonância com a Nursing Outcomes Classification - NOC para avaliação das complicações no acesso vascular pós-procedimentos percutâneos. Trata-se de um estudo de Análise de Conceito segundo o modelo de Walker e Avant. Como suporte teórico para a identificação dos possíveis usos do conceito foi realizada uma revisão de escopo com base na metodologia proposta pelo Instituto Joanna Briggs. Elaborou-se um protocolo da revisão com estratégia de busca em três etapas: busca inicial nas bases de dados PubMed e CINAHL; segunda busca nas bases de dados PubMed, CINAHL, Scopus e LILACS; e terceira estratégia de busca nas referências dos artigos identificados, considerados estudos adicionais. Os aspectos éticos foram respeitados. Foram incluídas 128 publicações, que permitiram mapear os diferentes contextos de estudo das complicações vasculares relacionadas ao local de acesso, a ocorrência das complicações de acordo com as vias, bem como a apresentação e evolução clínica das complicações. Quanto ao conceito em estudo, “complicações vasculares” em procedimentos percutâneos, constatou-se ser amplamente estudado pela área médica, com contribuições relevantes da área de enfermagem. O conceito pode ser entendido como um conjunto de complicações no local de acesso vascular do procedimento, que podem desenvolver-se isoladamente ou agrupadas, e apresentar diferentes níveis de gravidade. O novo Resultado de Enfermagem foi denominado Nível de complicação: acesso vascular, composto por definição e 11 indicadores. Foram construídas definições conceitual e operacional para cada indicador, bem como para os cinco níveis da escala likert: 1-Grave, 2-Substancial, 3-Moderado, 4-Leve e 5-Nenhum. Propôs-se a inserção deste resultado no Domínio II- Saúde Fisiológica, Classe E - Cardiopulmonar. Esta pesquisa poderá contribuir para o aperfeiçoamento da taxonomia da NOC ao dispor de um novo resultado que atenda às necessidades da prática clínica, com indicadores mais específicos e padronizados para uma avaliação acurada dos níveis de complicação no acesso vascular de pacientes após procedimentos percutâneos. Planeja-se validar o novo resultado e submetê-lo à apreciação da equipe de pesquisadores da NOC. / There is extensive data from studies on the occurrence of vascular complications following percutaneous procedures conducted in hemodynamics laboratories. However, assessment of clinical outcomes in patients submitted to nursing interventions, aimed to minimize or prevent such complications, is incipient, without objective and systematic records. Therefore, the Nursing Outcomes Classification (NOC), a classification of outcomes sensitive to nursing interventions, allows developing tools with clinical indicators that can be measured during clinical examination conducted by nurses. However, this classification still lacks outcomes that contemplate the various situations faced by patients in clinical practice. Therefore, the present study aimed to develop a new Nursing Outcome, consistent with the Nursing Outcomes Classification – NOC, for assessment of vascular complications resulting from percutaneous interventions. The study used a concept analysis method based on Walker and Avant’s model. For theoretical support to the identification of the possible uses of the concept, scope review based on Joanna Briggs methodology was conducted. A protocol of the review was created, with a search strategy in three steps: initial search in PubMed and CINAHL databases; second search in databases PubMed, CINAHL, Scopus and LILACS; and third search strategy in the references of the identified articles, considered additional studies. The ethical aspects were observed. In total, 128 publications were included, which allowed mapping the different contexts of study of the vascular complications related to the access site, occurrence of vascular complications according to the access routes, as well as clinical presentation and evolution of complications. The study concept “vascular complications” in percutaneous interventions has been widely studied in the medical field, with relevant contributions in the nursing area. The concept can be understood as a set of complications in the vascular access site of the intervention that may occur separately or associated, with different levels of severity. The new Nursing Outcome was named Level of Complication: vascular access, composed by a definition and 11 indicators. Conceptual and operational definitions were constructed for each indicator and for the five levels of the Likert scale: 1- Severe, 2- Substantial, 3- Moderate, 4- Mild and 5- None. Insertion of this outcome in Domain II- Physiological Health, Class E- Cardiopulmonary is proposed. This study may contribute to the improvement of NOC taxonomy by proposing a new outcome that meets the needs of clinical practice, including more specific and standardized indicators to ensure a more accurate assessment of the rates of complications in vascular access of patients after percutaneous interventions. The new outcome shall be validated and submitted to appreciation by NOC researchers. / Datos de grandes estudios sobre la ocurrencia de complicaciones vasculares post-procedimientos percutáneos realizados en laboratorios de hemodinamia son amplios en la literatura. Sin embargo, la evaluación de los resultados clínicos de los pacientes después de intervenciones de enfermería visualizando minimizarlas o evitarlas aún son incipientes en la práctica, con registros poco objetivos y sistemáticos. En esta perspectiva, la Nursing Outcomes Classification (NOC), que es una clasificación de resultados sensibles a las intervenciones de enfermería, posibilita el desarrollo de instrumentos con indicadores clínicos plausibles de ser medidos durante la evaluación clínica del enfermero. Sin embargo, esa clasificación aún carece de resultados que contemplen la diversidad de situaciones enfrentadas por los pacientes en la práctica clínica. En esa perspectiva, el presente estudio tuvo por objetivo desarrollar un nuevo Resultado de Enfermería en consonancia con la Nursing Outcomes Classification – NOC para evaluación de las complicaciones en el acceso vascular post-procedimientos percutáneos. Se trata de un estudio de Análisis de Concepto según el modelo de Walker y Avant. Como soporte teórico para la identificación de los posibles usos del concepto fue realizada una revisión de Scoping con base en la metodología propuesta por el Instituto Joanna Briggs. Se elaboró un protocolo de la revisión con estrategia de búsqueda en tres etapas: búsqueda inicial en las bases de datos PubMed y CINAHL; segunda búsqueda en las bases de datos PubMed, CINAHL, Scopus y LILACS; y tercera estrategia de búsqueda en las referencias de los artículos identificados, considerados estudios adicionales. Los aspectos éticos fueron respetados. Fueron incluidas 128 publicaciones, que permitieron mapear los diferentes contextos de estudio de las complicaciones vasculares relacionadas al local de acceso, la ocurrencia de las complicaciones de acuerdo con las vías, así como la presentación y evolución clínica de las complicaciones. En cuanto al concepto en estudio, “complicaciones vasculares” en procedimientos percutáneos, se constató ser ampliamente estudiado por el área médica, con contribuciones relevantes del área de enfermería. El concepto puede ser entendido como un conjunto de complicaciones en el local de acceso vascular del procedimiento, que pueden desarrollarse aisladamente o agrupadas, y presentar diferentes niveles de gravedad. El nuevo Resultado de Enfermería fue denominado Nivel de complicación: acceso vascular, compuesto por definición y 11 indicadores. Fueron construidas definiciones conceptual y operacional para cada indicador, así como para los cinco niveles de la escala Likert: 1-Grave, 2-Sustancial, 3-Moderado, 4-Leve y 5-Ninguno. Se propuso la inserción de este resultado en el Dominio II – Salud Fisiológica, Clase E – Cardiopulmonar. Esta investigación podrá contribuir para el perfeccionamiento de la taxonomía del NOC al disponer de un nuevo resultado que atienda las necesidades de la práctica clínica, con indicadores más específicos y estandarizados para una evaluación precisa de los niveles de complicación en el acceso vascular de los pacientes después de procedimientos percutáneos. Se planea validar el nuevo resultado y someterlo a la apreciación del equipo de investigadores del NOC.

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

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.

L'anévrisme de l'aorte abdominale est une pathologie devant être traitée par chirurgie quand son diamètre atteint 5.5cm, en raison d’un risque de rupture qui est souvent mortelle. La chirurgie endovasculaire consiste à déployer une endoprothèse dans l’anévrisme pour l’exclure de la circulation sanguine. Cette chirurgie souffre cependant d'un taux relativement élevé de complications post-opératoires à long terme, nécessitant des interventions coûteuses. Ces complications sont principalement d’origine mécanique et pourraient être anticipées grâce à la simulation numérique.Cette thèse a pour objectif d'élaborer une méthodologie de simulation personnalisée de déploiement d'endoprothèses dans des anévrismes, dans le but final de fournir un outil d'aide à la décision aux praticiens hospitaliers pour améliorer leur planning pré-opératoire.Une méthodologie permettant de déployer numériquement des endoprothèses bifurquées, composées de plusieurs modules, dans des anévrismes aortiques personnalisés, de géométries quelconques, a été conçue. Des simulations numériques ont été effectuées sur cinq cas cliniques réels, dont des cas fortement tortueux et complexes àplanifier pour les praticiens hospitaliers. La méthodologie a été validée par comparaison des résultats numériques avec la position des stents sur les scanners post-opératoires.La capacité de la méthodologie numérique à simuler le déploiement d’endoprothèses dans des géométries personnalisées d’anévrismes aortiques a été démontrée. Ces simulations possèdent un fort potentiel, en pouvant permettre de mieux adapter les endoprothèses aux patients et d’anticiper les complications post-opératoires dès le planning pré-opératoire. / Abdominal aortic aneurysm is a pathology which needs to be treated by surgery when its diameter reaches 5.5cm, due to high risk of rupture that is often lethal. Endovascular repair consists in deploying a stent-graft inside the aneurysmal sac to exclude it from the blood flow. However, the drawback of this surgery is the relatively important post-operative complication rate at long-term, requiring costly secondary interventions. The origin of these complications is mainly related to mechanics and therefore, they could be prevented thanks to numerical simulation.The objective of this thesis is to elaborate a simulation methodology to deploy in silico stent-grafts in patient-specific aneurysms. The ultimate goal is to provide practioners with a computer aided decision tool to improve their pre-operative planning.A methodology was developed to simulate the deployment of bifurcated stent-grafts, composed of several modules, in patient-specific aortic aneurysms, whatever their geometry. Finite-element analyses were performed on several clinical cases from real patients, some of them which were highly tortuous and complex for practioners to achieve an accurate preoperative planning. The methodology was validated by comparing numerical results with the position of the stents in the post-operative scans.The ability of finite-element analyses to simulate stent-graft deployment in patient-specific aortic aneurysm geometries was proved in this thesis. Simulations have great potential for adapting stent-grafts to each patient and for anticipating possible post-operative complications at the stage of pre-operative planning.

Η έρευνα για τα καρδιαγγειακά νοσήματα έχει εστιάσει την προσοχή της σε νέους ελάχιστα επεμβατικούς τρόπους επαναιμάτωσης, όπως είναι η θεραπευτική αγγειογένεση, η οποία αποτελεί μία νέα δυναμική θεραπευτική μέθοδο που επάγει τη δημιουργία νέων αιμοφόρων αγγείων σε ασθενείς με στεφανιαία νόσο. Η θρομβίνη, εκτός από τον κεντρικό της ρόλο στον καταρράκτη της πήξης του αίματος, ασκεί ένα ευρύ φάσμα δράσεων στα κύτταρα του ενδοθηλίου και μπορεί να συμβάλλει στη ρύθμιση πολλών διεργασιών, συμπεριλαμβανομένης της αγγειογένεσης. Αρχικά ο σκοπός της συγκεκριμένης ερευνητικής δουλειάς ήταν να ταυτοποιηθεί ένα πειραματικό μοντέλο διαδερμικής πρόκλησης οξέος εμφράγματος του μυοκαρδίου σε κόνικλους με εφαρμογή επεμβατικών ακτινολογικών τεχνικών υπό ακτινοσκοπική καθοδήγηση, καθώς και σύγκριση αυτής με την κλασσική χειρουργική τεχνική απολίνωσης της στεφανίαιας αρτηρίας. Η ανωτέρω μεθοδολογία επιτρέπει μέσω διωτιαίας προσπέλασης τον μη χειρουργικό υπερεκλεκτικό καθετηριασμό των στεφανιαίων αγγείων και την πρόκληση μυοκαρδιακού εμφράκτου με τοποθέτηση ειδικού σπειράματος (coil) στον πρόσθιο κατιόντα κλάδο. Ο εμβολισμός στη θέση αυτή φαίνεται ότι προκαλεί οξύ έμφραγμα του μυοκαρδίου, που αναγνωρίζεται όχι μόνο ηλεκτροκαρδιογραφικά και ιστολογικά, αλλά και αιμοδυναμικά, ενζυμικά και απεικονιστικά. Με την διωτιαία διαδερμική μυοκαρδιακή ισχαιμία μπορεί να αποφευχθεί η θωρακοτομή, περικαρδιακή τομή και άλλες τοπικές και συστηματικές ανεπιθύμητες ενέργειες μίας μείζονος χειρουργικής επέμβασης και μπορεί να επιτευχθεί ως εκ τούτου ένα πιο φυσιολογικό μοντέλο μυοκαρδιακής ισχαιμίας, χωρίς να παρατηρείται στατιστικά σημαντική διαφορά στα βιοχημικά, υπερηχογραφικά και ιστολογικα δεδομένα σε σχέση με το κλασσικό χειρουργικό μοντέλο. Επόμενος σκοπός της μελέτης ήταν να διερευνηθεί η πρόκληση αγγειογένεσης σε ίσχαιμο μυοκάρδιο με τη χρήση θρομβίνης, η οποία αποτελεί έναν αποδεδειγμένο ενεργοποιητή της αγγειογένεσης σε άλλα όργανα–στόχους και της οποίας η αγγειογενετική δράση δεν έχει μελετηθεί στο μυοκάρδιο. Μελετήσαμε αρχικώς τις αγγειογενετικές ιδιότητες της θρομβίνης μετά από ενδομυοκαρδιακή χορήγηση, σε ένα μοντέλο οξέος εμφράγματος κονίκλου και δείξαμε για πρώτη φορά ότι η εξωγενής χορήγηση θρομβίνης ενισχύει το σχηματισμό νέων λειτουργικών και σταθερών παράπλευρων αγγειακών δικτύων και αποκαθιστά την αιματική άρδευση του ίσχαιμου μυοκαρδίου, καθώς μια στατιστικά σημαντική αύξηση στην πυκνότητα των αγγείων στην μεταβατική ζώνη, όπως εκτιμήθηκε με την CD31 ανοσοϊστοχημεία, παρατηρήθηκε στην ομάδα χορήγησης θρομβίνης σε σύγκριση με την ομάδα ελέγχου. Η βελτίωση της μυοκαρδιακής αιμάτωσης συνοδεύονταν από βελτίωση της καρδιακής λειτουργίας, όπως εκφράζονταν από την στατιστικά σημαντική μείωση της LVEDP την ημέρα της ευθανασίας σε σύγκριση με τις αυξημένες μετεμφραγματικές τιμές αυτής στην ομάδα θρομβίνης. Μετέπειτα, μελετήσαμε την αγγειογενετική δράση της θρομβίνης σε μοντέλο χρόνιας ισχαιμίας μυοκαρδίου σε κονίκλους. Παρατηρήθηκε ότι μία ενδοπερικαρδιακή χορήγηση προάγει την ανάπτυξη παράπλευρου μυοκαρδιακού δικτύου και συμβάλλει στην αποκατάσταση της καρδιακής λειτουργίας. Επομένως η παρούσα μελέτη παρέχει τα πρώτα επιστημονικά δεδομένα για την αγγειογενετκή δράση της θρομβίνης σε ισχαιμικό μυοκάρδιο. Η ανάδειξη της θετικής αγγειογενετικής δράσης της θρομβίνης σε ίσχαιμο μυοκάρδιο, καθιστά την εξωγενή χορήγηση της μια πιθανή νέα θεραπευτική επιλογή σε ασθενείς με στεφανιαία νόσο. / Therapeutic angiogenesis is based on the premise that the development of new blood vessels can be augmented by exogenous administration of the appropriate growth factors and is a rapidly evolving field of modern research in the cardiovascular system. Since a variety of angiogenic factors have been tested with inconsistent so far clinical results, the challenge remains in identifying the factor that will stimulate functional neovascularization. Thrombin is a potent activator of angiogenesis, apart from its central role in blood coagulation. The aim of the present study was to establish a closed-chest, solely percutaneous, minimally invasive technique in order to induce experimental myocardial infarction by employing interventional catheterization techniques and involving fluoroscopy-guided percutaneous transauricular intra-arterial access, superselective catheterization of the left coronary artery of the rabbit heart and distal coronary embolization with a micro-coil. This model of percutaneous transauricular myocardial ischemia in the rabbit was compared with the gold standard of experimental myocardial infarction as induced by coronary ligation with a plain suture. The presented model avoids major surgery and thoracotomy and may be an equally reliable and reproducible platform for the experimental study of myocardial ischemia, with a pathophysiology similar to human pathology without statistically significant difference in troponin increase, LVEDP measurement and histopathologic results in comparison with surgical model. The next aim of this study was to investigate the angiogenic action of thrombin in a rabbit model of ischemic myocardium, as it is proven activator of angiogenesis in other target tissues. Firstly, we investigated the effects of direct intramyocardial administration of thrombin and the ability to induce vessel growth in a rabbit model of myocardial ischemia. It enhanced the angiogenic response to ischemia with a significant increase of regional collateralization, as a statistically significant increase in the vascular density at the infarct border zone, as evaluated by CD31 immunohistochemistry, was observed in the thrombin treated group compared to the control group. These benefits were accompanied by improvements in cardiac function in the ischemic territory as the thrombin treated animals also showed a statistically significant reduction in LVEDP values on the day of euthanasia compared to the postinfarct day. Afterwards, we examined the angiogenic action of thrombin in a model of chronic myocardial ischemia. A single intrapericardial administration of thrombin seems to promote the development of mature functional blood vessels and improve cardiac function. This is the first study investigating, in our knowledge, the angiogenic action of thrombin in ischemic myocardium. These results provide new insights in understanding the involvement of thrombin in vascular formation and point to a novel role of thrombin in angiogenesis. The present investigation raises the possibility that such an intervention might eventually be applied clinically for achieving optimal therapeutic angiogenesis

Orientador: Regina Moura Ceranto / Resumo: A correção endovascular do aneurisma de aorta abdominal (EVAR) modificou o tratamento desta patologia, reduzindo a mortalidade e as complicações, á curto prazo quando comparada à cirurgia aberta. Ainda assim, os pacientes necessitam de seguimento rigoroso a fim de reconhecer as possíveis complicações. O crescimento do diâmetro do saco aneurismático pós-EVAR está relacionado ao risco de rotura ou necessidade de reabordagem, sendo que alguns fatores pré-operatórios podem prever esse aumento. OBJETIVO:Identificar se os sintomas pré-tratamento EVAR podem ser um fator preditivo para a continuidade da expansão do saco aneurismático após tratamento, no seguimento em 12 meses. MATERIAL E MÉTODOS: Estudo retrospectivo realizado através da coleta de dados do prontuário dos pacientes em seguimento na Faculdade de Medicina de Botucatu e que preencheram critérios de inclusão. Os pacientes foram separados em dois grupos de estudos: G1- Pacientes assintomáticos quanto a presença do aneurisma de aorta infrarenal; G2- Pacientes sintomáticos quanto a presença do aneurisma de aorta infrarenal. Todos os grupos foram acompanhados por 12 meses e avaliados quanto ao crescimento do saco aneurismático após o procedimento endovascular, através de AngioTC e Duplex Scan e coleta do exame “proteína C Reativa” para avaliação inflamatória relacionada ao EVAR. RESULTADOS: Foram estudados 112 pacientes. A faixa etária apresentou uma média de 68,6 anos. 80% eram do sexo masculino e 95% brancos. A maioria dos ... (Resumo completo, clicar acesso eletrônico abaixo) / Mestre