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Made available in DSpace on 2016-08-19T18:15:54Z (GMT). No. of bitstreams: 1 Silvia Teresa Evangelista.pdf: 209991 bytes, checksum: 497a2c5c02aa5d734a85bd23ce11c2b1 (MD5) Previous issue date: 2007-09-24 / Airway aspiration of foreign body (FB) is a universal problem and an important cause of morbidity and mortality especially for children and the elderly. FB aspiration was evaluated in 72 children and teenagers varying from 7 months to 15 years of age who underwent rigid bronchoscopy at the CMUH (Children Maternal University Hospital), in São Luís-MA/ Brazil, for FB aspiration in the period from 1995 to 2005. For data collecting, an index card was filled out for each patient. Epi-info and Bio-estata programs were used for processing and statistical analysis. A major prevalence of FB aspiration from 1998 through 2001 was observed. Most patients were from the countryside (55.6%). The predominant age was the firsts three years of life (81.9%). The prevalence was greater among the male sex (63.9%). In 83.3% of the cases the initial diagnosis was FB aspiration. The elapsed time between the aspiration and the bronchoscopy was greater than 72h (52.8 %). The most frequent site was the right lung (38.9 %). The most common types of FB found were of organic nature (83.3 %). The most prevailing radiological finding was hypotransparence (56.9%). Bronchitis was the most frequently reported complication related to FB aspiration (45.9%), and glottis edema was a major complication upon bronchoscopy (47.6%), with no deaths reported in the studied group. It is concluded that bronchoscopy is a safe, highly sensible and efficient procedure for the diagnosis and treatment of FB aspiration, and that a late diagnosis suggests a need for better qualification of the health professionals. / A aspiração de corpo estranho (ACE) para via aérea é um problema universal e uma importante causa de morbidade e mortalidade, especialmente em crianças e idosos. Avaliou-se a aspiração de corpo estranho em 72 crianças na faixa etária de 7 meses a 15 anos submetidas à endoscopia respiratória no Hospital Universitário Materno Infantil (HUMI) por ACE, no período de 1995 a 2005, São Luís - Maranhão. Para cada paciente estudado foi preenchida uma ficha de coleta de dados. Utilizou-se os programas Epi- Info e BioEstata para o processamento e análise estatística. Observou-se uma maior prevalência de ACE nos anos de 1998 a 2001. A maior procedência foi das cidades do interior (55,6%). A idade predominante foi nos três primeiros anos de vida (81,9%). A prevalência foi maior no sexo masculino (63,9%). Em 83,3% dos casos, o diagnóstico inicial foi de ACE. O tempo decorrido entre a aspiração e o exame endoscópico foi maior que 72h (52,8%). A localização mais freqüente foi o pulmão direito (38,9%). O tipo de corpo estranho (CE) mais encontrado foi o orgânico (83,3%). O achado radiológico mais prevalente foi a hipotransparência (56,9%). A complicação mais freqüente relacionada ao CE foi a bronquite (45,9%) A complicação relacionada ao exame endoscópico mais freqüente foi o edema de glote (47,6%), não havendo óbitos. Concluiu-se que a endoscopia respiratória mostrou-se um procedimento seguro, eficaz e de alta sensibilidade no diagnóstico e tratamento do ACE e que a demora no seu diagnóstico sugere a necessidade de melhor qualificação dos profissionais de saúde.

Background: Tobacco smoking is the main cause of chronic obstructive pulmonary disease, COPD, but the mechanisms by which cigarette smoke induces COPD are still elusive. T lymphocytes have been implicated in the pathogenesis of the disease, but their role in the airway inflammation in COPD is not fully understood. The aim of this thesis was therefore to address T lymphocyte subsets and their activation in the airways of subjects with COPD, in comparison to smokers with normal lung function (S) and never smokers (NS). Methods: Subjects with moderate to severe COPD were recruited along with controls. They were all non-atopic and clinically stable, without any exacerbation during at least three months prior to inclusion. Only medication with short-acting β2-agonists and/or anti-cholinergic drugs was permitted. All subjects underwent bronchoscopy with endobronchial mucosal biopsy sampling as well as bronchial wash, BW, and bronchoalveolar lavage, BAL, collection. Biopsies were immunohistochemically stained for inflammatory cells and markers. BW and BAL fluids were prepared for differential cell counts. Soluble markers were measured in BW and lymphocyte subsets were determined in BAL using flow cytometry. Results: In biopsies, an increase in epithelial CD3+ and CD8+ cells was found in COPD, compared to NS. In BAL fluid, CD8+ cells were enhanced, whereas CD4+ cells were reduced in subjects with COPD and S, compared to NS. Furthermore, CD4+ and CD8+ cells were more activated both in COPD and S, in terms of increased expression of CD25, CD69 and HLA-DR. NKG2D-expressing CD8+ T cells in BAL fluid were enhanced in both COPD and S. CD4+CD25bright cells were upregulated in COPD and S, suggesting the presence of regulatory T cells. Further analyses of T cell subsets with the more specific markers for regulatory T cells, FoxP3 and CD127, indicated a smoking-induced expansion of non-regulatory T cells, which tended to normalize after smoking cessation in COPD. Currently smoking subjects with COPD still expressed high proportions of activated non-regulatory CD4+ T cells. The data on FoxP3 expression further indicated that the increase in CD25 expression in COPD and S was not only associated with the expansion of regulatory T cells. As CD127 expression is reported to be inversely associated with FoxP3, the data indicate the expansion of a non-regulatory CD25+ population in smokers and patients with stable COPD. The immunohistochemical staining for the NKG2D ligands MICA and MICB on epithelial cells was unchanged. Conclusion: The results of this thesis suggest a role for CD4+ and CD8+ T-cells in clinically stable COPD, indicating that T-cells are of importance in the long-term inflammatory response in COPD. Regardless of current smoking habits, activated CD8+ T lymphocytes were found to be increased in BAL fluid from subjects with COPD, suggesting that changes in CD8+ T cells are associated with a persistent immune response and, thus, of importance in COPD pathogenesis. In contrast, the expansion of non-regulatory CD25+CD4+ cells in BAL fluid seemed to be preferentially smoke-related. In summary, the data indicate that, among airway T cells, changes in CD8+ cells seem to be highly associated with COPD pathogenesis, whereas changes in CD4+ cells appear to be related to cigarette smoke-induced responses. Further, a non regulatory population of helper T cells was identified in BAL fluid of COPD patients, which may contribute to the persistent cytotoxic T cell responses.

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Darbo tikslas. Įvertinti endoskopinio tyrimo reikšmę neužkrečiamųjų ligų diagnostikai arkliams. Darbo uždaviniai. Susipažinti su užsienio autorių publikuojama literatūra, apie endoskopinių tyrimų pritaikymą veterinarinėje medicinoje; įvertinti, kokiems tikslams naudojami endoskopijos metodai; įvertinti, kuris endoskopinis tyrimas dažniausiai atliekamas; įvertinti, kokios patologijos dažniausiai aptinkamos; nustatyti, pagal kokius simptomus atliekamas endoskopinis tyrimas. Tyrimo metodika. Tyrimas buvo atliekamas 2011 – 2013 metais magistrantūros studijų metais LSMU VA Stambiųjų gyvūnų klinikose. Tyrimo metu buvo atliekami endoskopiniai tyrimai: gastroskopija, bronchoskopija, laringoskopija. Tyrimo įranga – videoendoskopo sistema VIDEO MED. Iš viso konsultuoti 169 pacientai, iš jų 35 pacientams buvo atliktas endoskopinis tyrimas. Tyrimas buvo atliekamas remiantis klinikiniais simptomais. Rezultatai. Endoskopiniu tyrimu tirti 35 pacientai, kuriems pasireiškė būdingi klinikiniai simptomai. Gastroskopija buvo atlikta 17 pacientų (49 proc.), bronchoskopija atlikta 12 arklių (34proc.), o laringoskopija – 6 arkliams (17 proc.). Tyrimo metu nustatytos šios patologijos: EGUS, LOPL, gerklų paralyžius. Arklių skrandžio opų sindromas buvo nustatytas visiems 17 pacientų, kuriems buvo atliekama gastroskopija, tai sudaro 100 proc. LOPL nustatyta 10 pacientų iš 18, kuriems buvo atliekamas kvėpavimo takų endoskopinis tyrimas, tai sudaro 56 proc. Gerklų paralyžius buvo nustatytas visiems 6... [toliau žr. visą tekstą] / Objectives of the research paper. To get acquainted with material, about the appliance of endoscopic diagnosis in veterinary medicine, published by foreign authors; to study what these are the aims to use endoscopy methods; to discover the most highly endoscopic diagnosis used; to research what most common cases of pathology are diagnosed; to identify which symptoms are clues to determine an endoscopic diagnosis. Methodology. The research was carried out in 2011 – 2013, during the years of obtaining Master’s Degree in Heavy Animals clinics at LHSU VA. The following diagnoses of endoscopy were made in the course of the research: gastroscopy, bronchoscopy, laryngoscopy. The research equipment used was a video endoscopy system VIDEO MED. In total 169 patients were consulted and 35 out of the total were examined using endoscopy. The study was carried out on the basis of clinical symptoms. Results. 35 patients with clinical symptoms were examined using the method of endoscopy. Gastroscopy was carried out on 17 patients which make 49 per cent, bronchoscopy – 12 horses ( 34 per cent), laryngoscopy – 6 horses (17 per cent). During the research, the following cases of pathology were diagnosed: EGUS, COPD, laryngeal paralysis. Gastric ulcer syndrome in horses was diagnosed in all 17 patients (100 per cent), which underwent the medical examination. COPD was diagnosed in 10 patients out of 18 examined by the method of endoscopy, which makes 56 per cent. Laryngeal paralysis was... [to full text]

The diagnostic accuracy attained with the use of transbronchial fine needle aspiration biopsy, aspiration of bronchial secretion, bronchial washing, brush biopsy and forceps biopsy via a flexible fiberoptic bronchoscope was compared in patients with carcinoma of the lung. In endoscopic visible tumours the sensitivity of forceps biopsy was higher than that of the other methods. When forceps biopsy was combined with bronchial washing the overall diagnostic accuracy was significantly higher than that of any of the single methods, while no appreciable increase was obtained by adding additional methods. Selective brush biopsy from every segment bronchus has been established as a method in the search for occult bronchial carcinoma. The extent of respiratory mucosal damage and wound healing after brush biopsy was therefore studied in rabbits. Large differences in the extension and depth of the damage was observed. The basement membrane was often penetrated. Regeneration started during the first day after brush biopsy and a normal ciliated epithelium was restored within three weeks. To determine if the bronchoscope itself damaged the respiratory epithelium, bronchial mucosa was studied in the pig after examination with a flexible fiberoptic bronchoscope. The columnar epithelial cells were torn off in areas where the bronchoscope had rubbed against the airway wall but the basement membrane was not damaged. Since the function of the respiratory epithelium is to remove inhaled particles from the airways, mucociliary clearance was studied in man after fiberoptic bronchoscopy. The study suggests that the tracheobronchial clearance system has a large reserve for mechanical trauma. Mucociliary clearance can however be decreased after fiberoptic bronchoscopy in some patients. An increasing number of patients with impaired cardiopulmonary function are today subjected to examination with flexible fiberoptic broncoscopy. The haemodynamic effects of fiberoptic bronchoscopy performed under topical anaesthesia were therefore studied in patients with restrictive lung disease. The procedure induced marked haemodynamic changes during passage of the larynx and during suctioning. A slight fall in arterial oxygen tension was observed during bronchial suctioning and in the post-bronchoscopic period. Three of ten patients developed ST-T-segment changes during bronchial suctioning. / <p>S. 1-48: sammanfattning, s. 49-126: 5 uppsatser</p> / digitalisering@umu.se

The aim of this work has been the development and optimization of methods for early diagnosis of lung cancer, their utility and integration into daily practice. Firstly, we developed a device for measurement of endobronchial temperature (thermobronchoscopy) and found significant difference in endoluminal temperature above tumors and infiltrated lymph nodes compared to healthy regions. We further designed an appliance for near infrared spectroscopy of the bronchial mucosa and identified spectroscopic features useful for localization of solitary pulmonary nodule. The use of the appliance improved yield of endobronchial biopsy compared to endobronchial ultrasound. In the next part of the study, we describe further techniques for early diagnosis of lung cancer including endobronchial ultrasound, optical coherence tomography, confocal fluorescence microendoscopy, reflectance spectroscopy, autofluorescence bronchoscopy, fluorescence bronchoscopy, and narrow band imaging with concise introduction of our experience gained in several pilot projects. Next, we showed the utility of measurement of acetic acid in exhaled air as a promising biomarker for non-invasive identification of patients with symptomatic acid gastroesophageal reflux. Lastly, we demonstrated significant difference in radiation dose in HRCT...

The aim of this work has been the development and optimization of methods for early diagnosis of lung cancer, their utility and integration into daily practice. Firstly, we developed a device for measurement of endobronchial temperature (thermobronchoscopy) and found significant difference in endoluminal temperature above tumors and infiltrated lymph nodes compared to healthy regions. We further designed an appliance for near infrared spectroscopy of the bronchial mucosa and identified spectroscopic features useful for localization of solitary pulmonary nodule. The use of the appliance improved yield of endobronchial biopsy compared to endobronchial ultrasound. In the next part of the study, we describe further techniques for early diagnosis of lung cancer including endobronchial ultrasound, optical coherence tomography, confocal fluorescence microendoscopy, reflectance spectroscopy, autofluorescence bronchoscopy, fluorescence bronchoscopy, and narrow band imaging with concise introduction of our experience gained in several pilot projects. Next, we showed the utility of measurement of acetic acid in exhaled air as a promising biomarker for non-invasive identification of patients with symptomatic acid gastroesophageal reflux. Lastly, we demonstrated significant difference in radiation dose in HRCT...

Introdução - Pacientes com enfisema pulmonar avançado submetidos a redução volumétrica pulmonar endoscópica (ELVR) com válvulas unidirecionais (EBV) apresentam melhores resultados quando o lobo tratado não possui ventilação colateral e atelectasia lobar é alcançada. No entanto, a resposta positiva de desinsuflação está associada a maior ocorrência de pneumotórax nessa população. Recomendações recentes enfatizam a importância de condutas no intra- e pós-operatório que busquem minimizar os riscos associados, porém muito pouco é abordado em relação ao manejo da ventilação mecânica durante a intervenção. Elevada fração inspirada de oxigênio (FiO2) é reconhecida na indução de atelectasia por absorção e pode desempenhar um papel relevante na modulação de redução volumétrica após oclusão seletiva. Atualmente não se monitora os efeitos regionais da ELVR com EBV em tempo real. A tomografia de impedância elétrica (TIE) é uma ferramenta de imagem não-invasiva e sem radiação que fornece dados regionais em tempo real de variação de volume pulmonar por meio de uma cinta de eletrodos aplicadas no tórax. Neste contexto, o objetivo deste estudo é usar a TIE para avaliar a influência da FiO2 na ELVR com EBV em um modelo experimental de pulmão normal suíno, animal que não possui ventilação colateral. Métodos - 5 suínos foram submetidos a um estudo cruzado de oclusão do lobo inferior esquerdo por dois métodos, válvulas unidirecionais (válvulas) e cateter-balão intrabronquial (balão), com FiO2 de 50% e 100% por 15 minutos em cada etapa. O balão serviu como um controle, com oclusão assegurada por visão direta via broncoscópio e medida da pressão expiratória distal à oclusão em um animal representativo. A pressão expiratória positiva final usada foi titulada pela TIE para cada animal e recrutamento alveolar foi realizado ao final de cada etapa para reverter o colapso induzido. Foram analisados o mínimo Z (MinZ), como estimativa do volume pulmonar ao final da expiração, e o DeltaZ, variação cíclica proporcional ao volume corrente, ambos expressos em unidades arbitrárias de variação relativa, desde antes da oclusão (Pré) e em cada minuto do momento da oclusão (T0) até 15 minutos (T15). Em um animal adicional foi realizada aquisição simultânea de tomografia computadorizada (TC) e TIE para quantificação do conteúdo de gás. Em todas as análises as regiões de interesse foram direita (Dir) e esquerda (Esq). Resultados - Houve redução rápida e progressiva do MinZ Esq após oclusão com balão, sendo a magnitude quase 3 vezes maior na FiO2 de 100% comparada a 50% (p < 0,001). Com válvulas a 50% o MinZ Esq apresentou redução inicial, mas teve incremento progressivo de forma que em T15 não mostrou diferença em relação ao Pré (p=0,20). Em média, o MinZ Dir não sofreu alteração significativa. Os dados da TC e pressão distal tiveram padrão similar aos achados de MinZ da TIE. O DeltaZ Esq apresentou redução imediata após oclusão e se manteve estável ao longo dos 15 minutos, sem diferença entre as FiO2 em cada método de oclusão. Conclusão- FiO2 a 100% promove maior taxa de redução volumétrica secundária a oclusão lobar seletiva quando comparado a 50% e a TIE apresentou resultados coerentes e concordantes com métodos complementares / Introduction - Patients with advanced pulmonary emphysema undergoing endoscopic lung volume reduction (ELVR) with one-way endobronchial valves (EBV) present better results when the treated lobe has negative collateral ventilation and lobar atelectasis is achieved. However, the positive response of deflation is associated with a higher occurrence of pneumothorax in this population. Recent recommendations emphasize the importance of intra- and postoperative procedures that seek to minimize the associated risks, but very little is addressed regarding the management of mechanical ventilation during the intervention. High inspired oxygen fraction (FiO2) is known to induce atelectasis by absorption and may play a relevant role in the modulation of volumetric reduction after selective occlusion. Currently, regional effects of ELVR with EBV is not monitored in real-time. Electrical impedance tomography (EIT) is a non-invasive and radiation-free imaging tool that provides regional real-time lung volume variation data by means of an electrode belt applied to the chest. In this context, the objective of this study is to use EIT to evaluate the influence of FiO2 on ELVR with EBV in an experimental normal lung swine model, an animal that lacks collateral ventilation. Methods - Five pigs were used in a crossover study of left lower lobe occlusion by two methods, one-way valves (valves) and intrabronchial balloon catheter (balloon), with FiO2 of 50% and 100% for 15 minutes at each stage. The balloon served as a control, where occlusion was ensured by direct bronchoscopic inspection and allowed a measurement of expiratory pressure distal to the occlusion in a representative animal. The positive end-expiratory pressure used was titrated by EIT for each animal and alveolar recruitment was performed at the end of each step to reverse the induced collapse. Minimum impedance value (MinZ) was recorded as an estimate of end-expiratory lung volume and tidal impedance variation (DeltaZ) as proportional to tidal volume, both expressed in arbitrary units of relative variation, from pre-occlusion (Pre) and every minute since occlusion (T0) up to 15 minutes (T15). In an additional animal, simultaneous acquisition of computed tomography (CT) and EIT was performed to quantify gas content. In all the analysis, regions of interest were right (R) and left (L). Results - There was a rapid and progressive reduction of MinZ-L after occlusion, with almost 3 times greater magnitude in FiO2 100% compared to 50% (p < 0.001). With valves at 50%, the MinZ-L presented initial reduction, but had a progressive increase so that in T15 there was no difference in relation to Pre (p = 0.20). On average, MinZ-R did not change significantly. CT and distal pressure data were consistent with EIT MinZ findings. DeltaZ-L presented immediate reduction after occlusion and remained stable throughout all 15 minutes, with no difference between FiO2 in each method of occlusion. Conclusion- FiO2 of 100% promotes greater rate of volumetric reduction following selective lobar occlusion when compared to 50%, and EIT presented coherent results in agreement with complementary methods

As fístulas broncopleurais habitualmente decorrem de procedimentos cirúrgicos de ressecção pulmonar por diversas etiologias, com incidência na literatura de 0% a 28%, e mortalidade de 16% a 72%, sendo mais frequente em homens, e nos casos de pneumonectomia do que em lobectomia. As deiscências totais de coto brônquico apresentam indicação de tratamento cirúrgico, porém a condição clínica destes pacientes geralmente é precária com alto risco anestésico e cirúrgico. Os tratamentos endoscópicos de fístulas broncopleurais até então descritos foram utilizados apenas em fístulas parciais menores que 8 milímetros. Objetivo: Este estudo propõe-se a avaliar a viabilidade do tratamento endoscópico de fístulas totais de coto brônquico utilizando o dispositivo oclusor de defeitos septais cardíacos Occlutech-Fígulla®. Casuística e métodos: Foram incluídos pacientes com fistula broncopleural total secundária a ressecção pulmonar. Os pacientes foram submetidos inicialmente à broncoscopia para avaliação e medida da fístula e a uma cintilografia pulmonar de inalação para documentação do padrão inicial de vazamento. A colocação do dispositivo foi feita através da broncoscopia realizada sob sedo-analgesia com o paciente em ventilação espontânea com suplementação de oxigênio. Os pacientes foram acompanhados durante 12 meses e avaliados quanto à cobertura do dispositivo por tecido cicatricial, fechamento do trajeto fistuloso e desenvolvimento de complicações relacionadas como o deslocamento do dispositivo, lesões de estruturas adjacentes e desenvolvimento de infecção. As análises descritivas dos dados quantitativos com distribuição normal foram apresentadas através das médias acompanhadas dos respectivos desvios padrão. Os dados sem distribuição normal foram apresentados através de suas medianas com os respectivos intervalos interquartil 25-75%. A análise inferencial utilizou a Análise de Variância de Medidas Repetidas para os dados com distribuição normal e os testes não-paramétricos Anova de Friedman para os dados que não apresentavam distribuição normal. Foi considerada uma probabilidade de erro do tipo I (alfa) de 0,05. Resultados: Foram selecionados nove pacientes com predomínio do sexo masculino (77,8%), com média de idade de 45 ±11,1 anos, com ressecções motivadas em sua maioria por sequelas de doença infecciosa (78%), com predomínio de pneumonectomia direita (66,6%), com fístulas que apresentavam diâmetro de 6 a 17 mm. Do grupo de 9 pacientes tratados tivemos três casos de fechamento completo, dois casos de fechamento parcial, duas falhas sendo uma por deslocamento e retirada do dispositivo e outra por retirada ao término do período de seguimento com permanência dos sintomas e dois óbitos não relacionados. Durante o período de acompanhamento não evidenciamos complicações infecciosas ou lesão de estruturas adjacentes relacionadas à permanência do dispositivo. Conclusão: O dispositivo para tratamento de defeitos do septo atrial pode ser uma alternativa no tratamento endoscópico de fístulas totais de coto brônquico, funcionando como tratamento definitivo em alguns casos e servindo como suporte nos pacientes que aguardam melhora das condições clínicas para uma intervenção cirúrgica tardia com menor risco. Não foram detectados eventos graves como infecções ou lesão vascular relacionados à presença do dispositivo / Bronchopleural fistulas are possible complications following lung resection procedures for different etiologies. The reported incidence is 0 % to 28%, and the related mortality is 16% to 72%. More frequently in men and pneumonectomy cases than lobectomy cases. Total dehiscence of the bronchial stump should be treated by surgical interventions; however, the clinical status of these patients is generally poor with high anesthetic and surgical risks. Endoscopic treatment of bronchopleural fistulas previously described were used only in 8mm or smaller partial fistulas. Objective To evaluate the endoscopic treatment of total bronchial stump fistulas using the Occlutech - Fígulla®, a device used to close cardiac septal defects. Patients and methods: We select patients with total bronchial stump fistula. Patients underwent bronchoscopy for local fistula evaluation and an inhalation lung scintigraphy for the initial leak parameter documentation. The placement of the device was made by bronchoscopy performed under sedation - analgesia with the patient in spontaneous ventilation with oxygen supplementation. Patients were followed for 12 months and assessed for scar tissue coverage device, fistula closure and development of related complications such as displacement device, adjacent structures lesions and infection. The descriptive analysis of quantitative data with normal distribution were presented through the mean along with the related standard deviations. Non-normal distribution data were presented by their medians with their respective interquartile ranges 25-75 %. The inferential analysis used Repeated Measures Analysis of Variance for data with normal distribution and non-parametric tests of Friedman ANOVA to data with nonnormal distribution. It was considered an error probability of a type I (alfa) 0.05. Results: This study evaluated nine patients with a males predominance (77.8% ) with mean age of 45 ± 11.1 years with resections for sequelae of infectious disease (78%), predominantly right pneumonectomy (66.6% ), with fistulas diameter ranging from 6 to 17 mm. The group of 9 patients had three cases of complete closure, two cases of partial closure, two failures one per displacement and removal of the device another for withdrawal at the end of follow-up with persistence of symptoms and two unrelated death. During the follow-up period was not detect complications such as infections or injury to adjacent structures related to the device. Conclusion: The device for treatment of atrial septal defects can be an alternative to the endoscopic treatment of total fistula bronchial stump, functioning as definitive treatment in some cases and serving as a support for patients awaiting improvement of clinical conditions for a later surgical intervention with lower risk. No severe events were detected as infections or vascular injury related to the device