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Simulators are widely used in medical education, but objective and automatic assessment is not feasible with low-fidelity simulators, which can be solved with artificial intelligence (AI) and virtual reality (VR) solutions. The effectiveness of a custom-made VR simulator and an AI-based evaluator of a laparoscopic peg transfer exercise was investigated. Sixty medical students were involved in a single-blinded randomised controlled study to compare the VR simulator with the traditional box trainer. A total of 240 peg transfer exercises from the Fundamentals of Laparoscopic Surgery programme were analysed. The experts and AI-based software used the same criteria for evaluation. The algorithm detected pitfalls and measured exercise duration. Skill improvement showed no significant difference between the VR and control groups. The AI-based evaluator exhibited 95% agreement with the manual assessment. The average difference between the exercise durations measured by the two evaluation methods was 2.61 s. The duration of the algorithmic assessment was 59.47 s faster than the manual assessment. The VR simulator was an effective alternative practice compared with the training box simulator. The AI-based evaluation produced similar results compared with the manual assessment, and it could significantly reduce the evaluation time. AI and VR could improve the effectiveness of basic laparoscopic training.
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Inteligência Artificial , Laparoscopia , Realidade Virtual , Humanos , Laparoscopia/educação , Feminino , Masculino , Adulto Jovem , Adulto , Estudantes de Medicina , Competência Clínica , Treinamento por Simulação/métodos , Simulação por Computador , Método Simples-Cego , AlgoritmosRESUMO
BACKGROUND: Echocardiographic strain measurements require extensive operator experience and have significant intervendor variability. Creating an automated, open-source, vendor-agnostic method to retrospectively measure global longitudinal strain (GLS) from standard echocardiography B-mode images would greatly improve post hoc research applications and may streamline patient analyses. OBJECTIVES: This study was seeking to develop an automated deep learning strain (DLS) analysis pipeline and validate its performance across multiple applications and populations. METHODS: Interobserver/-vendor variation of traditional GLS, and simulated effects of variation in contour on speckle-tracking measurements were assessed. The DLS pipeline was designed to take semantic segmentation results from EchoNet-Dynamic and derive longitudinal strain by calculating change in the length of the left ventricular endocardial contour. DLS was evaluated for agreement with GLS on a large external dataset and applied across a range of conditions that result in cardiac hypertrophy. RESULTS: In patients scanned by 2 sonographers using 2 vendors, GLS had an intraclass correlation of 0.29 (95% CI: -0.01 to 0.53, P = 0.03) between vendor measurements and 0.63 (95% CI: 0.48-0.74, P < 0.001) between sonographers. With minor changes in initial input contour, step-wise pixel shifts resulted in a mean absolute error of 3.48% and proportional strain difference of 13.52% by a 6-pixel shift. In external validation, DLS maintained moderate agreement with 2-dimensional GLS (intraclass correlation coefficient [ICC]: 0.56, P = 0.002) with a bias of -3.31% (limits of agreement: -11.65% to 5.02%). The DLS method showed differences (P < 0.0001) between populations with cardiac hypertrophy and had moderate agreement in a patient population of advanced cardiac amyloidosis: ICC was 0.64 (95% CI: 0.53-0.72), P < 0.001, with a bias of 0.57%, limits of agreement of -4.87% to 6.01% vs 2-dimensional GLS. CONCLUSIONS: The open-source DLS provides lower variation than human measurements and similar quantitative results. The method is rapid, consistent, vendor-agnostic, publicly released, and applicable across a wide range of imaging qualities.
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Aprendizado Profundo , Ecocardiografia , Interpretação de Imagem Assistida por Computador , Variações Dependentes do Observador , Valor Preditivo dos Testes , Função Ventricular Esquerda , Humanos , Reprodutibilidade dos Testes , Masculino , Estudos Retrospectivos , Feminino , Pessoa de Meia-Idade , Contração Miocárdica , Fenômenos Biomecânicos , Idoso , AutomaçãoRESUMO
Simulation-based training (SBT) has a significant role in training in complex procedure like laparoscopic pyeloplasty. We propose a new training model for laparoscopic pyeloplasty which has been compared to other models. Trainees (n = 22) evaluated our balloon model (BM) and three other models -glove finger model (GFM), chicken thigh model (ChTM) and chicken crop model (ChCrM)- subjectively, based on a 5-point Likert scale. The face validity mean score of our BM model was 3.58 ± 0.69. Our novel model can be a cost-effective, hygienic, and easy-access alternative to other laparoscopic pyeloplasty models.
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Laparoscopia , Procedimentos de Cirurgia Plástica , Ureter , Obstrução Ureteral , Humanos , Procedimentos Cirúrgicos Urológicos/métodos , Laparoscopia/métodos , Ureter/cirurgia , Rim/cirurgia , Pelve Renal/cirurgia , Obstrução Ureteral/cirurgiaRESUMO
Introduction: Despite the significant contribution of circumferential shortening to the global ventricular function, data are scarce concerning its prognostic value on long-term mortality. Accordingly, our study aimed to assess both left (LV) and right ventricular (RV) global longitudinal (GLS) and global circumferential strain (GCS) using three-dimensional echocardiography (3DE) to determine their prognostic importance. Methods: Three hundred fifty-seven patients with a wide variety of left-sided cardiac diseases were retrospectively identified (64 ± 15 years, 70% males) who underwent clinically indicated 3DE. LV and RV GLS, and GCS were quantified. To determine the prognostic power of the different patterns of biventricular mechanics, we divided the patient population into four groups. Group 1 consisted of patients with both LV GLS and RV GCS above the respective median values; Group 2 was defined as patients with LV GLS below the median while RV GCS above the median, whereas in Group 3, patients had LV GLS values above the median, while RV GCS was below median. Group 4 was defined as patients with both LV GLS and RV GCS below the median. Patients were followed up for a median of 41 months. The primary endpoint was all-cause mortality. Results: Fifty-five patients (15%) met the primary endpoint. Impaired values of both LV GCS (HR, 1.056 [95% CI, 1.027-1.085], p < 0.001) and RV GCS (1.115 [1.068-1.164], p < 0.001) were associated with increased risk of death by univariable Cox regression. Patients with both LV GLS and RV GCS below the median (Group 4) had a more than 5-fold increased risk of death compared with those in Group 1 (5.089 [2.399-10.793], p < 0.001) and more than 3.5-fold compared with those in Group 2 (3.565 [1.256-10.122], p = 0.017). Interestingly, there was no significant difference in mortality between Group 3 (with LV GLS above the median) and Group 4, but being categorized into Group 3 versus Group 1 still held a more than 3-fold risk (3.099 [1.284-7.484], p = 0.012). Discussion: The impaired values of both LV and RV GCS are associated with long-term all-cause mortality, emphasizing the importance of assessing biventricular circumferential mechanics. Reduced RV GCS is associated with significantly increased risk of mortality even if LV GLS is preserved.
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Despite the well-known importance of left atrial (LA) mechanics in diastolic function, data are scarce regarding the prognostic power of LA longitudinal strain and its potential added value in the risk stratification of an elderly population. Accordingly, our aim was to determine the long-term prognostic importance of 2D speckle-tracking echocardiography-derived peak atrial longitudinal strain (PALS) in a community-based screening sample. Three hundred and fourteen volunteers were retrospectively identified from a population-based screening program (mean age 62 ± 11 years; 58% female) with a median follow-up of 9.5 years. All subjects who participated in the screening program underwent 2D echocardiography to measure left ventricular (LV) ejection fraction (EF), global longitudinal strain (GLS), and PALS, as well as low-dose cardiac CT to determine the Agatston score. The primary endpoint was all-cause mortality. Thirty-nine subjects (12.4%) met the primary endpoint. Subjects with adverse outcomes had significantly lower LV GLS (dead vs. alive; - 19.2 ± 4.3 vs. - 20.6 ± 3.5%, p < 0.05) and PALS (32.3 ± 12.0 vs. 41.8 ± 14.2%, p < 0.001), whereas LV EF did not show a difference between the two groups (51.1 ± 7.0 vs. 52.1 ± 6.2, %, p = NS). By multivariable Cox regression analysis, PALS was found to be a significant predictor of adverse outcomes independent of LV GLS, and Agatston and Framingham scores. In subjects with PALS values below the standard cut-off of 39%, the risk of all-cause mortality was almost 2.5 times higher (hazard ratio: 2.499 [95% confidence interval: 1.334-4.682], p < 0.05). Beyond the assessment of LV EF and LV GLS, PALS offers incremental value in cardiovascular risk stratification in a community-based elderly cohort. PALS was found to be a significant and independent predictor of long-term mortality among other classical cardiovascular risk estimators.
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Fibrilação Atrial , Humanos , Feminino , Idoso , Masculino , Prognóstico , Estudos Retrospectivos , Função Ventricular Esquerda , Volume SistólicoRESUMO
BACKGROUND: We designed a new Esophageal Magnetic Anastomosis Device (EMAD) for thoracoscopic repair of esophageal atresia (EA) with tracheoesophageal fistula (TEF) without the need of handheld suturing or additional gastrostomy. METHODS: Synthetic EA-TEF model: Spherical and tubular shaped rubber balloons and a term infant sized plastic doll were used. Medical students (n = 10) and surgical trainees (n = 10) were asked to perform thoracoscopic repair of an "EA" with a hand sutured anastomosis (HA) and with the EMAD. Euthanized animal model: The esophagus in 5 piglets (3-4 kg) was dissected and a thoracoscopic esophageal magnetic anastomosis (EMA) was performed. Bursting pressure (BP) and pulling force (PF): HA and EMA were created on ex vivo New Zealand white rabbit (2.5-3 kg) esophagi (n = 25 in each test series). BP and PF were measured and compared against each other. RESULTS: Medical students were unable to complete HA, but were successful with the EMAD in 11.1 ± 2.78 min. Surgical trainees completed EMA in 4.6 ± 2.06 min vs. HA 30.8 ± 4.29 min (p<0.001). The BP following a HA (14.1 ± 3.32 cmH2O) was close to the physiological intraluminal pressure reported in a neonatal esophagus (around 20 cmH2O), whereas the BP with the EMAD was extremely high (>90 cmH2O) (p<0.001). The PF of an EMA (1.8 ± 0.30 N) was closer to the safety limits of anastomotic tension reported in the literature (i.e. 0.75 N) compared with the HA (3.6 ± 0.43 N) (p<0.0001). CONCLUSION: The EMAD could simplify, shorten, and potentially improve the outcome of thoracoscopic repair for EA with TEF in the future. A high BS and a relative low PF following EMAD application may lower the risk of postoperative complications such as esophageal leakage and stricture formation.
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Atresia Esofágica , Fístula Traqueoesofágica , Suínos , Animais , Coelhos , Fístula Traqueoesofágica/cirurgia , Fístula Traqueoesofágica/complicações , Atresia Esofágica/cirurgia , Atresia Esofágica/complicações , Estudo de Prova de Conceito , Toracoscopia/educação , Anastomose Cirúrgica , Fenômenos Magnéticos , Resultado do Tratamento , Estudos RetrospectivosRESUMO
According to the World Health Organization's 2018 Global Cancer Survey, cancer is the second leading cause of death. From this survey, the third most common is breast cancer, the fifth is melanoma malignum and pancreatic adenocarcinoma ranks twentieth. Undoubtedly, the early diagnosis and monitoring of these tumors and related research is important for aspects of patient care. The aim of our present review was to explain an impressive methodology that is deemed suitable in reference to studying blood sample deviations in the case of solid tumors. Essentially, we compared the heat denaturation responses of blood plasma components through differential scanning calorimetry (DSC). In the control, between five and seven separable components can be detected, in which the primary component was albumin, while in the case of tumorous patients, the peaks of immunoglobulins were dominant. Moreover, the shape of the plasma DSC curves changed with a shift in the higher temperature ranges; thus, their pattern can be used as a suitable marker of direct immunological responses. The further development of the analysis of DSC curves raises the possibility of the early diagnosis of a potential tumor, the monitoring of diseases, or testing the efficacy of the therapy from a single drop of blood.
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Background: A significant difference exists between the reported optimal timing of indocyanine green (ICG) injection during fluorescence cholangiography and ICG dissipation time from the serum. There are no reports on alterations in ICG concentration in biliary fluid over time. Herein, we measured the concentration of ICG and the fluorescence intensity ratio between the common bile duct (CBD) and liver, which was recognized as a parameter of the visibility of the CBD. Materials and methods: ICG (0.05 mg/kg) was injected intravenously into female pigs (n = 7). Afterwards, the fluorescence of the CBD and liver was detected at 30 min, 2 h, and 4 h. Biliary fluid was collected from cannulated CBD tubes. The fluorescence intensity was measured using captured images and calculated using the ImageJ image-processing program. ICG concentration was measured using spectrophotometry and compared using an analysis of variance test. Results: Biliary ICG concentrations at 30 min, 2 h, and 4 h were 92.07 ± 27.72 µg/mL, 37.14 ± 9.76 µg/mL (p < 0.05 vs. 30 min), and 13.91 ± 5.71 µg/mL (p < 0.05 vs. 30 min), respectively; p < 0.01. The CBD/liver fluorescence intensity ratios at 30 min, 2 h, and 4 h were 1.25 ± 0.72, 2.39 ± 1.28 (p < 0.05 vs. 30 min and 4 h), and 3.38 ± 1.73 (p < 0.05 vs. 30 min and 2 h), respectively. Conclusions: The ICG biliary concentration was highest at 30 min, whereas the CBD/liver fluorescence intensity ratio was highest at 4 h. Decreasing the fluorescence intensity of the liver may be an important approach for improving the visualization of the CBD during fluorescence cholangiography. Institutional protocol number: PE/EA/491-5/2020.
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When exposed to an alternating magnetic field, superparamagnetic nanoparticles can elicit the required hyperthermic effect while also being excellent magnetic resonance imaging (MRI) contrast agents. Their main drawback is that they diffuse out of the area of interest in one or two days, thus preventing a continuous application during the typical several-cycle multi-week treatment. To solve this issue, our aim was to synthesise an implantable, biodegradable membrane infused with magnetite that enabled long-term treatment while having adequate MRI contrast and hyperthermic capabilities. To immobilise the nanoparticles inside the scaffold, they were synthesised inside hydrogel fibres. First, polysuccinimide (PSI) fibres were produced by electrospinning and crosslinked, and then, magnetitc iron oxide nanoparticles (MIONs) were synthesised inside and in-between the fibres of the hydrogel membranes with the well-known co-precipitation method. The attenuated total reflectance Fourier-transform infrared spectroscopy (ATR-FTIR) investigation proved the success of the chemical synthesis and the presence of iron oxide, and the superconducting quantum interference device (SQUID) study revealed their superparamagnetic property. The magnetic hyperthermia efficiency of the samples was significant. The given alternating current (AC) magnetic field could induce a temperature rise of 5 °C (from 37 °C to 42 °C) in less than 2 min even for five quick heat-cool cycles or for five consecutive days without considerable heat generation loss in the samples. Short-term (1 day and 7 day) biocompatibility, biodegradability and MRI contrast capability were investigated in vivo on Wistar rats. The results showed excellent MRI contrast and minimal acute inflammation.
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The European Union is earmarking more and more resources each cycle to support research, development and innovation, and the projects set up by the working groups are helping to develop innovative solutions to reflecting societal issues of today. Since 2014, the Department of Surgical Research and Techniques of the Cardiovascular Center at Semmelweis University has been participating in international consortia supported by the Erasmus+ programme, which aim to modernise the teaching methodology of surgical training and to integrate IT technology into the training of surgical residents at pan-European level. This paper briefly summarises the international projects in which the Department has been involved over the last 7 years.
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Introduction: Adhesion formation is a complex series of events that results from cellular and molecular processes where, in contrast to the normal case, events that support adhesion genesis dominate over adhesion lysis. Tissue injury, haemorrhage, tissue desiccation and inflammatory processes, among others, play a role in its induction. Since the presence of adhesions can be associated with a number of negative complications, the primary aim is to prevent their development. There are several preventive targets for the process, but in many cases therapy is only provided immediately after the procedure. In this study, we present an experimental rat model of adhesion, where the aim is to understand the stabilization period of adhesion. All animals underwent the same surgical procedure, inducing tissue injury, minor haemorrhage and tissue desiccation, differing only in the timing of reoperations and sampling. On postoperative days 17, we assessed macroscopically and histopathologically the type of adhesions formed, the adhesive tissue, the stability of the adhesion. We found that stabilization was a process lasting several days, with unstable and moderately stable adhesions predominating by postoperative day 4. Knowing this allows to broaden the therapeutic window, targeting the most appropriate period in the early postoperative period, possibly combining treatments, to make adhesion prevention even more effective.
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Adesão Celular , Adesões Focais , Animais , Hemorragia , Inflamação , RatosRESUMO
Introduction: Not only atraumatic surgical technique, precise bleeding control, removal foreign materials from the abdomen, but also avoiding desiccation or mechanical damage of peritoneal surface at abdominal surgery mean today evidence based expectation. Peritoneum with its extensive surface and special histological structure represents an important factor in normal physiological processes, furthermore as "Guard of abdomen" it has an important role to localise inflammatory reactions, useful as dialysing surface and provides also possibility for hyperthermic abdominal chemotherapy in tumour treatment. Largest part of peritoneal sac covers small intestine and colon. To prevent postoperative complications it is necessary to avoid desiccation of intestinal tract at laparoscopic and at open procedures as well consequently "rehyration" is a routine recommendation today. Desiccation of intestinal tract results postoperative adhesions, furthermore damage of serosa will increase permeability of intestine wall and can result perforation. All the surgical recommendations suggest keeping intestine moist, whereas there are only a few real studies in surgical literature to support or to deny this theory. Our study reviews the pathophysiological and surgical respects of this situation and summarizes the results of latest researches of combined functions of peritoneum.
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Laparoscopia , Peritônio , Humanos , Complicações Pós-OperatóriasRESUMO
Hernia is a defect of the abdominal wall. Treatment is principally surgical mesh implantation. Non-degradable surgical meshes produce numerous complications and side-effects such as inflammatory response, mesh migration and chronic pain. In contrast, the biodegradable, poly (vinyl alcohol) (PVA) based polymers have excellent chemical, mechanical and biological properties and after their degradation no chronic pain can be expected. The toxicology of PVA solution and fibers was investigated with Human dermal fibroblast- Adult cell line. Implantation tests were observed on long-term contact (rat) and large animal (swine) models. To measure the adhesion formation, Diamond and Vandendael score were used. Macroscopical and histological responses were graded from the samples. In vitro examination showed that PVA solution and fibers are biocompatible for the cells. According to the implantation tests, all samples were integrated into the surrounding tissue, and there was no foreign body reaction. The average number of adhesions was found on the non-absorbable suture line. The biocompatibility of the PVA nanofiber mesh was demonstrated. It has a non-adhesive, non-toxic and good quality structure which has the potential to be an alternative solution for the part of the hernia mesh.
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Álcool de Polivinil , Telas Cirúrgicas , Animais , Materiais Biocompatíveis , Hérnia , Polímeros , Ratos , Suínos , Aderências TeciduaisRESUMO
In this work two types of biodegradable polysuccinimide-based, electrospun fibrous membranes are presented. One contains disulfide bonds exhibiting a shorter (3 days) in vivo biodegradation time, while the other one has alkyl crosslinks and a longer biodegradation time (more than 7 days). According to the mechanical measurements, the tensile strength of the membranes is comparable to those of soft the connective tissues and visceral tissues. Furthermore, the suture retention test suggests, that the membranes would withstand surgical handling and in vivo fixation. The in vivo biocompatibility study demonstrates how membranes undergo in vivo hydrolysis and by the 3rd day they become poly(aspartic acid) fibrous membranes, which can be then enzymatically degraded. After one week, the disulfide crosslinked membranes almost completely degrade, while the alkyl-chain crosslinked ones mildly lose their integrity as the surrounding tissue invades them. Histopathology revealed mild acute inflammation, which diminished to a minimal level after seven days.
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Aminoácidos/química , Materiais Biocompatíveis/química , Membranas Artificiais , Animais , Linhagem Celular Tumoral , Humanos , Masculino , Ratos Wistar , Estresse MecânicoRESUMO
BACKGROUND: Current hand hygiene guidelines do not provide recommendations on a specific volume for the clinical hand rubbing procedure. According to recent studies volume should be adjusted in order to achieve complete coverage. However, hand size is a parameter that highly influences the hand coverage quality when using alcohol-based handrubs (ABHR). The purpose of this study was to establish a quantitative correlation between applied ABHR volume and achieved hand coverage. METHOD: ABHR based hand hygiene events were evaluated utilizing a digital health device, the Semmelweis hand hygiene system with respect to coverage achieved on the skin surface. Medical students and surgical residents (N = 356) were randomly selected and given predetermined ABHR volumes. Additionally, hand sizes were calculated using specialized software developed for this purpose. Drying time, ABHR volume awareness, as well spillage awareness were documented for each hand hygiene event. RESULTS: Hand coverage achieved during a hand hygiene event strongly depends on the applied ABHR volume. At a 1 ml dose, the uncovered hand area was approximately 7.10%, at 2 ml it decreased to 1.68%, and at 3 ml it further decreased to 1.02%. The achieved coverage is strongly correlated to hand size, nevertheless, a 3 ml applied volume proved sufficient for most hand hygiene events (84%). When applying a lower amount of ABHR (1.5 ml), even people with smaller hands failed to cover their entire hand surface. Furthermore, a 3 ml volume requires more than the guideline prescribed 20-30 s to dry. In addition, results suggest that drying time is not only affected by hand size, but perhaps other factors may be involved as well (e.g., skin temperature and degree of hydration). ABHR volumes of 3.5 ml or more were inefficient, as the disinfectant spilled while the additional rubbing time did not improve hand coverage. CONCLUSIONS: Hand sizes differ a lot among HCWs. After objectively measuring participants, the surface of the smallest hand was just over half compared to the largest hand (259 cm2 and 498 cm2, respectively). While a 3 ml ABHR volume is reasonable for medium-size hands, the need for an optimized volume of handrub for each individual is critical, as it offers several advantages. Not only it can ensure adequate hand hygiene quality, but also prevent unnecessary costs. Bluntly increasing the volume also increases spillage and therefore waste of disinfectant in the case of smaller hands. In addition, adherence could potentially decrease due to the required longer drying time, therefore, adjusting the dosage according to hand size may also increase the overall hand hygiene compliance.
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Infecção Hospitalar/prevenção & controle , Etanol/administração & dosagem , Desinfecção das Mãos , Higienizadores de Mão/administração & dosagem , Feminino , Fidelidade a Diretrizes , Mãos , Humanos , Internato e Residência , Masculino , Estudos Prospectivos , Estudantes de MedicinaRESUMO
Mast cells have been shown to release extracellular vesicles (EVs) in vitro. However, EV-mediated mast cell communication in vivo remains unexplored. Primary mast cells from GFP-transgenic and wild type mice, were grown in the presence or absence of lipopolysaccharide (LPS), and the secreted EVs were separated from the conditioned media. Mast cell-derived EVs were next cultured with LPS-naïve mast cells, and the induction of TNF-α expression was monitored. In addition, primary mast cells were seeded in diffusion chambers that were implanted into the peritoneal cavities of mice. Diffusion chambers enabled the release of GFP+ mast cell-derived EVs in vivo into the peritoneal cavity. Peritoneal lavage cells were assessed for the uptake of GFP+ EVs and for TNF-α production. In vitro, LPS-stimulated mast cell-derived EVs were efficiently taken up by non-stimulated mast cells, and induced TNF-α expression in a TLR4, JNK and P38 MAPK dependent manner. In vivo, using implanted diffusion chambers, we confirmed the release and transmission of mast cell-derived EVs to other mast cells with subsequent induction of TNF-α expression. These data show an EV-mediated spreading of pro-inflammatory response between mast cells, and provide the first in vivo evidence for the biological role of mast cell-derived EVs.
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Vesículas Extracelulares/metabolismo , Sistema de Sinalização das MAP Quinases , Mastócitos/metabolismo , Animais , Células Cultivadas , Vesículas Extracelulares/genética , Regulação da Expressão Gênica/efeitos dos fármacos , Inflamação/induzido quimicamente , Inflamação/genética , Inflamação/metabolismo , Lipopolissacarídeos/toxicidade , Camundongos , Camundongos Transgênicos , Fator de Necrose Tumoral alfa/biossíntese , Fator de Necrose Tumoral alfa/genéticaRESUMO
Due to the fast spread of laparoscopic cholecystectomy, surgical procedures have been changed essentially. The new techniques applied for both abdominal and thoracic procedures provided the possibility for minimally invasive access with all its advantages. Robots - originally developed for industrial applications - were retrofitted for laparoscopic procedures. The currently prevailing robot-assisted surgery is ergonomically more advantageous for the surgeon, as well as for the patient through the more precise preparative activity thanks to the regained 3D vision. The gradual decrease of costs of robotic surgical systems and development of new generations of minimally invasive devices may lead to substantial changes in routine surgical procedures.