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Background: Biliary tract cancer (BTC) is a heterogeneous group of tumours, including cholangiocarcinoma (intrahepatic and extrahepatic) and gallbladder carcinoma (GC). With this ...work, we aim to perform an epidemiological characterization of patients with BTC, their management and survival outcomes from a nationwide registry in Spain. Methods: We performed an epidemiologic analysis of a cohort of patients from the Spanish RETUD registry diagnosed with BTC between 1 January 2017 and 31 December 2020. Data collected included sociodemographic and clinical outcomes, molecular analysis, oncological treatments, and survival. Patients with all the aforementioned data available on the cut-off date of 7 July 2021 were considered in the analysis. It included descriptive statistics of patient characteristics, tumour molecular markers and treatments. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Results: A total of 778 evaluable patients were included in 19 sites, with a median (interquartile range, IQR) age of 72.2 (64.5-78.5) years, 54.8% men. At primary diagnosis, the tumour was mostly intrahepatic (57.2%); followed by extrahepatic (27.4%) and GC (13.8%) and histologically diagnosed (83.7%). Most of the patients has advanced disease at diagnosis (72.0%). At database cut-off, the disease was metastatic in 525 (67.5%) patients, and the main metastatic sites were the liver n = 333 (63.4%), lymph distant nodes n = 187 (35.6%) and peritoneum n = 175 (33.3%). Any biomarker analysis was done in 245 (31.5%) patients whose main findings were: IDH1 mutations (n = 33, 17.7%), FGFR2 fusions (n = 15, 8.4%), BRAFV600E mutation (n = 10, 5.7%), MSI (n = 14, 6.8%) and HER2 amplification (n = 5, 3.0%). Previous surgeries were reported in 261 (33.5%) patients, and systemic oncologic therapies in 586 (75.3%): neoadjuvant n = 11 (1.9%), adjuvant n = 135 (23.0%), first line n = 549 (93.7%), second line n = 237 (40.4%), and third line and beyond n = 113 (19.3%). The main first-line treatment was cisplatin/gemcitabine (CISGEM; n = 331, 64.4%), followed by gemcitabine monotherapy (n = 100, 19.5%) and gemcitabine plus oxaliplatin (GEMOX; n = 48, 9.3%). The median (95% CI) PFS from first line in patients exposed to CISGEM was 5.1 (4.6-5.8) months. The median OS in metastatic population (95% CI) was 8.3 (7.2-9.1) months. Conclusions: This analysis provides insights into the characterization of BTC, its therapeutic management and clinical outcomes in Spanish sample patients. Obtained data are consistent with the published literature; nevertheless, we must consider them in the context of a currently evolving scenario. Although molecular analysis has gained relevance, it is still poorly performed in daily practice in Spain.
ResumenIntroducciónLa endocarditis infecciosa (EI) sobre transcatheter aortic valve implantation (TAVI) es una complicación emergente. Existen datos incompletos y dispares sobre su incidencia. Se ...aporta la experiencia en nuestro centro sobre incidencia, mortalidad y factores asociados de la EI post-TAVI y se compara con datos de la literatura. MétodosEstudio retrospectivo observacional de los casos de EI diagnosticados en pacientes que habían recibido TAVI, entre el 1 de junio de 2009 y el 1 de noviembre de 2017, en un centro universitario tras una mediana de seguimiento de 15,3 meses (rango intercuartil RIC 9,1-36,2). Se analizaron la incidencia, los datos clínicos, microbiológicos y pronósticos, y los factores asociados a EI post-TAVI. ResultadosSe detectaron 11 pacientes con EI de 200 TAVI. Incidencia global: 5,5% (2,77 casos por 100 años-paciente). La mediana de tiempo hasta la EI post-TAVI fue de 112 días (RIC 36-578), la tasa de mortalidad intrahospitalaria fue del 36,4% y la mortalidad al año, del 54,5%. Todos los microorganismos identificados fueron grampositivos (4 Enterococcus faecalis, 3 Staphylococcus coagulasa negativo). Los pacientes con EI post-TAVI eran significativamente más jóvenes (mediana 78, RIC 73-80, frente a 82, RIC 79-84, p = 0,002), tenían un EuroSCORE mayor (5,1 ± 2,4 frente a 3,2 ± 1,2, p < 0,001) y más frecuentemente antecedentes de neoplasia (18,2% frente al 4,2%, p < 0,03). ConclusionesEn nuestro medio, la incidencia de EI post-TAVI es mayor que la descrita en series multicéntricas, lo que concuerda con la tendencia publicada en la literatura. Conlleva una elevada mortalidad y se asocia con una peor situación clínica basal.
Vector or reservoir species of five fish diseases listed in the Animal Health Law were identified, based on evidence generated through an extensive literature review (ELR), to support a possible ...updating of Regulation (EU) 2018/1882. Fish species on or in which highly polymorphic region‐deleted infectious salmon anaemia virus (HPR∆ ISAV), Koi herpes virus (KHV), epizootic haematopoietic necrosis virus (EHNV), infectious haematopoietic necrosis virus (IHNV) or viral haemorrhagic septicaemia virus (VHSV) were detected, in the field or during experiments, were classified as reservoir species with different levels of certainty depending on the diagnostic tests used. Where experimental evidence indicated transmission of the pathogen from a studied species to another known susceptible species, the studied species was classified as a vector species. Although the quantification of the risk of spread of the pathogens by the vectors or reservoir species was not part of the terms or reference, such risks do exist for the vector species, since transmission from infected vector species to susceptible species was proven. Where evidence for transmission from infected fish was not found, these were defined as reservoirs. Nonetheless, the risk of the spread of the pathogens from infected reservoir species cannot be excluded. Evidence identifying conditions that may prevent transmission by vectors or reservoir fish species during transport was collected from scientific literature. For VHSV, IHNV or HPR∆ ISAV, it was concluded that under transport conditions at temperatures below 25°C, it is likely (66–90%) they will remain infective. Therefore, vector or reservoir species that may have been exposed to these pathogens in an affected area in the wild, aquaculture establishments or through water supply can possibly transmit VHSV, IHNV or HPR∆ ISAV into a non‐affected area when transported at a temperature below 25°C. The conclusion was the same for EHN and KHV; however, they are likely to remain infective under all transport temperatures.
This publication is linked to the following EFSA Journal articles: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.8172/full, http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.8173/full
This publication is linked to the following EFSA Supporting Publications articles: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-8122/full, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-8123/full, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-8124/full
Infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) is an emerging complication. There are incomplete and disparate data on its incidence. We present the experience of a ...single-centre of incidence, mortality and associated factors of IE after TAVI.
A retrospective observational study of IE cases in people who received a TAVI, between 06/01/2009 and 11/01/2017, in a university hospital, during a median follow-up period of 15.3 months (interquartile range IQR 9.1–36.2). Incidence, clinical, microbiological and prognostic data, and factors associated with IE after TAVI were analysed.
Eleven patients with IE of 200 TAVI were detected. Global incidence: 5.5% (2.77 cases per 100 patient-year). The median of days from TAVI to IE was 112 (IQR 36–578), the in-hospital mortality rate was 36.4%, and the one-year mortality rate was 54.5%. All the organisms identified were gram-positive (4 Enterococcus faecalis, 3 coagulase-negative Staphylococcus). The patients with IE after TAVI were significantly younger (median 78 years, IQR 73–80, versus 82 years, IQR 79–84, p=.002), they had a higher EuroSCORE (5.1±2.4 versus 3.2±1.2, p<.001), and they more frequently had a history of neoplasia (18.2% versus 4.2%, p<.03).
In our area, IE after TAVI has an incidence greater than that described in multicentre series, this is in line with the trend published in the literature. It leads to high mortality and is associated with a worse baseline clinical situation.
La endocarditis infecciosa (EI) sobre transcatheter aortic valve implantation (TAVI) es una complicación emergente. Existen datos incompletos y dispares sobre su incidencia. Se aporta la experiencia en nuestro centro sobre incidencia, mortalidad y factores asociados de la EI post-TAVI y se compara con datos de la literatura.
Estudio retrospectivo observacional de los casos de EI diagnosticados en pacientes que habían recibido TAVI, entre el 1 de junio de 2009 y el 1 de noviembre de 2017, en un centro universitario tras una mediana de seguimiento de 15,3 meses (rango intercuartil RIC 9,1-36,2). Se analizaron la incidencia, los datos clínicos, microbiológicos y pronósticos, y los factores asociados a EI post-TAVI.
Se detectaron 11 pacientes con EI de 200 TAVI. Incidencia global: 5,5% (2,77 casos por 100 años-paciente). La mediana de tiempo hasta la EI post-TAVI fue de 112 días (RIC 36-578), la tasa de mortalidad intrahospitalaria fue del 36,4% y la mortalidad al año, del 54,5%. Todos los microorganismos identificados fueron grampositivos (4 Enterococcus faecalis, 3 Staphylococcus coagulasa negativo). Los pacientes con EI post-TAVI eran significativamente más jóvenes (mediana 78, RIC 73-80, frente a 82, RIC 79-84, p=0,002), tenían un EuroSCORE mayor (5,1±2,4 frente a 3,2±1,2, p<0,001) y más frecuentemente antecedentes de neoplasia (18,2% frente al 4,2%, p<0,03).
En nuestro medio, la incidencia de EI post-TAVI es mayor que la descrita en series multicéntricas, lo que concuerda con la tendencia publicada en la literatura. Conlleva una elevada mortalidad y se asocia con una peor situación clínica basal.
To identify and characterise the severe complications of diagnostic confirmation colonoscopies carried out as part of the Colorectal Cancer Screening Program of the Valencian Community (CCSP-VC).
A ...retrospective observational study from 2005 to 2012. To identify complications, the CCSP-VC information system was used, as well as Spanish Minimum Basic Data Set hospital discharge summaries and medical records. Cumulative incidence rates were estimated for all complications, immediate complications (occurring the same day as the colonoscopy) and delayed complications (occurring 1-30 days after the colonoscopy) for the 1,000 colonoscopies performed. A bivariate analysis using the Chi-square test was performed for the onset of complications, according to gender, age and type of test (guaiac/immunological), as well as for the complication onset time (immediate/delayed) based on the type of colonoscopy (diagnostic/therapeutic) and type of complication (haemorrhage/perforation).
Of the total 8,831 screening colonoscopies performed, 23 severe complications were observed, 13 of which were perforations (56.5%) and 10 haemorrhages (43.5%). No serious vagal syndrome, peritonitis or deaths were recorded. The cumulative incidence rate was 2.60‰; 2.85‰ for the guaiac test and 2.56‰ for the immunological test. The incidence rate was higher in men (2.93‰) than in women (2.16‰), as well as in older groups (3.02‰ versus 1.98‰). Of the total complications, 61% (n=14) were immediate.
The severe complication rates of screening colonoscopies are a quality indicator for population-based colorectal cancer screening programs that require extensive research in order to maintain the appropriate risk/benefit ratio of such programs.
Resumen Objetivo Identificar y caracterizar las complicaciones graves de las colonoscopias de confirmación diagnóstica del Programa de Prevención de Cáncer Colorrectal de la Comunitat Valenciana ...(PPCCR-CV). Método Estudio observacional retrospectivo (2005-2012). Para identificar las complicaciones se utilizó el sistema de información del PPCCR-CV, las altas hospitalarias del conjunto mínimo básico de datos (CMBD) y la historia clínica. Se estimaron tasas de incidencia acumulada para el total de complicaciones, para inmediatas (mismo día de la colonoscopia) y tardías (1-30 días desde la colonoscopia) por 1.000 colonoscopias. Análisis bivariado con la prueba Chi cuadrado para la aparición de complicación según sexo, edad y tipo de test (guayaco/inmunológico) y para el tiempo de aparición de la complicación (inmediata/tardía) según el tipo de colonoscopia (diagnóstica/terapéutica) y el tipo de complicación (hemorragia/perforación). Resultados De las 8.831 colonoscopias del estudio se detectaron 23 complicaciones graves de las cuales 13 fueron perforaciones (56,5%) y 10 hemorragias (43,5%) y ningún síndrome vagal grave, peritonitis o fallecimiento. La tasa de incidencia acumulada fue del 2,60‰, para el test de guayaco del 2,85‰ y del 2,56‰ para el inmunológico. La tasa de incidencia fue mayor en hombres (2,93‰) que en mujeres (2,16‰) y en grupos de mayor edad (3,02‰ vs. 1,98‰). El 61% (n = 14) de las complicaciones fueron inmediatas. Conclusiones Las tasas de complicaciones de las colonoscopias de cribado graves son un indicador de calidad de los programas poblacionales de cribado de cáncer colorrectal y requieren una investigación exhaustiva para mantener el balance adecuado de beneficios y efectos adversos de estos programas.
To evaluate the degree of implementation of protocols associated with the prevention of intensive-care-unit (ICU) acquired muscle weakness, and the presence of the physiotherapist in various ICU in ...Spain.
A descriptive, cross-sectional study performed in 86 adult ICU in Spain between March and June 2017. Neurosurgical and major burns ICU were excluded. A multiple-choice survey was used that included questions on protocols for glycaemia control, sedation, pain assessment, delirium prevention, delirium management and early mobilisation. The survey was completed using a user-protected application and password. The Student's t-test or Mann-Whitney U test and Pearson's correlation or Spearman's Rho test were used for the inferential analysis.
Eighty-nine point five percent of the ICU had a glycaemia control protocol, with a predominating range of 110-140mg/dl. Seventy-four point four percent evaluated sedation levels, although only 36% had sedation protocols. Pain assessment was carried out on communicative patients in 73.7%, and on uncommunicative patients in only 47.5%. Only 37.2% performed daily screening to detect delirium and 31.4% of the ICU had delirium prevention protocols, 26.7% had delirium management protocols and 14% had protocols for early mobilisation. Thirty-four point nine percent requested cross consultation with the rehabilitation department.
The implementation of the different protocols associated with the prevention of ICU-acquired muscle weakness was high in relation to glycaemia control protocols, sedation level and pain assessment in communicative patients, and was low for early mobilisation and delirium screening and prevention. Similarly, the physiotherapist was seldom present in the ICU.
