Nephrogenic systemic fibrosis risk after liver magnetic resonance imaging with gadoxetate disodium in patients with moderate to severe renal impairment: results of a prospective, open-label, multicenter study.

OBJECTIVE: The objective of this study was to assess the risk of gadoxetate disodium in liver imaging for the development of nephrogenic systemic fibrosis (NSF) in patients with moderate to severe renal impairment. MATERIALS AND METHODS: We performed a prospective, multicenter, nonrandomized, open-label phase 4 study in 35 centers from May 2009 to July 2013. The study population consisted of patients with moderate to severe renal impairment scheduled for liver imaging with gadoxetate disodium. All patients received a single intravenous bolus injection of 0.025-mmol/kg body weight of liver-specific gadoxetate disodium. The primary target variable was the number of patients who develop NSF within a 2-year follow-up period. RESULTS: A total of 357 patients were included, with 85 patients with severe and 193 patients with moderate renal impairment, which were the clinically most relevant groups. The mean time period from diagnosis of renal disease to liver magnetic resonance imaging (MRI) was 1.53 and 5.46 years in the moderate and severe renal impairment cohort, respectively. Overall, 101 patients (28%) underwent additional contrast-enhanced MRI with other gadolinium-based MRI contrast agents within 12 months before the start of the study or in the follow-up. No patient developed symptoms conclusive of NSF within the 2-year follow-up. CONCLUSIONS: Gadoxetate disodium in patients with moderate to severe renal impairment did not raise any clinically significant safety concern. No NSF cases were observed.

Modelo de control de calidad para marcadores bioquímicos y ecográficos del cribado prenatal de aneuploidías fetales centralizado en el laboratorio / Quality control model for biochemical and ultrasound markers in prenatal screening for fetal aneuploidies with laboratory-centralized management

Introducción. El modelo de cribado combinado de primer trimestre de aneuploidías fetales es el más extendido a nivel nacional. Sin embargo, aunque está bien establecido que deben realizarse controles de calidad de las medidas bioquímicas, su implantación en las ecográficas es escasa. El objetivo de este artículo es describir cómo implantar desde el laboratorio un modelo de control de calidad que incluya todos los marcadores que se realizan en el cribado prenatal de aneuploidías. Material y métodos. Se valoró la precisión y el sesgo de los marcadores bioquímicos. En el caso de la TN se ha utilizado el método WIHRI como control de calidad y se ha aplicado el CUSUM a cada ecografista con los valores extraídos de la base de datos del software de cálculo. Resultados. Para los parámetros bioquímicos el CV se situó por debajo del 4%. El sesgo se situó dentro de especificaciones para las concentraciones de analito, tal y como ocurrió con los MoM excepto en una mensualidad. El control de calidad de la TN mostró que 5 de los 8 ecografistas evaluados no cumplieron con los criterios de calidad establecidos cuando se utilizó el método WIHRI y 6 cuando se aplicó el CUSUM. Conclusiones. Al mostrar desde el laboratorio a los profesionales implicados la dificultad de conseguir medidas veraces de la TN, se ha consensuado el método CUSUM como control de calidad para la misma. El laboratorio enviará un informe a cada ecografista en el momento en el que sobrepase el límite de desviación establecido (AU)

Introduction. First trimester combined fetal aneuploidy screening is the most widely implemented model at national level. Although it is well established to perform quality control of biochemical measurements, it has been seldom applied to ultrasound measures. The aim of this paper is to describe how to implement a model of quality control in the laboratory, which includes all markers in prenatal screening for aneuploidy. Methods. We have evaluated the precision and bias of biochemical markers. In the case of nuchal translucency (NT), the WIHRI method was employed to control quality, and CUSUM was applied to each ultrasound operator with the values extracted from the computer software database. Results. For the biochemical parameters CV was below 4%. The bias was within the specification for the analyte concentration levels, as was the case for MoMs, except for one month. Quality control of NT showed that 5 of the 8 ultrasound operators evaluated sdid not comply with the quality criteria when using the WIHRI method, and 6 when CUSUM was applied. Conclusions. After showing the difficulty in obtaining accurate NT measurements to the professionals involved, it was possible to reach a consensus on using the CUSUM method for quality control of NT. In this way, the laboratory will be responsible for sending a report to each ultrasound operatorin the cases where the deviation exceeds the established limit (AU)

Análisis comparativo de tres métodos de ELISA frente aInmunodot para la determinación de antígenos extraíbles del núcleo (ENAs) / Comparative analysis of three ELISA methods versus simple dot-blot method for the determination of extractable nuclear antigens (ENA)

La detección y la especificidad de los autoanticuerpos contra antígenos extraíbles del núcleo (ENA) tienen un importante papel en la ayuda aldiagnóstico de ciertas enfermedades autoinmunes. Existen diversos métodos para detectar estos autoanticuerpos entre los que se encuentran el enzimoinmunoanálisis (ELISA) y el “Inmunodot” como los más utilizados.En este estudio evaluamos cuatro métodos para la detección de ENAs,comparando un ensayo Inmunodot frente a tres ensayos ELISA. Se analizaron muestras de 26 pacientes en las que fueron determinados los autoanticuerpos antinucleares (ANAs) por Inmunofluorescencia (IFI) y los anticuerpos frente a ENAs (Ro, La, Sm-RNP, Sm, Scl-70 y Jo-1) por Inmunodot y porlos tres ensayos de ELISA. Se obtuvo que en un 27% de los casos todas lastécnicas eran coincidentes en el resultado y se correlacionaron con los síntomas clínicos del paciente. La concordancia entre las técnicas de ELISA evaluadas fue de un 88% para ELISA 1 vs 2, 73% para ELISA 1 vs 3 y 73% paraELISA 2 vs 3, y la de los métodos de ELISA frente el método de Inmunodotfueron de un 38%, 42% y 27% (vs ELISA1, 2 y 3 respectivamente).Las técnicas de ELISA tienen un porcentaje de concordancia entre sí másalto que con Inmunodot, y además se correlacionan mejor con los síntomasclínicos y el patrón ANA del paciente. Los resultados muestran que la presencia de autoanticuerpos ENA no siempre tiene relación con la presentación clínica del paciente, por ello el laboratorio y el clínico deben ser conscientes de la sensibilidad y la especificidad de cada método empleado en ellaboratorio clínico (AU)

The detection and the specificity of the autoantibodies to extractablenuclear antigens (ENAs) play a critical role in the development of the diagnosis of certain autoimmune diseases. There are several methods to detectthese autoantibodies, and enzyme-linked immunosorbent assay (ELISA)or the simple dot-blot are the most frequently used.Here, we evaluate four methods to detect ENAs, namely an Immunodot test along with three different ELISA tests. Twenty six samples ofpatients were analysed. Antibodies to nuclear antigens (ANAS) weredetermined by indirect immunofluorescence (IFI), whereas antibodies todifferent ENAs (Ro, La, Sm-RNP, Sm, Scl-70 and Jo-1) were determinedby simple dot-blot and by the three ELISA tests. In 27% of the cases all thetechniques yielded similar results, and were related to the clinical symptoms of the patient. The concordance among the different ELISA techniques tested was 88% for ELISA 1 vs 2, 73% for ELISA 2 vs 3, and 73% forELISA 2 vs 3. The concordance of the ELISA methods with the Immunodot was 38%, 42% and 27% for ELISA 1, 2, and 3, respectively. The ELISA techniques obtained a higher percentage of concordanceamong them than with Immunodot and, moreover, they related better tothe clinical symptoms and ANA pattern of the patients. The results alsoshow that the presence or the specific type of ENA autoantibody does notalways have a relation to the clinical status of the patient, so that the laboratory and the clinic must be conscious of the sensitivity and specificitylimits of each method used in the clinical laboratory (AU)

[Clinical and radiological criteria for the therapeutic decision for vesicoureteral refux. Retrospective analysis of our experience]. / Criterios clínicos y radiológicos en la decisión terapéutica del reflujo vesicoureteral. Un análisis retrospectivo de nuestra experiencia.

OBJECTIVES: According to our experience, we present a proposal for the treatment of vesicoureteral reflux, based on both clinical and radiological evidences. We also describe how the introduction of endoscopic procedures has influenced the evolution of treatment indications as well as the time intervals for treatment. METHODS: We have analysed all cases of vesicoureteral reflux treated in our Department in two periods of similar length: The first one (106 patients) comprised from 1995 to March 2001 (when endoscopic procedures were introduced). The second one (138 patients), comprised from March, 2001 to March 2007. Clinical, diagnostic, therapeutic and outcome-related variables were studied for all cases. RESULTS: The number of patients was higher in the second period. In this period the number of cases requiring ureteral reimplantation decreased with respect to the first one (from 24 to 7). The success rate with endoscopic treatment reached 94.9%, with no significant differences regarding age or grade of reflux, although higher rates of failures were observed in children aged less than 3 years old and in high-grade reflux. The association of reflux with other malformations was not related with a worse evolution after treatment. CONCLUSIONS: Endoscopic treatment, due to its similar efficacy and low aggressiveness, should be considered a valid alternative to open surgery (which offers good results but non-negligible comorbidity) for persistent reflux in which medical treatment has not been useful. We propose a tentative therapeutic scheme to establish the indications for each type of treatment depending on the grade of reflux and its clinical evolution.

Criterios clínicos y radiológicos en la decisión terapéutica del reflujo vesicoureteral. Un análisis retrospectivo de nuestra experiencia / Clinical and radiological criteria for the therapeutic decision for vesicoureteral reflux. Retrospective analysis of our experience

Objetivo: Establecer, en base a nuestra experiencia, unos esquemas terapéuticos del reflujo vesicoureteral en el niño, apoyándonos en resultados clínicos y radiológicos, observando cómo han ido evolucionando las indicaciones y tiempos de tratamiento con el advenimiento de las técnicas endoscópicas. Métodos: Se han analizado los pacientes con reflujo vesicoureteral tratados en dos periodos de similar duración: el primero (106 pacientes), entre 1995 y marzo 2001 (fecha en que se introdujeron las técnicas endoscópicas); el segundo, (138 pacientes), desde esa fecha hasta marzo de 2007. En todos los pacientes se estudiaron variables clínicas, diagnósticas y terapéuticas, así como el resultado obtenido. Resultados: El número de pacientes tratados aumentó en el segundo período, en él disminuyó ostensiblemente (de 24 a 7) el número de pacientes que requirieron reimplantación vesicoureteral. La proporción de éxitos del tratamiento endoscópico ascendió al 94,9%, no apreciándose diferencias significativas en función de la edad o el grado de reflujo, aunque se observa un mayor porcentaje de fracasos en niños menores de 3 años y en reflujos de alto grado. La presencia de malformaciones asociadas no se relacionó con una peor evolución tras el tratamiento. Conclusiones: En aquellos reflujos donde el tratamiento médico no ha sido eficaz, persistiendo o empeorando el mismo, y como alternativa a la cirugía abierta (con buenos resultados pero con una morbilidad no desdeñable), el tratamiento endoscópico se convierte en una alternativa de eficacia similar y mínimamente agresiva. Proponemos un esquema orientativo para establecer las indicaciones de cada estrategia terapéutica en función del grado de reflujo y su evolución clínica (AU)

Objectives: According to our experience, we present a proposal for the treatment of vesicoureteral reflux, based on both clinical and radiological evidences. We also describe how the introduction of endoscopic procedures has influenced the evolution of treatment indications as well as the time intervals for treatment. Methods: We have analysed all cases of vesicoureteral reflux treated in our Department in two periods of similar length: The first one (106 patients) comprised from 1995 to March 2001 (when endoscopic procedures were introduced). The second one (138 patients), comprised from March, 2001 to March 2007. Clinical, diagnostic, therapeutic and outcome-related variables were studied for all cases. Results: The number of patients was higher in the se-cond period. In this period the number of cases requiring ureteral reimplantation decreased with respect to the first one (from 24 to 7). The success rate with endoscopic treatment reached 94,9%, with no significant differences regarding age or grade of reflux, although higher rates of failures were observed in children aged less than 3 years old and in high-grade reflux. The association of reflux with other malformations was not related with a worse evolution after treatment. Conclusions: Endoscopic treatment, due to its similar efficacy and low aggressiveness, should be considered a valid alternative to open surgery (which offers good results but non-negligible comorbidity) for persistent reflux in which medical treatment has not been useful. We propose a tentative therapeutic scheme to establish the indications for each type of treatment depending on the grade of reflux and its clinical evolution (AU)

[External genital injuries during childhood]. / Traumatismos de genitales externos durante la infancia.

OBJECTIVE: Genitalia trauma are relatively frequent pediatric emergencies. There is a wide spectrum of lesions that can be produced. The purpose of this study is to descriptively analyse our experience with pediatric urologic trauma over the last five years. METHODS: We review 152 cases of male children ages 1 to 15 years old who presented with external genitalia trauma at our hospital's paediatric emergency room and required urologic evaluation or treatment. All cases were evaluated for type of lesion, mechanism of trauma production, complementary diagnostic tests performed and treatment: conservative or surgery. RESULTS: 33.5% of lesions were prepucial or penile, and the remainder 66.5% were to the scrotum or its content. In 60 cases (61.2% of scrotal trauma) a scrotal ultrasound was performed. Treatment was conservative in 73.1% cases, and in the remainder 41 boys primary suture or surgical exploration were performed in cases of hematoma, parenchymal rupture, important penile-scrotal tears, and in one case of suprapubic cellulitis secondary to a prepucial wound. A deferred orchiectomy was necessary in one case only: a case with hematocele in which an initial surgical examination was not performed. CONCLUSIONS: External genitalia trauma during childhood are usually mild and the majority of cases do not request surgical treatment. When in doubt about parenchymal involvement or existence of hematocele surgical exploration must be performed trying to preserve testicular integrity.

Traumatismos de genitales externos durante la infancia / External genitalia trauma during childhood

Objetivos: Los traumatismos en genitales externos son una urgencia relativamente frecuente en pediatría. Las lesiones que se producen pueden abarcar un amplio espectro. En este trabajo nos planteamos analizar descriptivamente nuestra casuística de traumatismos urológicos infantiles en los últimos cinco años. Métodos: Revisamos 152 casos de varones con edades comprendidas entre los uno a los quince años que acudieron a la consulta de Urgencias de pediatría de nuestro Hospital por traumatismo genital externo y que requirieron valoración o tratamiento por parte del urólogo. En todos ellos se valora el tipo de lesión, el mecanismo de producción del trauma, las pruebas complementarias practicadas y el tratamiento aplicado: conservador o quirúrgico. Resultados: En el 33,5 por ciento de los casos las lesiones se produjeron sobre pene y prepucio y en el 66,5 por ciento restante sobre escroto y su contenido. En 60 casos (61,2 por ciento de los traumatismos escrotales) se realizó ecografía escrotal. El tratamiento fue conservador en el 73,1 por ciento de los casos, en los 41 niños restantes se realizó sutura de primera inten ción o exploración quirúrgica en caso de hematoma, rotura de parénquima, desgarros penoescrotales importantes, y en un caso de celulitis suprapúbica secundaria a herida prepucial. Sólo hubo que realizar una orquiectomía diferida en un caso de hematocele donde no se realizó exploración quirúrgica inicial. Conclusión: Los traumatismos infantiles de genitales externos suelen ser leves y en su mayoría no precisan tratamiento quirúrgico. Ante la duda de que haya afectación del parénquima o existencia de un hematocele, debe realizarse exploración quirúrgica para tratar de preservar la integridad testicular (AU)