In-office Laryngeal Procedures: a Modern Perspective for Vocal Fold Interventions

Introduction: The purpose of this article is to discuss in-office laryngeal procedures as an alternative to surgical intervention under general anesthesia. In-office procedures have become more common due to technological advancements. As a result, these approaches are less invasive and more patient-friendly, with increased pain tolerance and reduced procedure time and cost. Methods: We conducted a thematic analysis of published reports regarding the best known and performed in-office laryngeal interventions. Three questions guided our analysis: What laryngological procedures can be performed in the office setting? What are the advantages of in-office laryngology procedures compared to operating room surgical procedures? Why aren't more in-office procedures performed in some Latin American countries? Discussion: Despite being performed more frequently, there is still controversy whether in-office procedures should be performed as often due to the risk of complications. Furthermore, procedures that are done in the office setting are more popular in some countries than in others, even though their benefit has been well demonstrated. This article describes various in-office procedures, including biopsy, vocal fold injections, and laser surgery. We also discuss what factors might contribute to having office-procedures being performed more frequently in some countries than others. Conclusion: Awake interventions offer numerous benefits, including shorter procedure time, reduced costs, and lower patient morbidity. These advantages have significantly transformed the treatment of laryngeal diseases in modern laryngology practice in a global manner.

Introducción: El propósito de este artículo es discutir los procedimientos laríngeos en el consultorio como una alternativa a la intervención quirúrgica bajo anestesia general. Los procedimientos en consultorio se han vuelto más comunes debido a los avances tecnológicos. Como resultado, estos enfoques son menos invasivos y más amigables para el paciente, con mayor tolerancia al dolor y reducción del tiempo y costo del procedimiento. Métodos: Realizamos un análisis temático de los informes publicados sobre las intervenciones laríngeas más conocidas y realizadas. Tres preguntas guiaron nuestro análisis: ¿Qué procedimientos laringológicos se pueden realizar en el consultorio y cuales sin los más frecuentes?, ¿cuáles son las ventajas de los procedimientos laringológicos fuera del quirófano frente a los que se realizan bajo anestesia general?, ¿por qué no se realizan más procedimientos laringológicos en el consultorio en la mayoría de los países en Latinoamérica? Discusión: A pesar de que se realizan con mayor frecuencia, aún existe controversia sobre si los procedimientos en consultorio deben realizarse con tanta frecuencia debido al riesgo de complicaciones. Además, los procedimientos que se realizan en el consultorio son más populares en algunos países que en otros, aunque sus beneficios han sido bien demostrados. Este artículo describe varios procedimientos en el consultorio, incluida la biopsia, las inyecciones de cuerdas vocales y la cirugía con láser. También se discutieron los factores que podrían contribuir a que los procedimientos en el consultorio se realicen con más frecuencia en algunos países que en otros. Conclusión: Las intervenciones con pacientes despiertos ofrecen numerosos beneficios, incluido un tiempo de procedimiento más corto, costos reducidos y una menor morbilidad para el paciente. Estas ventajas han transformado significativamente el tratamiento de las enfermedades laríngeas en la práctica de la laringología moderna a nivel mundial.

Non-valvular atrial fibrillation in patients on peritoneal dialysis, prevalence, treatment and professionals involved.

Atrial fibrillation is the most frequent chronic arrhythmia in patients with chronic kidney disease. Oral anticoagulation with vitamin K antagonists and now direct oral anticoagulants have been and are the fundamental pillars for the prevention of thromboembolic events. However, there are no randomized clinical trials on the risk-benefit profile of oral anticoagulation in patients with chronic kidney disease stage 5 on peritoneal dialysis and there is little evidence in the literature in this population. The objective of our study was to know the prevalence, treatment and professionals involved in the management of atrial fibrillation in peritoneal dialysis patients. For this purpose, we performed a descriptive analysis through a survey sent to different peritoneal dialysis units in Spain. A total of 1,403 patients on peritoneal dialysis were included in the study, of whom 186 (13.2%) had non-valvular atrial fibrillation. In addition, the assessment of the scores of thromboembolic and bleeding risks for the indication of oral anticoagulation was mainly carried out by the cardiologist (60% of the units), as well as its prescription (cardiologist 47% or in consensus with the nephrologist 43%). In summary, patients on peritoneal dialysis have a remarkable prevalence of non-valvular atrial fibrillation. Patients frequently receive oral anticoagulation with vitamin K antagonists, as well as direct oral anticoagulants. The data obtained regarding the scores used for the assessment of thromboembolic and bleeding risk, treatment and involvement by Nephrology indicates that there is a need for training and involvement of the nephrologist in this pathology.

Situación actual de los anticoagulantes orales de acción directa en atención primaria de España. Posicionamiento de SEMERGEN en 2023 / Current situation of direct oral anticoagulants in primary care in Spain: Positioning of SEMERGEN in 2023

La anticoagulación oral es clave para disminuir el riesgo de ictus en la fibrilación auricular. Aunque clásicamente los antagonistas de la vitaminaK (AVK) se han empleado para este fin, han sido ampliamente superados por los anticoagulantes orales de acción directa (ACOD), como lo demuestran las evidencias provenientes de los ensayos clínicos, estudios de vida real y poblacionales. De hecho, todas las guías de práctica clínica recomiendan su uso de manera preferencial sobre los AVK. Sin embargo, en España la prescripción de los ACOD está subordinada a un visado de inspección que recoge las condiciones clínicas definidas en el Informe de Posicionamiento Terapéutico de la Agencia Española del Medicamento, y que todavía impone importantes restricciones a su uso, limitando los beneficios del empleo de los ACOD en los pacientes con fibrilación auricular (FA), y generando además inequidades entre las diferentes comunidades autónomas. De hecho, el empleo de los ACOD en España es muy inferior a los países de nuestro entorno. Esto ha provocado que en otros países ha disminuido la incidencia de ictus isquémico a nivel poblacional, junto con una reducción del coste por paciente con FA, pero en España este descenso ha sido discreto. Por todo ello, y en aras de la sostenibilidad del sistema sanitario, pedimos la eliminación del visado para que los ACOD se puedan prescribir de acuerdo a las recomendaciones realizadas por las guías. Además, también apostamos por el refuerzo de la formación y de las decisiones consensuadas con el paciente, siendo el médico de familia un actor clave en la protección del paciente con FA.(AU)

Oral anticoagulation is the key to reduce the risk of stroke in atrial fibrillation. Although vitaminK antagonists (VKA) have classically been used for this purpose, they have been largely overcome by direct oral anticoagulants (DOAC), as demonstrated by evidence from clinical trials, real-life and population studies. In fact, all clinical practice guidelines recommend their use preferentially over VKA. However, in Spain the prescription of DOAC is subordinated to an inspection visa that includes the clinical conditions defined in the Therapeutic Positioning Report of the Spanish Medicines Agency, and that still imposes important restrictions on their use, limiting the benefits of using DOACs in patients with atrial fibrillation (AF), and also generating inequalities between the different autonomous communities. In fact, the use of DOAC in Spain is much lower than that observed in neighboring countries. This has made that while in other countries the incidence of ischemic stroke has decreased at the population level, along with a reduction in the cost per patient with AF, in Spain this decrease has been modest. For all these reasons, and for assuring the sustainability of the health care system, we ask for the elimination of the visa so that DOAC can be prescribed according to the recommendations made by the guidelines. In addition, we are also committed to reinforce medical education and decisions made by consensus with the patient, with the primary care physician acquiring a key role in the protection of the patient with AF.(AU)

Fibrilación auricular no valvular en pacientes en diálisis peritoneal: prevalencia, tratamiento y profesionales implicados / Non-valvular atrial fibrillation in patients on peritoneal dialysis: prevalence, treatment and professionals involved

La fibrilación auricular (FA) es la arritmia crónica más frecuente en pacientes con enfermedad renal crónica (ERC). La anticoagulación oral con antagonistas de la vitamina K (AVK) y actualmente los anticoagulantes orales de acción directa (ACOD) han sido el pilar fundamental para la prevención de eventos tromboembólicos. Sin embargo, no existen ensayos clínicos aleatorizados de su perfil riesgo-beneficio en pacientes con ERC estadio 5 en diálisis peritoneal (DP) y son pocas las evidencias en la literatura sobre esta población. El objetivo del estudio fue conocer la prevalencia, tratamiento y profesionales implicados en el manejo de la FA en DP en nuestro entorno mediante el análisis descriptivo de una encuesta enviada a diferentes unidades de DP de España. Se incluyeron en el estudio 1.403 pacientes en programa de DP, de los cuales 186 (13,2%) presentaban FA no valvular (FANV). Además, observamos que la valoración de los scores para el inicio del tratamiento anticoagulante la realizaba mayoritariamente el cardiólogo (60% de los centros), así como la prescripción de anticoagulación (cardiólogo 47% o en conjunto con el nefrólogo 43%). En conclusión, los pacientes en DP presentan una notable prevalencia de FANV. Reciben frecuentemente anticoagulación oral (ACO) con AVK, así como con ACOD. Los datos obtenidos respecto a las escalas utilizadas para la valoración de riesgo tromboembólico y de sangrado, tratamiento e implicación por parte de Nefrología indican que existe una necesidad de formación e involucramiento del nefrólogo en esta patología.(AU)

Atrial fibrillation is the most frequent chronic arrhythmia in patients with chronic kidney disease. Oral anticoagulation with vitamin K antagonists and now direct oral anticoagulants have been and are the fundamental pillar for the prevention of thromboembolic events. However, there are no randomized clinical trials on the risk-benefit profile of oral anticoagulation in patients with chronic kidney disease stage 5 on peritoneal dialysis and there is little evidence in the literature in this population. The objective of our study was to know the prevalence, treatment and professionals involved in the management of atrial fibrillation in peritoneal dialysis patients. For this purpose, we performed a descriptive analysis through a survey sent to different peritoneal dialysis units in Spain. A total of 1403 patients on peritoneal dialysis were included in the study, of whom 186 (13.2%) had non-valvular atrial fibrillation. In addition, the assessment of the scores of thromboembolic and bleeding risks for the indication of oral anticoagulation was mainly carried out by the cardiologist (60% of the units), as well as its prescription (cardiologist 47% in consensus with the nephrologist 43%). In summary, patients on peritoneal dialysis have a remarkable prevalence of non-valvular atrial fibrillation. Patients frequently receive oral anticoagulation with vitamin K antagonists, as well as direct oral anticoagulants. The data obtained regarding the scales used for the assessment of thromboembolic and bleeding risk, treatment and involvement by Nephrology indicates that there is a need for training and involvement of the nephrologist in this pathology.(AU)

Evidence of the association between increased use of direct oral anticoagulants and a reduction in the rate of atrial fibrillation-related stroke and major bleeding at the population level (2012–2019) / Evidencia a nivel poblacional de la asociación entre el aumento del uso de anticoagulantes orales directos y una reducción de la incidencia de ictus y hemorragias mayores relacionados con fibrilación auricular (2012-2019)

Background: The introduction of direct-acting oral anticoagulants (DOACs) has shown to decrease atrial fibrillation (AF)-related stroke and bleeding rates in clinical studies, but there is no certain evidence about their effects at the population level. Our aim was to assess changes in AF-related stroke and major bleeding rates between 2012 and 2019 in Andalusia (Spain), and the association between DOACs use and events rates at the population level. Methods: All patients with an AF diagnosis from 2012 to 2019 were identified using the Andalusian Health Population Base, that provides clinical information on all Andalusian people. Annual ischemic and hemorrhagic stroke, major bleeding rates, and used antithrombotic treatments were determined. Marginal hazard ratios (HR) were calculated for each treatment. Results: A total of 95,085 patients with an AF diagnosis were identified. Mean age was 76.1±10.2 years (49.7% women). An increase in the use of DOACs was observed throughout the study period in both males and females (p<0.001). The annual rate of ischemic stroke decreased by one third, while that of hemorrhagic stroke and major bleeding decreased 2–3-fold from 2012 to 2019. Marginal HR was lower than 0.50 for DOACs compared to VKA for all ischemic or hemorrhagic events. Conclusions: In this contemporary population-based study using clinical and administrative databases in Andalusia, a significant reduction in the incidence of AF-related ischemic and hemorrhagic stroke and major bleeding was observed between 2012 and 2019. The increased use of DOACs seems to be associated with this reduction.(AU)

Introducción: La introducción de los anticoagulantes orales de acción directa (ACOD) ha demostrado disminuir las tasas de accidentes cerebrovasculares y hemorragias relacionados con fibrilación auricular (FA) en estudios clínicos, pero no hay tanta evidencia sobre sus efectos a nivel poblacional. Nuestro objetivo fue evaluar los cambios en la incidencia de ictus y hemorragias mayores relacionados con FA entre 2012 y 2019 en Andalucía (España), y estudiar la asociación entre el uso de ACOD y estos eventos a nivel poblacional. Métodos: Se incluyeron pacientes con diagnóstico de FA entre los años 2012 y 2019 en la Base de Población Sanitaria de Andalucía, que proporciona información clínica de todos los andaluces. Se determinaron los accidentes cerebrovasculares isquémicos y hemorrágicos anuales, las tasas de sangrado mayor y los tratamientos antitrombóticos utilizados. Se estimaron los hazard ratio para cada tratamiento. Resultados: Se identificaron un total de 95.085 pacientes con diagnóstico de FA. La edad media fue de 76,1±10,2 años (49,7% mujeres). Se observó un aumento en el uso de ACOD a lo largo del período de estudio, tanto en varones como en mujeres (p<0,001). La tasa anual de ictus isquémico disminuyó en un tercio, mientras que la de ictus hemorrágico y hemorragia mayor se redujo de 2 a 3 veces entre 2012 y 2019. Los hazard ratio fueron inferiores a 0,50 para los ACOD en comparación con los antivitamina K para todos los eventos isquémicos o hemorrágicos. Conclusiones: En este estudio poblacional contemporáneo, se observó, utilizando bases de datos clínicas y administrativas de Andalucía, una reducción significativa en la incidencia de ictus isquémico y hemorrágico, y hemorragia mayor relacionados con FA entre los años 2012 y 2019. El mayor uso de ACOD parece estar asociado con esta reducción.(AU)

Evidence of the association between increased use of direct oral anticoagulants and a reduction in the rate of atrial fibrillation-related stroke and major bleeding at the population level (2012-2019).

BACKGROUND: The introduction of direct-acting oral anticoagulants (DOACs) has shown to decrease atrial fibrillation (AF)-related stroke and bleeding rates in clinical studies, but there is no certain evidence about their effects at the population level. Our aim was to assess changes in AF-related stroke and major bleeding rates between 2012 and 2019 in Andalusia (Spain), and the association between DOACs use and events rates at the population level. METHODS: All patients with an AF diagnosis from 2012 to 2019 were identified using the Andalusian Health Population Base, that provides clinical information on all Andalusian people. Annual ischemic and hemorrhagic stroke, major bleeding rates, and used antithrombotic treatments were determined. Marginal hazard ratios (HR) were calculated for each treatment. RESULTS: A total of 95,085 patients with an AF diagnosis were identified. Mean age was 76.1±10.2 years (49.7% women). An increase in the use of DOACs was observed throughout the study period in both males and females (p<0.001). The annual rate of ischemic stroke decreased by one third, while that of hemorrhagic stroke and major bleeding decreased 2-3-fold from 2012 to 2019. Marginal HR was lower than 0.50 for DOACs compared to VKA for all ischemic or hemorrhagic events. CONCLUSIONS: In this contemporary population-based study using clinical and administrative databases in Andalusia, a significant reduction in the incidence of AF-related ischemic and hemorrhagic stroke and major bleeding was observed between 2012 and 2019. The increased use of DOACs seems to be associated with this reduction.

[Current situation of direct oral anticoagulants in primary care in Spain: Positioning of SEMERGEN in 2023]. / Situación actual de los anticoagulantes orales de acción directa en atención primaria de España. Posicionamiento de SEMERGEN en 2023.

Oral anticoagulation is the key to reduce the risk of stroke in atrial fibrillation. Although vitaminK antagonists (VKA) have classically been used for this purpose, they have been largely overcome by direct oral anticoagulants (DOAC), as demonstrated by evidence from clinical trials, real-life and population studies. In fact, all clinical practice guidelines recommend their use preferentially over VKA. However, in Spain the prescription of DOAC is subordinated to an inspection visa that includes the clinical conditions defined in the Therapeutic Positioning Report of the Spanish Medicines Agency, and that still imposes important restrictions on their use, limiting the benefits of using DOACs in patients with atrial fibrillation (AF), and also generating inequalities between the different autonomous communities. In fact, the use of DOAC in Spain is much lower than that observed in neighboring countries. This has made that while in other countries the incidence of ischemic stroke has decreased at the population level, along with a reduction in the cost per patient with AF, in Spain this decrease has been modest. For all these reasons, and for assuring the sustainability of the health care system, we ask for the elimination of the visa so that DOAC can be prescribed according to the recommendations made by the guidelines. In addition, we are also committed to reinforce medical education and decisions made by consensus with the patient, with the primary care physician acquiring a key role in the protection of the patient with AF.

Predictive models for hepatocellular carcinoma development after sustained virological response in advanced hepatitis C / Modelos predictivos para el desarrollo de carcinoma hepatocelular tras la respuesta viral sostenida en pacientes con hepatitis C avanzada

Background & aims: Life-long hepatocellular carcinoma (HCC) surveillance is recommended after sustained virological response (SVR) in patients with advanced hepatitis C. Since the identification of patients who could be safely discontinued for surveillance is essential, we aimed to identify subsets of patients with low-risk HCC. Methods: 491 patients with advanced and compensated fibrosis (≥F3) were prospectively followed after achieving SVR with interferon-free therapies. Clinical–biological parameters and liver stiffness measurement (LSM) were performed before starting treatment (ST) and at SVR, and HCC surveillance was carried out. Results: During a median follow-up of 49.8 months, 29 (5.9%) patients developed HCC [incidence rate: 1.6/100 patient-years (PYs)]. Two predictive models based on LSM (Model-A) or FIB-4 score (Model-B) were proposed. Only SVR parameters were included in the models, because they showed a higher accuracy for predicting HCC than ST measurements. Variables independently associated with HCC were LSM (HR, 1.03; 95% CI, 1.01–1.05), age (HR, 1.04; 95% CI, 1.01–1.08) and albumin levels (HR, 0.90; 95% CI, 0.84–0.97) in Model-A, and FIB-4 (HR, 1.22; 95% CI, 1.08–1.37) and albumin (HR, 0.90; 95% CI, 0.84–0.97) in model-B. Both models allow HCC risk stratification, identifying low-risk groups with an HCC incidence rate of 0.16/100 and 0.25/100 PYs, respectively. An overall increased hazard of HCC was observed over time. (AU)

Antecedentes y objetivos: En pacientes con hepatitis C avanzada se recomienda la vigilancia del carcinoma hepatocelular (CHC) de por vida tras la respuesta viral sostenida (RVS). La identificación de pacientes que podrían interrumpir de manera segura el screening es esencial, por ello nuestro objetivo fue identificar subgrupos de pacientes con bajo riesgo de desarrollo de CHC. Métodos: Se realizó un seguimiento prospectivo de 491 pacientes con fibrosis avanzada y compensada (≥F3) tras la RVS obtenida con terapias libres de interferón. Se registraron parámetros clínico-biológicos y se midió la rigidez hepática mediante elastografía de transición (ET) antes del inicio del tratamiento y en la respuesta viral sostenida y se realizó screening para el desarrollo de CHC. Resultados: Durante una mediana de seguimiento de 49,8 meses, 29 (5,9%) pacientes desarrollaron CHC. (Tasa de incidencia: 1,6/100 pacientes-año [PA]). Se propusieron dos modelos predictivos basados en la puntuación de ET (Modelo-A) o FIB-4 (Modelo-B). Se incluyeron los parámetros en RVS en los modelos porque mostraron una mayor precisión para predecir CHC que las mediciones basales. Las variables asociadas de forma independientes con CHC fueron: ET (HR 1,03 IC; IC 95%, 1,01-1,05), edad (HR 1,04; IC 95%, 1,01-1,08) y niveles de albúmina (HR 0,90; IC 95%, 0,84-0,97) en el Modelo-A, y FIB-4 (HR 1,22; IC 95%, 1,08-1,37) y albúmina (HR 0,90; IC 95%, 0,84-0,97) en el Modelo-B. Ambos modelos permiten la estratificación del riesgo de CHC, identificando grupos de bajo riesgo con una tasa de incidencia de CHC de 0,16/100 y 0,25/100 PA, respectivamente. Se observó un aumento general del riesgo de desarrollar CHC con el tiempo. (AU)

Implementación del mini-CEX en el pregrado médico: Una experiencia con simulación / Implementation of the Mini-CEX in Medical Undergraduate Education: A Simulation-Based Experience

Resumen La evaluación es un proceso sistemático que resulta en un juicio de valor para tomar decisiones. Los instrumentos empleados para obtener datos sobre el desempeño de los estudiantes requieren de un proceso sistemático y objetivo para su implementación. El mini-CEX es un instrumento de observación directa que ha sido empleado para la evaluación de la competencia clínica en los estudiantes de pre y posgrado desde su invención en 1955. Cuenta con diferentes evidencias de validez para su uso en distintos contextos educativos y clínicos. Permite realizar evaluaciones rápidas, acompañadas de realimentación y que proporcionan información relevante del desarrollo de la competencia clínica. El objetivo de este escrito es exponer la experiencia de la implementación del mini-CEX en el pregrado médico para la evaluación formativa de los estudiantes utilizando la simulación con pacientes estandarizados. Para lograr este objetivo se empleó la siguiente secuencia: búsqueda, planeación, integración y aplicación. Posterior a estos pasos se dan una serie de recomendaciones para la implementación del mini-CEX. Se concluye que la evaluación de la competencia clínica es importante para la mejora continua y permanente de los estudiantes de pre y posgrado. Es necesario sistematizar la evaluación ajustada siempre a objetivos y necesidades específicas de la evaluación.

Abstract Evaluation is a systematic process that results in a judgment to make decisions. The instruments used to obtain data on student performance require a systematic and objective process for their implementation. The mini-CEX is a direct observation tool that has been used for the evaluation of clinical competence in undergraduate and postgraduate students since its invention in 1955. It has different validity evidence for use in different educational and clinical contexts. It allows rapid evaluations, accompanied by feedback and providing relevant information on the development of clinical competence. The objective of this paper is to expose the experience of the implementation of the mini-CEX in the medical undergraduate for the formative evaluation of students using simulation with standardized patients. To achieve this goal, the following sequence was used: search, planning, integration, and application. After these steps we make some recommendations for the implementation of the mini-CEX. Its is concluded that the evaluation of clinical competence is important for the continuous and permanent improvement of undergraduate and graduate students. It is necessary to systematize the evaluation always adjusted to objectives and specific needs of the evaluation.

Hepatitis C virus-positive donors in HCV-negative recipients in liver transplantation: Is it possible in Mexico?

Hepatitis C virus (HCV) infection is a worldwide public health problem associated with significant morbidity and mortality. In the context of liver transplantation, the demand for organs continues to exceed the supply, prompting the consideration of using organs from HCV-positive donors in HCV-negative recipients. The introduction of direct-acting antivirals (DAAs), which have demonstrated great efficacy in eradicating the virus, has made transplantation of organs from donors with HCV infection possible. The present article provides a brief review of the current evidence on the use of organs from HCV-infected patients.

Long-term follow-up of HCV-infected patients with end-stage chronic kidney disease after sustained virological response with direct-acting antiviral therapy / Seguimiento a largo plazo de pacientes infectados por el virus de la hepatitis C con insuficiencia renal crónica terminal tras una respuesta virológica sostenida con tratamiento antiviral de acción directa

Background and aim: Patients with chronic kidney disease (CKD) and hepatitis C infection can be safely and effectively treated with direct-acting antivirals (DAAs). However, there is scarce data on the long-term impact of hepatitis C cure on CKD. The aim of this study was to assess the long-term mortality, morbidity and hepatic/renal function outcomes in a cohort of HCV-infected individuals with CKD treated with DAAs. Methods: 135 HCV patients with CKD stage 3b-5 who received ombitasvir/paritaprevir/ritonavir±dasabuvir in a multicenter study were evaluated for long-term hepatic and renal outcomes and their associated mortality. Results: 125 patients achieved SVR and 66 were included. Prior to SVR, 53 were under renal replacement therapy (RRT) and 25 (37.8%) had liver cirrhosis. After a follow-up of 4.5 years, 25 (38%) required kidney transplantation but none combined liver–kidney. No changes in renal function were observed among the 51 patients who did not receive renal transplant although eGFR values improved in those with baseline CKD stage 3b-4. Three (5.6%) subjects were weaned from RRT. Eighteen (27.3%) patients died, mostly from cardiovascular events; 2 developed liver decompensation and 1 hepatocellular carcinoma. No HCV reinfection was observed. Conclusions: Long-term mortality remained high among end-stage CKD patients despite HCV cure. Overall, no improvement in renal function was observed and a high proportion of patients required kidney transplantation. However, in CKD stage 3b-4 HCV cure may play a positive role in renal function. (AU)

Introducción y objetivo: Los pacientes con insuficiencia renal crónica (IRC) e infección por el virus de la hepatitis C (VHC) pueden ser tratados de forma efectiva y segura con antivirales de acción directa (AAD). El objetivo de este estudio fue evaluar la mortalidad y la evolución de la función renal y hepática a largo plazo en una cohorte de pacientes con infección por VHC e IRC tratados con AAD. Métodos: Se analizó la evolución de la función hepática y renal, así como la mortalidad en 135 pacientes con infección por VHC e IRC estadio 3b-5 que recibieron ombitasvir/paritaprevir/ritonavir±dasabuvir en un estudio multicéntrico. Resultados: Ciento veinticinco pacientes se curaron (RVS), y 66 de ellos fueron incluidos. Antes de RVS, 53 estaban bajo terapia renal sustitutiva (TRS) y 25 (37,8%) tenían cirrosis hepática. Tras un seguimiento medio de 4,5 años, 25 (38%) requirieron trasplante renal, pero ninguno combinado renal-hepático. No se observaron cambios en la función renal entre aquellos 51 pacientes que no recibieron trasplante renal a pesar de que los valores de eFGR mejoraron en aquellos pacientes con IRC estadio 3b-4 de base. Tres (5,6%) pacientes pudieron dejar la TRS. Dieciocho (27,3%) pacientes fallecieron, principalmente por eventos cardiovasculares, 2 presentaron descompensación hepática y uno carcinoma hepatocelular. No se observó ninguna reinfección por VHC. Conclusiones: La mortalidad a largo-plazo fue alta. Globalmente no se objetivó una mejora en la función renal. A pesar de ello, en estadios 3b-4, la curación del VHC podría tener un papel positivo en la función renal. (AU)

Sofosbuvir plus glecaprevir/pibrentasvir as salvage therapy after liver transplantation in NS5A inhibitor-experienced patients. A case series.

BACKGROUND: Treatment of chronic hepatitis C virus (HCV) infection with direct-acting antivirals achieves a sustained virologic response rate higher than 95%. However, virologic failure remains a clinical challenge, and data on retreatment are limited, especially in special populations such as liver transplant (LT) recipients. OBJECTIVES: This study evaluated the sofosbuvir plus glecaprevir-pibrentasvir (GLE/PIB) regimen in LT recipients who had failed to a nonstructural protein 5A (NS5A) inhibitor-based regimen. MATERIAL AND METHODS: Retrospective study of 111 liver transplant recipients between January 2018 and December 2020; 18 patients presented with HCV recurrent infection after LT, out of whom three had a history of at least one NS5A inhibitor-based regimen. Salvage therapy with sofosbuvir plus GLE/PIB was started for 12 weeks; baseline characteristics and outcomes were recorded. RESULTS: All three patients (100%) achieved an undetectable HCV viral load 12 weeks after treatment completion. No serious adverse events were observed. CONCLUSION: In our series, sofosbuvir plus GLE/PIB for 12 weeks is an effective and safe salvage therapy after LT in patients previously treated with NS5A inhibitors.

ANTECEDENTES: El tratamiento del virus de la hepatitis C (VHC) crónica con antivirales de acción directa logra tasas de respuesta virológica sostenida superiores a 95 %. Sin embargo, el manejo del fracaso virológico sigue siendo un desafío clínico y la evidencia sobre el retratamiento es limitada, especialmente en poblaciones como los receptores de trasplante hepático (TH). OBJETIVO: Este estudio evaluó el régimen de sofosbuvir más glecaprevir/pibrentasvir (GLE/PIB) en receptores de TH en quienes falló el régimen basado en inhibidores de la proteína no estructural 5A (NS5A). MATERIAL Y MÉTODOS: Estudio retrospectivo de 111 pacientes trasplantados entre enero de 2018 y diciembre de 2020; 18 pacientes presentaron infección recurrente por VHC posterior al TH, tres de ellos tuvieron antecedentes de al menos un régimen basado en inhibidores de NS5A. Se inició terapia de rescate con sofosbuvir más GLE/PIB durante 12 semanas posterior al TH; se registraron las características basales de los pacientes y sus desenlaces. RESULTADOS: En los tres pacientes se logró obtener una carga viral indetectable de VHC a las 12 semanas de finalizar el tratamiento. No se observaron eventos adversos graves. CONCLUSIÓN: En nuestra serie, sofosbuvir más GLE/PIB durante 12 semanas demostró ser una terapia de rescate efectiva y segura posterior al TH en pacientes previamente tratados con inhibidores de NS5A.

ACOD frente a AVK en pacientes con fibrilación auricular y bioprótesis: revisión sistemática y metanálisis / DOAC versus VKA in patients with atrial fibrillation and bioprosthetic valves: a systematic review and meta-analysis

Introducción y objetivos: Los anticoagulantes orales directos (ACOD) se han mostrado eficaces y seguros en pacientes con fibrilación auricular; sin embargo, los pacientes con FA y bioprótesis están infrarrepresentados en los ensayos clínicos, por lo que la evidencia en este grupo es menor. Nuestro objetivo fue analizar la seguridad y eficacia de los ACODs en esta población revisando la información existente en la literatura. Métodos: Se realizó una búsqueda y revisión sistemática con los ensayos clínicos aleatorizados y estudios observacionales comparativos desde 2017 a enero de 2022, que comparasen ACODs y antagonistas de vitamina K (AVK) en pacientes con FA y bioprótesis. Se utilizó la hazard ratio al 95% del intervalo de confianza para comparar ambos grupos en términos de mortalidad total y cardiovascular, ictus/embolia sistémica y hemorragia mayor. Se realizó un metanálisis combinando los resultados de los estudios incluidos. Resultados: Se incluyeron 12 estudios (un total de 30.283 pacientes). Los ACODs se asociaron a una reducción significativa del 9% de la mortalidad total (HR=0,91; IC95%, 0,85-0,97; p=0,0068; I2=8%), sin diferencias significativas en el riesgo de ictus/embolismo sistémico (HR=0,87; IC95%, 0,67-1,14; p=0,29; I2=45%) o hemorragia mayor (HR=0,82; IC95%, 0,67-1,00; p=0,054; I2=48.7%). Conclusiones: En pacientes con FA portadores de bioprótesis, los ACODs podrían asociarse a una reducción de la mortalidad total sin reducción de eficacia en la prevención de ictus/embolia sistémica o aumento del riesgo de hemorragia mayor.(AU)

Introduction and objectives: Direct oral anticoagulant (DOAC) therapy has been shown to be safe and effective in patients with atrial fibrillation (AF). However, outcomes in AF patients with bioprosthetic valves are unclear, as this population has been underrepresented in clinical trials. The aim of this study was to assess the safety and efficacy of DOACs in this population based on the existing published literature. Methods: A systematic search and review were conducted to identify randomized clinical trials and comparative observational studies published from 2017 to January 2022 that compared DOACs and vitamin K antagonists (VKAs) in AF patients with bioprosthetic valves. Hazard ratios (HR) were collected to compare the 2 treatments in terms of cardiovascular and all-cause mortality, stroke/systemic embolism, and major bleeding. A meta-analysis combining the results was performed. Results: We included 12 studies (30 283 patients). DOACs and VKAs were compared based on HRs at the 95% confidence interval. DOAC therapy was associated with a significant 9% reduction in all-cause mortality (HR, 0.91; 95%CI, 0.85-0.97; P=.0068; I2=8%), with no significant differences in the risk of stroke/systemic embolism (HR, 0.87; 95%CI, 0.67-1.14; P=.29; I2=45%) or major bleeding (HR, 0.82; 95%CI, 0.67-1.00; P=.054; I2=48.7%). Conclusions: DOAC therapy in AF patients with bioprosthetic valves may be associated with a significant reduction in all-cause mortality, with no reduction in the efficacy of stroke/systemic embolism prevention or increase in major bleeding risk.(AU)

Efectos de la estimulación transcraneal por corriente directa y de la estimulación magnética transcraneal en pacientes con fibromialgia. Revisión sistemática / Effects of transcranial direct current stimulation and transcranial magnetic stimulation in patients with fibromyalgia. A systematic review

ntroducción: La fibromialgia (FM) es una patología crónica caracterizada por la presenciade dolor musculoesquelético generalizado que se asocia a trastornos psicológicos que afectana la calidad de vida. En los últimos a˜nos, la estimulación transcraneal con corriente directa(tDCS) y la estimulación magnética transcraneal (TMS) se han estudiado para el abordaje deldolor crónico. El objetivo de esta revisión es determinar los efectos de la tDCS y la TMS en lossíntomas característicos de los pacientes con FM.Desarrollo: Se realizó una revisión sistemática acorde a los criterios PRISMA. Se realizaronbúsquedas en las bases de datos Medline, Scopus, PEDro y Cochrane Library. Se seleccionaronensayos clínicos aleatorizados que analizaran los efectos de estas intervenciones en el dolor, elumbral de dolor a la presión, la fatiga, la ansiedad y depresión, el catastrofismo y la calidad devida en pacientes con FM. Se incluyeron 14 estudios.Conclusiones: La aplicación de tDCS en el córtex motor es la única intervención que ha mos-trado disminuir el dolor a corto y medio plazo en pacientes con FM. La aplicación de ambasintervenciones ha mostrado mejoras en el umbral de dolor a la presión, el catastrofismo y lacalidad de vida cuando se aplica en el córtex motor, y de la fatiga cuando se aplica en la cortezadorsolateral prefrontal. Los efectos de estas intervenciones en la ansiedad y depresión no sonconcluyentes.(AU)

Introduction: Fibromyalgia syndrome (FM) is a chronic pathology characterized by widespreadpain commonly associated with psychological distress affecting quality of life. In recent years,transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) havebeen investigated to treat chronic pain. The aim of the current review is to determine theeffects of tDCS and TMS on the main symptoms of patients with FM.Development: A systematic review based on PRISMA guidelines was carried out. The searchstrategy was performed in Medline, Scopus, PEDro and Cochrane Library. Randomized controlledtrials based on the effects of tDCS and TMS on pain, pressure pain threshold, fatigue, anxietyand depression, catastrophizing and quality of life in patients with FM were analysed. Fourteenstudies were included.Conclusions: The application of tDCS to the motor cortex is the only intervention shown todecrease pain in the short and medium-term in patients with FM. The application of bothinterventions showed improvements in pressure pain threshold, catastrophizing and quality oflife when applied to the motor cortex, and in fatigue when applied to the dorsolateral prefrontalcortex. The effects of these interventions on anxiety and depression are unclear.(AU)

Sofosbuvir más glecaprevir/pibrentasvir como terapia de rescate postrasplante hepático en pacientes con exposición previa a inhibidores de NS5A. Serie de casos / Sofosbuvir plus glecaprevir/pibrentasvir as salvage therapy after liver transplantation in NS5A inhibitor-experienced patients. A case series

Resumen Antecedentes: El tratamiento de la infección crónica por el virus de la hepatitis C (VHC) con antivirales de acción directa logra tasas de respuesta virológica sostenida superiores a 95 %. Sin embargo, el manejo del fracaso virológico sigue siendo un desafío clínico y la evidencia sobre el retratamiento es limitada, especialmente en poblaciones como los receptores de trasplante hepático (TH). Objetivo: Este estudio evaluó el régimen de sofosbuvir más glecaprevir/pibrentasvir (GLE/PIB) en receptores de TH en quienes falló el régimen basado en inhibidores de la proteína no estructural 5A (NS5A). Material y métodos: Estudio retrospectivo de 111 pacientes trasplantados entre enero de 2018 y diciembre de 2020; 18 pacientes presentaron infección recurrente por VHC posterior al TH, tres de ellos tuvieron antecedentes de al menos un régimen basado en inhibidores de NS5A. Se inició terapia de rescate con sofosbuvir más GLE/PIB durante 12 semanas posterior al TH; se registraron las características basales de los pacientes y sus desenlaces. Resultados: En los tres pacientes se logró obtener una carga viral indetectable de VHC a las 12 semanas de finalizar el tratamiento. No se observaron eventos adversos graves. Conclusión: En nuestra serie, sofosbuvir más GLE/PIB durante 12 semanas demostró ser una terapia de rescate efectiva y segura posterior al TH en pacientes previamente tratados con inhibidores de NS5A.

Abstract Background: Treatment of chronic hepatitis C virus (HCV) infection with direct-acting antivirals achieves a sustained virologic response rates higher than 95%. However, virologic failure remains a clinical challenge, and data on retreatment are limited, especially in special populations such as liver transplant (LT) recipients. Objective: This study evaluated the sofosbuvir plus glecaprevir-pibrentasvir (GLE/PIB) regimen in LT recipients who had failed to a nonstructural protein 5A (NS5A) inhibitor-based regimen. Material and methods: Retrospective study of 111 liver transplant recipients between January 2018 and December 2020; 18 patients presented with HCV recurrent infection after LT, out of whom three had a history of at least one NS5A inhibitor-based regimen. Salvage therapy with sofosbuvir plus GLE/PIB was started for 12 weeks; baseline characteristics and outcomes were recorded. Results: All three patients (100%) achieved an undetectable HCV viral load 12 weeks after treatment completion. No serious adverse events were observed. Conclusion: In our series, sofosbuvir plus GLE/PIB for 12 weeks is an effective and safe salvage therapy after LT in patients previously treated with NS5A inhibitors.

The conventional diagnosis challenge: Real-time PCR and nested PCR correlation with the scoring system for individuals at high-risk of Pneumocystis jirovecii pneumonia

Introduction. Pneumocystis jirovecii is an opportunistic fungus that affects mainly people living with HIV (CD4 cell count lower than 200 cells/ml) and other immunosuppressed patients. Since P. jirovecii does not grow on routine mycological media, diagnosis of P. jirovecii pneumonia relies on indirect evidence of its presence in respiratory samples. Objectives. To associate the results of direct immunofluorescence and two molecular methods with a score to predict P. jirovecii pneumonia in patients with AIDS. Materials and methods. A prospective study was conducted with 40 patients. A respiratory sample collected before treatment was subjected to direct immunofluorescence using the Merifluor kit, to nested PCR targeting the mitochondrial large subunit ribosomal RNA, and to the VIASURE real-time PCR kit. Results. These three techniques revealed P. jirovecii in 6, 12, and 15 samples, respectively. All positive samples by direct immunofluorescence were positive by nested PCR, and all positive samples by nested PCR amplified by real-time PCR. There was a statistically significant association between the P. jirovecii pneumonia score and the molecular methods. Two patients were early diagnosed and responded well to treatment. Conclusion. Molecular methods, especially real-time PCR, are recommended for early diagnosis of P. jirovecii pneumonia in AIDS patients.

Introducción. Pneumocystis jirovecii es un hongo oportunista que afecta principalmente a personas con HIV (recuento de CD4 menor de 200 células/ml) y a otros pacientes inmunosuprimidos. Como P. jirovecii no crece en los medios micológicos de rutina, el diagnóstico de neumonía por P. jirovecii se basa en la evidencia presente en muestras respiratorias. Objetivos. Asociar los resultados de la inmunofluorescencia directa y los de dos métodos moleculares con un puntaje para predecir la neumonía causada por P. jirovecii en pacientes con sida. Materiales y métodos. Se realizó un estudio prospectivo de 40 pacientes. Se recolectó una muestra respiratoria antes del inicio de tratamiento y se sometió a una prueba de inmunofluorescencia directa con el kit Merifluor, una PCR anidada para la amplificación de la subunidad larga del ribosoma mitocondrial y una PCR en tiempo real usando el kit VIASURE. Resultados. Estas tres técnicas evidenciaron la presencia de P. jirovecii en 6, 12 y 15 muestras, respectivamente. Todas las muestras positivas por inmunofluorescencia directa fueron positivas en la PCR anidada y todas las muestras positivas en la PCR anidada amplificaron por PCR en tiempo real. Se encontró una asociación estadística entre los valores de la neumonía causada por P. jirovecii y los métodos moleculares. Dos pacientes con diagnóstico temprano respondieron satisfactoriamente al tratamiento. Conclusión. Se recomiendan los métodos moleculares, especialmente la PCR en tiempo real, para el diagnóstico temprano de neumonía causada por P. jirovecii en pacientes con sida.

Patients with severe mental illness and hepatitis C virus infection benefit from new pangenotypic direct-acting antivirals: Results of a literature review / Los beneficios de los nuevos antivirales pangenotípicos de acción directa en pacientes con enfermedad mental grave e infección por el virus de la hepatitis C: resultados de una revisión bibliográfica

Introduction: Hepatitis C virus (HCV) infection is a global health problem that can results in cirrhosis, hepatocellular carcinoma and even death. HCV infection is 3–20-fold more prevalent among patients with versus without severe mental illness (SMI), such as major depressive disorder, personality disorder, bipolar disorder and schizophrenia. Treatment options for HCV were formerly based on pegylated interferon alpha, which is associated with neuropsychiatric adverse events, and this contributed to the exclusion of patients with SMI from HCV treatment, elimination programmes, and clinical trials. Moreover, the assumption of poor adherence, scant access to healthcare and the stigma and vulnerability of this population emerged as barriers and contributed to the low rates of treatment and efficacy. Methods: This paper reviews the literature published between December 2010 and December 2020 exploring the epidemiology of HCV in patients with SMI, and vice versa, the effect of HCV infection, barriers to the management of illness in these patients, and benefits of new therapeutic options with pangenotypic direct antiviral agents (DAAs). Results: The approval of DAAs has changed the paradigm of HCV infection treatment. DAAs have proven to be an equally efficacious and safe option that improves quality of life (QoL) in patients SMI. Conclusions: Knowledge of the consequences of the HCV infection and the benefits of treatment with new pangenotypic DAAs among psychiatrists can increase screening, referral and treatment of HCV infection in patients with SMI.(AU)

Introducción: La infección por el virus de la hepatitis C (VHC) es un problema de salud mundial que puede provocar cirrosis, carcinoma hepatocelular e incluso la muerte. La infección por el VHC es de 3 a 20 veces más prevalente entre los pacientes con enfermedades mentales graves (EMG), como el trastorno depresivo mayor, el trastorno de personalidad, el trastorno bipolar y la esquizofrenia. Las opciones de tratamiento para el VHC se basaban anteriormente en el interferón pegilado alfa, que se asocia con efectos adversos neuropsiquiátricos, y esto contribuyó a la exclusión de los pacientes con EMG del tratamiento del VHC, tanto de los programas de eliminación como de los ensayos clínicos. Además, la mala adherencia terapéutica, el escaso acceso de los pacientes a la asistencia sanitaria y el estigma y la vulnerabilidad de esta población surgieron como barreras y contribuyeron a las bajas tasas de tratamiento y eficacia. Métodos: En este trabajo se revisa la literatura publicada entre diciembre de 2010 y diciembre de 2020 en la que se explora la epidemiología del VHC en pacientes con EMG, y vice versa, el efecto de la infección por VHC, las barreras para el manejo de la enfermedad en estos pacientes y los beneficios de las nuevas opciones terapéuticas con agentes antivirales directos pangenotípicos (AAD). Resultados: La aprobación de los AAD ha cambiado el paradigma del tratamiento de la infección por VHC. Los AAD han demostrado ser una opción igualmente eficaz y segura que mejora la calidad de vida (QoL) en los pacientes SMI. Conclusiones: El conocimiento de las consecuencias de la infección por el VHC y los beneficios del tratamiento con los nuevos AAD pangenotípicos entre los psiquiatras puede aumentar el cribado, la derivación y el tratamiento de la infección por el VHC en pacientes con EMG.(AU)

Effects of transcranial direct current stimulation and transcranial magnetic stimulation in patients with fibromyalgia. A systematic review.

BACKGROUND: Fibromyalgia syndrome (FM) is a chronic pathology characterised by widespread pain commonly associated with psychological distress affecting quality of life. In recent years, transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) have been investigated to treat chronic pain. The aim of the current review is to determine the effects of tDCS and TMS on the main symptoms of patients with FM. DEVELOPMENT: A systematic review based on PRISMA guidelines was carried out. The search strategy was performed in MEDLINE, SCOPUS, PEDro and Cochrane Library. Randomised controlled trials based on the effects of tDCS and TMS on pain, pressure pain threshold (PPT), fatigue, anxiety and depression, catastrophising and quality of life in patients with FM were analysed. Fourteen studies were included. CONCLUSIONS: The application of tDCS to the motor cortex is the only intervention shown to decrease pain in the short and medium-term in patients with FM. The application of both interventions showed improvements in PPT, catastrophising and quality of life when applied to the motor cortex, and in fatigue when applied to the dorsolateral prefrontal cortex. The effects of these interventions on anxiety and depression are unclear.

Patterns and outcomes of switching direct oral anticoagulants in non-valvular atrial fibrillation: A real-world experience from Spain.

AIMS: The aim is to evaluate a management program for direct oral anticoagulants (DOACs) in non-valvular atrial fibrillation (NVAF) patients according to their profiles, appropriateness of dosing, patterns of crossover, effectiveness and safety. This is an observational and longitudinal prospective study in a cohort of patients attended in daily clinical practice in a regional hospital in Spain with 3-year a follow-up plan for patients initiating dabigatran, rivaroxaban or apixaban between JAN/2012-DEC/2016. METHODS: We analyzed 490 episodes of treatment (apixaban 2.5 9.4%, apixaban 5 21.4%, dabigatran 75 0.6%, dabigatran 110 12,4%, dabigatran 150 19.8%, rivaroxaban 15 17.8% and rivaroxaban 20 18.6%) in 445 patients. 13.6% of patients on dabigatran, 9.7% on rivaroxaban, and 3.9% on apixaban switched to other DOACs or changed dosing. RESULTS: Apixaban was the most frequent DOAC switched to. The most frequent reasons for switching were toxicity (23.8%), bleeding (21.4%) and renal deterioration (16.7%). Inappropriateness of dose was found in 23.8% of episodes. Rates of stroke/transient ischemic attack (TIA) were 1.64/0.54 events/100 patients-years, while rates of major, clinically relevant non-major (CRNM) bleeding and intracranial bleeding were 2.4, 5, and 0.5 events/100 patients-years. Gastrointestinal and genitourinary bleeding were the most common type of bleeding events (BE). On multivariable analysis, prior stroke and age were independent predictors of stroke/TIA. Concurrent platelet inhibitors, male gender and age were independent predictors of BE. CONCLUSION: This study complements the scant data available on the use of DOACs in NVAF patients in Spain, confirming a good safety and effectiveness profile.

[Direct-acting oral anticoagulants in antiphospholipid syndrome: A systematic review]. / Anticoagulantes de acción directa en el síndrome antifosfolípido. Revisión sistemática.

The objective of the systematic review is to analyze the efficacy of direct-acting oral anticoagulants (DOAC) in the prophylaxis of thrombosis in antiphospholipid syndrome (APS). We searched for clinical trials, cohort studies and meta-analyses published from January 1, 2012 to September 30, 2022. Articles that analyzed the efficacy of DOAC in the prevention of thrombosis recurrence, with or without comparison with antivitamin K (VKA) drugs, were selected. DOACs, specifically rivaroxaban and apixaban, were significantly less effective than VKAs in preventing recurrence of thrombosis in patients with APS and prior arterial thrombosis or the concomitant presence of two or three different antiphospholipid antibodies. The proportion of patients with severe bleeding as side effect are similar in those treated with DOAC and with VKA. The results argue against the use of DOAC in the treatment of patients with thrombotic APS.