Comparación de la eficacia y seguridad de flecainida y dronedarona como terapias antiarrítmicas para mantenimiento de ritmo sinusal en fibrilación auricular / Comparison of the efficacy and safety of dronedarone and flecainide as maintenance antiarrhythmic therapy for sinus rhythm in atrial fibrillation

Resumen Introducción y objetivos: Dronedarona y flecainida son antiarrítmicos de primera elección para reducir recurrencias de fibrilación auricular (FA), sin existir estudios que los comparen entre sí. Nuestro objetivo es comparar la eficacia en cuanto a prevención de recurrencias y seguridad de ambos fármacos. Métodos: Estudio retrospectivo en el que se incluyeron 123 pacientes de forma consecutiva en tratamiento con flecainida o dronedarona desde octubre de 2010 hasta febrero de 2013 por FA paroxística (76.4%) y FA persistente (23.6%). Se realizó cardioversión eléctrica en un 7.3% de los pacientes y farmacológica en un 16.3%. La mediana (rango intercuartílico) de seguimiento fue de 301 días (92-474), con una media de 2.8 revisiones por paciente. Se realizó análisis de tiempo hasta el primer evento mediante Kaplan-Meier y regresión de Cox ajustada por un índice de propensión. Resultados: De entre los 123 sujetos incluidos con FA, 71 fueron tratados con flecainida y 52 con dronedarona. Durante el seguimiento se registraron 36 recurrencias y 20 efectos adversos. Se documentaron un 36.6% de recurrencias en los pacientes tratados con flecainida en comparación con un 21% en los tratados con dronedarona (p = 0.073). En el análisis multivariante, dronedarona se mostró al menos tan eficaz como flecainida para prevenir recurrencias de FA (HR: 0.53, IC 95%: 0.20-1.44, p = 0.221) y demostró un perfil de seguridad comparable al de flecainida (HR: 0.68, IC 95%: 0.18-2.53, p = 0.566). Conclusiones: Según nuestra experiencia, dronedarona resulta al menos tan eficaz como flecainida para el mantenimiento de ritmo sinusal, con un buen perfil de tolerabilidad, a pesar de pautarse en pacientes con un perfil clínico más desfavorable.

Abstract Introduction and objectives: Dronedarone and flecainide are the first pharmacological choice to reduce recurrence of atrial fibrillation (AF); however, there are no studies comparing them. A study was performed to compare the efficacy in terms of recurrence of AF and safety of both drugs. Methods: A retrospective cohort study was conducted that included 123 consecutive patients treated with flecainide or dronedarone due to paroxysmal AF (76.4%) or persistent AF (23.6%), from October 2010 to February 2013. Electrical cardioversion was performed in 7.3% of patients and pharmacological cardioversion in 16.3%. The median (interquartile range) follow-up was 301 days (92-474) with a mean of 2.8 reviews per patient. Time to first event analysis was performed using Kaplan-Meier and Cox regression, adjusted for propensity score. Results: Of the 123 consecutive patients with AF included, 71 were on dronedarone and 52 on flecainide. During the follow-up, there were 36 AF recurrences and 20 safety events. There were recurrences in 36.6% of patients treated with flecainide, compared with 21% of those receiving dronedarone (P = .073). Dronedarone showed to be at least as effective as flecainide in preven- ting recurrence of atrial fibrillation (HR: 0.53, 95% CI: 0.20-1.44, P = .221), and demonstrated an acceptable safety profile when compared with flecainide (HR: 0.68, 95% CI: 0.18-2.53, P = .566). Conclusions: In our experience, dronedarone has been at least as effective and safe as flecainide, despite it was most frequently prescribed in patients with worse baseline risk profile.

Análisis de la cultura de seguridad en una Unidad de Cardiología gestionada por procesos / Analysis of the safety culture in a Cardiology Unit managed by processes

Resumen La cultura sobre seguridad se perfila como uno de los requisitos para evitar la aparición de efectos adversos, sin embargo, no se ha estudiado en el ámbito de la cardiología. Objetivo: es evaluar la cultura de seguridad en una unidad de cardiología que tiene implantado y certificado un sistema integrado de gestión de calidad y riesgos para la seguridad del paciente. Método: Se realizó un estudio observacional trasversal en 2 años consecutivos utilizando la encuesta Hospital Survey on Patient Safety Culture de la «Agency for Healthcare Research and Quality¼ en su versión española (42 ítems agrupados en 12 dimensiones) sobre todo el personal. Se comparó el porcentaje de respuestas positivas de cada dimensión en 2014 y 2015, así como con los datos a nivel nacional y en EE. UU., siguiendo las recomendaciones establecidas. Resultados: La valoración global, sobre un máximo de 5, fue de 4.5 en 2014 y de 4.7 en 2015. Identificamos 7 dimensiones como fortaleza. Las peor valoradas fueron: Dotación de personal, Apoyo de la gerencia y Trabajo en equipo entre unidades. La comparación mostró superioridad en todas las dimensiones a nivel nacional, y en 8 respecto a los datos del registro americano. Conclusiones: La cultura de seguridad en una unidad de cardiología con un sistema integrado de gestión de calidad y riesgos y seguridad del paciente es elevada, superior a la nacional en todas sus dimensiones y en la mayoría de ellas respecto al registro de EE. UU.

Abstract Safety culture is one of the requirements for preventing the occurrence of adverse effects. However, this has not been studied in the field of cardiology. The aim of this study is to evaluate the safety culture in a cardiology unit that has implemented and certified an integrated quality and risk management system for patient safety. Methods: A cross-sectional observational study was conducted in 2 consecutive years, with all staff completing the Spanish version of the questionnaire, ''Hospital Survey on Patient Safety Culture'' of the ''Agency for Healthcare Research and Quality'', with 42 items grouped into 12 dimensions. The percentage of positive responses in each dimension in 2014 and 2015 were compared, as well as national data and United States data, following the established rules. Results: The overall assessment out of a possible 5, was 4.5 in 2014 and 4.7 in 2015. Seven dimensions were identified as strengths. The worst rated were: staffing, management support and teamwork between units. The comparison showed superiority in all dimensions compared to national data, and in 8 of them compared to American data. Conclusions: The safety culture in a Cardiology Unit with an integrated quality and risk management patient safety system is high, and higher than nationally in all its dimensions and in most of them compared to the United States.

Impacto pronóstico a largo plazo de la anticoagulación en pacientes en hemodiálisis con fibrilación auricular / Long-term prognostic impact of anticoagulation on patients with atrial fibrillation undergoing hemodialysis

INTRODUCCIÓN Y OBJETIVOS: La evidencia de la eficacia y seguridad de la anticoagulación oral con dicumarínicos en pacientes en hemodiálisis con fibrilación auricular (FA) es controvertida. El objetivo de nuestro estudio es evaluar las implicaciones a nivel pronóstico a largo plazo de la anticoagulación con dicumarínicos en una cohorte de pacientes con FA no valvular en programa de hemodiálisis debido a insuficiencia renal terminal. MÉTODOS: Estudio observacional retrospectivo con inclusión consecutiva de 74 pacientes en hemodiálisis con FA. El periodo de inclusión fue de enero de 2005 a octubre de 2016. Las variables principales fueron mortalidad por todas las causas, reingresos no programados y sangrados. RESULTADOS: La edad media fue de 75 ± 10 años; el 66,2% fueron hombres y 43 pacientes (58,1%) recibieron acenocumarol. Durante una mediana de seguimiento de 2,40 años (IQR = 0,88-4,15), el acenocumarol no demostró beneficio en supervivencia [HR = 0,76, IC 95% (0,35-1,66), p = 0,494]. Sin embargo, los pacientes anticoagulados presentaron más riesgo de hospitalizaciones cardiovasculares recurrentes [IRR=3,94, IC 95% (1,06-14,69), p = 0,041]. Hubo una tendencia a un aumento de hospitalizaciones repetidas de causa isquémica en los pacientes anticoagulados [IRR = 5,80, IC 95% (0,86-39,0), p = 0,071]. Se observó una tendencia estadística hacia un mayor riesgo de sangrados totales recurrentes en los anticoagulados [IRR = 4,43, IC 95% (0,94-20,81), p = 0,059]. CONCLUSIONES: En el presente estudio, la anticoagulación oral con acenocumarol en pacientes en hemodiálisis con FA no supuso un aumento de la supervivencia, y sin embargo, se asoció con un mayor riesgo de hospitalizaciones de causa cardiovascular y una tendencia a mayor riesgo de sangrados totales

INTRODUCTION AND OBJECTIVES: Evidence for the efficacy and safety of oral anticoagulation with dicumarines in patients with atrial fibrillation (AF) on hemodialysis is controversial. The aim of our study is to evaluate the long-term prognostic implications of anticoagulation with dicumarines in a cohort of patients with non-valvular AF on a hemodialysis program due to end-stage renal disease. METHODS: Retrospective, observational study with consecutive inclusion of 74 patients with AF on hemodialysis. The inclusion period was from January 2005 to October 2016. The primary variables were all-cause mortality, non-scheduled readmissions and bleeding during follow-up. RESULTS: Mean age was 75 ± 10 years; 66.2% were men and 43 patients (58.1%) received acenocoumarol. During a median follow-up of 2.40 years (IQR = 0.88-4.15), acenocoumarol showed no survival benefit [HR = 0.76, 95% CI (0.35-1.66), p = 0.494]. However, anticoagulated patients were at increased risk of recurrent cardiovascular hospitalizations [IRR = 3.94, 95% CI (1.06-14.69), p = 0.041]. There was a trend towards an increase in repeated hospitalizations of ischemic cause in anticoagulated patients [IRR = 5.80, 95% CI (0.86-39.0), p = 0.071]. There was a statistical trend towards a higher risk of recurrent total bleeding in patients treated with acenocoumarol [IRR = 4.43, 95% CI (0.94-20.81), p = 0.059]. CONCLUSIONS: In this study, oral anticoagulation with acenocoumarol in patients with AF on hemodialysis did not increase survival. However, it was associated with an increased risk of hospitalizations of cardiovascular causes and a tendency to an increased risk of total bleeding

Long-term prognostic impact of anticoagulation on patients with atrial fibrillation undergoing hemodialysis. / Impacto pronóstico a largo plazo de la anticoagulación en pacientes en hemodiálisis con fibrilación auricular.

INTRODUCTION AND OBJECTIVES: Evidence for the efficacy and safety of oral anticoagulation with dicumarines in patients with atrial fibrillation (AF) on hemodialysis is controversial. The aim of our study is to evaluate the long-term prognostic implications of anticoagulation with dicumarines in a cohort of patients with non-valvular AF on a hemodialysis program due to end-stage renal disease. METHODS: Retrospective, observational study with consecutive inclusion of 74 patients with AF on hemodialysis. The inclusion period was from January 2005 to October 2016. The primary variables were all-cause mortality, non-scheduled readmissions and bleeding during follow-up. RESULTS: Mean age was 75±10 years; 66.2% were men and 43 patients (58.1%) received acenocoumarol. During a median follow-up of 2.40 years (IQR=0.88-4.15), acenocoumarol showed no survival benefit [HR=0.76, 95% CI (0.35-1.66), p=0.494]. However, anticoagulated patients were at increased risk of recurrent cardiovascular hospitalizations [IRR=3.94, 95% CI (1.06-14.69), p=0.041]. There was a trend towards an increase in repeated hospitalizations of ischemic cause in anticoagulated patients [IRR=5.80, 95% CI (0.86-39.0), p=0.071]. There was a statistical trend towards a higher risk of recurrent total bleeding in patients treated with acenocoumarol [IRR=4.43, 95% CI (0.94-20.81), p=0.059]. CONCLUSIONS: In this study, oral anticoagulation with acenocoumarol in patients with AF on hemodialysis did not increase survival. However, it was associated with an increased risk of hospitalizations of cardiovascular causes and a tendency to an increased risk of total bleeding.

[Comparison of the efficacy and safety of dronedarone and flecainide as maintenance antiarrhythmic therapy for sinus rhythm in atrial fibrillation]. / Comparación de la eficacia y seguridad de flecainida y dronedarona como terapias antiarrítmicas para mantenimiento de ritmo sinusal en fibrilación auricular.

INTRODUCTION AND OBJECTIVES: Dronedarone and flecainide are the first pharmacological choice to reduce recurrence of atrial fibrillation (AF); however, there are no studies comparing them. A study was performed to compare the efficacy in terms of recurrence of AF and safety of both drugs. METHODS: A retrospective cohort study was conducted that included 123 consecutive patients treated with flecainide or dronedarone due to paroxysmal AF (76.4%) or persistent AF (23.6%), from October 2010 to February 2013. Electrical cardioversion was performed in 7.3% of patients and pharmacological cardioversion in 16.3%. The median (interquartile range) follow-up was 301days (92-474) with a mean of 2.8 reviews per patient. Time to first event analysis was performed using Kaplan-Meier and Cox regression, adjusted for propensity score. RESULTS: Of the 123 consecutive patients with AF included, 71 were on dronedarone and 52 on flecainide. During the follow-up, there were 36 AF recurrences and 20 safety events. There were recurrences in 36.6% of patients treated with flecainide, compared with 21% of those receiving dronedarone (P=.073). Dronedarone showed to be at least as effective as flecainide in preventing recurrence of atrial fibrillation (HR: 0.53, 95% CI: 0.20-1.44, P=.221), and demonstrated an acceptable safety profile when compared with flecainide (HR: 0.68, 95% CI: 0.18-2.53, P=.566). CONCLUSIONS: In our experience, dronedarone has been at least as effective and safe as flecainide, despite it was most frequently prescribed in patients with worse baseline risk profile.

[Analysis of the safety culture in a Cardiology Unit managed by processes]. / Análisis de la cultura de seguridad en una Unidad de Cardiología gestionada por procesos.

Safety culture is one of the requirements for preventing the occurrence of adverse effects. However, this has not been studied in the field of cardiology. The aim of this study is to evaluate the safety culture in a cardiology unit that has implemented and certified an integrated quality and risk management system for patient safety. METHODS: A cross-sectional observational study was conducted in 2 consecutive years, with all staff completing the Spanish version of the questionnaire, "Hospital Survey on Patient Safety Culture" of the "Agency for Healthcare Research and Quality", with 42 items grouped into 12 dimensions. The percentage of positive responses in each dimension in 2014 and 2015 were compared, as well as national data and United States data, following the established rules. RESULTS: The overall assessment out of a possible 5, was 4.5 in 2014 and 4.7 in 2015. Seven dimensions were identified as strengths. The worst rated were: staffing, management support and teamwork between units. The comparison showed superiority in all dimensions compared to national data, and in 8 of them compared to American data. CONCLUSIONS: The safety culture in a Cardiology Unit with an integrated quality and risk management patient safety system is high, and higher than nationally in all its dimensions and in most of them compared to the United States.

[Value of NTproBNP concentration in an out-of-hospital adult population]. / Valor del nivel de NTproBNP en población adulta extrahospitalaria.

INTRODUCTION: The diagnosis of chronic heart failure (CHF) is based on demonstrating the cardiac origin of clinical manifestations. Echocardiography is the method of choice for the detection of left ventricular systolic dysfunction (LVSD). Brain natriuretic peptide (BNP) rises during LVSD. OBJECTIVES: To analyze the plasma concentration of N-terminal brain natriuretic propeptide (NTproBNP) in a general adult population in relation to different spontaneous circumstances and to study its capacity for identifying patients with LVSD.Methods. A cardiological examination was made and plasma NTproBNP levels were measured in a randomized group of 203 people (49-81 years old) from the Community of Valencia. RESULTS: The average NTproBNP concentration was 52.2 98.2 pmol/l. NTproBNP levels varied with age, gender and functional stage (NYHA). The highest NTproBNP values were observed in people who had previously suffered from acute pulmonary edema or who had an ejection fraction (EF) of less than 40%. There was also a significant elevation in patients with nocturnal dyspnea, orthopnea, atrial fibrillation, EF < or = 50%, angina, and ankle edema. The best concentration of NTproBNP for differentiating EF < or = 50% was 37.7 pmol/l, with 92% sensitivity and 68% specificity. CONCLUSIONS: The elevation of NTproBNP concentration indicates the cardiac origin of clinical manifestations and serves to select patients for echocardiographic examination. Low NTproBNP concentrations help to rule out LVSD.

Valor del nivel de NTproBNP en población adulta extrahospitalaria / Value of NTproBNP Concentration in an Out-Of-Hospital Adult Population

Introducción. El diagnóstico de insuficiencia cardíaca crónica se basa en la demostración del origen cardíaco de las manifestaciones clínicas. El ecocardiograma es el método de elección para la detección de disfunción sistólica ventricular izquierda (DSVI). El péptido natriurético cerebral se incrementa durante la DSVI. Objetivo. Estudiar las concentraciones plasmáticas del N terminal propéptido natriurético cerebral (NTproBNP) en un grupo de población general adulta y relacionarlas con las distintas circunstancias que se dan espontáneamente y su capacidad para identificar DSVI (ecocardiográfica).Métodos. Se realizó un estudio cardiológico y una determinación válida de las concentraciones séricas de NTproBNP a 203 personas (entre 49 y 81 años), seleccionadas de la Comunidad Valenciana mediante un método de azar. Resultados. La cifra promedio de NTproBNP fue de 52,2 ñ 98,2 pmol/l. Los valores de NTproBNP variaron en razón de sexo, edad y estadio funcional (NYHA). Los más elevados coincidieron con antecedentes de edema de pulmón o con una fracción de eyección (FE) < 40 por ciento. También resultaron significativamente aumentados en presencia de disnea nocturna, ortopnea, FE 50 por ciento, fibrilación auricular, angina y edemas maleolares. El valor de NTproBNP que mejor discriminó la FE 50 por ciento fue de 37,7 pmol/l con una sensibilidad del 92 por ciento y una especificidad del 68 por ciento. Conclusiones. Valores elevados de NTproBNP apoyan un origen cardíaco de las manifestaciones clínicas y seleccionan pacientes para ecocardiografía. Valores bajos descartan DSVI (AU)