Vernakalant for Cardioversion of Recent-Onset Atrial Fibrillation in the Emergency Department: The SPECTRUM Study.

INTRODUCTION: Intravenous vernakalant is a therapeutic option for symptomatic, recent-onset atrial fibrillation (AF). This secondary analysis from the large SPECTRUM study assessed the safety and effectiveness of vernakalant when used in the emergency department setting (ED group) or in an inpatient hospital setting (non-ED group). METHODS: This post hoc analysis of the international, observational, post-authorization SPECTRUM study included 1,289 and 720 recent-onset AF episodes in adults in the ED and non-ED groups, respectively. Safety endpoints included the evaluation of pre-defined health outcomes of interest (HOIs) and other serious adverse events (SAEs) during vernakalant treatment and during the first 24 h after the last infusion. Effectiveness endpoints comprised the rate of successful vernakalant cardioversion, the time from the start of the vernakalant infusion to cardioversion, and the length of hospital stay. Data were analysed using descriptive statistics. RESULTS: The safety profile of vernakalant was similar in the ED and non-ED groups. In the ED group, 12 pre-defined HOIs were reported in 11 patients (0.9%); all but one occurred within 2 h after start of the first infusion. These events comprised nine significant bradycardia cases, of which one was associated with transient hypotension and three with sinus arrest, and 2 cases of atrial flutter with 1:1 conduction. Five other SAEs were reported. All patients with vernakalant-related events recovered without sequelae. No Torsade de Pointes, ventricular fibrillation, or deaths occurred. Successful cardioversion was reported in 67.8% (95% confidence interval: 65.2-70.4) and 66.4% (62.5-70.1) of episodes, with a median time to conversion of 11.0 and 10.0 min in the ED and non-ED groups, respectively. Patients had a median length of hospital stay of 7.4 h and 17.1 h in the ED and non-ED groups, respectively. CONCLUSION: Intravenous vernakalant was well tolerated with similar cardioversion rates in patients treated in the ED or non-ED setting and does not require admission to a coronary care unit or intensive care unit. First-line treatment with vernakalant could allow an early discharge in patients with recent-onset AF treated in the ED.

Vernakalant for Rapid Cardioversion of Recent-Onset Atrial Fibrillation: Results from the SPECTRUM Study.

AIMS: Rapid restoration of sinus rhythm using pharmacological cardioversion is commonly indicated in patients with symptomatic recent-onset atrial fibrillation (AF). The objectives of this large, international, multicenter observational study were to determine the safety and effectiveness of intravenous (IV) vernakalant for conversion of AF to sinus rhythm in daily practice. METHODS AND RESULTS: Consenting patients with symptomatic recent-onset AF (< 7 days) treated with IV vernakalant were enrolled and followed up to 24 h after the last infusion or until discharge, in order to determine the incidence of predefined serious adverse events (SAEs) and other observed SAEs and evaluate the conversion rate within the first 90 min. Overall, 2009 treatment episodes in 1778 patients were analyzed. The age of patients was 62.3 ± 13.0 years (mean ± standard deviation). Median AF duration before treatment was 11.1 h (IQR 5.4-27.0 h). A total of 28 SAEs occurred in 26 patients including 19 predefined SAEs, i.e., sinus arrest (n = 4, 0.2%), significant bradycardia (n = 11, 0.5%), significant hypotension (n = 2, 0.1%), and atrial flutter with 1:1 conduction (n = 2, 0.1%). There were no cases of sustained ventricular arrhythmias or deaths. All patients who experienced SAEs recovered fully (n = 25) or with sequelae (n = 1). Conversion rate to sinus rhythm was 70.2%, within a median of 12 min (IQR 8.0-28.0 min). CONCLUSIONS: This large multicenter, international observational study confirms the good safety profile and the high effectiveness of vernakalant for the rapid cardioversion of recent-onset AF in daily hospital practice.

Safety of emergency-department electric cardioversion for recent-onset atrial fibrillation. / Seguridad de la cardioversión de la fibrilación auricular de reciente comienzo en urgencias.

OBJECTIVES: To analyze the safety of electric cardioversion performed for recent-onset atrial fibrillation in a hospital emergency department. MATERIAL AND METHODS: Observational retrospective analysis of consecutive emergency department cases of atrial fibrillation of less than 48 hours' duration in hemodynamically stable patients. All included cases were either treated with emergency electric cardioversion or referred for evaluation and scheduling of outpatient cardioversion. The outcome variable was the occurrence of a thromboembolic or hemorrhagic event within 90 days. RESULTS: A total of 718 cardioversions in 570 patients were analyzed. The mean (SD) age of the patients was 64 (13.5) years. Four hundred seventy-nine emergency cardioversions (66.7%) and 239 (33.3%) scheduled cardioversions were performed. Eleven adverse events (1.5% of the cohort) occurred: 2 were thromboembolic events (0.3%) and 9 were hemorrhagic (1.3%). All bleeds were minor. There were no statistically significant differences in the rate of adverse events between the emergency and scheduled cardioversion groups. CONCLUSION: Emergency cardioversion for recent-onset atrial fibrillation is safe.

OBJETIVO: Analizar la seguridad de la cardioversión de la fibrilación auricular (FA) de reciente comienzo realizada en un servicio de urgencias hospitalario (SUH). METODO: Estudio observacional, retrospectivo y analítico en un SUH. Se recogieron de forma consecutiva los episodios de FA de menos de 48 horas de evolución y hemodinámicamente estables, en los que se realizó una cardioversión urgente (CVU) y los episodios derivados para valorar cardioversión programada ambulatoria (CVP). La variable de resultado fue la presencia de eventos embólicos (EE) o hemorrágicos (EH) a los 90 días. RESULTADOS: Se analizaron 718 cardioversiones en 570 pacientes. La edad media fue de 64 años (DE 13,5). Se realizaron 479 (66,7%) CVU y 239 (33,3%) CVP. Se recogieron un total de 11 (1,5%) eventos: dos EE (0,3%) y 9 EH (1,3%). Todos los EH fueron hemorragias menores. No se encontraron diferencias estadísticamente significativas entre ambos grupos. CONCLUSIONES: La CVU de la FA de reciente comienzo en los SUH es una estrategia segura.

Seguridad de la cardioversión de la fibrilación auricular de reciente comienzo en urgencias / Safety of emergency-department electric cardioversion for recent-onset atrial fibrillation

Objetivo. Analizar la seguridad de la cardioversión de la fibrilación auricular (FA) de reciente comienzo realizada en un servicio de urgencias hospitalario (SUH). Método. Estudio observacional, retrospectivo y analítico en un SUH. Se recogieron de forma consecutiva los episodios de FA de menos de 48 horas de evolución y hemodinámicamente estables, en los que se realizó una cardioversión urgente (CVU) y los episodios derivados para valorar cardioversión programada ambulatoria (CVP). La variable de resultado fue la presencia de eventos embólicos (EE) o hemorrágicos (EH) a los 90 días. Resultados. Se analizaron 718 cardioversiones en 570 pacientes. La edad media fue de 64 años (DE 13,5). Se realizaron 479 (66,7%) CVU y 239 (33,3%) CVP. Se recogieron un total de 11 (1,5%) eventos: dos EE (0,3%) y 9 EH (1,3%). Todos los EH fueron hemorragias menores. No se encontraron diferencias estadísticamente significativas entre ambos grupos. Conclusión. La CVU de la FA de reciente comienzo en los SUH es una estrategia segura

Objective. To analyze the safety of electric cardioversion performed for recent-onset atrial fibrillation in a hospital emergency department. Methods. Observational retrospective analysis of consecutive emergency department cases of atrial fibrillation of less than 48 hours’ duration in hemodynamically stable patients. All included cases were either treated with emergency electric cardioversion or referred for evaluation and scheduling of outpatient cardioversion. The outcome variable was the occurrence of a thromboembolic or hemorrhagic event within 90 days. Results. A total of 718 cardioversions in 570 patients were analyzed. The mean (SD) age of the patients was 64 (13.5) years. Four hundred seventy-nine emergency cardioversions (66.7%) and 239 (33.3%) scheduled cardioversions were performed. Eleven adverse events (1.5% of the cohort) occurred: 2 were thromboembolic events (0.3%) and 9 were hemorrhagic (1.3%). All bleeds were minor. There were no statistically significant differences in the rate of adverse events between the emergency and scheduled cardioversion groups. Conclusion. Emergency cardioversion for recent-onset atrial fibrillation is safe

[Vernakalant in hospital emergency practice: safety and effectiveness]. / Seguridad y eficacia de vernakalant en la práctica clínica de los servicios de urgencias.

OBJECTIVES: To study the effectiveness and safety of vernakalant for restoration of sinus rhythm in patients with atrial fibrillation (AF) in routine hospital emergency department care, and to evaluate factors associated with a more effective response. MATERIAL AND METHODS: Prospective multicenter cohort study enrolling consecutive patients who were administered vernakalant for medical cardioversion of AF between September 2014 through March 2016 in 5 hospitals in the Spanish autonomous community of Valencia. RESULTS: We studied 165 cases. The median (interquartile range) was 68 years (56-77) years. Cardioversion with vernakalant was effective in 77.6% (95% CI, 71.1%-84%). The median time to conversion was 8 ( 6-12) minutes after a first dose and 34 (22-62) minutes after a second dose. A prior history of cardiac insufficiency was nonsignificantly less common in patients who converted with vernakalant (6.3%) than in those who did not (18.9%) (adjusted odds ratio [OR], 0.45 [95% CI, 0.13-1.56]; P=.208). Having no prior history of AF was nonsignificantly related to greater effectiveness (in 54.7% vs in 35.1% with prior AF). Duration less than 12 hours was significantly associated with greater effectiveness (83.6% vs 59.5%; adjusted OR, 2.76 [95% CI, 1.12-6.80]; P=.028). Adverse events were reported for 30 patients. None of the events had clinically important consequences, and in only 2 cases (1.2%) was it necessary to suspend treatment. CONCLUSION: Vernakalant is effective and safe for restoring sinus rhythm in the hospital emergency department.

OBJETIVO: Describir la eficacia y seguridad de vernakalant para la reversión de la fibrilación auricular (FA) a ritmo sinusal en la práctica clínica habitual de los servicios de urgencias hospitalarios (SUH), así como evaluar las características asociadas a mayor respuesta eficaz. METODO: Estudio de cohortes multicéntrico, analítico, prospectivo, con inclusión consecutiva de pacientes en los que se administra vernakalant para realizar cardioversión farmacológica de una FA, llevado a cabo desde Septiembre 2014 hasta Marzo 2016 en 5 hospitales de la Comunidad Valenciana. RESULTADOS: Se analizaron 165 casos con una mediana de edad de 68 años [rango intercuartil (RIC): 56-77]. La reversión eficaz fue de 77,6% (IC 95%: 71,1%-84,0%). La mediana del tiempo de reversión fue de 8 minutos (RIC: 6-12) con la primera dosis y de 34 minutos (RIC: 22-62) con la segunda. La presencia de insuficiencia cardiaca previa fue menos frecuente en el grupo que revirtió con vernakalant, 6,3% frente a 18,9%, con una OR ajustada de 0,45 (IC 95%: 0,13-1,56), p = 0,208. Ser un primer episodio de FA y tener una duración de menos de 12 horas se relacionó con mayores tasas de reversión, 54,7% frente a 35,1% y de 83,6% frente a 59,5%, respectivamente, pero solo la segunda fue significativa con una OR ajustada de 2,76 (IC 95%: 1,12-6,80), p = 0,028. Se notificaron eventos adversos en 30 pacientes. Ninguno de ellos tuvo consecuencias relevantes y sólo dos (1,2%) motivaron la suspensión del fármaco. CONCLUSIONES: Vernakalant es un fármaco eficaz y seguro para la restauración del ritmo sinusal en los SUH.

Seguridad y eficacia de vernakalant en la práctica clínica de los servicios de urgencias / Vernakalant in hospital emergency practice: safety and effectiveness

Objetivo. Describir la eficacia y seguridad de vernakalant para la reversión de la fibrilación auricular (FA) a ritmo sinusal en la práctica clínica habitual de los servicios de urgencias hospitalarios (SUH), así como evaluar las características asociadas a mayor respuesta eficaz. Método. Estudio de cohortes multicéntrico, analítico, prospectivo, con inclusión consecutiva de pacientes en los que se administra vernakalant para realizar cardioversión farmacológica de una FA, llevado a cabo desde Septiembre 2014 hasta Marzo 2016 en 5 hospitales de la Comunidad Valenciana. Resultados. Se analizaron 165 casos con una mediana de edad de 68 anos [rango intercuartil (RIC): 56-77]. La reversión eficaz fue de 77,6% (IC 95%: 71,1%-84,0%). La mediana del tiempo de reversión fue de 8 minutos (RIC: 6-12) con la primera dosis y de 34 minutos (RIC: 22-62) con la segunda. La presencia de insuficiencia cardiaca previa fue menos frecuente en el grupo que revirtió con vernakalant, 6,3% frente a 18,9%, con una OR ajustada de 0,45 (IC 95%: 0,13-1,56), p = 0,208. Ser un primer episodio de FA y tener una duración de menos de 12 horas se relacionó con mayores tasas de reversión, 54,7% frente a 35,1% y de 83,6% frente a 59,5%, respectivamente, pero solo la segunda fue significativa con una OR ajustada de 2,76 (IC 95%: 1,12-6,80), p = 0,028. Se notificaron eventos adversos en 30 pacientes. Ninguno de ellos tuvo consecuencias relevantes y solo dos (1,2%) motivaron la suspensión del fármaco. Conclusiones. Vernakalant es un fármaco eficaz y seguro para la restauración del ritmo sinusal en los SUH (AU))

Objectives. To study the effectiveness and safety of vernakalant for restoration of sinus rhythm in patients with atrial fibrillation (AF) in routine hospital emergency department care, and to evaluate factors associated with a more effective response. Methods. Prospective multicenter cohort study enrolling consecutive patients who were administered vernakalant for medical cardioversion of AF between September 2014 through March 2016 in 5 hospitals in the Spanish autonomous community of Valencia. Results. We studied 165 cases. The median (interquartile range) was 68 years (56-77) years. Cardioversion with vernakalant was effective in 77.6% (95% CI, 71.1%-84%). The median time to conversion was 8 ( 6-12) minutes after a first dose and 34 (22-62) minutes after a second dose. A prior history of cardiac insufficiency was nonsignificantly less common in patients who converted with vernakalant (6.3%) than in those who did not (18.9%) (adjusted odds ratio [OR], 0.45 [95% CI, 0.13-1.56]; P=.208). Having no prior history of AF was nonsignificantly related to greater effectiveness (in 54.7% vs in 35.1% with prior AF). Duration less than 12 hours was significantly associated with greater effectiveness (83.6% vs 59.5%; adjusted OR, 2.76 [95% CI, 1.12-6.80]; P=.028). Adverse events were reported for 30 patients. None of the events had clinically important consequences, and in only 2 cases (1.2%) was it necessary to suspend treatment. Conclusion. Vernakalant is effective and safe for restoring sinus rhythm in the hospital emergency department (AU)

Terapia de alto flujo de oxígeno con cánulas nasales en la insuficiencia cardiaca aguda / High-flow therapy via nasal cannula in acute heart failure

En el tratamiento de la insuficiencia respiratoria en la insuficiencia cardiaca aguda se utilizan diferentes métodos de oxigenación. En ocasiones los pacientes, tras ser estabilizados con dichos modos ventilatorios, mantienen un grado de disnea o hipoxemia que no mejora y no es atribuible a un empeoramiento del grado funcional o la necesidad de optimizar el tratamiento farmacológico. Los sistemas de alto flujo con interfase nasal con un calentador humidificador acoplado (AFHC) son una buena alternativa como método de oxigenación, de fácil aplicación y escasas complicaciones. Presentamos una serie de 5 pacientes con insuficiencia cardiaca aguda por edema agudo de pulmón con disnea o hipoxemia mantenidas tras la aplicación de ventilación no invasiva. Todos ellos fueron tratados con sistemas de AFHC de forma satisfactoria, con mejoría clínica y gasométrica, sin complicaciones ni fracasos de la técnica. Describimos nuestra experiencia y discutimos diversos aspectos relacionados con dicho sistema de oxigenación (AU)

Various oxygenization methods are used in the treatment of respiratory failure in acute heart failure. Occasionally, after patients are stabilized by these ventilation methods, some maintain a degree of dyspnea or hypoxemia which does not improve and is unrelated to deterioration in the functional class or the need to optimize pharmacological treatment. High-flow oxygen systems administered via nasal cannula that are connected to heated humidifiers (HFT) are a good alternative for oxygenation, given that they are easy to use and have few complications. We studied a series of 5 patients with acute heart failure due to acute pulmonary edema with stable dyspnea or hypoxemia following noninvasive ventilation. All the patients were successfully treated with HFT, showing clinical and gasometric improvement and no complications or technical failures. We report our experience and discuss different aspects related to this oxygenation system (AU)

High-Flow therapy via nasal cannula in acute heart failure.

Various oxygenization methods are used in the treatment of respiratory failure in acute heart failure. Occasionally, after patients are stabilized by these ventilation methods, some maintain a degree of dyspnea or hypoxemia which does not improve and is unrelated to deterioration in the functional class or the need to optimize pharmacological treatment. High-flow oxygen systems administered via nasal cannula that are connected to heated humidifiers (HFT) are a good alternative for oxygenation, given that they are easy to use and have few complications. We studied a series of 5 patients with acute heart failure due to acute pulmonary edema with stable dyspnea or hypoxemia following noninvasive ventilation. All the patients were successfully treated with HFT, showing clinical and gasometric improvement and no complications or technical failures. We report our experience and discuss different aspects related to this oxygenation system.

[Clinical experience with levosimendan in the emergency department of a tertiary care hospital]. / Experiencia clínica con levosimendán en un servicio de urgencias de un hospital de tercer nivel.

The efficacy and safety of levosimendan administration in patients with acute heart failure admitted to intensive care units has been well established. However, no information is available on the drug's beneficial effects in emergency departments. We studied 40 patients with acute heart failure who showed no or only partial improvement after conventional treatment and who received levosimendan during the period 2005-2006. The patients' mean age was 76 (9) years. The most common etiology was ischemic heart disease, and 85% of patients were in New York Heart Association (NYHA) class III or IV. The clinical response was favorable in 82% of patients, while adverse effects occurred in 18%. Some 70% were admitted to the emergency department short-stay unit. These findings indicate that levosimendan can be used safely and effectively in hospital emergency departments.

Experiencia clínica con levosimendán en un servicio de urgencias de un hospital de tercer nivel / Clinical experience with levosimendan in the emergency department of a tertiary care hospital

La eficacia y la seguridad de la administración de levosimendán en las unidades de cuidados intensivos en pacientes con insuficiencia cardiaca aguda está bien establecida, pero no hay pruebas científicas de sus efectos favorables en los servicios de urgencias (SUH). Hemos estudiado a 40 pacientes con insuficiencia cardiaca aguda con ausencia de mejoría o mejoría parcial tras tratamiento convencional a los que se administró levosimendán entre 2005 y 2006. La media de edad fue de 76 ± 9 años. La cardiopatía isquémica fue la etiología más frecuente; el 85% de los pacientes se encontraba en estadio III-IV de la New York Heart Association. La respuesta clínica fue favorable en un 82% de los pacientes y sólo un 18% presentó efectos adversos. El 70% de los pacientes ingresó en la unidad de corta estancia dependiente del SUH. Los resultados obtenidos indican que levosimendán puede utilizarse de forma segura y eficaz en los SUH (AU)

The efficacy and safety of levosimendan administration in patients with acute heart failure admitted to intensive care units has been well established. However, no information is available on the drug's beneficial effects in emergency departments. We studied 40 patients with acute heart failure who showed no or only partial improvement after conventional treatment and who received levosimendan during the period 2005-2006. The patients' mean age was 76 (9) years. The most common etiology was ischemic heart disease, and 85% of patients were in New York Heart Association (NYHA) class III or IV. The clinical response was favorable in 82% of patients, while adverse effects occurred in 18%. Some 70% were admitted to the emergency department short-stay unit. These findings indicate that levosimendan can be used safely and effectively in hospital emergency departments (AU)