Effects of MIdazolam versus MOrphine in acute cardiogenic pulmonary edema and chronic obstructive pulmonary disease: An analysis of MIMO trial.

AIMS: Chronic obstructive pulmonary disease (COPD) is an important comorbidity in heart failure. The MIMO trial showed that patients with acute cardiogenic pulmonary edema (ACPE) treated with midazolam had fewer serious adverse events than those treated with morphine. In this post hoc analysis, we examined whether the presence/ absence of COPD modifies the reduced risk of midazolam over morphine. METHODS: Patients >18 years old clinically diagnosed with ACPE and with dyspnea and anxiety were randomized (1:1) at emergency department arrival to receive either intravenous midazolam or morphine. In this post hoc analysis, we calculated the relative risk (RR) of serious adverse events in patients with and without COPD. Calculating the CochranMantel-Haenszel interaction test, we evaluated if COPD modified the reduced risk of serious adverse events in the midazolam arm compared to morphine. RESULTS: Overall, 25 (22.5%) of the 111 patients randomized had a history of COPD. Patients with COPD were more commonly men with a history of previous episodes of heart failure, than participants without COPD. In the COPD group, the RR for the incidence of serious adverse events in the midazolam versus morphine arm was 0.36 (95%CI, 0.1-1.46). In the group without COPD, the RR was 0.44 (95%CI, 0.22-0.91). The presence of COPD did not modify the reduced risk of serious adverse events in the midazolam arm compared to morphine (p for interaction =0.79). CONCLUSIONS: The reduced risk of serious adverse events in the midazolam group compared with morphine is similar in patients with and without COPD.

Influence of type of household on prognosis at one year in patients ≥65 years attending hospital emergency departments in Spain. The EDEN-6 study.

OBJECTIVE: To investigate whether the type of household is associated with prognosis at one year in patients ≥65 years of age discharged after medical consultation requiring emergency department care. METHODS: Data from the Emergency Department and Elder Needs (EDEN) cohort were used. This retrospective cohort included all patients ≥65 years of age seen in 52 Spanish emergency departments over one week (April 1-7, 2019) in whom the type of household was recorded and categorized as living at home alone, with relatives, with professional caregivers, or in a nursing home. Patient demographic and other baseline characteristics and management during the index emergency department episode were recorded and used to adjust the following 1-year outcomes: all-cause mortality, hospitalization and emergency department revisit. Associations between type of household and outcomes are expressed as adjusted hazard ratios with 95% confidence intervals using living alone as the reference category. RESULTS: 13,442 patients with a median age of 79 years (interquartile range 72-86) were included; 56% were women, 12.2% of patients lived alone, 74.9% with relatives, 3.9% with a professional caregiver, and 9.1% in a nursing home. During the year following discharge, the mortality rate was 14.0%, the hospitalization rate 29.7%, and the emergency department revisit rate 59.3%. In the fully adjusted model, the risk of death was associated only with living in a nursing home (hazard ratio 1.366 (1.101-1.695)). On the other hand, the risk of hospitalization was lower in individuals living in nursing homes (hazard ratio 0.783 [0.676-0.907]) and at home with relatives (hazard ratio 0.897 [0.810-0.992]), while the risk of emergency department revisit was lower in individuals living in nursing homes (hazard ratio 0.826 [0.742-0.920]) or at home with caregivers (hazard ratio 0.856 [0.750-0.976]). CONCLUSION: The type of household was modestly associated with the one-year prognosis of patients ≥65 years of age discharged after attendance at an emergency department. Living in a nursing home is associated with an increased risk of death but a decreased risk of rehospitalization or emergency department revisit, while living at home with relatives or professional caregivers is associated only with a decreased risk of hospitalization and emergency department revisit, respectively.

Impact of the COVID-19 pandemic on demand for emergency department care for older patients: the EDEN-7 COVID cohort study. / Estudio EDEN-7: impacto de la pandemia COVID-19 sobre la demanda asistencial de personas mayores en los servicios de urgencias españoles.

OBJECTIVES: To analyze the impact of the COVID-19 pandemic on Spanish emergency department (ED) care for patients aged 65 years or older during the first wave vs. a pre-pandemic period. MATERIAL AND METHODS: Retrospective cross-sectional study of a COVID-19 portion of the EDEN project (Emergency Department and Elder Needs). The EDEN-COVID cohort included all patients aged 65 years or more who were treated in 52 EDs on 7 consecutive days early in the pandemic. We analyzed care variables, discharge diagnoses, use of diagnostic and therapeutic resources, use of observation units, need for hospitalization, rehospitalization, and mortality. These data were compared with data for an EDEN cohort in the same age group recruited during a similar period the year before the pandemic. RESULTS: The 52 participating hospital EDs attended 33 711 emergencies during the pandemic vs. 96 173 emergencies in the pre-COVID period, representing a 61.7% reduction during the pandemic. Patients aged 65 years or older accounted for 28.8% of the caseload during the COVID-19 period and 26.4% of the earlier cohort (P .001). The COVID-19 caseload included more men (51.0%). Comorbidity and polypharmacy were more prevalent in the pandemic cohort than in the earlier one (comorbidity, 92.6% vs. 91.6%; polypharmacy, 65.2% vs. 63.6%). More esturesources (analgesics, antibiotics, heparins, bronchodilators, and corticosteroids) were applied in the pandemic period, and common diagnoses were made less often. Observation wards were used more often (for 37.8% vs. 26.2% in the earlier period), and hospital admissions were more frequent (in 56.0% vs. 25.3% before the pandemic). Mortality was higher during the pandemic than in the earlier cohort either in ED (1.8% vs 0.5%) and during hospitalization (11.5 vs 2.9%). CONCLUSION: The proportion of patients aged 65 years or older decreased in the participating Spanish EDs. However, more resources were required and the pattern of diagnoses changed. Observation ward stays were longer, and admissions and mortality increased over the numbers seen in the reference period.

OBJETIVO: Analizar el impacto de la pandemia COVID-19 sobre la asistencia a las personas mayores ($ 65 años) en los servicios de urgencias hospitalarios (SUH) españoles durante la primera oleada pandémica, comparándola con un periodo previo. METODO: Estudio transversal retrospectivo de la cohorte EDEN-COVID (Emergency Department and Elder Needs during COVID), que incluyó a todos los pacientes $ 65 años atendidos en 52 SUH españoles durante 7 días consecutivos de un periodo pandémico. Se analizaron variables asistenciales, diagnósticos de alta, consumo de recursos diagnósticos y terapéuticos, utilización de las unidades de observación, necesidad de ingreso, rehospitalización y mortalidad. Estos datos se compararon con la cohorte EDEN (Emergency Department and Elder Needs), que reclutó a pacientes del mismogrupo de edad durante un periodo similar del año anterior. RESULTADOS: Durante el periodo COVID-19 se atendieron 33.711 episodios en los 52 SUH participantes, frente a 96.173 del periodo pre-COVID, lo que supone una disminución de la demanda de 61,7%. La proporción de asistencias a pacientes de 65 o más años fue de 28,8% en el periodo COVID-19 y 26,4% en el periodo previo (p 0,001). Durante el periodo COVID hubo mayor proporción de hombres (51,0% vs 44,9%), mayor comorbilidad (92,6% vs 91,6%) y polifarmacia (65,2% vs 63,6%), mayor uso de recursos, de analgésicos, antibióticos, heparinas, broncodilatadores y corticoides, menor proporción de los diagnósticos más habituales, mayor utilización de las unidades de observación (37,8% vs 26,2%) y un incremento de la proporción de ingresos (56,0% vs 25,3%), y de mortalidad en urgencias (1,8% vs 0,5%) y durante la hospitalización (11,5% vs 2,9%). CONCLUSIONES: La primera ola de la pandemia COVID-19 ha provocado una disminución global de las asistencias a personas mayores ($ 65 años) en los SUH españoles analizados, mayor consumo de recursos, un mapa diferente de procesos diagnósticos asistidos y un aumento proporcional de estancias en observación, de ingresos y de mortalidad, respecto al periodo de referencia.

Midazolam versus morphine in acute cardiogenic pulmonary edema patients with and without atrial fibrillation: findings from the MIMO trial.

BACKGROUND AND IMPORTANCE: The MIMO clinical trial showed that patients with acute cardiogenic pulmonary edema (ACPE) treated with midazolam had fewer serious adverse events than those treated with morphine. Atrial fibrillation (AF) is a common comorbidity in heart failure and affects patient's outcome. OBJECTIVE: The primary endpoint of this substudy is to know if AF modified the reduced risk of serious adverse events in the midazolam arm compared to morphine. The first secondary endpoint is to know if AF modified the reduced risk of serious adverse events or death at 30 days in the midazolam arm. The second secondary objective of this substudy is to analyze whether AF modified the reduced risk of midazolam against morphine on the total number of serious adverse events per patient. DESIGN: We conducted a secondary analysis of the MIMO trial. Patients more than 18 years old clinically diagnosed with ACPE and with dyspnea and anxiety were randomized (1:1) at emergency department arrival to receive either intravenous midazolam or morphine. OUTCOME MEASURES AND ANALYSIS: In this post hoc analysis, we calculated the relative risk (RR) of serious adverse events in patients with and without AF. Calculating the Cochran-Mantel-Haenszel interaction test, we evaluated if AF modified the reduced risk of serious adverse events in the midazolam arm compared to morphine. MAIN RESULTS: One hundred eleven patients (median = 78.9 years; IQR, 72.3-83.7; women, 52.2%) were randomized in the MIMO trial, 55 to receive midazolam and 56 to morphine. All randomized patients received the assigned drug and there were no losses to follow-up. Forty-four patients (39.6%) had AF. In the AF group, the RR for the incidence of serious adverse events in the midazolam versus morphine arm was 0.42 (95% CI, 0.14-1.3). In the group without AF, the RR was 0.46 (95% CI, 0.21-1). The presence of AF did not modify the reduced risk of serious adverse events in the midazolam arm compared with morphine ( P for interaction = 0.88). CONCLUSION: This post hoc analysis of the MIMO trial suggests that the reduced risk of serious adverse events in the midazolam group compared to morphine is similar in patients with and without AF.

Effects of midazolam vs morphine in patients with acute pulmonary edema with left ventricular systolic dysfunction: a secondary analysis of data from the MIMO trial. / Efectos del midazolam frente a la morfina en pacientes con edema agudo de pulmón con disfunción sistólica ventricular izquierda: un análisis secundario del ensayo MIMO.

OBJECTIVES: The midazolam vs morphine (MIMO) trial showed that patients treated with midazolam had fewer serious adverse events than those treated with morphine. In many patients with acute pulmonary edema, the left ventricular ejection fraction (LVEF) is preserved, at 50% or higher. We aimed to determine whether left ventricular (LV) systolic dysfunction (D), defined by an LVEF of less than 50%, modifies the protective effect of midazolam vs morphine. MATERIAL AND METHODS: The MIMO trial randomized 111 patients with acute pulmonary edema to receive intravenous midazolam in 1-mg doses to a maximum of 3 mg (n = 55) or morphine in 2- to 4-mg doses to a maximum of 8 mg (n= 56). We calculated the relative risk (RR) for a serious adverse event in patients with and without systolic LVD. RESULTS: LVEF was preserved in 84 (75.7%) of the patients with acute pulmonary edema. In patients with systolic LVD, 4 patients (26.9%) in the midazolam arm vs 6 (50%) in the morphine arm developed serious adverse events (RR, 0.53; 95% CI, 0.2-1.4). In patients without systolic LVD, 6 patients (15%) in the midazolam arm vs 18 (40.9%) in the morphine arm experienced such events (RR, 0.37; 95% CI, 0.16-0.83). The presence of systolic LVD did not modify the protective effect of midazolam on serious adverse effects (P=.57). CONCLUSION: The effect of midazolam vs morphine in protecting against the development of serious adverse events or death is similar in patients with and without systolic LVD.

OBJETIVO: El ensayo clínico MIMO demostró que los pacientes con edema agudo de pulmón (EAP) tratados con midazolam tenían menos eventos adversos graves (EAG) que los tratados con morfina. Muchos pacientes con EAP tienen fracción de eyección del ventrículo izquierdo (FEVI) preservada ($ 50%). El objetivo fue conocer si la disfunción sistólica ventricular izquierda (DSVI) (fracción eyección ventrículo izquierdo 50%) modifica el efecto protector del midazolam frente a la morfina. METODO: El estudio MIMO asignó al azar 111 pacientes con EAP a tratamiento con midazolam (dosis de 1 mg intravenosa, hasta una dosis máxima de 3 mg, n = 55) o morfina (dosis de 2-4 mg, hasta una dosis máxima de 8 mg, n = 56). Se calculó el riesgo relativo (RR) de padecer un EAG en pacientes con y sin DSVI. RESULTADOS: La FEVI preservada estuvo presente en 84 (75,7%) pacientes con EAP. En el grupo con DSVI, 4 pacientes (26,9%) en el brazo midazolam frente a 6 (50%) en el brazo morfina presentaron EAG (RR = 0,53; IC 95: 0,2-1,4). En el grupo sin DSVI 6 pacientes (15%) del brazo midazolam frente a 18 (40,9%) del brazo morfina presentaron EAG (RR = 0,37; IC 95: 0,16-0,83). La DSVI no modificó el efecto protector del midazolam en la aparición de EAG con respecto a la morfina (p = 0,57). CONCLUSIONES: En pacientes con EAP el efecto protector del midazolam sobre la morfina en la aparición de EAG y EAG o muerte fue similar en pacientes con y sin DSVI.

Efectos del midazolam frente a la morfina en pacientes con edema agudo de pulmón con disfunción sistólica ventricular izquierda: un análisis secundario del ensayo MIMO / Effects of midazolam vs morphine in patients with acute pulmonary edema with left ventricular systolic dysfunction: a secondary analysis of data from the MIMO trial

Objetivo. El ensayo clínico MIMO demostró que los pacientes con edema agudo de pulmón (EAP) tratados con midazolam tenían menos eventos adversos graves (EAG) que los tratados con morfina. Muchos pacientes con EAP tienen fracción de eyección del ventrículo izquierdo (FEVI) preservada ($ 50%). El objetivo fue conocer si la disfunción sistólica ventricular izquierda (DSVI) (fracción eyección ventrículo izquierdo < 50%) modifica el efecto protector del midazolam frente a la morfina.Método. El estudio MIMO asignó al azar 111 pacientes con EAP a tratamiento con midazolam (dosis de 1 mg intravenosa, hasta una dosis máxima de 3 mg, n = 55) o morfina (dosis de 2-4 mg, hasta una dosis máxima de 8 mg, n = 56). Se calculó el riesgo relativo (RR) de padecer un EAG en pacientes con y sin DSVI.Resultado. La FEVI preservada estuvo presente en 84 (75,7%) pacientes con EAP. En el grupo con DSVI, 4 pacientes (26,9%) en el brazo midazolam frente a 6 (50%) en el brazo morfina presentaron EAG (RR = 0,53; IC 95: 0,2-1,4). En el grupo sin DSVI 6 pacientes (15%) del brazo midazolam frente a 18 (40,9%) del brazo morfina presentaron EAG (RR = 0,37; IC 95: 0,16-0,83). La DSVI no modificó el efecto protector del midazolam en la aparición de EAG con respecto a la morfina (p = 0,57)Conclusiones. En pacientes con EAP el efecto protector del midazolam sobre la morfina en la aparición de EAG y EAG o muerte fue similar en pacientes con y sin DSVI. (AU)

Background and objective. The midazolam vs morphine (MIMO) trial showed that patients treated with midazolam had fewer serious adverse events than those treated with morphine. In many patients with acute pulmonary edema, the left ventricular ejection fraction (LVEF) is preserved, at 50% or higher. We aimed to determine whether left ventricular (LV) systolic dysfunction (D), defined by an LVEF of less than 50%, modifies the protective effect of midazolam vs morphine. Methods. The MIMO trial randomized 111 patients with acute pulmonary edema to receive intravenous midazolam in 1-mg doses to a maximum of 3 mg (n = 55) or morphine in 2- to 4-mg doses to a maximum of 8 mg (n= 56). We calculated the relative risk (RR) for a serious adverse event in patients with and without systolic LVD. Results. LVEF was preserved in 84 (75.7%) of the patients with acute pulmonary edema. In patients with systolic LVD, 4 patients (26.9%) in the midazolam arm vs 6 (50%) in the morphine arm developed serious adverse events (RR, 0.53; 95% CI, 0.2-1.4). In patients without systolic LVD, 6 patients (15%) in the midazolam arm vs 18 (40.9%) in the morphine arm experienced such events (RR, 0.37; 95% CI, 0.16-0.83). The presence of systolic LVD did not modify the protective effect of midazolam on serious adverse effects (P=.57). Conclusions. The effect of midazolam vs morphine in protecting against the development of serious adverse eventsor death is similar in patients with and without systolic LVD. (AU)

Midazolam versus morphine in acute cardiogenic pulmonary oedema: results of a multicentre, open-label, randomized controlled trial.

AIMS: Benzodiazepines have been used as safe anxiolytic drugs for decades and some authors have suggested they could be an alternative for morphine for treating acute cardiogenic pulmonary oedema (ACPE). We compared the efficacy and safety of midazolam and morphine in patients with ACPE. METHODS AND RESULTS: A randomized, multicentre, open-label, blinded endpoint clinical trial was performed in seven Spanish emergency departments (EDs). Patients >18 years old clinically diagnosed with ACPE and with dyspnoea and anxiety were randomized (1:1) at ED arrival to receive either intravenous midazolam or morphine. Efficacy was assessed by in-hospital all-cause mortality (primary endpoint). Safety was assessed through serious adverse event (SAE) reporting, and the composite endpoint included 30-day mortality and SAE. Analyses were made on an intention-to-treat basis. The trial was stopped early after a planned interim analysis by the safety monitoring committee. At that time, 111 patients had been randomized: 55 to midazolam and 56 to morphine. There were no significant differences in the primary endpoint (in-hospital mortality for midazolam vs. morphine 12.7% vs. 17.9%; risk ratio[RR] 0.71, 95% confidence interval [CI] 0.29-1.74; p = 0.60). SAE were less common with midazolam versus morphine (18.2% vs. 42.9%; RR 0.42, 95% CI 0.22-0.80; p = 0.007), as were the composite endpoint (23.6% vs. 44.6%; RR 0.53, 95% CI 0.30-0.92; p = 0.03). CONCLUSION: Although the number of patients was too small to draw final conclusions and there were no significant differences in mortality between midazolam and morphine, a significantly higher rate of SAEs was found in the morphine group.

El ritual / The ritual

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Sociodemographic characteristics, comorbidity, and baseline functional status of older patients treated in emergency departments during the COVID-19 pandemic and associations with mortality: an analysis based on the EDENCOVID cohort. / Sociodemografía, comorbilidad y situación funcional basal de los pacientes mayores atendidos en urgencias durante la pandemia de COVID y su relación con la mortalidad: análisis a partir de la cohorte EDEN-Covid.

OBJECTIVES: To describe the sociodemographic characteristics, comorbidity, and baseline functional status of patients aged 65 or older who came to hospital emergency departments (EDs) during the first wave of the COVID-19 pandemic, and to compare them with the findings for an earlier period to analyze factors of the index episode that were related to mortality. MATERIAL AND METHODS: We studied data from the EDEN-COVID cohort (Emergency Department and Elder Needs During COVID-19) of patients aged 65 years or older treated in 40 Spanish EDs on 7 consecutive days. Nine sociodemographic variables, 18 comorbidities, and 7 function variables were registered and compared with the findings for the EDEN cohort of patients included with the same criteria and treated a year earlier in the same EDs. In-hospital mortality was calculated in the 2 cohorts and a multivariable logistic regression model was used to explore associated factors. RESULTS: The EDEN-COVID cohort included 6806 patients with a median age of 78 years; 49% were women. The pandemic cohort had a higher proportion of men, patients covered by the national health care system, patients brought from residential facilities, and patients who arrived in an ambulance equipped for advanced life support. Pandemic-cohort patients more often had diabetes mellitus, chronic kidney disease, and dementia; they less often had connective tissue and thromboembolic diseases. The Barthel and Charlson indices were worse in this period, and cognitive decline was more common. Fewer patients had a history of depression or falls. Eight hundred ninety these patients (13.1%) died, 122 of them in the ED (1.8%); these percentages were lower in the earlier EDEN cohort, at 3.1% and 0.5%, respectively. Independent sociodemographic factors associated with higher mortality were transport by ambulance, older age, male sex, and living in a residential facility. Mortalityassociated comorbidities were neoplasms, chronic kidney disease, and heart failure. The only function variable associated with mortality was the inability to walk independently. A history of falls in the past 6 months was a protective factor. CONCLUSION: The sociodemographic characteristics, comorbidity, and functional status of patients aged 65 years or older who were treated in hospital EDs during the pandemic differed in many ways from those usually seen in this older-age population. Mortality was higher than in the prepandemic period. Certain sociodemographic, comorbidity, and function variables were associated with in-hospital mortality.

OBJETIVO: Investigar sociodemografía, comorbilidad y situación funcional de los pacientes de 65 o más años de edad que consultaron a los servicios de urgencias hospitalarios (SUH) durante la primera oleada epidémica de COVID, compararlas con un periodo previo y ver su relación. METODO: Se utilizaron los datos obtenidos de la cohorte EDEN-Covid (Emergency Department and Elder Needs during COVID) en la que participaron 40 SUH españoles que incluyeron todos los pacientes de $ 65 años atendidos durante 7 días consecutivos. Se analizaron 9 características sociodemográficas, 18 comorbilidades y 7 variables de funcionalidad, que se compararon con las de la cohorte EDEN (Emergency Department and Elder Needs), que contiene pacientes con el mismo criterio de inclusión etario reclutados por los mismos SUH un año antes. Se recogió la mortalidad intrahospitalaria y se investigaron los factores asociados mediante regresión logística multivariable. RESULTADOS: La cohorte EDEN-Covid incluyó 6.806 pacientes (mediana edad: 78 años; 49% mujeres). Hubo más varones, con cobertura sanitaria pública, procedentes de residencia y que llegaron con ambulancia medicalizada que durante el periodo prepandemia. Presentaron más frecuentemente diabetes mellitus, enfermedad renal crónica, enfermedad cerebrovascular y demencia y menos conectivopatías y enfermedad tromboembólica, peores índices de Barthel y Charlson, más deterioro cognitivo y menos antecedentes de depresión o caídas previas. Fallecieron durante el episodio 890 pacientes (13,1%), 122 de ellos en urgencias (1,8%), porcentajes superiores al periodo prepandemia (3,1% y 0,5%, respectivamente). Se asociaron de forma independiente a mayor mortalidad durante el periodo COVID la llegada en ambulancia, mayor edad, ser varón y vivir en residencia como variables sociodemográficas, y neoplasia, enfermedad renal crónica e insuficiencia cardiaca como comorbilidades. La única variable funcional asociada a mortalidad fue no deambular respecto a ser autónomo, y la existencia de caídas los 6 meses previos resultó un factor protector. CONCLUSIONES: La sociodemografía, comorbilidad y funcionalidad de los pacientes de 65 o más años que consultaron en los SUH españoles durante la primera ola pandémica difirieron en muchos aspectos de lo habitualmente observado en esta población. La mortalidad fue mayor a la del periodo prepandémico. Algunos aspectos sociodemográficos, de comorbilidad y funcionales se relacionaron con la mortalidad intrahospitalaria.

Características de la fibrilación ventricular refractaria extrahospitalaria y uso de la doble desfibrilación secuencial / Out-of-hospital refractory ventricular fibrillation: characteristics and the use of dual sequential Desfibrillation

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