First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer: The real-life study PALBOSPAIN.

PURPOSE: To evaluate the efficacy and safety of first-line therapy with palbociclib in a Spanish cohort treated after palbociclib approval. METHODS: PALBOSPAIN is an observational, retrospective, multicenter study evaluating real-world patterns and outcomes with 1 L palbociclib in men and women (any menopausal status) with advanced HR+/HER2- BC diagnosed between November 2017 and November 2019. The primary endpoint was real-world progression-free survival (rw-PFS). Secondary endpoints included overall survival (OS), the real-world response rate (rw-RR), the clinical benefit rate, palbociclib dose reduction, and safety. RESULTS: A total of 762 patients were included. The median rw-PFS and OS were 24 months (95% CI 21-27) and 42 months (40-not estimable [NE]) in the whole population, respectively. By cohort, the median rw-PFS and OS were as follows: 28 (95% CI 23-39) and 44 (95% CI 38-NE) months in patients with de novo metastatic disease, 13 (95% CI 11-17) and 36 months (95% CI 31-41) in patients who experienced relapse < 12 months after the end of ET, and 31 months (95% CI 26-37) and not reached (NR) in patients who experienced relapse > 12 months after the end of ET. rw-PFS and OS were longer in patients with oligometastasis and only one metastatic site and those with non-visceral disease. The most frequent hematologic toxicity was neutropenia (72%; grade ≥ 3: 52.5%), and the most common non-hematologic adverse event was asthenia (38%). CONCLUSION: These findings, consistent with those from clinical trials, support use of palbociclib plus ET as 1 L for advanced BC in the real-world setting, including pre-menopausal women and men. TRIAL REGISTRATION NUMBER: NCT04874025 (PALBOSPAIN). Date of registration: 04/30/2021 retrospectively registered.

Loneliness impact on healthcare utilization in primary care: A retrospective study.

BACKGROUND: An increased number of patients seek help for loneliness in primary care. OBJECTIVE: To analyze whether loneliness was associated with a higher utilization of healthcare facilities. METHODS: Observational, retrospective study based on the review of routinely coded data in the digital medical record system in a random sample of patients aged 65 or older, stratified by population size of their residence area. A minimum sample size was estimated at 892 medical records. Loneliness was defined as the negative feeling that arises when there is a mismatch between the quantity and quality of a person's social relationships and those, they desire. Thirty-three primary care nurses (30 females and 3 males) were reviewing the data. RESULTS: A total of 932 medical records of patients were reviewed (72% belonged to female patients). Of these, 657 individuals were living alone (71.9%). DeJong Scale average scores was 8.9 points (SD 3.1, 95CI 8.6-9.1). The average annual attendance to primary care ranged from 12.2 visits per year in the case of family practice, 10.7 nurse, 0.7 social workers. The average number of home visits was 3.2, and the urgent consultations attended at health centers were 1.5 per year. Higher feelings of loneliness were associated with extreme values in the frequency of healthcare resource usage. Compared to their peers of the same age, the additional healthcare resource consumption amounted to €802.18 per patient per year. CONCLUSION: Loneliness is linked to higher healthcare resource usage in primary care, with individuals experiencing poorer physical and mental health utilizing these resources up to twice as much as their peers of the same age.

Factores asociados al tratamiento crónico no justificado con digoxina en pacientes con insuficiencia cardiaca aguda y relación con el pronóstico a corto plazo / Factors associated with unjustified chronic treatment with digoxin in patients with acute heart failure and relationship with short-term prognosis

Objetivos Analizar los factores relacionados con el tratamiento crónico inadecuado con digoxina, y si esta inadecuación impacta en la evolución a corto plazo. Método Se incluyeron pacientes diagnosticados de insuficiencia cardiaca aguda (ICA) en tratamiento crónico con digoxina, y se clasificaron como con tratamiento indicado o no indicado, investigándose los factores asociados a este hecho, y si se asociaba a mortalidad intrahospitalaria a 30 días, estancia hospitalaria prolongada (>7 días) y evento adverso combinado (reconsulta a urgencias, hospitalización por ICA o muerte por cualquier causa) durante los 30 días postalta. Resultados Se analizaron 2.366 pacientes en tratamiento crónico con digoxina (mediana=83 años, mujeres=61%): adecuado en 1.373 casos (58,0%), inadecuado en 993 (42,0%). La inadecuación se asoció con mayor edad, menor comorbilidad, menor tratamiento con betabloqueantes e IECA, mejor función ventricular y peor índice de Barthel. La mortalidad intrahospitalaria y a 30 días fue mayor en pacientes con tratamiento inadecuado (9,9 versus 7,6%, p=0,05; y 12,6 versus 9,1%, p<0,001; respectivamente); no hubo diferencias en estancia prolongada (35,7 versus 33,8%) ni en eventos adversos posalta (32,9 versus 31,8%). Ajustando las diferencias basales y del episodio de descompensación, el tratamiento crónico inadecuado con digoxina no se asoció con ningún resultado, con odds ratio de 1,31 (IC 95%: 0,85-2,03) para mortalidad intrahospitalaria, 1,29 (0,74-2,25) para mortalidad a 30 días; 1,07 (0,82-1,40) para estancia prolongada y 0,88 (0,65-1,19) para evento adverso posalta. Conclusión Existe un perfil de paciente que recibe de forma inadecuada tratamiento crónico con digoxina, si bien ello no se asocia con resultados adversos a corto plazo durante los episodios de ICA (AU)

Objectives To analyze the factors related to inadequate chronic treatment with digoxin and whether the inadequacy of treatment has an impact on short-term outcome. Method Patients diagnosed with AHF who were in chronic treatment with digoxin were selected. Digoxin treatment was classified as adequate or inadequate. We investigated factors associated to inadequacy and whether such inadequacy was associated with in-hospital and 30-day mortality, prolonged hospital stay (>7 days) and combined adverse event (re-consultation to the ED or hospitalization for AHF or death from any cause) during the 30 days after discharge. Results We analyzed 2366 patients on chronic digoxin treatment (median age=83 years, women=61%), which was considered adequate in 1373 cases (58.0%) and inadequate in 993 (42.0%). The inadequacy was associated with older age, less comorbidity, less treatment with beta-blockers and renin–angiotensin inhibitors, better ventricular function, and worse Barthel index. In-hospital and 30-day mortality was higher in patients with inadequate digoxin treatment (9.9% vs. 7.6%, p=0.05; and 12.6% vs. 9.1%, p<0.001, respectively). No differences were recorded in prolonged stay (35.7% vs. 33.8%) or post-discharge adverse events (32.9% vs. 31.8%). In the model adjusted for baseline and decompensation episode differences, inadequate treatment with digoxin was not significantly associated with any outcome, with an odds ratio of 1.31 (95% CI=0.85-2.03) for in-hospital mortality; 1.29 (0.74-2.25) for 30-day mortality; 1.07 (0.82-1.40) for prolonged stay; and 0.88 (0.65-1.19) for post-discharge adverse event. Conclusion There is a profile of patients with AHF who inadequately receive digoxin, although this inadequateness for chronic digitalis treatment was not associated with short-term adverse outcomes (AU)

Factors associated with unjustified chronic treatment with digoxin in patients with acute heart failure and relationship with short-term prognosis.

OBJECTIVES: To analyze the factors related to inadequate chronic treatment with digoxin and whether the inadequacy of treatment has an impact on short-term outcome. METHOD: Patients diagnosed with AHF who were in chronic treatment with digoxin, were selected. Digoxin treatment was classified as adequate or inadequate. We investigated factors associated to inadequacy and whether such inadequacy was associated with in-hospital and 30-day mortality, prolonged hospital stay (>7 days) and combined adverse event (re-consultation to the ED or hospitalization for AHF or death from any cause) during the 30 days after discharge. RESULTS: We analyzed 2,366 patients on chronic digoxin treatment (median age = 83 years, women = 61%), which was considered adequate in 1,373 cases (58.0%) and inadequate in 993 (42.0%). The inadequacy was associated with older age, less comorbidity, less treatment with beta-blockers and renin-angiotensin inhibitors, better ventricular function, and worse Barthel index. In-hospital and 30-day mortality was higher in patients with inadequate digoxin treatment (9.9% versus 7.6%, p = 0.05; and 12.6% versus 9.1%, p < 0.001, respectively). No differences were recorded in prolonged stay (35.7% versus 33.8%) or post-discharge adverse events (32.9% versus 31.8%). In the model adjusted for baseline and decompensation episode differences, inadequate treatment with digoxin was not significantly associated with any outcome, with an odds ratio of 1.31 (95%CI = 0.85-2.03) for in-hospital mortality; 1.29 (0.74-2.25) for 30-day mortality; 1.07 (0.82-1.40) for prolonged stay; and 0.88 (0.65-1.19) for post-discharge adverse event. CONCLUSION: There is a profile of patients with AHF who inadequately receive digoxin, although this inadequateness for chronic digitalis treatment was not associated with short-term adverse outcomes.

[Family planning in men and women with multiple sclerosis. Analysis of the Andalusian Registry (2018-2022)]. / Planificación familiar en hombres y mujeres con esclerosis múltiple. Análisis del Registro Andaluz (2018-2022).

INTRODUCTION: The Andalusian Registry of Pregnancies in patients with multiple sclerosis is the largest Spanish registry on multiple sclerosis (MS) and family planning. For the first time, it includes information on the fertility of men with MS. The influence of the use of a disease-modifying treatment (DMT) on the health of the foetus/newborn and the impact of breastfeeding on MS are also analysed. SUBJECTS AND METHODS: This is a multicentre, prospective and observational study. Recruitment of patients took place between December 2018 and December 2020. Women were followed up for one year after delivery. Altogether 100 women and 16 men were included, with a total of 103 newborn infants. RESULTS: The annualised relapse rate of the women with MS decreased significantly during pregnancy (from 0.23 to 0.065). A total of 11.2% of patients resorted to assisted reproductive techniques in order to conceive a child. No association was found between the use of a DMT at conception and/or pregnancy and the risk of miscarriage, prematurity or low birth weight. Over half the women with MS (54.2%) chose to breastfeed (26.7% of them while on a DMT). CONCLUSIONS: MS does not affect the fertility of men. Neither does the use of a DMT at the time of conception affect their fertility or their children's health. Assisted reproductive techniques did not have a negative impact on the course of MS. Breastfeeding is a common practice among women with MS and there is no evidence of positive or negative effects on disease progression.

TITLE: Planificación familiar en hombres y mujeres con esclerosis múltiple. Análisis del Registro Andaluz (2018-2022).Introducción. El Registro Andaluz de Embarazos en pacientes con esclerosis múltiple (EM) es el mayor registro español sobre EM y planificación familiar. Por primera vez se incluye información sobre la fertilidad de hombres con EM. También se analizan la influencia del uso de un tratamiento modificador de la enfermedad (TME) en la salud del feto o recién nacido y el impacto de la lactancia materna en la EM. Sujetos y métodos. Es un estudio observacional, prospectivo y multicéntrico. El reclutamiento de pacientes se hizo entre diciembre de 2018 y diciembre de 2020. El seguimiento de las mujeres tras el parto fue de un año. Se incluyó a 100 mujeres y 16 hombres, con un total de 103 recién nacidos. Resultados. La tasa anualizada de brotes de las mujeres con EM descendió durante el embarazo de forma significativa (de 0,23 a 0,065). Un 11,2% de los pacientes recurrieron a técnicas de reproducción asistida para conseguir la gestación. No se encontró relación entre el uso de un TME en la concepción y/o embarazo y el riesgo de aborto, prematuridad o bajo peso al nacer. El 54,2% de las mujeres con EM optaron por dar lactancia (el 26,7% de ellas usando un TME). Conclusiones. La EM no afecta a la fertilidad de los hombres. Tampoco influye en ésta, ni en la salud de sus hijos, el uso de un TME en el momento de la concepción. Las técnicas de reproducción asistida no impactaron negativamente en la evolución de la EM. La lactancia se impone como una práctica habitual entre las mujeres con EM y no se evidencian efectos positivos o negativos sobre la evolución de la enfermedad.

Planificación familiar en hombres y mujeres con esclerosis múltiple. Análisis del Registro Andaluz (2018-2022) / Family planning in men and women with multiple sclerosis. Analysis of the Andalusian Registry (2018-2022)

Introducción: El Registro Andaluz de Embarazos en pacientes con esclerosis múltiple (EM) es el mayor registro español sobre EM y planificación familiar. Por primera vez se incluye información sobre la fertilidad de hombres con EM. También se analizan la influencia del uso de un tratamiento modificador de la enfermedad (TME) en la salud del feto o recién nacido y el impacto de la lactancia materna en la EM. Sujetos y métodos: Es un estudio observacional, prospectivo y multicéntrico. El reclutamiento de pacientes se hizo entre diciembre de 2018 y diciembre de 2020. El seguimiento de las mujeres tras el parto fue de un año. Se incluyó a 100 mujeres y 16 hombres, con un total de 103 recién nacidos. Resultados: La tasa anualizada de brotes de las mujeres con EM descendió durante el embarazo de forma significativa (de 0,23 a 0,065). Un 11,2% de los pacientes recurrieron a técnicas de reproducción asistida para conseguir la gestación. No se encontró relación entre el uso de un TME en la concepción y/o embarazo y el riesgo de aborto, prematuridad o bajo peso al nacer. El 54,2% de las mujeres con EM optaron por dar lactancia (el 26,7% de ellas usando un TME). Conclusiones: La EM no afecta a la fertilidad de los hombres. Tampoco influye en ésta, ni en la salud de sus hijos, el uso de un TME en el momento de la concepción. Las técnicas de reproducción asistida no impactaron negativamente en la evolución de la EM. La lactancia se impone como una práctica habitual entre las mujeres con EM y no se evidencian efectos positivos o negativos sobre la evolución de la enfermedad.(AU)

Introduction: The Andalusian Registry of Pregnancies in patients with multiple sclerosis is the largest Spanish registry on multiple sclerosis (MS) and family planning. For the first time, it includes information on the fertility of men with MS. The influence of the use of a disease-modifying treatment (DMT) on the health of the foetus/newborn and the impact of breastfeeding on MS are also analysed. Subjects and methods: This is a multicentre, prospective and observational study. Recruitment of patients took place between December 2018 and December 2020. Women were followed up for one year after delivery. Altogether 100 women and 16 men were included, with a total of 103 newborn infants. Results: The annualised relapse rate of the women with MS decreased significantly during pregnancy (from 0.23 to 0.065). A total of 11.2% of patients resorted to assisted reproductive techniques in order to conceive a child. No association was found between the use of a DMT at conception and/or pregnancy and the risk of miscarriage, prematurity or low birth weight. Over half the women with MS (54.2%) chose to breastfeed (26.7% of them while on a DMT). Conclusions: MS does not affect the fertility of men. Neither does the use of a DMT at the time of conception affect their fertility or their children’s health. Assisted reproductive techniques did not have a negative impact on the course of MS. Breastfeeding is a common practice among women with MS and there is no evidence of positive or negative effects on disease progression.(AU)

Is minimising waste volume for drawing blood samples in critically ill patients feasible?

INTRODUCTION: Drawing blood samples through a central venous catheter (CVC) is a customary practice in Intensive Care Units (ICUs). It is indicated to discard a volume of waste blood to avoid interference in the results. AIM: To determine whether a lower discard volume for obtaining blood samples from temporary CVCs placed into the internal jugular, femoral or subclavian vein offers valid results. METHOD: A quasi-experimental prospective cross-sectional study for which sixty-five patients of over 18 years of age in ICUs, who had been fitted with a triple lumen central venous catheter, were recruited over a period of eight months. Two consecutive blood samples were extracted with tubes for biochemistry, coagulation and hemogram from each patient from the distal lumen. The first sample was obtained with a discarded waste of 1.5 ml from a total extracted volume of 10.2 ml, similar to the usual waste in our ambit (10 ml). Subsequently the second sample was obtained. The paired t-test was used to analyse the data. The Bland-Altman plot and intraclass correlation coefficient (ICC) were used to measure the agreement between methods. The reference change value (RCV) was established as the admissible limit of variation between the pairs of samples. RESULTS: A total of 65 sample pairs were drawn (intervention-control). The paired t-test found statistically significant differences with a significance level of α = .05 for chlorine (-.536; .012); prothrombin time (-.092; .019) and prothrombin activity (.284; 1.375).The ICC was greater than .9 in all the variables and the limit determined for the RCV was not surpassed by any value. CONCLUSIONS: The results show the reliability of the blood samples drawn with a discard volume of 1.5 ml.

Minimizar el volumen de descarte para la extracción de muestras sanguíneas en los pacientes críticos: ¿es factible? / Is minimising waste volume for drawing blood samples in critically ill patients feasible?

Introducción: La extracción de muestras sanguíneas a través de un catéter venoso central es una práctica habitual en las unidades de cuidados intensivos. Está indicado desechar un volumen de sangre, denominado volumen de descarte, con la finalidad de evitar que los resultados puedan verse alterados. Objetivo: Determinar si un menor volumen de descarte para la obtención de analíticas procedentes de catéter venoso central temporales alojados en la vena yugular interna, femoral o subclavia ofrece resultados válidos. Método: Estudio cuasiexperimental, prospectivo, transversal donde se seleccionaron 65 pacientes críticos mayores de 18 años portadores de catéter venoso central temporal de 3 luces durante un período de 8 meses. Para cada paciente se extrajeron 2 analíticas consecutivas de la luz distal con los valores de hemograma, bioquímica y coagulación comúnmente analizados en el paciente crítico. Se obtuvieron 2 muestras consecutivas: la primera, con un descarte de 1,5ml y un volumen extraído total de 10,2ml, similar al desecho habitual en nuestro medio (10 ml). Seguidamente se obtuvo la segunda muestra. Para el análisis de datos se utilizó la prueba t pareada; para medir la concordancia entre métodos, la representación de Bland-Altman y el coeficiente de correlación intraclase. Se estableció el valor de referencia del cambio como límite admisible de variación entre los pares de muestras. Resultados: Se extrajeron un total de 65 pares de muestras (intervención-control). El contraste de medias encontró diferencias estadísticamente significativas con α=0,05 para cloro (−0,536; 0,012), tiempo de protrombina (−0,092; 0,019) y actividad de protrombina (0,284; 1,375). El coeficiente de correlación intraclase resultó mayor de 0,9 en todas las variables y el valor de referencia del cambio no fue superado por ningún valor. Conclusiones: Los resultados muestran la validez de los análisis de las muestras de sangre extraídas con un volumen de descarte de 1,5ml.(AU)

Introduction: Drawing blood samples through a central venous catheter is a customary practice in intensive care units. It is indicated to discard a volume of waste blood to avoid interference in the results. Aim: To determine whether a lower discard volume for obtaining blood samples from temporary central venous catheters placed into the internal jugular, femoral or subclavian vein offers valid results. Method: A quasi-experimental prospective cross-sectional study for which 65 patients of over 18 years of age in intensive care units, who had been fitted with a triple lumen central venous catheter, were recruited over a period of 8 months. Two consecutive blood samples were extracted with tubes for biochemistry, coagulation and haemogram from each patient from the distal lumen. The first sample was obtained with a discarded waste of 1.5ml from a total extracted volume of 10.2ml, similar to the usual waste in our ambit (10ml). Subsequently the second sample was obtained. The paired t-test was used to analyse the data. The Bland-Altman plot and intraclass correlation coefficient were used to measure the agreement between methods. The reference change value was established as the admissible limit of variation between the pairs of samples. Results: A total of 65 sample pairs were drawn (intervention-control). The paired t-test found statistically significant differences with a significance level of α=0.05 for chlorine (−0.536; 0.012); prothrombin time (−0.092; 0.019) and prothrombin activity (0.284; 1.375). The intraclass correlation coefficient was greater than 0.9 in all the variables and the limit determined for the reference change value was not surpassed by any value. Conclusions: The results show the reliability of the blood samples drawn with a discard volume of 1.5ml.(AU)

Anatomic description of the basivertebral nerve and meningeal branch of the spinal nerve in the dog.

PURPOSE: The existence of the basivertebral nerve and meningeal branch of the spinal nerve has not been proven in dogs to date. The objectives of this study are to 1) determine whether dogs have a meningeal branch of the spinal nerve (MBSN) and a basivertebral nerve (BVN) and to (2) describe anatomical characteristics of these two nerves. Authors also put forward a discussion on the possible clinical relevance of these findings. MATERIAL AND METHODS: Dissections were performed on six embalmed dogs at the Veterinary Faculty of Barcelona with the use of stereomicroscopy and microsurgery equipment. RESULTS: The MBSN (grossly) and BVN (grossly and histologically) were identified in the cervical, thoracic, and lumbar region in all dog specimens. In addition, other small fibers (suspected nerves) entering the vertebral body through small foramina close to the end plates were identified. Histological examination of the tissues confirmed the presence of nerve fibers (myelinated and unmyelinated) in suspected BVN samples. Results of the present study indicated that dogs have BVNs. Also, suspected nerve fibers were identified among the epidural fat, running from the intervertebral foramina, that likely represent the MBSN. CONCLUSION: These findings open up the discussion on extrapolation of treatment options employed in human medicine for "low back pain", such as BVN ablation, which is discussed in this article. Further anatomic and clinical studies of the innervation for the vertebral body, periosteum, vasculature, dorsal longitudinal ligament and anulus fibrosus are necessary to elucidate possible anatomical variants and breed differences as well as potential clinical (e.g., therapeutic) relevance.

Análisis de la efectividad y seguridad de las unidades de estancia corta en la hospitalización de pacientes con insuficiencia cardíaca aguda. Propensity Score UCE-EAHFE / Analysis of the effectiveness and safety of short-stay units in the hospitalization of patients with acute heart failure. Propensity Score SSU-EAHFE

Objetivos Analizar si la hospitalización en unidades de corta estancia (UCE) de pacientes diagnosticados en urgencias de insuficiencia cardíaca aguda (ICA) resulta efectiva en términos de estancia hospitalaria y si se asocia con diferencias en la evolución a corto plazo. Método Se incluyeron los pacientes del registro EAHFE diagnosticados de ICA que ingresaron en UCE (grupo UCE) y se compararon con los hospitalizados en otros servicios (grupo No-UCE) procedentes de todos los hospitales (comparación A) y, separadamente, de hospitales con UCE (comparación B) y sin UCE (comparación C). Para cada comparación, se emparejaron pacientes de los grupos UCE/No-UCE por puntuación de propensión, y se comparó la estancia hospitalaria (eficacia) y mortalidad a 30 días y evento adverso posalta a 30 días (seguridad). Resultados Se identificaron 2.003 pacientes UCE y 12.193 No-UCE. Se emparejaron 674 pares de pacientes para la comparación A, 634 para la comparación B y 588 para la comparación C. La estancia hospitalaria fue significativamente inferior en el grupo UCE en todas las comparaciones (A: mediana 4 días [RIC = 2–5] versus 8 [5–12] días, p < 0,001; B: 4 [2–5] versus 8 [5–12], p < 0,001; C: 4 [2–5] versus 8 [6–12], p < 0,001). El ingreso en UCE no se asoció a diferencias en mortalidad (A: HR = 1,027, IC95% = 0,681−1,549; B: 0,976, 0,647−1,472; C: 0,818, 0,662−1,010) ni en eventos adversos posalta (A: 1,002, 0,816−1,232; B: 0,983, 0,796−1,215; C: 1,135, 0,905−1,424). Conclusión La hospitalización de los pacientes con ICA en UCE se asocia con estancias más cortas sin diferencias en la evolución a corto plazo (AU)

Objectives This work aims to analyze if hospitalization in short-stay units (SSU) of patients diagnosed in the emergency department with acute heart failure (AHF) is effective in terms of the length of hospital stay and if it is associated with differences in short-term progress. Method Patients from the EAHFE registry diagnosed with AHF who were admitted to the SSU (SSU group) were included and compared to those hospitalized in other departments (non-SSU group) from all hospitals (comparison A) and, separately, those from hospitals with an SSU (comparison B) and without an SSU (comparison C). For each comparison, patients in the SSU/non-SSU groups were matched by propensity score. The length of hospital stay (efficacy), 30-day mortality, and post-discharge adverse events at 30 days (safety) were compared. Results A total of 2,003 SSU patients and 12,193 non-SSU patients were identified. Of them, 674 pairs of patients were matched for comparison A, 634 for comparison B, and 588 for comparison C. The hospital stay was significantly shorter in the SSU group in all comparisons (A: median 4 days (IQR = 2–5) versus 8 (5–12) days, p < 0.001; B: 4 (2–5) versus 8 (5–12), p < 0.001; C: 4 (2–5) versus 8 (6–12), p < 0.001). Admission to the SSU was not associated with differences in mortality (A: HR = 1.027, 95%CI = 0.681–1.549; B: 0.976, 0.647–1.472; C: 0.818, 0.662–1.010) or post-discharge adverse events (A: HR = 1.002, 95%CI = 0.816–1.232; B: 0.983, 0.796–1.215; C: 1.135, 0.905–1.424). Conclusion The hospitalization of patients with AHF in the SSU is associated with shorter hospital stays but there were no differences in short-term progress (AU)

Analysis of the effectiveness and safety of short-stay units in the hospitalization of patients with acute heart failure. Propensity Score SSU-EAHFE.

OBJECTIVES: This work aims to analyze if hospitalization in short-stay units (SSU) of patients diagnosed in the emergency department with acute heart failure (AHF) is effective in terms of the length of hospital stay and if it is associated with differences in short-term progress. METHOD: Patients from the EAHFE registry diagnosed with AHF who were admitted to the SSU (SSU group) were included and compared to those hospitalized in other departments (non-SSU group) from all hospitals (comparison A) and, separately, those from hospitals with an SSU (comparison B) and without an SSU (comparison C). For each comparison, patients in the SSU/non-SSU groups were matched by propensity score. The length of hospital stay (efficacy), 30-day mortality, and post-discharge adverse events at 30 days (safety) were compared. RESULTS: A total of 2,003 SSU patients and 12,193 non-SSU patients were identified. Of them, 674 pairs of patients were matched for comparison A, 634 for comparison B, and 588 for comparison C. The hospital stay was significantly shorter in the SSU group in all comparisons (A: median 4 days (IQR = 2-5) versus 8 (5-12) days, p < 0.001; B: 4 (2-5) versus 8 (5-12), p < 0.001; C: 4 (2-5) versus 8 (6-12), p < 0.001). Admission to the SSU was not associated with differences in mortality (A: HR = 1.027, 95%CI = 0.681-1.549; B: 0.976, 0.647-1.472; C: 0.818, 0.662-1.010) or post-discharge adverse events (A: HR = 1.002, 95%CI = 0.816-1.232; B: 0.983, 0.796-1.215; C: 1.135, 0.905-1.424). CONCLUSION: The hospitalization of patients with AHF in the SSU is associated with shorter hospital stays but there were no differences in short-term progress.

El modelo Clinical outcomes, healthcare resource utilization, and related costs (COHERENT). Aplicación en pacientes con insuficiencia cardiaca / The Clinical outcomes, healthcare resource utilization, and related costs (COHERENT) model. Application in heart failure patients

Introducción y objetivos: Los resultados combinados se utilizan ampliamente, pero tienen diversas limitaciones. El modelo Clinical outcomes, healthcare resource utilization and related costs (COHERENT) es una aproximación nueva para presentar y comparar visualmente todos los componentes de los resultados combinados (incidencia, tiempo, duración) y los costes relacionados. El objetivo es evaluar su utilidad en una cohorte de pacientes. Métodos: Se diseñó un sistema de colores que representa gráficamente el porcentaje de pacientes en cada situación clínica (estado vital y ubicación: domicilio, urgencias, hospital), codificada jerárquicamente, en cada momento del seguimiento. Se aplicó a 1.126 pacientes con insuficiencia cardiaca aguda de 25 hospitales seguidos durante 30 días tras su visita a urgencias, y se calculó el tiempo en cada situación clínica y sus costes sanitarios. Resultados: El modelo ilustra visualmente los componentes del objetivo combinado a los 30 días (el 2,12% en urgencias, el 23,6% en hospitalización índice, el 2,7% en reingresos, el 65,5% vivo en casa y el 6,02% fallecido) y muestra diferencias significativas entre grupos de pacientes, hospitales o sistemas sanitarios. El instrumento también calcula y muestra los costes diarios y acumulados (total, 4.895.070 euros; media, 144,91 euros/paciente/día). Conclusiones: El modelo COHERENT es un nuevo método para mostrar visualmente resultados combinados y sus costes que permite comparar grupos de pacientes y cohortes. El nuevo sistema puede ser útil como un nuevo criterio de valoración para ensayos clínicos o estudios observacionales, y un instrumento para la evaluación comparativa, la planificación clínica, el análisis económico y la implementación de la atención sanitaria basada en valor (AU)

Introduction and objectives: Composite endpoints are widely used but have several limitations. The Clinical outcomes, healthcare resource utilization and related costs (COHERENT) model is a new approach for visually displaying and comparing composite endpoints including all their components (incidence, timing, duration) and related costs. We aimed to assess the validity of the COHERENT model in a patient cohort. Methods: A color graphic system displaying the percentage of patients in each clinical situation (vital status and location: at home, emergency department [ED] or hospital) and related costs at each time point during follow-up was created based on a list of mutually exclusive clinical situations coded in a hierarchical fashion. The system was tested in a cohort of 1126 patients with acute heart failure from 25 hospitals. The system calculated and displayed the time spent in each clinical situation and health care resource utilization-related costs over 30 days. Results: The model illustrated the times spent over 30 days (2.12% in ED, 23.6% in index hospitalization, 2.7% in readmissions, 65.5% alive at home, and 6.02% dead), showing significant differences between patient groups, hospitals, and health care systems. The tool calculated and displayed the daily and cumulative health care-related costs over time (total, €4 895 070; mean, €144.91 per patient/d). Conclusions: The COHERENT model is a new, easy-to-interpret, visual display of composite endpoints, enabling comparisons between patient groups and cohorts, including related costs. The model may constitute a useful new approach for clinical trials or observational studies, and a tool for benchmarking, and value-based health care implementation (AU)

Pronóstico de la insuficiencia cardíaca aguda basado en datos clínicos de congestión / Prognosis of acute heart failure based on clinical data of congestion

Antecedentes y objetivos Evaluar si los síntomas/signos de congestión en pacientes con insuficiencia cardíaca aguda (ICA) atendidos en los servicios de urgencias hospitalarios (SUH) permiten predecir la evolución a corto plazo. Pacientes y métodos Pacientes consecutivos diagnosticados de ICA en 45 SUH del registro EAHFE. Recogimos variables clínicas de congestión sistémica (edemas en miembros inferiores, ingurgitación yugular, hepatomegalia) y pulmonar (disnea de esfuerzo, disnea paroxística nocturna, ortopnea y crepitantes pulmonares) analizando su asociación con la mortalidad por cualquier causa a 30 días, de forma cruda y ajustada por diferencias entre grupos. Resultado Analizamos 18.120 pacientes (mediana=83 años, rango intercuartil [RIC]=76-88; mujeres=55,7%). El 44,6% presentaba >3 síntomas/signos congestivos. Individualmente, el riesgo ajustado de muerte a 30 días se incrementó un 14% para la existencia de ingurgitación yugular (hazard ratio [HR]=1,14; intervalo de confianza al 95% [IC 95%]=1,01-1,28) y un 96% para la disnea de esfuerzo (HR=1,96; IC 95%=1,55-2,49). Valorados conjuntamente, el riesgo se incrementó progresivamente con el número de síntomas/signos presentes; así, respecto a los pacientes sin síntomas/signos de congestión, el riesgo incrementó un 109, 123 y 156% en pacientes con 1-2, 3-5 y 6-7 síntomas/signos, respectivamente. Estas asociaciones no mostraron interacción con la disposición final del paciente tras su atención en urgencias (alta/hospitalización), con excepción de edemas en extremidades inferiores, que tuvieron mejor pronóstico en pacientes dados de alta (HR=0,66; IC 95%=0,49-0,89) que en los hospitalizados (HR=1,01; IC 95%=0,65-1,57; p interacción <0,001). Conclusión La presencia de mayor número de síntomas/signos congestivos se asoció a una mayor mortalidad de cualquier causa a los 30 días. Individualmente, la ingurgitación yugular y la disnea de esfuerzo se asocian a mayor mortalidad a corto plazo (AU)

Background and objectives This work aims to assess whether symptoms/signs of congestion in patients with acute heart failure (AHF) evaluated in hospital emergency departments (HED) allows for predicting short-term progress. Patients and methods The study group comprised consecutive patients diagnosed with AHF in 45 HED from EAHFE Registry. We collected clinical variables of systemic congestion (edema in the lower extremities, jugular vein distention, hepatomegaly) and pulmonary congestion (dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, and pulmonary crackles) and analyzed their individual and group association with all-cause 30-day of mortality crudely and adjusted for differences between groups. Results We analyzed 18,120 patients (median=83 years, interquartile range [IQR]=76-88; women=55.7%). Of them, 44.6% had >3 congestive symptoms/signs. Individually, the 30-day adjusted risk of death increased 14% for jugular vein distention (hazard ratio [HR]=1.14, 95% confidence interval [95% CI]=1.01-1.28) and 96% for dyspnea on exertion (HR=1.96, 95% CI=1.55-2.49). Assessed jointly, the risk progressively increased with the number of symptoms/signs present; compared to patients without symptoms/signs of congestion, the risk increased by 109%, 123%, and 156% in patients with 1-2, 3-5, and 6-7 symptoms/signs, respectively. These associations did not show interaction with the final disposition of the patient after their emergency care (discharge/hospitalization) with the exception of edema in the lower extremities, which had a better prognosis in discharged patients (HR=0.66, 95% CI=0.49 -0.89) than hospitalized patients (HR=1.01, 95% CI=0.65-1.57; interaction p<0.001). Conclusion The presence of a greater number of congestive symptoms/signs was associated with greater all-cause 30-day mortality. Individually, jugular vein distention and dyspnea on exertion were associated with higher short-term mortality (AU)

Impacto de las características estructurales y organizativas hospitalarias y de urgencias en el resultado evolutivo de la insuficiencia cardiaca aguda / Impact of hospital and emergency department structural and organizational characteristics on outcomes of acute heart failure

Introducción y objetivos: Investigar si diferentes características estructurales/organizativas del hospital y del servicio de urgencias (SU) impactan en los resultados de la insuficiencia cardiaca aguda (ICA). Métodos: Análisis secundario del Registro EAHFE. Se recogieron 6 características hospitalarias y del SU, y se relacionaron con 7 resultados tras el evento índice y tras el alta, ajustados por año de inclusión, características basales y del episodio de ICA y por dichas características estructurales/organizativas. También se relacionó el porcentaje de altas directas desde urgencias (ADU) y resultados, y si había interacción según las características hospitalarias o del SU. Resultados: Cuarenta SU españoles incluyeron 17.974 episodios de ICA. Hubo menos estancias prolongadas en hospitales de alta tecnología, con hospitalización a domicilio y con SU con alta frecuentación, y más estancias prolongadas en hospitales con unidad de insuficiencia cardiaca y área de observación en urgencias. Los hospitales de alta tecnología presentaron menor mortalidad hospitalaria (OR=0,78; IC95%, 0,65-0,94). Respecto a eventos 30 días tras el alta, los hospitales con unidad de corta estancia (UCE) tuvieron más hospitalizaciones (OR=1,19; IC95%, 1,02-1,38); los SU con alta afluencia, menor mortalidad (OR=0,73; IC95%, 0,56-0,96) y eventos combinados (OR=0,87; IC95%, 0,76-0,99), y los hospitales con unidad de insuficiencia cardiaca, menos reconsultas a urgencias (OR=0,83; IC95%, 0,76-0,91), hospitalizaciones (OR=0,85; IC95%, 0,75-0,97) y eventos combinados (OR=0,84; IC95%, 0,77-0,92). A más ADU, menos estancias prolongadas. Entre otras interacciones, el incremento de ADU se asoció con más reconsultas, hospitalizaciones y eventos combinados a los 30 días del alta en hospitales sin UCE, pero no en hospitales con UCE (AU)

Introduction and objectives: To determine whether structural/organizational characteristics of hospitals and emergency departments (EDs) affect acute heart failure (AHF) outcomes. Methods: We performed a secondary analysis of the EAHFE Registry. Six hospital/ED characteristics were collected and were related to 7 postindex events and postdischarge outcomes, adjusted by the period of patient inclusion, baseline patient characteristics, AHF episode features, and hospital and ED characteristics. The relationship between discharge directly from the ED (DDED) and outcomes was assessed, and interaction was analyzed according to the hospital/ED characteristics. Results: We analyzed 17 974 AHF episodes included by 40 Spanish EDs. Prolonged stays were less frequent in high-technology hospitals and those with hospitalization at home and with high-inflow EDs, and were more frequent in hospitals with a heart failure unit (HFU) and an ED observation unit. In-hospital mortality was lower in high-technology hospitals (OR, 0.78; 95%CI, 0.65-0.94). Analysis of 30-day postdischarge outcomes showed that hospitals with a short-stay unit (SSU) had higher hospitalization rates (OR, 1.19; 95%CI, 1.02-1.38), high-inflow EDs had lower mortality (OR, 0.73; 95%CI, 0.56-0.96) and fewer combined events (OR, 0.87; 95%CI, 0.76-0.99), while hospitals with HFU had fewer ED reconsultations (OR, 0.83; 95%CI, 0.76-0.91), hospitalizations (OR, 0.85; 95%CI, 0.75-0.97), and combined events (OR, 0.84; 95%CI, 0.77-0.92). The higher the percentage of DDED, the fewer the prolonged stays. Among other interactions, we found that more frequent DDED was associated with more 30-day postdischarge reconsultations, hospitalizations and combined events in hospitals without SSUs, but not in hospitals with an SSU. Conclusions: AHF outcomes were significantly affected by the structural/organizational characteristics of hospitals and EDs and their aggressiveness in ED management (AU)

Prognosis of acute heart failure based on clinical data of congestion.

BACKGROUND AND OBJECTIVES: This work aims to assess whether symptoms/signs of congestion in patients with acute heart failure (AHF) evaluated in hospital emergency departments (HED) allows for predicting short-term progress. PATIENTS AND METHODS: The study group comprised consecutive patients diagnosed with AHF in 45 HED from EAHFE Registry. We collected clinical variables of systemic congestion (edema in the lower extremities, jugular vein distention, hepatomegaly) and pulmonary congestion (dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, and pulmonary crackles) and analysed their individual and group association with all-cause 30-day of mortality crudely and adjusted for differences between groups. RESULTS: We analysed 18,120 patients (median = 83 years, interquartile range [IQR] = 76-88; women = 55.7%). Of them, 44.6% had > 3 congestive symptoms/signs. Individually, the 30-day adjusted risk of death increased 14% for jugular vein distention (hazard ratio [HR] = 1.14, 95% confidence interval [95%CI] = 1.01-1.28) and 96% for dyspnea on exertion (HR = 1.96, 95% CI = 1.55-2.49). Assessed jointly, the risk progressively increased with the number of symptoms/signs present; compared to patients without symptoms/signs of congestion, the risk increased by 109%, 123 %, and 156% in patients with 1-2, 3-5, and 6-7 symptoms/signs, respectively. These associations did not show interaction with the final disposition of the patient after their emergency care (discharge/hospitalization) with the exception of edema in the lower extremities, which had a better prognosis in discharged patients (HR = 0.66, 95% CI = 0.49-0.89) than hospitalised patients (HR = 1.01, 95% CI = 0.65-1.57; interaction p < 0.001). CONCLUSION: The presence of a greater number of congestive symptoms/signs was associated with greater all-cause 30-day mortality. Individually, jugular vein distention and dyspnea on exertion were associated with higher short-term mortality.

Frequency, profile, and outcomes of patients with acute heart failure transferred directly to home hospitalization from emergency departments.

OBJECTIVE: To describe the frequency, clinical characteristics and outcomes of patients with acute heart failure (AHF) transferred directly from emergency departments to home hospitalisation (HH) and to compare them with those hospitalised in internal medicine (IM) or short-stay units (SSU). METHOD: We included patients with AHF transferred to HH by hospitals that considered this option during the Epidemiology of Acute Heart Failure in Spanish Emergency Departments (EAHFE) 4-5-6 Registries and compared them with patients admitted to IM or SSU in these centres. We compared the adjusted all-cause mortality at 1 year and adverse events 30 days after discharge. RESULTS: The study included 1473 patients (HH/IM/SSU:68/979/384). The HH rate was 4.7% (95% CI 3.8-6.0%). The patients in HH had few differences compared with those hospitalised in IM and SSUs. The HH mortality was 1.5%, and the HH median stay was 7.5 days (IQR, 4.5-12), similar to that of IM (median stay, 8 days; IQR, 5-13; p = .106) and longer than that of SSU (median stay, 4 days; IQR, 3-7; p < .001). The all-cause mortality at 1 year for HH did not differ from that of IM (HR, 0.91; 95% CI 0.73-1.14) or SSU (HR, 0.77; 95% CI 0.46-1.27); however, the emergency department readmission rate during the 30 days postdischarge was lower than that of IM (HR, 0.50; 95% CI 0.25-0.97) and SSU (HR, 0.37; 95% CI 0.19-0.74). There were no differences in the need for new hospitalisations or in the 30-day mortality rate. CONCLUSIONS: Direct transfer from the emergency department to HH is infrequent despite being a safe option for a certain patient profile with AHF.

Role of changes in plasma prolactin concentrations on ram and buck sperm cryoresistance.

Seasonal endocrine changes may modify sperm cryoresistance in certain small ruminant species. The present work examines the effect of prolactin (PRL) on ram and buck sperm cryoresistance. A dopamine agonist (bromocriptine [BCR] 60 mg i.m. twice per week from May 15 to June 15, that is, approaching the summer solstice) or antagonist (sulpiride [SLP] 100 mg s.c. daily from December 15 to January 15, that is, around the winter solstice) was administered under solstice-appropriate photoperiod conditions to modify PRL secretion. Control animals received the vehicle only. Compared to the corresponding controls, BCR reduced PRL secretion to basal levels in both the rams and bucks. In rams, the cryoresistance ratios for sperm curvilinear velocity (P < 0.05) and lateral head displacement (P < 0.01) were higher for the BCR-treated animals. In bucks, neither the characteristics of fresh nor frozen-thawed sperm were affected by BCR treatment. After the administration of SLP, PRL levels increased and remained high for more than 5 h in the rams though they immediately began to fall in the bucks. By 24 h, PRL had returned to basal concentrations in both species. In rams treated with SLP, the cryoresistance ratios for sperm progressive motility, straight line velocity, sperm mean path velocity, cross beat frequency, and the progression ratios linearity, straightness and oscillation, were all lower compared to the controls (P < 0.05), while the amplitude of lateral head displacement was higher (P < 0.01). In bucks, sperm cryoresistance was not affected by SLP administration. Together, these results suggest that high levels of PRL negatively affect the cryoresistance of ram sperm, while buck sperm seems unaffected.