Efficacy and safety of intermittent repeated levosimendan infusions in advanced heart failure patients: the LAICA study.

AIMS: The aim of the LAICA study was to evaluate the long-term effectiveness and safety of intermittent levosimendan infusion in patients with advanced heart failure (AdHF). METHODS AND RESULTS: This was a multicentre, randomized, double-blind, placebo-controlled clinical trial of intermittent levosimendan 0.1 µg/kg/min as a continuous 24-h intravenous infusion administered once monthly for 1 year in patients with AdHF. The primary endpoint [incidence of rehospitalization (admission to the emergency department or hospital ward for >12 h) for acute decompensated HF or clinical deterioration of the underlying HF] occurred in 23/70 (33%) of the levosimendan group (Group I) and 12/27 (44%) of the placebo group (Group II) (P = 0.286). The incidence of hospital readmissions for acute decompensated HF (Group I vs. Group II) at 1, 3, 6, and 12 months was 4.2% vs. 18.2% (P = 0.036); 12.8% vs. 33.3% (P = 0.02); 25.7% vs. 40.7% (P = 0.147); 32.8% vs. 44.4% (P = 0.28), respectively. In a secondary pre-specified time-to-event analysis no differences were observed in admission for acute decompensated HF between patients treated with levosimendan compared with placebo (hazard ratio 0.66; 95% CI, 0.32-1.32; P = 0.24). Cumulative incidence for the aggregated endpoint of acute decompensation of HF and/or death at 1 and 3 months were significatively lower in the levosimendan group than in placebo group [5.7% vs. 25.9% (P = 0.004) and 17.1% vs. 48.1% (P = 0.001), respectively], but not at 6 and 12 months [34.2% vs. 59.2% (P = 0.025); 41.4% vs. 66.6% (P = 0.022), respectively]. Survival probability was significantly higher in patients who received levosimendan compared with those who received placebo (log rank: 4.06; P = 0.044). There were no clinically relevant differences in tolerability between levosimendan and placebo and no new safety signals were observed. CONCLUSIONS: In our study, intermittent levosimendan in patients with AdHF produced a statistically non-significant reduction in the incidence of hospital readmissions for acute decompensated HF, a significantly lower cumulative incidence of acute decompensation of HF and/or death at 1 and 3 month of treatment and a significant improvement in survival during 12 months of treatment.

[Treatment adherence in a hospital emergency service]. / Adhesión al tratamiento en un servicio de urgencias hospitalarias.

OBJECTIVE: Patients do not always follow medical indications. This is a public health problem, with implications in health care and costs. The objective of this study was to calculate the percentage of non-adherence of adults to the treatment prescribed in a Hospital Emergency Service ("HES") and understanding wich factors led to poor adherence so improvements can be established. METHODS: Prospective observational study. Cohort of adults who attended the HES. We collected sociodemographic data, medical history, chronic treatments, diagnosis and treatment at discharge from each individual. We applied Morisky-Green test (tailor made to the HES) to asses secondary non-adherence and multivariate analysis to find a correlation with the factors studied. RESULTS: We established a non-adherence of 36.6% (IC95%=30.0-43.8). Patients with chronic endocrine pathology (RR=11.2; IC95%=2.1-60.8), diagnosed with ophthalmological problems (RR=9.8; IC95%=1.1-89.6) or contusions, sprains or fractures (RR=2.9; IC95%=1.1- 7.8), those who were prescribed antibiotics (RR=5.4; IC95%=2.4-11.9), or those who considered that they had received sufficient explanations (RR=3.5; IC95%=1.0-13.2) were more adherent. Those who received analgesics or anti-inflammatories were less adherent (RR=0.4; IC95%=0.2-0.9). CONCLUSIONS: Our results provide information on adherence in acute pathologies in the emergency department. Diabetes and ophthalmological problems or trauma are predictors of increased adherence. We observe more adherence in people with antibiotic treatments, although 20% did not complete treatment. There is a lack of adherence to analgesic/anti-inflammatory treatments. We consider it is important for professionals to take into account patient´s concerns about the medication. Patients who considered they had received enough explanations on their treatment were more adherent tan others. We believe it would be useful to provide further information about the outcomes of the medication we prescribe using new technologies such as mobile applications so we could increase adherence. Further studies would be needed to asses the benefit of the changes recently introduced (electronic hisory and prescription).

OBJETIVO: Que los pacientes no siempre sigan las indicaciones médicas es un problema de salud pública, que tiene implicaciones sobre los cuidados de salud y el coste de los servicios sanitarios. El objetivo del estudio fue determinar el porcentaje de no adhesión al tratamiento pautado en adultos en un Servicio de Urgencias Hospitalarias (SUH), así como identificar los factores que influyen en ello para instaurar así medidas de mejora. METODOS: Se realizó un estudio observacional prospectivo, mediante una cohorte de personas adultas que acudieron al SUH. De cada persona se recogieron datos sociodemográficos, antecedentes, tratamientos crónicos y diagnóstico y tratamiento al alta. Se evaluaron, por medio de encuesta, la no adhesión primaria y secundaria (test de Morisky-Green adaptado a Urgencias), y se relacionó con los factores recogidos empleando análisis multivariable. RESULTADOS: Se detectó una no adhesión del 36,6% (IC95%=30,0-43,8). Fueron más adherentes las personas con antecedente de enfermedad endocrina (RR=11,2; IC95%=2,1-60,8) y las que al alta fueron diagnosticadas de contusiones, esguinces o fracturas (RR=2,9; IC95%=1,1-7,8), o de algún problema oftalmológico (RR=9,8; IC95%=1,1-89,6). También fueron más adherentes los que al alta recibieron tratamiento antibiótico (RR=5,4; IC95%=2,4-11,9) o recibieron suficientes explicaciones (RR=3,5; IC95%=1,0-13,2). Fueron menos adherentes los pacientes con tratamiento analgésico o antinflamatorio (RR=0,4; IC95%=0,2-0,9). CONCLUSIONES: Los resultados aportan información sobre la adhesión en patologías agudas en Urgencias. El ser diabético y el acudir debido a un problema oftalmológico o traumatológico son predictores de una mayor adhesión. En las personas con tratamiento antibiótico se observa una mayor adhesión, aunque todavía son necesarios esfuerzos para mejorar la situación, ya que un 20% no realizó adecuadamente el tratamiento. Se observa una importante falta de adhesión a los tratamientos con analgésicos o antiinflamatorios. A la vista de nuestros resultados, parece fundamental una buena comunicación. Es necesario sensibilizar a los profesionales para que tengan en cuenta las inquietudes y deseos del paciente acerca de la medicación, así como realizar esfuerzos dirigidos a mejorar la legibilidad del informe de alta y de las prescripciones.

Adhesión al tratamiento en un servicio de urgencias hospitalarias / Treatment adherence in a hospital emergency service

OBJETIVO: Que los pacientes no siempre sigan las indicaciones médicas es un problema de salud pública, que tiene implicaciones sobre los cuidados de salud y el coste de los servicios sanitarios. El objetivo del estudio fue determinar el porcentaje de no adhesión al tratamiento pautado en adultos en un Servicio de Urgencias Hospitalarias (SUH), así como identificar los factores que influyen en ello para instaurar así medidas de mejora. MÉTODOS: Se realizó un estudio observacional prospectivo, mediante una cohorte de personas adultas que acudieron al SUH. De cada persona se recogieron datos sociodemográficos, antecedentes, tratamientos crónicos y diagnóstico y tratamiento al alta. Se evaluaron, por medio de encuesta, la no adhesión primaria y secundaria (test de Morisky-Green adaptado a Urgencias), y se relacionó con los factores recogidos empleando análisis multivariable. RESULTADOS: Se detectó una no adhesión del 36,6% (IC95%=30,0-43,8). Fueron más adherentes las personas con antecedente de enfermedad endocrina (RR=11,2; IC95%=2,1-60,8) y las que al alta fueron diagnosticadas de contusiones, esguinces o fracturas (RR=2,9; IC95%=1,1-7,8), o de algún problema oftalmológico (RR=9,8; IC95%=1,1-89,6). También fueron más adherentes los que al alta recibieron tratamiento antibiótico (RR=5,4; IC95%=2,4-11,9) o recibieron suficientes explicaciones (RR=3,5; IC95%=1,0-13,2). Fueron menos adherentes los pacientes con tratamiento analgésico o antinflamatorio (RR=0,4; IC95%=0,2-0,9). CONCLUSIONES: Los resultados aportan información sobre la adhesión en patologías agudas en Urgencias. El ser diabético y el acudir debido a un problema oftalmológico o traumatológico son predictores de una mayor adhesión. En las personas con tratamiento antibiótico se observa una mayor adhesión, aunque todavía son necesarios esfuerzos para mejorar la situación, ya que un 20% no realizó adecuadamente el tratamiento. Se observa una importante falta de adhesión a los tratamientos con analgésicos o antiinflamatorios. A la vista de nuestros resultados, parece fundamental una buena comunicación. Es necesario sensibilizar a los profesionales para que tengan en cuenta las inquietudes y deseos del paciente acerca de la medicación, así como realizar esfuerzos dirigidos a mejorar la legibilidad del informe de alta y de las prescripciones

OBJECTIVE: Patients do not always follow medical indications. This is a public health problem, with implications in health care and costs. The objective of this study was to calculate the percentage of non-adherence of adults to the treatment prescribed in a Hospital Emergency Service ("HES") and understanding wich factors led to poor adherence so improvements can be established. METHODS: Prospective observational study. Cohort of adults who attended the HES. We collected sociodemographic data, medical history, chronic treatments, diagnosis and treatment at discharge from each individual. We applied Morisky-Green test (tailor made to the HES) to asses secondary non-adherence and multivariate analysis to find a correlation with the factors studied. RESULTS: We established a non-adherence of 36.6% (IC95%=30.0-43.8). Patients with chronic endocrine pathology (RR=11.2; IC95%=2.1-60.8), diagnosed with ophthalmological problems (RR=9.8; IC95%=1.1-89.6) or contusions, sprains or fractures (RR=2.9; IC95%=1.1- 7.8), those who were prescribed antibiotics (RR=5.4; IC95%=2.4-11.9), or those who considered that they had received sufficient explanations (RR=3.5; IC95%=1.0-13.2) were more adherent. Those who received analgesics or anti-inflammatories were less adherent (RR=0.4; IC95%=0.2-0.9). CONCLUSIONS: Our results provide information on adherence in acute pathologies in the emergency department. Diabetes and ophthalmological problems or trauma are predictors of increased adherence. We observe more adherence in people with antibiotic treatments, although 20% did not complete treatment. There is a lack of adherence to analgesic/anti-inflammatory treatments. We consider it is important for professionals to take into account patient's concerns about the medication. Patients who considered they had received enough explanations on their treatment were more adherent tan others. We believe it would be useful to provide further information about the outcomes of the medication we prescribe using new technologies such as mobile applications so we could increase adherence. Further studies would be needed to asses the benefit of the changes recently introduced (electronic hisory and prescription)

Usefulness of clinical, electrocardiographic, and echocardiographic parameters to detect cardiac asynchrony in patients with left ventricular dysfunction secondary to ischemic or nonischemic heart disease.

OBJECTIVES: Specific evaluation using echocardiographic Doppler is superior to the measurement of the QRS complex to detect cardiac asynchrony. Nevertheless, no clinical, electrocardiographic, or echocardiographic parameters have been evaluated to obtain an accurate and easy-to-use marker of cardiac asynchrony in patients with depressed left ventricular (LV) ejection fraction. Our aim was to determine whether there is any marker of cardiac asynchrony in patients with LV systolic dysfunction that allows us to obviate the performance of a specific echocardiographic study before cardiac resynchronization therapy. METHODS: In all, 316 consecutive patients with LV ejection fraction less than 40% were enrolled. Interventricular asynchrony was defined as an interventricular mechanical delay longer than 40 milliseconds. Intraventricular asynchrony was defined as the difference between time from Q wave to LV ejection end and the time from Q wave to the end of the systolic wave of the most delayed basal segment by Doppler tissue imaging greater than 50 milliseconds. RESULTS: In all, 177 (56%) had ischemic and 139 (44%) had nonischemic heart disease. The logistic regression analysis showed that only the presence of left bundle branch block was an independent predictor of interventricular asynchrony despite the cause of the underlying disease (odds ratio and 95% confidence interval 7.2 [3.9-13.4], P < .001; 5.99 [2.7-13.2], P < .001; and 8.75 [3.2-23.8], P < .001 for the total population, ischemic and nonischemic groups, respectively). Nevertheless, none of the studied parameters was found as a predictor of intraventricular asynchrony. CONCLUSIONS: The presence of left bundle branch block is a marker of interventricular asynchrony in patients with ventricular dysfunction despite the cause of the underlying cardiac disease. Nevertheless, intraventricular cardiac asynchrony cannot be detected using conventional parameters. A specific echocardiographic evaluation before cardiac resynchronization therapy must be performed in all these patients. Our aim was to determine whether there is any marker of cardiac asynchrony in patients with left ventricular systolic dysfunction that allows us to obviate the performance of a specific echocardiographic study before cardiac resynchronization therapy. Our results showed that only the presence of left bundle branch block was an independent predictor of interventricular asynchrony despite the cause of the underlying disease but none of the studied parameters was found as a predictor of intraventricular asynchrony.

[A case of transient left ventricular apical ballooning with an unusual complication]. / Síndrome de discinesia apical transitoria con una complicación inhabitual.

A retrospective study of patients with acute myocardial ischemia syndrome, mainly middle-aged and elderly women, was published in july 2001. The main features of acute myocardial ischemia were typical triggering circumstances, initial ECG mimicking acute myocardial infarction (AMI with transient appearance of Q waves and large negative T waves), mild or no enzymatic changes, and a combination of a normal coronary angiogram and transient left ventricular apical dyskinesia that normalized within days. The clinical course and prognosis were completely different from those of conventional AMI, with an increased number of acute-phase complications such as acute pulmonary edema, cardiogenic shock, and ventricular tachycardia. Despite this, the long-term outcome was better than that of AMI. We report a typical case diagnosed in a Spanish woman who developed embolic stroke, a complication not previously described, most likely related with her apical dyskinesia.

Síndrome de discinesia apical transitoria con una complicación inhabitual / A case of transient left ventricular apical ballooning with an unusual complication

En julio de 2001se ha publicado un estudio retrospectivo de pacientes, sobre todo mujeres de edad mediana y avanzada, que presentaban un síndrome de isquemia miocárdica aguda precedido de un desencadenante típico, con evolución inesperada en el electrocardiograma (aparición transitoria de ondas Q, ondas T negativas gigantes), leve o inexistente elevación enzimática y la combinación de coronarias normales y discinesia apical transitoria en la fase aguda, con normalización de la función ventricular días más tarde. El curso y el pronóstico son completamente diferentes de los del IAM convencional, con más complicaciones iniciales, como edema agudo pulmonar, shock cardiogénico y taquicardia ventricular y, sin embargo, mejor pronóstico a medio-largo plazos. Describimos un caso típico en una enferma de nuestro medio que presentó una embolia cerebral, complicación aún no descrita, probablemente relacionada con su discinesia apical (AU)