Cost-effectiveness of implantable cardioverter-defibrillators for primary prevention of sudden cardiac death.

INTRODUCTION AND OBJECTIVES: Implantable cardioverter-defibrillators (ICD) are a cost-effective alternative for secondary prevention of sudden cardiac death, but their efficiency in primary prevention, especially among patients with nonischemic heart disease, is still uncertain. METHODS: We performed a cost-effectiveness analysis of ICD plus conventional medical treatment (CMT) vs CMT for primary prevention of cardiac arrhythmias from the perspective of the national health service. We simulated the course of the disease by using Markov models in patients with ischemic and nonischemic heart disease. The parameters of the model were based on the results obtained from a meta-analysis of clinical trials published between 1996 and 2018 comparing ICD plus CMT vs CMT, the safety results of the DANISH trial, and analysis of real-world clinical practice in a tertiary hospital. RESULTS: We estimated that ICD reduced the likelihood of all-cause death in patients with ischemic heart disease (HR, 0.70; 95%CI, 0.58-0.85) and in those with nonischemic heart disease (HR, 0.79; 95%CI, 0.66-0.96). The incremental cost-effectiveness ratio (ICER) estimated with probabilistic analysis was €19 171/quality adjusted life year (QALY) in patients with ischemic heart disease and €31 084/QALY in those with nonischemic dilated myocardiopathy overall and €23 230/QALY in patients younger than 68 years. CONCLUSIONS: The efficiency of single-lead ICD systems has improved in the last decade, and these devices are cost-effective in patients with ischemic and nonischemic left ventricular dysfunction younger than 68 years, assuming willingness to pay as €25 000/QALY. For older nonischemic patients, the ICER was around €30 000/QALY.

Prevalence, clinical features and risk assessment of pre-diabetes in Spain: the prospective Mollerussa cohort study.

PURPOSE: The Mollerussa prospective cohort was created to study pre-diabetes in a population-based sample from the primary care setting in the semirural area of Pla d'Urgell in Catalonia (Spain). The aims of the study were to assess the prevalence of pre-diabetes in our population, the likelihood to develop overt diabetes over time and to identify risk factors associated with the progression of the condition. PARTICIPANTS: The cohort includes 594 subjects randomly selected between March 2011 and July 2014 from our primary care population, who were older than 25 years, consented to participate and did not have a recorded diagnosis of diabetes. FINDINGS TO DATE: At baseline, we performed a clinical interview to collect demographic, clinical and lifestyle (including a nutritional survey) characteristics; carotid ultrasound imaging to assess subclinical cardiovascular disease was also performed, and a blood sample was collected, with an overall <5% rate of missing data. An additional blood draw was performed 12 months after initial recruitment to reassess laboratory results in patients initially identified as having pre-diabetes, with an 89.6% retention rate. Several studies investigating various hypotheses are currently ongoing. FUTURE PLANS: All subjects recruited during the cohort creation will be followed long-term through annual extraction of data from health records stored in the electronic Clinical station in Primary Care database. The Mollerussa cohort will thus be a sound population-based sample for multiple future research projects to generate insights into the epidemiology and natural history of pre-diabetes in Spain.

Metabolic risk management, physical exercise and lifestyle counselling in low-active adults: controlled randomized trial (BELLUGAT).

BACKGROUND: The primary aim of this study is to evaluate the effectiveness of different doses (intensity) of supervised exercise training - concomitant with lifestyle counselling - as a primary care intervention tool for the management of metabolic syndrome risk factors in low-active adults with one or more such factors (programme name in Catalan: Bellugat de CAP a peus). METHODS/DESIGN: Three-arm, randomized controlled clinical trial implemented in the primary care setting, with a duration of 40 weeks (16 weeks intervention and 24-week follow-up). Adults aged 30 to 55 years with metabolic risk factors will be randomized into three intervention groups: 1) aerobic interval training (16 supervised training lessons) plus a healthy lifestyle counselling programme (6 group and 3 individual meetings); 2) low-to-moderate intensity continuous training (16 supervised training lessons) plus the same counselling programme; or 3) the counselling- programme without any supervised physical exercise. The main output variables assessed will be risk factors for metabolic syndrome (waist circumference, blood pressure, and levels of plasma triglycerides, high-density lipoproteins and glucose), systemic inflammation, cardiorespiratory fitness, physical activity and sedentary behaviour, dietary habits, health-related quality of life, self-efficacy and empowerment. Economic factors will also be analysed in order to determine the cost-effectiveness of the programme. These variables will be assessed three times during the study: at baseline, at the end of the intervention, and at follow-up. We estimate to recruit 35 participants per group. DISCUSSION: The results of this study will provide insight into the immediate and medium-term effects on metabolic risk and lifestyle of a combined approach involving aerobic interval training and a multidisciplinary behavioural intervention. If effective, the proposed intervention would provide both researchers and practitioners in this field with a platform on which to develop similar intervention programmes for tackling the repercussions of an unhealthy lifestyle. TRIAL REGISTRATION: Clinical trials.gov. NTC02832453 . Registered 6 July 2016 (retrospectively registered).

Risk of exacerbation in chronic obstructive pulmonary disease: a primary care retrospective cohort study.

BACKGROUND: The risk of exacerbation in chronic obstructive pulmonary disease (COPD) depends on the severity of disease and other less well known factors. Predictive models of exacerbation are more accurate than the forced expiratory volume in one second (FEV1). The objective was to design a model that predicts the risk of exacerbation in COPD. METHODS: Retrospective cohort study with data from the electronic medical records of patients diagnosed with COPD in the province of Lleida (Spain). A total of 2501 patients were followed during 3 years. The dependent variable was acute exacerbation; independent variables were: clinical parameters, spirometry results, severity of disease, influenza and 23-valent pneumococcal immunisation, comorbidities, smoking and history of exacerbation. The association of these variables with disease exacerbation was measured by the adjusted odds ratio using a logistic regression model. RESULTS: Mean age at the start of the study was 68.38 years (SD = 11.60) and 74.97% patients were men; severity of disease was considered mild in 50.82% of patients, moderate in 35.31%, severe in 9.44% and very severe in 4.44%. During the three year study period up to 83.17% of patients experienced at least one exacerbation. Predictive factors in the model were age, gender, previous exacerbations, influenza and 23-valent pneumococcal immunisations, number of previous visits to the General Practice and severity (GOLD), with an area under the ROC curve (AUROC) of 0.70. CONCLUSIONS: This model can identify patients at high risk of acute exacerbation. Preventive measures and modification of treatment in these high-risk patients would improve survival.

Predictive Model of Hospital Admission for COPD Exacerbation.

BACKGROUND: The objective of this work was to determine predictive factors of hospital admission for exacerbation during primary care visits in patients with COPD. METHODS: A retrospective cohort study was undertaken to assess risk of hospital admission for COPD exacerbation in primary care patients from November 1, 2010 to October 31, 2013. Data sources were primary care electronic medical records and the hospital discharge minimum data set. A total of 2,501 subjects >40 y of age with a spirometry-based COPD diagnosis were included and followed up for 3 y. The dependent variable was hospital admission for exacerbation; independent variables were: clinical parameters, spirometry results, and severity of disease (according to Global Initiative for Chronic Obstructive Lung Disease criteria). The association of these variables with hospital admission was analyzed with the adjusted odds ratio using a logistic regression model. RESULTS: Mean age of subjects at the beginning of the study was 68.4 y (SD = 11.6), and 75% were men. Severity was mild in 50.8% of subjects, moderate in 35.3%, severe in 9.4%, and very severe in 4.4%. After 3 y, 32.5% of subjects had been admitted for exacerbation. Predictive values for hospital admission were: age, sex, previous exacerbations, number of visits to the primary care center, comorbidities, smoking, severity (Global Initiative for Chronic Obstructive Lung Disease), and influenza immunization. The area under the receiving operator characteristic curve was 0.72. CONCLUSIONS: This model can identify patients at high risk of hospital admission for COPD exacerbation in our setting. Further studies are needed to validate the model in different populations and settings.