Budgetary Impact Analysis of Reimbursement Varenicline for the Smoking-Cessation Treatment in Patients with Cardiovascular Diseases, Chronic Obstructive Pulmonary Disease or Type-2 Diabetes Mellitus: A National Health System Perspective.

AIMS: The study aimed to assess the budgetary impact (BI) of reimbursing varenicline in patients with chronic obstructive pulmonary disease (COPD), type-2 diabetes mellitus (t2-DM) or cardiovascular diseases (CVD). METHODS: The BI was estimated comparing the current non-reimbursed scenario versus a projected reimbursed scenario using the Spanish National Health System (SNHS) perspective. A hybrid model was developed using epidemiological data and Markov chains to estimate smoking cessation rates with varenicline during a 5-year horizon. Costs of cessation were considered in the reimbursement scenario only. Efficacy, expressed as a 1-year continuous abstinence rate, was derived from clinical trials. Cost savings due to smoking cessation were extracted from local cost-of-illness studies. Results are shown as incremental cost savings. Univariate sensitivity analysis was also applied. RESULTS: A total of 68,684 patients stopped smoking in the reimbursed scenario compared with 15,208 without reimbursement. In the reimbursed scenario, total savings accounted for €36.3 million, showing 14.6 million accumulated additional savings compared with the scenario without reimbursement. Sensitivity analyses showed results to be robust with monetary savings starting in the third year of modeling. CONCLUSION: Reimbursement of varenicline in smoking cessation is a cost-effective health policy in the SNHS in COPD, t2-DM or CVD, and could produce cost savings starting in the third year of implementation.

[Cardiovascular risk in Spanish smokers compared to non-smokers: RETRATOS study]. / Riesgo cardiovascular: evaluación del tabaquismo y revisión en atención primaria del tratamiento y orientación sanitaria. Estudio RETRATOS.

AIM: To evaluate the level of cardiovascular risk in smokers seenin Primary Care clinics. DESIGN: Epidemiologic, cross-sectional and multicentre study. SETTING: Primary Care. PATIENTS: Every investigator included 4 consecutive patients (3 smokers, 1 non-smoker) aged 35-50 years, who came to the clinic for any reason. A total of 2,184 patients were included; 2,124 (1,597 smokers; 527 non-smokers) were evaluated and 60 patients were excluded because they did not meet with selection criteria. MEASUREMENTS: The 10-year risk of suffering from a fatal cardiovascular disease (CVDR) was calculated according to the SCORE (Systematic Coronary Risk Evaluation) model. The 10-year lethal CVR according SCORE model, was classified as: very high (> 15%), high (10-14%), slightly high (5-9%), average (3-4%), low (2%), very low (1%) and negligible (< 1%). A logistical regression model was used to estimate the relationship between smoking and prior cardiovascular events. RESULTS: 10-year fatal CVDR according to the SCORE model was significantly higher in smokers (40±5.3) vs. non-smokers (1.9±2.5) (P<.0001). RISK STRATIFICATION: low (< 3%) [78.0% non-smokers vs. 60.7% smokers (P<.0001)]; intermediate (3-5%) [11.1% non-smokers vs. 12.6% smokers (P<.001)]; high (> 5%) [10.9% non-smokers vs. 26.7% smokers (P<.001)]. The logistical regression model showed that non-smokers vs. smokers had less probability of suffering myocardial infarction (OR 0.3; 95% confidence interval (95% CI): 0.1-0.8; P<.0001), peripheral vascular disease (OR 0.6; 95% CI: 0.4-1.0; P=.0180) and chronic obstructive lung disease (OR 0.18; 95% CI: 0.1-0.2; P=.0507). CONCLUSIONS: Smoking is related to a high risk of fatal cardiovascular disease. Active promotion in Primary Care clinics of measures aimed at reducing the prevalence of the smoking habit would lead to a lowering of cardiovascular morbidity and mortality.

[All-cause mortality and incidence of major cardiovascular events in hypertensive patients with ASCOT-type profile in a Spanish population setting]. / Mortalidad por cualquier causa e incidencia de enfermedad cardiovascular en hipertensos con perfil tipo Anglo-Scandinavian Cardiac Outcomes Trial en un ámbito poblacional español.

OBJECTIVES: Mediterranean populations are traditionally considered to be associated with lower incidence of cardiovascular events (CVE). However, this might not be homogeneous throughout different patient strata. The goal was to compare the incidence of CVE and all-causes mortality in hypertensive patients with an ASCOT-type profile with that of the rest hypertensive subjects. METHODS: A retrospective analysis was carried out using a claim database. Hypertensive patients without known cardiovascular disease on antihypertensive therapy included during year 2006 were followed up for two consecutive years to ascertain the incidence of all-causes mortality and any CVE. CVE included any of the following: coronary heart disease, acute myocardial infarction (AMI), angina, stroke, transient ischemic attack (TIA) and peripheral artery disease. Patients with ASCOT and ASCOT-LLA type profiles were identified and compared with non-ASCOT-type profile hypertensive subjects. RESULTS: A total of 11,104 were included in the analysis; 68.0+/-11.4 years, 41.6% males. More than 73% of subjects fulfilled criteria for ASCOT-type profile. All-causes mortality were numerically higher in ASCOT and ASCOT-LLA subjects compared with non-ASCOT-type; hazard ratio (95% CI)=1.3 (0.8-1.9) and 1.6 (0.9-2.8), respectively. However, any-coronary event rate was significantly higher in ASCOT-type [2.3 (1.8-2.8), p<0.001], as well as in ASCOT-LLA subjects [1.8 (1.3-2.4), p<0.001]. CONCLUSIONS: Hypertensive patients on treatment with ASCOT-type profile are more likely to have any cardiovascular event than those hypertensive patients without ASCOT profile in a Mediterranean setting in Spain.

Long term clinical outcomes in survivors after out-of-hospital cardiac arrest.

INTRODUCTION AND OBJECTIVES: Information regarding long-term outcomes in patients surviving out-of-hospital cardiac arrest (OHCA) is scarce. Our aim was to study the long-term clinical outcomes of a large cohort of OHCA patients surviving until hospital discharge and to identify predictors of mortality and cardiovascular events. METHODS: Consecutive OHCA patients admitted in the Acute Cardiac Care Unit who survived at least until hospital discharge between 2007 and 2019 were included. All received therapeutic hypothermia according to the local protocol. Pre- and intra-hospital clinical and analytical variables were analyzed, as well as the clinically relevant events during follow-up. RESULTS: A total of 201 patients were included, with a mean age of 57.6 ± 14.2 years, 168 (83.6%) were male. Thirty-six (17.9%) died during a median follow-up of 40.3 months (18.9-69.1), the most frequent causes of death being cardiovascular and neurological, followed by cancer. We calculated a predictive model for mortality during follow-up using Cox regression that included the following variables: poor neurological outcome [HR 3.503 (1.578-7.777)], non-shockable rhythm [HR 2.926 (1.390-6.163)], time to onset of CPR [HR 1.063 (0.997-1.134)], older age [1.036 (1.008-1.064)) and worse ejection fraction at discharge [1.033 (1.009-1.058)]. CONCLUSIONS: Even though few patients experience recurrent cardiac arrest events, survivors after OHCA face high morbidity and mortality during long-term follow-up. Therefore, they may benefit from multidisciplinary teams providing an integral management and ensuring continuity of care.

Dataset regarding baseline and follow-up characteristics of out-of-hospital cardiac arrest patients focused on neurological outcomes.

This data article contains the data related to the research article entitled "Long-term neurological outcomes in out-of-hospital cardiac arrest patients treated with targeted-temperature management" (Caro-Codón et al., 2018). In this dataset, we report details regarding the flow chart of the included patients and the specific exclusion criteria. We also include information on the difference between the patients who attended the structured personal interview (and therefore were finally included in the study) and those who did not attend. Neuropsychiatric and functional data before and after cardiac arrest are also reported. Finally, we list all the "de novo" focal neurological deficits identified after cardiac arrest in the related population.

Long-term neurological outcomes in out-of-hospital cardiac arrest patients treated with targeted-temperature management.

BACKGROUND: This study aimed to assess long-term cognitive and functional outcomes in out-of-hospital cardiac arrest (OHCA) patients treated with targeted-temperature management, investigate the existence of prognostic factors that could be assessed during initial admission and evaluate the usefulness of classic neurological scales in this clinical scenario. METHODS: Patients admitted due to OHCA from August 2007 to November 2015 and surviving at least one year were included. Each patient completed a structured interview focused on the collection of clinical, social and demographic data. All available information in clinical records was reviewed and a battery of neurocognitive and psychometric tests was performed. RESULTS: Seventy-nine patients were finally included in the analysis. Forty-three patients (54.4%) scored below the usual cut-off points for the diagnosis of mild cognitive impairment, even though most of these deficits went unnoticed when patients were assessed using CPC and modified Rankin scale. Nineteen (24%) developed certain degree of impairment in their attention capacity and executive functions. A significant proportion developed new memory-related disorders (43%), depressive symptoms (17.7%), aggressive/uninhibited behavior (12.7%) and emotional lability (8.9%). A greater number of weekly hours of intellectual activity and a qualified job were independent protective factors for the development of cognitive impairment. However, being older at the time of the cardiac arrest was identified as a poor prognostic factor. CONCLUSIONS: There is a high prevalence of long-term cognitive deficits and functional limitations in OHCA survivors. Most commonly used clinical scales in clinical practice are crude and lack sensitivity to detect most of these deficits.

Use of aspirin for primary and secondary prevention of cardiovascular disease in diabetic patients in an ambulatory care setting in Spain.

BACKGROUND: This study was conducted in order to determine the use of aspirin and to assess the achievement of therapeutic targets in diabetic patients according to primary (PP) or secondary prevention (SP). METHODS: This is a retrospective, observational study including patients > or =18 years with diabetes mellitus followed in four primary care centers. Measurements included demographics, use of aspirin and/or anticoagulant drugs, co-morbidities, clinical parameters and proportion of patient at therapeutic target (TT). Descriptive statistics, chi-square test and logistic regression model were used for significance. RESULTS: A total of 4,140 patients were analyzed, 79.1% (95% confidence intervals [CI]: 77.7-80.5%) in PP and 20.9% (95% CI: 18.2-23.7%) in SP. Mean age was 64.1 (13.8) years, and 49.3% of patient were men (PP: 46.3, SP: 60.7, p = 0.001). Aspirin was prescribed routinely in 20.8% (95% CI: 19.4-22.2%) in PP and 60.8% (95% CI: 57.6-64.0%) in SP. Proportion of patient at TT was 48.0% for blood pressure and 59.8% for cholesterol. Use of aspirin was associated to increased age [OR = 1.01 (95% CI: 1.00-1.02); p = 0.011], cardiovascular-risk factors [OR = 1.14 (95% CI: 1.03-1.27); p = 0.013], LDL-C [OR = 1.42 (95% CI: 1.06-1.88); p = 0.017] and higher glycated hemoglobin [OR = 1.51 (95% CI: 1.22-1.89); p = 0.000] were covariates associated to the use of aspirin in PP. CONCLUSION: Treatment with aspirin is underused for PP in patients with diabetes mellitus in Primary Care. Achievement of TT should be improved.

Percutaneous balloon mitral valvuloplasty and closure of the left atrial appendage: Synergy of two procedures in one percutaneous intervention.

Mitral stenosis (MS) is frequently associated with the development of atrial fibrillation (AF) as a consequence of hemodynamic and inflammatory changes in the left atrium. Both conditions predispose to thrombus formation, with frequent involvement of the left atrial appendage (LAA), and consequent increase in the incidence of systemic thromboembolic events. Percutaneous mitral valvuloplasty (PMV) reduces the risk of thromboembolism in patients with significant mitral stenosis. Percutaneous LAA closure is also associated with a reduction in thromboembolic risk in patients with AF, but there are no data regarding the use of this technique in patients with significant mitral valve disease. We report the case of a 57-year-old-woman with significant MS and permanent AF, in New York Heart Association functional class II, who despite adequate oral anticoagulation with acenocoumarol, presented several clinical episodes of systemic thromboembolism in the last four years. It was decided to perform a combined percutaneous procedure, including both PMV and percutaneous LAA closure with the Amplatzer Cardiac Plug device. No significant acute complications occurred and the patient was discharged on indefinite treatment with acenocoumarol associated with aspirin 100 mg/d for three months. After a one-year follow-up, there have been no new embolic episodes or other complications.

Update in cardiology: vascular risk and cardiac rehabilitation.

As in other fields, understanding of vascular risk and rehabilitation is constantly improving. The present review of recent epidemiological update shows how far we are from achieving good risk factor control: in diet and nutrition, where unhealthy and excessive societal consumption is clearly increasing the prevalence of obesity; in exercise, where it is difficult to find a balance between benefit and risk, despite systemization efforts; in smoking, where developments center on programs and policies, with the electronic cigarette seeming more like a problem than a solution; in lipids, where the transatlantic debate between guidelines is becoming a paradigm of the divergence of views in this extensively studied area; in hypertension, where a nonpharmacological alternative (renal denervation) has been undermined by the SYMPLICITY HTN-3 setback, forcing a deep reassessment; in diabetes mellitus, where the new dipeptidyl peptidase-4 and sodium-glucose cotransporter type 2 inhibitors and glucagon like peptide 1 analogues have contributed much new information and a glimpse of the future of diabetes treatment, and in cardiac rehabilitation, which continues to benefit from new information and communication technologies and where clinical benefit is not hindered by advanced diseases, such as heart failure. Our summary concludes with the update in elderly patients, whose treatment criteria are extrapolated from those of younger patients, with the present review clearly indicating that should not be the case.

Update in cardiology: vascular risk and cardiac rehabilitation.

Cardiovascular disease develops in a slow and subclinical manner over decades, only to manifest suddenly and unexpectedly. The role of prevention is crucial, both before and after clinical appearance, and there is ample evidence of the effectiveness and usefulness of the early detection of at-risk individuals and lifestyle modifications or pharmacological approaches. However, these approaches require time, perseverance, and continuous development. The present article reviews the developments in 2013 in epidemiological aspects related to prevention, includes relevant contributions in areas such as diet, weight control methods (obesity is now considered a disease), and physical activity recommendations (with warnings about the risk of strenuous exercise), deals with habit-related psychosocial factors such as smoking, provides an update on emerging issues such as genetics, addresses the links between cardiovascular disease and other pathologies such as kidney disease, summarizes the contributions of new, updated guidelines (3 of which have recently been released on topics of considerable clinical importance: hypertension, diabetes mellitus, and chronic kidney disease), analyzes the pharmacological advances (largely mediocre except for promising lipid-related results), and finishes by outlining developments in the oft-neglected field of cardiac rehabilitation. This article provides a briefing on controversial issues, presents interesting and somewhat surprising developments, updates established knowledge with undoubted application in clinical practice, and sheds light on potential future contributions.

[Cost-effectiveness of managing familial hypercholesterolemia using atorvastatin-based preventive therapy]. / Coste-efectividad del manejo de la hipercolesterolemia familiar con estrategias de tratamiento preventivo basadas en atorvastatina.

INTRODUCTION AND OBJECTIVES: A cost-effectiveness model was developed to evaluate the efficiency of different preventive strategies in familial hypercholesterolemia (FH) in comparison with routine clinical practice (CP): atorvastatin monotherapy, 40 mg (A40) or 80 mg (A80, and atorvastatin combined with ezetimibe, 10 mg (A40+E10 or A80+E10). METHODS: A longitudinal population model with a time horizon for life-expectancy was developed within the context of the Spanish public healthcare system. Life tables for the Spanish population (2002) were modified using the standardized mortality rate for individuals with FH. Effectiveness was expressed in life-years gained (LYG), after taking into account reductions for risk (ie, Framingham risk score) and cardiovascular mortality. The costs (in 2005 terms) of the intervention (CI) and care (CC) were discounted at 6%, while effects were discounted at 3%. RESULTS: Routine CP, based on the Spanish FH registry: 1.97 LYG per patient vs. no treatment; CI euro5321, CC euro23,389. A40: 2.59 LYG; reduction in CC compared with CP 4.5%; total costs (TC) euro30 569. A80: 2.75 LYG; reduction in CC 6.4%; TC euro30 133. A40+E10: 3.38 LYG; reduction in CC 14.3%; TC euro36 104. A80+E10: 3.62 LYG; reduction in CC 17.6%; TC euro35 317. From most to least efficient strategy, the incremental cost-effectiveness per LYG compared with CP was: a) A80: euro1821; b) A40: euro3012; c) A80+E10: euro4021, and d) A40+E10: euro5250. CONCLUSIONS: Preventive treatment of FH with atorvastatin was cost-effective. The greatest cost-effectiveness was obtained with atorvastatin monotherapy, 80 mg. The addition of ezetimibe could produce further benefits at an acceptable incremental cost.