Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation.

AIMS: The introduction of direct oral anticoagulants (DOACs) has broadened the treatment arsenal for nonvalvular atrial fibrillation, but observational studies on the benefit-risk balance of DOACs compared to vitamin K antagonists (VKAs) are needed. The aim of this study was to characterize the risk of major bleeding in DOAC users using longitudinal data collected from electronic health care databases from 4 different EU-countries analysed with a common study protocol. METHODS: A cohort study was conducted among new users (≥18 years) of DOACs or VKAs with nonvalvular atrial fibrillation using data from the UK, Spain, Germany and Denmark. The incidence of major bleeding events (overall and by bleeding site) was compared between current use of DOACs and VKAs. Cox regression analysis was used to calculate hazard ratios and 95% confidence intervals (CI) and adjust for confounders. RESULTS/CONCLUSION: Overall, 251 719 patients were included across the 4 study cohorts (mean age ~75 years, % females between 41.3 and 54.3%), with overall hazard ratios of major bleeding risk for DOACs vs VKAs ranging between 0.84 (95% CI: 0.79-0.90) in Denmark and 1.13 (95% CI 1.02-1.25) in the UK. When stratifying according to the bleeding site, risk of gastrointestinal bleeding was increased by 48-67% in dabigatran users and 30-50% for rivaroxaban users compared to VKA users in all data sources except Denmark. Compared to VKAs, apixaban was not associated with an increased risk of gastrointestinal bleeding in all data sources and seemed to be associated with the lowest risk of major bleeding events compared to dabigatran and rivaroxaban.

Use of hydrochlorothiazide and risk of skin cancer in a large nested case-control study in Spain.

PURPOSE: Hydrochlorothiazide (HCTZ) use has been linked to skin cancer in northern European countries. We assessed the association between HCTZ exposure and risk of malignant melanoma (MM) and keratinocyte carcinoma (KC) in a European Mediterranean population. METHODS: Two parallel nested case-control studies were conducted in Spain using two electronic primary healthcare databases, each one providing data on both exposure and outcomes: SIDIAP and BIFAP. Cancer cases were matched to 10 controls by age and gender through risk-set sampling. The ORs and 95% CI for MM and KC associated with previous HCTZ use were estimated using conditional logistic regression. In BIFAP, KC cases were further identified as basal cell carcinoma (BCC) or squamous cell carcinoma (SCC). RESULTS: In adjusted analyses, both ever and cumulative high (≥50,000 mg) use of HCTZ were associated with an increased risk of KC. The risk estimates for high use were 1.30 (1.26-1.34) in SIDIAP and 1.20 (1.12-1.30) in BIFAP, with a lower risk for BCC (1.11 [1.02-1.21]) than for SCC (1.71 [1.45-2.02]). A dose-response relationship was observed between cumulative doses of HCTZ and KC risk. Inconsistent results were found for high use of HCTZ and risk of MM: 1.25 (1.09-1.43) in SIDIAP and 0.85 (0.64-1.13) in BIFAP. CONCLUSIONS: In this European Mediterranean population, a high cumulative use of HCTZ was related to an increased risk of KC with a clear dose-response pattern.

Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies.

OBJECTIVE: To establish the risk of major bleeding in direct oral anticoagulant (DOAC) users (overall and by class) versus vitamin K antagonist (VKA) users, using health care databases from four European countries and six provinces in Canada. METHODS: A retrospective cohort study was performed according to a similar protocol. First-users of VKAs or DOACs with a diagnosis of non-valvular atrial fibrillation (NVAF) were included. The main outcome of interest was major bleeding and secondary outcomes included gastrointestinal (GI) bleeding and intracranial haemorrhage (ICH). Incidence rates of events per 1000 person years were calculated. Hazard ratios (HRs) and 95% confidence intervals (95% CI) were estimated using a Cox proportional hazard regression model. Exposure and confounders were measured and analysed in a time-dependant way. Risk estimates were pooled using a random effect model. RESULTS: 421 523 patients were included. The risk of major bleeding for the group of DOACs compared to VKAs showed a pooled HR of 0.94 (95% CI: 0.87-1.02). Rivaroxaban showed a modestly increased risk (HR 1.11, 95% CI: 1.06-1.16). Apixaban and dabigatran showed a decreased risk of respectively HR 0.76 (95% CI: 0.69-0.84) and HR 0.85 (95% CI: 0.75-0.96). CONCLUSIONS: This study confirms that the risk of major bleeding of DOACs compared to VKAs is not increased when combining all DOACs. However, we observed a modest higher risk of major bleeding for rivaroxaban, whereas for apixaban and dabigatran lower risks of major bleeding were observed compared to VKAs.

Repetitive syncopal episodes in a child with documented ventricular tachycardia, early repolarization pattern in leads I an aVL, Brugada syndrome, and fever.

We present a small child with febrile peaks and syncopal episodes secundary to ventricular tachycardia, in whom it was eventually possible to demostrate the Brugada Syndrome with a special presentation in the ECG; early repolarization pattern in lead I and a aVL and Brugada pattern during fever in V1-V2. This is, to our knowledge, tha first case with this special ECG presentation in a small child.

Incidence of direct oral anticoagulant use in patients with nonvalvular atrial fibrillation and characteristics of users in 6 European countries (2008-2015): A cross-national drug utilization study.

AIMS: To estimate the incidence of direct oral anticoagulant drug (DOAC) use in patients with nonvalvular atrial fibrillation and to describe user and treatment characteristics in 8 European healthcare databases representing 6 European countries. METHODS: Longitudinal drug utilization study from January 2008 to December 2015. A common protocol approach was applied. Annual period incidences and direct standardisation by age and sex were performed. Dose adjustment related to change in age and by renal function as well as concomitant use of potentially interacting drugs were assessed. RESULTS: A total of 186 405 new DOAC users (age ≥18 years) were identified. Standardized incidences varied from 1.93-2.60 and 0.11-8.71 users/10 000 (2011-2015) for dabigatran and rivaroxaban, respectively, and from 0.01-8.12 users/10 000 (2012-2015) for apixaban. In 2015, the DOAC incidence ranged from 9 to 28/10 000 inhabitants in SIDIAP (Spain) and DNR (Denmark) respectively. There were differences in population coverage among the databases. Only 1 database includes the total reference population (DNR) while others are considered a population representative sample (CPRD, BIFAP, SIDIAP, EGB, Mondriaan). They also varied in the type of drug data source (administrative, clinical). Dose adjustment ranged from 4.6% in BIFAP (Spain) to 15.6% in EGB (France). Concomitant use of interacting drugs varied between 16.4% (SIDIAP) and 70.5% (EGB). Cardiovascular comorbidities ranged from 25.4% in Mondriaan (The Netherlands) to 82.9% in AOK Nordwest (Germany). CONCLUSION: Overall, apixaban and rivaroxaban increased its use during the study period while dabigatran decreased. There was variability in patient characteristics such as comorbidities, potentially interacting drugs and dose adjustment. (EMA/2015/27/PH).

Metabolic syndrome and insulin resistance are associated with frailty in older adults: a prospective cohort study.

Background: diabetes increases the risk of frailty that is a leading cause of disability and premature mortality in older people. Metabolic syndrome (MS) and insulin resistance (IR) are strong risk factors for diabetes and could, thus, lead to frailty. However, the association between MS or IR and frailty has barely been investigated. Methods: data were obtained from a cohort of 1,499 community-dwelling individuals aged ≥60, who were free of diabetes at 2008-10 and were followed up for 3.5 years. At baseline, MS was ascertained according to the harmonised definition, and IR with the Homoeostatic Model Assessment for IR index (HOMA-IR). Frailty was defined as having three or more of the Fried's criteria: exhaustion, low physical activity, slow walking, unintentional weight loss and low grip strength. Statistical analyses were performed with logistic regression, and adjusted for the main confounders. Results: in 2012, 84 cases of incident frailty were identified. Compared with subjects without MS, those with MS showed increased risk of frailty (multivariate odds ratio [OR]: 1.85; 95% confidence interval [CI] 1.12-3.05). The association persisted after further adjustment for fibrinogen and C-reactive protein. When the frailty criteria were considered individually, low grip strength was the criterion that showed a stronger association with MS (OR: 1.67; 95% CI: 1.25-2.21). Higher HOMA-IR values were also associated with higher risk of frailty. Conclusion: MS and IR were associated with increased risk of frailty. This work extends the spectrum of harmful consequences of MS, and suggests that preventing or controlling MS may serve to delay frailty.

[Application of a social capital scale in older women attending public primary care clinics]. / Capital social de las mujeres mayores usuarias de la red pública de la Atención Primaria de Salud.

BACKGROUND: Social capital is an economical idea that refers to connections between individuals and entities that can be economically valuable. AIM: To establish the relationship of social capital as a health care asset, with sociodemographic variables of older women attending public health care services. MATERIAL AND METHODS: Chen’s Personal Social Capital scale was applied to 113 women aged between 64 and 80 years during 2014. Cronbach’s alpha of the instrument was calculated. RESULTS: The Cronbach’s alpha of the instrument was 0.86. The average score for social capital was 23.9 points of a maximum of 50. Bridging capital scores had the higher disparity, specifically in participation in community organizations and the representation of their interest in them. Bonding capital decreased along with a higher age of interviewed women (r = -0,43, p < 0,01). Higher territorial roots were associated with a lower perception of social community resource availability (r = -0,42, p < 0,01). CONCLUSIONS: The social capital scores in these women were low. Their better support networks were close relationships and relatives. The sensation of solitude increased with age.

Major dietary patterns and risk of frailty in older adults: a prospective cohort study.

BACKGROUND: There is emerging evidence of the role of certain nutrients as risk factors for frailty. However, people eat food, rather than nutrients, and no previous study has examined the association between dietary patterns empirically derived from food consumption and the risk of frailty in older adults. METHODS: This is a prospective cohort study of 1,872 non-institutionalized individuals aged ≥60 years recruited between 2008 and 2010. At baseline, food consumption was obtained with a validated diet history and, by using factor analysis, two dietary patterns were identified: a 'prudent' pattern, characterized by high intake of olive oil and vegetables, and a 'Westernized' pattern, with a high intake of refined bread, whole dairy products, and red and processed meat, as well as low consumption of fruit and vegetables. Participants were followed-up until 2012 to assess incident frailty, defined as at least three of the five Fried criteria (exhaustion, weakness, low physical activity, slow walking speed, and unintentional weight loss). RESULTS: Over a 3.5-year follow-up, 96 cases of incident frailty were ascertained. The multivariate odds ratios (95% confidence interval) of frailty among those in the first (lowest), second, and third tertile of adherence to the prudent dietary pattern were 1, 0.64 (0.37-1.12), and 0.40 (0.2-0.81), respectively; P-trend = 0.009. The corresponding values for the Westernized pattern were 1, 1.53 (0.85-2.75), and 1.61 (0.85-3.03); P-trend = 0.14. Moreover, a greater adherence to the Westernized pattern was associated with an increasing risk of slow walking speed and weight loss. CONCLUSIONS: In older adults, a prudent dietary pattern showed an inverse dose-response relationship with the risk of frailty while a Westernized pattern had a direct relationship with some of their components. Clinical trials should test whether a prudent pattern is effective in preventing or delaying frailty.

Sleep quality and the metabolic syndrome: the role of sleep duration and lifestyle.

BACKGROUND: This study examined the association between sleep quality and the metabolic syndrome and whether if it is independent of sleep duration and if it can be explained by lifestyles linked to sleep quality. METHODS: Cross-sectional study conducted from 2008 to 2010 with 10 342 individuals representative of the population aged ≥18 years in Spain. Poor sleep quality was ascertained through self-reported difficulty falling asleep, difficulty maintaining sleep and sleeping pill consumption. Metabolic syndrome was defined according to the recent harmonized definition. Analyses were conducted with logistic regression and adjusted for the main confounders. RESULTS: Difficulty falling asleep was associated with higher frequency of metabolic syndrome after adjustment for sociodemographic variables, lifestyle and diagnosed morbidity [odds ratio (OR) = 1.25; 95% confidence interval (CI) = 1.06-1.47]. The association was slightly attenuated after further adjusting for sleep duration (OR = 1.23; 95% CI = 1.04-1.46) and held after additional adjustment for energy intake, adherence to a Mediterranean dietary pattern, energy spent in physical activity and time watching TV (OR = 1.20; 95% CI = 1.01-1.42). No associations were found between metabolic syndrome and other sleep quality indicators. Difficulty falling asleep was associated with high blood pressure in the fully adjusted analyses (OR = 1.17; 95% CI = 1.00-1.37) but not with the rest of components of metabolic syndrome. CONCLUSIONS: Difficulty falling asleep is associated with metabolic syndrome and, in particular, with high blood pressure. This association is independent of sleep duration and is not due to lifestyles related to poor sleep. This finding should be replicated in prospective studies using objective sleep measures; also, the influence of antihypertensive and lipid-lowering drug treatment on this association should be further studied.

Binge drinking in Spain, 2008-2010.

BACKGROUND: Most alcohol-related research has focused on northern and eastern Europe and the United States. Data on Mediterranean countries point to drinking patterns approaching the sporadic and excessive patterns found in northern and eastern Europe. This is the first study to estimate the prevalence of binge drinking (BD) and the joint distribution of BD, regular heavy alcohol consumption, and alcohol abuse or dependence (AAD) in a nationally representative sample of the adult population of Spain. METHODS: Cross-sectional study conducted in 2008 to 2010 with 9,130 persons aged 18 to 64 years. BD was defined as intake of ≥80 g of alcohol in men (≥60 g in women) during any drinking occasion in the previous month, with ≥3 BD episodes discriminating between frequent and sporadic BD. Regular alcohol consumption was measured with a validated diet history, and the threshold between moderate and heavy drinking was ≥40 g of alcohol/d in men (≥24 g in women). AAD was defined by a CAGE score ≥2. RESULTS: BD prevalence was 10% (95% confidence interval [CI]: 8.8 to 11.2) in men and 4.2% (95% CI: 3.5 to 4.8) in women, and proved highest among 18- to 24-year-olds (19.5% in men and 10.3% in women). During the latest BD episode, men consumed a mean of 114 g of alcohol versus 85.3 g in women; spirits accounted for 65.2 and 66.2% of total intake, respectively. The mean number of monthly BD episodes was 2.3 in men and 2 in women. Among binge drinkers, 61% were 18- to 34-year-olds, over 80% had regular moderate drinking, 25% reported frequent BD, and 22.8% reported AAD. In multivariate analyses, sporadic BD and frequent BD were associated with AAD independently of regular alcohol intake. CONCLUSIONS: Prevalence of BD in Spain is moderately high. Prevention interventions should consider that the majority of binge drinkers are young men with regular moderate consumption and no AAD traits.

Household physical activity and mortality in older adults: a national cohort study in Spain.

OBJECTIVE: To examine the association between household physical activity (HPA) and all-cause mortality in a cohort of older adults from Spain, and the role of sedentary time on this association. METHOD: Prospective cohort study of 2874 individuals aged ≥ 62 years. In 2003, the time spent in HPA and the time spent seated were self-reported. The association of HPA with all-cause mortality through 2011 was assessed with Cox regression. RESULTS: During the follow-up, 970 participants died. In men, HPA was inversely associated with the risk of death only among those with longer sitting time (≥ 8 h/d): compared to those who did not do HPA, the mortality hazard ratio (HR) was 0.80 (95% confidence interval (CI): 0.60-1.08) and 0.43 (95% CI: 0.27-0.69) for those who spent >0 to 2h/d and >2h/d in HPA, respectively (P for trend<0.001). In women, sitting time did not modify the study association. Thus, compared to women who spent <2h/d in HPA, the HR for mortality was 0.72 (95% CI: 0.56-0.93) and 0.52 (95% CI: 0.39-0.70) for those who spent >2 to 4h/d, and >4h/d in HPA, respectively (P for trend<0.001). CONCLUSION: In women, HPA is associated with reduced mortality regardless of sitting time. HPA may also contribute to longer survival among men with longer sitting time.

The association of major patterns of physical activity, sedentary behavior and sleep with health-related quality of life: a cohort study.

OBJECTIVE: To examine the prospective association of patterns of physical activity, sedentary behavior and sleep with health-related quality of life (HRQL) in the general population of Spain. METHODS: A cohort study with 4271 individuals aged ≥ 18 years was recruited in 2008-2010 and followed-up prospectively through 2012. Activity patterns were derived from factor analysis. HRQL was assessed with the SF-12 questionnaire, and suboptimal HRQL was defined as a score below the sex-specific sample median. RESULTS: Three main activity patterns were identified. A higher adherence to the pattern named "vigorous activity-seated at the computer" was inversely associated with a suboptimal score in the physical-composite summary (PCS) of the SF-12 (multivariate adjusted odds ratio [aOR] for the highest vs. the lowest quartile 0.71; 95% confidence interval [IC] 0.55-0.90; p-trend=0.003). The "light activity-seated for reading" pattern was inversely associated with a suboptimal score in the mental-composite summary (aOR=0.73; 95% CI=0.61-0.89; p-trend=0.002). However, a higher adherence to the "seated for watching TV-daytime sleeping" pattern was directly associated with suboptimal PCS (aOR=1.35; 95% CI=1.10-1.66; p-trend=0.008). CONCLUSION: Patterns including any physical activity were associated with better physical or mental HRQL. However, a pattern defined by sedentary behavior with diurnal sleep showed worse HRQL and should be a priority target of preventive interventions.

Combined impact of traditional and non-traditional health behaviors on mortality: a national prospective cohort study in Spanish older adults.

BACKGROUND: Data on the combined effect of lifestyles on mortality in older people have generally been collected from highly selected populations and have been limited to traditional health behaviors. In this study, we examined the combined impact of three traditional (smoking, physical activity and diet) and three non-traditional health behaviors (sleep duration, sedentary time and social interaction) on mortality among older adults. METHODS: A cohort of 3,465 individuals, representative of the Spanish population aged ≥60 years, was established in 2000/2001 and followed-up prospectively through 2011. At baseline, the following positive behaviors were self-reported: never smoking or quitting tobacco >15 years, being very or moderately physically active, having a healthy diet score ≥ median in the cohort, sleeping 7 to 8 h/d, spending <8 h/d in sitting time, and seeing friends daily. Analyses were performed with Cox regression and adjusted for the main confounders. RESULTS: During an average nine-year follow-up, 1,244 persons died. Hazard ratios (95% confidence interval) for all-cause mortality among participants with two, three, four, five and six compared to those with zero to one positive behaviors were, respectively, 0.63 (0.46 to 0.85), 0.41 (0.31 to 0.55), 0.32 (0.24 to 0.42), 0.26 (0.20 to 0.35) and 0.20 (0.15 to 0.28) (P for trend <0.001). The results were similar regardless of age, sex and health status at baseline. Those with six vs. zero to one positive health behaviors had an all-cause mortality risk equivalent to being 14 years younger. Adding the three non-traditional to the four traditional behaviors improved the model fit (likelihood ratio test, P <0.001) and the accuracy of mortality prediction (c-statistic: + 0.0031, P = 0.040). CONCLUSIONS: Adherence to some traditional and non-traditional health behaviors may substantially reduce mortality risk in older adults.

Adherence to the Mediterranean diet pattern has declined in Spanish adults.

This work examined the Spanish population's degree of accordance with the Mediterranean diet (MD). This was a cross-sectional study conducted in 2008-2010 among 11,742 individuals representative of the Spanish population aged ≥ 18 y. Habitual food consumption was assessed with a computerized diet history. Accordance of food consumption with the MD was assessed with the MD Adherence Screener (MEDAS) score using the cutoffs ≥ 9 to define strict accordance and ≥ 7 (mid-range value) for modest accordance. Accordance of nutrient intake with the MD was defined as ≥ 4.5 points (mid-range value) on the high-unsaturated fat OmniHeart diet score. The diet of 12% (95% CI: 11.3-12.7%) of the Spanish population reached MEDAS-based strict accordance with the MD and 46% (95% CI: 44.7-47.7) attained modest accordance. Moreover, 39.0% (95%: 37.8-40.1%) of the population achieved OnmiHeart-based MD accordance. Factor analysis identified 2 main dietary patterns. The first one was called "Westernized" and was rich in red and processed meat, French fries, refined cereals, and sweetened beverages and poor in fresh fruit; the second pattern was named "Mediterranean" and was rich in olive oil and plant-based foods. Regardless of how it was defined, MD accordance was less frequent and the Westernized pattern was more frequent among the younger, the less educated, current smokers, and those less physically active and more sedentary. In conclusion, the Spanish population is drifting away from the MD to adopt a less healthy diet, typical of Western countries. The departure from the MD mostly affects the socially disadvantaged and clusters with other unhealthy lifestyles, which may have synergistic undesirable effects on health.

Obesity-related eating behaviors are associated with low physical activity and poor diet quality in Spain.

This study examined the association of obesity-related eating behaviors (OREB) with physical activity, sedentariness, and diet quality. Data were taken from a cross-sectional study in 10,791 persons representative of the Spanish population who were ≥18 y of age in 2008-2010. The following self-reported information was collected on 12 OREB: not planning how much to eat before sitting down, not deciding the amount of food on the plate, skipping breakfast, eating precooked/canned food or snacks bought at vending machines or at fast-food restaurants, not choosing low-energy foods, not removing visible fat from meat or skin from chicken, eating while watching television or seated on a sofa or an armchair, and taking a short time for meals. Analyses were performed with linear or logistic regression, as appropriate, and adjusted for the main confounders. In comparison to participants with ≤1 OREB, those with ≥5 OREB performed less physical activity [ß: -2.61 (95% CI: -4.44, -0.78); P-trend < 0.001] and spent more time watching television [ß: 2.17 (95% CI: 1.39, 2.95); P-trend < 0.001]; furthermore, they had greater total energy intake [ß: 160 (95% CI: 115, 210); P-trend < 0.001] and were less likely to follow a Mediterranean diet [OR: 0.55 (95% CI: 0.41, 0.73); P-trend < 0.001]. In conclusion, the association between OREB and obesity is biologically plausible because OREB are associated with energy intake and poor accordance with the Mediterranean diet. Studies on the association between OREB and obesity should control for the confounding effect of physical activity and sedentariness.

The prevalence and incidence rate of overweight and obesity among 2.5 million children and adolescents in Spain.

INTRODUCTION AND OBJECTIVES: Childhood obesity trends are plateauing in Spain, but limited information is available about how they differ by region. This study assessed childhood and adolescent the prevalence and incidence of overweight and obesity from 2005 to 2017 across 8 Spanish regions. METHODS: This longitudinal study used height and weight measurements from 2.5 million children aged 2 to 17 years to calculate overweight and obesity, according to the World Health Organization (WHO) guidelines. Data were obtained from The Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria, and the Information System for Research in Primary Care. Prevalence and incidence rates and trends from 2005 to 2017 were calculated and stratified by age, sex, and region. RESULTS: The overall obesity prevalence increased in boys and girls from age 2 (0.8%; 95%CI, 0.8-0.9 in both sexes) until peaking at age 7 in girls (17.3%; 95%CI, 17.1-17.5) and age 9 in boys (24.1%; 95%CI 23.9-24.3). The highest and lowest obesity prevalences were observed in Murcia and Navarre. Overall obesity prevalence trends decreased from 2005 to 2017 in all age-sex groups and in most regions. Highest obesity incidence rates were found in children aged 6 to 7 years, (4.5 [4.5-4.5] and 3.5 [3.5-3.5] new obesity cases per 100 person-years in boys and girls, respectively). Boys had higher prevalence and incidence rates than girls across all regions. Overweight/obesity prevalence and incidence rates and their trends were consistently higher than the obesity results, although a similar pattern was observed across sex and age. CONCLUSIONS: Overweight and obesity prevalence slightly decreased in Spain from 2005 to 2017, but regional, sex, and age differences persisted. Because incidence peaked around the age of 6 years, it may be important to begin health promotion programs at an early age.

Flecainide and risk of skin neoplasms: Results of a large nested case-control study in Spain and Denmark.

Background: A previous study in Denmark suggested an increased melanoma risk associated with the use of flecainide. Objective: To study the association between flecainide use and the risk of melanoma and non-melanoma skin cancer in Spain and Denmark. Methods: We conducted a multi-database case-control study in (database/study period) Spain (SIDIAP/2005-2017 and BIFAP/2007-2017) and Denmark (Danish registries/2001-2018). We included incident cases of melanoma or non-melanoma skin cancer (NMSC) aged ≥18 with ≥2 years of previous data (≥10 years for Denmark) before the skin cancer and matched them to controls (10:1 by age and sex). We excluded persons with immunosuppression or previous cancer. We defined ever-use as any prescription fill and high-use as a cumulative dose of at least 200 g (reference: never-use). We categorized a cumulative dose for a dose-response assessment. We used conditional logistic regression to compute ORs (95% CI) adjusted for photosensitizing, anti-neoplastic, disease-specific drugs and comorbidities. Results: The total numbers of melanoma/NMSC cases included were 7,809/64,230 in SIDIAP, 4,661/31,063 in BIFAP, and 27,978/152,821 in Denmark. In Denmark, high-use of flecainide was associated with increased adjusted ORs of skin cancer compared with never-use [melanoma: OR 1.97 (1.38-2.81); NMSC: OR 1.34 (1.15-1.56)]. In Spain, an association between high-use of flecainide and NMSC was also observed [BIFAP: OR 1.42 (1.04-1.93); SIDIAP: OR 1.19 (0.95-1.48)]. There was a non-significant dose-response pattern for melanoma in Denmark and no apparent dose-response pattern for NMSC in any of the three databases. We found similar results for ever-use of flecainide. Conclusion: Flecainide use was associated with an increased risk of melanoma (Denmark only) and NMSC (Denmark and Spain) but without substantial evidence of dose-response patterns. Further studies are needed to assess for possible unmeasured confounders.

Housing conditions and mortality in older patients hospitalized for heart failure.

BACKGROUND: Although decent housing is recognized as a prerequisite for good health, very few studies in developed countries have examined the influence of housing characteristics on disease prognosis. This work examined whether housing conditions predict mortality in older adults with heart failure (HF). METHODS: This is a cohort study comprising 433 patients hospitalized for HF-related emergencies in 4 Spanish hospitals between January 1, 2000, and June 30, 2001. At baseline, patients reported whether their homes lacked an elevator (in an apartment building), hot water, heating, an indoor bathroom, a bathtub or shower, individual bedroom, automatic washing machine, and telephone and whether they frequently felt cold. Analyses included all-cause deaths identified prospectively until January 1, 2005. RESULTS: Among study participants, 165 (38.1%) lived in a home without one of the services considered; and 111 (25.6%) lacked ≥2 services. During follow-up, 260 deaths (60%) occurred. After adjustment for the main confounders, mortality was higher in those who lived in homes without an elevator (hazard ratio [HR] 1.39, 95% CI 1.07-1.80) and in those who frequently felt cold (HR 1.39, 95% CI 1.01-1.92). In comparison with living in a home with all the services considered, mortality was higher for persons living in a home lacking 1 service (HR 1.42, 95% CI 1.10-1.93) or ≥2 services (HR 1.94, 95% CI 1.37-2.74). Patients living in homes lacking any of the services more often had poor functional status, higher comorbidity, lower educational level, and less income. CONCLUSION: Poor housing conditions are associated with higher mortality in HF. Patients living in these homes are especially vulnerable because they have poorer clinical situation and lower socioeconomic position.

Cavotricuspid isthmus catheter ablation without the use of fluoroscopy as a first-line treatment.

INTRODUCTION AND OBJECTIVES: The use of intracardiac navigation systems has enabled a significant reduction of the radiation dose in the majority of ablation procedures. The purpose of this study is to evaluate the feasibility and safety of cavotricuspid isthmus ablation without the use of fluoroscopy as a first-line treatment. METHODS AND RESULTS: An observational study without a control group in patients referred for treatment of common atrial flutter. In all of the procedures, Ensite-NavX™ was the only guidance system used to visualize the catheters. One or two diagnostic catheters and a cooled-tip ablation catheter were used in each procedure. Bidirectional cavotricuspid isthmus block was considered to indicate a successful procedure. Eighty-three ablation procedures were performed in 80 patients (82.5% men, 61 ± 10 years of age). The procedure was repeated in 3 patients (3.75%) due to flutter recurrence. Success was obtained in 98.8% of the procedures; in 1 patient it was necessary to implant a pacemaker for sinus node dysfunction and 4 patients experienced minor complications. In 75 procedures (90.4%), fluoroscopy was not required. Visualization of the diagnostic catheters was the most common reason for using fluoroscopy. The time required to perform the ablation procedure was similar to that published in other series. CONCLUSIONS: Cavotricuspid isthmus ablation using a nonfluoroscopic three-dimensional (3D) navigation system is effective and safe.

Longitudinal association of physical activity and sedentary behavior during leisure time with health-related quality of life in community-dwelling older adults.

BACKGROUND: Evidence on the relation between leisure-time physical activity (LTPA) and health-related quality of life (HRQoL) in older adults is based primarily on clinical trials of physical exercise programs in institutionalized persons and on cross-sectional studies of community-dwelling persons. Moreover, there is no evidence on whether leisure-time sedentary behavior (LTSB) is associated with HRQoL independently of LTPA. This study examined the longitudinal association between LTPA, LTSB, and HRQoL in older community-dwelling adults in Spain. METHODS: Prospective cohort study of 1,097 persons aged 62 and over. In 2003 LTPA in MET-hr/week was measured with a validated questionnaire, and LTSB was estimated by the number of sitting hours per week. In 2009 HRQoL was measured with the SF-36 questionnaire. Analyses were done with linear regression and adjusted for the main confounders. RESULTS: Compared with those who did no LTPA, subjects in the upper quartile of LTPA had better scores on the SF-36 scales of physical functioning (ß 5.65; 95% confidence interval [CI] 1.32-9.98; p linear trend < 0.001), physical role (ß 7.38; 95% CI 0.16-14.93; p linear trend < 0.001), bodily pain (ß 6.92; 95% CI 1.86-11.98; p linear trend < 0.01), vitality (ß 5.09; 95% CI 0.76-9.41; p linear trend < 0.004) social functioning (ß 7.83; 95% CI 2.89-12.75; p linear trend < 0.001), emotional role (ß 8.59; 95% CI 1.97-15.21; p linear trend < 0.02) and mental health (ß 4.20; 95% CI 0.26-8.13; p linear trend < 0.06). As suggested by previous work in this field, these associations were clinically relevant because the ß regression coefficients were higher than 3 points. Finally, the number of sitting hours showed a gradual and inverse relation with the scores on most of the SF-36 scales, which was also clinically relevant. CONCLUSIONS: Greater LTPA and less LTSB were independently associated with better long-term HRQoL in older adults.