Living with advanced heart failure: A qualitative study.

INTRODUCTION: Information about how patients with advanced heart failure (HF) live and cope with their disease remains scarce. The objective of this study was to explore, from phenomenological and holistic perspectives, the experiences of patients suffering from advanced HF, attended at home in the primary care setting in 2018. MATERIALS AND METHODS: Qualitative study conducted in 4 primary healthcare centers in Barcelona (Spain). Twelve in-depth interviews were conducted in advanced HF patients, aged over 65 and visited regularly at home. We developed a purposeful sampling, accounting for variability in gender, age, and socioeconomic level. Leventhal's framework was used to analyze the interviews. RESULTS: Participants received insufficient and contradictory information about HF. They talked about their cognitive representation and claimed a better communication with healthcare professionals. Due to their advanced age, subjects considered their daily living limitations to be normal rather than as a consequence of HF. Gender differences in emotional representation were clearly observed. Women considered themselves the keystone of correct family "functioning" and thought that they were not useful if they could not correspond to gendered societal expectations. Cognitive coping strategies included specific diets, taking medication, and registering weight and blood pressure. Nevertheless, they perceived the locus of control as external and felt unable to manage HF progression. Their emotional coping strategies included some activities at home such as watching television and reading. Social support was perceived crucial to the whole process. CONCLUSIONS: Locus of control in advanced HF was perceived as external. Healthcare professionals should adapt emotional health interventions in patients with advanced HF based on a gender perspective. Social support was found to be crucial in facing the disease. Patients reported poor communication with healthcare professionals.

Design and Validation of an FPGA-Based Configurable Transcranial Doppler Neurofeedback System for Chronic Pain Patients.

Neurofeedback is a self-regulation technique that can be applied to learn to voluntarily control cerebral activity in specific brain regions. In this work, a Transcranial Doppler-based configurable neurofeedback system is proposed and described. The hardware configuration is based on the Red Pitaya board, which gives great flexibility and processing power to the system. The parameter to be trained can be selected between several temporal, spectral, or complexity features from the cerebral blood flow velocity signal in different vessels. As previous studies have found alterations in these parameters in chronic pain patients, the system could be applied to help them to voluntarily control these parameters. Two protocols based on different temporal lengths of the training periods have been proposed and tested with six healthy subjects that were randomly assigned to one of the protocols at the beginning of the procedure. For the purposes of the testing, the trained parameter was the mean cerebral blood flow velocity in the aggregated data from the two anterior cerebral arteries. Results show that, using the proposed neurofeedback system, the two groups of healthy volunteers can learn to self-regulate a parameter from their brain activity in a reduced number of training sessions.

Effect of EDTA conditioning on cervical restorations bonded with a self-etch adhesive: A randomized double-blind clinical trial.

OBJECTIVE: To compare the 18-month retention rates of composite restorations in non-carious cervical lesions [NCCLs] bonded with a self-etch adhesive with and without preliminary conditioning with EDTA. METHODS: Forty-eight patients with two similar-sized NCCL were selected and randomly allocated to one of two groups. Two calibrated operators placed 96 restorations with a one-step self-etch adhesive (Adper Easy One, 3M ESPE). Half of the restorations were placed according to the manufacturer's instructions while, for the other half, the surfaces of the lesions were conditioned with 17% EDTA for 2 min prior to adhesive application. Two blinded and independent examiners evaluated the restorations at baseline, 6, 12, and 18 months, according to the FDI criteria. The comparison between groups in each period was conducted with the Fisher's exact test, and the performance of each group at the different periods was evaluated by McNemar's test (α=0.05). RESULTS: After 18 months, significantly higher retention rates (95% CI) were observed for the EDTA group (95.5 [84.9-98.7]) than the control group (79.6% [65.5-88.9]) (p=0.02). Significant deterioration of the marginal adaptation and marginal discoloration were observed for both groups over the 18-month evaluation. CONCLUSIONS: The preliminary conditioning with EDTA before application of a one-step self-etch adhesive significantly improved the retention rates of composite restorations in cervical lesions. CLINICAL SIGNIFICANCE: Conditioning with EDTA is an alternative that improves the 18-month retention rate of cervical restorations bonded with a self-etch adhesive.

Dietary intake of vitamin K is inversely associated with mortality risk.

Vitamin K has been related to cardiovascular disease and cancer risk. However, data on total mortality are scarce. The aim of the present study was to assess the association between the dietary intake of different types of vitamin K and mortality in a Mediterranean population at high cardiovascular disease risk. A prospective cohort analysis was conducted in 7216 participants from the PREDIMED (Prevención con Dieta Mediterránea) study (median follow-up of 4.8 y). Energy and nutrient intakes were evaluated using a validated 137-item food frequency questionnaire. Dietary vitamin K intake was calculated annually using the USDA food composition database and other published sources. Deaths were ascertained by an end-point adjudication committee unaware of the dietary habits of participants after they had reviewed medical records and linked up to the National Death Index. Cox proportional hazard models were fitted to assess the RR of mortality. Energy-adjusted baseline dietary phylloquinone intake was inversely associated with a significantly reduced risk of cancer and all-cause mortality after controlling for potential confounders (HR: 0.54; 95% CI: 0.30, 0.96; and HR: 0.64; 95% CI: 0.45, 0.90, respectively). In longitudinal assessments, individuals who increased their intake of phylloquinone or menaquinone during follow-up had a lower risk of cancer (HR: 0.64; 95% CI: 0.43, 0.95; and HR: 0.41; 95% CI: 0.26, 0.64, respectively) and all-cause mortality (HR: 0.57; 95% CI: 0.44, 0.73; and HR: 0.55; 95% CI: 0.42, 0.73, respectively) than individuals who decreased or did not change their intake. Also, individuals who increased their intake of dietary phylloquinone had a lower risk of cardiovascular mortality risk (HR: 0.52; 95% CI: 0.31, 0.86). However, no association between changes in menaquinone intake and cardiovascular mortality was observed (HR: 0.76; 95% CI: 0.44, 1.29). An increase in dietary intake of vitamin K is associated with a reduced risk of cardiovascular, cancer, or all-cause mortality in a Mediterranean population at high cardiovascular disease risk. This trial was registered at http://www.controlled-trials.com as ISRCTN35739639.

Effect of the Mediterranean diet on heart failure biomarkers: a randomized sample from the PREDIMED trial.

AIMS: Scarce data are available on the effect of the traditional Mediterranean diet (TMD) on heart failure biomarkers. We assessed the effect of TMD on biomarkers related to heart failure in a high cardiovascular disease risk population. METHODS AND RESULTS: A total of 930 subjects at high cardiovascular risk (420 men and 510 women) were recruited in the framework of a multicentre, randomized, controlled, parallel-group clinical trial directed at testing the efficacy of the TMD on the primary prevention of cardiovascular disease (The PREDIMED Study). Participants were assigned to a low-fat diet (control, n = 310) or one of two TMDs [TMD + virgin olive oil (VOO) or TMD + nuts]. Depending on group assignment, participants received free provision of extra-virgin olive oil, mixed nuts, or small non-food gifts. After 1 year of intervention, both TMDs decreased plasma N-terminal pro-brain natriuretic peptide, with changes reaching significance vs. control group (P < 0.05). Oxidized low-density lipoprotein decreased in both TMD groups (P < 0.05), the decrease in TMD + VOO group reaching significance vs. changes in control group (P = 0.003). Changes in lipoprotein(a) after TMD + VOO were less than those in the control group (P = 0.046) in which an increase (P = 0.035) was observed. No changes were observed in urinary albumin or albumin/creatinine ratio. CONCLUSIONS: Individuals at high risk of cardiovascular disease (CVD) who improved their diet toward a TMD pattern reduced their N-terminal pro-brain natriuretic peptide compared with those assigned to a low-fat diet. The same was found for in vivo oxidized low-density lipoprotein and lipoprotein(a) plasma concentrations after the TMD + VOO diet. From our results TMD could be a useful tool to mitigate against risk factors for heart failure. From our results TMD could modify markers of heart failure towards a more protective mode.

Prevention of diabetes with Mediterranean diets: a subgroup analysis of a randomized trial.

BACKGROUND: Interventions promoting weight loss can reduce the incidence of type 2 diabetes mellitus. Whether dietary changes without calorie restriction also protect from diabetes has not been evaluated. OBJECTIVE: To assess the efficacy of Mediterranean diets for the primary prevention of diabetes in the Prevención con Dieta Mediterránea trial, from October 2003 to December 2010 (median follow-up, 4.1 years). DESIGN: Subgroup analysis of a multicenter, randomized trial. (Current Controlled Trials: ISRCTN35739639) SETTING: Primary care centers in Spain. PARTICIPANTS: Men and women without diabetes (3541 patients aged 55 to 80 years) at high cardiovascular risk. INTERVENTION: Participants were randomly assigned and stratified by site, sex, and age but not diabetes status to receive 1 of 3 diets: Mediterranean diet supplemented with extra-virgin olive oil (EVOO), Mediterranean diet supplemented with nuts, or a control diet (advice on a low-fat diet). No intervention to increase physical activity or lose weight was included. MEASUREMENTS: Incidence of new-onset type 2 diabetes mellitus (prespecified secondary outcome). RESULTS: During follow-up, 80, 92, and 101 new-onset cases of diabetes occurred in the Mediterranean diet supplemented with EVOO, Mediterranean diet supplemented with mixed nuts, and control diet groups, respectively, corresponding to rates of 16.0, 18.7, and 23.6 cases per 1000 person-years. Multivariate-adjusted hazard ratios were 0.60 (95% CI, 0.43 to 0.85) for the Mediterranean diet supplemented with EVOO and 0.82 (CI, 0.61 to 1.10) for the Mediterranean diet supplemented with nuts compared with the control diet. LIMITATIONS: Randomization was not stratified by diabetes status. Withdrawals were greater in the control group. CONCLUSION: A Mediterranean diet enriched with EVOO but without energy restrictions reduced diabetes risk among persons with high cardiovascular risk. PRIMARY FUNDING SOURCE: Instituto de Salud Carlos III.

Dietary magnesium intake is inversely associated with mortality in adults at high cardiovascular disease risk.

The relation between dietary magnesium intake and cardiovascular disease (CVD) or mortality was evaluated in several prospective studies, but few of them have assessed the risk of all-cause mortality, which has never been evaluated in Mediterranean adults at high cardiovascular risk. The aim of this study was to assess the association between magnesium intake and CVD and mortality risk in a Mediterranean population at high cardiovascular risk with high average magnesium intake. The present study included 7216 men and women aged 55-80 y from the PREDIMED (Prevención con Dieta Mediterránea) study, a randomized clinical trial. Participants were assigned to 1 of 2 Mediterranean diets (supplemented with nuts or olive oil) or to a control diet (advice on a low-fat diet). Mortality was ascertained by linkage to the National Death Index and medical records. We fitted multivariable-adjusted Cox regressions to assess associations between baseline energy-adjusted tertiles of magnesium intake and relative risk of CVD and mortality. Multivariable analyses with generalized estimating equation models were used to assess the associations between yearly repeated measurements of magnesium intake and mortality. After a median follow-up of 4.8 y, 323 total deaths, 81 cardiovascular deaths, 130 cancer deaths, and 277 cardiovascular events occurred. Energy-adjusted baseline magnesium intake was inversely associated with cardiovascular, cancer, and all-cause mortality. Compared with lower consumers, individuals in the highest tertile of magnesium intake had a 34% reduction in mortality risk (HR: 0.66; 95% CI: 0.45, 0.95; P < 0.01). Dietary magnesium intake was inversely associated with mortality risk in Mediterranean individuals at high risk of CVD. This trial was registered at controlled-trials.com as ISRCTN35739639.

Primary prevention of cardiovascular disease with a Mediterranean diet.

BACKGROUND: Observational cohort studies and a secondary prevention trial have shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. We conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular events. METHODS: In a multicenter trial in Spain, we randomly assigned participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly individual and group educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4.8 years. RESULTS: A total of 7447 persons were enrolled (age range, 55 to 80 years); 57% were women. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. A primary end-point event occurred in 288 participants. The multivariable-adjusted hazard ratios were 0.70 (95% confidence interval [CI], 0.54 to 0.92) and 0.72 (95% CI, 0.54 to 0.96) for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, versus the control group (109 events). No diet-related adverse effects were reported. CONCLUSIONS: Among persons at high cardiovascular risk, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events. (Funded by the Spanish government's Instituto de Salud Carlos III and others; Controlled-Trials.com number, ISRCTN35739639.).

Effect of a traditional Mediterranean diet on apolipoproteins B, A-I, and their ratio: a randomized, controlled trial.

OBJECTIVES: Apolipoprotein (Apo)B, ApoA-I, and their ratio could predict coronary heart disease (CHD) risk more accurately than conventional lipid measurements. Our aim was to assess the effect of a traditional Mediterranean diet (TMD) on apolipoproteins. METHODS: High-cardiovascular risk subjects (n=551, 308 women and 243 men), aged 55-80 years, were recruited into a large, multicenter, randomized, controlled, parallel-group, clinical trial (The PREDIMED Study) aimed at testing the efficacy of TMD on primary cardiovascular disease prevention. Participants assigned to a low-fat diet (control) (n=177), or TMDs (TMD+virgin olive oil (VOO), n=181 or TMD+nuts, n=193) received nutritional education and either free VOO (ad libitum) or nuts (dose: 30 g/day). A 3-month evaluation was performed. RESULTS: Both TMDs promoted beneficial changes on classical cardiovascular risk factors. ApoA-I increased, and ApoB and ApoB/ApoA-I ratio decreased after TMD+VOO, the changes promoting a lower cardiometabolic risk. Changes in TMD+VOO versus low-fat diet were -2.9 mg/dL (95% CI, -5.6 to -0.08), 3.3mg/dL (95% CI, 0.84 to 5.8), and -0.03 mg/dL (-0.05 to -0.01) for ApoB, ApoA-I, and ApoB/ApoA-I ratio, respectively. CONCLUSIONS: Individuals at high-cardiovascular risk who improved their diet toward a TMD pattern rich in virgin olive oil, reduced their Apo B and ApoB/ApoA-I ratio and improved ApoA-I concentrations.

Effect of the methylenetetrahydrofolate reductase C677T polymorphism on patients with cisplatin/gemcitabine-treated stage IV non-small-cell lung cancer.

Single nucleotide polymorphisms (SNPs) in the metabolic pathways of S-adenosylmethionine have been related to global hypomethylation and a lower number of hypermethylated CpG islands of tumor suppressor genes. Hypermethylation of checkpoint and DNA repair genes has been shown to be indicative of chemosensitivity. In the present study, we have examined the SNP of methylenetetrahydrofolate reductase (MTHFR) C677T, which affects DNA methylation patterns and is linked to elevated plasma homocysteine levels in 208 patients with gemcitabine/cisplatin-treated stage IV non-small-cell lung cancer (NSCLC). No differences in response rate were observed according to the MTHFR genotype. However, time to progression was 7.4 months for 68 patients with CC genotype, 5.5 months for 108 patients with heterozygous CT genotype, and 5.2 months for 28 patients with TT genotype. These findings can lead us to distinguish different outcome patterns among patients with stage IV NSCLC whose similar clinical prognostic factors would otherwise indicate similar outcomes. Carriers of the MTHFR 677T allele could benefit from supplementation with folic acid and vitamin B12. The Spanish Lung Cancer Group has undertaken a phase III randomized trial to elucidate this concept.