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Heart failure (HF) is a condition with growing morbidity and mortality. Dyslipidemia in HF is not concentrated around hypercholesterolemia as in coronary artery disease. As a corollary, the robust benefits seen with statins across the spectrum of CAD have not been replicated in HF. Multiple potential pleiotropic effects of statins include anti-inflammatory, antioxidant, endothelial stabilization, antiapoptotic, anti-thrombotic, and modulation of the autonomic system apart from lipid lowering. These benevolent actions need to be counterbalanced with the potential derangement of ubiquinone, selenoprotein and endotoxin pathways. While small randomized and non-randomized studies demonstrated a multitude of benefits in clinical and surrogate endpoints, two large RCTs failed to demonstrate unequivocal benefits. However, multiple large meta-analyses do demonstrate definite improvement in clinical endpoints including death and heart failure hospitalization. The clinical likelihood of benefit was higher in younger patients with less advanced HF and use of lipophilic statins. [ABSTRACT FROM AUTHOR]

OBJECTIVE: As of today, healthcare systems worldwide face severe challenges that undermine their sustainability. The value-based healthcare (VBHC) approach has been proposed as a strategic and methodological framework to ensure the delivery of the best patient outcomes with economic efficiency. Through the illustrative example of B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) for heart failure (HF) patient management in the context of the Italian National Healthcare system, this article explores the role that in vitro diagnostics (IVDs) can play in enabling value-based care models. SUBJECTS AND METHODS: 14 healthcare professionals representing the relevant professional figures involved in HF patient management met to revise the current HF patient journey and design a new care pathway that, leveraging on BNP/NT-proBNP, reflects the VBHC principles. RESULTS: The literature recognizes the dosage of BNP/NT-proBNP as the gold standard for diagnosing HF. However, as of today, these IVDs are not employed at their full potential regarding HF patient management. A new patient journey is proposed so that patients are diagnosed early and properly monitored in the aftermath of hospitalization, improving outcomes at contained costs. CONCLUSIONS: As testified by the example of HF patient management in Italy, laboratory medicine can represent a lever for adopting value-based care models. Still, large-scale adoption of VBHC will call for structural reforms that revise how healthcare delivery is organized, measured, and reimbursed. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Osteoporosis is a chronic metabolic syndrome associated with debilitating consequences that represents one of the major non-communicable diseases and the most common bone illness that affects both men and women. This observational study evaluates the amount of physical activity and the nutritional intake in a group of postmenopausal women who have a sedentary job. PATIENTS AND METHODS: All subjects underwent a medical evaluation, a body impedance analysis to evaluate body composition (fat mass, fat-free mass, and body cell mass), and a dual-energy X-ray absorptiometry to analyze bone mineral density. Additionally, a 3-day food record questionnaire and the International Physical Activity Questionnaire were administered respectively to evaluate patients’ foods and beverages assumptions and the participants’ Physical Activity levels. RESULTS: The study showed that most of the patients had a moderate activity level and inadequate calcium and vitamin D assumption compared to guidelines. CONCLUSIONS: The onset of osteoporosis seemed to be reduced at higher levels of leisure time, domestic, and transport activities, even in subjects who have a sedentary job and insufficient assumption of micronutrients. [ABSTRACT FROM AUTHOR]

Patients with diabetes mellitus (DM) often present other chronic comorbidities including arterial hypertension (AH), chronic kidney disease (CKD), ischemic heart disease (IHD) and heart failure with preserved ejection fraction (HFpEF). The frequent association of the latter conditions is considered part of the spectrum of cardio-renal syndromes (CRS), a group of disorders of the heart and kidneys whereby acute or chronic dysfunction in one organ may induce acute or chronic dysfunction of the other. Verapamil is a non-dihydropyridine calcium channel blocker (CCB) widely used in the treatment of hypertension, chronic stable angina, secondary prevention of reinfarction, paroxysmal supra-ventricular tachycardia and for rate control in atrial fibrillation/flutter. In addition to its antihypertensive and anti-ischemic actions verapamil exerts favorable effects also on glycemic control, proteinuric diabetic nephropathy, left ventricular diastolic dysfunction and sympathetic nervous system overactivity which may potentially benefit patients with DM and CRS. In this narrative review, we summarize the current evidence on the potential role of verapamil in the prevention and treatment of CRS in diabetic hypertensive patients. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Understanding changes of right ventricular (RV) geometry and function in repaired Tetralogy of Fallot (rToF) patients can improve decision-making for pulmonary valve replacement. Therefore, we aimed to assess the magnitude and clinical correlations of RV changes in rToF patients. PATIENTS AND METHODS: Clinical and MRI data of rToF patients who underwent repeated cardiac magnetic resonance imaging (MRI) at two centers between December 2003 and September 2020 were analyzed together with anatomical factors, including RV outflow tract obstruction, pulmonary artery branch stenosis, and tricuspid regurgitation. Adverse cardiac events and/or NYHA class worsening were documented and correlated with MRI changes. QRS length was reported at each MRI. RESULTS: Two-hundred-and-nineteen rToF patients (53% males, aged 20.2 ± 10.1 years) were enrolled. An increase of ventricular dimensions, except LVEDVi, and worsening of right and left ejection fractions were found over an average period of 5 years of follow-up. These changes were statistically significant but within 10% of the initial value. No significant changes were reported on a year-to-year basis, except in a small group of patients (6%) in whom no predictive factors were identified. Despite similar RV dimensions at the first examination, younger patients had a higher RV ejection fraction and a different annual rate of change of ventricular dimensions compared to older ones. Patients with arrhythmias (20%) were more frequently older and had larger RV dimensions but showed no significant correlations with MRI changes/years. CONCLUSIONS: Changes in RV dimensions and function occur rarely and very slowly in rToF patients. A small percentage of patients experience a significant worsening in a short time interval without any recognized risk factors. Arrhythmias appear to occur in a small percentage of cases in the late follow-up. [ABSTRACT FROM AUTHOR]

OBJECTIVE: It was hypothesized that activity exercise at professional levels could lead to an increase in metabolic levels and a decrease in performance parameters. These trends are explained by physical activity as a cellular stressor. SUBJECTS AND METHODS: We used an algorithm, Laboratory Index which evaluates salivary cortisol, CK and d-ROMs, collected previously from elite Italian soccer players, compared to InStat Index. The last one estimates analytically the athlete's performance in soccer pitch, applying the Heath Maps. RESULTS: A good agreement between the two Index was obtained, especially for two players, who showed an ideal combined trend. CONCLUSIONS: We would investigate the clinical and activity profile of soccer players with the aim of providing information for the development of training strategies. Also, the performances, during training and match time, are an objective evaluation of the athlete's physical preparation. As a consequence, the combination of two Index could be used for a new approach to the sports world. [ABSTRACT FROM AUTHOR]

Obesity is linked to other systemic diseases, such as diabetes mellitus, dyslipidemia, and arterial hypertension. These comorbidities increase the risk of developing cardiovascular disease risk. Adipose tissue is a true endocrine organ and releases various pro-inflammatory cytokines. Periodontal disease (PD) is a chronic inflammatory disorder of the gingiva and bone support (periodontal tissues) that surrounds the teeth. The relationship between obesity and an increased risk of developing PD is already known in the literature. Many studies correlated the cardiometabolic risk with periodontal disease. Bariatric surgery is a way to reduce the adipose tissue in obese patients, that meet specific criteria. It has been observed that this type of surgery usually reduces both the systemic inflammation and the cardiometabolic risk. Some authors have hypothesized that, as a result, the progression of periodontal disease is also reduced. Five articles are analyzed in this systematic review. In these papers, the periodontal health before and after the bariatric surgery was compared. However, the conclusion of the previous studies demonstrated a scarce literature and did not confirm the reduction of periodontal disease after bariatric surgery, but a reduction of cardiometabolic risk. Therefore, periodontal disease in no way influences the reduction of cardiovascular risk after bariatric surgery. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We studied the impact of transcatheter aortic valve implantation (TAVI) compared to the surgical aortic valve replacement (SAVR) on 30-day and one-year mortality from randomized controlled trials (RCTs) in patients with severe aortic stenosis at high or low-intermediate surgical risk. MATERIALS AND METHODS: All RCTs were retrieved through PubMed computerized database and the site https://www.clinicaltrials.gov from January 2010 until March 31st, 2019. The absolute risk reduction (RD) with the 95% confidence interval (CI) was used to assess the effectiveness of the intervention under comparison. We evaluated overall mortality rates at 30-day and one-year follow-up in the comparison between TAVI vs. SAVR. We also evaluated the role played by the site access for TAVI performed through the femoral or subclavian artery (TV-TAVI) vs. SAVR, or transapically (TA-TAVI) vs. SAVR. RESULTS: In the "as-treated population" the overall 30-day mortality was significantly lower in TAVI (p=0.03) with respect to SAVR. However, the analysis for TAVI subgroups showed that 30-day mortality was (1) significantly lower in TV-TAVI vs. SAVR (p=0.006), (2) increased, not significantly, in TA-TAVI vs. SAVR (p=0.62). No significant differences were found between TAVI vs. SAVR at one-year follow-up. CONCLUSIONS: The results of our meta-analysis suggest that TV-TAVI is a powerful tool in the treatment of severe aortic stenosis at high or low-intermediate surgical risk, with a significant lower mortality with respect to SAVR. On the contrary, SAVR seems to provide better results than TA-TAVI. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The patients with repaired Tetralogy of Fallot (rToF) are a growing population due to the improvement of surgical management in neonatal age. However, the significant pulmonary regurgitation, consequent to the repair, is the most frequent sequelae and leads to a progressive right ventricle dilation over time. The latter, in turn, is responsible for the possible dysfunction of right and/or left ventricle and an increased risk of dangerous ventricular arrhythmias. Therefore, right ventricle monitoring is necessary for rToF patients and a 3D method is required due to its three anatomical and functional subunits. Magnetic resonance imaging (MRI) has become the 3D modality of choice in the evaluation of both cardiac anatomy and ventricular volumes in rToF patients since it is able to evaluate both the pathophysiology and anatomy, it is free of radiation and, when strictly necessary, it uses a non-iodinated contrast agent. Cardiac CT should be considered in the evaluation of the sequelae in rToF only in selected cases, given that it implies a radiation dose and iodinated contrast, in addition to not evaluating the pathophysiology as MRI. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The aim of the study was to examine the safety and efficacy of dronedarone in patients with a history of atrial fibrillation and amiodarone-induced hyperthyroidism. PATIENTS AND METHODS: We conducted a prospective study to evaluate the use of amiodarone and dronedarone in 124 patients with a history of paroxysmal atrial fibrillation who had no additional structural heart disease. All patients received amiodarone 200 mg qd. Out of 124 patients, 56 (45%) switched to dronedarone 400 mg bid due to amiodarone-induced hyperthyroidism and the remaining 68 patients (55%), with normal thyroid function, continued to receive amiodarone. The follow-up period was 12 months, and the patients were regularly monitored. RESULTS: The primary outcome after 6 months dronedarone and amiodarone group was 56 and 68, including 38 (68%) and 54 (79.4%) (Odds ratio [OR] = 1.17, 95% confidence interval [95% CI] = 0.68-2.02) patients with sinus rhythm (SR) and 18 (32.14%) and 14 (28.6%) (odds ratio [OR] = 0.64, confidence interval [95% CI] = 0.29-1.40) patients with atrial fibrillation (AF). The secondary outcome after 12 months showed significant difference in thyroid function in the dronedarone group. Out of 46 patients, 24 (56.18%) patients reduced hyperthyroidism compared to the amiodarone group; out of 68, 6 (8.9%) patients were observed to have hyperthyroidism. At 12 months, there were 24 (43%) and 22 (62%) (odds ratio [OR] = 0.75, confidence interval [95% CI] = 0.38-1.49) patients with SR, and 32 (57%) and 26 (38%) (odds ratio [OR] = 0.67, confidence interval [95% CI] = 0.36-1.25) patients with AF. CONCLUSIONS: In our study, dronedarone appears to be a good therapeutic option in the treatment of atrial fibrillation in patients with amiodarone-induced hyperthyroidism. However, long-term studies are needed to estimate the efficacy and toxicity of both drugs. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Intra-aortic balloon pump (IABP) is the device most commonly investigated in patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI). Recently meta-analyses on this topic showed opposite results: some complied with the actual guideline recommendations, while others did not, due to the presence of bias. We investigated the reasons for the discrepancy among meta- analyses and strategies employed to avoid the potential source of bias. MATERIALS AND METHODS: Scientific databases were searched for meta-analyses of IABP support in AMI complicated by CS. The presence of clinical diversity, methodological diversity and statistical heterogeneity were analyzed. When we found clinical or methodological diversity, we reanalyzed the data by comparing the patients selected for homogeneous groups. When the fixed effect model was employed despite the presence of statistical heterogeneity, the meta-analysis was repeated adopting the random effect model, with the same estimator used in the original meta-analysis. RESULTS: Twelve meta-analysis were selected. Six meta-analyses of randomized controlled trials (RCTs) were inconclusive because underpowered to detect the IABP effect. Five included RCTs and observational studies (Obs) and one only Obs. Some meta-analyses on RCTs and Obs had biased results due to presence of clinical and/or methodological diversity. The reanalysis of data reallocated for homogeneous groups was no more in contrast with guidelines recommendations. CONCLUSIONS: Meta-analyses performed without controlling for clinical and/or methodological diversity, represent a confounding message against a good clinical practice. The reanalysis of data demonstrates the validity of the current guidelines recommendations in addressing clinical decision making in providing IABP support in AMI complicated by CS. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To verify safety respect to weight loss, cardiometabolic diseases of short-term Very low-calorie ketogenic diets (VLCKDs, <800 kcal day-1). PATIENTS AND METHODS: Randomized cross-over trial with placebo. The study had no. 2 dietary treatment (DT), conducted in two arms: (1) VLCKD1 in which 50% of protein intake is replaced with synthetic amino acids; (2) VLCKD2 with placebo. The VLCKDs (<800 kcal day-1) were different in term of protein content and quality each arm lasted three weeks (wks). Between the two arms a 3-wks washout period was performed to avoid additive effects on DT to follow. At the baseline, at start and end of each arm, all the subjects were evaluated for their health and nutritional status, by anthropometric analysis, body composition (Dual X-ray Absorptiometry (DXA), Bioimpedentiometry, biochemical evaluation, and Peroxisome Proliferator- Activated Receptor γ (PPAR) γ expression by transcriptomic analysis. RESULTS: After VLCKD1 were reduced: Body Mass Index (BMI) (Δ%=-11.1%, p=0.00), Total Body Water (TBW) (p<0.05); Android Fat Percentage (AFP) (Δ%=-1.8%, p=0.02); Android Fat Mass (AFM) (Δ%=-12.7%, p=0.00); Gynoid Fat Mass (GFM) (Δ%=-6.3%, p=0.01); Intermuscular Adipose Tissue (IMAT) (Δ%= -11.1%, p=0.00); Homeostasis Model Assessment of Insulin Re-sistance (HOMA-IR) (Δ%=-62.1%, p=0.01). After VLCKD1 a significant increase of uricemia, cre-atinine and aspartate aminotransferase (AST) (respectively Δ%=35%, p=0.01; Δ%=5.9%, p=0.02; Δ%=25.5%, p=0.03). After VLCKD2 were reduced: BMI (Δ%=- 11.2%, p=0.00); AFM (Δ%=-14.3%, p=0.00); GFM (Δ%=-6.3%, p=0.00); Appendicular Skeletal Muscle Mass Index (ASMMI) (Δ%=-17.5%, p=0.00); HOMA-IR (Δ%=-59,4%, p=0.02). After VLCKD2, uricemia (Δ%=63.1%, p=0.03), and Vitamin D levels (Δ%=25.7%, p=0.02) were increased. No significant changes of car-diovascular disease (CVD) indexes were observed after DTs. No significant changes of PPARγ lev-el in any DTs. CONCLUSIONS: 21-days VLCKDs not impair nutritional state; not cause negative changes in global measurements of nutritional state including sarcopenia, bone mineral content, hepatic, renal and lipid profile. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Postprandial oxidative stress is characterized by an increased susceptibility of the organism towards oxidative damage after consumption of a meal rich in lipids and/or carbohydrates. Micronutrients modulate the immune system and exert a protective action by reducing low-density lipoproteins oxidation (ox-LDL) via induction of antioxidant enzymes. SUBJECTS AND METHODS: The clinical study was a randomized and cross-over trial, conducted through the CONSORT flowchart. We evaluated the gene expression of 103 genes related to oxidative stress (HOSp) and human inflammasome pathways (HIp), and ox-LDL level at fasting and after 40 g raw "Tonda Gentile delle Langhe" hazelnut consumption, in association with a McDonald's® Meal (McDM) in 22 healthy human volunteers. RESULTS: Ox-LDL levels significantly increased comparing no dietary treatment (NDT) vs. McDM, and decreased comparing McDM vs. McDM + H (p<0.05). Percentage of significant genes expressed after each dietary treatment were the follows: (A) NDT vs. McDM: 3.88% HIp and 17.48% HOSp; (B) NDT vs. McDM + H: 17.48% HIp and 23.30% HOSp; (C) McDM vs. McDM + H: 17.48% HIp and 33.98% HOSp. CONCLUSIONS: Hazelnut consumption reduced post prandial risk factors of atheroscle-rosis, such as ox-LDL, and the expression of inflammation and oxidative stress related genes. Chronic studies on larger population are necessary before definitive conclusions. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Very low-calorie diets (VLCDs, < 800 kcal day-1) and Ketogenic diet (KD) are generally used as part of integrated intervention, medical monitoring and a program of lifestyle modification, to improve a multitude of clinical states. The effect of three different very low calories KD (VLCKD), with (VLCKD1) or without (VLCKD2,3) synthetic amino acid replacement of the 50% protein intake, were analyzed after weight loss. PATIENTS AND METHODS: The clinical study used a cross-over randomized double-blind placebo- controlled trial. Obese subjects, who were eligible for the study, were randomly (R) divided into three groups: one intervention group (IG) and two control groups (CG1 and CG2). We comprehensively analyzed body composition, serum metabolites, superoxide dismutase (SOD1), nuclear factor kappa-light-chain-enhancer of activated B cells (NfKB), Chemokine (C-C Motif) Ligand 2 (CCL2) gene expression. RESULTS: After VLDKDs a significant decreased in BMI was observed. TBF (kg) significantly decrease after VLCKD1 and VLCKD3. After VLCKD2, a reduction of waist circumference (p = 0.02), FM L2-L5 (p < 0.05) was observed. After VLCKD1 reduction of IMAT (p = 0.00), LDL-C (p = 0.00) and HDL-C (p = 0.00) were observed. No significant changes of GH, ESR, and fibrinogen were highlighted. CRP (p = 0.02) reduced significantly after VLCKD3. Significant modulation of SOD1 expression (p = 0.009), CRP and decrease of glucose levels (p = 0.03) were obtained after VLCKD3. CONCLUSIONS: This is the first study that analyzes comprehensively body composition, metabolic profile, and inflammation and oxidative stress genes expression after VLCKD. Our results show the efficacy of VLCKD with synthetic aminoacidic protein replacement, for the reduction of cardiovascular risk, without the development of sarcopenia and activation of inflammatory and oxidative processes. [ABSTRACT FROM AUTHOR]