Publications by authors named "Alberto Mazza"

98 Publications

The role of sacubitril/valsartan in the treatment of chronic heart failure with reduced ejection fraction in hypertensive patients with comorbidities: From clinical trials to real-world settings.

Biomed Pharmacother 2020 Oct 21;130:110596. Epub 2020 Aug 21.

Nuclear Medicine Unit, Santa Maria della Misericordia Hospital, Rovigo, Italy. Electronic address:

Background: Sacubitril/valsartan, the first agent to be approved in a new class of drugs called angiotensin receptor neprilysin inhibitors (ARNIs), has been shown to reduce cardiovascular mortality and morbidity compared to enalapril in outpatient subjects with chronic heart failure (HF) and reduced left ventricular ejection fraction (HFrEF). However, there is little real-world evidence about the efficacy of ARNIs in elderly hypertensive patients with HFrEF and comorbidities.

Methods: In this prospective open-label study, 108 subjects, 54 of them (mean age 78.6 ± 8.2 years, 75.0 % male), with HFrEF (29.8 ± 4.3 %) and New York Heart Association (NYHA) class II-III symptoms were assigned to receive ARNIs twice daily, according to the recommended dosage of 24/26, 49/51, 97/103 mg. Patients were gender- and age-matched with a control arm of patients with HFrEF receiving the optimal standard therapy for HF. The clinic blood pressure (BP), N-terminal pro-B-type natriuretic peptide (NT-proBNP), estimated glomerular filtration rate (eGFR), blood glucose and glycated hemoglobin (HbA1c), uric acid (UA), left ventricular ejection fraction (LVEF) and NYHA class were evaluated at a mean follow-up of 12 months. During the follow-up, the clinical outcomes, including mortality and re-hospitalization for HF, were collected.

Results: NYHA class significantly improved in the ARNI arm compared to the control (24.9 vs. 6.4 %, shifting from class III to II, and 55.4 vs. 25.2 %, from class II to I, p < 0.05 for all). A significant improvement in LVEF and eGFR levels was found in the ARNI arm compared to controls (42.4 vs. 34.2 %, 73.8 vs. 61.2 mL/min, respectively; p < 0.001 for all). NT-proBNP, clinic systolic and diastolic BP, blood glucose, HbA1c and UA values were reduced in both treatment arms, but they were lower in the ARNI arm compared controls (3107 vs. 4552 pg/mL, 112.2 vs. 120.4 and 68.8 vs. 75.6 mmHg, 108.4 vs. 112.6 mg/dL, 5.4 vs. 5.9 % and 5.9 vs. 6.4 mg/dL, respectively, p < 0.05). Mortality and re-hospitalization for HF was lower in the ARNI arm than controls (20.1 vs. 33.6 % and 27.7 vs. 46.3 % respectively; p < 0.05 for all). Gender differences were not found in either arm. No patients refused to continue the study, and no side effects to the ARNI treatment were observed.

Conclusions: In elderly patients with HFrEF and comorbidities, ARNI treatment seems effective and safe. The improvement in LVEF and cardiac remodeling, BP, eGFR, serum glucose, UA and HbA1c could be the mechanisms by which ARNIs play their beneficial role on clinical outcomes. However, these results need to be confirmed in studies involving a greater number of subjects, and with a longer follow-up.
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http://dx.doi.org/10.1016/j.biopha.2020.110596DOI Listing
October 2020

Prevalence of Pulmonary Hypertension in an Unselected Community-Based Population: A Retrospective Echocardiographic Study-RES-PH Study.

J Pers Med 2021 May 31;11(6). Epub 2021 May 31.

Department of Clinical and Experimental Medicine, University of Messina, 98100 Messina, Italy.

Introduction: The actual prevalence of pulmonary hypertension (PH) in Italy is unknown. Echocardiography is useful in the screening of patients with suspected PH by estimation of the pulmonary artery systolic pressure (PASP) from the regurgitant tricuspid flow velocity evaluation, according to the simplified Bernoulli equation.

Objectives: We aimed to evaluate the frequency of suspected PH among unselected patients.

Methods: We conducted a retrospective cross-sectional database search of 7005 patients, who underwent echocardiography, to estimate the prevalence of PH, between January 2013 and December 2014. Medical and echocardiographic data were collected from a stratified etiological group of PH, using criteria of the European Society of Cardiology classifications.

Results: The mean age of the study population was 57.1 ± 20.5 years, of which 55.3% were male. The prevalence of intermediate probability of PH was 8.6%, with nearly equal distribution between men and women (51.3 vs. 48.7%; = 0.873). The prevalence of high probability of PH was 4.3%, with slightly but not significant higher prevalence in female patients (43.2 vs. 56.8%; = 0.671). PH is predominant in patients with chronic obstructive pulmonary disease (COPD) or left ventricle (LV) systolic dysfunction and related with age. PASP was significantly linked with left atrial increase and left ventricular ejection fraction. In addition, an increased PASP was related to an enlargement of the right heart chamber.

Conclusions: PH has a frequency of 4.3% in our unselected population, but the prevalence may be more relevant in specific subgroups. A larger epidemiological registry could be an adequate strategy to increase quality control and identify weak points in the evaluation and treatment of these patients.
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http://dx.doi.org/10.3390/jpm11060489DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8226693PMC
May 2021

Pooled prevalence of three major cardiovascular risk factors in patients undergoing left main bifurcation stenting: a systematic review and meta-analysis.

Minerva Cardiol Angiol 2021 May 4. Epub 2021 May 4.

Division of Cardiology, Rovigo General Hospital, Rovigo, Italy.

Background: Prevalence of the major risk factors in patients with Left Main (LM) bifurcation disease has not been yet clearly assessed, although it would important for building up bifurcation computational models. We perform a systematic review and metaanalysis on the three major cardiovascular risk factors in patients treated for LM bifurcation disease using either single or 2-stent strategy.

Mehtods: In accordance with the PRISMA guidelines, Cochrane Library, Embase, PubMed and Google Scholar were queried to locate articles published between January 2015 to October 2020, comparing single- versus 2-stent strategy and reporting the prevalence of arterial hypertension (HT), hyperlipidaemia (HyperL) and diabetes mellitus (DM).

Results: Out of a total of 230 articles, 7 articles were included into the final analysis. A total of 4559 patients were enrolled: 2666 (58.4%, mean age 60.4 years, 2318 males) and 1933 patients (42.3%, mean age 64.8 years, 1763 males) received a single- and 2-stent stenting strategies, respectively. A random effect model revealed a pooled prevalence of HT, HyperL and DM in 69.4%, 38.9% and in 31% of cases, respectively. Prevalence of HT was lower in patients treated with single versus 2-stent strategy (63 versus 66.7% of patients, p=0.01) while HyperL and DM were more represented in single versus 2-stent strategy: 41.6 versus 34.1% (p<0.001), and 32.5 versus 31.8% of patients (p=0.61), respectively.

Conclusions: In patients with LM bifurcation disease undergoing either single or 2- stent strategy, HT, HyperL and DM are frequent comorbidities. In severe LM disease requiring 2-stent technique, HT is the most prevalent risk factor.
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http://dx.doi.org/10.23736/S2724-5683.21.05666-0DOI Listing
May 2021

Association of uric acid with kidney function and albuminuria: the Uric Acid Right for heArt Health (URRAH) Project.

J Nephrol 2021 Mar 23. Epub 2021 Mar 23.

Department of Medicine, University of Padua, Padua, Italy.

Background: Hyperuricemia is commonly observed in patients with chronic kidney disease (CKD). However, a better understanding of the relationship among uric acid (UA) values, glomerular filtration rate (GFR) and albuminuria may shed light on the mechanisms underlying the excess of cardiovascular mortality associated with both chronic kidney disease and hyperuricemia and lead to better risk stratification. Our main goal was to study the relationships between serum uric acid and kidney disease measures (namely estimated GFR [eGFR] and albuminuria) in a large cohort of individuals at cardiovascular risk from the URic acid Right for heArt Health (URRAH) Project database.

Methods: Clinical data of 26,971 individuals were analyzed. Factors associated with the presence of hyperuricemia defined on the basis of previously determined URRAH cutoffs for cardiovascular and all-cause mortality were evaluated through multivariate analysis. Chronic kidney disease was defined as eGFR < 60 ml/min per 1.73 m and/or abnormal urinary albumin excretion diagnosed as: (i) microalbuminuria if urinary albumin concentration was > 30 and ≤ 300 mg/L, or if urinary albumin-to-creatinine ratio (ACR) was > 3.4 mg/mmol and ≤ 34 mg/mmol; (ii) macroalbuminuria if urinary albumin concentration was > 300 mg/L, or if ACR was > 34 mg/mmol.

Results: Mean age was 58 ± 15 years (51% males, 62% with hypertension and 12% with diabetes), mean eGFR was 81 ml/min per 1.73m2with a prevalence of eGFR < 60 and micro- or macroalbuminuria of 16, 15 and 4%, respectively. Serum uric acid showed a trend towards higher values along with decreasing renal function. Both the prevalence of gout and the frequency of allopurinol use increased significantly with the reduction of eGFR and the increase in albuminuria. Hyperuricemia was independently related to male gender, eGFR strata, and signs of insulin resistance such as body mass index (BMI) and triglycerides.

Conclusions: The lower the eGFR the higher the prevalence of hyperuricemia and gout. In subjects with eGFR < 60 ml/min the occurrence of hyperuricemia is about 10 times higher than in those with eGFR > 90 ml/min. The percentage of individuals treated with allopurinol was below 2% when GFR was above 60 ml/min, it increased to 20% in the presence of CKD 3b and rose further to 35% in individuals with macroalbuminuria.
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http://dx.doi.org/10.1007/s40620-021-00985-4DOI Listing
March 2021

The importance of including uric acid in the definition of metabolic syndrome when assessing the mortality risk.

Clin Res Cardiol 2021 Jul 18;110(7):1073-1082. Epub 2021 Feb 18.

Department of Cardiovascular, Neural and Metabolic Sciences, Istituto Auxologico Italiano, IRCCS S. Luca Hospital, Lucca, Italy.

Introduction: Serum uric acid (SUA) has been depicted as a contributory causal factor in metabolic syndrome (MS), which in turn, portends unfavourable prognosis.

Aim: We assessed the prognostic role of SUA in patients with and without MS.

Methods: We used data from the multicentre Uric Acid Right for Heart Health study and considered cardiovascular mortality (CVM) as death due to fatal myocardial infarction, stroke, sudden cardiac death, or heart failure.

Results: A total of 9589 subjects (median age 58.5 years, 45% males) were included in the analysis, and 5100 (53%) patients had a final diagnosis of MS. After a median follow-up of 142 months, we observed 558 events. Using a previously validated cardiovascular SUA cut-off to predict CVM (> 5.1 mg/dL in women and 5.6 mg/dL in men), elevated SUA levels were significantly associated to a worse outcome in patients with and without MS (all p < 0.0001) and provided a significant net reclassification improvement of 7.1% over the diagnosis of MS for CVM (p = 0.004). Cox regression analyses identified an independent association between SUA and CVM (Hazard Ratio: 1.79 [95% CI, 1.15-2.79]; p < 0.0001) after the adjustment for MS, its single components and renal function. Three specific combinations of the MS components were associated with higher CVM when increasing SUA levels were reported, and systemic hypertension was the only individual component ever-present (all p < 0.0001).

Conclusion: Increasing SUA levels are associated with a higher CVM risk irrespective of the presence of MS: a cardiovascular SUA threshold may improve risk stratification.
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http://dx.doi.org/10.1007/s00392-021-01815-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8238697PMC
July 2021

High heart rate amplifies the risk of cardiovascular mortality associated with elevated uric acid.

Eur J Prev Cardiol 2021 Feb 14. Epub 2021 Feb 14.

Hypertension Unit, Division of Cardiology, Department of Clinical and Molecular Medicine, Faculty of Medicine and Psychology, University of Rome Sapienza, Sant'Andrea Hospital, Rome, Italy.

Aims : Whether the association between uric acid (UA) and cardiovascular disease is influenced by some facilitating factors is unclear. The aim of this study was to investigate whether the risk of cardiovascular mortality (CVM) associated with elevated UA was modulated by the level of resting heart rate (HR).

Methods And Results : Multivariable Cox analyses were made in 19 128 participants from the multicentre Uric acid Right for heArt Health study. During a median follow-up of 11.2 years, there were 1381 cases of CVM. In multivariable Cox models both UA and HR, either considered as continuous or categorical variables were independent predictors of CVM both improving risk discrimination (P ≤ 0.003) and reclassification (P < 0.0001) over a multivariable model. However, the risk of CVM related to high UA (≥5.5 mg/dL, top tertile) was much lower in the subjects with HR
Conclusion : This data suggest that the contribution of UA to determining CVM is modulated by the level of HR supporting the hypothesis that activation of the sympathetic nervous system facilitates the action of UA as a cardiovascular risk factor.
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http://dx.doi.org/10.1093/eurjpc/zwab023DOI Listing
February 2021

Relationships between diuretic-related hyperuricemia and cardiovascular events: data from the URic acid Right for heArt Health study.

J Hypertens 2021 02;39(2):333-340

Medicina Interna I, Ca' Foncello University Hospital, Treviso.

Objective: Although the relationship between hyperuricemia and cardiovascular events has been extensively examined, data on the role of diuretic-related hyperuricemia are still scanty. The present study was designed to collect information on the relationship between diuretic-related hyperuricemia and cardiovascular events.

Methods: The URic acid Right for heArt Health (URRAH) study is a nationwide, multicentre, observational cohort study involving data on individuals recruited from all the Italy territory under the patronage of the Italian Society of Hypertension with an average follow-up period of 122.3 ± 66.9 months. Patients were classified into four groups according to the diuretic use (yes vs. no) and serum uric acid (SUA) levels (higher vs. lower than the median value of 4.8 mg/dl). All-cause death, cardiovascular deaths and first cardiovascular event were considered as outcomes.

Results: Seventeen thousand, seven hundred and forty-seven individuals were included in the analysis. Mean age was 57.1 ± 15.2 years, men were 45.3% and SBP and DBP amounted to 144.1 ± 24.6 and 85.2 ± 13.2 mmHg. 17.2% of individuals take diuretics of whom 58% had SUA higher than median value. Patients with hyperuricemia without diuretic use served as reference group. In multivariate adjusted analysis (sex, age, SBP, BMI, glucose, total cholesterol, and glomerular filtration rate) individuals with hyperuricemia and diuretic use exhibit a similar risk for the three outcomes as compared with the reference group.

Conclusion: Our study showed that diuretic-related hyperuricemia carry a similar risk of cardiovascular events and all-cause mortality when compared with individuals that present hyperuricemia in absence of diuretic therapy.
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http://dx.doi.org/10.1097/HJH.0000000000002600DOI Listing
February 2021

Impact of number of run-off vessels on interwoven nitinol mesh stents patency in the femoropopliteal segment.

J Geriatr Cardiol 2020 Sep;17(9):561-565

Department of Surgery, Vascular Surgery Unit, Rovigo General Hospital, Rovigo, Italy.

Objective: To evaluate the impact of run-off vessels number on the outcomes of Supera stent (Abbott Vascular, Santa Clara, Calif, USA) for treatment of femoropopliteal occlusive disease.

Methods: We retrospectively evaluated the medical records of 188 consecutive patients (mean age 68.2 ± 9.6 years, 100 males) undergone angiography and woven mesh stent implantation in femoral or popliteal arteries or both arterial segments, in our institution between January 1 2014 and January 1 2018. Target lesion revascularization and major adverse limb events at 12-month were evaluated comparing patients with 1-, 2- or 3-run-off vessels in the foot.

Results: Interventional success was achieved in 100%. Stent implantation involved in the femoral site in 56 patients (30.3%), the femoropopliteal in 92 patients (48.9%) and the popliteal site in 40 patients (21.3%). A significant improvement of ankle-brachial index (0.29 ± 0.6 . 0.88 ± 0.3, < 0.001) and Rutherford class (5.3 ± 0.8 . 0.7 ± 1.9, < 0.01) were observed before discharge. The median follow-up duration was 12.3 months (inter quartile range: 11.0 to 13.9). During the follow-up period, 52 patients (27.6%) had clinical events. Primary patency at 12 months was 72.4%. The primary patency significantly increased when the runoff status. Comparing the number of events among patients with different number of run-off vessels, a significant difference ( < 0.001) was observed for patients having one (24.0%) and two run-off vessels (15.0%).

Conclusions: The outcomes of Supera stent in femoropopliteal occlusive disease depend strictly on the number of run-off vessels.
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http://dx.doi.org/10.11909/j.issn.1671-5411.2020.09.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7568043PMC
September 2020

Ultrathin Biodegradable-Polymer Orsiro Drug-Eluting Stent Performance in Real Practice Challenging Settings.

Cardiovasc Revasc Med 2021 Sep 23;30:12-17. Epub 2020 Sep 23.

Department of Cardiology, Rovigo General Hospital, Rovigo, Italy.

Background: The Orsiro cobalt-chromium stent platform (Biotronik, Bülach, Switzerland) is one of the first devices in the era of ultrathin struts. However, data regarding the efficacy of Orsiro stent in patients with challenging anatomical conditions obtained from daily clinical practice are scant.

Methods: We retrospectively reviewed the long-term outcomes, defined as target lesion revascularization (TLR), target vessel revascularization (TVR), stent thrombosis (ST) and cardiovascular (CV) mortality over a six years period, in 1161 consecutive patients (mean age 64.3 ± 11.2 years old, 681 males) treated with 2327 Orsiro stents in our institution who presented with challenging anatomic/angiographic features.

Results: The mean number of implanted stents was 1.7 ± 2.1 whereas the mean stent diameter and length were 3.6 ± 1.1 and 32.7 ± 15.6 mm, respectively. Mean follow-up duration was 35.6 ± 17 months (range 1-77 months); 923 patients (79.5%) reached the 3-year follow-up. The global rates of TLR, TVR, ST and CV mortality were 0.1%, 1.37%, 0.002%, and 1.9%, respectively with scarce statistically significant differences in multivessel disease, severe calcification, and lesion length > 41 mm. Multivariate regression analysis revealed that age, stent dislodgement, early stent thrombosis (p = 0.001) and lesion length ≥ 41 mm (p = 0.001) were independent predictors of TVR. Similarly, the occurrence of TLR was independently predicted by age, severe calcification, use of IVUS and Rotablator (p = 0.002), early stent thrombosis, LM bifurcation and length ≥ 41 mm (p = 0.001).

Conclusions: The Orsiro stent confirmed a very high efficacy profile in all anatomical scenarios with very low rates of clinically driven TLR and TVR, CV mortality and ST at 3-years.
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http://dx.doi.org/10.1016/j.carrev.2020.09.027DOI Listing
September 2021

Serum uric acid, predicts heart failure in a large Italian cohort: search for a cut-off value the URic acid Right for heArt Health study.

J Hypertens 2021 01;39(1):62-69

Hospital S. Maria della Misericordia, Perugia, Italy.

Objective: To assess the prognostic cut-off values of serum uric acid (SUA) in predicting fatal and morbid heart failure in a large Italian cohort in the frame of the Working Group on Uric Acid and Cardiovascular Risk of the Italian Society of Hypertension.

Methods: The URic acid Right for heArt Health (URRAH) study is a nationwide, multicentre, cohort study involving data on individuals aged 18-95 years, recruited on a community basis from all regions of Italy under the patronage of the Italian Society of Hypertension with a mean follow-up period of 128 ± 65 months. Incident heart failure was defined on the basis of International Classification of Diseases Tenth Revision codes and double-checked with general practitioners and hospital files. Multivariate Cox regression models having fatal and morbid heart failure as dependent variables, adjusted for sex, age, SBP, diabetes, estimated glomerular filtration rate, smoking habit, ethanol intake, BMI, haematocrit, LDL cholesterol, previous diagnosis of heart failure and use of diuretics as possible confounders, were used to search for an association between SUA as a continuous variable and heart failure. By means of receiver operating characteristic curves, two prognostic cut-off values (one for all heart failure and one for fatal heart failure) were identified as able to discriminate between individuals doomed to develop the event. These cut-off values were used as independent predictors to divide individuals according to prognostic cut-off values in a multivariate Cox models, adjusted for confounders.

Results: A total of 21 386 individuals were included in the analysis. In Cox analyses, SUA as a continuous variable was a significant predictor of all [hazard ratio 1.29 (1.23-1.359), P < 0.0001] and fatal [hazard ratio 1.268 (1.121-1.35), P < 0.0001] incident heart failure. Cut-off values of SUA able to discriminate all and fatal heart failure status were identified by mean of receiver operating characteristic curves in the whole database: SUA more than 5.34 mg/dl (confidence interval 4.37-5.6, sensitivity 52.32, specificity 63.96, P < 0.0001) was the univariate prognostic cut-off value for all heart failure, whereas SUA more than 4.89 mg/dl (confidence interval 4.78-5.78, sensitivity 68.29, specificity 49.11, P < 0.0001) for fatal heart failure. The cut-off for all heart failure and the cut-off value for fatal heart failure were accepted as independent predictors in the Cox analysis models, the hazard ratios being 1.645 (1.284-2.109, P < 0.0001) for all heart failure and 1.645 (1.284-2.109, P < 0.0001) for fatal heart failure, respectively.

Conclusion: The results of the current study confirm that SUA is an independent risk factor for all heart failure and fatal heart failure, after adjusting for potential confounding variables and demonstrate that a prognostic cut-off value can be identified for all heart failure (>5.34 mg/dl) and for fatal heart failure (>4.89 mg/dl).
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http://dx.doi.org/10.1097/HJH.0000000000002589DOI Listing
January 2021

Effectiveness and Safety of Novel Nutraceutical Formulation Added to Ezetimibe in Statin-Intolerant Hypercholesterolemic Subjects with Moderate-to-High Cardiovascular Risk.

J Med Food 2021 Jan 22;24(1):59-66. Epub 2020 May 22.

Italian Society of Nutraceutical Formulators (SIFNUT), Treviso, Italy.

The effectiveness of statins in the primary and secondary prevention of cardiovascular (CV) diseases has been widely proven. However, the onset of adverse events associated with their use prevents to achieve the therapeutic targets recommended by the guidelines (GL) for the management of dyslipidemia. In the event of statin intolerance, the GL recommend to use bile acid sequestrants, fibrates, and ezetimibe in monotherapy, but their benefits in improving lipid pattern are quite modest. This study aims at evaluating the effectiveness and safety of a nutraceutical compound (NC) associated with ezetimibe (EZE) on the lipid profile in statin-intolerant patients with moderate-to-high CV risk. Ninety-six statin-intolerant hypertensive and hypercholesterolemic subjects treated pharmacologically with EZE 10 mg daily were randomized in open label ( = 48) to take for 3 months a NC containing Monacolin-K (MK), Berberine Hydrochloride (BC), t-Resveratrol (RES), Quercetin (QUER), and Chromium (CH) in the form of a gastro-resistant tablet that improves enteric bioaccessibility and bioavailability of these substances. The control group ( = 48) took only EZE in monotherapy at the same dosage; both groups followed a standardized lipid-lowering diet. The total serum cholesterol (TC), low density lipoprotein cholesterol (LDLC), high density lipoprotein cholesterol (HDLC), triglycerides (TG), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatinine phosphokinase (CPK) levels were compared at the follow-up in both groups using Student's -test. TC and LDL levels reduced in both groups, but were lower in the group treated with EZE + NC (-25.9% vs. -15%,  < .05 and -38.7% vs. -21.0%,  < .05, respectively). No changes were observed in either group regarding a decrease in TG (-9.4% vs. -11.7%, NS) and an increase in HDLC (+4.2% vs. +1.1%, NS). The AST, ALT, and CPK levels increased in the group treated with the EZE + NC compared to the control group, but were still within the acceptable range. There was no difference concerning the lipid-lowering treatment between gender, and no patient withdrew from the study. In the short term, the EZE + NC combination therapy is well tolerated and effective in improving TC and LDLC levels in statin-intolerant patients with moderate-to-high CV risk.
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http://dx.doi.org/10.1089/jmf.2020.0019DOI Listing
January 2021

Italian Society of Arterial Hypertension (SIIA) Position Paper on the Role of Renal Denervation in the Management of the Difficult-to-Treat Hypertensive Patient.

High Blood Press Cardiovasc Prev 2020 Apr 10;27(2):109-117. Epub 2020 Mar 10.

University of L'Aquila, L'Aquila, Italy.

Renal denervation is a device-based procedure for hypertension for which safety and efficacy has been demonstrated. At present, its clinical use is still matter of debate, despite the most recent clinical trials have shown promising results with new-generation devices in various hypertensive populations. This position paper was deemed necessary by the Italian Society of Arterial Hypertension, in order to provide indications about the applications of renal denervation in the clinical setting. A state-of-the art review of the literature, focusing on safety and efficacy data, is provided. Furthermore, based on current evidence and expert consensus, clinical profiles of possible candidates for renal denervation are proposed. The selection process should take into account not only blood pressure values, global cardiovascular risk profile, but also drug adherence and tolerability and patient preferences. This position paper also defines minimum requirements for renal denervation selection centers and a flowchart for the difficult-to-treat hypertensive patient. Further studies are needed to support these preliminary indications, which are based on expert-consensus only.
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http://dx.doi.org/10.1007/s40292-020-00367-0DOI Listing
April 2020

Identification of the Uric Acid Thresholds Predicting an Increased Total and Cardiovascular Mortality Over 20 Years.

Hypertension 2020 02 9;75(2):302-308. Epub 2019 Dec 9.

Studium Patavinum, Department of Medicine (E.C., P.P.), University of Padua, Italy.

Serum uric acid (SUA) levels discriminating across the different strata of cardiovascular risk is still unknown. By utilizing a large population-based database, we assessed the threshold of SUA that increases the risk of total mortality and cardiovascular mortality (CVM). The URRAH study (Uric Acid Right for Heart Health) is a multicentre retrospective, observational study, which collected data from several large population-based longitudinal studies in Italy and subjects recruited in the hypertension clinics of the Italian Society of Hypertension. Total mortality was defined as mortality for any cause, CVM as death due to fatal myocardial infarction, stroke, sudden cardiac death, or heart failure. A total of 22 714 subjects were included in the analysis. Multivariate Cox regression analyses identified an independent association between SUA and total mortality (hazard ratio, 1.53 [95% CI, 1.21-1.93]) or CVM (hazard ratio, 2.08 [95% CI, 1.146-2.97]; <0.001). Cutoff values of SUA able to discriminate total mortality (4.7 mg/dL [95% CI, 4.3-5.1 mg/dL]) and CVM status (5.6 mg/dL [95% CI, 4.99-6.21 mg/dL]) were identified. The information on SUA levels provided a significant net reclassification improvement of 0.26 and of 0.27 over the Heart Score risk chart for total mortality and CVM, respectively (<0.001). Sex-specific cutoff values for total mortality and CVM were also identified and validated. In conclusion, SUA levels increasing the risk of total mortality and CVM are significantly lower than those used for the definition of hyperuricemia in clinical practice. Our data provide evidence of a cardiovascular SUA threshold that might contribute in clinical practice to improve identification of patients at higher risk of CVM.
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http://dx.doi.org/10.1161/HYPERTENSIONAHA.119.13643DOI Listing
February 2020

Correlations between serum homocysteine levels and RoPE score in patients with patent foramen ovale.

Heart Vessels 2020 May 1;35(5):705-711. Epub 2019 Nov 1.

Department of Internal Medicine, Hypertension Centre, Rovigo General Hospital, Rovigo, Italy.

The pathophysiological relationship between elevated serum homocysteine (Hcy) levels and patent foramen ovale (PFO) has not yet been completely clarified. In the present study, we assess the correlation between serum homocysteine levels and the RoPE score in PFO patients. We retrospectively reviewed clinical and instrumental data of 244 subjects referred to a single tertiary center for PFO evaluation and/or treatment between January 2010 and January 2018,stratified as closure and control group, respectively. Patients in the closure group had an higher serum Hcy levels compared to the control group (28.5 ± 8.5 vs 10.2 ± 6.6 μg/dL, p < 0.0001). A significant direct correlation was observed between serum Hcy levels and the RoPE Score in the entire population. A positive significant correlation continued to exist also in the closure and control groups (r = 0.472, p < 0.0001 and r = 0.378, p < 0.0001, respectively). A receiver operating characteristics curve identified the optimal cutoff value of homocysteinemia as a predictor of RoPE score > 7 in the closure group (AUC 0.90, 95% CI 0.81-0.94, p < 0.0001) when 19.5 μg/dL. Multivariate logistic regression analysis demonstrated that an Hcy serum level ≥ 19.5 μg/dL predict an RoPE score > 7 (OR 3.21, 95% CI 2.82-3.26, p < 0.0001) in closed patients independently from the presence of permanent right-to-left (RLS) (OR 2.28, 95% CI 2.01-2.43, p = 0.001) and atrial septal aneurysm (ASA) (OR 3.04, 95% CI 2.64-3.51, p < 0.0001). Serum homocysteine levels in PFO patients are positively correlated with the RoPE score. Moreover, a homocysteinemia ≥ 19.5 μg/dL predicts an RoPE score > 7 independently from the presence of a permanent RLS and a concomitant ASA.
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http://dx.doi.org/10.1007/s00380-019-01528-5DOI Listing
May 2020

Serum uric acid and fatal myocardial infarction: detection of prognostic cut-off values: The URRAH (Uric Acid Right for Heart Health) study.

J Hypertens 2020 03;38(3):412-419

Department of Clinical and Experimental Sciences, University of Brescia, Brescia.

Objective: The Working Group on Uric Acid and Cardiovascular Risk of the Italian Society of Hypertension conceived and designed an ad-hoc study aimed at searching for prognostic cut-off values of serum uric acid (SUA) in predicting fatal myocardial infaction (MI) in women and men.

Methods: The URic acid Right for heArt Health study is a nationwide, multicentre, observational cohort study involving data on individuals aged 18-95 years recruited on a regional community basis from all the territory of Italy under the patronage of the Italian Society of Hypertension with a mean follow-up period of 122.3 ± 66.9 months.

Results: A total of 23 467 individuals were included in the analysis. Cut-off values of SUA able to discriminate MI status were identified by mean of receiver operating characteristic curves in the whole database (>5.70 mg/dl), in women (>5.26 mg/dl) and in men (>5.49 mg/dl). Multivariate Cox regression analyses adjusted for confounders (age, arterial hypertension, diabetes, chronic kidney disease, smoking habit, ethanol intake, BMI, haematocrit, LDL cholesterol and use of diuretics) identified an independent association between SUA and fatal MI in the whole database (hazard ratio 1.381, 95% confidence intervals, 1.096-1.758, P = 0.006) and in women (hazard ratio 1.514, confidence intervals 1.105-2.075, P < 0.01), but not in men.

Conclusion: The results of the current study confirm that SUA is an independent risk factor for fatal MI after adjusting for potential confounding variables, and demonstrate that a prognostic cut-off value associated to fatal MI can be identified at least in women.
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http://dx.doi.org/10.1097/HJH.0000000000002287DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7012356PMC
March 2020

Long-term effect of the perindopril/indapamide/amlodipine single-pill combination on left ventricular hypertrophy in outpatient hypertensive subjects.

Biomed Pharmacother 2019 Dec 15;120:109539. Epub 2019 Oct 15.

Department of Nuclear Medicine, Radiology, Neuroradiology, Medical Physics, Clinical Laboratory, Microbiology, Pathology, Trasfusional Medicine, Santa Maria della Misericordia Hospital, Rovigo, Italy.

Background: Most antihypertensive drugs used in monotherapy or in combination therapy reduce the left ventricular mass index (LVMI). However, little is known about the effects on LVMI of a triple fixed-dose combination (TFC) therapy, containing in a single pill an angiotensin-converting enzyme inhibitor (ACEI), a diuretic and a calcium channel blocker (CCB).

Methods: In this prospective open-label study, 92 patients with essential hypertension were randomized to treatment with a TFC of perindopril/indapamide/amlodipine at different doses or a triple free combination therapy (FCT) including ACEI/diuretic/CCB. Office blood pressure (BP) measurement, 24 h-ambulatory BP monitoring and echocardiography were performed at baseline and during a 14-month follow-up. The BP variability (BPV) over 24 h was calculated as ± standard deviation of the daytime systolic BP. Differences between office and monitored BP and LVMI were evaluated by ANOVA for repeated measures.

Results: A significant BP-lowering effect was observed for both treatments. At follow-up, BPV was reduced in both the treatment groups vs. the baseline (14.0±1.5 vs. 17.0±1.8 and 16.2±2.1 vs. 17.6±2.3, respectively), but it was lower in the TFC vs. the FCT group (14.0±1.5 vs. 16.1±2.2, P < 0.05). LVMI was lower in both the treatment groups, but the change was greater for TFC vs. FCT (-8.3±4.9% vs. -2.0 ±2.1%, P < 0.0001). Left ventricular hypertrophy (LVH) regression was greater in the TFC vs. the FCT group (43.5% vs. 30.4%, P < 0.05).

Conclusions: Independently of BP values achieved, the antihypertensive TFC therapy was more effective than FCT in LVMI reduction and LVH regression, possibly related to drugs' intrinsic properties and to BPV modulation.
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http://dx.doi.org/10.1016/j.biopha.2019.109539DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7104809PMC
December 2019

The Effects of a New Generation of Nutraceutical Compounds on Lipid Profile and Glycaemia in Subjects with Pre-hypertension.

High Blood Press Cardiovasc Prev 2019 Aug 27;26(4):345-350. Epub 2019 Jul 27.

Hypertension Centre and Internal Medicine and Geriatrics, San Donato Hospital, USL 8, Arezzo, Italy.

Introducion: Treatment strategies for patients with pre-hypertension and low-moderate cardiovascular (CV) risk may include nutraceutical compounds (NCs).

Aim: To investigate the efficacy and safety of a new-generation of NC in lowering BP values and improving metabolic profile, in a group of hyper-cholesterolemic subjects with pre-hypertension.

Methods: 131 subjects with pre-hypertension (systolic BP 130-139 mmHg and/or diastolic BP 85-89 mmHg) without organ damage and history of CV diseases were enrolled. 66 subjects were treated with a once-daily oral formulation of a NC (red yeast rice, Berberine, Coenzyme Q10, folic acid and chrome) added to diet for 3 months, while 65 patients followed a diet only. Differences in serum total cholesterol (TC), low- and high-density lipoprotein cholesterol (LDLC and HDLC), triglycerides (TG), glycemia, creatine phosphokinase (CPK), aspartate aminotransferase (AST) alanine aminotransferase (ALT) and body mass index (BMI) were evaluated.

Results: At the end of treatment, significant reductions of TC, LDLC, TG glucose levels were observed in both treatment groups, while HDLC values increased in the active treatment group only. A greater reduction of TC, LDLC and glycemia was observed in the treatment group. TG levels were not different within the two groups. BP and BMI levels remained unchanged, as well AST, ALT; CPK slightly increased in both groups, but it remained in the normal range.

Conclusions: In patients with pre-hypertension, NC supplementation was safe, well tolerated and effective in improving lipid pattern and glucose levels and in preventing the progression to overt hypertension.
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http://dx.doi.org/10.1007/s40292-019-00332-6DOI Listing
August 2019

Left atrial enlargement as a maker of significant high-risk patent foramen ovale.

Int J Cardiovasc Imaging 2019 Nov 19;35(11):2049-2056. Epub 2019 Jul 19.

Division of Cardiology, Echocardiography Lab, Rovigo General Hospital, Rovigo, Italy.

Left atrial (LA) enlargement is a marker of LA cardiopathy and, in patients with patent foramen ovale (PFO), is associated with an increased risk of ischemic stroke. The primary study outcome was the comparison of LA diameter between patients undergoing percutaneous PFO closure versus those treated conservatively. The secondary endpoints were the association of LA diameter with the Risk of Paradoxical Emboli (ROPE) score and the presence of Atrial septal aneurysm (ASA) and Right-To-Left Shunt (RLS). Retrospective analysis of clinical and instrumental data of 1040 subjects referred to a single tertiary center for PFO evaluation and treatment. Seven hundred and nineteen patients were enrolled: 495 patients (closure group, mean RoPE score 7.6 ± 0.8) underwent PFO closure while 224 patients (control group, mean RoPE score 4.1 ± 0.9. p < 0.001) were left to medical therapy. Preoperative LA diameter was significantly larger in closure group and reduced from 44.3 ± 9.1 to 37.3 ± 4.1 mm (p = 0.01) 1 year after the procedure to the size of controls. A larger LA diameter was associated with permanent RLS, RLS curtain pattern, ASA presence and multiple ischemic brain lesions pattern at neuroimaging. A LA diameter ≥ 43 mm was a predictor a RoPEscore > 7. In our patients' cohort, LA diameter was associated with the clinic severity of PFO and RLS. The reversal of LA enlargement after PFO closure suggests a role for RLS to induce LA cardiopathy. LA enlargement has the potential to be considered per se as an indication to transcatheter PFO repair.
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http://dx.doi.org/10.1007/s10554-019-01666-xDOI Listing
November 2019

Long-Term Clinical Outcomes of Isolated Ostial Left Anterior Descending Disease Treatment: Ostial Stenting Versus Left Main Cross-Over Stenting.

Cardiovasc Revasc Med 2019 Dec 31;20(12):1058-1062. Epub 2019 Jan 31.

Interventional Cardiology Department, Whintorp Hospital, New York, NY, USA.

Background: The optimal strategy for treating ostial left anterior descending coronary artery (LAD) disease remains matter of speculation. We evaluated the impact on long-term outcomes of ostial LAD disease treated by means of ostial stenting (the floating-stent) or left main (LM)-to-LAD cross-over stenting.

Methods: Clinical and instrumental records of 74 consecutive patients with isolated ostial LAD disease, enrolled between the 1st January 2012 and the 1st January 2017 were reviewed. Patients have been stratified according the stenting techniques adopted: ostial stenting (OS) or LM cross-over (CO).

Results: Seventy-four consecutive patients (54 males, mean age 73.39 ± 9.54 years old) have been analyzed. In CO patients the SYNTAX score (16.2 ± 3.3 vs 24.1 ± 2.5, p < 0.0001) and the percentages of rotablation resulted higher than in OS group. IVUS has been predominantly used in CO groups revealing a significant extension of plaque burden of at least 10 mm of LM proximal to the LAD ostium in all the 18 out of 21 patients (85.7%) undergone IVUS-guided procedure. Fluoroscopy time and contrast medium volume were higher in OS versus CO group of patients. On a mean follow-up of 49.7 ± 7.9 months, MACE and target vessel revascularization (TVR) were 21.0% and 21.0% in OS groups versus 10.1 and 5.6% in the CO group (p = 0.20 and p = 0.04, respectively). Restenosis was higher in the OS than in CO group of patients and was located angiographically at the ostium.

Conclusions: On long-term follow-up CO seems to be superior to OS technique for isolated ostial LAD disease especially in the presence of heavy calcification.
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http://dx.doi.org/10.1016/j.carrev.2019.01.030DOI Listing
December 2019

Hypertensive Crisis with Neurological Impairment Mimicking a Guillain-Barrè Syndrome: Searching for a Link.

High Blood Press Cardiovasc Prev 2018 Dec 8;25(4):421-424. Epub 2018 Oct 8.

Studium Patavium (Formerly Department of Medicine), University of Padova, Padua, Italy.

Guillain-Barré syndrome (GBS) may be complicated by severe hypertension (HT) and in turns severe HT can occur with neurological damage mimicking a GBS, so that underlying causes should be investigated. We describe a case of a 62-year-old woman presented to the emergency department for hypertensive crisis with symmetric flaccid paralysis, hypotonia and hyporeflexia of both upper and lower limbs. Brain computed tomography, magnetic resonance imaging and lumbar puncture were normal. Laboratory investigations revealed severe hypokalemia, renal failure, liver impairment, rabdomyolysis, metabolic alkalosis, and low plasma renin and aldosterone levels. Continuous potassium replacement led to complete clinical resolution. A detailed history revealed chronic intake of 250 g/day black liquorice. Hypokalaemic muscle weakness may simulate a GBS. When serum potassium level falls below 2.5 mmol/l, rhabdomyolysis may occur. In this clinical case, an apparent mineralocorticoid excess syndrome was induced by chronic ingestion of liquorice. This latter contains the glycyrrhetic acid that inhibits the enzyme 11-β-hydroxysteroid dehydrogenase enzyme type-2 leading an aldosterone-like effect and causing hypertension, hypokalemia, metabolic alkalosis and low renin values. The clinical presentation is similar to that observed in the primary aldosteronism, but in this syndrome plasma aldosterone levels are low rather than elevated as in primary aldosteronism. Liquorice-induced hypertension with severe hypokalemia and rhabdomyolysis is a rare condition and the initial presentation with acute muscle paralysis is still more unusual. Before performing instrumental examinations in middle-aged peoples with hypertension crisis and neurological impairment, a detailed clinical history is mandatory.
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http://dx.doi.org/10.1007/s40292-018-0283-yDOI Listing
December 2018

Effect of Monacolin K and COQ10 supplementation in hypertensive and hypercholesterolemic subjects with metabolic syndrome.

Biomed Pharmacother 2018 09 19;105:992-996. Epub 2018 Jun 19.

Department of Nuclear Medicine, Radiology, Neuroradiology, Medical Physics, Clinical Laboratory, Microbiology, Pathology, Trasfusional Medicine, Santa Maria della Misericordia Hospital, Viale Tre Martiri 140, Rovigo, Italy. Electronic address:

Introduction: Metabolic syndrome (MetS) is a world-wide epidemic disease with an increased risk of morbidity and mortality. Treatment strategies of MetS include pharmacologic and non-pharmacologic interventions and in this respect a relevant role has been shown for nutraceutical compounds (NCs). The aim of this study was to investigate the efficacy and safety of NCs incorporated with diet and lifestyle management versus diet alone, in lowering blood pressure (BP) values and improving lipid and glucose profile, in a group of hypertensives and hyper-cholesterolemic patients with MetS.

Methods: 104 subjects with MetS (mean age 57.4 ± 8.8 years, 51% males) without history of cardio-vascular (CV) diseases were enrolled in the study. 52 subjects were treated with a once-daily oral formulation of a NCs containing red yeast rice and coenzyme Q10 added to their diet for 2 months and were compared with the 52 patients following a diet program. Differences in BP, serum total cholesterol (TC), low- and high-density-lipoprotein cholesterol (LDLC and HDLC), triglycerides (TG) and glucose values were compared by analysis of variance.

Results: A significant reduction of BP, TC, TG, LDLC and glucose levels was observed in both treatment groups. However, a greater reduction of systolic BP (-5.2 vs. -3.0 mmHg), diastolic BP (-4.9 vs. 2.9 mmHg), total cholesterol (-17.2%), LDLC (-21.8%), TG (-16.0%) and serum glucose (-3.4%) was observed in the treatment group relative to the control (p < 0.001 for all); HDLC remained unchanged (p = N.S.). Gender difference was not found in either group (p = N.S.).

Conclusions: In patients with MetS, NC supplementation was safe, well tolerated and effective in improving clinic BP, lipid and glucose profile.
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http://dx.doi.org/10.1016/j.biopha.2018.06.076DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6361161PMC
September 2018

The short-term supplementation of monacolin K improves the lipid and metabolic patterns of hypertensive and hypercholesterolemic subjects at low cardiovascular risk.

Food Funct 2018 Jul;9(7):3845-3852

ESH Excellence Hypertension Centre, Internal Medicine Unit, Santa Maria della Misericordia General Hospital, AULSS 5 Polesana, Rovigo, Italy.

Background - The clinical hypocholesterolemic effect of nutraceutical compounds (NCs) containing red yeast rice extracts providing a daily dose of 2.5-10 mg of monacolin K is now well established. For this reason, NCs may be a viable alternative to the statin drugs commonly used to lower cholesterol levels. However, in order to avoid some possible statin-like side effects, most NCs available on the market contain low doses of monacolin K, which could reduce their efficacy. The aim of this study was to investigate the efficacy and safety of a NC containing high doses of monacolin K (10 mg) in improving the lipid profile and glucose metabolism when added to the diet versus the diet alone in a group of hypertensive and hyper-cholesterolemic subjects at low cardiovascular risk. Methods - Thirty subjects with grade-1 essential hypertension (mean age 51.5 ± 7.8 years, 62.9% males) were enrolled in the treatment group (NC group). These subjects followed a programmed diet and took one tablet a day of a NC containing red yeast rice, policosanols, resveratrol and chromium picolinate for 1 month and were compared with an equivalent group of subjects that followed only a diet program. Differences in serum total cholesterol (TC), low-density- and high-density-lipoprotein cholesterol (LDLC and HDLC), triglycerides (TG) and blood glucose between groups were compared by analysis of variance. Results - In both groups, a significant reduction of TC, TG and LDLC was observed. In the treatment group from the baseline to the follow-up the reduction of TC (230.93 ± 28.0 vs. 188.63 ± 18.1, p < 0.001) and LDLC (153.10 ± 22.5 vs. 116.54 ± 17.7, p < 0.001) was significantly greater compared to the control group (differences between treatments = 9.19% and 12.29%, respectively); in addition a significant higher reduction in blood glucose (89.1 ± 7.6 vs. 83.7 ± 4.6, p < 0.001) was also observed (differences between treatments = 4.28%). HDLC levels remained unchanged in both groups. Conclusions - In summary, the NC containing high doses of monacolin K appeared to be safe, well tolerated and effective at improving lipid and glucose patterns.
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http://dx.doi.org/10.1039/c8fo00415cDOI Listing
July 2018

Caffeine intake reduces incident atrial fibrillation at a population level.

Eur J Prev Cardiol 2018 07 25;25(10):1055-1062. Epub 2018 Apr 25.

1 Department of Medicine, University of Padua, Italy.

Background The general belief is that caffeine increases the risk of hyperkinetic arrhythmias, including atrial fibrillation. The aim of this study is to investigate the effect of chronic caffeine intake on incident atrial fibrillation in general population. Design and methods A population cohort of 1475 unselected men and women observed for 12 years and left free to intake food or beverages containing caffeine was studied. Subjects were stratified into tertiles of caffeine intake both in the whole cohort and after genotyping for the -163C > A polymorphism of the CYP1A2 gene, regulating caffeine metabolism. Results In the whole cohort, the 12-year incidence of atrial fibrillation was significantly lower in the third (2.2%) than in the first (10.2%) or second (5.7%) tertile of caffeine intake ( P < 0.001). The same trend was observed in all genotypes; the apparently steeper reduction of atrial fibrillation in slow caffeine metabolisers found at univariate analysis was proved wrong by multivariate Cox analysis. Age, chronic pulmonary disease, history of heart failure and of coronary artery disease, and systolic blood pressure - but not the genotype or the caffeine ×  CYP1A2 interaction term - were significant confounders of the association between incident atrial fibrillation and being in the third tertile of caffeine intake (hazard ratio 0.249, 95% confidence intervals 0.161-0.458, P < 0.01). Conclusions A higher caffeine intake (>165 mmol/day or > 320 mg/day) is associated with a lower incidence of atrial fibrillation in the 12-year epidemiological prospective setting based on the general population.
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http://dx.doi.org/10.1177/2047487318772945DOI Listing
July 2018

Caffeine intake and abstract reasoning among 1374 unselected men and women from general population. Role of the -163C>A polymorphism of CYP1A2 gene.

Clin Nutr ESPEN 2017 Aug 29;20:52-59. Epub 2017 Apr 29.

Department of Medicine, Unit of Vascular Medicine, University of Padua, Via Giustiniani No. 2, 35128 Padua, Italy.

Background And Aims: The possible effect of caffeine as an enhancer of cognitive performance, particularly that on abstract reasoning, has never been studied in an epidemiological setting, especially in relation to -163C>A polymorphism of CYP1A2 gene, largely controlling caffeine metabolism. Aim of this study was to ascertain whether in general population free chronic caffeine intake modifies abstract reasoning, and if this effect is influenced by the above mentioned genotype, by age, schooling, ethanol intake and smoking habits.

Methods: We studied 1374 unselected men and women aged 51 ± 15 years (range 18-89) from a general population. Daily caffeine intake deriving from coffee, tea, chocolate or cola was calculated from an anamnestic questionnaire and from a 7-day dietary diary. Abstract reasoning was measured in the frame of a neuropsychological assessment as the ability to find a concept linking two words indicating objects or actions and explaining how they were connected.

Results: In age-schooling-adjusted linear regression, the higher the caffeine intake, the better the abstraction score. Abstract reasoning depended on caffeine in the -163C>A CC homozygous only (so-called slow metabolizers), where it was higher in the 3rd tertile of caffeine intake. Age and ethanol reduced while smoking and schooling enhanced this association. The interaction term between caffeine and the -163C>A polymorphism was accepted in linear regressions. Caffeine consumption resulted innocuous for the A-carriers (so-called fast metabolizers).

Conclusions: In general population, a positive association between caffeine intake and abstract reasoning exists in the CC homozygous of the -163C>A polymorphism of CYP1A2 gene.
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http://dx.doi.org/10.1016/j.clnesp.2017.04.001DOI Listing
August 2017

Hybrid metal/scaffold-jacket versus full-metal jackets in left anterior descending coronary artery diffuse disease: Differences in radiation exposure and fluoroscopic/procedural times.

Cardiovasc Revasc Med 2017 Dec 18;18(8):592-595. Epub 2017 May 18.

Section of Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, Rovigo, Italy.

Background/purpose: Bioabsorbable vascular scaffolds (BVS) are made from a radiolucent material. Their multiple implantations on a single long diffused segment requires a specific technique with imaging magnification, which could cause an increase in dose delivered during percutaneous coronary intervention (PCI) procedure. We aimed to identify differences in radiation dose, fluoroscopy and procedural times in Hybrid DES+ multiple BVS (Absorb, Abbott Inc., USA) implantation (hybrid metal/scaffold jacket) versus multiple III generation Drug-eluting stents (DES) (full-metal jacket) in patients with long and diffuse coronary artery disease of the left anterior descending (LAD) coronary artery.

Methods/materials: Patients with long and diffuse LAD disease were enrolled in a registry from 1st February 2015 to 1st February 2017. Patients treated with hybrid DES/BVS (at least three) jacket (n=72 procedure) were compared with a 2:1 matched cohort of exclusive multiple overlapped DES (full-metal jacket) patients in the same period (n=114 procedures).

Results: Patients had similar baseline characteristics due to matching. Radiation exposure (6035.7±2846.8 vs 4251.1±1787.3cGy∗cm, p<0.0001, Δ=1784.5±1055.6), fluoroscopy time (16.2±4.5 vs 9.1±2.4, p<0.0001) and procedure time (64.2±18.5 vs 5 8.7±13.5, p=0.02) were higher in patients treated using hybrid metal/scaffold jacket compared that regular full-metal jacket.

Conclusion: The use of hybrid metal/scaffold jacket for the treatment of long and diffuse disease of LAD is associated with a higher fluoroscopy time and radiation exposure compared to full-metal jacket, quantifiable in approximately 35%.
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http://dx.doi.org/10.1016/j.carrev.2017.05.015DOI Listing
December 2017

Cost-benefit effectiveness of angiotensin-II receptor blockers in patients with uncomplicated hypertension: A comparative analysis.

Biomed Pharmacother 2017 Jun 14;90:665-669. Epub 2017 Apr 14.

Departement of Nuclear Medicine, Hospital Santa Maria della Misericordia, Rovigo, Italy.

Objective: The treatment of hypertensive patients (HTs) requires a long-term commitment of compliance for the patient and resources by the healthcare system. This poses an economic dilemma in countries where universal healthcare is standard. The aim of this study was to evaluate the costs/health benefit and effectiveness of treatment with angiotensin-II receptor blockers (ARBs) in uncomplicated essential hypertension.

Design And Methods: The daily and annual economic commitment for treating patients with ARBs was estimated using pharmacy dispensing records and the BP-lowering effects of candesartan, irbesartan, losartan, olmesartan, telmisartan and valsartan was evaluated retrospectively. In 114 HTs (mean age 59.4±13.5year, 57.5% men), the BP-lowering effect of ARBs as in monotherapy and in fixed-dose combination (FDC) with hydrochlorothiazide at the doses commonly used in the market to reach BP control (i.e. BP <140/90mmHg) was analyzed. The BP lowering-effect was evaluated after an average of 6-month follow-up consulting medical professionals. Analysis of variance for repeated measures was provided.

Results: Treatment with candesartan (14.1%) and olmesartan (32,4%) versus other ARBs resulted in a significant decrease in BP as for mono- than for FDC therapy. Our studies suggest that daily (data not shown) and annual costs of olmesartan were higher than candesartan as in mono- (4577.71±1120.55 vs. 894.25±127.75 €) than for FDC therapy (5715.90±459.90 vs. 1580.45±113.15 €).

Conclusions: Treatment: of BP with candesartan appears to be the most favorable option in terms of cost-effectiveness coupled with favorable health outcomes. These data have some limitations, but open the question if candesartan should be preferred to olmesartan in BP management. Further prospective studies comparing ARBs based on their effect on BP control in uncomplicated HTs are needed for validation.
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http://dx.doi.org/10.1016/j.biopha.2017.04.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5553545PMC
June 2017

Fixed-Dose Triple Combination of Antihypertensive Drugs Improves Blood Pressure Control: From Clinical Trials to Clinical Practice.

Adv Ther 2017 04 15;34(4):975-985. Epub 2017 Mar 15.

Department of Medicine, S. Maria della Misericordia Hospital, AULSS 5 Polesana, Rovigo, Italy.

Introduction: Blood pressure (BP) control is the main clinical goal in the management of hypertensive patients; however, BP in most of these patients remains uncontrolled, despite the widespread availability of antihypertensive drugs as free-combination therapy. This study compared the efficacy of a fixed-dose triple combination (FDTC) of antihypertensive drugs with that of a free combination of three antihypertensives in patients with uncontrolled hypertension.

Methods: Ninety-two patients (mean age 60.8 ± 12.1, 58.0% male) with uncontrolled essential hypertension (office systolic BP ≥ 140 or diastolic BP ≥ 90 mmHg) previously treated with a renin-angiotensin-aldosterone system (RAAS) inhibitor plus hydrochlorothiazide were switched to once-daily FDTC therapy with perindopril/indapamide/amlodipine (5-10/1.25-2.5/5-10 mg). Patients were age- and sex-matched with a control group of hypertensive patients receiving free-combination therapy with three drugs including a RAAS inhibitor, a diuretic, and a calcium channel blocker. Office BP and 24-h ambulatory BP monitoring (ABPM) were evaluated at baseline and after 1 and 4 months.

Results: Significant reductions in ambulatory 24-h, daytime, and nighttime systolic BP, and pulse pressure (PP) were found in the FDTC group relative to reductions seen with free-combination therapy, after the first month only of follow-up. Target BP values (mean 24-h ambulatory systolic/diastolic BP < 130/80 mmHg) were reached by more recipients of FDTC than free-combination therapy (64.8% vs. 46.9%, p < 0.05) at month 4 of follow-up, despite reductions in 24-h ABPM values from baseline being similar in both groups at this time point.

Conclusion: FDTC of perindopril/indapamide/amlodipine was effective at reducing SBP and PP in previously treated patients with uncontrolled hypertension, and well tolerated, providing support for clinicians in choosing a fixed-dose triple combination over the free-combination of a RAAS inhibitor, a diuretic, and a calcium antagonist.
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http://dx.doi.org/10.1007/s12325-017-0511-1DOI Listing
April 2017

Catecholamine-Induced Chest Pain Mimicking Infarction Due to an MIBG-Negative and DOPA-Positive Succinate Dehydrogenase Syndrome Subunit B-Related Pheochromocytoma.

Clin Nucl Med 2017 Jun;42(6):489-491

From the Departments of *Internal Medicine, and †Nuclear Medicine, Radiology, Neuroradiology, Medical Physics, Clinical Laboratory, Microbiology, Pathology, Molecular Biology, "Santa Maria della Misericordia" Hospital, Rovigo, Italy; and ‡Department of Radiology, University of Southern California, Los Angeles, CA.

This 16-year-old boy presented with acute retrosternal pain possibly representing acute myocardial infarction. Cardiac enzymes were within reference ranges. There were marked increases in metanephrine to 3299 μg/24 h (reference, <400 μg/24 h), normetanephrine to 1309 μg/24 h (reference, 0-390 μg/24 h), and chromogranin A to 1605 ng/mL (reference, 0-150 μg/24 h). An incidental left adrenal mass was found during CTPA performed to exclude pulmonary embolism. I-MIBG scintigraphy was negative, and genetic screening detected SDHB (succinate dehydrogenase syndrome subunit B) gene mutation. Based on the gene mutation, F-DOPA PET/CT was performed, confirming a left-sided pheochromocytoma.
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http://dx.doi.org/10.1097/RLU.0000000000001634DOI Listing
June 2017

Asymptomatic hyperuricemia is a strong risk factor for resistant hypertension in elderly subjects from general population.

Biomed Pharmacother 2017 Feb 24;86:590-594. Epub 2016 Dec 24.

Department of Internal Medicine, University of Padova, Padova, Italy.

Objective: In clinical practice, patient characteristics predicting resistant hypertension (RH) include higher blood pressure levels, left ventricular hypertrophy, older age, obesity, chronic kidney disease and diabetes. On the contrary little is known about the role of serum uric acid (SUA) as a risk factor for RH in subjects from general population.

Material And Methods: 580 elderly subjects aged ≥65 years were enrolled in the Risk Of Vascular complications Impact of Genetics in Old people (ROVIGO) study. RH was defined as the failure to maintain blood pressure values below 140mmHg (systolic) and 90mmHg (diastolic) despite therapeutic interventions that include appropriate lifestyle measures plus adherence to treatment with full doses of at least three antihypertensive drugs, including a diuretic. RH was confirmed using 24-h ambulatory blood pressure measurement. Hyperuricemic was defined as the subjects having SUA ≥6.8mg/dl or taking uricosuric drugs. Gender-specific odds ratio (OR) for RH was calculated by logistic regression analysis.

Results: The prevalence of RH was 5.7% in the cohort and was higher in women (8.3%) than in men (3.0%, p<0.05). Independent of chronic kidney disease (OR 3.89, 95% confidence interval 1.49-10.1), hyperuricemia predicted resistant hypertension in women (odds ratio 3.11, 95% confidence intervals 1.06-9.1, p=0.03) but not in men.

Conclusions: In elderly women from the general population, an SUA value of ≥6.8mg/dl triples the risk of RH. SUA assessment should be recommended to better define the pattern of risk associated with RH.
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http://dx.doi.org/10.1016/j.biopha.2016.11.104DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5331939PMC
February 2017
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