Trend in potassium intake and Na/K ratio in the Italian adult population between the 2008 and 2018 CUORE project surveys.

BACKGROUND AND AIMS: Low potassium intake, in addition to high sodium, has been associated with higher risk of hypertension and CVD. The Study assessed habitual potassium intake and sodium/potassium ratio of the Italian adult population from 2008 to 2012 to 2018-2019 based on 24-h urine collection, in the framework of the CUORE Project/MINISAL-GIRCSI/MENO SALE PIU' SALUTE national surveys. METHODS AND RESULTS: Data were from cross-sectional surveys of randomly selected age-and-sex stratified samples of resident persons aged 35-74 years in 10 (out of 20) Italian regions. Urinary electrolyte and creatinine measurements were performed in a central laboratory. Analyses considered 942 men and 916 women, examined in 2008-2012, and 967 men and 1010 women, examined in 2018-2019. In 2008-2012, the age-standardized mean of potassium intake (urinary potassium accounts for 70% of potassium intake) was 3147 mg (95% CI 3086-3208) in men and 2784 mg (2727-2841) in women, whereas in 2018-2019, it was 3043 mg (2968-3118) and 2561 mg (2508-2614) respectively. In 2008-2012, age-adjusted prevalence of persons with an adequate potassium intake (i.e. ≥ 3510 mg/day) was 31% (95% CI 28-34%) for men and 18% (16-21%) for women; in 2018-2019, it was 26% (23-29%) and 12% (10-14%) respectively. The sodium/potassium ratio significantly decreased both in men and women. CONCLUSIONS: The average daily potassium intake of the Italian general adult population remains lower than the WHO and EFSA recommended level. These results suggest the need of a revision to strengthen initiatives for the promotion of an adequate potassium intake at the population level.

Trend of salt intake measured by 24-h urine collection in the Italian adult population between the 2008 and 2018 CUORE project surveys.

BACKGROUND AND AIMS: The WHO Global Action Plan for the Prevention of non-communicable diseases (NCDs) recommends a 30% relative reduction in mean population salt/sodium intake. The study assessed the trend in the habitual salt intake of the Italian adult population from 2008 to 2012 to 2018-2019 based on 24-h urinary sodium excretion, in the framework of the CUORE Project/MINISAL-GIRCSI/MENO SALE PIU' SALUTE national surveys. METHODS AND RESULTS: Data were from cross-sectional surveys of randomly selected age and sex-stratified samples of resident persons aged 35-74 years in 10 (out of 20) Italian Regions distributed in North, Centre and South of the Country. Urinary sodium and creatinine measurements were carried out in a central laboratory. The analyses included 942 men and 916 women examined in 2008-2012, and 967 men and 1010 women examined in 2018-2019. The age-standardized mean daily population salt (sodium chloride) intake was 10.8 g (95% CI 10.5-11.1) in men and 8.3 g (8.1-8.5) in women in 2008-2012 and respectively 9.5 g (9.3-9.8) and 7.2 g (7.0-7.4) in 2018-2019. A statistically significant (p<0.0001) salt intake reduction was thus observed over 10 years for both genders, and all age, body mass index (BMI) and educational classes. CONCLUSIONS: The average daily salt intake of the Italian general adult population remains higher than the WHO recommended level, but a significant reduction of 12% in men and 13% in women has occurred in the past ten years. These results encourage the initiatives undertaken by the Italian Ministry of Health aimed at the reduction of salt intake at the population level.

Organ donor screening for carbapenem-resistant gram-negative bacteria in Italian intensive care units: the DRIn study.

The 759 cases of brain death declaration (BDD [Italian law, 6 hours of observation time]) that occurred in 190 Italian intensive care units (ICUs) between May and September 2012 were studied to quantify carbapenem-resistant gram-negative bacteria (CR-GN) isolated in organ donors, to evaluate adherence to national screening guidelines, and to identify risk factors for CR-GN isolation. Mandatory blood, bronchoalveolar lavage, and urine cultures were performed on the BDD day in 99% of used donors. Because results were rarely made available before transplant, >20% of transplants were performed before obtaining any microbiological information, and organs from 15 of 22 CR-GN cases were used. Two (lung-liver) of the 37 recipients died, likely because of donor-derived early CR-GN sepsis. ICU stay >3 days (odds ratio [OR] = 7.49, P = .004), fever (OR = 3.11, P = .04), age <60 years (OR = 2.80, P = .06), and positive ICU epidemiology (OR = 8.77, P = .07) were associated with CR-GN isolation. An association between single ICU and risk of CR-GN was observed, as a result of differences across ICUs (ICC = 29%; 95% confidence interval [CI] 6.5%-72%) probably related to inadequate practices of infection control. Continuous education aimed at implementing priority actions, including stewardship programs for a rational use of antimicrobials, is a priority in healthcare systems and transplant networks. Improved awareness among ICU personnel regarding the importance of early CR-GN detection and timely alert systems might facilitate decisions regarding organ suitability and eventually save recipient lives.

Infections in liver and lung transplant recipients: a national prospective cohort.

Infections are a major complication of solid organ transplants (SOTs). This study aimed to describe recipients' characteristics, and the frequency and etiology of infections and transplant outcome in liver and lung SOTs, and to investigate exposures associated to infection and death in liver transplant recipients. The study population included recipients of SOTs performed in Italy during a 1-year period in ten Italian lung transplant units and eight liver transplant units. Data on comorbidities, infections, retransplantation, and death were prospectively collected using a web-based system, with a 6-month follow-up. The cumulative incidence of infection was 31.7% and 47.8% in liver and lung transplants, respectively, with most infections occurring within the first month after transplantation. Gram-negatives, which were primarily multidrug-resistant, were the most frequent cause of infection. Death rates were 0.42 per 1000 recipient-days in liver transplants and 1.41 per 1000 recipient-days in lung transplants. Infection after SOT in adult liver recipients is associated to an increased risk of death (OR = 13.25; p-value < 0.001). Given the frequency of infection caused by multidrug-resistant microorganisms in SOT recipients in Italy and the heavy impact of infections on the transplant outcome, the reinforcement of surveillance and control activities to prevent the transmission of multidrug-resistant microorganisms in SOT recipients represents a priority. The implementation of the study protocol in liver and lung transplant units and the sharing of results have increased the awareness about the threat due to antimicrobial resistance in the country.

From the EU Legislation to the Application of the Single European Code: Support to the Implementation.

The Italian National Transplant Centre (CNT) is coordinating with the Italian National Blood Centre (CNS) the Joint Action '!' (www.eurocet128.eu), already built the European Tissue Establishment and Tissue and Cell Product Compendia between 2011 and 2014 in order to provide European Member States with a tool which would grant traceability of tissues and cells at human transplant purpose across the European Union. The two compendia are available on an online platform hosted and managed by the European Commission.

Cardiovascular Risk Profile in Master Paralympic Athletes, a High-Risk Undertreated Population: A Cross-Sectional Longitudinal Study.

INTRODUCTION: Recently, European Society of Cardiology (ESC) validated a prediction model to estimate 10-year fatal and non-fatal cardiovascular disease risk (CVDR) in individuals (aged 40-60 years) without previous cardiovascular disease or diabetes (ESC-SCORE2) and to provide indications for treatment. At present, data describing the CVDR in Paralympic athletes (PAs) are scarce and inconsistent. Therefore, we sought to assess the prevalence of risk factors in PAs to estimate their CVDR through SCORE2. METHODS: We enrolled 99 PAs aged ≥ 40 y.o., who participated at 2012-2022 Paralympic Games, competing in 22 different sport disciplines classified according to sport type (power, skills, endurance and mixed) and disabilities: spinal cord injuries (SCI) and non-SCI. CVDR factors, anthropometric measurements and blood samples were collected. RESULTS: Among the 99 PAs (78% males, mean age 45.7 ± 4.7 y.o.), 52.5% had SCI; 54% were dyslipidemic and 23% were smokers. According to ESC-SCORE2, 29% had high and 1% very-high CVDR. Women (compared to men) and endurance (compared to other sport) exhibited better CV profile. SCI showed no differences when compared with non-SCI for CVDR, excepted for a lower HDL and lower exercise performance. None of the dyslipidemic athlete was on pharmacologically treatment, despite the altered lipid profile had already been detected at younger age. CONCLUSION: PAs are a selected population, presenting a high CV risk profile, with 30% showing either high or very-high CVDR according to ESC-SCORE2. Dyslipidemia was the most common risk factor, underestimated and undertreated, emphasizing the need for specific preventive strategies in this special setting of athletes.

Nutrition, Physical Activity and Smoking Habit in the Italian General Adult Population: CUORE Project Health Examination Survey 2018-2019.

BACKGROUND: Tobacco consumption, incorrect nutrition and insufficient physical activity/sedentariness represent modifiable NCDs risk factors in Western countries. To evaluate recent lifestyle indicators in Italy, data from the national Health Examination Survey (HES), implemented in 2018-2019 within the CUORE Project, were assessed. METHODS: Age-sex standardized results from random samples of Italian general population (35-74 years) were reported by sex, age-class, educational level and geographical area. From 2106 participants, 2090 were considered for smoking habit, 2016 for physical activity and 1578 for nutrition. Standardized questionnaires were used for smoking habit and physical activity, and the EPIC questionnaire for nutrition. RESULTS: Total cigarette current smokers were 23% in men and 19% in women; sedentariness during leisure time was 34% in men and 45% in women and at work 45% and 47% in men and women, respectively. Prevalence of balanced eating behaviours for vegetables was 28% in men and 39% in women; and for fruits 50% and 52%, respectively; prevalence of correct lifestyle (not smoker, regular physical activity and following at least five correct eating behaviours) was 7% and 12% for men and women, respectively. CONCLUSIONS: In 2018-2019, levels of unhealthy lifestyles were found to be still epidemic and basically stable compared to 10 years earlier (slight smoking habit decrease, slight sedentariness increase and slight nutrition improvements); intersectoral strategies and monitoring need to be continued.

Incretins-Based Therapies and Their Cardiovascular Effects: New Game-Changers for the Management of Patients with Diabetes and Cardiovascular Disease.

Atherosclerosis is the leading cause of death worldwide, especially in patients with type 2 diabetes mellitus (T2D). GLP-1 receptor agonists and DPP-4 inhibitors were demonstrated to play a markedly protective role for the cardiovascular system beyond their glycemic control. Several cardiovascular outcome trials (CVOT) reported the association between using these agents and a significant reduction in cardiovascular events in patients with T2D and a high cardiovascular risk profile. Moreover, recent evidence highlights a favorable benefit/risk profile in myocardial infarction and percutaneous coronary revascularization settings. These clinical effects result from their actions on multiple molecular mechanisms involving the immune system, platelets, and endothelial and vascular smooth muscle cells. This comprehensive review specifically concentrates on these cellular and molecular processes mediating the cardiovascular effects of incretins-like molecules, aiming to improve clinicians' knowledge and stimulate a more extensive use of these drugs in clinical practice as helpful cardiovascular preventive strategies.

The Regulatory Approach for Faecal Microbiota Transplantation as Treatment for Clostridioides difficile Infection in Italy.

Faecal microbiota transplantation (FMT) is regarded as an efficacious treatment for recurrent C. difficile infection. Unfortunately, widespread patient access is hindered by regulatory hurdles, which are the primary barriers to incorporating FMT into clinical practice. At the European and International level, there is no uniform perspective on FMT classification, and a coordinated effort is desirable to solve this regulatory puzzle. In this communication, we report the regulatory principles and the implementation approach for FMT application in Italy. Our experience suggests that the EU Tissue and Cell Directives are suited to ensure safe and efficient FMT for C. difficile management, especially through extensive high-quality donor selection and full traceability maintenance.

Trends of overweight, obesity and anthropometric measurements among the adult population in Italy: The CUORE Project health examination surveys 1998, 2008, and 2018.

BACKGROUND/OBJECTIVES: Obesity is associated with an increased risk of noncommunicable diseases, such as diabetes, coronary heart disease, stroke, cancers, and conditions, including obstructive sleep apnea and osteoarthritis. Obesity is largely preventable, and halting its rise is one of the World Health Organization Global Action Plan for the Prevention of Noncommunicable Diseases targets. This study aimed to assess trends of anthropometric measurements in Italy using the data collected within the CUORE Project health examination surveys (HESs) 1998, 2008, and 2018. SUBJECTS/METHODS: Within the HESs 1998-2002, 2008-2012, and 2018-2019, anthropometric measurements were collected in random samples of the resident population aged 35-74 years, stratified by age and sex, from 10 Italian Regions in Northern, Central, and Southern Italy (2984 men and 2944 women, 2224 men and 2188 women, 1035 men and 1065 women, respectively). Weight, height, and waist and hip circumferences were measured using standardized methodologies. A standardized questionnaire was used to collect data on education. Indicators were age standardized. RESULTS: For both men and women, mean body mass index in 2018 was comparable with those in 1998 and 2008 (in 1998, 2008, and 2018-men: 26.7, 27.5, and 27.0 kg/m2; women: 26.2, 26.6, and 26.3 kg/m2). In 1998, 2008, 2018 prevalence of overweight resulted 49%, 47%, 46% in men and 33%, 32%, 28% in women respectively; prevalence of obesity resulted 17%, 24% 20% in men and 19%, 23%, 23% in women respectively. All indicators of excess weight worsen with increasing age and are more severe in persons with a lower educational level. CONCLUSIONS: Although the overall trend of excess weight over the past two decades appeared to be substantially stable in the Italian adult population, the continuous strengthening of undertaken initiatives should continue since there remains a high proportion of overweight or obesity and a gap between educational levels.

Lumen apposing metal stents vs double pigtail plastic stents for the drainage of pancreatic walled-off necrosis.

BACKGROUND: Few studies compared lumen-apposing metal stents (LAMS) and standard double pigtail plastic stents (PS) for the endoscopic drainage of pancreatic walled-off necrosis (WON). Albeit sometimes large, previously described cohorts display considerable heterogeneity and often pooled together data from several centers, involving multiple operators and techniques. Moreover, they often lack a control group for the comparison of outcomes. AIM: to compare clinical efficacy and safety of PS versus LAMS for the endoscopic drainage of infected WON. METHODS: Single-centre, 1:1 case-control study. We compared patients undergoing endoscopic drainages of infected WON through LAMS (cases) or PS (controls). The primary endpoint was the clinical efficacy (resolution of the WON/sepsis), the secondary endpoint was safety (procedure-related complications). RESULTS: Thirty patients were enrolled between 2011 and 2017. Cases and controls were homogeneous in terms of etiology and clinical characteristics. 93% of cases and 86.7% of controls were clinically successfully treated, with no significant differences in rates of post-operative infections, bleedings and stent migrations (respectively 13.3% vs 21.4%; p=0.65; 13.3% vs 0%; p=0.48; 13.3% vs 7.1%; p=1.00). No difference was shown regarding the need for additional percutaneous or surgical treatments (33.3% vs 13.3%; p=0.39). Cases, however, displayed a significantly prolonged mean hospital stay (90.2 days vs 18.5 days; p<0.01) and a higher mean number of endoscopic procedures per patient (4.8 vs 1.5; p<0.01). CONCLUSIONS: PS might be not inferior to LAMS for the treatment WONs. Further prospective RCT is needed to compare clinical efficacy and safety in the two groups.

Trends of blood pressure, raised blood pressure, hypertension and its control among Italian adults: CUORE Project cross-sectional health examination surveys 1998/2008/2018.

OBJECTIVES: To assess in the Italian general adult population the trends of blood pressure (BP) and prevalence of raised BP (RBP), hypertension and its control in order to evaluate population health and care, and the achievement of an RBP 25% relative reduction as recommended by the WHO at population level. DESIGN: Results comparison of health examination surveys, cross-sectional observational studies based on health examination of randomly selected age and sex stratified samples including residents aged 35-74 years. Data of the 2018/2019 survey were compared with the previous ones collected in 1998/2002 and 2008/2012. SETTING: Health examination surveys conducted in Italy within the CUORE Project following standardised methodologies. PARTICIPANTS: 2985 men and 2955 women examined in 1998/2002, 2218 men and 2204 women examined in 2008/2012 and 1031 men and 1066 women examined in 2018/2019. PRIMARY AND SECONDARY OUTCOME MEASURES: Age-standardised mean of BP, prevalence of RBP (systolic BP and/or diastolic BP ≥140/90 mm Hg), hypertension (presenting or being treated for RBP) and its awareness and control, according to sex, age class and educational level. RESULTS: In 2018/2019, a significant reduction was observed in systolic BP and diastolic BP in men (1998/2002: 136/86 mm Hg; 2008/2012: 132/84 mm Hg; and 2018/2019: 132/78 mm Hg) and women (132/82 mm Hg, 126/78 mm Hg and 122/73 mm Hg), and in the prevalence of RBP (50%, 40% and 30% in men and 39%, 25% and 16% in women) and of hypertension (54%, 49% and 44% in men and 45%, 35% and 32% in women). Trends were consistent by age and education attainment. In 2018/2019, hypertensive men and women with controlled BP were only 27% and 41%, but a significant favourable trend was observed. CONCLUSIONS: Data from 2018/2019 underlined that RBP is still commonly observed in the Italian population aged 35-74 years, however, the WHO RBP target at that time may be considered met.

The EUROCET Network: Support for Coding, Vigilance and Surveillance.

BACKGROUND: In the last years, there have been increasing concerns about the safety and traceability of human tissues and cells in Europe. In order to regulate this part of medical practice, the European Commission issued 3 directives between 2004 and 2006 and endorsed EUROCET to support member states in fulfilling some of their obligations. MATHODS: EUROCET created a connection with the European Union (EU) Competent Authorities (CAs) and set up a website where lists of the CAs, the authorized Tissue Establishments (TEs) and the activity data are published and updated. Moreover, EUROCET is involved within the Vigilance and Surveillance of Substances of Human Origin (SOHO V&S) project, aiming to support the EU member states in the establishment of vigilance and surveillance systems for tissues and cells. EUROCET is also working with EU stakeholders to develop a common coding system concerning donation and products. RESULTS: There are 33 countries in EUROCET and 57 CAs. 3,974 TEs are recorded: 1,108 for tissues, 1,480 for haematopoietic progenitor cells and 1,386 for assisted reproduction. On the website, it is possible to find the 2010 activity data report. CONCLUSION: Based on its cooperation with the CAs, EUROCET represents them in the European network. Nowadays, the EU member states can rely on a web portal and database in order to put the tissue and cell directives into practice.

The Italian National Faecal Microbiota Transplantation Program: a coordinated effort against Clostridioides difficile infection.

Clostridioides (previously Clostridium) difficile infection (CDI) is a common cause of antibiotic-associated diarrhea, whose symptoms range from mild diarrhea to life-threatening pseudomembranous colitis. CDI is characterized by significant recurrence rate following initial resolution and recurrent C. difficile infection (rCDI) represents an onerous burden for the healthcare systems. Conventional antibiotic-based approaches are generally used for the treatment of rCDI but the effective therapy remains elusive. Recently, the faecal microbiota transplantation (FMT) has emerged as an alternative therapeutic strategy against rCDI, with high treatment success rate. In 2018, the Italian National FMT Program was launched, with the aim to provide high quality standards in FMT application to adults with rCDI not responding to antibiotic therapy. Here, we sketch out the key characteristics and the progress of the Italian National FMT Program during the COVID-19 pandemic.

HLA and AB0 Polymorphisms May Influence SARS-CoV-2 Infection and COVID-19 Severity.

BACKGROUND: SARS-CoV-2 infection is heterogeneous in clinical presentation and disease evolution. To investigate whether immune response to the virus can be influenced by genetic factors, we compared HLA and AB0 frequencies in organ transplant recipients and waitlisted patients according to presence or absence of SARS-CoV-2 infection. METHODS: A retrospective analysis was performed on an Italian cohort composed by transplanted and waitlisted patients in a January 2002 to March 2020 time frame. Data from this cohort were merged with the Italian registry of COVID+ subjects, evaluating infection status of transplanted and waitlisted patients. A total of 56 304 cases were studied with the aim of comparing HLA and AB0 frequencies according to the presence (n = 265, COVID+) or absence (n = 56 039, COVID-) of SARS-CoV-2 infection. RESULTS: The cumulative incidence rate of COVID-19 was 0.112% in the Italian population and 0.462% in waitlisted/transplanted patients (OR = 4.2; 95% CI, 3.7-4.7; P < 0.0001). HLA-DRB1*08 was more frequent in COVID+ (9.7% and 5.2%: OR = 1.9, 95% CI, 1.2-3.1; P = 0.003; Pc = 0.036). In COVID+ patients, HLA-DRB1*08 was correlated to mortality (6.9% in living versus 17.5% in deceased: OR = 2.9, 95% CI, 1.15-7.21; P = 0.023). Peptide binding prediction analyses showed that these DRB1*08 alleles were unable to bind any of the viral peptides with high affinity. Finally, blood group A was more frequent in COVID+ (45.5%) than COVID- patients (39.0%; OR = 1.3; 95% CI, 1.02-1.66; P = 0.03). CONCLUSIONS: Although preliminary, these results suggest that HLA antigens may influence SARS-CoV-2 infection and clinical evolution of COVID-19 and confirm that blood group A individuals are at greater risk of infection, providing clues on the spread of the disease and indications about infection prognosis and vaccination strategies.

Incidence of carbapenem-resistant gram negatives in Italian transplant recipients: a nationwide surveillance study.

BACKGROUND: Bacterial infections remain a challenge to solid organ transplantation. Due to the alarming spread of carbapenem-resistant gram negative bacteria, these organisms have been frequently recognized as cause of severe infections in solid organ transplant recipients. METHODS AND FINDINGS: Between 15 May and 30 September 2012 we enrolled 887 solid organ transplant recipients in Italy with the aim to describe the epidemiology of gram negative bacteria spreading, to explore potential risk factors and to assess the effect of early isolation of gram negative bacteria on recipients' mortality during the first 90 days after transplantation. During the study period 185 clinical isolates of gram negative bacteria were reported, for an incidence of 2.39 per 1000 recipient-days. Positive cultures for gram negative bacteria occurred early after transplantation (median time 26 days; incidence rate 4.33, 1.67 and 1.14 per 1,000 recipient-days in the first, second and third month after SOT, respectively). Forty-nine of these clinical isolates were due to carbapenem-resistant gram negative bacteria (26.5%; incidence 0.63 per 1000 recipient-days). Carbapenems resistance was particularly frequent among Klebsiella spp. isolates (49.1%). Recipients with longer hospital stay and those who received either heart or lung graft were at the highest risk of testing positive for any gram negative bacteria. Moreover recipients with longer hospital stay, lung recipients and those admitted to hospital for more than 48h before transplantation had the highest probability to have culture(s) positive for carbapenem-resistant gram negative bacteria. Forty-four organ recipients died (0.57 per 1000 recipient-days) during the study period. Recipients with at least one positive culture for carbapenem-resistant gram negative bacteria had a 10.23-fold higher mortality rate than those who did not. CONCLUSION: The isolation of gram-negative bacteria is most frequent among recipient with hospital stays >48 hours prior to transplant and in those receiving either heart or lung transplants. Carbapenem-resistant gram negative isolates are associated with significant mortality.