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Background Nursing home (NH) residents have been dramatically affected by COVID-19, with extremely high rates of hospitalization and mortality. Aims To describe the features and impact of an assistance model involving an intermediate care mobile medical specialist team (GIROT, Gruppo Intervento Rapido Ospedale Territorio) aimed at delivering “hospital-at-nursing home” care to NH residents with COVID-19 in Florence, Italy. Methods The GIROT activity was set-up during the first wave of the pandemic (W1, March–April 2020) and became a structured healthcare model during the second (W2, October 2020–January 2021). The activity involved (1) infection transmission control among NHs residents and staff, (2) comprehensive geriatric assessment including prognostication and geriatric syndromes management, (3) on-site diagnostic assessment and protocol-based treatment of COVID-19, (4) supply of nursing personnel to understaffed NHs. To estimate the impact of the GIROT intervention, we reported hospitalization and infection lethality rates recorded in SARS-CoV-2-positive NH residents during W1 and W2. Results The GIROT activity involved 21 NHs (1159 residents) and 43 NHs (2448 residents) during W1 and W2, respectively. The percentage of infected residents was higher in W2 than in W1 (64.5% vs. 38.8%), while both hospitalization and lethality rates significantly decreased in W2 compared to W1 (10.1% vs 58.2% and 23.4% vs 31.1%, respectively). Discussion Potentiating on-site care in the NHs paralleled a decrease of hospital admissions with no increase of lethality. Conclusions An innovative “hospital-at-nursing home” patient-centred care model based on comprehensive geriatric assessment may provide a valuable contribution in fighting COVID-19 in NH residents.

Background The aim of this work is to examine the performance of surgeries, by evaluating the results. The evaluation of the results, with particular attention to complications, is the corner stone to identify the causes leading to correction of any predisposing factors and reducing risks, to improve quality of care. Methods We performed a retrospective analysis of 952 consecutive patients who had elective or emergency surgery from November 1, 2018 to October 31, 2019. We classified surgical intervention according to their complexity. The Clavien Dindo classification was used to categorize the complications. We performed a stepwise multivariate logistic-regression analysis, with the presence of post-operative complications as dependent variable and age, gender, BMI, ASA, type of surgery procedures, complexity of surgery, operative time as covariates. Results A total of 952 surgical procedures were included in this study. Abdominal procedures were the most frequent type of surgery performed (52.1%). Post-operative complications occurred in 120 surgical procedures (12.6%), these are related to the increase of the ASA score and the longer average operative time, with an increase of developing complication of 5% for each additional 10 minutes of surgery. Conclusions many factors influence postoperative morbidity and mortality. Particular attention was due to complication's evaluation, about all in abdominal surgery and high complexity procedures. We argue that key factors which influence the favourable surgical outcome are: compliance with standardized safety procedures, volume of activity of the structure, presence of interdisciplinary care groups, and ability of health professionals in recognizing and promptly treating complications.

Background In randomized clinical trials, compared to Internal Medicine, admission to Geriatrics improved clinical outcomes of frail older patients accessing the Emergency Department (ED). Whether this advantage is maintained also in the “real world” is uncertain. We compared long-term survival of patients admitted to Geriatrics or Internal Medicine wards after stratification for background risk and across a variety of discharge diagnoses. Method Data were derived from the “Silver Code National Project,” an observational study of 180,079 unselected 75+ years old persons, admitted via the ED to Internal Medicine (n = 169,717, 94.2%) or Geriatrics (n = 10,362) wards in Italy. The Dynamic Silver Code (DSC), based on administrative data, was applied to balance for background risk between participants admitted to Geriatrics or Internal Medicine. Results One-year mortality was 33.7%, lower in participants discharged from Geriatrics (32.1%) than from Internal Medicine (33.8%; p < .001), and increased progressively across four DSC risk classes (p < .001). Admission to Geriatrics was associated with survival advantage in DSC class II to IV participants, with HR (95% CI) of 0.88 (0.83–0.94), 0.86 (0.80–0.92), and 0.92 (0.86–0.97), respectively. Cerebrovascular diseases, cognitive disorders, and heart failure were the discharge diagnoses with the widest survival benefit from admission to Geriatrics, which was mostly observed in DSC class III. Conclusions Admission to Geriatrics may provide long-term survival benefit in subjects who, based on the DSC, may be considered at an intermediate risk. Specific clinical conditions should be considered in the ED to improve selection of patients to be targeted for Geriatrics admission.

to assess the extent of the excess mortality from all causes in 2020 compared to 2015-2019 in Central Tuscany (Italy) as a proxy to estimate COVID-19-related excess mortality and to identify demographic and clinical differences between subjects who died from COVID-19 and those who died from other causes in 2020.descriptive analysis of the temporal trend of general mortality.the study population is represented by the 1.6 million residents living in the territory of the Central Tuscany Healthcare Authority in Central Italy, i.e., little less than half of the population of Tuscany, in an area of just over one fifth of the entire region, where the provinces of Florence, Pistoia, and Prato are comprised. MAIN OUTCOME MEASURES: using the Italian National Resident Population Registry (ANPR) as a source of mortality data, standardized mortality ratios with 95% confidence intervals were calculated to compare the number of deaths in 2020 with the number of deaths expected on the basis of mortality data from 2015 to 2019. Furthermore, after record linkage with data from the integrated surveillance of cases of SARS-CoV-2 virus infection and with the MaCro dataset of comorbidities, the characteristics of subjects who died from COVID-19 were compared with those of patients who died from other causes using a multivariate logistic regression model; odds ratios with 95% confidence intervals were calculated.a statistically significant excess mortality was observed during the first pandemic wave in March and April, and during the second wave in the fall; it ranged between +9% in March and +51% in November. On the contrary, in January, February, and May, all-cause mortality was significantly lower than in previous years. The male gender, dyslipidaemia, and dementia were positively associated with death from COVID-19 rather than from all other causes. On the contrary, heart failure and recent tumours were more represented among deaths from other causes. CONCLUSIONS: much of the over-mortality observed in spring is attributable to the harvesting effect COVID-19 exerted on a segment of population with serious underlying chronic conditions and who in the previous months had survived a mild winter and a flu season of medium intensity. In the second pandemic wave, in autumn, the impact of both direct and indirect effects of COVID-19 was substantially higher. Consistently with the available evidence, death from COVID-19 was related to the male gender and to clinical conditions such as dyslipidaemia and dementia.

SARS-CoV-2 vaccination has significantly reduced infection, hospitalization, and lethality rates among nursing home (NH) residents, but durability of vaccine effects remains unknown. This study investigated the long-term impact of BNT162b2 SARS-CoV-2 vaccine on breakthrough infection rates in the NHs of Florence, Italy.Participants included residents living in Florence NHs as of April 1st, 2021, who had completed the primary SARS-CoV2 vaccination course by February 15th, 2021. Weekly rates of breakthrough infection were calculated between April 1st and October 31st 2021, with 7-day incidence defined as the number of new confirmed SARS-CoV-2-positive residents over the vaccinated resident census. Hospital admissions and deaths were recorded from local administrative and clinical sources. Patients admitted to NHs after April 1st were excluded to avoid confounding effect of different vaccination timing.Among 2271 vaccinated residents (mean age 86.6, 74% female), we recorded 105 cases of breakthrough infections. Rates of breakthrough infection remained very low in the 6 months after vaccination, but started to rise over the following months, peaking at 0.94%, and then became stable around 0.2%-0.3%. Over the study period, infection rates remained low as compared to the incidence of SARS-CoV-2 infection during pre-vaccination period. Overall hospitalization and lethality rates were 8%.Among vaccinated NH residents, rates of breakthrough SARS-CoV-2 infection, hospitalization and lethality remained low up to 9 months following primary vaccination course. A mild resurgence of SARS-CoV-2 infection, after 6 months from vaccination, suggests a decline of vaccine effectiveness in preventing transmission.

Objective Studies suggesting that vulnerability increased short-term mortality in older patients with COVID-19 enrolled hospitalized patients and lacked COVID-negative comparators. Aim of this study was aim to examine the relationship between frailty and 1-year mortality in older patients with and without COVID-19, hospitalized and non-hospitalized. Design Cohort study Setting and Participants Patients 75+ accessing the Emergency Departments (ED) were identified from the ED archives in [location]. Methods Vulnerability status was estimated with the Dynamic Silver Code (DSC). COVID-19 hospital discharges (HC+) were compared to non-COVID-19 discharges (HC-). Linkage with a national COVID-19 registry identified non-hospitalized ED visitors with (NHC+) or without COVID-19 (NHC-). Results In 1 year, 48.4% and 33.9% of 1,745 HC+ and 15,846 HC- participants died (p, Vulnerability increased long-term mortality similarly in hospitalized subjects with and without COVID-19. In non-hospitalized subjects, COVID-19 impaired survival relatively more in robust patients.

Evidence on the effectiveness of SARS-CoV-2 vaccines in nursing home (NHs) residents is limited. We examined the impact of the BNT162b2 mRNA SARS-CoV-2 vaccine on the course of the epidemic in NHs in the Florence Health District, Italy, before and after vaccination. Moreover, we assessed survival and hospitalization by vaccination status in SARS-CoV-2-positive cases occurring during the post-vaccination period. We calculated the weekly infection rates during the pre-vaccination (1 October–26 December 2020) and post-vaccination period (27 December 2020–31 March 2021). Cox analysis was used to analyze survival by vaccination status. The study involved 3730 residents (mean age 84, 69% female). Weekly infection rates fluctuated during the pre-vaccination period (1.8%–6.5%) and dropped to zero during the post-vaccination period. Nine unvaccinated (UN), 56 partially vaccinated (PV) and 35 fully vaccinated (FV) residents tested SARS-CoV-2+ during the post-vaccination period. FV showed significantly lower hospitalization and mortality rates than PV and UV (hospitalization: FV 3%, PV 14%, UV 33%; mortality: FV 6%, PV 18%, UV 56%). The death risk was 84% and 96% lower in PV (HR 0.157, 95%CI 0.049–0.491) and FV (HR 0.037, 95%CI 0.006–0.223) versus UV. SARS-CoV-2 vaccination was followed by a marked decline in infection rates and was associated with lower morbidity and mortality among infected NH residents.

Background: Tdap (Tetanus-Diphtheria-acellular Pertussis) vaccination is nowadays a worldwide-recommended practice to immunize pregnant women. The vaccine administration at the third trimester of pregnancy (as recommended by the WHO) would ensure antibody protection to both the mother and the newborn and has contributed to the significant drop of pertussis cases in infants. The aim of this observational study was to describe for the first time the socio-demographic characteristics and determinants of Tdap vaccination adhesion of pregnant women in the Florentine area. Methods: Information about parents’ vaccination status, their citizenship, employment type and mothers’ previous pregnancies and/or abortions were collected at the time of birth through the assistance birth certificates (CedAP) both for the years 2019 and 2020. This archive and the regional SISPC (Collective Prevention Healthcare Information System) linked using an anonymous unique personal identifier to retrieve the mother’s vaccination status. Results: We found an overall Tdap vaccination adhesion of 43% in 2019 and 47.3% in 2020. Several socio-demographic parameters would determine an increased vaccination adhesion, including parents’ geographical origin, mothers’ age and educational background, as well as the number of previous deliveries, abortions or voluntary termination of pregnancy. Conclusions: Since not much data are available on this topic in Italy, this study may constitute the baseline information for Tdap vaccination adhesion in pregnant women in the Florentine area (Italy). Thus, future successful vaccination strategies may be designed accordingly.

OBJECTIVES To assess concurrent validity of the Dynamic Silver Code (DSC), a tool based on administrative data that predicts prognosis in older adults accessing the emergency department (ED), in terms of association with markers of poor functional and cognitive status. DESIGN Cross-sectional. SETTING AND PARTICIPANTS Data were obtained in the AIDEA study, which enrolled a cohort of ≥75-year-old patients, accessing the ED of 2 hospitals in Florence, Italy. METHODS The DSC score and classes (I to IV, corresponding to an increasing risk of death) were obtained from administrative data. Information on health and functional status prior to ED access were collected from face-to-face, direct, or proxy interviews. The 4AT test was administered to screen for possible delirium. Bivariate comparisons of the prevalence of each functional and cognitive marker across 4 DSC classes were performed. Multinomial logistic regression was used to assess the multivariable risk of being in II, III, or IV DSC class vs I. RESULTS Among 3358 participants (mean age 83 years, men 44%), 32.9%, 30.3%, 19.5%, and 17.2% were in DSC class I, II, III, and IV. Preadmission abnormal functional and cognitive conditions, and delirium in the ED, were increasingly more common from DSC class I through IV (P < .001). In particular, the prevalence of total inability to walk increased from 2.9% (class I) to 23.4% (class IV). In multivariable analyses, this was the strongest predictor of being in progressively worse DSC classes, whereas feeling of exhaustion, reporting of serious falls, weight loss, and severe memory loss or diagnosis of dementia gave some contribution. CONCLUSIONS AND IMPLICATIONS The ability of the DSC to predict survival in older persons appears to rely on its prevailing association with markers of functional impairment. These results may support clinical use of the tool.

Background and Aims Aim of the present study is to determine the role of obesity as a risk factor for COronaVirus Disease-19 (COVID-19) hospitalization. Methods and Results This observational study was performed using Istituto Superiore di Sanità (ISS) Tuscany COVID-19 database by the Agenzia Regionale Sanità (ARS), including all COVID-19 cases registered until April 30th, 2020, with reported information on chronic diseases. The principal outcome was hospitalization. An age and gender-adjusted logistic regression model was used to assess the association of clinical and demographic characteristics with hospitalization. Further multivariate models were applied. Of 4,481 included subjects (36.9% aged over 70 years), 1,907 (42.6%) were admitted to hospital. Obesity was associated with hospitalization after adjusting for age and gender. The association of obesity with hospitalization retained statistical significance in a fully adjusted model, including possible confounders (OR: 2.99 [IC 95% 2.04-4.37]). The effect of obesity was more evident in younger (, Highlights • Obesity is a relevant prognostic factor in patients with COVID19. • Available studies, performed in cohorts of hospitalized patients with COVID19, showed that obesity is associated with increased risk of Intensive Care Unit (ICU) admission and mortality. • This study was performed in Tuscany, a region of central Italy which had a relatively contained incidence of COVID19. The saturation of available hospital beds and ventilators was never reached during the outbreak, with hospitalized and ICU patients never surpassing the system’s surge capacity. • In our study obesity is associated with an increased risk of hospitalization in patients with COVID19. The association of obesity with hospitalization was greater in younger (

the COVID-19 pandemic represents a challenge for health systems around the world, with just under 10,000 cases in Tuscany Region (Central Italy) and about 4,500 in the Local Health Unit (LHU) 'Toscana Centro', updated on 11 May 2020. The risk factors reported are several, including age, being male, and some chronic diseases such as hypertension, diabetes, respiratory and cardiovascular diseases. However, the relative importance of chronic diseases is still to be explored.to evaluate the role of chronic diseases on the risk to develop clinically evident (at least mild symptomatic) forms of SARS-CoV-2 infection in the population of the LHU Toscana Centro.case-population study.'case' is a subject with SARS-CoV-2 positive swab with at least mild clinical status, who lives in the LHU Toscana Centro area; 'controls' are all people residing in the LHU Toscana Centro area at 1 January 2020. People aged under 30 and patients living in nursing care homes are excluded from the analysis.the analysis assesses the effect of gender, age, neoplasm, and the main chronic diseases on the onset of an infection with at least mild symptoms by calculating odds ratios (OR) by multivariate logistic regression models (to produce adjusted OR by potential confounders).among the 1,840 cases, compared to the general population, the presence of males and over-60-year-old people is greater. Almost all the considered chronic diseases are more frequent among the cases, compared to the general population. A chronic patient has a 68% greater risk to be positive with at least mild symptoms. Many of the considered diseases show an effect on the risk of getting COVID-19 in a symptomatic form, which remains even adjusting by other comorbidities. The main ones include heart failure, psychiatric disorders, Parkinson's disease, and rheumatic diseases.these results confirm evidence already shown in other studies on COVID-19 patients and add information on the chronic diseases attributable risk in the population, referred to the symptomatic forms and adjusted by age, gender or the possible copresence of more diseases. These risk estimates should guide prevention interventions by health services in order to protect the chronic patients affected by the pathologies most at risk.

Background Rigorous analysis of levels and trends in exposure to leading risk factors and quantification of their effect on human health are important to identify where public health is making progress and in which cases current efforts are inadequate. The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 provides a standardised and comprehensive assessment of the magnitude of risk factor exposure, relative risk, and attributable burden of disease. Methods GBD 2019 estimated attributable mortality, years of life lost (YLLs), years of life lived with disability (YLDs), and disability-adjusted life-years (DALYs) for 87 risk factors and combinations of risk factors, at the global level, regionally, and for 204 countries and territories. GBD uses a hierarchical list of risk factors so that specific risk factors (eg, sodium intake), and related aggregates (eg, diet quality), are both evaluated. This method has six analytical steps. (1) We included 560 risk-outcome pairs that met criteria for convincing or probable evidence on the basis of research studies. 12 risk-outcome pairs included in GBD 2017 no longer met inclusion criteria and 47 risk-outcome pairs for risks already included in GBD 2017 were added based on new evidence. (2) Relative risks were estimated as a function of exposure based on published systematic reviews, 81 systematic reviews done for GBD 2019, and meta-regression. (3) Levels of exposure in each age-sex-location-year included in the study were estimated based on all available data sources using spatiotemporal Gaussian process regression, DisMod-MR 2.1, a Bayesian meta-regression method, or alternative methods. (4) We determined, from published trials or cohort studies, the level of exposure associated with minimum risk, called the theoretical minimum risk exposure level. (5) Attributable deaths, YLLs, YLDs, and DALYs were computed by multiplying population attributable fractions (PAFs) by the relevant outcome quantity for each age-sex-location-year. (6) PAFs and attributable burden for combinations of risk factors were estimated taking into account mediation of different risk factors through other risk factors. Across all six analytical steps, 30 652 distinct data sources were used in the analysis. Uncertainty in each step of the analysis was propagated into the final estimates of attributable burden. Exposure levels for dichotomous, polytomous, and continuous risk factors were summarised with use of the summary exposure value to facilitate comparisons over time, across location, and across risks. Because the entire time series from 1990 to 2019 has been re-estimated with use of consistent data and methods, these results supersede previously published GBD estimates of attributable burden. Findings The largest declines in risk exposure from 2010 to 2019 were among a set of risks that are strongly linked to social and economic development, including household air pollution; unsafe water, sanitation, and handwashing; and child growth failure. Global declines also occurred for tobacco smoking and lead exposure. The largest increases in risk exposure were for ambient particulate matter pollution, drug use, high fasting plasma glucose, and high body-mass index. In 2019, the leading Level 2 risk factor globally for attributable deaths was high systolic blood pressure, which accounted for 10.8 million (95% uncertainty interval [UI] 9.51-12.1) deaths (19.2% [16.9-21.3] of all deaths in 2019), followed by tobacco (smoked, second-hand, and chewing), which accounted for 8.71 million (8.12-9.31) deaths (15.4% [14.6-16.2] of all deaths in 2019). The leading Level 2 risk factor for attributable DALYs globally in 2019 was child and maternal malnutrition, which largely affects health in the youngest age groups and accounted for 295 million (253-350) DALYs (11.6% [10.3-13.1] of all global DALYs that year). The risk factor burden varied considerably in 2019 between age groups and locations. Among children aged 0-9 years, the three leading detailed risk factors for attributable DALYs were all related to malnutrition. Iron deficiency was the leading risk factor for those aged 10-24 years, alcohol use for those aged 25-49 years, and high systolic blood pressure for those aged 50-74 years and 75 years and older. Interpretation Overall, the record for reducing exposure to harmful risks over the past three decades is poor. Success with reducing smoking and lead exposure through regulatory policy might point the way for a stronger role for public policy on other risks in addition to continued efforts to provide information on risk factor harm to the general public. Copyright (C) 2020 The Author(s). Published by Elsevier Ltd.

We present here the differential analysis of metabolite-metabolite association networks constructed from an array of 24 serum metabolites identified and quantified via nuclear magnetic resonance spectroscopy in a cohort of 825 patients of which 123 died within 2 years from acute myocardial infarction (AMI). We investigated differences in metabolite connectivity of patients who survived, at 2 years, the AMI event, and we characterized metabolite-metabolite association networks specific to high and low risks of death according to four different risk parameters, namely, acute coronary syndrome classification, Killip, Global Registry of Acute Coronary Events risk score, and metabolomics NOESY RF risk score. We show significant differences in the connectivity patterns of several low-molecular-weight molecules, implying variations in the regulation of several metabolic pathways regarding branched-chain amino acids, alanine, creatinine, mannose, ketone bodies, and energetic metabolism. Our results demonstrate that the characterization of metabolite-metabolite association networks is a promising and powerful tool to investigate AMI patients according to their outcomes at a molecular level.

Optimal blood pressure (BP) control can prevent major adverse health events, but target values are still controversial, especially in older patients with comorbidities, frailty and disability. To evaluate mortality according to BP values in a cohort of older adults enrolled in the Fiesole Misurata Study, after a 6-year follow-up. Living status as of December 31, 2016 was obtained in 385 subjects participating in the Fiesole Misurata Study. Patients' characteristics were analysed to detect predictors of mortality. At baseline, all participants had undergone office BP measurement and a comprehensive geriatric assessment. After a 6-year follow-up, 97 participants had died (25.2%). After adjustment for comorbidities and comprehensive geriatric assessment, mortality was significantly lower for SBP 140–159 mmHg as compared with 120–139 mmHg (HR 0.54, 95% CI 0.33–0.89). This result was also confirmed in patients aged 75 + (HR 0.49, 95% CI 0.29–0.85), and in those with disability (HR 0.36, 95% CI 0.15–0.86) or taking antihypertensive medications (HR 0.49, 95% CI 0.28–0.86). An intensive BP control may lead to greater harm than benefit in older adults. Indeed, the European guidelines recommend caution in BP lowering in older patients, especially if functionally compromised, to minimize the risk of hypotension-related adverse events. After a 6-year follow-up, mortality risk was lower in participants with SBP 140–159 mmHg as compared with SBP 120–139 mmHg, in the overall population and in the subgroups of subjects aged 75 + , with a disability or taking anti-hypertensive medications.

Background. Postdischarge deterioration in health-related quality of life (HRQoL) is a major clinical issue for patients after an intensive care unit (ICU) hospitalization. A significant proportion of these patients is known to develop a progressive worsening of mental and physical performance—the so-called post-intensive care syndrome (PICS). Aim. We aimed at exploring the effects of a structured program for the management of ICU patients, aimed at improving postdischarge HRQoL and reducing the risk of PICS. Methods. A total of 159 patients hospitalized in our ICU with a length of stay >72 hours were enrolled in an institutional management protocol including specific recommendations: adequate sedation and analgesia protocols, to ensure a valid delirium prevention strategy, and to provide a planned midterm after discharge. The main endpoint was the occurrence of PICS at the 6-month follow-up visitation, defined as an abnormal physical or mental score in the SF-12 questionnaire in the presence of clinical evidence of new or worsening impairment in physical, cognitive, or mental health status. An additional questionnaire was administered, to assess the effects of ICU-related memories. Results. Most patients positively rated their health at the 6-month follow-up and had no significant impairment in physical or mental health status. The mean normalized values of the physical and mental component of the SF-12 score were 46 ± 11 and 48 ± 14, suggesting a normal physical and mental health status in most patients. Twenty-nine patients (18.2%) showed evidence of PICS. Similar good results were found by the questionnaire of memories. In multivariable analysis, no variable was found to predict the risk of PICS in our population. Conclusion. In this real-world analysis that lacks a control group, patients who used a program aimed at minimizing the risk of HRQoL deterioration and PICS reported a good perception of their state of health with a relatively low prevalence of PICS.

In randomized clinical trials, compared to Internal Medicine (IM), admission to Geriatrics (G) improved clinical outcomes of frail older patients accessing the Emergency Department (ED). Whether this advantage is maintained also in the “real world” is uncertain. We compared long-term survival of patients admitted to G or IM wards after stratification for background risk and across a variety of discharge diagnoses. Data were derived from the “Silver Code National Project (SCNP)”, an observational study of 180,079 unselected 75+ years old persons, admitted via the ED to IM (n=169,717, 94.2%) or G (n=10,362) wards in Italy. The Dynamic Silver Code (DSC), based on administrative data, was applied to balance for background risk between participants admitted to G or IM. One-year mortality was 33.7%, it was lower in participants discharged from G than IM (32.1 and 33.8%, respectively; p

Background Risk stratification and management of acute myocardial infarction patients continue to be challenging despite considerable efforts made in the last decades by many clinicians and researchers. The aim of this study was to investigate the metabolomic fingerprint of acute myocardial infarction using nuclear magnetic resonance spectroscopy on patient serum samples and to evaluate the possible role of metabolomics in the prognostic stratification of acute myocardial infarction patients. Methods In total, 978 acute myocardial infarction patients were enrolled in this study; of these, 146 died and 832 survived during 2 years of follow-up after the acute myocardial infarction. Serum samples were analyzed via high-resolution 1H-nuclear magnetic resonance spectroscopy and the spectra were used to characterize the metabolic fingerprint of patients. Multivariate statistics were used to create a prognostic model for the prediction of death within 2 years after the cardiovascular event. Results In the training set, metabolomics showed significant differential clustering of the two outcomes cohorts. A prognostic risk model predicted death with 76.9% sensitivity, 79.5% specificity, and 78.2% accuracy, and an area under the receiver operating characteristics curve of 0.859. These results were reproduced in the validation set, obtaining 72.6% sensitivity, 72.6% specificity, and 72.6% accuracy. Cox models were used to compare the known prognostic factors (for example, Global Registry of Acute Coronary Events score, age, sex, Killip class) with the metabolomic random forest risk score. In the univariate analysis, many prognostic factors were statistically associated with the outcomes; among them, the random forest score calculated from the nuclear magnetic resonance data showed a statistically relevant hazard ratio of 6.45 (p = 2.16×10−16). Moreover, in the multivariate regression only age, dyslipidemia, previous cerebrovascular disease, Killip class, and random forest score remained statistically significant, demonstrating their independence from the other variables. Conclusions For the first time, metabolomic profiling technologies were used to discriminate between patients with different outcomes after an acute myocardial infarction. These technologies seem to be a valid and accurate addition to standard stratification based on clinical and biohumoral parameters. Electronic supplementary material The online version of this article (10.1186/s12916-018-1240-2) contains supplementary material, which is available to authorized users.

Background Informing health systems and monitoring hospital performances using administrative data sets, mainly hospital discharge data coded according to International-Classification-Diseases-9edition-Clinical-Modifiers (ICD9-CM), is now commonplace in several countries, but the reliability of diagnostic coding of acute ischemic stroke in the routine practice is uncertain. This study aimed at estimating accuracy of ICD9-CM codes for the identification of acute ischemic stroke and the use of thrombolysis treatment comparing hospital discharge data with medical record review in all the six hospitals of the Florence Area, Italy, through 2015. Methods We reviewed the medical records of all the 3915 potential acute stroke events during 2015 across the six hospitals of the Florence Area, Italy. We then estimated sensitivity and Positive Predictive Value of ICD9-CM code-groups 433*1, 434*1 and thrombolysis code 99.10 against medical record review with clinical adjudication. For each false-positive case we obtained the actual diagnosis. For each false-negative case we obtained the primary and secondary ICD9-CM diagnoses. Results The medical record review identified 1273 acute ischemic stroke events. The hospital discharge records identified 898 among those (true-positive cases),but missed 375 events (false-negative cases), and identified 104 events that were not eventually confirmed as acute ischemic events (false-positive cases). Code-group specific Positive Predictive Value was 85.7% (95%CI,74.6–93.3) for 433*1 and 89.9% (95%CI, 87.8–91.7) for 434*1 codes. Thrombolysis treatment, as identified by ICD9-CM code 99.10, was only documented in 6.0% of acute ischemic stroke events, but was 13.6% in medical record review. Conclusions Hospital discharge data were found to be fairly specific but insensitive in the reporting of acute ischemic stroke and thrombolysis, providing misleading indications about both quantity and quality of acute ischemic stroke hospital care. Efforts to improve coding accuracy should precede the use of hospital discharge data to measure hospital performances in acute ischemic stroke care.

Introduction The aim of the current study was to define the rate of emergency department visits for late-onset dyspnea in acute coronary syndrome patients treated with ticagrelor. Methods We conducted a population-based study on about 850 000 residents of Florence metropolitan area, by using data from healthcare records. Results Between 2012 and 2014, 1073 subjects in Florence metropolitan area had at least one prescription of ticagrelor. Two-hundred and thirty-four patients were diagnosed with 'respiratory system or other chest symptoms' or 'other diseases of lung', and among them we identified 20 subjects with ticagrelor-related late-onset dyspnea. These, and the 979 nonevent subjects (receiving ticagrelor but not developing dyspnea), contributed to 413 person-years overall. The dyspnea rate was 4.84 per 100 person-years (95% confidence interval: 3.12-7.51). Conclusion Late-onset dyspnea rate is notably lower than early-onset one; nevertheless prescribing clinicians should be aware that about one in 20 outpatients with a stabilized ticagrelor treatment might develop a dyspnea leading to an emergency department visit, and they should consider ticagrelor replacement only in patients who cannot tolerate dyspnea.

The existence of gender differences in the management of statin therapy among patients with chronic heart failure (HF) is still poorly investigated. We aimed at exploring the effect of gender on statin prescription rates and adequacy of dosing and on the association between statin therapy and all-cause 1-year mortality, after HF hospitalization in a community setting.Statin prescription rates, adequacy of dosing (estimated as a PDD/DDD ratio0.80), and 1-year mortality were retrospectively assessed in 2088 consecutive patients discharged from 5 local community hospitals with a definite diagnosis of HF after a mean length of stay of 7.6 days. The effect of gender was explored using multivariable logistic and Cox analyses adjusting to confounders.Women showed a lower statin prescription rate (25.7 vs 35.3%, P 0.0001) and a lower prevalence of adequate statin dose (32.6 vs 42.3%, P 0.0001) than men. Female gender was independently associated with a 24% lower probability of statin prescription and a 48% higher probability of inadequate statin dose. Statin prescription and adequacy of dosing were associated with 35 and 44% decreases in the risk of 1-year mortality, respectively, irrespective of gender. A nested case/control analysis confirmed that adequate statin dose was associated with 48% lower 1-year mortality, again without interaction with gender.In patients with chronic HF, female gender is independently associated with lower statin prescription rates and higher probability of inadequate dose. Statin therapy in these subjects is associated with improved 1-year survival in both men and women. This prognostic benefit is not affected by gender.

Introduction Limited data are available on the natural history of high on treatment platelet reactivity (HPR) by arachidonic acid and ADP - markers of unfavorable prognosis in acute coronary syndrome patients -. Material and methods In a cohort of acute coronary syndrome male patients (n = 101), we evaluated the time-course of HPR by ADP (platelet aggregation by 10 μM ADP ≥ 70%) and arachidonic acid (platelet aggregation by 1 mmol arachidonic acid ≥ 20%) measuring platelet function in the acute phase (T0), at 6 months (T1) and 1 year (T2). Results We identified persistent (HPR at T0,T1 and T2), acute non persistent (HPR only at T0), and late (HPR only at T1 or T2). Patients with persistent HPR by ADP were more frequently with higher values of BMI. Patients carrying CYP2C19*2 variant were more prevalent in the group of persistent HPR (33%). Significant higher values of immature platelet fraction and high immature platelet fraction at 6 and 12 months and mean platelet volume were present in patients with late HPR. Immature platelet fraction was the only variable significantly associated with late HPR by ADP at multivariate analysis (OR = 1.6 (1.08-2.3), p = 0.016). Patients with persistent HPR by arachidonic acid were more frequently diabetics. Immature platelet fraction at 6 months and high immature platelet fraction at 6 and 12 months were the parameters associated with late HPR by AA (OR = 1.4 (1.0-1.9), p = 0.036; OR = 1.5 (1.08-2.4), p = 0.05; OR = 4.9 (1.3-18.8), p = 0.018, respectively). Conclusions About 25% of 101 patients has persistent HPR; they are more frequently diabetics, overweight or carriers of CYP2C19*2. The occurrence of an inflammatory state, indicated by the increase of immature platelet fraction, is associated with the occurrence of late HPR.

Ageing represents a non-modifiable risk factor for the most common cardiovascular diseases (CVD), from hypertensive to coronary heart disease, atrial fibrillation, aortic stenosis and heart failure. These conditions may profoundly affect global health status (i.e. physical and cognitive functioning, quality of life and survival) of older patients. At the same time, specific aspects of ageing frequently modify presentation, clinical management, therapeutic approach and outcomes of CVD.

Background and purpose Although several studies reported that drug-eluting stents (DES) are able to reduce restenosis incidence without increasing mortality, concerns still exist about their safety in ST-segment elevation myocardial infarction (STEMI) patients mainly for a possible higher rate of in-stent thrombosis. Recent evidence suggests a better safety profile of second-generation DES, but data on their outcome in STEMI are still poor. In this study we evaluated the impact on mortality and target lesion revascularization (TLR) of DES or bare metal stent (BMS) implantation in STEMI patients submitted to primary angioplasty. Methods and subjects We analyzed mortality and TLR in 1150 STEMI patients during a mean 43-month follow-up after DES (44.6%) or BMS (55.4%) implantation. A propensity score method was used to minimize bias. During follow-up, 223 deaths occurred. Essential results Unadjusted for potential confounders, DES implantation was associated with a significant reduction in all-cause mortality [hazard ratio (HR) 0.40; 95%CI 0.30–0.54] and TLR (HR 0.55; 95%CI 0.36–0.86); this latter was confirmed after propensity score analysis (HR 0.39; 95%CI 0.21–0.67). Second- (n = 179) vs. first- (n = 337) generation DES showed a further reduction in TLR (HR 0.17; 95%CI 0.05–0.57). Adjusted analyses showed a significant reduction in the combined end-point of all-cause mortality or TLR after both first- and second-generation DES vs. BMS implantation with a trend to a lower risk for second- vs. first-generation DES. Principal conclusions DES implantation in STEMI patients showed a significant reduction in TLR and in the combined endpoint of TLR or mortality. Second-generation DES showed a more protective effect on the combined endpoint, suggesting that they would be preferred in this setting.

Objective Many studies have investigated the potential role of ozone exposure in cardiovascular mortality and morbidity. The effects on specific cardiovascular outcome and the role of individual susceptibility are less studied. This paper focuses on the short-term effects of ozone on acute coronary events and it investigates comorbidities as indicators of personal susceptibility. Setting and patients This study was conducted in five urban areas of the Tuscany region (Italy) covering the period January 2002–December 2005. Air quality and meteorological data from urban background monitoring sites were collected. Hospital admissions for acute myocardial infarction and out-of-hospital coronary deaths were extracted from administrative database. Design Both time series and case-crossover designs were applied. The confounding effects of some time-dependent variables, such as temperature, were taken into account. Some potential susceptibility factors were investigated. Pooled estimates were derived from random-effect meta-analysis. Results During the warm season 4555 hospitalized acute myocardial infarctions and 1931 out-of-hospital coronary deaths occurred. Authors estimated a 6.3% (95% confidence interval, 1.2%, 11.7%) increase in out-of-hospital coronary deaths for a 10 μg/m 3 increase in ozone (lag 0–5). Results also suggested higher risks for females, elderly, and patients previously hospitalized for cerebrovascular and artery diseases. Conclusions This study adds further evidence to the relation between cardiovascular diseases and ozone exposure, showing an adverse effect on out-of-hospital coronary deaths, but not on hospitalized acute myocardial infarctions. Some susceptible subgroups, such as females, elderly, and patients affected by some chronic diseases, are likely to be at major risk.

Several studies have evaluated the prognostic impact of atrial fibrillation (AF) in ST-elevation myocardial infarction (STEMI) patients, but scarce data are available on the role of AF in non-ST-elevation acute coronary syndromes (NSTE-ACS). The aim of this study was to investigate long-term outcome of NSTE-ACS patients experiencing an episode of AF during in-hospital course. Of 1,147 NSTE-ACS patients, 54.4% for non-STEMI (NSTEMI) and 45.6% for unstable angina, 65 (5.7%) had an episode of AF. Long-term survival was compared with that of 1,082 NSTE-ACS patients who did not develop AF. Patients who developed AF, with respect to those who did not, were older and more frequently with NSTEMI at admission (69.2 vs. 53.5%, p = 0.013), diabetes, dyslipidemia and history of heart failure. Moreover, patients who developed AF had a significantly higher New York Heart Association class and lower values of glomerular filtration rate. During a median follow-up of 40.7 months, we observed a significantly higher mortality in NSTE-ACS patients who developed AF versus those who did not (42.2 vs. 19.8%, p0.001). AF occurrence in NSTE-ACS was a significant predictor of mortality at Cox regression (adjusted HR: 1.85; p = 0.03). After propensity score analysis, only patients with AF duration6 h showed a significantly higher mortality at Cox regression (p = 0.021). Our results suggest that NSTE-ACS patients who develop AF are characterized by a higher clinical complexity. The occurrence of AF, when longer than 6 h, represents an important negative prognostic factor for long-term survival.

SummaryReticulated platelets (RP) are newly-formed platelets with a greater mass, a residual amount of RNA and an increased prothrombotic potential. No studies investigating the association between RP and the risk of cardiovascular death in acute coronary syndrome (ACS) patients are available. In the frame of the AMI-Florence 2 study, we investigated RP in 229 (154 M/ 75 F) ACS patients (125 ST-elevation myocardial infarction [STEMI]; 104 Non-STEMI/Unstable Angina). RP were measured by using the Sysmex XE-2100 haematology analyzer and were expressed as the percentage of RP out of the total optical platelet count (immature platelet fraction; IPF) and as the percentage of RP highly fluorescent (H-IPF). At one-year follow-up, 22 out of 229 patients (9.6%) died from cardiovascular causes. Higher values of IPF (p=0.05) and H-IPF (p=0.006) were detected in dead compared to alive patients. A receiver operating characteristics curve analysis identified IPF ≥3.3% and H-IPF ≥0.9% as optimal cut-off values to predict cardiovascular death. At the multivariate model adjusted for the Global Registry of Acute Coronary Events (GRACE) risk score, the association between RP and cardiovascular death remained significant for both IPF [OR (95%CI) : 4.15 (1.24–13.91) p=0.02] and H-IPF [OR (95%CI): H-IPF 5.03 (1.38–18.38) p=0.01]. In conclusion, RP are independent predictors of cardiovascular death and may be useful in improving risk stratification for ACS patients. Future prospective studies to evaluate the role of RP in determining cardiovascular events are warranted.

Thrombin generation (TG) is a central step of the coagulation system involved in hemostatic and thrombotic roles. Scarce data evaluating in the acute phase the association between TG and the risk of cardiovascular death of acute coronary syndrome (ACS) patients are available, in the era of percutaneous coronary intervention (PCI) and stenting with the use of dual antiplatelet treatment.We investigated TG in 292 ACS patients undergoing PCI with stent implantation on dual antiplatelet treatment. Venous samples were obtained 12-24h after PCI. TG was assessed using the Calibrated Automated Thrombogram (CAT).At two years of follow-up, 57 out of 292 patients (19.5%) died from cardiovascular causes. Higher values of endogenous thrombin potential (ETP) [1115.9 (705-1441.3) vs 940.2 (666.0-1253.1), p=0.049], peak [176.1 (80.5-259.4) vs 107.3 (59.9-181.1), p=0.002] and velocity index [61.75 (21.03-97.88) vs 25.64 (11.95-50.90), p0.001] were observed in relation to survival patients. At the multivariate model adjusted for the Global Registry of Acute Coronary Events risk score, the association between TG and cardiovascular death remained significant for ETP [OR (95% CI): 2.58 (1.10-6.03), p=0.029], peak [OR (95%CI): 3.27 (1.35-7.92), p=0.009] and velocity index [OR (95% CI): 3.06 (1.27-7.39), p=0.013]. This result was confirmed after adjustment for high on-treatment platelet reactivity [ETP: OR (95% CI) 2.35 (1.11-5.00), p=0.027; peak: OR (95% CI) 2.42 (1.13-5.15), p=0.022; velocity index: OR (95% CI) 2.43 (1.14-5.20), p=0.022].ACS patients with a residual TG after PCI and stent implantation have a significantly higher risk of long-term cardiovascular death. These results might be useful in improving risk stratification for ACS patients and support the need of a tailored antithrombotic therapy.

prevalence estimation of mental disorders and mental health services (SSM) utilization in 2011, using the administrative regional health databases (hospital discharge records, pharmaceutical prescriptions) and the Regional Database on Mental Health (SIRSM).descriptive population-based study.residents in a Local Health Unit (Florence) of Tuscany Region (Central Italy) who have access to SSM and/or to hospital departments of psychiatry/neuropsychiatry and/ or have psycholeptic/psychoanalectic prescriptions.frequencies; crude and age-standardized prevalence of patients who have access to the SSM or have admission to a hospital psychiatric ward or have psycholeptic/psychoanalectic prescriptions.a high prevalence (11.2%) of residents had at least one contact with health services for mental health problems, mostly (84%) for drug prescriptions only (20% of patients had a unique prescription during 2011). Depression is the most important disease (9.8% of residents had at least one prescription of antidepressants); mood disorders are the most common cause of adult access to SSM (35%-36%) and hospitalization in psychiatric ward (about 36% of admissions). Only a small proportion (about 15%) of patients with mental health problems have access to the SSM, presumably those with more severe diseases.results show that the information of the SIRSM database, together with pharmaceutical prescriptions (psycholeptic/ psychoanalectic) and hospitalisation in psychiatric ward, is a useful tool for assessing the prevalence of mental health problems in a population.

Aims Long-term prognosis of ST segment elevation myocardial infarction (STEMI) in the era of primary percutaneous coronary intervention (pPCI) remains relatively poorly investigated in unselected patients. This study analyzed 8-year follow-up of STEMI patients enrolled in the Florence Acute Myocardial Infarction Registry, a population-based, observational study performed in Italy in 2000-2001. Methods The prognostic effect of pPCI adjusted for clinical and demographic characteristics on a composite end-point of new myocardial infraction, urgent revascularization or death, and on all-cause mortality separately, was assessed in multivariable Cox analysis, calculating hazard ratios and 95% confidence intervals. This analysis is concerned with 875 STEMI patients (mean age 70.6 ± 12.9 years), treated with pPCI (459) or conservatively (416). Results After 8 years, 59% of patients had experienced the composite end-point and 49% had died. The multivariable analysis showed a significantly better prognosis in patients receiving pPCI (hazard ratio 0.72, P = 0.001), evident also in the 645 patients who were event-free after the first year of follow-up (hazard ratio 0.72, P = 0.010). Other independent prognostic factors were advanced age, Killip class greater than 1, some cardiovascular or noncardiovascular comorbidities, in-hospital cardiogenic shock, ejection fraction less than 30%, and treatment with aspirin and statin during hospitalization. The beneficial effect of pPCI observed both in cases younger (adjusted hazard ratio 0.65, P = 0.013) and older than 75 years (adjusted hazard ratio 0.65, P = 0.001) was also confirmed considering as outcome all-cause mortality only. Conclusions In unselected STEMI patients, survival advantage from pPCI extends for a long term (8 years). This survival advantage is maintained at advanced ages, thus enforcing the importance of improving delivery of appropriate care to older STEMI patients.

ST-segment and non-ST-segment elevation myocardial infarction (STEMI, NSTEMI) have opposite epidemiology, the latter being nowadays more common than the former. Consistently with these epidemiological trends, application of evidence-based clinical practice guidelines on the management of NSTEMI should be promoted. We compared clinical features, hospital management and prognosis of STEMI/NSTEMI in an unselected cohort of 1,496 prospectively enrolled patients (STEMI, 36.9 % and NSTEMI, 63.1 %), admitted in 1 year to one of the six hospitals in Florence health district (Italy). Vital status was assessed after 1 year. NSTEMI patients were older, more often female, and affected by cardiovascular and non-cardiovascular comorbidities. Percutaneous coronary intervention (PCI) was performed more often in STEMI (82 %) than in NSTEMI patients (48 %, p < 0.001). Aspirin, clopidogrel, statins, beta-blockers, and ACE-inhibitors were prescribed more frequently in STEMI. In-hospital mortality was significantly lower in NSTEMI than in STEMI (4.2 vs. 8.9 %, p < 0.001), even after adjusting for confounders in a multivariable logistic model (OR 0.27, 95 % CI 0.16–0.45). One-year mortality was similar in NSTEMI and STEMI patients in an unadjusted comparison (18.0 vs. 16.7 %, p = 0.51), but it was lower in NSTEMI patients in multivariable Cox analysis (HR 0.56, 95 % CI 0.42–0.75). PCI reduced the risk of 1-year mortality similarly in STEMI (HR 0.47, 95 % CI 0.28–0.79) and NSTEMI (HR 0.41, 95 % CI 0.28–0.60). PCI reduces mortality in both STEMI and NSTEMI, but it is underutilised in patients with NSTEMI. To improve overall prognosis of AMI, efforts should be made at improving the care of NSTEMI patients.

ABSRACT Introduction Intracavernous alprostadil injection (ICI) test has been considered useless in assessing the vascular status of subjects with erectile dysfunction (ED). Aim To analyze the clinical correlates of ICI test in patients with ED and to verify the value of this test in predicting major adverse cardiovascular events (MACE). Methods A consecutive series of 2,396 men (mean age 55.9 ± 11.9 years) attending our outpatient clinic for sexual dysfunction was retrospectively studied. A subset of this sample (N = 1,687) was enrolled in a longitudinal study. Main Outcome Measures Several clinical, biochemical, and instrumental (penile color Doppler ultrasound; PCDU) factors were evaluated. All patients underwent an ICI test, and responses were recorded on a four‐point scale ranging from 1 = no response to 4 = full erection. Results Among the patients studied, 16.4%, 41.2%, 40.2% and 2.2% showed grade 4, 3, 2, and 1 ICI test response, respectively. After adjusting for confounders, subjects with grade 1 ICI test response showed reduced perceived sleep‐related, masturbation‐related, and sexual‐related erections when compared with the rest of the sample. In addition, a worse response to ICI test was associated with a higher prevalence of hypogonadism‐related symptoms and signs along with lower testosterone levels. The prevalence of both diabetes mellitus and metabolic syndrome was inversely related to ICI test response. Accordingly, dynamic and basal peak systolic velocity (PSV), as well as acceleration at PCDU, decreased as a function of ICI test response. In the longitudinal study, after adjusting for confounders, grade 1 response was independently associated with a higher incidence of MACE (hazard ratio = 2.745 [1.200–6.277]; P 25 cm/s) were considered. Conclusions Our results demonstrate that poor ICI test response is associated with several metabolic disturbances and higher incidence of MACE. We strongly recommend performing ICI test with alprostadil in all ED subjects. Rastrelli G, Corona G, Monami M, Melani C, Balzi D, Sforza A, Forti G, Mannucci E, and Maggi M. Poor response to alprostadil ICI test is associated with arteriogenic erectile dysfunction and higher risk of major adverse cardiovascular events. J Sex Med **;**:**–**.

The aim of this study was to evaluate the adherence to recommendations for secondary prevention of cardiovascular diseases in patients with acute coronary syndromes (ACS).Physical examination, a careful medical interview with assessment for lifestyle habits, adherence to pharmacological therapy and blood analyses were performed in 130 patients at the time of the acute event and after 6 months of follow-up. At follow-up examination, 7 patients persisted to smoke (5.4%), 41 (31.5%) continued to have high blood pressure, 34 (26.1%) had high levels of total cholesterol, 38 (29.2%) high levels of triglycerides, 64 (49.2%) high levels of LDL-cholesterol and 46 (35.4%) low levels of HDL-cholesterol. Despite all treatments no significant change occurred. A high percentage of patients (47%) reported a lower daily consumption of fruit and vegetables with respect to the recommended daily portions, nearly the whole population (92.3%) did not reach the recommended portions of legumes per week recommended, and a consistent percentage of patients (81.5%) did not consume fish twice a week, as recommended.These findings demonstrate the difficulty of modifying the lifestyle habits in patients with ACS.

Introduction Obesity is an independent cardiovascular (CV) risk factor. Testosterone (T) is inversely related to body mass index (BMI) in males. There is substantial evidence suggesting that low T could play a role as a moderator of CV mortality in men. Aim This study is designed to assess the possible interaction between T and obesity in predicting major CV events (MACE) in a sample of subjects with erectile dysfunction. Methods A consecutive series of 1,687 patients were studied. Different clinical, biochemical, and instrumental parameters were evaluated. According to BMI, subjects were divided into normal weight (BMI = 18.5–24.9 kg/m2), overweight (BMI = 25.0–29.9 kg/m2), and obese (BMI ≥ 30.0 kg/m2). Hypogonadism was defined as total T below 10.4 nmol/L. Information on MACE was obtained through the City of Florence Registry Office. Main Outcome Measures Information on MACE was obtained through the City of Florence Registry Office. Results Among the patients studied, 39.8% had normal weight, whereas 44.1% and 16.1% were overweight and obese, respectively. Unadjusted analysis in the whole sample showed that while hypogonadism and obesity were significantly associated with an increased risk of MACE, their interaction term was associated with a protective effect. In a Cox regression model, adjusting for confounders, hypogonadism showed a significant increased risk of MACE in normal weight subjects, whereas it was associated with a reduced risk in obese patients. Conclusions Hypogonadism-associated CV risk depends on the characteristics of subjects, being more evident in normal weight than in obese patients. Further studies are advisable to clarify if low T in obese patients is a (positive) consequence of a comorbid condition (i.e., to save energy) or if it represents a pathogenetic issue of the same illness. Hence, possible misuse/abuse of T treatment in obese subjects must be avoided.

The relationship between extramarital affairs and cardiovascular risk is still not completely clarified. The aim of this study was to investigate whether extramarital affairs have a protective effect on cardiovascular risk or, conversely, a deleterious one. Among patients studied, 91.8% of the whole sample reported no or occasional extramarital affairs, while 8.2% declared a stable secondary relationship. During a median follow-up of 4 [0-8] years, 95 major adverse cardiovascular events (MACE), eight of which were fatal, were observed. Cox analysis, after adjustment for confounding factors, showed that presence of stable extramarital affair was associated with a higher incidence of MACE (HR = 2.13 [1.12; 4.07], p = 0.023). The introduction in the Cox model of patient perceived partner's hypoactive sexual desire (PPPHSD) attenuates the association (HR 1.86 [0.93; 3.70], p = 0.078). The sample was therefore divided according to PPPHSD. We observed that unadjusted incidence of MACE was significantly associated with presence of extramarital affairs only in men reporting a primal partner without PPPHSD. This association was also confirmed in a Cox regression model, after adjusting for confounders (HR = 2.87 [1.81; 6.98], p = 0.020). We can conclude that to be unfaithful represents an independent risk factor for MACE. Therefore, infidelity induces not only heart trouble in the betrayed partners, but seems to be also able to increase the betrayer's heart-related events.

Introduction Although several studies have demonstrated that MetS is associated with a two‐fold increase in the risk of cardiovascular (CV) diseases, this risk does not appear to be greater than the sum of risks associated with each of its individual components. Aim To determine the association of men with ED and individual components of MetS and their subsequent relationship to CV risk, and, more specifically whether the sum of the MetS components is greater than the individual components in predicting CV risk. Methods We longitudinally studied a consecutive series of 1,687 (mean age 52.9 ± 12.8; range 17–88 years) patients attending our clinic for ED and evaluated different clinical and biochemical parameters. Main Outcome Measures Information on major adverse CV event (MACE) was obtained through the City of Florence Registry Office. Results One hundred thirty‐nine MACE, 15 of which were fatal, occurred during a mean follow‐up of 4.3 ± 2.6 years. Subjects with MetS at baseline showed a higher incidence of MACE (hazard ratio [HR] = 1.77), after adjusting for age, however, the association disappeared in an alternative Cox model, adjusting both for age and for individual MetS components (HR = 1,525 [0,564–4,123]; P = 0.408). The two most predictive MetS components of CV risk were low high‐density lipoprotein (HDL) cholesterol and high triglycerides. Exploring possible interactions between individual components of MetS and their effect on CV risk using two alternative approaches indicates that the effect of MetS components on CV risk is additive, but not synergistic. Among subjects with hypertension, after adjusting for age, elevated glycemia, and low HDL cholesterol confer relevant additional risk, while in subjects with high triglycerides, hyperglycemia increased the risk of incident MACE. Conclusions With regards to CV risk, the MetS construct seems to add little or nothing to the careful assessment of its components. Thus, there is no reason to recommend the use of MetS as a diagnostic category in patients with ED. Corona G, Monami M, Rastrelli G, Melani C, Balzi D, Sforza A, Forti G, Mannucci E, and Maggi M. Is metabolic syndrome a useless category in subjects with high cardiovascular risk? Results from a cohort study in men with erectile dysfunction. J Sex Med 2011;8:504–511.

Background Acute myocardial infarction (AMI; ICD9-CM 410*) is a leading cause of morbidity and mortality all over the world, and its community surveillance is essential to monitor variation in the occurrence of the disease. Between the late 1990s and the early 2000s more sensitive and specific biomarkers of myocardial necrosis (ie, troponins) were introduced and new diagnostic criteria, emphasising the role of biomarkers, have been developed for clinical and epidemiological purposes. Methods Tosc-AMI is a population-based registry based on the record linkage between hospital and mortality databases; it provides trends of coronary events in Tuscany, Italy. Two random samples of patients admitted to hospital in 2003 were validated according to the American Heart Association (AHA; 2003) and the Multinational MONItoring of trends and determinants in CArdiovascular disease (MONICA) (1983) criteria. Sample 1 (380 cases) was represented by patients admitted to hospital for AMI and sample 2 (380 cases) for other coronary diagnosis. Results Tosc-AMI attack rates increased from the period 1997 to 2005 (men: +17%; women: +30%) and then they decreased in the following 2 years (men: −8%; women: −13%). The rise of AMI hospital admissions was due to cases with ICD9-CM code 410.7 (largely representing non-ST elevation MI). According to the AHA criteria, 94.6% events of sample 1 and 29.8% events of sample 2 fulfilled the most extensive criteria for definite, probable or possible AMI. As expected, the more updated AHA definition identified as definite AMI an additional 33.3% when compared to the MONICA criteria (86.0% vs 52.7%). Conclusions The study suggests an influence of the new diagnostic criteria on the rising AMI trend observed in the early 2000s, an increase of less severe cases and a decreasing trend of forms with a more extended myocardial damage.

Introduction Erectile dysfunction (ED) and mood depression are often associated and both are correlated with an increased risk of cardiovascular morbidity and mortality. Aim The aim of the present study is to explore biological and clinical correlates of depressive symptomatology in a sample of men consulting for sexual dysfunction and to verify possible associations between depressive symptoms and incidence of major cardiovascular events (MACE). Methods A consecutive series of 2,303 male patients attending the Outpatient Clinic for sexual dysfunction was retrospectively studied. A subset of the previous sample (N=1,687) was enrolled in a longitudinal study. All patients were investigated using a Structured Interview on Erectile Dysfunction (SIEDY), composed of 3 scales which explore organic, relational and intra-psychic components of ED. MHQ-D scoring from Middlesex Hospital Questionnaire (MHQ) was used as a putative marker of depressive symptoms. Main Outcome Measures Information on MACE was obtained through the City of Florence Registry Office. Results We found a positive relationship between MHQ-D score and a progressive impairment in obtaining an erection hard enough for penetration, even after adjusting for confounding factors. Moreover, we observed positive relationships between MHQ-D score and the three pathogenetic domains underlying ED. When the longitudinal subset was evaluated, during a mean follow-up of 4.3±2.6 years, 139 MACE, 15 of which were fatal, were observed. Unadjusted incidence of MACE was significantly associated with baseline depressive symptoms. When the presence of severe depressive symptoms were introduced in a Cox regression model, along with the arteriogenic ED and partner's hypoactive sexual desire, after adjusting for age, Chronic Diseases Score, and ΣMHQ (a broader index of psychopathology), severe depressive symptomatology was independently associated with a higher incidence of MACE. Conclusion Depressive symptomatology constitutes an independent risk factor for cardiac morbidity and mortality in men with ED. Bandini E, Fisher AD, Corona G, Ricca V, Monami M, Boddi V, Balzi D, Melani C, Forti G, Mannucci E, and Maggi M. Severe depressive symptoms and cardiovascular risk in subjects with erectile dysfunction.

The definition of polycystic ovary syndrome in very young girls is complicated by the fact that many features typical of the syndrome can also be seen as physiological stages in the maturation of the hypothalamus-pituitary-ovarian axis. The role of reduced insulin sensitivity in the pathogenesis and evolution of the disorder has gained more importance over recent years: both elevated androgen levels and being overweight may influence the impairment of glucose metabolism. Our study focused on 250 girls in the first 8 years of gynecological age. We analyzed the prevalence of different phenotypes according to the Rotterdam criteria and the impact of higher BMI on androgen levels and on fasting screening markers of glucose metabolism. In a smaller sample, we performed a more detailed evaluation of the glucose metabolism parameters; our findings indicated that in this age group, being overweight plays a major role in the deterioration of the clinical picture.

Introduction The relationship between alcohol consumption and erectile function is still not completely clarified. Aim Aims of the present study are to explore a number of biological and clinical correlates of alcohol consumption in a sample of men consulting for sexual dysfunction, and to verify possible associations with the incidence of major adverse cardiovascular events (MACEs). Methods A consecutive series of 1956 (mean age 55 ± 11.9 years old) attending our outpatient clinic for sexual dysfunction was retrospectively studied. A subset of the previous sample (N = 1687) was enrolled in a longitudinal study. Main Outcome Measures Different clinical, biochemical, instrumental (penile Doppler ultrasound [PCDU]), and intrapsychic (Middlesex Hospital Questionnaire [MHQ]) were evaluated. We considered alcohol abuse more than three drinks per day. Results Among the patients studied 81% reported no or mild ( 6 drinks/day) alcohol abuse, respectively. After adjustment for confounders, both moderate or severe alcohol abuse was associated with low perceived partner's sexual desire, worse couple relationship, and smoking abuse. Furthermore, moderate and severe alcohol abuse was associated with low prolactin and thyroid-stimulating hormone levels, as well as an increase in triglycerides and total cholesterol levels. Penile blood flow was reduced in moderate and severe alcohol drinkers even after adjustment for confounders. In the longitudinal study, after adjusting for confounding factors, any kind of alcohol abuse was independently associated with a higher incidence of MACE (hazard ratio = 2.043 [1.059–3.943]; P Conclusions Our findings demonstrate that, in subjects consulting for erectile dysfunction, severe alcohol consumption is associated with a worse sexual function and a higher incidence of MACE. Boddi V, Corona G, Monami M, Fisher AD, Bandini E, Melani C, Balzi D, Sforza A, Patussi V, Forti G, Mannucci E, and Maggi M. Priapus is happier with Venus than with Bacchus. J Sex Med 2010;7:2831–2841.

OBJECTIVE Recent epidemiological studies suggested that some insulin analogues could be associated with increased risk of cancer. The present study is aimed at assessing the long-term association of different insulin analogues with cancer incidence. RESEARCH DESIGN AND METHODS A nested case-control study dataset was generated from the cohort study dataset (n = 1,340 insulin-treated diabetic outpatients) by sampling control subjects from the risk sets. For each case subject, the control subjects (up to five) were chosen randomly from those members of the cohort who are at risk for the same follow-up time of the case subject. Five-year age classes, sex, and BMI classes ( RESULTS During a median follow-up of 75.9 months (interquartile range 27.4–133.7), 112 case subjects of incident cancer were compared with 370 matched control subjects. A significantly higher mean daily dose of glargine was observed in case subjects than in control subjects (0.24 IU/kg/day [0.10–0.39] versus 0.16 IU/kg/day [0.12–0.24], P = 0.036). Incident cancer was associated with a dose of glargine ≥0.3 IU/kg/day even after adjusting for Charlson comorbidity score, other types of insulin administration, and metformin exposure (odds ratio 5.43 [95% CI 2.18–13.53], P < 0.001). No association between incident cancer and insulin doses was found for human insulin or other analogues. CONCLUSIONS The possibility of association between cancer and higher glargine doses suggests that dosages should always be considered when assessing the possible association of insulin and its analogues with cancer.

Summary The physiological role of prolactin (PRL) in men is not completely clarified. We previously reported that in subjects consulting for sexual dysfunction, lower PRL plasma levels were associated with worse lipid and glycaemic profile, as well as with a higher prevalence of metabolic syndrome and arteriogenic erectile dysfunction (ED). The aim of this study was to assess possible associations between PRL levels and incident major cardiovascular events (MACE) in subjects with ED. When only subjects without pathological hyperprolactinaemia (PRL