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Background: The prospective, single-arm, observational, phase 4 ETNA-AF Europe study collected real-world data about safety, effectiveness and therapeutic adherence in European patients with non-valvular atrial fibrillation newly prescribed with edoxaban and followed up for 4 years., Methods: Overall, 13 164 patients were included in the full-analysis set, which means that they had at least one documentation after baseline at 4 years. The current paper reports about the 3329 Italian patients out of the whole European population., Results: In the Italian cohort, median age was 76.0 (69.0-82.0) years, with 57.4% of the patients being ≥75 years old. The CHA2DS2-VASc score was >4 in 586 (18.1%) patients. At baseline, 670 (20.8%) patients were classified as frail by the investigators. Edoxaban 30 mg/day was prescribed to 1013 (31.8%) patients: these were older, with more comorbidities and a lower estimated creatinine clearance compared with those receiving 60 mg/day. All-cause mortality was 4.1%/year and there were very low yearly rates of bleeding and thromboembolic events: major bleeding, 0.9%; intracranial hemorrhage, 0.2%; ischemic stroke, 0.3%; systemic embolism, <0.1%. These events were more frequent in patients ≥75 years or in patients with renal impairment or treated with edoxaban 30 mg/day. Advancing age was not associated with an increased incidence of intracranial bleeding., Conclusions: These findings confirm the favorable long-term safety and effectiveness profile of edoxaban in non-valvular atrial fibrillation patients treated in routine clinical care in Italy.

Background: The Cardiology Complex Structure of the Azienda Socio Sanitaria Territoriale (ASST) of Lodi, Italy, assists patients with clinical conditions ranging from emergency to chronicity. The model of Homogeneous Waiting Groups should guide the appropriateness of prescriptions categorized as U (urgent), B (brief), D (deferrable), and P (programmable). This study aims to describe and analyze the characteristics of prescription and delivery of clinical and instrumental cardiology outpatient services with U and B priority during the November 2023-January 2024 quarter, paying particular attention to the clinical appropriateness of prescribing., Methods: A prospective observational study was conducted. Computerized data were anonymously extracted from the company's Management Control and provided with the authorization of the Data Protection Officer., Results: During the observed quarter, the Cardiology Complex Structure provided 7379 services for outpatients. Out of 123 U services, 94 (76.4%) were managed through SBC (Single Booking Center) and 29 (23.6%) were managed outside the SBC. From 529 services with B priority, 504 (95%) were managed through SBC and 25 (5%) outside the SBC. Requests with U priority mainly referred to ECG (n = 50; 40.6%) and first cardiological visit (n = 46; 37.4%). Fifty percent of U and B requests were prescribed by 4% and 8% of general practitioners, respectively. The prescribed priority was correct for 13% of requests (n = 64)., Conclusions: This study shows a vastly inappropriate use of resources allocated to urgent outpatient cardiological services. Actions aimed at promoting the adherence to the Homogeneous Waiting Groups Manual and enhancing telemedicine services, currently limited to heart failure, are necessary for resource optimization in cardiology within the ASST of Lodi.

Registers collecting data from clinical practice (real world data) have gained increasing interest in recent years in the scientific, administrative, and regulatory fields. The value of longitudinal data collection in deepening knowledge about a specific pathology and its healthcare complexity is increasingly recognized. This article describes the development, organizational structure, and technical characteristics of the Italian Multiple Sclerosis and Related Disorders Register (RISM). This multicentre and prospective study gathers demographic, clinical, and epidemiological data from the Italian population with multiple sclerosis and related diseases. The study, officially launched in 2015, but containing data collected since the 1990's, currently involves the active participation of 136 specialized clinical centres and more than 80,000 enrolled patients. The analysis of data in RISM allows for a detailed description of the characteristics of multiple sclerosis and related diseases, providing new insights useful for healthcare planning, cost evaluation, treatment efficacy and safety assessment, and scientific research studies. The main demographic and clinical data of enrolled patients are reported, with a focus on specific study cohorts. In a continuous effort to improve data quality, RISM has implemented specific quality indicators. Starting from the RISM experience, crucial aspects such as the institutional recognition of the disease register, the contribution that register can provide in pharmacovigilance studies, the organizational and management challenges, and privacy issues are discussed.

Introduction: The LIfestyle for BRAin Health (LIBRA) index yields a dementia risk score based on modifiable lifestyle factors and is validated in Western samples. We investigated whether the association between LIBRA scores and incident dementia is moderated by geographical location or sociodemographic characteristics., Methods: We combined data from 21 prospective cohorts across six continents (N = 31,680) and conducted cohort-specific Cox proportional hazard regression analyses in a two-step individual participant data meta-analysis., Results: A one-standard-deviation increase in LIBRA score was associated with a 21% higher risk for dementia. The association was stronger for Asian cohorts compared to European cohorts, and for individuals aged ≤75 years (vs older), though only within the first 5 years of follow-up. No interactions with sex, education, or socioeconomic position were observed., Discussion: Modifiable risk and protective factors appear relevant for dementia risk reduction across diverse geographical and sociodemographic groups., Highlights: A two-step individual participant data meta-analysis was conducted. This was done at a global scale using data from 21 ethno-regionally diverse cohorts. The association between a modifiable dementia risk score and dementia was examined. The association was modified by geographical region and age at baseline. Yet, modifiable dementia risk and protective factors appear relevant in all investigated groups and regions., (© 2024 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.)

Background: Cancer is an important condition associated with the development of atrial fibrillation (AF). The objectives of the BLITZ-AF Cancer study were to collect real-life information on the clinical profile and use of antithrombotic drugs in patients with AF and cancer to improve clinical management, as well as the evaluation of the association between different antithrombotic treatments (or their absence) and the main clinical events., Methods: European multinational, multicenter, prospective, non-interventional study conducted in patients with AF (electrocardiographically confirmed) and cancer occurring within 3 years. The CHA2DS2-VASc and the HAS-BLED scores were calculated in all enrolled patients., Results: From June 2019 to July 2021, 1514 patients were enrolled, 36.5% women, from 112 cardiology departments in 6 European countries (Italy, Belgium, the Netherlands, Spain, Portugal and Ireland). Italy enrolled 971 patients in 77 centers. Average age of patients was 74 ± 9 years, of which 20.9% affected by heart failure, 18.1% by ischemic heart disease, 9.8% by peripheral arterial disease and 38.5% by valvular diseases; 41.5% of patients had a CHA2DS2-VASc score ≥4. The most represented cancer sites were lung (14.9%), colorectal tract (14.1%), prostate (8.8%), or non-Hodgkin's lymphoma (8.1%). Before enrollment, 16.6% of patients were not taking antithrombotic therapy, while 22.7% were on therapy with antiplatelet agents and/or low molecular weight heparin. After enrollment these percentages decreased to 7.7% and 16.6%, respectively and, at the same time, the percentage of patients on direct oral anticoagulant (DOAC) therapy increased from 48.4% to 68.4%, also to the detriment of those on vitamin K antagonist therapy., Conclusions: The BLITZ-AF Cancer study, which enrolled patients diagnosed with AF and cancer, highlights that the use of DOACs by cardiologists in this clinical context has increased, even though the guidelines on AF do not give accurate indications about oral anticoagulant therapy in patients with cancer.

Patent foramen ovale (PFO) is a remnant of normal fetal anatomy which may persist into adulthood, mostly asymptomatic. In some adults, PFO may result in a potential for shunting venous thromboembolism to the arterial circulation; less frequently it can cause interatrial, right-to-left shunting of deoxygenated blood. The pathogenesis of several medical conditions is related to the presence of PFO. Some randomized clinical trials have shown evidence of benefit for device closure as compared with medical therapy in patients with cryptogenic stroke. The literature reported several cases of carbon dioxide embolism during general laparoscopic surgery and sometimes stroke after laparoscopic or neurosurgery but there are neither prospective studies addressing these issues, nor randomized clinical trials assessing the effectiveness of pharmacotherapy or interventional procedures at decreasing risk. The European position paper suggests routine monitoring in non-cardiac surgery of patients with a PFO and no actual indications for closure. This article aims to further stratify the risk of periprocedural stroke and paradoxical embolism in this category of patients.

. The need for palliative care in home care patients. Prospective observational study with the implementation of two algorithms., Introduction: The early identification of patients with palliative care needs is crucial for defining appropriate care settings and interventions., Objective: To detect the need for palliative care in home care patients and to compare two instruments: the SPICT™ and the I-CURPAL-029., Methods: All new patients taken on in home care in the South-West and North-West Districts of the ASL Città di Torino between 27/12/2021 and 19/02/2022 were included and assessed with the two systems at intake, at two and six weeks. Data collected on patients: demographic characteristics, diagnosis, reason and duration of admission, reason for discharge, degree of autonomy and mobility, presence of cognitive and behavioural disorders, social support., Results: 170 patients were included. At admission, 99 (58.2%) patients with SPICT™ and 84 (49.4%) with I-CURPAL-029 were assessed as needing palliative care; 78 (45.9%) by both instruments. Of the 13 with a need for specialist palliation, 8 were transferred to specialist palliative care. Changes in patients' conditions between controls were detected by both instruments and only affected 12.4% of the sample. SPICT™ and I-CURPAL-029 were sensitive in detecting the need for palliation. SPICT™ was suitable for the home context due to the presence of indicators on caregiving., Conclusions: Many patients in home care need palliative care. To support decisions for specialistic care, patients classified as palliative by SPICT™ could be assessed with I-CURPAL-029 to identify the need for specialist palliative care.

Electrical storm (ES) is characterized by at least three separate episodes of ventricular arrhythmia (VA) over 24 h that require treatment or an incessant VA lasting >12 h. The incidence is higher in patients with implantable cardioverter-defibrillators (ICDs) in secondary prevention and the main manifestation is monomorphic VA. ES onset represents a major event in the history of patients with cardiomyopathies that significantly worsens prognosis. The management of ES is complex and requires a multidisciplinary approach including a comprehensive clinical assessment, resuscitation and sedation management skills, ICD reprogramming, ablation, and neuromodulation procedures. ES early recognition and prompt treatment initiation increase the chances of therapeutic success. Each one of these aspects will be properly discussed in the present decalogue. Notably, ES management remains a challenge, with only limited available evidence from small retrospective series and a substantial lack/limited number of randomized or prospective trials. The spectrum of available antiarrhythmic drugs is limited, as well as their efficacy. The future hope is that larger prospective studies will be able to answer important questions, concerning the most effective pharmacologic strategies, the timing for the invasive treatment, the indications for acute neuromodulation strategies and for the circulatory support tools.

Objectives: to quantify the temperature-related global health impacts of the Taranto steel plant CO2e emissions., Design: using the risk functions available in the literature, a prospective global health impact assessment of the marginal CO2e emissions declared by the steel plant for 2020 was conducted., Setting and Participants: world population in the period 2020-2100., Main Outcomes Measures: deaths in the period 2020-2100 attributable to the marginal CO2e emitted by the Taranto steel plant in 2020., Results: considering the central estimates in the baseline emission scenario (4.1°C warming by 2100), the Taranto steel plant 2020 CO2e emissions will cause 1,876 deaths worldwide between 2020 and 2100. The largest part will be attributable to steelmaking processes, accounting for 1,093 deaths. The same emissions will cause 5.56 × 10-4 deaths worldwide between 2020 and 2100 per tonne of steel produced in 2020, i.e. one death for every 1,799 tonnes of steel. If the 2020 CO2e emissions of the steel plant had been reduced by 25%, 50% or 75%, the deaths avoided in the world in the period 2020-2100 would have been 469, 938 and 1,407 respectively., Conclusions: estimates predict a probably significant mortality impact worldwide by the end of the century associated with the greenhouse gases emissions of the Taranto steel plant. Just reducing emissions by 50% in a single year could maybe avoid over 900 deaths worldwide by the end of the century. This confirms the importance of implementing incisive policies to reduce greenhouse gases emissions in all sectors.

The conduct of prospective studies on large numbers and with the support of banks of biological samples has been strongly influenced by the increasingly restrictive evolution of laws and regulations enacted to protect the privacy of study participants, often with significant repercussions in terms of delayed achievement of results and increased consumption of human and financial resources. A brief summary of the effects of this evolution on Italian studies in recent decades is reported, along with a reflection on possible solutions.

Artificial intelligence (Ai) tools, in particular those based on machine learning (Ml) and deep learning techniques, have found application in numerous fields of medicine. They are used to create chatbots to provide health information to citizens and patients, to make medical diagnoses, to identify the best treatment to use for a specific patient, to predict a patient's risk of experiencing a specific event, to identify the most promising drug candidate in which to invest in clinical research, and to identify possible cause-effect relationships between pathologies and data collected through the various available sources. The results of published clinical trials measuring the reliability, safety, and efficacy of these tools are often encouraging. However, there are systematic reviews and meta-analyses highlighting the methodological limitations of these studies. Many of these are retrospective and based on previously assembled datasets, while few are prospective ones conducted in real clinical settings and very few are those based on randomized controlled clinical trials. Furthermore, many of these adopt an internal validation of the Ai system to the detriment of an external validation, while the comparison between the performance of the Ml models and that of the experts is only in a few cases conducted using the same dataset. Before being used in the healthcare field, Ai and Ml systems should pass through the scrutiny of rigorous scientific validation, based on methodologically solid studies (prospective, possibly randomized and conducted in real clinical environments) which demonstrate non-inferiority, or superiority, as well as cost-effectiveness, compared to the conventional diagnostic and decision-making pathway. Furthermore, it is necessary to demonstrate the safety and reproducibility in the use of the software and to consider the emerging ethical and legal issues inherent in the professional liability of the doctor in the interaction with the algorithms.

Dialysis adequacy and a state of "eunutrition" are two essential elements to consider in the evaluation of patient undergoing dialysis treatment. Dialysis inadequacy is often associated with malnutrition, and the combination of these two factors significantly worsens the prognosis. In the following monocentric and prospective study, the correlation between nutritional markers and dialytic adequacy was tested in a cohort of patients permanently followed by the peritoneal dialysis clinic, followed consistently for two years. It was therefore evaluated if modification of dialysis therapy, aimed to reach adequacy parameters, could simultaneously improve metabolic parameters. Although there were no frankly malnourished patients, the group of "inadequate" patients had a significantly lower nPCR value. In this same group, after about 6 months, therapeutic measures adopted allowed an overall improvement in Kt/V and nPCR, with other nutritional parameters (such as body weight, albumin, pre-albumin, total cholesterolemia) remaining stable. At the end of the follow-up period the Kt/V of the "inadequate" (<1.7) was higher ​​than the baseline, reaching statistical significance at the 12th and 24th months. Early identification of a dialysis inadequacy, therefore, allowed the execution of therapeutic changes necessary to achieve a lasting improvement in "adequate" replacement therapy, and a temporary improvement in the patient's nutritional status. Suddenly, despite the persistent improvement of the Kt/V there was a new reduction of the nPCR., (Copyright by Società Italiana di Nefrologia SIN, Rome, Italy.)

Cetuximab in combination with chemotherapy is a standard first-line treatment regimen for patients with metastatic colorectal cancer (mCRC) RAS wild-type (wt); however, the efficacy of cetuximab plus leucovorin, fluorouracil and oxaliplatin (FOLFOX) had never been demonstrated in a prospective, randomized, controlled phase III study. The TAILOR study is the first randomized, multicenter, prospective Phase III study evaluating the addition of cetuximab to FOLFOX in a RAS wt Chinese population and thus providing confirmatory data for the efficacy and safety of cetuximab plus FOLFOX versus FOLFOX alone.

Aim: AIM: The aim of this study was to evaluate variations in ICU nurses ' mental health status over the COVID-19 outbreak by quantifying the extent of symptoms of depression, anxiety and PTSD over time., Methods: METHODS: This study was an Italian multicenter prospective cohort study assessing caseness of anxiety, depression and PTSD at 6 and 12 months from the beginning of the COVID-19 outbreak in Italy., Results: RESULTS: A total of 359 nurses, 233 (64.9%) were males and 126 (35.1%) were females were enrolled. At 6 months the caseness prevalence for anxiety, depression and PTSD were 31.3%, 32.1% and 18.7% respectively. At 12 months the caseness prevalence for anxiety, depression and PTSD were 34.8%, 36.4% and 24.1 % respectively. No statistically significant increase between 6 and 12 months was recorded for the caseness prevalence anxiety (p= .29) and depression (p= .19). However, an increase for the caseness prevalence PTSD at 12 months was observed (p= .049). The significant risk factors for the 221 patients with at least one disorders were age 31-40 (RR= 1.44, IC= 1.25-1.89; p < .001), female gender (RR= 1.31, IC= 1.02-1.51; p=. 042) and had 0-5 years of professional experience (RR= 1.36, IC= 1.02-1.63; p = .031)., Conclusion: The results of our study may provide support for the implementation of some interventions for well-being in COVID-19 outbreak condition.

Myocardial dysfunction and heart failure (HF), frequently described as cardiotoxicity, are the most concerning cardiovascular complications of cancer therapies, causing an increase in morbidity and mortality, even due to early discontinuation of antineoplastic drugs. Research efforts have been done to prevent and treat this phenomenon, in particular through early administration of drugs inducing renin-angiotensin-aldosterone system blockade. Sacubitril/valsartan, a combination of an angiotensin receptor blocker and a neprilysin inhibitor pro-drug, has recently represented a game changer in the scenario of treatment of HF with reduced ejection fraction. However, patients with HF induced by cancer therapy were a priori excluded from the approval study. Therefore, safety and efficacy of this drug in this special population require further investigation. Available evidence, even though only derived from case reports or observational studies, seems to confirm the promising role of this new pharmacological strategy, paving the way for the use of sacubitril/valsartan in cardio-oncology. Prevention and treatment of HF in these highly vulnerable patients is a special need to allow full oncologic treatment and improve overall survival, highlighting the need for ad hoc prospective studies.

Background: Patients who suffered from acute coronary syndrome (ACS) need a tight follow-up in order to optimize therapy and prevent adverse events. The aim of the PONTE-SCA Puglia program was to evaluate the impact of an integrated management of patients between hospital and local territorial outpatient facilities on adherence and outcome of patients discharged after ACS event., Methods: This was a prospective, longitudinal, cohort study which enrolled patients who suffered ACS and/or coronary revascularization in a Hub hospital of ASL Bari. Patients underwent clinical and laboratory evaluation at 30 days, 3 months, 6 months, and 1 year after the index event. The following endpoints were considered: all-cause mortality, ACS recurrence/cardiac ischemia/angina, restenosis/intrastent thrombosis, stroke/transient ischemic attack, heart failure, all-cause bleeding. We evaluated persistence on therapies and the percentage of patients who attained therapeutic goals., Results: A total of 2476 patients (mean age 67.2 ± 12.0 years, 77.4% male) were enrolled. At 1-year follow-up, 99.5% of patients (p<0.05) were on statin therapy, 16.1% (p<0.01) on ezetimibe, and 9.9% (p<0.01) on proprotein convertase subtilisin/kexin type 9 inhibitors. All-cause mortality was 3.1% at 1-year follow-up, whereas recurrence of ACS/cardiac ischemia/angina and restenosis/stent thrombosis were 3% and 1.3%, respectively. The prevalence of all bleeding complications was 2.2%., Conclusions: The PONTE-SCA Puglia program allowed to implement a dedicated taking in charge of patients after an ACS/coronary revascularization event, to manage a dedicated follow-up route for them, to ameliorate persistence on recommended therapies, and to keep lower the incidence of major adverse cardiovascular events and bleedings.

. Measuring the nursing workload in a medical-surgical high dependency unit through nursing activities score (NAS). a prospective observational study., Introduction: Measuring the nursing staff workload allows adequate delivery of resources within the intensive care unit and high dependency unit to ensure an adequate nurse to patient ratio., Aim: Exploring the nursing workload in the medical-surgical high dependency unit (HDU) at Careggi University Hospital (Florence, Italy)., Methods: Monocentric prospective observational study. We enrolled patients admitted in HDU from 11 February to 13 March 2021. Nursing Activity Score (NAS) was measured every 24 hours., Results: Patients included in the study were 75. Three groups based on their admission diagnosis were identified (medical, surgical, trauma). The median NAS score was 59.7 (IQR: 53.7-68.2; range 34.7-119.7). Statistically significant differences were found between the median NAS values for the three admission diagnoses: 67.4 (IQR: 54.4-73.4) for medical patients, 60.2 (IQR: 54.4-63.3) for trauma patients and 59.1 (IQR: 55.1-64.7) for surgical patients. These results showed that the items of NAS that mostly affect workload are "monitoring", "mobilization", "patient hygiene", and "admission and discharge procedures"., Conclusions: This study confirms that the NAS scoree can be used in HDUs as well as in intensive care units. The ideal nurse-to-patient ratio was equal to 0.6.

Sacubitril/valsartan (S/V) has been shown to reduce the risk of cardiovascular death or heart failure hospitalization and improve symptoms in chronic heart failure with reduced ejection fraction compared to enalapril. After 7 years since the publication of the results of PARADIGM-HF, further insight has been gained with potential new indications. Two prospective randomized multicenter studies (PIONEER-HF and TRANSITION) in patients hospitalized for acute heart failure (AHF) have shown an improved clinical outcome and biomarker profile as compared to enalapril, and good tolerability, safety and feasibility of initiating in-hospital administration of S/V. Furthermore, some studies have highlighted the favorable effects of S/V in attenuating adverse myocardial remodeling, supporting an early benefit after treatment. Observational data from non-randomized studies in AHF report that in-hospital and pre-discharge prescription of evidence-based drugs associated with better survival still remains suboptimal. Additionally, the COVID-19 pandemic has also negatively impacted on outpatient activities. Therefore, hospitalization, a real crossroads in the history of heart failure, must become a management and therapeutic opportunity for our patients. The objective of this ANMCO position paper is to encourage and facilitate early S/V administration in stabilized patients during hospitalization after an AHF episode, with the aim of improving care efficiency and clinical outcome.

Introduction: Hospitalisation represents a significant risk factor for the decline in the general conditions of the elderly. Loss of autonomy in elderly inpatients, together with immobilisation, has been defined as 'Hospital-Acquired Disability' and affects 65% of this class of patients. Less than half of them will regain independent mobilisation. Included among the negative effects are: falls, increased percentage of admission to nursing homes, longer hospital admissions, increased mortality and morbitity. Despite these facts, elderly patients remain in bed for 83-95% of their hospital stay; they rarely walk or are mobilised. Only on an international level has this issue been analysed OBJECTIVES: To analyse active mobilisation in inpatients., Methods: Prospective analytical and descriptive study performed from December 2018 - May 2019 in the Clinical Medicine department of the AUSL of Reggio Emilia. Descriptive analysis of the data has been performed., Results: A total of 1725 patients were screened for the study. After applying the inclusion criteria, 295 patients were enrolled in the study, 9 of which were then excluded for failure to be mobilised. 66.4% of these patients were mobilized the morning during hygiene-rounds. According to the nurse, they appeared in a stable state, alert and oriented (88.1%) and used a variety of aids (from 1 to 3) (57.3%). The frequency of mobilisations were: 44.4% once a day, 31.2% twice, 24.4% three times or more., Discussion: This study highlighted that mobilisation is strictly correlated to first assistance, frequently relying on health care assistants, and is mostly applied to oriented patients who only need one assistant. Further studies are required to investigate connections between patient's features and mobilisation.

Polytherapy is a common condition in the elderly patient and represents a risk factor for the onset of adverse drug reactions (ADRs). The objectives of this prospective study were the verification of the compliance with implicit criteria (Lipton, MAI and POM) to geriatric prescriptions, the identification of ADRs and the estimatation of the intake of drugs, over-the-counter (OTC) drugs, supplements and herbal products through the administration of a questionnaire. A total of 400 elderly patients (average age 73 years) were analyzed between September 2018 and September 2019. 79.5% of them were in polytherapy (≥4 drugs). The most frequently prescribed drugs were antihypertensives (75%). The use of OTC drugs was reported for 12% patients; the use of supplements for 25% of patients and the use of herbal products only for 2% patients. The prescriptions analysed resulted in compliance with the implicit criteria in terms of dosage, therapeutic indications and the presence of any drug allergies. ADRs were reported for 10% of patients: those related to nintedanib (53%) and pirfenidone (34%) were the most frequent.

Background: Home care for patients with chronic diseases and specifically with heart failure (HF) is one of the main challenges of health care for the future. Telemedicine, applied to HF, allows intensive home monitoring of the most advanced patients, improving their prognosis and quality of life. The European SmartCare project was carried out in the Friuli Venezia Giulia (FVG) region with the aim of improving integrated health and social care in patients with chronic non-communicable diseases (CNCD) through home telemonitoring (TM) and promoting self-management and patient empowerment., Methods: The SmartCare project in FVG was a prospective, randomized and controlled cohort study that enrolled, from November 2014 to February 2016, 201 patients in integrated home care ("usual care" [UC] in our study) to TM (n=100) or UC (n=101). Inclusion criteria were age >50 years, at least 1 CNCD (HF, chronic obstructive pulmonary disease, or diabetes) and 1 missing BADL. There were 19 drop-outs (9%) (12 in the TM arm; 7 in the UC arm; p=NS). All patients were followed by a multiprofessional team and stratified in the short-term pathway (3-6 months; average 4 ± 1 months; n=101), enrolled at discharge from hospitalization, or in the long-term pathway (6-12 months; mean 10 ± 3 months; n=100) for frail/chronic patients already followed in home care., Results: The most frequent main diagnosis was HF (n=108, 54%), followed by diabetes (30%) and chronic obstructive pulmonary disease (16%). A Charlson score ≥3 was present in 75% of cases and over 60% were taking at least 7 drugs. Among the social characteristics of the enrolled population, 55% were living alone or with non-familial caregivers, 62% had primary education and 48% were non-self-sufficient. The days of hospitalization were significantly reduced only in the TM arm of the post-acute pathway (20 days of hospitalization avoided for 10 patient-months of follow-up, p=0.03) and the effect was mainly evident in patients with HF (p=0.02). A significant increase in the number of home accesses and telephone contacts were also documented in the TM group (12.7 and 13.7 more home interventions for 10 patient-months of follow-up; p=0.01 and p=0.002 in the post-acute and chronic pathway, respectively)., Conclusions: The SmartCare-FVG project showed in patients with chronic diseases (mainly HF), in the post-acute phase of the disease, to significantly reduce the days of hospitalization with a limited and sustainable increase in the use of nursing home care resources.

Background: In patients with an indication for oral anticoagulation (OAC) with warfarin, the management of OAC peri-procedure of percutaneous coronary intervention (PCI) is still not fully defined. To investigate clinical practice and outcomes associated with continuation vs interruption of OAC, with or without bridging with low-molecular-weight heparin (LMWH), we examined the database of the observational, prospective, multicenter Italian WAR-STENT registry., Methods: The WAR-STENT registry was conducted in 2008-2010 in 37 Italian centers and included 411 consecutive patients in 157 of whom the peri-procedural international normalized ratio (INR) value was available. In relation to the continuation vs interruption of OAC, patients were divided into group 1 (n = 106) and group 2 (n = 51) respectively, and compared., Results: The basal characteristics of the two groups were similar. The most frequent indication for OAC was atrial fibrillation and for PCI acute coronary syndromes, respectively. The pre-procedural mean value of INR was significantly different in group 1 vs group 2 (2.3 ± 0.4 vs 1.5 ± 0.2; p <0.001), while the use of antithrombotic drugs did not differ, except for LMWH which, albeit limited to only 14% of cases, was used significantly more frequently in group 2 (14% vs 2%; p=0.006). The radial approach was used significantly more often in group 1 vs group 2 (72% vs 45%; p=0.002). The in-hospital incidence of major bleeding complications was similar in groups 1 and 2 (4% vs 8%; p=0.27), as well as the occurrence of major adverse cardio-cerebrovascular events, including cardiovascular death, non-fatal myocardial infarction, re-revascularization of the treated vessel, stent thrombosis, stroke and venous thromboembolism (6% vs 6%; p=0.95). There was a tendency towards a higher incidence of minor access-site bleeding complications in group 1 patients treated by the femoral route., Conclusions: In unselected patients with an indication for OAC with warfarin and undergoing PCI, the continuation vs interruption of OAC (essentially without LMWH bridging) strategies appears similar in terms of efficacy and safety. In consideration of the superior convenience, peri-procedural continuation of OAC should therefore generally be preferred, with the possible exception of patients in whom the femoral approach is required for the procedure.

Objectives: To evaluate the effectiveness and the frequency of use of a pulsed xenon ultraviolet light-emitting no-touch portable device (PX-UV), applied after perform current cleaning, in reducing environmental bacterial burden and the presence of pathogens on surfaces in the operating rooms at the Policlinico University Hospital of Foggia., Design: Prospective before-and-after study with a follow up duration of four months, from May to August 2019., Setting and Participants: Two operating rooms of an Orthopaedic and a Neurosurgical ward in a 780-bed university hospital in the District of Foggia, Italy (about 600,000 inhabitants)., Main Outcome Measures: According to the hygienic standards proposed by the Italian Workers Compensation Authority (ISPESL), the total and the average bacterial load and the presence of six pathogens were evaluated between pre- and post- PX-UV use combined with routine manual cleaning., Results: The PX-UV system was applied at five distinct time points: t1: start of the experiment, t2: after 28 days, t3: after 13 days, t4: after 7 days, and t5: after 8 days (t2-t5: 28 days in total). About 16-min of PX-UV cycle showed significant reduction in the level of environmental contamination by decreasing the mean colony count by 87.5%, compliant with the standard (5&lt; X ≤15 CFU per plat). Staphylococcus aureus and Acinetobacter baumannii that had been isolated in some of the samplings before PX-UV were no longer detected after t1, t2 and t5 treatments. Before PX-UV, the mean colony count was similar between t1 and t2 (p&gt;0.05); after t3 and t4 treatments, it was lower before t5 in both the Orthopaedic and Neurosurgical operating rooms (= -97% and -75%, respectively; p&lt;0,01)., Conclusions: Implication for practice: PX-UV could supplement the standard cleaning process in reducing the microbial burden in the operating rooms and potentially achieving lower healthcare-associated surgical site infections rates.

Precision medicine (MP), using machine learning (ML) techniques of artificial intelligence (AI), analyzes the so-called "big data" to improve diagnostic skills and predictive response to therapy, in order to tailor the treatment on individual characteristics. Furthermore, the use of large databases is limited by their very nature, as data and not values, capable of threatening the validity and generalizability of the conclusions. Currently, for this reason, interventions on populations, subpopulations or groups are still fundamental, favoring, especially in the pharmacological field, the response of the "average patient", over the particular case. Therefore, it is essential to carry out methodologically robust, prospective studies of comparison between teams of doctors who use systems based on algorithms and teams that do not are using them, avoiding direct comparisons, less significant, between doctors and AI. Only in this case will technologies effectively applicable in real rather than experimental clinical contexts be implemented in the near future.

Introduction: Mindfulness indicates a state of mind, connected with attention and awareness that can be developed and cultivated through meditation., Purpose: The research hypothesis foresees that the mindfulness attitude significantly correlates with the psychological variables considered: anger, anxiety, depression and feelings towards oneself (self-hatred, inadequacy of the self and self-forgiveness). The aim of this research was to highlight the relationship between mindfulness attitude and previous constructions in a sample of italian teenagers., Methods: The sample includes 867 subjects, aged between 13 and 20, from the region of Lazio (Rieti and Rome). The participants compiled, under supervision, a battery of tests consisting of self-report questionnaires. To evaluate the psychological dimensions of our interest, we used four measures: CAMS-R, CDI, STAI-Y Trait, STAXI C/A, FSCRS., Results: The study highlighted significantly a positive correlations between high mindfulness disposition and psychological well-being. Specifically, the study showed that adolescents with a high mindfulness disposition are less depressed, less anxious and angry and they have a higher ability to forgive themselves., Discussion: The mindfulness attitude is a tendency that individuals can present to a greater or lesser extent, regardless of the practice of mindfulness. The data obtained from this study support the prospective for further investigations that could lead to improvements in terms of psychological well-being.

Background: The ongoing prospective, single-arm, observational, phase 4 ETNA-AF Europe study is collecting real-world data about the safety and, secondarily, the effectiveness and therapeutic adherence of newly prescribed edoxaban for non-valvular atrial fibrillation in Europe., Methods: At the end of enrollment in 2018, 13 980 subjects were included, of whom 3509 were Italian. Of them, 3341 (95.2%) had follow-up data available at 1 year., Results: Their mean age was 75 ± 9.3 years, with 56.9% being ≥75 years old. The CHA2DS2-VASc score was ≥4 in 1380 (41.3%) patients. Overall, 662 patients (19.7%) were judged as "frail" by the investigators. Edoxaban 30 mg/day was given to 1048 (31.4%) subjects, who were older with more comorbidities and a lower estimated creatinine clearance than those prescribed the 60 mg/day dose. Overall, the rates of bleeding and thromboembolic events were low: major bleeding was 1.63%/year, intracranial hemorrhage 0.16%/year, stroke or systemic embolism 0.50%/year and all-cause mortality 3.72%/year. Rates were higher in subjects ≥75 years or with a CHA2DS2-VASc score ≥4 and in frail individuals. Remarkably, there was a trend for no increase in intracranial bleeding with more advanced age., Conclusions: These findings confirm the favorable safety and effectiveness profile of edoxaban in atrial fibrillation patients in routine clinical care in Italy.

Autosomal dominant polycystic kidney disease (ADPKD) is the most frequent monogenic kidney disease, alone responsible for over 10% of patients with end-stage renal disease, and with an important impact on public health. Tolvaptan (TOLV) has recently been approved in many European countries for its ability to slow disease progression in patients that are eligible for treatment. Nevertheless, the doctor's choice to prescribe the drug and the patient's compliance are strongly influenced by the aquaretic effect complications. In a cohort of patients pertaining to the Nephrology clinic of the AOU Federico II of Naples and treated with TOLV, we assessed not only the adherence to the treatment and the safety of the drug, but also the real feasibility of this therapy through specific questionnaires on sleep quality, abdominal-renal pain, quality of life and patients' general satisfaction. Within the limits of preliminary data and on the basis of the responses of our population, followed for a period of at least one year and administered the maximum titration dosage, it can be asserted that the doubts regarding the real compliance of the patients can be overcome., (Copyright by Società Italiana di Nefrologia SIN, Rome, Italy.)

Background: The OBSERVANT study evaluated the medium and long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement obtaining comparative effectiveness results at least for the first-generation devices. The OBSERVANT II study enrolled a new series of TAVI procedures to evaluate whether the use of new-generation devices has modified outcome differences recorded in the OBSERVANT study. The aim of this paper is to describe the clinical characteristics of the OBSERVANT II population and compare them with those of the OBSERVANT population., Methods: OBSERVANT II is a prospective multicenter observational study, which enrolled patients with severe aortic stenosis, who underwent a TAVI procedure in 30 Italian centers from December 2016 to September 2018. Clinical, anatomical and procedural information was recorded for each patient as well as procedure characteristics and any periprocedural outcomes. An administrative follow-up will allow to obtain information on medium and long-term outcomes., Results: The enrolled population consists of 3001 patients with a mean age similar to that recorded in OBSERVANT (81.7 ± 6.3 vs 81.9 ± 6.2 years; p=0.336). OBSERVANT II patients show a lower prevalence of several morbid conditions than OBSERVANT patients (i.e. chronic obstructive pulmonary disease, coronary artery disease, peripheral arterial disease, etc.), though having very similar mean values of EuroSCORE II (7.2 ± 7.6% vs 7.4 ± 7.9%; p=0.558). According to three EuroSCORE II risk classes (≤3; 3-7; ≥7), the in-hospital mortality rates for patients enrolled in the two studies are 1.0% vs 2.0% (p≤0.000), 1.4% vs 4.1% (p<0.000) and 2.4% vs 7.7% (p<0.000), respectively., Conclusions: The first results of the OBSERVANT II study show that patients undergoing TAVI with new-generation devices are elderly, have a lower risk profile than patients enrolled in the OBSERVANT study but comparable mean values of EuroSCORE II. The in-hospital mortality rate for patients enrolled in the OBSERVANT II study is lower than that recorded in the OBSERVANT study across all the EuroSCORE II risk classes.

Background: The introduction of transcatheter aortic valve replacement (AVR) mandates attention to outcomes after surgical AVR (SAVR). The aim of this study was to assess 1-year outcomes in a contemporary large cohort of patients undergoing AVR., Methods: Data from 520 patients who underwent isolated SAVR between October 2016 and April 2019 were prospectively collected., Results: The mean age of the study population was 72.8 ± 10.1 years and the average EuroSCORE II was 1.8 ± 1.5%. SAVR was performed using minimally invasive approaches (MI-AVR) in 306 patients (58.9%). However, the rate of MI-AVR considerably increased over the observational period from 47.9% to 86.7% (p<0.001). MI-AVR patients received rapid deployment valves in 40% of cases, minimally invasive extracorporeal circulation system in 34.4% and ultra fast track anesthetic management with table extubation in 38.2%. Overall 30-day mortality was 0.4% (n=2). The rates of postoperative stroke and atrioventricular block requiring pacemaker implantation were 0.6% (n=3) and 3.8% (n=20), respectively. At 1 year, the estimated survival, stroke and rehospitalization rates were 97.3%, 1% and 4.5%, respectively. Overall, the estimated incidence of the composite endpoint - death, stroke and rehospitalization - was 7%., Conclusions: Contemporary SAVR in a high-volume center yields excellent clinical outcomes with very low mortality and morbidity. In this setting, the extensive use of minimally invasive approaches combined with the modern techniques and technologies demonstrated to improve clinical outcomes and increase patient and family satisfaction.

Atrial fibrillation is the most common cardiac disorder among chronic nephropathic patients. Possible therapeutic approaches include the use of anticoagulants, which are able to reduce the risk of thromboembolism but lead to an increasing bleeding risk, especially in this cohort of patients. Also, novel oral anticoagulant agents (NAO), due to their mainly renal clearance, are a relative contraindication in advanced renal disease. As an alternative to the oral anticoagulant therapy, left atrial appendage occlusion seems a promising opportunity in high risk, difficult to manage patients. Since there is limited evidence of LAAO in advanced chronic renal disease or dialysis patients, we report here a monocenter experience on 12 patients (6 of which in regular dialytic treatment) with a median clinical follow-up of fourteen months (3-22 months)., (Copyright by Società Italiana di Nefrologia SIN, Rome, Italy.)

. Continuous bedside pressure mapping in a general intensive care unit: a prospective observational study., Introduction: A continuous bedside pressure mapping device (PMD) can provide real-time feedback of ideal body position to allow off-loading of high-pressure areas to prevent pressure ulcers development., Objective: To describe the implementation of a PMD to measure tissue interface pressure (PIT) in Intensive Care (ICU) patients., Methods: Prospective observational study in ICU critically ill mechanically ventilated adults, in an Italian University Hospital. Subjects were enrolled in the first 24 hours after ICU admission. A pressure mapping system (M.A.P. System TM) was used and 3 measurements of PIT with patient in supine position, every 6 hours after admission, were performed. The following anti-decubitus surfaces were used: Duo2® - Hill-Rom, Proficare®, Nimbus 3® or Therakair Visio® - Arjohuntleigh, Getinge Group., Results: 27 patients (8 females) were enrolled; average Body Mass Index 27±6 (range: 16-43); 4 patients (14%) were diabetic. The average pressure of the 1215 areas analyzed was 26.7±19.6 mmHg (range: 3-78); the region with the highest contact pressure was the dorsal region (average: 48.7±12.5 mmHg), followed by the occipital (44.7±19.6 mmHg), and sacrum (44.7±10.7 mmHg). The three anti-decubitus surfaces showed different performances in the distribution of PITs, with statistically significant differences for the following factors: body weight (p = 0.017), patient height (p = 0.034), with increased pressures in taller patients, and higher BMI (p <0.0001)., Conclusions: Mean values of PIT were above critical levels, especially in the dorsal, occipital and sacrum region.

Early detection and progression in the treatment of cancer patient have improved the prognosis of many patients. In view of this improvement, cancer should be considered less as a terminal illness, but as a chronic disease, and the number of cancer survivors continues to increase in the West countries. Work coud be very important for cancer patients and for society; however studies on this topic from Italy are fragmentary and very poor., Material and Methods: A prospective observational study started at the Medical oncology unit, Hospital of Piacenza (North Italy). All the patients between 18 and 65 years of age, diagnosed with early or metastatic cancer, admitted to the outpatient clinic, were analyzed for employment and work-related issues (job interruption, returning to work, job loss). A questionnaire with socio-demographic and job related information was submitted to each patient., Results: From January 2015 to June 2017, 2,187 patients with a new diagnosis of cancer were admitted to the outpatient clinic, 550 patients (25.15%) were be-tween 18 and 65 year old, and 416 patients (75.64%) participated to the study. 278 (66.83%) women and 138 (33.17%) men, mean age 50.32±7.90 years (range 18-65), 39.18% were employees, 29.81% workers, 328 (78.85%) with subordinate job, the majority of patients had an high school or academic degree (63.46%). 196 (47.12%) patients had breast cancer, 85 (20.43%) gas-trointestinal cancer, 41 (9.86%) lung cancer, and 94 pa-tients (22.59%) had other cancer; 105 patients (25.24%) showed metastatic cancer and 134 (32.21%) had comor-bidity. After 6 months 178 patients (42.79%) interrupted their work, of these, 99 were women, 35.61% of the 278 female and 79 men, 57.25% of the 138 males, 69 worker (38.76%), 94 with low level of education (52.81%). The majority of patients (86.67%) with metastatic cancer, or treated with chemotherapy (61.60%), or with comorbidity (50.75%), left their work after 6 months from diagnosis. Only 22 of 178 patients (12.36%) in our series returned to work, of these, 20 (90.90%) were women, 17 with breast cancer (85%)., Discussion: Our findings suggest that there is a significant association between job loss and gender (male), low level of education/heavy works, advanced stage of cancer, chemotherapy and comorbidity. It is important that clinicians and institutions consider work-related issue in cancer patients and perform adequate organizational and normative interventions.

Background: We sought to evaluate the epidemiology and the management of ST-elevation acute myocardial infarction (STEMI) in the Veneto Region (VENERE 2) in 2014, 10 years after a similar survey conducted in the early 2000s., Methods: Between October 2014 and March 2015, all consecutive patients admitted to the Cardiology Divisions of the Veneto Region with STEMI were enrolled in an observational, prospective, multicenter register, called VENERE 2. The main diagnostic and therapeutic efficiency indicators were analyzed and compared with data from the previous VENERE study performed 10 years earlier., Results: Overall, 1165 patients were enrolled, 902 (77%) with an interval <12 h between symptom onset and diagnosis. The incidence of STEMI was 657/million inhabitants per year (vs 697/million inhabitants in VENERE). For 883 (99%) patients, the chosen reperfusion strategy was primary percutaneous coronary intervention (pPCI) (vs 52.3% in VENERE); among these, 503 (55.8%) alerted the 118 (vs 29.7% in VENERE) and pre-hospital ECG was performed in 319 (35.4%) (vs 0% in VENERE). The proportion of patients who underwent recanalization within 90 min of diagnosis was 76.6% in patients treated in hospitals and 50% in transferred patients (vs 70% and 32% in VENERE, respectively). The median delay between symptom onset and recanalization was 60 min (vs 81 min in VENERE). In-hospital mortality was 5.4% (vs 7.3% in VENERE). The cumulative in-hospital incidence of urgent stroke, reinfarction, urgent revascularization was 5.1% (vs 7.1% in VENERE)., Conclusions: The current reperfusion treatment of STEMI in the Veneto Region is pPCI. Compared to the data of the VENERE registry, an improvement of all diagnostic and therapeutic efficiency indicators was observed.