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Background Cardiovascular disease (CVD) can occur in COVID-19 and has impact on clinical course. Data on CVD prevalence in hospitalized COVID-19 patients and sequelae in survivors is limited. Aim of this prospective study carried out on consecutive unselected COVID-19 population, was to assess: 1) CVD occurrence among hospitalized COVID-19 patients, 2) persistence or new onset of CVD at one-month and one-year follow-up. Methods Over 30 days n = 152 COVID-19 patients underwent cardiovascular evaluation. Standard electrocardiogram (ECG), Troponin and echocardiography were integrated by further tests when indicated. Medical history, arterial blood gas, blood tests, chest computed tomography and treatment were recorded. CVD was defined as the occurrence of a new condition during the hospitalization for COVID-19. Survivors attended a one-month follow-up visit and a one-year telephone follow-up. Results Forty-two patients (28%) experienced a wide spectrum of CVD with acute myocarditis being the most frequent. Death occurred in 32 patients (21%) and more frequently in patients who developed CVD (p = 0.032). After adjustment for confounders, CVD was independently associated with death occurrence. At one-month follow-up visit, 7 patients (9%) presented persistent or delayed CVD. At one-year telephone follow-up, 57 patients (48%) reported persistent symptoms. Conclusion Cardiovascular evaluation in COVID-19 patients is crucial since the occurrence of CVD in hospitalized COVID-19 patients is common (28%), requires specific treatment and increases the risk of in-hospital mortality. Persistence or delayed presentation of CVD at 1-month (9%) and persistent symptoms at 1-year follow-up (48%) suggest the need for monitoring COVID-19 survivors.

The extent and quality of the involvement of cardiology units in health programs delivered by Italian centers for heart transplantation (HTx) have not been investigated previously.The Italian Association of Hospital Cardiologists (ANMCO) and the Italian Society for Organ Transplantation (SITO) developed and delivered a nationwide survey to the Directors of the Italian centers for HTx to investigate the extent to which cardiology units contribute to HTx programs. The survey investigated: (i) the organization of the centers and institutional frame under which cardiology units contributed to HTx programs; (ii) the volumes of procedures and clinical services delivered by cardiology units to HTx centers for listing patients, following those waiting for HTx, managing acute heart failure, selecting and allocating organs to recipients, following and managing organ rejection after HTx.Of the 14 Italian centers involved, 13 provided full responses to the survey. Between 2017-2019, on average, 46% of the respondents performed up to 15 HTx/year, and additional 46% performed between 16 and 30 HTx/year. Of the respondents, 62% were included in a department of cardiac Surgery which did not include a cardiology unit; furthermore, 54% declared not to be included in a formal network for heart failure management. Cardiology units were the source for referrals of candidates to HTx in 85% cases. Of the respondents, 15% declared to be able to provide cardiological services thorough intra-center multidisciplinary team including cardiologists, whereas cardiological services were outsourced in 61% of the respondents. The clinical follow-up of patients waiting for HTx was performed directly by surgeons in 38% of the respondents. Worsening heart failure was managed directly by the HTx center in 33% of the cases using dedicated beds. Post-HTx follow-up, including endomyocardial biopsy, involved external cardiology units in less than 25% of the centers.The ANMCO-SITO survey shows that in Italy a very wide variability exists in terms of organization of HTx centers and their relationships with cardiology units for delivering specific cardiological services and procedures. In large majority, patient referral to HTx centers is mediated by cardiology units, whereas HTx was rarely included in a structured cardiological network for heart failure management.

The benefits associated with randomized clinical trials (RCTs) for patients, investigators, and sponsors are well known. However, little has been done to estimate the economic benefits related to spon- soring a RCT. Herein, a methodological analysis is proposed to assess the economic benefits and cost-savings of a RCT, namely the trial avoided costs (TAC). The TAC was considered to be cost-saving for the investigational medicinal product (IMP) (i.e., the drug adverted cost) and the diagnostic tests (i.e., procedure adverted cost) in a RCT. This tool is potentially helpful in understanding the financial impact of RCTS on healthcare institutions and provides the opportunity to invest budgets in other resources (i.e., core facilities, research infrastructure, human resources) that can increase the quality of clinical research.

Background The detection of a low amount of viral RNA is crucial to identify a SARS-CoV-2 positive individual harboring a low level of virus, especially during the convalescent period. However, the detection of one gene at high Cycle threshold (Ct) has to be interpreted with caution. In this study we address this specific issue and report our real-life experience. Study design A total of 1639 nasopharyngeal swabs (NPS) were analyzed with Xpert® Xpress SARS-CoV-2. Positive samples showing high Ct values (Ct>35) were concentrated by centrifugation and re-tested with Cepheid or other methods (RealStar SARS-CoV2 RT-PCR, Altona Diagnostics; GeneFinder COVID-19 Plus RealAmp Kit, Elitech). Results 1599 (97.5%) negative samples, 36 (2.3%) positive samples and 4 (0.2%) presumptive positive samples were detected. In 17 out of 36 positive patients, very low viral RNA copies were suspected since positivity was detected at high Ct. We confirmed positivity for patients who showed both E and N genes detected and for patients with only N detected but with Ct 39 were found negative. NPS taken 24 hours after the first collection confirmed the negativity of the 12 samples. Clinical data sustained these results since only 2 of these 12 patients showed COVID-19-like symptoms. Conclusions These data support our consideration that detection of the N2 gene at high Ct needs to be interpreted with caution, suggesting that collaboration between virologists and clinicians is important for better understanding of results.

Background Functional decline from preadmission to admission may represent an important predictor of functional trajectories during hospitalization among older patients. Therefore, we aimed at describing the impact of preadmission decline on functional trajectories among older hospitalized patients. Methods Our series consisted of 2,011 patients aged 65 years or more consecutively admitted to four acute care wards of Geriatric Medicine participating to a multicenter observational study. Enrolled patients underwent comprehensive geriatric assessment (CGA) by Inter-RAI Minimum Data Set. Main outcomes were functional decline or improvement from hospital admission to discharge based on Activities of Daily Living (ADL) scale. The main exposure variable was ADL decline during the preadmission period (ie, 3 days before the onset of acute illness), and its impact on functional trajectories during stay was investigated by Cox regression models after adjusting for potential confounders. Results After adjusting for potential confounders, preadmission functional decline was significantly associated with functional improvement during stay (hazard ratio [HR] = 6.65; 95% confidence interval [CI] = 5.01-8.84), but not with functional decline. Severe cognitive impairment (HR = 0.28, 95% CI = 0.13-0.60), visual impairment (HR = 0.60, 95% CI = 0.41-0.89), and weight loss (HR = 0.67, 95% CI = 0.47-0.94) were associated with functional improvement during stay. Hearing impairment (HR = 1.94, 95% CI = 1.17-3.23) and mild (HR = 2.54, 95% CI = 1.41-4.58) or severe cognitive impairment (HR = 2.72, 95% CI = 1.13-6.56) were associated with functional decline during stay. Conclusions Patients experiencing recent preadmission functional decline should be considered as those for which the geriatric approach may lead to the better functional result in the acute care setting. CGA allows to individuate risk factors to be addressed in the acute care setting.

To estimate health care costs for heart failure patients in Marche region in 2003 through record linkage of administrative and demographic databases of hospitalisations, pharmaceutical prescriptions and outpatient services. Patients hospitalised with heart failure as primary or secondary diagnosis and those with co-payment exemption due to heart failure were identified. Their consumptions of health care services (inpatient, outpatient care, and drugs) in 2003 were retrieved by record linkage from three databases. Health care costs were estimated on the basis of Marche regional hospital DRG tariffs, national outpatient tariffs and regional drug gross expenditure, respectively. Total health care costs, average costs per patient, consumption patterns by age and sex were analysed. 17.870 patients out of 1,5 million inhabitants in Marche region are recorded with heart failure (1,2% prevalence rate). The total health care costs are estimated around € 27,5 million in 2003, equals to 1,3% of the regional public health expenditure. Hospital care, drugs and outpatient care cover respectively 77%, 21%, and 2% of the total costs. The average cost per patient is € 1,543. Older patients register on average lower unit costs of health care, particularly for drugs prescriptions (cost per DDD decreases from € 0.55 in age class 50–54 yrs to € 0.37 in age class 90+ yrs) and outpatient services (cost per service decreases from € 31 in age class 19–49 yrs to € 19 in age class 90+ yrs). Moreover males report overall higher average costs per patient than females. Findings confirm the relevance of heart failure within the health care services and highlight some critical areas in disease management, i.e. limited access to day-hospital, repeated hospitalisations, different patterns of access to health care according to age and sex. The analysis demonstrates also the relevance of record linkage of administrative databases for integrated health care and cost assessments.

Background Heart failure (HF) and chronic obstructive pulmonary disease (COPD) share a common organ failure trajectory marked by prognostic uncertainty, which is a barrier to appropriate provision of palliative care. We describe in a prospective cohort from specialist hospital services the epidemiology and late clinical course of these chronic diseases to trace criteria for transition to palliative care in the community. Methods and results Seven centers enrolled 267 patients with advanced HF (n=174) or COPD (n=93) using common (multiple hospitalizations or severely impaired functional status or cachexia) and disease-specific (HF: systolic dysfunction, NYHA classes III–IV, end-organ hypoperfusion; COPD: very severe airflow obstruction, hypoxemia, hypercapnia, or long-term oxygen therapy) entry criteria. These patients represented 7.2% and 13% respectively of the overall HF and COPD population hospitalized during one year. They showed similar symptom burden, functional and quality of life impairment, recurrent hospitalizations, and 6-month mortality (39% and 37%, respectively). Organ failure progression was the cause of death in >75%. In-hospital overall stay during the previous year was the main mortality predictor in both. Disease-specific predictors included anemia, hyponatremia, no beta-blockers in HF; older age, hypercapnia in COPD. Conclusions Patients with advanced HF/COPD represent almost 10% of subjects hospitalized yearly with a primary diagnosis of HF or COPD, have similarly impaired functional status, disabling symptoms and reduced survival. Overall days spent in-hospital during the previous year, a "red flag" in the late clinical course of both diseases, might be used as a simple, reliable screening tool for appropriate transition to palliative care in the community.

Background and aim: This cluster randomized trial evaluated the efficacy of a disease and care management (D&CM) model in cardiovascular (CVD) prevention in primary care. Methods and results: Eligible subjects had ≥1 among: blood pressure≥140/90mmHg; glycated hemoglobin≥7%; LDL-cholesterol≥160 or ≥100mg/dL (primary or secondary prevention, respectively); BMI≥30; current smoking. The D&CM intervention included a teamwork including nurses as care managers for the implementation of tailored care plans. Control group was allocated to usual-care. The main outcome was the proportion of subjects achieving recommended clinical targets for ≥1 of uncontrolled CVD risk factors at 12-month. During 2008-2009 we enrolled 920 subjects in the Abruzzo/Marche regions, Italy. Following the exclusion of L'Aquila due to 2009 earthquake, final analyses included 762 subjects. The primary outcome was achieved by 39.1% (95%CI: 34.2-44.2) and 25.2% (95%CI: 20.9-29.9) of subjects in the intervention and usual-care group, respectively (p

Chronic diseases represent a major clinical and social problem. Both institutions and professionals are called upon to provide accurate and efficient care at all stages in the clinical pathway. Heart failure (HF) is one of the most chronic diseases with the highest impact on survival, quality of life, and overall costs and assistance. However, healthcare support is often fragmented and with little attention to coordination through the different stages of the clinical pathway.On the basis of the synergistic approach for implementation of clinical pathways between the Regional Healthcare Agency of the Marche Region and the consensus document of the Italian Federation of Cardiology, we decided to conduct a survey on assistance programs to patients with HF in the Marche Region. The questionnaire was modeled on one developed by the Italian Association of Hospital Cardiologists (ANMCO) during the years 2004-2005, and was sent to all facilities participating in the Cardiology Network of the Marche Region; all the 15 facilities surveyed answered correctly.An outpatient HF clinic is available only in 5 of the 15 facilities surveyed. Five facilities have dedicated medical staff, whereas only 3 facilities have nursing staff. A clinical pathway is planned with general practitioners only in 2. The discharge letter is well structured and also provides a direct management of follow-up controls. None of the facilities offer medical or nursing staff to support patients at home.In the Marche Region, although few in number, outpatient HF clinics provide good-quality care. Clinical pathways are currently implemented in 2 facilities. Another clinical pathway, however, is going to be developed including all hospital facilities (Cardiology, Internal Medicine, Geriatrics) and out-of-hospital healthcare providers (local care planning, general practitioners, outpatient specialists) with the active participation of all professionals involved in the clinical pathways of HF patients.

Cluster randomization, where groups (or clusters) of subjects, rather than single individuals, are randomly allocated to intervention groups, is increasingly being adopted in studies to evaluate interventions directed at a whole area or healthcare unit (such as a hospital ward, or a medical practice). Studies that use this method of randomization are referred to as cluster randomized trials (CRT) and have considerable organizational and economic advantages. However, CRTs have distinctive ethical issues that need to be considered and most importantly, require a series of methodological modifications during data analysis and calculation of sample size (during which additional parameters, such as the intracluster correlation coefficient and the design effect, need to be obtained). Methodological guidelines for conducting CRTs have been published in November 2002. However, no scientific articles dealing with the methodology associated with the design and analysis of this type of study have yet been published in Italian. The aim of this article, therefore, is to provide methodological support to healthcare researchers who are planning a CRT, through a description of the methodology used in the Raffaello project. This project is in the start-off phase in the Marche and Abruzzo regions of Italy and represents an excellent case study, it being a CRT aimed at evaluating the efficacy of a Disease Management model in the general population (with general practitioners therefore, being the cluster of randomization).