[Cardiology units and organizational models of heart transplantation centers in Italy: a survey by the Italian Association of Hospital Cardiologists-Italian Society of Organ Transplantation (ANMCO-SITO)]. / Cardiologie e modelli organizzativi dei centri trapianto di cuore: indagine ANMCO-SITO.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Cardiac involvement in consecutive unselected hospitalized COVID-19 population: In-hospital evaluation and one-year follow-up.

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 Synergistic Effect of Time of Exposure, Distance and No Use of Personal Protective Equipment in the Determination of SARS-CoV-2 Infection: Results of a Contact Tracing Follow-Up Study in Healthcare Workers.

The aim of this study is to assess the effect of contact time, contact distance and the use of personal protective equipment on the determination of SARS-CoV-2 infection in healthcare workers (HCWs). This study consists of an analysis of data gathered for safety reasons at the Sapienza Teaching Hospital Policlinico Umberto I in Rome through the surveillance system that was put into place after the worsening of the COVID-19 pandemic. The studied subjects consist of HCWs who were put under health surveillance, i.e., all employees who were in contact with subjects who were confirmed to have tested positive for SARS-CoV-2. The HCWs under surveillance were monitored for a period encompassing ten days after the date of contact, during which they undertook nasopharyngeal swab tests analysed through RT-PCR (RealStar® SARS-CoV-2 Altona Diagnostic-Germany). Descriptive and univariate analyses have been undertaken, considering the following as risk factors: (a) no personal protective equipment use (PPE); (b) Distance < 1 m between the positive and contact persons; (c) contact time > 15'. Finally, a Cox regression and an analysis of the level of synergism between factors, as specified by Rothman, were carried out. We analysed data from 1273 HCWs. Of these HCWs, 799 (62.8%) were females, with a sample average age of 47.8 years. Thirty-nine (3.1%) tested positive during surveillance. The overall incidence rate was 0.4 per 100 person-days. Time elapsed from the last exposure and a positive RT-PCR result ranged from 2 to 17 days (mean = 7, median = 6 days). In the univariate analysis, a distance <1 m and a contact time > 15' proved to be risk factors for the SARS-CoV-2 infection, with a hazard ratio (HR) of 2.62 (95% CI: 1.11-6.19) and 3.59 (95% IC: 1.57-8.21), respectively. The synergism analysis found the highest synergism between the "no PPE use" x "Contact time". The synergy index S remains strongly positive also in the analysis of the factors "no PPE use" x "Distance" and "Time of contact" x "Distance". This study confirms the absolute need to implement safety protocols during the pandemic and to use the correct PPE within health facilities in order to prevent SARS-CoV-2 infection. The analysis shows that among the factors considered (contact time and distance, no use of PPE), there is a strong synergistic effect.

Detection of SARS-COV N2 Gene: Very low amounts of viral RNA or false positive?

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. On the contrary, samples with only gene N detected with Ct values >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.

Preadmission Functional Decline Predicts Functional Improvement Among Older Patients Admitted to Acute Care Hospital.

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.

[Methodological problems associated with the planning of.]. / Problematiche metodologiche nella pianificazione e nel calcolo della dimensione del campione di un cluster randomized trial (CRT): il caso del Progetto Raffaello.

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).

Palliative needs for heart failure or chronic obstructive pulmonary disease: Results of a multicenter observational registry.

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.

Early discharge of infectious disease patients: an opportunity or extra cost for the Italian Healthcare System?

In order to assess the economic benefits of an early discharge (ED) programme for patients with complicated skin and soft tissue infections (cSSTIs) in terms of hospital and regional authority costs, an economic analysis was conducted comparing two possible alternatives: standard hospital management vs. an ED strategy followed by a period of outpatient management. Utilization of resources and costs were derived from the literature and expert panel evaluation. Patients were classified into four groups: low-intensity non-walking (LINW), low-intensity walking (LIW), high-intensity non-walking (HINW) and high-intensity walking (HIW). The overall costs (inpatient/outpatient) of hospitalization with ED for cSSTIs range from Euros 2,079 for LIW to Euros 2,193 for HINW, with the most expensive regimen (HINW) being 50% lower than the costs for 12.6 days of hospitalization alone (Euros 4,619). The weighted average Diagnosis Related Group (DRG) reimbursement for cSSTIs (Euros 2,042) does not cover the costs of such hospitalization. In conclusion, when a patient's conditions allow for early discharge there is an economic advantage for the hospital with an outpatient management plan, especially for patients requiring low-intensity care. However, this could be disadvantageous in terms of regional costs if outpatient management has to be paid in addition to payment by the DRG.

[Questionnaire survey of the management of heart failure in the Marche Region, Italy]. / Indagine conoscitiva sulla gestione dello scompenso cardiaco nella Regione Marche.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.