Traumatic brain injury incidence and mortality: a large population-based study.

BACKGROUND: Traumatic brain injury (TBI) is a severe condition that represents a major global public health concern. OBJECTIVES: Provide a comprehensive epidemiological outlook encompassing TBI incidence, healthcare provision and mortality. METHODS: Population-based study in Veneto (4.9 million inhabitants), Italy, from 2012 to 2021. Hospital discharge and mortality records were used to assess incidence and mortality. Kaplan-Meier survival estimator and Cox regression models were fitted to investigate determinants of mortality. RESULTS: Between 2012 and 2021, there were 37,487 incident TBI cases, corresponding to an age-standardized rate of 77.30/100,000 people (95% CI 76.52-78.09), higher among males, with an exponential growth after age 70. Leading causes were domestic (33.1%) and traffic accidents (17.7%), the first predominating among the elderly and children, while the latter in males 15-24 and older people. After rates stably declined between 2012 and 2019, the study captured a sharp decrease especially for traffic and occupational accidents in males, due to COVID-19 lockdown in 2020. Overall, 48.9% TBI patients were hospitalized in a specialized trauma center, with 2.6% requiring a transfer after accessing a spoke hospital. Over a 3.7 years median follow-up, 16,145 deaths were recorded, with higher mortality for those undergoing neurosurgical interventions, regardless of their access point. Risks of death increased with age, male gender, and comorbidities. DISCUSSION: TBI incidence is characterized by distinct patterns, affecting particularly older individuals and males. Minimal hospital transfers with comparable survival irrespective of access point suggests an effective patient management within the network. The study underscores the critical need for acute-phase support and prolonged care strategies for older TBI patients.

Home care models dedicated to COVID-19 patients: the experience of a Local Health District of Veneto Region (Italy).

Background: During COVID-19 pandemic, health professionals have been working in an extreme uncertainty context. Affected patients needed to be cared at home as long as possible to avoid virus spreading and hospital resources saturation. The Veneto Regional Administration (North-east of Italy) released Regional guidelines about it. The Western Healthcare District of the Local Health Authority of the city of Vicenza (180,000 inhabitants) implemented a healthcare pathway following them. Aim of the study is to describe the results and outcomes of such implementation. Methods: In the implemented health care pathway, a new service called "Special Unit of continuity of care" (USCA) with physicians and nurses has been dedicated to the prise en charge at home of patients suffering from Sars-CoV-2. They were referred to the USCA by general practitioners or by hospital specialists, and managed through a daily clinical monitoring by regular home visits and phone calls, specialist consultations and therapy management. In order to prevent hospital admission, an oxygen concentrator when possible has been employed and managed at home by the members of the USCA when the oxygen saturation was below 93%. An observational retrospective study has been conducted using anonymized data from different databases: the USCA activity database (from 12/01/20 to 21/31/21), the hospital and Emergency Department discharge databases, and the "healthcare co-payments exemptions database". The latter database refers to the people excluded - because of their chronicity - from the co-payment of a list of medical exams and services. Descriptive and multivariate logistic regression analyses have been implemented. Results: 1,419 patients suffering from Sars-CoV-2 have been cared and managed by the USCA in the considered period of time (mean 11.4 days), of whom 787 (55.5%) with at least one chronic condition (described in the above quoted "healthcare co-payments exemption database") and 261 provided with oxygen concentrator. 275 (19.4%) needed a hospital admission, 39 (2.8%) in intensive unit; 53 died during hospitalization (3.8%). Out of the 261 patients utilizing oxygen concentrator, 103 have been admitted to hospital (39.5%), 7.3% in intensive unit and 8.0% died. In implemented multivariate analyses, the use of oxygen concentrator, proxy measure of the severity of the condition, is the major determinant for the risk of hospital admission (adj OR: 3.2, CI 2.3-4.3) and of dying within 30 days (adj OR: 2.8 CI 1.5-5.1). Among the 261 patients provided with oxygen concentrator, 158 (60,5%) have been managed at home without any admission to emergency department and/or hospitalization. Conclusions: In an uncertain context such as COVID-19 pandemic, the already-implemented home care model has been modified by integrating the USCA physicians and nurses and specialist care networks to prevent hospitalization and the sense of isolation and abandonment of people as much as possible. Almost 1,500 patients suffering from COVID-19 have been cared for at home over 13 months by such new service with complex and multidisciplinary activities. The risk of hospitalization and death appears determined by the severity of the pathology with high and significant OR 60% of patients with oxygen concentrators who, despite an initial high hyposaturation were not hospitalized, represent, partly, the group of patients who would have been requiring hospital care in the absence of a home care pathway in a standard situation.

Mortality related to HCV and other chronic liver diseases in Veneto (Italy), 2008-2021: Changes in trends and age-period-cohort effects.

BACKGROUND AND AIMS: The objective of this study was to assess the impact of the COVID-19 pandemic and direct-acting antiviral (DAA) agents on mortality related to chronic liver diseases (CLD). METHODS: Age-standardized mortality rates were computed based on CLD as the underlying cause of death (UCOD) and as any mention in death certificates (multiple causes of death-MCOD). Time trends in age-standardized mortality rates were investigated using generalized estimation equation models. Additionally, we conducted age, period, and birth cohort (APC) analyses on CLD-related mortality associated with alcohol and hepatitis C virus (HCV). RESULTS: Between 2008 and 2021, among residents in the Veneto region (Northeastern Italy) aged ≥35 years, there were 20 409 deaths based on the UCOD and 30 069 deaths based on MCOD from all CLD. We observed a 4% annual decline in age-standardized MCOD-based mortality throughout 2008-2021, with minor peaks corresponding to COVID-19 epidemic waves. Starting in 2016, the decline in HCV-related mortality accelerated further (p < .001). A peak in HCV-related mortality in the 1963-1967 birth cohort was observed, which levelled off by the end of the study period. Mortality related to alcoholic liver disease declined at a slower pace, becoming the most common aetiology mentioned in death certificates. CONCLUSIONS: The study demonstrates a significant decrease in HCV-related mortality at the population level in Italy with the introduction of DAAs. Continuous monitoring of MCOD data is warranted to determine if this favourable trend will continue. Further studies utilizing additional health records are needed to clarify the role of other CLD etiologies.

Hyperthyroidism incidence in a large population-based study in northeastern Italy.

Objective: An improvement in iodine status in Veneto Region has been documented in the last decade. We aimed at estimating the incidence of hyperthyroidism in the Veneto Region (Italy) over the period 2013-2022. Methods: Retrospective population-based study conducted in Veneto (4.9 million people) using the population registry, an administrative health database. Between 2012 and 2022, hyperthyroidism incidence was defined thank to a health-care co-payment exemption for hyperthyroidism or any hospital diagnosis of hyperthyroidism. Incident hyperthyroidism was defined from 2013 to 2022 to exclude prevalent cases. Standardized incidence rates (IRs) were reported by age, sex, and etiology of thyroid hyperfunction too. Results: We identified 26,602 incident cases (IR of 54.38 per 100,000 person-years, 2.47-fold higher in females than in males). IR decreased from 69.87 (95% CI: 67.49, 72.25) in 2013 to 42.83 (95% CI: 40.99, 44.66) in 2022. In 2020, an out-of-trend decrease in hyperthyroidism incidence was documented, corresponding to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic outbreak, with a realignment to the trend in the subsequent years. The annual percentage change according to the cause of hyperthyroidism was as follows: -6.62% (95% CI: 8.47, 4.73) (P < 0.0001) in toxic multinodular goiter, -7.56% in toxic uninodular goiter (95% CI: 10.54, 4.48) (P < 0.001) and -4.70% (95% CI: 6.33, 3.04) in toxic diffuse goiter (Graves' disease) (P < 0.001). Conclusions: We documented a decline in the incidence of hyperthyroidism in Veneto Region, paralleling the improvement of the iodine status, thanks to a long and sustained iodine prophylaxis campaign. SARS-CoV-2 pandemic and vaccination campaign did not change the declining trend of hyperthyroidism incidence in our study region. Significance statement: An improvement in iodine status in the population residing in the Veneto region has been documented in the last decade, thanks to a nationwide voluntary iodine prophylaxis program running since 2005, but its impact on the epidemiology of thyroid disease has never been documented. This is the largest study on the incidence rates of hyperthyroidism carried out in Italy and covers the longest observation period among all regionwide population-based studies of hyperthyroidism in our country. We documented a reduction in the incidence of hyperthyroidism, which was more pronounced in nodular goiter diagnosis but involved also toxic diffuse goiter. The decline in the incidence of hyperthyroidism in Veneto Region shows the efficacy and safety of the iodine prophylaxis campaign.

Trends in hospital volume and operative mortality in hepato-biliary surgery in Veneto region, Italy.

Hepatobiliary resections are among the most complex and technically challenging surgical procedures. Even though robust evidence showed that complex surgical procedures such as hepatobiliary surgery have better short- and long-term outcomes and lower mortality rate when performed in high-volume centers, the minimal criteria of centers that can perform hepatobiliary activity are not clearly defined. We conducted a retrospective population study of patients who underwent hepatobiliary surgery for malignant disease in a single Italian administrative region (Veneto) from 2010 to 2021 with the aim to investigate the hospitals annual surgical volume for hepatobiliary malignant diseases and the effect of hospital volume on in-hospital, 30- and 90-day postoperative mortality. The centralization process of hepatobiliary surgery in Veneto is rapidly increasing over the past 10 years (rate of performed in highly specialized centers increased from 62% in 2010 to 78% in 2021) and actually it is really established. The crude and adjusted (for age, sex, Charlson Index) mortality rate after hepatobiliary surgery resulted significantly lower in centers with high-volume activity compared to them with low-volume activity. In the Veneto region, the "Hub and Spoke" model led to a progressive centralization of liver and biliary cancer treatment. High surgical volume has been confirmed to be related to better outcomes in terms of mortality rate after hepatobiliary surgical procedures. Further studies are necessary to clearly define the minimal criteria and associated numerical cutoffs that can help define the characteristics of centers that can perform hepatobiliary activities.

Mortality from chronic liver disease: Recent trends and impact of the COVID-19 pandemic.

Prepandemic time trends in mortality from chronic liver disease (CLD) differed according to specific cause of death (decreasing for liver cirrhosis, stable or increasing for liver cancer), etiology (increasing for nonalcoholic fatty liver disease, generally decreasing for other etiologies), and world region (decreasing in areas with the highest burden of hepatitis B virus, increasing in Eastern Europe and other countries). The coronavirus disease 2019 (COVID-19) pandemic affected mortality of patients with CLD both directly, with a higher risk for severe illness and death depending on age, stage and etiology of the disease, and indirectly, through social isolation and loss of support, harmful drinking, and difficulties in access to care. Nevertheless, only sparse data are available on variations in CLD as a cause of death during the pandemic. In the USA, in 2020-2021 a growth in mortality was registered for all liver diseases, more marked for alcoholic liver disease, especially among young people aged 25-44 years and in selected ethnic groups. COVID-19 related deaths accounted only for a minor part of the excess. Further data from mortality registers of other countries are warranted, preferably adopting the so-called multiple cause-of-death approach, and extended to deaths attributed to viral hepatitis and liver cancer.

Hospital readmissions and mortality following discharge against medical advice: a five-year retrospective, population-based cohort study in Veneto region, Northeast Italy.

OBJECTIVES: The aim of this study was to examine the odds of readmission and mortality after discharge against medical advice (DAMA) in the Veneto region of Northeast Italy, drawing on data from the regional archives of emergency department records and hospital discharge records. DESIGN: A retrospective cohort study. SETTING: Hospital discharges, Veneto region, Italy. PARTICIPANTS: All patients discharged after being admitted to a public or accredited private hospital between January 2016 and 31 January 2021 in the Veneto region were considered. A total of 3 574 124 index discharges were examined for inclusion in the analysis. PRIMARY AND SECONDARY OUTCOME MEASURES: Readmission and overall mortality at 30 days after the index discharge against admission. RESULTS: In our cohort, 7.6‰ of patients left hospital against their doctor's advice (n=19 272). These DAMA patients were more likely to be younger (mean age: 45.5 vs 55.0), foreign (22.1% vs 9.1%). The adjusted odds of readmission after DAMA was 2.76 (CI 95% 2.62-2.90) at 30 days (9.5% DAMA vs 4.6% not-DAMA), and the highest readmission rate was recorded in the first 24 hours after the index discharge. Mortality was higher for DAMA patients after adjusting for patient-level and hospital-level characteristics (with adjusted ORs of 1.40 for in-hospital mortality and 1.48 for overall mortality). CONCLUSIONS: The present study shows that DAMA patients are more likely to die and to need hospital readmission than patients discharged by their doctors. DAMA patients should be more committed to a proactive and diligent postdischarge care.

Respiratory Syncytial Virus in Veneto Region: Analysis of Hospital Discharge Records from 2007 to 2021.

Respiratory Syncytial Virus (RSV) is a known cause of acute lower respiratory infections in infants and young children. The present study aims to analyze the temporal trends and characteristics of hospitalization related to RSV in the Veneto region (Italy) in the period between 2007 and 2021. The analysis is performed on all the hospital discharge records (HDRs) of public and accredited private hospitals corresponding to hospitalizations occurring in the Veneto region (Italy). HDRs are considered if they included at least one of the following ICD9-CM codes: 079.6-Respiratory Syncytial Virus (RSV); 466.11-acute bronchiolitis due to RSV; and 480.1-pneumonia due to RSV. Total annual cases, sex, and age-specific rates and trends are evaluated. Overall, an increasing trend in the number of hospitalizations due to RSV was observed between 2007 and 2019, with a slight drop in RSV seasons 2013-2014 and 2014-2015. From March 2020 to September 2021, almost no hospitalization was registered, but in the last quarter of 2021, the number of hospitalizations reached its highest value in the series. Our data confirm the preponderance of RSV hospitalizations in infants and young children, the seasonality of RSV hospitalizations, and acute bronchiolitis as the most frequent diagnosis. Interestingly, the data also show the existence of a significant burden of disease and a non-negligible number of deaths also in older adults. The present study confirms RSV is associated with high rates of hospitalization in infants and sheds light on the burden in the 70+ age group in which a considerable number of deaths was observed, as well as the parallelism with other countries, which is consistent with a wide underdiagnoses issue.

Mortality and causes of death in systemic lupus erythematosus over the last decade: Data from a large population-based study.

OBJECTIVE: To assess mortality rates (MRs), standardized mortality ratios, and causes of death in systemic lupus erythematosus (SLE) in a population-based study. METHODS: We analyzed linked administrative health databases of the Veneto Region (Italy, 4,900,000 residents). SLE was defined by any hospital diagnosis or healthcare copayment exemption for SLE. We analyzed mortality from January 1st, 2012, until December 31st, 2021. MRs per 1000 were stratified by year, sex, and age group. Standardized mortality ratios were derived by comparing MRs of the general regional population. Causes of death were coded using the ICD-10 coding system and they were grouped in: SLE, infectious diseases, cardiovascular diseases (CVD), cancer, or others. RESULTS: Among 4283 SLE prevalent cases, 603 deaths occurred, corresponding to an average annual standardized MR of 18.6 per 1000 person/year (95% CI 17.0-20.2). Out of 1092 incident SLE patients, 90 died with a peak in the first year after diagnosis (MR 26.5 per 10,000 person/month). Standardized mortality ratio was 2.65 (95% CI 2.13-3.26) overall, and highest among younger patients (<45 years: 5.59, 95% CI 2.05-12.4). Five- and 8-year survival were 91% and 89%, respectively. About half of the deaths had CVD or cancer as underlying cause, whereas infections were less frequently reported. CONCLUSIONS: Although the medium-term survival since diagnosis is good, SLE mortality is still higher than that of the general population, especially in youngest patients. Nowadays, CVD seems to be the major cause of deaths in SLE, whereas infections account for a low proportion of deaths, at least in Western countries.

Current territorial organization for access to revascularization therapies for acute ischemic stroke in the Veneto region (Italy) from 2017 to 2021.

INTRODUCTION: To evaluate the access to treatments with intravenous thrombolysis (IVT) and/or mechanical thrombectomy (MT) in acute ischemic stroke patients admitted to stroke units (SUs) of Veneto region (Italy) according to current "hub-and-spoke" model from 2017 to 2021. PATIENTS AND METHODS: We retrospectively analyzed data on treatments with IVT and/or MT for stroke patients admitted to the 23 SUs (6 Hubs and 17 Spokes) of the 6 macro-areas including 9 local sanitary units (LSUs) and 2 hospitals. RESULTS: We reported 6093 treatments with IVT alone, 1114 with IVT plus MT, and 921 with MT alone. Number of stroke unit (SU) beds/100,000 inhabitants ranges from 2.3 to 2.8, and no difference was found among different macro-areas. Number of treatments/100,000 inhabitants/year ranges from 19 to 34 for IVT alone, from 2 to 7 for IVT plus MT, and from 2 to 5 for MT alone. Number of IVT alone/SU bed/year ranges from 9 to 21 in the Hub and from 6 to 12 in the Spokes. Rate of IVT plus MT in patients directly arrived in the same LSU's Hub ranges from 50 to 81%, likewise the one of MT alone ranges from 49 to 84%. CONCLUSIONS: Treatment target rates of IVT and MT set by Action Plan for Stroke in Europe 2018-2030 has been globally exceeded in the Veneto region. However, the target rate of MT and access revascularization treatments is heterogeneous among different macro-areas. Further efforts should be made to homogenize the current territorial organization.

Systemic lupus erythematosus incidence and prevalence in a large population-based study in northeastern Italy.

OBJECTIVES: We aimed at estimating the incidence and prevalence of SLE in northeastern Italy over the period 2012-20. METHODS: A retrospective population-based study was conducted in Veneto Region (4.9 million people) using the population registry, an administrative health database where all residents are recorded. Between 2012 and 2020, SLE prevalence was defined by a healthcare co-payment exemption for SLE (national registry code 028) or any hospital diagnosis of SLE (International Classification of Disease , Ninth Revision, Clinical Modification 710.0), whichever came first. Incident SLE was defined from 2013 to 2020 to exclude prevalent cases. Standardized incidence and prevalence rates were reported by age and sex. RESULTS: During the study period, we identified 4283 SLE patients (85% female), with 1092 incident cases. Across the study period, SLE standardized point prevalence increased from 63.5 (95% CI 61.2, 65.8) to 70.6 (95% CI 68.3, 73.0) per 100 000 residents, corresponding to an annual increment of 1.14% (P < 0.0001). The highest prevalence was observed in females aged 60-69 years. SLE incidence corresponded to 2.8 per 100 000 person-years (95% CI 2.6, 2.9), with an annual decline of 7.3% (P < 0.0001). Incidence was 5-fold higher in females (female-to-male incidence rate ratio: 5.00, 95% CI 4.25, 5.87; P < 0.0001), with a peak among women aged 30-39 years. At diagnosis, women were significantly younger (45 years, IQR 33-58) than men (52 years, IQR 38-64). CONCLUSIONS: Over the last decade, SLE prevalence has increased, while incidence has stably declined. In view of the introduction of new high-cost drugs, a clear definition of the epidemiology of SLE is crucial for all healthcare stakeholders.

COVID-19 Vaccine Effectiveness against Omicron Variant among Underage Subjects: The Veneto Region's Experience.

Even if most of the complications due to COVID-19 are observed in the elderly, in Italy the impact of COVID-19 among young people has not been negligible. Furthermore, their contribution to SARS-CoV-2 circulation is still unclear. These reasons have driven policy makers to involve subjects aged 5 to 17 years in the COVID-19 vaccination campaign. However, the trade-off of vaccinating this age-group should be further investigated, especially in view of the rise of new immunologically evasive variants of concern (VOCs). We used regional databases to retrospectively estimate vaccine effectiveness over time of each approved vaccination schedule among children (5-11) and adolescents (12-17). Our findings suggest that COVID-19 vaccines were highly effective and their protection levels lasted longer during a period of Delta variant predominance, whereas they offered just mild to moderate levels of protection-apparently affected by a rapid waning effect-in a period of Omicron variant predominance. Considering these results, it is plausible to evaluate a reformulation of possible future COVID-19 vaccination campaigns among underage subjects. However, effectiveness against serious complications due to COVID-19, as well as indirect benefits of underage vaccinations, should first be addressed. Furthermore, vaccine effectiveness should be kept monitored, as new VOCs may arise, but also new adapted vaccines may start being administered.

Differences in Immunological Evasion of the Delta (B.1.617.2) and Omicron (B.1.1.529) SARS-CoV-2 Variants: A Retrospective Study on the Veneto Region's Population.

In December 2021-January 2022 the Veneto region in Italy faced an unprecedented wave of SARS-CoV-2 infections, even though both the vaccine coverage and the number of previously infected individuals keep increasing. In this study we address the protection against the SARS-CoV-2 infection offered by natural immunity and a three-dose regimen through a retrospective study based on Veneto's regional databases. In particular, we compared these protection levels during two distinct periods respectively representative of the Delta (B.1.617.2) and the Omicron (B.1.1.529) variants, in order to investigate and quantify the immunological evasion, especially of the Omicron. For each period we compared the incidence rate of infection among the population with various immunological protections against SARS-CoV-2 and performed a multivariable proportional hazard Cox binomial regression to assess the effectiveness afforded by both forms of active immunization. We found out that a previous SARS-CoV-2 infection (irrespective of its timing) offers 85% (83-87%) and 36% (33-39%) protection against being reinfected by Delta and Omicron, respectively. In addition, we estimated the third dose to be more effective in both periods and to have a minor proportional loss of effectiveness due to the rise of the Omicron variant, with an afforded effectiveness against SARS-CoV-2 Delta and Omicron infection of 97% (96-97%) and 47% (45-48%), respectively. Our findings suggest that viral variant factors may affect any form of active immunization but that receiving a booster vaccination cycle is more effective and less variable than natural immunity in terms of afforded protection against SARS-CoV-2 infections.

Parkinson's disease related mortality: Long-term trends and impact of COVID-19 pandemic waves.

INTRODUCTION: Parkinson's disease (PD) mortality burden is increasing worldwide, but accurate estimates on the magnitude of the impact of the COVID-19 pandemic are missing. Mortality rates vary largely when considering PD as underlying cause of death (UCOD), or as one among multiple causes reported in death certificates (MCOD). The aim of this study is to assess COVID-19 impact on PD-related mortality trends using the UCOD and MCOD approach. METHODS: Mortality records between 01/2008-12/2020 of residents aged ≥45 years in Veneto Region (Northeastern Italy) with any mention of PD were collected. Age-standardized sex-specific mortality rates were estimated for PD-related deaths as UCOD and MCOD to assess time trends. The average annual percentage change in age-standardized rates (AAPC) was estimated by linear regression models. Monthly mortality in 2020, the first year of the pandemic, was plotted against the 2018-2019 average. RESULTS: Overall, 13,746 PD-related deaths (2.3% of all deaths) were identified, 52% males, median age 84 years. Proportional mortality increased from 1.9% (2008) to 2.8% (2020). AAPC through 2008-2019 was +5.2% for males and +5.3% for females in analyses of the UCOD, and +1.4% in both genders based on MCOD. Excess in PD-related mortality during 2020 corresponded to 19% for UCOD and 28% for MCOD, with the latter showing two peaks corresponding to the first (28%) and second (59%) pandemic waves. CONCLUSION: Age-standardized PD-related mortality rates have steeply increased during COVID-19 pandemic, amplifying a pre-existing long-term trend. Hence, surveillance of mortality associated to PD is warranted in the forthcoming pandemic and post-pandemic years.

Epidemiology of traumatic spinal cord injury: a large population-based study.

STUDY DESIGN: A retrospective population-based study. OBJECTIVES: Describe the incidence of traumatic spinal cord injury (TSCI) and mortality risks, based on the characteristics of the patient, anatomical level of the lesion, setting/cause of the injury, and type of healthcare support received within the regional trauma network (highly specialized trauma center or spoke hospital). SETTING: Between 2011 and 2020, 1303 patients with incident TSCI were identified in a population of 4.9 million inhabitants. METHODS: Hospital discharge records and mortality records were used to identify patients and outcomes. Cox regression models were fitted to estimate mortality risks across several subgroups. RESULTS: Over the past decade, age-sex-standardized TSCI incidence rates remained stable with 26.5 cases (95% CI, 25.0-27.9) per 1,000,000 inhabitants (mean age 59.2 years) and most cases were males (68.3%). Incidence was directly associated with age while the male to female ratio was inversely related. Most TSCIs were cervical lesions (52.1%), and the most common cause of injury were traffic crashes (29.9%) followed by occupational accidents (29.8%). Sex, cause of the trauma, or inpatient hospital management were not associated with an increased risk of death. Mortality rates were greater for cervical lesions, and increased with age, remaining stably high among older individuals even 12 months after the accident. One-month mortality risk was significantly higher at ≥75 years compared to <55 years (adjusted HR 9.14 (95% CI, 4.17-20.03)). CONCLUSION: Public health policies should aim at reducing preventable TSCIs, and special attention should be drawn to long-term management of elderly patients in the attempt to decrease mortality rates.

The Effectiveness of a Diverse COVID-19 Vaccine Portfolio and Its Impact on the Persistence of Positivity and Length of Hospital Stays: The Veneto Region's Experience.

The vaccination campaign for the Veneto region (northeastern Italy) started on 27 December 2020. As of early December 2021, 75.1% of the whole Veneto population has been fully vaccinated. Vaccine efficacy has been demonstrated in many clinical trials, but reports on real-world contexts are still necessary. We conducted a retrospective cohort study on 2,233,399 residents in the Veneto region to assess the reduction in the COVID-19 burden, taking different outcomes into consideration. First, we adopted a non-brand-specific approach borrowed from survival analysis to estimate the effectiveness of vaccination against SARS-CoV-2 in preventing infections, hospitalizations, and deaths. We used t-tests and multivariate regressions to examine vaccine impact on breakthrough infections, in terms of the persistence of positivity and the length of hospital stays. Evidence emerging from this study suggests that unvaccinated individuals are significantly more likely to become infected, need hospitalization, and are at a higher risk of death from COVID-19 than those given at least one dose of vaccine. Cox models indicate that the effectiveness of full vaccination is 88% against infection, 94% against hospitalization, and 95% against death. Multivariate regressions suggest that vaccination is significantly correlated with a shorter period of positivity and shorter hospital stays, with each step toward completion of the vaccination cycle coinciding with a reduction of 3.3 days in the persistence of positivity and 2.3 days in the length of hospital stay.

Outcome of SARS CoV-2 inpatients treated with convalescent plasma: One-year of data from the Veneto region (Italy) Registry.

OBJECTIVES AND BACKGROUND: Convalescent plasma (CP) has been used worldwide to contrast SARS-CoV-2 infection. Since April 2020, it has also been used in the treatment of patients with COVID-19 in the Veneto region (Italy), along with all the other available drugs and therapeutic tools. Here we report data analysis and clinical results in 1,517 COVID-19 inpatients treated with CP containing high-titre neutralizing anti-SARS-CoV-2 antibodies (CCP). Mortality after 30 days of hospitalization has been considered primary outcome, by comparing patients treated with CCP vs all COVID-19 patients admitted to hospitals of the Veneto region in a one-year period (from April 2020 to April 2021). PATIENTS AND METHODS: Adult inpatients with a severe form of COVID-19 have been enrolled, with at least one of the following inclusion criteria: 1) tachypnea with respiratory rate (RR) ≥ 30 breaths/min; 2) oxygen saturation (SpO2) ≤ 93% at rest and in room air; 3) partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤ 200 mmHg, 4) radiological picture and/or chest CT scan showing signs of interstitial disease and/or rapid progression of lung involvement. Patients received a maximum of three therapeutic fractions (TFs) of CCP with a neutralizing antibody titre of ≥ 1:160, administered over a period of 3-5 days. If TFs of CCP with titre ≥ 1:160 were unavailable, 2 with antibody titre of ≥ 1:80 have been administered. RESULTS: Of the 1,517 patients treated with CCP, 209 deceased at the 30-day follow-up (14%). Death was significantly associated with an older age (p<0.001), a longer time of hospitalization before CCP infusion (p<0.001), a greater number of inclusion criteria (p<0.001) and associated comorbidities (p<0.001). Conditions significantly associated with an increased frequency of death were PaO2/FiO2 ≤ 200 (p<0.001) and tachypnea with RR>30 (p<0.05) at entry, concurrent arterial hypertension (p<0.001), cardiovascular disease (p<0.001), chronic kidney disease (p<0.001), dyslipidemia (p<0.05) and cancer (p<0.05). Moreover, factors leading to an unfavorable prognosis were a life-threatening disease (p<0.001), admission to Intensive Care Unit (p<0.001), high flow oxygen therapy or mechanical ventilation (p<0.05) and a chest X-ray showing consolidation area (p<0.001). By analyzing the regional report of hospitalized patients, a comparison of mortality by age group, with respect to our series of patients treated with CCP, has been made. Mortality was altogether lower in patients treated with CCP (14% v. 25%), especially in the group of the elderly patients (23% vs 40%,), with a strong significance (p<0.001). As regards the safety of CCP administration, 16 adverse events were recorded out of a total of 3,937 transfused TFs (0,4%). CONCLUSIONS: To overcome the difficulties of setting up a randomized controlled study in an emergency period, a data collection from a large series of patients with severe COVID-19 admitted to CCP therapy with well-defined inclusion criteria has been implemented in the Veneto region. Our results have shown that in patients with severe COVID-19 early treatment with CCP might contribute to a favourable outcome, with a reduced mortality, in absence of relevant adverse events.