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During the COVID-19 pandemic, excess mortality has been reported worldwide, but its magnitude has varied depending on methodological differences that hinder between-study comparability. Our aim was to estimate variability attributable to different methods, focusing on specific causes of death with different pre-pandemic trends. Monthly mortality figures observed in 2020 in the Veneto Region (Italy) were compared with those forecasted using: (1) 2018–2019 monthly average number of deaths; (2) 2015–2019 monthly average age-standardized mortality rates; (3) Seasonal Autoregressive Integrated Moving Average (SARIMA) models; (4) Generalized Estimating Equations (GEE) models. We analyzed deaths due to all-causes, circulatory diseases, cancer, and neurologic/mental disorders. Excess all-cause mortality estimates in 2020 across the four approaches were: +17.2% (2018–2019 average number of deaths), +9.5% (five-year average age-standardized rates), +15.2% (SARIMA), and +15.7% (GEE). For circulatory diseases (strong pre-pandemic decreasing trend), estimates were +7.1%, −4.4%, +8.4%, and +7.2%, respectively. Cancer mortality showed no relevant variations (ranging from −1.6% to −0.1%), except for the simple comparison of age-standardized mortality rates (−5.5%). The neurologic/mental disorders (with a pre-pandemic growing trend) estimated excess corresponded to +4.0%/+5.1% based on the first two approaches, while no major change could be detected based on the SARIMA and GEE models (−1.3%/+0.3%). The magnitude of excess mortality varied largely based on the methods applied to forecast mortality figures. The comparison with average age-standardized mortality rates in the previous five years diverged from the other approaches due to the lack of control over pre-existing trends. Differences across other methods were more limited, with GEE models probably representing the most versatile option.

to quantify the variability of COVID-19 mortality from the beginning of the pandemic to mid-July 2021, in relation to the immigrant status and by Region and period.observational incidence study.the study population consists of the residents at the beginning of 2020 in seven Regions (Piedmont, Lombardy, Veneto, Emilia-Romagna, Tuscany, Lazio, Sicily) aged=74 years.absolute frequency of deaths occurred in subjects who tested positive for SARS-CoV-2, crude and standardized rates (standard: Italian population at the beginning of 2020), and mortality rates ratios (obtained using Poisson models), by immigrant status and stratified by gender, Region of residence, and period. The study period was divided into 5 subperiods: 22.02.2020-25.05.2020, 26.05.2020-02.10.2020, 03.10.2020-26.02.2021, 27.02.2021-16.07.2021.the study includes more than one half of the Italian population and most of the immigrants residing in the country, who are younger than Italians and experienced fewer COVID-19 deaths. Deaths among those who tested positive varied greatly between Regions and periods; standardized rates showed considerable increases over time among immigrants. In terms of rate ratios, there were excesses among immigrant males in the third period (MRR: 1.46; 95%CI 1.30-1.65) and in the fourth period (MRR: 1.55; 95%CI 1, 34-1.81). Among immigrant females, there is an indication of lower risk in the third period (MRR: 0.79; 95%CI 0.65-0.97) and of greater risk in the fourth period (MRR: 1. 46; 95%CI 1.21-1.77). Finally, the effect is modified by the Region of residence, both in the third and in the fourth period for males and only in the fourth period for females.the risk of premature mortality due to COVID-19 is linked to immigrant status and with an intensity that varies by gender, Region, and period. More accessible tools for prevention, diagnosis and early healthcare can support immigrant communities in managing the risk factors linked to the spread of infections and, in particular, counteract their evolution into more severe disease outcomes.

to examine the differences in SARS-CoV-2 infection and hospitalization rates among migrant populations in Veneto Region (Northern Italy), according to the geographic area of origin.all residents in Veneto Region aged65 years were included in the analyses. All subjects infected by SARS-CoV-2 and hospitalized for COVID-19 were identified by means of the regional biosurveillance system.age- and gender-specific infection and hospitalization rates were stratified by geographic area of origin and were estimated using the number of incident cases over the resident population in Veneto on 01.01.2021. Incidence rate ratios (IRR) for infection and hospitalization rates were estimated using a Poisson model, adjusted for age and gender, among migrants compared to Italians.compared to Italians, SARS-CoV-2 infection rates were significantly higher among migrants from Central and South America and Central and South Asia, lower among those from North Africa and High-Income Countries (HIC), and were approximately halved for those coming from Other Asian Countries (mainly represented by China). Hospitalization rates were significantly higher for all migrant populations when compared to Italians, with the exception of those coming from HIC. Neither age nor gender seemed to modify the association of the geographic area of origin with SARS-CoV-2 infection and hospitalization rates. IRR for SARS-CoV-2 infection of migrants compared to Italians showed how migrants from Other Asian Countries had the lowest infection rates (-53%), followed by people from HIC (-25%), North Africa (-21%), and Eastern Europe (-10%). Higher infection rates were present for Central and South America and Central and South Asia (+17% and +10, respectively). Hospitalization rates were especially high among migrants from Central and South Asia, Africa, and Central and South America, ranging from 1.84 to 3.14 times those observed for Italians.a significant heterogeneity in SARS-CoV-2 infection and hospitalization rates of migrant populations from different geographic areas of origin were observed. The significantly lower incidence rate ratio for infections, compared to that observed for hospitalizations, is suggestive of a possible under-diagnosis of SARS-CoV-2 infection among migrant populations. Public health efforts should be targeted at increasing support among migrants to contrast the spread of the pandemic by potentiating vaccination campaigns, contact tracing, and COVID-19 diagnostic tests.

to describe differences in the incidence of SARS-CoV-2 infections between Italians and foreigners residing in seven Italian Regions during the different phases of the pandemic and by gender.retrospective observational study.all confirmed SARS-CoV-2 infections from 02.02. 2020 to 16.07.2021 in the seven Regions under study were included. Italian resident population calculated by the National Institute of Statistics as of 01.01.2020 was used to calculate the rates. The considered period is divided into 5 sub-periods (phases).number of confirmed SARS-CoV-2 infections in the five phases of the pandemic and crude rates by citizenship (Italian vs foreign). Distribution of infections by age group and by week. Crude and age-adjusted incidence rates ratios (IRR) were calculated, by Region, gender, and phase of the pandemic.an epidemic curve delay was observed in foreigners in the first phase of the epidemic, in particular in the northern Regions, the most affected in that phase. The first phase of the epidemic was characterized by a greater proportion of cases occurred in people aged over 60 years than the other phases, both in Italians and in foreigners. The incidence among foreigners is higher during the summer of 2020 (intermediate period: June-September 2020) and during the last period (May-July 2021) in all Regions. The overall figure shows a lower incidence among foreigners than Italians, except for males in Tuscany.the lower incidence rates among foreigners should be interpreted with caution as the available data suggest that it is at least partly attributable to less access to diagnostic tests. Regional differences found in the study deserve further research together with the effect of gender and country of origin.

Background Coronavirus disease 2019 (COVID-19) global pandemic has strikingly high mortality rate with hypercoagulability state being part of the imputed mechanisms. We aimed to compare the rates of in hospital mortality in propensity score matched cohorts of COVID-19 patients in chronic anticoagulation versus those that were not. Methods In this population-based study in the Veneto Region, we retrospectively reviewed all patients aged 65 years or older, with a laboratory-confirmed COVID-19 diagnosis. We compared, after propensity score matching, those who received chronic anticoagulation for atrial fibrillation with those who did not. Results Overall, 4697 COVID-19 patients fulfilled inclusion criteria, and the propensity score matching yielded 559 patients per arm. All-cause mortality rate ratio was significantly higher among non-anticoagulated patients (32.2% vs 26.5%, p = 0.036). On time to event analysis, all-cause mortality was found lower among anticoagulated patients, although the estimate was not statistically significant. (HR 0.81, 95%CI 0.65–1.01, p = 0.054). Conclusion Among elderly patients with COVID-19, those on chronic oral anticoagulant treatment for atrial fibrillation seem to be at lower risk of all-cause mortality compared to their propensity score matched non-anticoagulated counterpart. This finding needs to be confirmed in further studies., Highlights • COVID-19 infection has strikingly high mortality rate. • Hypercoagulability has been imputed as one of the pathological mechanisms. • Anticoagulation may improve outcomes in COVID-19 infection. • We found chronic anticoagulation to be related to lower mortality in COVID-19 patients.

AIMS To compare mortality between anticoagulated atrial fibrillation patients and general population and among anticoagulation specific categories [direct oral anticoagulants (DOACs) vs. vitamin K antagonists(VKA)]. METHODS This was a population-based study including all residents in the Veneto Region aged 18 years or older. Administrative claims from July 2013 to September 2017 were used to identify anticoagulation-naive atrial fibrillation patients. Propensity score matching was employed to compare patients on new and old anticoagulants. RESULTS Overall, 17 225 patients on direct anticoagulants were 1 : 1 matched to patients on VKA (49% males, median age 77 years). Mortality was higher with respect to the general population by 22 and 39% among patients on direct anticoagulants and VKA, respectively. Mortality from intracranial hemorrhage in the direct anticoagulant group was similar to that in the general population [standardized mortality ratio: 1.06, 95% confidence intervals (CI) 0.76-1.48], whereas it almost doubled in VKA group (1.92, 95% CI 1.49-2.46). When directly compared with the VKA cohort, the risk of death from intracranial hemorrhage halved with DOACs (hazard ratio 0.56, 95% CI 0.37-0.84). CONCLUSION The mortality rate of anticoagulated atrial fibrillation patients is increased with respect to the general population, particularly among patients treated with VKAs. The mortality rate for intracranial bleeding with DOACs is similar to that observed in the general population.

There has been an increase in surgical interventions in frailer elderly with concomitant chronic diseases. The purpose of this paper was to evaluate the impact of aging and comorbidities on outcomes in patients who underwent surgery for the treatment of colorectal cancer (CRC) in Veneto Region (Northeastern Italy). This is a retrospective cohort study in patients ≥ 40 years who underwent elective or urgent CRC surgical resection between January 2013 and December 2015. Independent variables included: age, sex, and comorbidities. We analyzed variables associated with the surgical procedure, such as stoma creation, hospitalization during the year before the index surgery, the surgical approach used, the American Society of Anesthesiologists (ASA) score, and the Charlson Comorbidity Index score. Eight thousand four hundred and forty-seven patients with CRC underwent surgical resection. Patient age affected both pre- and post-resection LOS as well as the overall survival (OS); however, it did not affect the 30-day readmission and reoperation rates. Multivariate analysis showed that age represented a risk factor for longer preoperative and postoperative LOS as well as for 30-day and 365-day mortality, but it was not associated with an increased risk of 30-day reoperation and 30-day readmission. Chronic Heart Failure increased the 30-day mortality risk by four times, the preoperative LOS by 51%, and the postoperative LOS by 33%. Chronic renal failure was associated with a 74% higher 30-day readmission rate. Advanced age and comorbidities require a careful preoperative evaluation and appropriate perioperative management to improve surgical outcomes in older patients undergoing elective or urgent CRC resection.

to describe the epidemiology of SARS-CoV-2 infection in relation with the use of nasal swabs in the immigrant population in Italy, using data from the COVID-19 national surveillance system and to verify if a difference is present comparing natives and immigrant.descriptive study based on longitudinal health-administrative data.general population of six Italian Regions (Piedmont, Lombardy, Veneto, Emilia-Romagna, Tuscany, Lazio) covering about 55% of the resident population and 72% of foreigners' population.regional rates of access to at least a nasal swab, separately by country of origin.across all the periods, a lower rate in the foreigners' group was observed, with the only exception of the period May-June 2021. Considering separately High Migratory Pressure Countries (HMPCs) and Highly Developed Countries (HDCs), a higher proportion of nasal swabs performed in people coming from HDC with respect to HMPCs and natives was noticed. This observation is consistent in males and females.during the first wave of the pandemic, Italians have had a higher proportion of nasal swabs compared to migrants across all Regions. This difference disappeared in the following periods, probably due to a major availability of diagnostic tests.

Anticoagulation therapy is central for the management of stroke in patients with non-valvular atrial fibrillation (NVAF). Persistence with oral anticoagulation is essential to prevent thromboembolic complications.We performed a population-based retrospective cohort study in the Veneto Region (north-eastern Italy, about 5 million inhabitants) using the regional health system databases. Naïve patients initiating direct oral anticoagulants (DOACs) for stroke prevention in NVAF from July 2013 to September 2017 were included in the study. Patients were identified using Anatomical Therapeutic Chemical (ATC) codes, excluding other indications for anticoagulation therapy using ICD-9CM codes. Treatment persistence was defined as the time from initiation to discontinuation of the therapy, including any therapeutic switching among DOACs. Baseline characteristics and comorbidities associated to the persistence of therapy with DOACs were explored by means of Kaplan-Meier curves and assessed through Cox regression.Naïve patients initiating direct oral anticoagulants for stroke prevention in NVAF identified in a 4.25-year period are 17,920. After one year, the persistence to the DOACs is 72.9%. Approximately 9.8% of the discontinuations are due to switch to vitamin k antagonists (VKAs). On multivariate analysis, factors negatively affecting persistence were female gender, age65 years, renal disease and history of bleeding. On the other hand, persistence was better in patients with hypertension, previous cerebral ischemic events, and previous acute myocardial infarction.In this study of real world data, one out four naive patients stopped treatment with DOACs within 12 months. Some characteristics may identify patients with poor persistence.

The coronavirus disease 2019 (COVID-19) pandemic will leave a profound imprint in the collective memory of humanity. In Italy, Long-Term Care Facilities (LTCFs) have seen a disproportionally high number of deaths during and the COVID-19 pandemic and, certainly, they may be considered as its epicenter. Aiming to leave a symbolic mark of what the pandemic did in these care settings, we report on an outbreak in a single LTCF where, 53 out of 64 residents, resulted infected. Our narration is based on an epidemiological field investigation together with a calendar of passages through the stages of disease in the infected population. We found an age-gradient in all clinical and epidemiological variables explored such as symptoms onset, illness severity, recovery from symptoms and deaths. According to the disease staging, 26 (49%) were asymptomatic; 9 (17%) had a mild disease; 7 (13%) a moderate stage and 11 (21%) a severe illness severity of whom 10 died. For a more comprehensive description of the impact of the pandemic on LTCFs, we compared the standard mortality ratio (SMR) in the first six months of 2020 to that of 2018 and 2019 in all the 34 facilities of the Vicenza province. Overall, there was a SMR higher 60% than the equivalent period of the previous years.

PURPOSE Patients with pT3 rectal cancer represent a heterogeneous prognostic group. A more accurate histological sub-classification of pT status has been suggested as an improvement of the TNM staging system. The aim of the study was to evaluate the prognostic implication of a histopathologic sub-classification of pT3 rectal cancer. METHODS In this retrospective single-center study, pT3 rectal cancer patients who underwent surgery from January 2000 to December 2018 were evaluated. The maximum depth of tumor invasion beyond the muscularis propria was recorded. A ROC curve identified the best prognostic cutoff value to classify patients in two prognostic groups. Survival curves were estimated by the Kaplan-Meier method, and univariate and multivariate analyses with the Cox regression model were used to find independent factors influencing survival. RESULTS Overall, 203 patients were included. Four millimeters was identified as the best cutoff value: 82 patients showed a depth of invasion

Aim: The use of oral anticoagulant drugs in patients with atrial fibrillation and one non-gender related risk factors is challenging. We compared the efficacy and safety of DOACs vs VKAs in low risk patients. Methods: We performed a population-based retrospective cohort study in anticoagulation-naive atrial fibrillation patients. The cohort was identified, characterized and followed-up using data from administrative claims, drug prescriptions archive, and regional inpatient and discharge register. Event-rates were assessed using as treated analysis. Hazard ratios (HR) of stroke and major bleeding were estimated by Cox regression analysis. Results: Overall, we identified 1829 patients treated with DOACs and 6083 patients treated with VKAs, that accumulated 2097 and 4681 person-years of follow up, respectively. Half of patients were in the 65-75 age group, while almost 38% were female. Stroke rates were lower with DOACs as compared to VKAs: 0.14% person-years versus 0.28% person-years (HR 0.50, 95%CI 0.14–1.74). Major bleeding (0.81% person-years versus 1.09% person-years (HR 0.80, 95%CI 0.46–1.40)) and intracranial hemorrhage (0.33% person-years versus 0.42% person-years (HR 0.85, 95%CI 0.36–2.04) were also lower with DOACs. Mortality rate with DOACs was 1.2% person-years and 1.1 person-years with VKA (HR 1.21, 95%CI 0.74-1.96) mostly driven by death from cancer in the DOACs group. Conclusions: In low risk patients with atrial fibrillation, there is a benefit (although non-significant) with DOACs as compared to VKAs. Other studies are required to directly test this finding.

// Salvatore Pucciarelli 1 , Manuel Zorzi 2 , Nicola Gennaro 3 , Francesco Marchegiani 1 , Andrea Barina 1 , Massimo Rugge 2, 4 , Matteo Zuin 1 , Alessandro Perin 1 , Isacco Maretto 1 , Francesca Bergamo 5 , Caterina Boso 6 , Emanuele Damiano Luca Urso 1 , Patrick Frambach 1 and Maria Chiara Corti 3 1 Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy 2 Regional Health Service, Veneto Tumor Registry, Veneto Region, Padua, Italy 3 Regional Health Service, Epidemiology Unit, Veneto Region, Padua, Italy 4 Department of Medicine DIMED, Pathology and Cytopathology Unit, University of Padua, Padua, Italy 5 Medical Oncology 1, Veneto Institute of Oncology IOV – IRCCS, Padua, Italy 6 Radiation Oncology, Veneto Institute of Oncology IOV – IRCCS, Padua, Italy Correspondence to: Salvatore Pucciarelli, email: puc@unipd.it Keywords: rectal cancer; hospital volume; volume-outcome relationship; short-term outcomes; population study Abbreviations: APR: abdominoperineal resection; CI: confidence interval; HV: hospital volume; LOS: length of stay; OR: odds ratio Received: July 12, 2017 Accepted: February 28, 2018 Published: March 30, 2018 ABSTRACT There is growing interest on the potential relationship between hospital volume (HV) and outcomes as it might justify the centralization of care for rectal cancer surgery. From the National Italian Hospital Discharge Dataset, data on 75,280 rectal cancer patients who underwent elective major surgery between 2002 and 2014 were retrieved and analyzed. HV was grouped into tertiles: low-volume performed 1-12, while high-volume hospitals performed 33+ procedures/year. The impact of HV on in-hospital mortality, abdominoperineal resection (APR), 30-day readmission, and length of stay (LOS) was assessed. Risk factors were calculated using multivariate logistic regression. The proportion of procedures performed in low-volume hospitals decreased by 6.7 percent (p

PURPOSE To determine the prevalence of obstructive sleep apnea (OSA) in patients with keratoconus (KCN) and to evaluate the association between the severity of KCN and OSA. METHODS OSA was diagnosed with an overnight home sleep apnea test. As estimated by home monitoring, an apnea-hypopnea index threshold of ≥5 sleep-related obstructive breathing events per hour was considered suggestive of OSA. For grading KCN severity (Amsler-Krumeich classification), slit-lamp biomicroscopy, corneal topography, and pachymetry measurements were performed. Preoperative measurements were included in the analysis for patients who had undergone surgery for KCN. RESULTS The study sample consisted of 50 consecutively enrolled patients: 33 men; mean age ± SD 43.6 ± 11.8 years; body mass index 29.7 ± 7.3 kg/m; and neck circumference 40.0 ± 3.4 cm. The overall prevalence of OSA was 38% (6 women and 13 men). Patients with OSA were older (49.8 ± 9.3 vs. 37.5 ± 10.8 years; P < 0.01) and had a higher body mass index (34.7 ± 8.1 vs. 26.2 ± 4.8 kg/m; P

Ugo Fedeli,1 Alfredo De Giorgi,2 Nicola Gennaro,1 Eliana Ferroni,1 Massimo Gallerani,3 Dimitri P Mikhailidis,4 Roberto Manfredini,2 Fabio Fabbian2 1Epidemiological Department, Veneto Region, 2Department of Medical Sciences, Clinica Medica Unit, School of Medicine, University of Ferrara, 3Department of Internal Medicine, University Hospital of Ferrara, Ferrara, Italy; 4Department of Clinical Biochemistry (Vascular Disease Prevention Clinic), University College London Medical School, London, UK Background: COPD is among the major causes of death, and it is associated with several comorbid conditions. Chronic kidney disease (CKD) is frequently diagnosed in older people living in Western societies and could impact COPD patients’ mortality. We evaluated the relationship between burden of comorbidities, CKD, and mortality in a population-based cohort of patients discharged with a diagnosis of COPD.Methods: A longitudinal cohort study was conducted evaluating 27,272 COPD patients. Recruitment of COPD subjects and identification of CKD and other comorbidities summarized by the Charlson comorbidity index (CCI) were based on claims data coded according to the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM). Severity of COPD was classified by hospital diagnosis or exemption from medical charges due to respiratory failure or previous hospitalizations for COPD. The impact of comorbidities on survival was assessed by Cox regression.Results: Less than 40% of patients were still alive at the end of a median follow-up of 37months (17months for patients who died and 56months for those alive at the end of follow-up). After adjustment for age, gender, and severity score of COPD, CKD (hazard ratio=1.36, 95% confidence interval 1.30–1.42) independently from comorbidities summarized by the CCI was a significant risk factor for mortality.Conclusion: In spite of limitations due to the use of claims data, long-term survival of COPD patients was heavily affected by the presence of CKD and other comorbidities. Keywords: COPD, chronic kidney disease, Charlson comorbidity index, mortality, comorbidity

Introduction Anticoagulation therapy is central for the management of stroke in patients with non-valvular atrial fibrillation (NVAF). Persistence with oral anticoagulation is essential to prevent thromboembolic complications. Purpose To assess persistence levels of DOACs and look for possible predictors of treatment discontinuity in NVAF patients. Methods We performed a population-based retrospective cohort study in the Veneto Region (north-eastern Italy, about 5 million inhabitants) using the regional health system databases. Naïve patients initiating direct oral anticoagulants (DOACs) for stroke prevention in NVAF from July 2013 to September 2017 were included in the study. Patients were identified using Anatomical Therapeutic Chemical (ATC) codes, excluding other indications for anticoagulation therapy using ICD-9CM codes. Treatment persistence was defined as the time from initiation to discontinuation of the therapy. Baseline characteristics and comorbidities associated to the persistence of therapy with DOACs were explored by means of Kaplan-Meier curves and assessed through Cox regression. Results Overall, 17920 patients initiated anticoagulation with DOACs in the study period. Most patients were older than 74 years old, while gender was almost equally represented. Comorbidities included hypertension (72%), diabetes mellitus (17%), congestive heart failure (9%), previous stroke/TIA (20%), and prior myocardial infarction (2%). After one year, the persistence to anticoagulation treatment was 82.7%, while the persistence to DOAC treatment was 72.9% with about 10% of the discontinuations being due to switch to VKAs. On multivariate analysis, factors negatively affecting persistence were female gender, younger age ( Persistence to DOAC therapy Conclusion This real-world data show that within 12 months, one out of four anticoagulation-naïve patients stop DOACs, while one out of five patients stop anticoagulation. Efforts should be made to correct modifiable predictors and intensify patient education.

Failure to rescue (FTR) patients from postoperative complications could contribute to the variability in surgical mortality seen among hospitals with different volumes. We sought to examine the impact of complications and FTR on mortality following rectal surgery.The National Italian Hospital Discharge Dataset allowed to identify 75,280 patients who underwent rectal surgery between 2002 and 2014. Hospital volume was stratified into tertiles. Rates of major complications, FTR from complications and mortality following rectal surgery were compared.During the study period, both the incidence of complications (2002, 23.7% versus 2014, 21.2%), and FTR decreased overtime (2002, 6.9% versus 2014, 3.8%) (both P 0.001). The complication rate was 24.4% in low-, 21.6% in intermediate- and 20.4% in high-volume hospitals (P 0.001). Complications were less common in minimally invasive surgery (MIS) versus open cases (18.2% versus 23.2%; P 0.001). The most frequent complications included prolonged ileus or small bowel obstruction (5.3%), and anemia requiring blood transfusions (5.3%). The rate of FTR was 5.5%, 5.6% and 3.7% for low-, intermediate- and high-volume hospitals, respectively (P 0.001). FTR after MIS was 2.6% vs. 5.5% after open surgery (P 0.001). After accounting for patient and hospital characteristics, patients treated at low-volume hospitals were 23% more likely to die after a complication, compared to patients at high-volume hospitals (OR 1.23, 95%CI 1.13-1.33).Hospital volume is the strongest predictor of complication and FTR. The reduction in mortality in high-volume hospitals could be determined by the better ability to rescue patients. These findings support the centralization policy of rectal cancer treatment.

To assess the long-term oncological outcomes in patients with locally advanced rectal cancer who underwent neoadjuvant therapy followed by local or total mesorectal excision. Patients with locally advanced rectal adenocarcinoma who received neoadjuvant therapy from 2005 to 2017 were evaluated. Those with major or complete clinical response underwent a full-thickness local excision. Kaplan-Meier estimates were used to evaluate overall, disease-free, and local recurrence-free survival of patients who underwent local excision (LE group) and were compared with a matched cohort of patients who underwent total mesorectal excision (TME group). Among 252 patients who received neoadjuvant therapy for rectal cancer, 51 (20.2%) underwent a local excision. At a median follow-up of 61 months, patients who underwent local excision were stoma-free in 88.2% of cases and with rectum preserved in 78.5% of cases, respectively. The estimated 5-year local, disease-free, and overall survival was 91.8% vs 97.6% (95% CI: 79.5–96.8 vs 84.6–99.6), 86.7% vs 86.4% (95% CI: 72.5–93.9 vs 70.1–94.1), and 85% vs 90% (95% CI: 69.0–93.0% vs 75.3–96.2), in the study and matched control group, respectively. None of the differences was statistically significant. One-fifth of patients with locally advanced rectal cancer are manageable with a rectum-sparing approach after neoadjuvant therapy. With this strategy, about 80% patients will have their rectum preserved and 90% will be without stoma at long term.

The laparoscopic approach is increasingly adopted in colorectal cancer surgery; however, its role in elderly patients is controversial. We sought to examine the relationship between age and short-term outcomes following laparoscopic surgery for colorectal cancer (CRC). Data of patients 65 + years old who underwent laparoscopic surgery for CRC between 2002 and 2014 were retrieved from the administrative National Italian Hospital Discharge Dataset. Patients were divided into three age categories (65–74, 75–84, and 85 +). The impact of age on length of stay, 30-day readmission, in-hospital mortality, and postoperative complications was evaluated. During the study period, 47,704 patients underwent laparoscopic surgery for CRC. The median postoperative length of stay was 9 days, and 30-day readmission and in-hospital mortality were 4.4% and 0.9%, respectively. Age was found to be an independent risk factor of prolonged length of stay and increased in-hospital mortality. With respect to patients in 65–74 years age category, patients aged 75–84 years and those aged 85 + years had a higher risk of complications (OR 1.43, 95% CI 1.36–1.50, and OR 2.00, 95% CI 1.83–2.17, respectively). However, no statistically significant association was found between age and anastomotic leakage or surgical site infection (p = 0.29, and p = 0.58, respectively). In patients with CRC who underwent laparoscopic surgery, age was found to be an independent risk factor for prolonged length of stay, in-hospital mortality, and global postoperative complications. These findings should be considered when planning laparoscopic surgery in elderly patients.

Importance: Obstructive apneas during sleep can affect the intraocular pressure fluctuation over 24 hours. Background: Several studies found an increased prevalence of normal-tension glaucoma (NTG) in patients with obstructive sleep apneas (OSA). Design: Prospective exploratory study conducted in academic setting. Participants: Three patients diagnosed with OSA and 3 with OSA and NTG. Methods: Ambulatory blood pressure monitoring (ABPM), overnight respiratory polygraphy and IOP-related changes monitoring in an eye by a contact lens sensor (CLS) over a 24-hour period. Main outcome measure: We analyzed the effect of apneas on the CLS reading. Wake to sleep slope (W/S) and sleep to wake slope (S/W) were tested. Results: An 11% increase in the mean (95% CI) overnight CLS outputs, from 185.2 (125.4-273.8) mVeq to 205.1 (192.4-219.3) mVeq, was associated with the occurrence of apneas lasted 120 s (p=0.001). We found no correlation between ABPM and IOP or ABPM and apneas' duration. The W/S slopes were similar between the two groups (P=0.41), while the S/W slopes in the NTG patients differ considerably from patients without NTG (P=0.03), with a far less steep slope in the first group. Conclusions and Relevance: Obstructive apneas during sleep could affect IOP-related changes in a cumulative way. The smoother W/S and S/W slopes in NTG reveal a sort of inertia that could make some eyes more susceptible to damage following exposure to apneas.

BACKGROUND Colorectal cancer (CRC) screening programs based on the fecal immunochemical test (FIT) were found to reduce overall CRC surgery rates, but to the authors’ knowledge data by subsite are lacking. The objective of the current study was to assess the impact of FIT-based screening on proximal and distal CRC surgical resection rates. METHODS The Veneto region in Italy can be subdivided into 3 areas with staggered introduction of FIT-based screening programs: early (2002-2004), intermediate (2005-2007), and late (2008-2009) areas. Time series of proximal and distal CRC surgery were investigated in the 3 populations between 2001 and 2012 by Joinpoint regression analysis and segmented Poisson regression models. RESULTS The impact of screening was similar in the study populations. Rates of distal CRC surgical resection were stable before screening, increased at the time of screening implementation (rate ratio [RR], 1.25; 95% confidence interval [95% CI], 1.14-1.37), and thereafter declined by 10% annually (RR, 0.90; 95% CI, 0.88-0.92). Rates of proximal CRC surgical resection increased by 4% annually before screening (RR, 1.04; 95% CI, 1.03-1.05) but, after a peak at the time of screening initiation, the trend was reversed. The percentage represented by proximal CRC surgery rose from 28% in 2001 to 41% in 2012. CONCLUSIONS In this natural multiple-baseline experiment, consistent findings across each time series demonstrated that FIT-based screening programs have an impact both on proximal and distal CRC surgery rates. However, underlying preexisting epidemiological trends are leading to a rapidly increasing percentage of proximal CRC. Cancer 2015;121:3982–3989. © 2015 American Cancer Society.

ObjectivesTo assess the occurrence of glaucoma, eyelid, corneal and macular disorders in a cohort of patients with obstructive sleep apnoea (OSA) diagnosed by overnight polysomnography and to investigate into the risk factors for the above eye diseases (EDs).DesignCross-sectional cohort study between 2014 and 2015.SettingUnit of Respiratory Medicine and Eye Clinic of the University of Verona.Participants431 consecutive patients were considered eligible. Of these, 87 declined to participate, 35 were untraceable and 13 were deceased.InterventionsA complete ophthalmic evaluation of both eyes for each patient.Primary and secondary outcome measuresBest-corrected distance visual acuity, intraocular pressure, corneal, macular and optic nerve optical coherence tomography, ocular aberrometry, optic nerve laser polarimetry, visual field test, and eyelid examination.Results296 patients aged 64.5±12.8 years, 23% female and 77% male, underwent ophthalmic examination. There was 56% (n=166) prevalence of eyelid disorders, 27% (n=80) of corneal disorders, 13% (n=39) of macular disorders and 11% (n=33) of glaucoma. Advancing age was not associated with the severity of OSA, while significant differences were found for gender, body mass index, Oxygen Desaturation Index, smoking habit, hypertension and diabetes. Severe OSA was significantly associated with glaucoma (OR, 95% CI 1.05 to 5.93, p=0.037).ConclusionsEDs were more prevalent in our patinets with OSA than in the general population. Severe Apnoea/Hypopnoea Index level seemed to play a role as risk factor only for glaucoma.

Background The global real-life impact of non-vitamin K antagonist oral anticoagulants (NOACs) introduction in the healthcare system in a setting of well-managed vitamin K antagonist (VKA) therapy has not been specifically addressed. Methods We did a population-based retrospective cohort study in naive patients initiating oral anticoagulants for stroke prevention in atrial fibrillation in a region with a well-managed VKA therapy. NOAC and VKA cohorts were identified using Anatomical Therapeutic Chemical (ATC) codes, while excluding other indications for anticoagulation therapy using ICD-9CM codes. Propensity score was conducted using two different approaches: stratification and 1:1 matching. Event-rates were assessed using both an intention to treat (ITT) and as treated analyses. Results Of the 137,800 selected patients, 40,411 (6923 treated with NOACs and 33,488 with VKAs) were identified (June 2013–December 2015). Overall ischaemic stroke and major bleeding risk did not significantly differ between the groups both in the ITT and as treated analyses. Noteworthy, intracranial bleeding risk was lower with NOACs (stratified model HR=0.69; 95%CI 0.48–0.99; 1:1 matched model HR=0.73; 95%CI 0.47–1.13) reaching statistical significance in the as treated analysis in both stratified and 1:1 matched models (HR=0.51; 95%CI 0.32–0.80 and HR=0.52; 95%CI 0.30–0.90, respectively). Conclusion Despite well-managed anticoagulation with VKAs, NOACs' introduction has a positive global impact in the public healthcare system in terms of effectiveness and safety especially by lowering intracranial bleeding.

Background: Recurrent keratoconus (RKC) develops as a progressive thinning of the peripheral and the inferior cornea after keratoplasty, in both graft and host, causing secondary astigmatism, refractive instability, and reduced visual acuity. We evaluated the effectiveness of corneal cross-linking (CXL) in patients diagnosed with RKC. Methods: Accelerated-CXL via the epi-off technique was performed in15 patients (18 eyes) diagnosed with RKC. Topographic and biomechanical changes were assessed at 12 months. Results: Differences in maximum keratometry, thinnest corneal thickness, and biomechanical parameters (deformation amplituderatio, inverse concave radius, applanation 1 velocity, and applanation 2 velocity, stiffness A1) versus baseline were statistically significant (p &lt, 0.05).Best corrected visual acuity was improved in 13 eyes and unchanged in 4, manifest refractive spherical equivalent was reduced in 13 eyes, increased in 3,and unchanged in 1 eye, topographic astigmatism was reduced in 9 eyes, remained stable in 1 eye, and increased in 7 eyes. Conclusions: Improved topographic and biomechanic indexes at 1 year after CXL suggest it&lsquo, s potential as first-line therapy for RKC, as it is for KC.

Background While the total number of persons affected by hip fractures may be increasing over time in the next decades, due to the progressive aging of the population, incidence rates appear to be declining in most countries. The objective of this study is to describe annual hip fracture incidence rate trends in the Veneto Region, Italy, over a decade (2001–2010). Methods All incident hip fractures in men and women above or aged 65 years old using ICD-9 diagnosis codes 820–820.9 in the Hospital Discharge Database were identified. Crude, sex- and age-specific and standardized annual incidence rates were calculated. Results The median age of patients has increased from 82 to 84 years in the last decade. The absolute number of hip fractures increased by 21%. The age-standardized hip fracture incidence rate for men increased from 304 per 100,000 person-years in 2001 to 319 in 2010. For women, incidence declined from 787 in 2001 to 751 in 2010. Hip fracture rates decreased through the study period in the 65–74 age group, especially among females. In the age group 75–84, there was a clear increase up to 2004, then a progressive decline in both genders. Among subjects aged 85 years or older, incidence rates were stable in women and showed a non-statistically significant increase in men. Conclusion The aging of the population, with a rapid increase concentrated particularly in the oldest old segment, implies that the overall number of hip fracture will continue to represent a major public health challenge to health and social systems.

Context Frequent end-of-life health care setting transitions can lead to an increased risk of fragmented care and exposure to unnecessary treatments. Objectives We assessed the relationship between the presence and the intensity of an Integrated Cancer Palliative Care (ICPC) plan and the occurrence of multiple transitions during the last month of life. Methods Decedents of cancer aged 18–85 years residents in two regions of Italy were investigated accessing their integrated administrative data (death certificates, hospital discharges, hospice, and home care records). The principal outcome was defined as having 3+ health care setting transitions during the last month of life. The ICPC plans instituted 90–31 days before death represented the main exposure of interest. Results Of the 17,604 patients, 6698 included in an ICPC, although spending in hospital a median number of only two days (interquartile range 1–2), experienced 1+ (59.8%), 2+ (21.1%), or 3+ (5.9%) health care transitions. Among the latter group, the most common trajectory of care is home-hospital-home-hospital (36.0%). The intensity of the ICPC plan showed a marked protective effect toward the event of 3+ health care setting transitions; the effect is already evident from an intensity of at least one home visit/week (odds ratio 0.73; 95% confidence interval 0.62–0.87). Conclusion A well-integrated palliative care approach can be effective in further reducing the percentage of patients who spent many days in hospital and/or undergo frequent and inopportune changes of their care setting during their last month of life.

Achalasia is a rare esophageal motility disorder, incurable but amenable to palliative treatments to relieve dysphagia. Given the rarity of the disease, there is a paucity of data from population-based studies on incidence and outcome of the two treatments most commonly used in clinical practice, i.e., endoscopic pneumatic dilation (PD) and surgical myotomy (SM).A retrospective longitudinal study was conducted on the Veneto region, in north-eastern Italy. All patients with achalasia as their primary diagnosis between 2001 and 2005 were identified and their demographics and treatment details obtained.The overall incidence of achalasia was 1.59 cases/100,000/year. Achalasia patients were mainly seen at University Hospitals. Fifty-five percent of the patients received treatment, 23.3% SM and 31.8% PD. The cumulative risk of any subsequent intervention for achalasia was 20% in treated patients (29.7% in patients treated primarily with PD and 4% in patients treated with SM first).The epidemiology of achalasia in the Veneto Region is in line with the situation reported elsewhere and did not change between 2001 and 2005. Achalasia patients are mostly seen at University Hospitals. We observed a greater risk of subsequent intervention for patients previously treated with PD compared with SM.

Background In up to 80% of patients with pulmonary embolism (PE) no peripheral symptomatic thrombosis can be identified. Whether the heart may represent a source of PE is unknown. Methods We conducted a cross-sectional survey of patients who were 60 years or older and were discharged from the hospitals of Veneto region, Italy between 2000 and 2006 with the diagnosis of PE. We compared the prevalence of several acute and chronic heart diseases in patients discharged with the diagnosis of PE alone with that of patients with co-occurring symptomatic peripheral deep venous thrombosis (PE/DVT). Results Out of 11,236 eligible patients, 9079 (81%) were discharged with the diagnosis of PE alone, and 2157 with that of PE/DVT. 3239 of the 9079 (35.7%) patients with isolated PE, and 666 of the 2157 (30.9%) with PE/DVT had at least one heart disease. The adjusted odds ratio (OR) for having at least one heart disease in patients with isolated PE as compared to those with PE/DVT was 1.26 (95% CI, 1.13–1.40). The heart diseases that significantly contributed to the study results were all-cause cardiomyopathies (adjusted OR, 2.31; 95% CI, 1.37–3.89), all-cause heart failure (1.82; 1.45–2.27), coronary heart disease (1.28; 1.08–1.52), and atrial fibrillation or flutter (1.28; 1.08–1.51). Conclusions There is an association between isolated PE and a number of heart diseases. The results of our survey generate the hypothesis that in older patients several heart diseases may directly account for the development of PE. Prospective studies are needed to confirm this hypothesis.

The aim of this study was to evaluate the impact of Surgical Unit volume on the 30-day reoperation rate in patients with CRC. Data were extracted from the regional Hospital Discharge Dataset and included patients who underwent elective resection for primary CRC in the Veneto Region (2005–2013). The primary outcome measure was any unplanned reoperation performed within 30 days from the index surgery. Independent variables were: age, gender, comorbidity, previous abdominal surgery, site and year of the resection, open/laparoscopic approach and yearly Surgical Unit volume for colorectal resections as a whole, and in detail for colonic, rectal and laparoscopic resections. Multilevel multivariate regression analysis was used to evaluate the impact of variables on the outcome measure. During the study period, 21,797 elective primary colorectal resections were performed. The 30-day reoperation rate was 5.5 % and was not associated with Surgical Unit volume. In multivariate multilevel analysis, a statistically significant association was found between 30-day reoperation rate and rectal resection volume (intermediate-volume group OR 0.75; 95 % CI 0.56–0.99) and laparoscopic approach (high-volume group OR 0.69; 95 % CI 0.51–0.96). While Surgical Unit volume is not a predictor of 30-day reoperation after CRC resection, it is associated with an early return to the operating room for patients operated on for rectal cancer or with a laparoscopic approach. These findings suggest that quality improvement programmes or centralization of surgery may only be required for subgroups of CRC patients.

Colorectal cancer (CRC) screening programs based on the fecal immunochemical test (FIT) were found to reduce overall CRC surgery rates, but to the authors' knowledge data by subsite are lacking. The objective of the current study was to assess the impact of FIT-based screening on proximal and distal CRC surgical resection rates.The Veneto region in Italy can be subdivided into 3 areas with staggered introduction of FIT-based screening programs: early (2002-2004), intermediate (2005-2007), and late (2008-2009) areas. Time series of proximal and distal CRC surgery were investigated in the 3 populations between 2001 and 2012 by Joinpoint regression analysis and segmented Poisson regression models.The impact of screening was similar in the study populations. Rates of distal CRC surgical resection were stable before screening, increased at the time of screening implementation (rate ratio [RR], 1.25; 95% confidence interval [95% CI], 1.14-1.37), and thereafter declined by 10% annually (RR, 0.90; 95% CI, 0.88-0.92). Rates of proximal CRC surgical resection increased by 4% annually before screening (RR, 1.04; 95% CI, 1.03-1.05) but, after a peak at the time of screening initiation, the trend was reversed. The percentage represented by proximal CRC surgery rose from 28% in 2001 to 41% in 2012.In this natural multiple-baseline experiment, consistent findings across each time series demonstrated that FIT-based screening programs have an impact both on proximal and distal CRC surgery rates. However, underlying preexisting epidemiological trends are leading to a rapidly increasing percentage of proximal CRC.

A high hospital utilisation at the end of life (EOL) is an indicator of suboptimal quality of health care. We evaluated the impact of the intensity of different Integrated Cancer Palliative Care (ICPC) plans on EOL acute medical hospitalisation among cancer decedents. Decedents of cancer aged 18-84 years, who were residents in two Italian regions, were investigated through integrated administrative data. Outcomes considered were prolonged hospital stay for medical reasons, 2+ hospitalisations during the last month of life and hospital death. The ICPC plans instituted 90 to 31 days before death represented the main exposure of interest. Other variables considered were gender, age class at death, marital status, recent hospitalisation and primary cancer site. Among 6,698 patients included in ICPC plans, 44.3% presented at least one critical outcome indicator; among these, 76.5% died in hospital, 60.3% had a prolonged (12+ days) medical hospitalisation, 19.1% had 2+ hospitalisations at the EOL. These outcomes showed a strong dose-response effect with the intensity of the ICPC plans, which is already evident at levels of moderate intensity. A well-ICPC approach can be very effective-beginning at low levels of intensity of care-in reducing the percentage of patients spending many days or dying in hospital.

Early implementation of home care and 30 day readmissions in65 years Veneto region patients discharged for heart failure and with disability.The effectiveness of Home care (HC) on preventing rehospitalizations in patients discharged for heart failure (HF) are uncertain.The aim of the study was to measure the impact of HC on early rehospitalizations of patients discharged for HF and with disabilities.Cohort retrospective study on65 years patients, discharged at home and with a Barthel index50. Variables considered were: previous hospitalizations for ischaemic cardiopathy ad/or chronic obstructive pulmonary disease, number of hospital admissions in the previous year, length of index hospitalization; outcomes considered were: hospital readmissions and days of hospitalizations 30 days from hospital discharge in patients with or without a home care visit within two days from hospital discharge.Of the 5.094 patients (60%85 years), 14.8% received a HC visit within 2 days from discharge (43.7% from a nurse); 18.3% of patients (933) were readmitted within one month. In multivariate analyses an HC access within 2 days did not reduce the risk for readmission (although with better results in younger males but not in older women). An early HC visit reduced the days of hospital stay in males of all ages (65-74 years IRR 0.53 CI 95% 0.37-0.75; 75-84 years IRR 0.71 CI95% 0.60-0.83; 85+ years IRR 0.79 CI 95% 0.67-0.93) while in75 years females there was a significant increase.An early HC visit (within two days from discharge) may have positive effects on males, but not in older women, possibly for the coexistence of socio-economic factors.

In a large cohort of subjects with diabetes cancer mortality increased by 30%, possibly due to lower survival, reverse causality, and an etiologic role of diabetes in cancer. A two-fold increased mortality from liver and pancreatic cancer was confirmed in both genders irrespective of follow-up period or disease duration.

Objectives Mortality from chronic liver diseases (CLDs) is increased in diabetes, but little is known about the etiology. The aim of this study was to assess mortality rates from CLD by etiology in known diabetic subjects living in the Veneto Region, Northern Italy. Methods A total of 167,621 diabetic subjects, aged 30-89 years (54.6% men), were identified in the year 2007 and their vital status was assessed between 2008 and 2010. Standardized mortality ratios (SMR) with 95% confidence intervals (CIs) were computed with regional mortality rates as reference. The underlying cause of death and all comordidities reported on the certificate were scrutinized in order to identify CLD deaths and their main etiologies. The latter were grouped into the following three categories: (i) virus-related, (ii) alcohol-related, and (iii) non-virus, non-alcohol-related (mainly represented by nonalcoholic fatty liver disease, NAFLD). Results Analyses were based upon 473,374 person-years of follow-up and 17,134 deaths. We observed an increased risk of dying from CLD in diabetic subjects with an SMR of 2.47 (95% CI=2.19-2.78) in men and 2.70 (2.24-3.23) in women. SMRs were 2.17 (1.90-2.47), 2.25 (1.98-2.54), and 2.86 (2.65-3.08) for virus-related, alcohol-related, and non-virus, non-alcohol-related CLD, respectively. Conclusions Diabetic patients have a twofold to threefold higher risk of dying of CLD, mainly associated with a non-virus and non-alcohol-related etiology, which is largely attributable to NAFLD. An early diagnosis and treatment of NAFLD, if any, may have a beneficial clinical impact on the survival of diabetic patients.

In up to 80% of patients with pulmonary embolism (PE) no peripheral symptomatic thrombosis can be identified. Whether the heart may represent a source of PE is unknown.We conducted a cross-sectional survey of patients who were 60 years or older and were discharged from the hospitals of Veneto region, Italy between 2000 and 2006 with the diagnosis of PE. We compared the prevalence of several acute and chronic heart diseases in patients discharged with the diagnosis of PE alone with that of patients with co-occurring symptomatic peripheral deep venous thrombosis (PE/DVT).Out of 11,236 eligible patients, 9079 (81%) were discharged with the diagnosis of PE alone, and 2157 with that of PE/DVT. 3239 of the 9079 (35.7%) patients with isolated PE, and 666 of the 2157 (30.9%) with PE/DVT had at least one heart disease. The adjusted odds ratio (OR) for having at least one heart disease in patients with isolated PE as compared to those with PE/DVT was 1.26 (95% CI, 1.13-1.40). The heart diseases that significantly contributed to the study results were all-cause cardiomyopathies (adjusted OR, 2.31; 95% CI, 1.37-3.89), all-cause heart failure (1.82; 1.45-2.27), coronary heart disease (1.28; 1.08-1.52), and atrial fibrillation or flutter (1.28; 1.08-1.51).There is an association between isolated PE and a number of heart diseases. The results of our survey generate the hypothesis that in older patients several heart diseases may directly account for the development of PE. Prospective studies are needed to confirm this hypothesis.

Background/Objective: Previous studies conducted both in the general and diabetic population have shown that pulse pressure (PP) can predict mortality from cardiovascular diseases. The aim of the present study was to investigate the relationship between PP and specific cardiovascular mortality, i.e. from cerebrovascular and ischemic heart diseases, in a well-characterized cohort of type 2 diabetic patients. Methods: A cohort of 1,128 known type 2 diabetic patients 56 to 74 years of age with at least 2 blood pressure measurements for each year between 1984–1986 was followed-up for ten years to assess specific causes of death. The analyses were carried out by using the mean and the coefficient of variation (CV) of PP. Results: By the end of the 10-year follow-up period, 375 patients (178 male, 197 female) had died (33%). The mean PP resulted as an independent predictor of all causes and cardiovascular mortality. Remarkably, the mean PP, but not the CV of PP, was highly predictive of mortality from cerebrovascular diseases. The risk of cerebrovascular mortality rose by 86% with a 10 mm Hg increase in mean PP. PP turned out to be the most important predictor of cerebrovascular mortality among various pressure indexes (mean, systolic and diastolic pressure). Conclusion: The mean pulse pressure, but not the coefficient of variation is a strong predictor of cardiovascular mortality, mainly from cerebrovascular diseases, in type 2 diabetic patients.