Search

Introduction: The therapeutic control of LDL-cholesterol is essential in cardiovascular prevention, as recommended by the recent guidelines. Objective: To evaluate gender differences in terms of demographic and clinical characteristics, treatment pattern, treatment adherence and healthcare costs in patients on lipid-lowering therapy, stratified by cardiovascular risk in the Italian real clinical practice. Methods: An observational analysis was conducted on the administrative databases of healthcare institutions, covering about 6.1 million health-assisted subjects. After inclusion of all patients on lipid-lowering therapy between January 2017 and June 2020, the population was investigated in the period before the first prescription of a lipid-lowering drug and followed-up for at least 12 months. Clinical and demographic variables were compared after stratification by gender and by cardiovascular risk (very high/high/other risk). The main outcome measures were treatment adherence and direct healthcare costs during follow-up. Results: Of the 684,829 patients with high/very high cardiovascular risk, 337,394 were men and 347,435 women, aged on average 69.3 years and 72.1 years, respectively (p < 0.001). Men were characterised by a worse comorbidity profile. Regardless of cardiovascular risk, female subjects were associated with larger utilisation of low-potency statins and lower adherence (p < 0.001). The annual healthcare costs per patient during follow-up were higher in men than in women (p < 0.001). Conclusions: The results highlighted larger utilisation of low-potency statins, a lower adherence and a milder comorbidity profile in women, the latter feasibly explaining the reduced healthcare costs compared to men.

Background: The benefits of mitral repair versus replacement for endocarditis are inconclusive. This study compares outcomes of patients with infective endocarditis undergoing mitral valve repair versus replacement and investigates the impact of microbial etiology. Methods: All 251 patients undergoing mitral valve surgery for active endocarditis between 2010 and 2023 were enrolled, 180 (71.7%) replacement and 71 (28.3%) repair. To adjust for imbalances, inverse probability of treatment weighting was applied and 187 patients were obtained. Results: The analysis between groups, following the application of inverse probability of treatment weighting, showed no statistically significant differences across all considered outcomes. Early and late death was observed respectively in 6 (8.5%) and 11 (15.5%) patients in the repair group versus 24 (13.3%) and 45 (25.0%) in the replacement group without statistical significance (p = 0.221 and p = 0.446). Relapse occurred in six patients (8.5%) in the repair group after a median time of 4.0 months and in six (3.3%) in the replacement after 6.9 months (p = 0.071). Conclusions: Surgical strategy in mitral endocarditis has no effect on major postoperative complications, mortality, or medium/long-term survival. Staphylococcus aureus and Coagulase-negative Staphylococci represent a risk for early mortality and relapse. However, mitral valve repair for endocarditis can be pursued when it ensures the complete eradication of all infected tissue, particularly in cases caused by Streptococcus infection, in young patients, and after a minimum of 18 days of antibiotic therapy.

Background: Despite advanced diagnosis and treatment, infective endocarditis (IE) is a potentially life-threatening condition. The impact of COVID-19 on the diagnosis and outcome of the surgical treatment of IE is uncertain. The aim of this study was to analyze the incidence, characteristics, and outcomes of surgically treated IE before and after the COVID-19 pandemic. Methods: This study retrospectively analyzed the data of 535 patients who underwent valve surgical procedures for IE between January 2010 and December 2022 in a single cardiac surgery center. Patients were divided into two groups depending on the date of their operation: before (n = 393) and after (n = 142) COVID-19 onset. In order to balance the groups, inverse probability of treatment weighting (IPTW) calculated from the propensity score (PS) was applied. Weighted univariate logistic regressions were reported for outcomes; weights were derived from IPTW. Interrupted time series analysis (ITSA) according to Linden’s method was used to evaluate the changes in the manifestation of IE after 11 March 2020. Results: Patients from the post-COVID-19 cohort (after 11 March 2020) had a greater number of comorbidities such as diabetes (29.6% vs. 16.3% p = 0.001), hypertension (71.1% vs. 59.5% p = 0.015), and preoperative kidney injury requiring dialysis (9.2% vs. 2.5% p = 0.002), but the median additive and logistic EuroSCORE were not statistically different. In the post-COVID-19 group, we observed a greater prevalence of Staphylococcus aureus-related endocarditis (24.5% vs. 15.4% p = 0.026), a consequent reduction in Staphylococcus non aureus-related endocarditis (12.2% vs. 20.1% p = 0.048), and a decrease in aortic valve replacements (43.0% vs. 53.9%), while the number of mitral valve replacements and repair was greater (21.1% vs. 15.0% and 6.3% vs. 4.3%, respectively). No differences were found in the two groups concerning early death, death, or relapse at 1 year after surgery. Data obtained by multivariable analysis identified preoperative renal dysfunction requiring dialysis as the only common risk factor for early mortality via stratifying by time periods in analysis. Conclusions: The incidence of surgically treated IE significantly increases after the COVID-19 pandemic with a higher incidence of mitral valve involvement with respect to the aortic valve. Although a delay in surgical timing occurred during the COVID-19 pandemic, data in terms of mortality and outcomes were largely unaffected.

In elderly patients undergoing cardiac surgery, extracorporeal circulation affects the incidence of post-operative delirium and cognitive impairment with an impact on quality of life and mortality. In this study, a new oxygenator system (RemoweLL 2) was tested against a conventional system to assess its efficacy in reducing the onset of postoperative delirium and cognitive dysfunction and the levels of serum inflammatory markers. A total of 154 patients (>65 y.o.) undergoing cardiopulmonary bypass (CPB) were enrolled and randomly assigned to oxygenator RemoweLL 2 (n = 81) or to gold standard device Inspire (n = 73) between September 2019 and March 2022. The aims of the study were to assess the incidence of delirium and the cognitive decline by neuropsychiatric tests and the MoCa test intra-hospital and at 6 months after CPB. Inflammation biomarkers in both groups were also evaluated. Before the CPB, the experimental groups were comparable for all variables. After CPB, the incidence of severe post-operative delirium showed a better trend (p = 0.093) in patients assigned to RemoweLL 2 (16.0%) versus Inspire (26.0%). Differences in enolase levels (p = 0.049), white blood cells (p = 0.006), and neutrophils (p = 0.003) in favor of RemoweLL 2 were also found. The use of novel and better construction technologies in CPB oxygenator devices results in measurable better neurocognitive and neurological outcomes in the elderly population undergoing CPB.

Background: Nowadays, one of the main goals of aortic valve surgery is to reduce the biological impact, mortality, and complications. It is well-known that long operative times in terms of the extracorporeal circulation, but above all, of the aortic cross-clamp time (ACC), represent a risk factor for mortality in patients undergoing cardiac surgery. In order to shorten the aortic cross-clamp time, many technological improvements, such as sutureless prostheses, have been introduced, but their actual effectiveness has not been proven yet. The aim of this study was to assess the 30-day outcomes of patients undergoing aortic valve replacement surgery, focusing on the ACC length. Methods: All 3139 patients undergoing aortic valve replacement between January 2013 and July 2022 at our institution were enrolled. The data were retrospectively collected and the baseline characteristics and intraoperative variables were recorded. In order to adjust the results according to the differences in the baseline characteristics, propensity score matching was performed and four groups of 351 patients were obtained based on the first, second, third, and fourth quartile of the ACC time. Results: The patient population included 132 redo surgeries (9.4%) and 61 cases of active endocarditis (4.3%), with an overall median EuroSCORE II of 1.8 (IQR 1.2–3.1). An increase across the groups was observed in terms of the acute kidney failure (p < 0.001) incidence, the number of blood transfusions (p = 0.022), prolonged hospital stays (p < 0.001), the and respiratory failure (p < 0.001) incidence. A p of < 0.1 was found for the 30-day mortality (p = 0.079). The predictors of an early 30-day mortality were standard full sternotomy (OR 2.48, 95% CI 1.14–5.40, p = 0.022), EuroSCORE II (OR 1.10, 95% CI 1.05–1.16, p < 0.001), and a trend for a longer ACC time (Q4 vs. Q1: OR 2.62, 95% CI 0.89–7.68, p = 0.080). Conclusions: Shortening the operative times resulted in marked improvements of the patients’ outcomes. The combined use of minimally invasive approaches and sutureless aortic valve prostheses allows for a lower 30-day events rate. New technologies should be assessed to obtain the best results with the least risk.

Abstract Introduction The objective of this study was to evaluate treatment patterns in patients with rheumatoid arthritis (RA), with a focus on the utilization of baricitinib, an oral highly selective Janus kinase 1 and 2 inhibitor, in an Italian real-world setting. Methods This observational retrospective analysis was based on data collected in selected Italian administrative databases. Patients aged ≥ 18 years with a diagnosis of RA defined by hospitalization discharge diagnosis (International Classification of Diseases, Ninth Revision, Clinical Modification code 714.0) or by disease exemption code 006 for RA in 2018 were included. The index date (ID) was defined as the date of first prescription for a drug indicated for RA during the inclusion period. Patients without a prescription for biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) before the ID were considered to be b/tsDMARD naïve. A further analysis was performed on patients only receiving baricitinib. Results A total of 41,290 RA patients were enrolled, of whom 55.6% were not treated with conventional synthetic DMARDs (csDMARDs) or b/tsDMARDs, 39.4% were receiving therapy with csDMARDs, and 5.0% were using b/tsDMARDs. In the latter group, 2.7% (n = 56) were receiving therapy with baricitinib. In 2018, 13.2% of csDMARD-treated patients switched to b/tsDMARDs, of whom 4.3% (n = 93) of these switched to baricitinib. In total, 149 patients (mean age ± standard deviation 57.6 ± 12.1; 12.8% male) had a baricitinib prescription, of whom 51% were b/tsDMARD naïve. At baseline, 61.7% of baricitinib users were receiving combination therapy with csDMARDs plus corticosteroids, 26.2% were receiving combination therapy with corticosteroids, and 8.1% were receiving combination therapy with csDMARDs; 4% were receiving baricitinib monotherapy. During follow-up, the proportion of patients receiving baricitinib monotherapy increased to 38.9%, while 26.9, 18.8, and 15.4% of baricitinib users received combination therapy with corticosteroids, csDMARDs plus corticosteroids, and csDMARDs, respectively. Conclusion This study provides a current view of the treatment patterns in Italian patients with RA in a real-world setting of daily clinical practice, with a focus on baricitinib utilization.

This real-world analysis aims to estimate the epidemiology and economic burden related to early-stage non-small-cell lung carcinoma (eNSCLC) in the clinical practice Italian setting. An observational analysis was performed using administrative databases linked to pathological anatomy data, covering around 2.5 mln health-assisted individuals. From 2015 to mid-2021, eNSCLC patients staged II–IIIA treated with chemotherapy after surgery were included. Patients were stratified into those presenting loco-regional or metastatic recurrence during follow-up and annualized healthcare direct costs covered by the Italian National Health System (INHS) were estimated. In 2019–2020, the prevalence of eNSCLC was 104.3–117.1/million health-assisted subjects, and the annual incidence was 38.6–30.3/million. Data projected to the Italian population estimated 6206 (2019) and 6967 (2020) prevalent and 2297 (2019) and 1803 (2020) incident cases. Overall, 458 eNSCLC patients were included. Of them, 52.4% of patients had a recurrence (5% loco-regional-recurrence, 47.4% metastatic-recurrence). Healthcare total direct costs/patient averaged EUR 23,607, in particular, in the first year after recurrence, costs averaged EUR 22,493 and EUR 29,337 in loco-regional and metastatic-recurrence patients, respectively. This analysis showed that about one-half of eNSCLC patients stage II–IIIA experience a recurrence, and in recurrence patients, total direct costs were almost two-fold those of no-recurrence patients. These data highlighted an unmet clinical need, as the therapeutic optimization of patients at early stages.

AIM: The aim of the study was to evaluate healthcare resource use and related costs for the management of people living with Human Immunodeficiency Virus (PLWHIV) with and without comorbidities, and to compare the burden of comorbidities in PLWHIV to the general population. METHODS: An observational retrospective analysis, based on administrative and laboratory databases from 6 Italian Local Health Units (LHUs) was performed. Individuals receiving either an HIV treatment [Antiretroviral therapy (ART) – ATC code: J05A)], or with an HIV positive laboratory test result between January 1st, 2014 and December 31st, 2014 were included. The date of first ART prescription or positive test of HIV was used as the Index Date (ID). Patients enrolled were followed-up for all time available from the ID (follow-up period) and their clinical characteristics were investigated from one year prior to the ID (characterization period). Comorbidities were measured by using the Charlson Comorbidity Index; findings were compared with those of a sample of the general population with the same age and sex distribution (OsMed 2015). Healthcare resource use and related cost was evaluated during the follow-up period. RESULTS: 1,214 patients were included, 837 were PLWHIV without any comorbidities and 377 were PLWHIV with at least one comorbidity. Mean prevalence of prescriptions for treatment of comorbidities was higher in the HIV-infected population than in the Italian general population. The annual healthcare cost of managing HIV patients with comorbidities, was significantly higher than that for patients without comorbidities (€ 10,615 vs. € 8,665, p < 0.001). CONCLUSIONS: Study results showed that 30% of PLWHIV had at least one comorbidity. The cost of managing PLWHIV who have comorbidities was significantly higher than that of managing PLWHIV without comorbidities. Our data confirm that care and treatment services should be adapted to address the specific needs of people living with both HIV and comorbidities.

This study investigates the effects of switching to different devices of the same active substance or between different active substances, in patients with Chronic Obstructive Pulmonary Disease (COPD) treated with Inhaled Corticosteroids (ICS) plus Long-acting β2-adrenergic agonists (LABAs) in terms of incidence of exacerbations. A retrospective cohort analysis, based on administrative databases of 3 Italian Local Health Units, was conducted. Patients with at least one prescription of a fixed dose combination of ICS/LABA from 1 January 2009 to 31 December 2011 were included. The index-date was defined as the earliest date within the inclusion period in which the patient had the first switch of drug or device (switchers) or the first prescription of ICS/LABA for patients continuing with the same treatment (non-switchers). Patients were observed until 31 December 2012. Propensity score matching was performed to check for cofounding effects. COPD exacerbations were defined as COPD-related hospitalization and prescription of corticosteroids and antibiotics. Number of: hospitalizations for COPD, oral corticosteroids and antibiotics prescriptions were analyzed using Poisson regression models. After matching, 1,759 patients per arm were analyzed. No statistically significant difference was found between study groups’. Incidence Rate Ratio in favor of non-switcher patients, as compared to switcher patients, was 1.41 (95% CI: 1.10–1.80) for number of hospitalizations, 1.05 (95% CI: 1.11–1.09) and 1.02 (95% CI: 0.96–1.09) for number of oral corticosteroids and antibiotics prescriptions, respectively. Our findings showed that switching to different devices of the same active substance or among different active substances in COPD patients treated with a fixed dose combination of ICS/LABA can lead to an higher likelihood of exacerbation COPD related rates than those who did not switch. Considering the study’s limitations, further studies are needed in order to confirm and enhance the generalizability of our findings.

INTRODUCTION: the objective of this study was to analyze adherence to therapeutic guidelines among patients treated with lipid lowering drugs (statins). MATERIAL AND METHODS: a retrospective observational study including 5 Local Health Units (LHUs) was conducted using administrative databases. Patients who received at least one prescription for statins between January 1st, 2007 and June 30th, 2008 were selected and followed for 12 months. Patients were classified according to their level of absolute cardiovascular risk (moderate, high, very high according to Nota 13 AIFA). RESULTS: a total of 71,855 patients were included (14,133 newly treated patients with statins, representing 19.4% of total sample), (age 68.8±10.7, male 51%). Level of absolute cardiovascular risk were: moderate risk (45.4%), high risk (33.4%), very high risk (16.3%), familial hypercholesterolemia (4.9%). Statins assumed by patients in analysis were stratified in two groups (first or second choice), accordingly to their efficacy (level of LDL cholesterol reduction) in relation to the patient’s cardiovascular risk (coherently with new Nota 13 AIFA, 2011). Among patients with a very high cardiovascular risk, only 52.8% used statins indicated by Nota13 as a first choice while 2.9% used a second choice statin and 44.3% used an inadequate statin and/or dosage; among familial hypercholesterolemia patients, those percentages were, respectively: 53.8%, 21.1% and 25.1%. When only patients naïve to statins treatment were analyzed, similar percentages were found. Only few patients in very high risk group used adequate dosages: among patients treated with rosuvastatin and atorvastatin, 11.2% used atorvastatin 40 mg, and 0.2% used atorvastatin 80 mg (this population was not analyzed for events because of low numerosity) while 4.1% used rosuvastatin 20 mg and 0.2% used rosuvastatin 40 mg; overall, 84.3% of patients in this group used inadequate dosages. Cardiovascular events at one year of follow up were 1.6% for patients treated with rosuvastatin 20 mg, 1.6% for rosuvastatin 40 mg and 6.1% for atorvastatin 40 mg; death rates (any cause) were 0.9%, 0.0%, 2.6% respectively. The analysis of the sub-population of patients treated with rosuvastatin 20 mg with previous CV event showed a percentage of patients with a CV event during the observational period of 3.4%, a percentage of patients with cerebrovascular event of 0.9% and a mortality percentage of 0.9%. Conclusions: in real practice setting, the percentage of patients prescribed for recommended statins and dosages is low.

Oral anticoagulant therapy is essential for the treatment and prevention of many thromboembolic disorders. The aim of the present study is to evaluate the level of anticoagulation intensity in patients treated with vitamin K antagonists (VKAs) in a clinical practice setting and to explore the relationship between anticoagulation intensity and adherence to VKA treatment. We conducted a retrospective cohort study using the administrative databases of three Italian Local Health Units. Patients were enrolled if they had filled at least one prescription for VKAs (ATC code B01AA) between January 1st, 2007 and June 30th, 2008. In the same period all determinations of the international normalised ratio (INR) were collected. The parameters evaluated were anticoagulation control and adherence to VKA treatment. The survey showed that only 47.9% and 56.3% of INR determinations, in VKA naïve and established patients respectively, were into the recommended range (2.0-3.0). Moreover, the percentage of INR determination below the recommended range was higher than the percentage of INR determination above the recommended range for both naïve and established patients. Moreover, adherence to VKA treatment was poor both in naïve and established patients and, consequently, anticoagulation control is poor. Also in patients with the highest adherence to VKA treatment, only about 60% of INR determinations were into the recommended range. Our findings evidence that the anticoagulation control in clinical practice settings is still unsatisfactory and it is necessary to evaluate interventions to increase the amount of time at which patients’ INR are within the recommended range.

All international Societies of Emergency Medicine have developed and promote courses on triage methods and guidelines, given their fundamental role in improving initial evaluation of patients in Emergency Department settings. However, as far as we know, few studies analyse the effect of triage courses on the allocation of priority codes. Since 2001, the Intra-Hospital Triage Guidelines have been implemented in Imola, where they are disseminated and illustrated in two-day courses. In this study, we analysed the effect of a two-day triage course on the quality of priority code allocation to patients evaluated at our ER. The Triage Guidelines course appears to improve two of the quality indicators analysed: observance of documentation standards and compliance with Triage Guidelines.

Italian guidelines require a 4-level in hospital triage based on an acuity scale measurement, but they don’t suggest common guidelines neither which triage models to adopt. Thus each hospital developed own triage guidelines based on consensus. But, to our knowledge, there aren’t data on the reliability and predictive validity of triage systems adopted by Italian Emergency Department. Also in the ED of Imola, a triage working group developed Guidelines on triage in 2001. In this study we measured the reliability and predictive validity of the Imola Triage Guidelines (LGTI).

The primary aim of the STAR Study (Statins Target Assessment in Real practice) was to determine the LDLcholesterol reduction and to analyse patient’s and therapeutic factors associated to LDL-cholesterol target attainment in newly treated subjects with statins in an unselected population in clinical practice setting. Administrative databases (including pharmaceutical prescriptions and hospital admissions) and laboratory test databases (including LDL-cholesterol values) of five Local Health Units, distributed in Emilia Romagna, Toscana and Umbria, were linked. A retrospective cohort study was conducted and all subjects aged ≥18 years with a first prescription for statins (newly treated subjects) between January 1st, 2007 and June 30th, 2008 were included. All statin prescriptions over a 12 months follow-up period were considered and used to calculate adherence to treatment. Baseline and follow-up LDL-cholesterol, respectively, were defined according to the nearest determination to the first prescription for statins and to the end of the follow-up period. A total of 3.232 subjects was included, 1.516 males (47%) and 1.716 females (53%), with an average age equal to 65,9 ± 11,3 years. Among included subjects, 22,6% had a gap to LDL-cholesterol target

In Italy there are many triage guidelines and methods based on consensus. But, to our knowledge, there are few data on the reliability and predictive validity of triage systems adopted by Italian emergency departments. The Triage Emergency Method version 2 (TEM v2) is a new four-level in-hospital triage system. This paper presentes a before-and-after observational study performed using triage scenarios from June 2008 to September 2009 in 6 Italian emergency departments. Twelve nurses who received a 5-h training on TEM and a panel of experts on TEM assigned priority code to 66 scenarios. To test the inter-rater reliability among participants and the panel of experts (before and after the course), we used the weighted K statistic. We assessed the validity of TEM by calculating sensitivity, specificity and accuracy for predicting the reference standard’s triage score. The TEM v2 showed good and very-good agreement among all 6 groups of nurses with a K range=0.61-1. Also, sensitivity, specificity and accuracy of nurses’ triage rating for predicting the reference standard’s triage code was good (accuracy range=78-90%). In this multicenter study, TEM v2 has a good inter-rater reliability for rating triage acuity among all groups of participating nurses, with a K value similar to the reference standard reliability (K=0.75). Thus, the Triage Emergency Method version 2 seems to be valid and accurate in predicting a reference standard rating.

Aim: To evaluate antithrombotic treatment patterns in patients in Italy with nonvalvular atrial fibrillation (NVAF) before and after direct oral anticoagulants (DOACs) were approved.Methods: This analysis included patients with a discharge diagnosis of NVAF in 2010 and 2014, which constituted the pre- and post-DOACs populations, respectively.Results: Approximately 90% of patients were eligible for oral anticoagulant (OAC) therapy. Overall use of OACs increased from 38% in 2010 to 45% in 2014; use of antiplatelet therapy decreased from 36 to 25%. Approximately 14% of eligible patients remained untreated.Conclusion: Although an improvement in OAC prescription was observed post-DOACs launch, treatment patterns in Italy suggest that a proportion of patients with NVAF are still undertreated or do not receive appropriate therapy. [ABSTRACT FROM AUTHOR]