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OBJECTIVES Diabetes mellitus is a risk factor for coronary artery disease, but its role following coronary artery bypass grafting (CABG) is still unclear and few data on long-term outcomes are available. This study aimed to evaluate the impact of diabetes on long-term outcomes after CABG. METHODS The PRIORITY (PRedictIng long-term Outcomes afteR Isolated coronary arTery bypass surgerY) project is an observational cohort study merging 2 prospective multicentre studies on isolated CABG. Follow-up information was obtained through administrative databases and was truncated 10 years after the intervention. Baseline differences between patients with and without diabetes were balanced with inverse probability of treatment weighting. RESULTS The cohort consisted of 10 989 patients with complete follow-up information who underwent isolated CABG (diabetes 32.3%). Diabetes did not affect short-term mortality [odds ratio (OR) 0.90, 95% confidence interval (CI) 0.73–1.10] and repeat revascularization (OR 0.79, 95% CI 0.42–1.49), while it is related to lower incidence of 30-day major adverse cardiac and cerebrovascular events (OR 0.67, 95% CI 0.60–0.76), acute myocardial infarction (OR 0.60, 95% CI 0.51–0.70) and stroke (OR 0.47, 95% CI 0.28–0.77). Diabetic patients had a higher long-term risk for major adverse cardiac and cerebrovascular event [weighted hazard ratio (HR) 1.31, 95% CI 1.26–1.37], mortality (HR 1.45, 95% CI 1.37–1.53), as well as stroke (HR 1.38, 95% CI 1.25–1.53) and myocardial infarction (HR 1.39, 95% CI 1.26–1. 53). Diabetes had not been associated with an increased incidence of repeated revascularization up to 10 years (HR 1.04, 95% CI 0.96–1.12). CONCLUSIONS Diabetic patients had worse long-term outcomes. Diabetes may have a greater negative impact on micro-vasculopathy than grafts, as evidenced by the increased long-term incidence of myocardial infarction without affecting myocardial revascularization. [ABSTRACT FROM AUTHOR]

Background: Paravalvular leak (PVL) was initially recognized as one of the most common complications after transcatheter aortic valve implantation (TAVI) and has been linked to adverse clinical outcomes, including mortality. This study aims to assess the long-term clinical effects of PVL in patients undergoing TAVI with the latest generation of transcatheter aortic valves, as part of the national observational prospective multicenter study OBSERVANT II. Methods: OBSERVANT II included all consecutive patients with severe aortic stenosis who underwent TAVI across 28 Italian centers from December 2016 to September 2018. A total of 2125 patients were included in this analysis and stratified according to the presence of moderate-to-severe PVL (significant PVL, n = 155) versus no/trace-to-mild PVL (no significant PVL, n = 1970). The primary endpoint was 5-year major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, stroke, myocardial infarction, and coronary revascularization. Five-year all cause death and re-hospitalization for heart failure (HF) were the secondary endpoints. Results: In our cohort, the incidence of moderate-to-severe PVL was 7%. Age, aortic anulus perimeter, and self-expandable valves were determinants of PVL. The risk of MACCE, all-cause death, and re-hospitalization for HF at the 5-year follow-up were not different between the study groups [HR = 1.07 (95% CI: 0.85–1.34) p = 0.571; HR = 1.10 (95% CI: 0.87–1.39) p = 0.435; HR = 1.20 (95% CI: 0.88–1.62) p = 0.245, respectively]. Conclusions: In this analysis of the OBSERVANT II study, moderate/severe PVL was not associated with a higher incidence of MACCE and re-hospitalization for heart failure at the 5-year follow-up. [ABSTRACT FROM AUTHOR]

Aims. The impact of the COVID-19 pandemic on the event rate of patients with ischemic stroke has been poorly investigated. We sought to evaluate the impact of the COVID-19 infection on mortality in patients with ischemic stroke admitted during the 2020 pandemic in Italy. Methods. We analyzed a nationwide, comprehensive, and universal administrative database of patients who were admitted for ischemic stroke during and after the national lockdown for the COVID-19 infection in 2020, and the equivalent periods over the previous 5 years in Italy. The 2020 observed hospitalization and mortality rates of stroke patients with and without COVID-19 infection were compared with the expected rates, in accordance with the trend of the previous 5 years. Results. During the period of observation, 300,890 hospitalizations for ischemic stroke occurred in Italy. In 2020, 41,302 stroke patients (1102 with concomitant COVID-19 infection) were admitted at 771 centers. The rate of admissions for ischemic stroke during the 2020 pandemic was markedly reduced compared with previous years (percentage change vs. 2015: −23.5). Based on the 5 year trend, the 2020 expected 30 day and 1 year mortality rates were 9.8% and 23.9%, respectively, and the observed incidence of death rates were 12.2% and 26.7%, respectively (both p < 0.001). After multiple corrections, higher rates of mortality were observed among patients admitted for stroke with a concomitant COVID-19 diagnosis. Conclusions. During the COVID-19 pandemic in 2020 in Italy, the rate of hospitalizations for ischemic stroke was dramatically reduced, although both the 30 day and 1 year mortality rates increased compared with the previous 5 year trend. [ABSTRACT FROM AUTHOR]

Background: Data reflecting the benefit of procedural improvements in real-world transcatheter aortic valve implantation (TAVI) practice are sparse. Aims: To compare outcomes and trends of two TAVI eras from real Italian practice. Methods: A total of 1811 and 2939 TAVI patients enrolled in the national, prospective OBSERVANT and OBSERVANT II studies in 2010–2012 and 2016–2018, respectively, were compared in a cohort study. Outcomes were adjusted using inverse propensity of treatment weighting and propensity score matching. Results: The median age (83.0 (79.0–86.0) vs. 83.0 (79.0–86.0)) and EuroSCORE II (5.2 (3.2–7.7) vs. 5.1 (3.1–8.1)) of OBSERVANT and OBSERVANT II patients were similar. At 1 year, patients of the OBSERVANT II study had a significantly lower risk of all-cause death (10.6% vs. 16.3%, Hazard Ratio (HR) 0.63 (95% Confidence Interval (CI) 0.52–0.76)) and rehospitalization for heart failure (HF) (14.3% vs. 19.5%, Sub-distribution HR 0.71 (95%CI 0.60–0.84)), whereas rates of stroke (3.1% vs. 3.6%) and permanent pacemaker implantation (PPI) (16.6% vs. 18.0%) were comparable between study groups. Conclusions: Age and risk profile among patients undergoing TAVI in Italy remained substantially unchanged between the 2010–2012 and 2016–2018 time periods. After adjustment, patients undergoing TAVI in the most recent era had lower risk of all-cause death and rehospitalization for HF at 1 year, whereas rates of stroke and PPI did not differ significantly. [ABSTRACT FROM AUTHOR]

The superiority of transcatheter (TAVR) over surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS) has not been fully demonstrated in a real-world setting. This prospective study included 5706 AS patients who underwent SAVR from 2010 to 2012 and 2989 AS patients who underwent TAVR from 2017 to 2018 from the prospective multicenter observational studies OBSERVANT I and II. Early adverse events as well as all-cause mortality, major adverse cardiac and cerebrovascular events (MACCEs), and hospital readmission due to heart failure at 1-year were investigated. Among 1008 propensity score matched pairs, TAVR was associated with significantly lower 30-day mortality (1.8 vs. 3.5%, p = 0.020), stroke (0.8 vs. 2.3%, p = 0.005), and acute kidney injury (0.6 vs. 8.2%, p < 0.001) compared to SAVR. Moderate-to-severe paravalvular regurgitation (5.9 vs. 2.0%, p < 0.001) and permanent pacemaker implantation (13.8 vs. 3.3%, p < 0.001) were more frequent after TAVR. At 1-year, TAVR was associated with lower risk of all-cause mortality (7.9 vs. 11.5%, p = 0.006), MACCE (12.0 vs. 15.8%, p = 0.011), readmission due to heart failure (10.8 vs. 15.9%, p < 0.001), and stroke (3.2 vs. 5.1%, p = 0.033) compared to SAVR. TAVR reduced 1-year mortality in the subgroups of patients aged 80 years or older (HR 0.49, 95% CI 0.33–0.71), in females (HR 0.57, 0.38–0.85), and among patients with EuroSCORE II ≥ 4.0% (HR 0.48, 95% CI 0.32–0.71). In a real-world setting, TAVR using new-generation devices was associated with lower rates of adverse events up to 1-year follow-up compared to SAVR. [ABSTRACT FROM AUTHOR]

Background: The OBSERVANT study evaluated the medium and long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement obtaining comparative effectiveness results at least for the first-generation devices. The OBSERVANT II study enrolled a new series of TAVI procedures to evaluate whether the use of new-generation devices has modified outcome differences recorded in the OBSERVANT study. The aim of this paper is to describe the clinical characteristics of the OBSERVANT II population and compare them with those of the OBSERVANT population., Methods: OBSERVANT II is a prospective multicenter observational study, which enrolled patients with severe aortic stenosis, who underwent a TAVI procedure in 30 Italian centers from December 2016 to September 2018. Clinical, anatomical and procedural information was recorded for each patient as well as procedure characteristics and any periprocedural outcomes. An administrative follow-up will allow to obtain information on medium and long-term outcomes., Results: The enrolled population consists of 3001 patients with a mean age similar to that recorded in OBSERVANT (81.7 ± 6.3 vs 81.9 ± 6.2 years; p=0.336). OBSERVANT II patients show a lower prevalence of several morbid conditions than OBSERVANT patients (i.e. chronic obstructive pulmonary disease, coronary artery disease, peripheral arterial disease, etc.), though having very similar mean values of EuroSCORE II (7.2 ± 7.6% vs 7.4 ± 7.9%; p=0.558). According to three EuroSCORE II risk classes (≤3; 3-7; ≥7), the in-hospital mortality rates for patients enrolled in the two studies are 1.0% vs 2.0% (p≤0.000), 1.4% vs 4.1% (p<0.000) and 2.4% vs 7.7% (p<0.000), respectively., Conclusions: The first results of the OBSERVANT II study show that patients undergoing TAVI with new-generation devices are elderly, have a lower risk profile than patients enrolled in the OBSERVANT study but comparable mean values of EuroSCORE II. The in-hospital mortality rate for patients enrolled in the OBSERVANT II study is lower than that recorded in the OBSERVANT study across all the EuroSCORE II risk classes.

Background: Although the improvement of therapeutic strategies is leading to a dramatic decline of in-hospital acute coronary syndrome (ACS) death rates, differences in care and prognosis of ACS patients exist when age, gender and admission department are considered., Methods: The national hospital informative system was used. Only data recorded in three Italian Regions from December 1, 2005 to November 30, 2007 were analyzed. This approach allowed to identify 70 413 patients reporting ACS as primary or secondary diagnosis. The ACS cohort was stratified by age (≤64, 65-74 and ≥75 years) and gender. ACS events were divided into two groups: 42 503 patients with non-ST-elevation ACS (NSTE-ACS) and 27 910 patients with ST-elevation ACS (STEMI). The proportion of NSTE-ACS and STEMI patients treated in general medicine or cardiology departments requiring a coronary procedure or extensive investigations, and in-hospital 30-day mortality rates adjusted by age and gender were analyzed., Results: 19% of STEMI and 15% of NSTE-ACS patients are admitted to a general medicine department. For STEMI patients, the proportion increases up to 37.6% when females aged ≥75 years are considered. Patients undergo a coronary procedure or extensive investigations less commonly in general medicine than in cardiology departments; in-hospital 30-day adjusted mortality rates in general medicine departments are approximately 2-fold higher than those recorded in cardiology departments (STEMI: 26.4 vs 16.7%; NSTE-ACS: 7.7 vs 4.2%)., Conclusions: In-hospital mortality rates of ACS patients admitted to cardiology departments are lower than those reported in general medicine departments. Nevertheless, in-hospital management of women and elderly ACS patients does not completely comply with the recommended guidelines and exposes them to unfavorable prognosis.

Observational outcome studies represent a valid approach to evaluating comparative treatment effectiveness in real populations. The main objective of outcome research is to underline what works and what does not work in the field of health assistance. In 2004 the Italian Ministry of Health launched the Project "Mattone Misura dell'Outcome" aimed at assessing the introduction of procedures and methods for the systematic evaluation of outcomes in the national health system. A new experience, the PROGRESSI program (PROGRamma ESiti per SIVeAS e LEA), started in 2008 with the aim to further develop the methodologies for outcome evaluation. In this Supplement the final results from four clinical studies named "Sperimentazioni dell'area cardiovascolare del Progetto Mattoni" are presented. These studies started between 2005 and 2007 and their main objectives were to evaluate: --the contribution of information from current informative systems and clinical studies in risk-adjustment methodologies; --the advisability of introducing some clinical items in current informative systems to improve outcome estimates; --the goodness of follow-up procedures from current informative systems; and --the role of disease registries in the validation of comparative evaluation measures. The four studies were designed as voluntary prospective multicentre studies. Results concerning the characteristics of the enrolled populations as well as the risk-adjustment models built using information from current informative systems and/or clinical information are presented. As expected, each study produced specific remarks both in terms of clinical findings and contribution of different informative systems to the risk-adjustment models. In general, models built with information from both current informative systems and clinical information show the best performance. Findings from these analyses will provide the public health system with suitable indications to improve statistical methodologies for outcome estimates.

Background: In early 2008, a new national prospective study on short-term outcomes of coronary artery bypass graft (CABG) procedures started in Italy. The aim was to describe short-term results in patients undergoing CABG and improve methodologies for comparative outcome evaluation., Methods: Only 26 Italian cardiac surgery centers participated in this survey. For each patient undergoing a CABG procedure, all centers were requested to provide specific data (type of procedure, hemodynamic conditions, comorbidities, recent myocardial infarction and unstable angina, ventricular function, emergency conditions, vital status at 30 days). Representativeness was tested by comparing characteristics of the enrolled population with information derived from national hospital discharge records. A multiple logistic regression analysis was used to perform indirect standardization; the mortality rate of the whole population was used as a reference standard. Comparison with the CABG model built on 34 310 patients in 2002-2004 was performed as well., Results: The analysis of 7436 isolated CABG procedures showed a 30-day mortality of approximately 2%. The study population seemed to be representative of the Italian population of CABG patients. Using the new estimate model, two cardiac surgery centers showed significantly better risk adjusted mortality rates than the national reference standard, and two others showed significantly worse rates. The application of the "CABG model" yielded similar results., Conclusions: Our study shows a high-quality level of Italian cardiac surgery centers and confirms the good applicability of the CABG model to the Italian CABG population. Comparison between results from the two models highlights the usefulness of regular outcome studies either for updating risk adjustment procedures and monitoring quality of care in Italian hospitals.

Background: The availability of two contemporary sources of information about coronary artery bypass graft (CABG) interventions, allowed 1) to verify the feasibility of performing outcome evaluation studies using administrative data sources, and 2) to compare hospital performance obtainable using the CABG Project clinical database with hospital performance derived from the use of current administrative data., Methods: Interventions recorded in the CABG Project were linked to the hospital discharge record (HDR) administrative database. Only the linked records were considered for subsequent analyses (46% of the total CABG Project). A new selected population "clinical card-HDR" was then defined. Two independent risk-adjustment models were applied, each of them using information derived from one of the two different sources. Then, HDR information was supplemented with some patient preoperative conditions from the CABG clinical database. The two models were compared in terms of their adaptability to data. Hospital performances identified by the two different models and significantly different from the mean was compared., Results: In only 4 of the 13 hospitals considered for analysis, the results obtained using the HDR model did not completely overlap with those obtained by the CABG model. When comparing statistical parameters of the HDR model and the HDR model + patient preoperative conditions, the latter showed the best adaptability to data., Conclusions: In this "clinical card-HDR" population, hospital performance assessment obtained using information from the clinical database is similar to that derived from the use of current administrative data. However, when risk-adjustment models built on administrative databases are supplemented with a few clinical variables, their statistical parameters improve and hospital performance assessment becomes more accurate.