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Risk stratification tools used in patients with severe aortic stenosis have been mostly derived from surgical series. Although specific predictors of early mortality with transcatheter aortic valve replacement (TAVR) have been identified, the prognostic impact of their combination is unexplored. We sought to develop a simple score, using preprocedural variables, for prediction of 30-day mortality after TAVR. A total of 1,878 patients from a national multicenter registry who underwent TAVR were randomly assigned in a 2:1 manner to development and validation data sets. Baseline characteristics of the 1,256 patients in the development data set were considered as candidate univariate predictors of 30-day mortality. A bootstrap multivariate logistic regression process was used to select correlates of 30-day mortality that were subsequently weighted and integrated into a scoring system. Seven variables were weighted proportionally to their respective odds ratios for 30-day mortality (glomerular filtration rate <45 ml/min [6 points], critical preoperative state [5 points], New York Heart Association class IV [4 points], pulmonary hypertension [4 points], diabetes mellitus [4 points], previous balloon aortic valvuloplasty [3 points], and left ventricular ejection fraction <40% [3 points]). The model showed good discrimination in both the development and validation data sets (C statistics 0.73 and 0.71, respectively). Compared with the logistic European System for Cardiac Operative Risk Evaluation in the validation data set, the model showed better discrimination (C statistic 0.71 vs 0.66), goodness of fit (Hosmer-Lemeshow p value 0.81 vs 0.00), and global accuracy (Brier score 0.054 vs 0.073). In conclusion, the risk of 30-day mortality after TAVR may be estimated by combining 7 baseline clinical variables into a simple risk scoring system., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Despite the widespread use of transcatheter aortic valve implantation (TAVI), the role of sex on outcome after TAVI or surgical aortic valve replacement (AVR) has been poorly investigated. We investigated the impact of sex on outcome after TAVI or AVR., Methods: There were 2108 patients undergoing TAVI or AVR who were enrolled in the Italian Observational Multicenter Registry (OBSERVANT). Thirty-day mortality, major periprocedural morbidity, and transprosthetic gradients were stratified by sex according to interventions., Results: Female AVR patients showed a worse risk profile compared with male AVR patients, given the higher mean age, prevalence of frailty score of 2 or higher, New York Heart Association class of 3 or higher, lower body weight, and preoperative hemoglobin level (P ≤ .02). Similarly, female TAVI patients had a different risk profile than male TAVI patients, given a higher age and a lower body weight and preoperative hemoglobin level (P ≤ .005), but with a similar New York Heart Association class, frailty score, EuroSCORE (P = NS), a better left ventricular ejection fraction and a lower prevalence of left ventricular ejection fraction less than 30%, porcelain aorta, renal dysfunction, chronic obstructive pulmonary disease, arteriopathy, and previous cardiovascular surgery or percutaneous coronary intervention (P ≤ .01). Women showed a smaller aortic annulus than men in both populations (P < .001). Female sex was an independent predictor in the AVR population for risk-adjusted 30-day mortality (odds ratio [OR], 2.34; P = .043) and transfusions (OR, 1.47; P = .003), but not for risk-adjusted acute myocardial infarction, stroke, vascular complications, permanent atrioventricular block (P = NS). Female sex was an independent predictor in the TAVI population for risk-adjusted major vascular complications (OR, 2.92; P = .018) and transfusions (OR, 1.93; P = .003), but proved protective against moderate to severe postprocedural aortic insufficiency (P = .018)., Conclusions: Female sex is a risk factor for mortality after aortic valve replacement, for major vascular complications after TAVI, and for transfusions after both approaches., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Background: OBSERVANT represents the first national observational study on the comparative effectiveness of transcatheter aortic valve implantation (TAVI) vs surgical aortic valve replacement (SAVR) at short, medium and long term, in a patient population with severe aortic stenosis (AS). The aim of this paper is to describe patient characteristics and short-term outcomes of the enrolled population., Methods: OBSERVANT is an observational prospective multicenter cohort study that enrolled AS patients undergoing SAVR or TAVI from December 2010 to June 2012 in the participating hospitals. Information on demographic characteristics, health status prior to intervention, therapeutic approach, intraprocedural and 30-day outcomes was collected. An administrative follow-up was set up to collect data on long-term outcomes., Results: The enrolled population included 7618 patients undergoing transfemoral/transubclavian TAVI (TF/TS-TAVI, n=1652), transapical TAVI (TA-TAVI, n=259) or SAVR (n=5707). SAVR patients were younger and with a lower risk profile than TAVI patients (logistic EuroSCORE: SAVR 6.4 ± 7.3%, TF/TS-TAVI 14.1 ± 12.1%, TA-TAVI 15.5 ± 11.0%; p<0.001). When 30-day mortality rates were stratified by logistic EuroSCORE, a statistically significant difference was found only in the patient subgroup with logistic EuroSCORE ≤5% (SAVR 1.0%, TF/TS-TAVI 4.7%, TA-TAVI 0.0%; p=0.005)., Conclusions: Findings from the OBSERVANT study confirm that patients undergoing TAVI are older and sicker than patients undergoing SAVR. Nevertheless, the logistic EuroSCORE shows that, in Italy, also patients at intermediate surgical risk are treated with TAVI. Stratifying by logistic EuroSCORE, SAVR seems to be superior to TAVI in the subgroup of patients at very low risk. More sophisticated analyses on patient subgroups with comparable risk profile and on long-term follow-up will allow to obtain valuable information on the effectiveness of TAVI and SAVR procedures.

Objective: Despite demonstration of the superior outcomes of transcatheter aortic valve implantation (TAVI) versus optimal medical therapy for severe left ventricular systolic dysfunction, studies comparing TAVI and surgical aortic valve replacement (AVR) in this high-risk group have been lacking., Methods: We performed propensity matching for age, gender, baseline comorbidities, previous interventions, priority at hospital admission, frailty score, New York Heart Association class, EuroSCORE, and associated cardiac diseases. Next, the 30-day mortality and procedure-related morbidity of 162 patients (81 TAVI vs 81 AVR) with severe left ventricular systolic dysfunction (ejection fraction ≤ 35%) were analyzed at the Italian National Institute of Health., Results: The 30-day mortality was comparable (P = .37) between the 2 groups. The incidence of periprocedural acute myocardial infarction (P = .55), low output state (P = .27), stroke (P = .36), and renal dysfunction (peak creatinine level, P = .57) was also similar between the 2 groups. TAVI resulted in significantly greater postprocedural permanent pacemaker implantation (P = .01) and AVR in more periprocedural transfusions (P < .01) despite a similar transfusion rate per patient (2.8 ± 3.7 for TAVI vs 4.4 ± 3.8 for AVR; P = .08). The postprocedural intensive care unit stay (median, 2 days after TAVI vs 3 days after AVR; P = .34), intermediate care unit stay (median, 0 days after both TAVI and AVR; P = .94), and hospitalization (median, 11 days after TAVI vs 14 days after AVR; P = .51) were comparable., Conclusions: In patients with severe left ventricular systolic dysfunction, both TAVI and AVR are valid treatment options, with comparable hospital mortality and periprocedural morbidity. Comparisons of the mid- to long-term outcomes are mandatory., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: To overcome the well-known prostate-specific antigen limits, several new biomarkers have been proposed. Since its introduction in clinical practice, the urinary prostate cancer gene 3 (PCA3) assay has shown promising results for prostate cancer (PC) detection. Furthermore, multiparametric magnetic resonance imaging (mMRI) has the ability to better describe several aspects of PC., Methods: A prospective study of 171 patients with negative prostate biopsy findings and a persistent high prostate-specific antigen level was conducted to assess the role of mMRI and PCA3 in identifying PC. All patients underwent the PCA3 test and mMRI before a second transrectal ultrasound-guided prostate biopsy. The accuracy and reliability of PCA3 (3 different cutoff points) and mMRI were evaluated. Four multivariate logistic regression models were analyzed, in terms of discrimination and the cost benefit, to assess the clinical role of PCA3 and mMRI in predicting the biopsy outcome. A decision curve analysis was also plotted., Results: Repeated transrectal ultrasound-guided biopsy identified 68 new cases (41.7%) of PC. The sensitivity and specificity of the PCA3 test and mMRI was 68% and 49% and 74% and 90%, respectively. Evaluating the regression models, the best discrimination (area under the curve 0.808) was obtained using the full model (base clinical model plus mMRI and PCA3). The decision curve analysis, to evaluate the cost/benefit ratio, showed good performance in predicting PC with the model that included mMRI and PCA3., Conclusion: mMRI increased the accuracy and sensitivity of the PCA3 test, and the use of the full model significantly improved the cost/benefit ratio, avoiding unnecessary biopsies., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Excellent late survival is expected after coronary artery bypass (CABG) in patients aged ≥80 years, but immediate postoperative mortality can be rather high. This study was planned to identify variables associated with very high operative risk in these fragile patients. This is a multicenter study including 2,246 patients aged ≥80 years who underwent isolated CABG at 68 Italian hospitals. The proportion of patients aged ≥80 years varied from 1.7 to 13.6 % (overall 5.6 %, p < 0.0001) in different institutions. The median logistic EuroSCORE varied from 6.2 to 31.7 % (overall median 11.3 %, p = <0.0001) in different institutions. Thirty-day mortality in patients aged ≥80 years correlated with that of patients aged <80 years (rho: 0.310, p = 0.027). The overall 30-day mortality rate was 6.5 %. Both logistic regression and CART showed that emergency procedure, low left ventricular ejection fraction, unstable hemodynamics, and use of nitrates infusion at arrival in the operating room were independent predictors of 30-day mortality. CART analysis showed that 30-day mortality among patients undergoing emergency CABG with unstable hemodynamic conditions was 32.60 % and it was 20.0 % in patients undergoing non-emergency operation with nitrates infusion at arrival in the operating room and left ventricular ejection fraction <30 %. The proportion and operative risk of patients aged ≥80 years and undergoing CABG significantly varied among institutions. Patients requiring emergency surgery, with unstable hemodynamic conditions, requiring nitrates infusion, and low ejection fraction have a prohibitive operative risk. This small proportion of patients may benefit from percutaneous coronary intervention in order to stabilize their preoperative conditions.

Background: Despite the well-known impact of female sex on outcome after surgical aortic valve replacement (sAVR), few studies investigated its role after transcatheter aortic valve replacement (TAVR)., Methods: After propensity-matching for age, baseline comorbidities, previous interventions, priority, frailty score, New York Heart Association class, left ventricular function and associated cardiac diseases, hospital mortality, and procedure-related morbidities of 388 women (194 TAVR versus 194 sAVR)-of 5,231 patients enrolled in 70 centers participating in this prospective multicenter national registry-were analyzed at a central management unit of the Italian National Institute of Health., Results: Although hospital mortality was comparable (4.1% TAVR versus 3.1% sAVR; p = 0.177), women undergoing sAVR showed a higher rate of transfusion (63.9% versus 37.1% TAVR; p = 0.0001); higher number of transfusions per patient (3.6 ± 0.4 versus 2.3 ± 0.3 TAVR; p = 0.049); a higher incidence of low cardiac output state (5.7% versus 3.6% TAVR; p = 0.017) and acute renal failure (8.8% versus 4.1% TAVR; p = 0.01); and higher mean transprosthetic gradients (15.7 ± 12.6 mm Hg versus 11.9 ± 10.7 mm Hg TAVR; p = 0.004). In contrast, women undergoing TAVR experienced significant postprocedural aortic regurgitation (mild, 37.6% versus 7.7% sAVR; moderate-to-severe, 7.1% versus 1.5% sAVR; p = 0.0001) and a higher rate of stroke (7.7% versus 2.5% sAVR; p = 0.037), major vascular complications (9.3% versus 0.5% sAVR; p = 0.0001), pacemaker implantation (12.4% versus 6.2% sAVR; p = 0.004), need for emergent percutaneous coronary intervention (1.0% versus 0% sAVR; p = 0.007), and longer intermediate care unit length of stay (2.5 ± 4.4 days versus 1.4 ± 2.6 days sAVR; p = 0.008). Perioperative myocardial infarction and lengths of intensive care unit stay and hospitalization were comparable (not significant)., Conclusions: Women undergoing sAVR and TAVR experienced different periprocedural morbidities. These data strongly suggest the need to strictly individualize the indications., (Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Few studies have yielded information on comparative effectiveness of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) procedures in a real-world setting. The aim of this analysis is to describe procedural and post-procedural outcomes in a TAVI/SAVR intermediate risk propensity-matched population., Methods: OBSERVANT is an observational prospective multicenter cohort study, enrolling AS patients undergoing SAVR or TAVI. Propensity score method was applied to analyze procedural and post-procedural outcomes. Pairs of patients with the same probability score were matched (caliper matching)., Results: The unadjusted enrolled population (N=2108) comprises 1383 SAVR patients, 602 transarterial-TAVI patients and 123 transapical-TAVI patients. Matched population comprised a total of 266 patients (133 patients for each group). A relatively low risk population was selected (mean logistic EuroSCORE 9.4 ± 10.4% vs 8.9 ± 9.5%, SAVR vs TAVI; p=0.650). Thirty-day mortality was 3.8% for both SAVR and TAVI (p=1.000). The incidence of stroke (1.5% SAVR and 0.0% TAVI; p=0.156) and myocardial infarction (0.8% SAVR and 0.8% TAVI; p=1.000) was not statistically different between groups, whereas a higher requirement for blood transfusion was reported across the surgical cohort (49.6% vs 36.1%; p=0.026). A higher incidence of major vascular damage (5.3% vs. 0.0%; p=0.007) and pacemaker implantation(0.8% vs 12.0%; p=0.001) were reported in the TAVI group., Conclusions: Patients undergoing transcatheter and surgical treatment of severe aortic stenosis are still extremely distinct populations. In the relatively low-risk propensity-matched population analyzed, despite similar procedural and 30-day mortality, SAVR was associated with a higher risk for blood transfusion, whereas TAVI showed a significantly increased rate of vascular damage, permanent AV block and residual aortic valve regurgitation., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Background: Young patients requiring myocardial revascularization are considered at low operative risk, but data on their outcome are scarce. This study was undertaken to evaluate the prevalence and 30-day mortality of patients aged <50 years after isolated coronary artery bypass surgery (CABG)., Materials and Methods: This is a multicenter study including 2207 patients aged <50 years undergoing isolated CABG at 68 Italian hospitals., Results: The proportion of patients aged <50 years in this series was 5.3% and varied significantly from 0% to 9.9% in different institutions (p < 0.0001). The 30-day mortality rate was 0.9%. One-to-one propensity score matching of patients aged <50 years versus older patients resulted in 2013 pairs whose 30-day mortality was 0.9% and 2.2%, respectively (p = 0.001). Logistic regression showed that left ventricular ejection fraction <30% (OR 5.5, 95% CI 1.6-18.6), peripheral vascular disease (OR 3.6, 95% CI 1.1-12.0), pulmonary hypertension (OR 18.1, 95% CI 1.8-187.0), critical preoperative state (OR 4.7, 95% CI 1.5-14.3), and emergency operation (OR 3.8, 95% CI 1.1-12.9) were independent predictors of 30-day mortality. Meta-analysis of five studies reporting on patients aged <50 years who underwent isolated CABG showed that operative mortality in these patients was 0.9% (95% CI, 0.8-1.1%, I(2) 0%, 135/14,316 patients)., Conclusions: The proportion of patients aged <50 years undergoing CABG is low and varies significantly among institutions. The results of this study and a meta-analysis of the literature data showed that CABG can be carried out in young patients with an extremely low risk of operative mortality., (© 2013 Wiley Periodicals, Inc.)

Objective: Risk stratification models perform poorly regarding elderly patients. This study aims to evaluate the performance of the Italian Coronary Artery Bypass Graft Outcome Project (ItCABG) model and the logistic European System for Cardiac Operative Risk Evaluation (LogEuroSCORE) model by age group to build a model specifically for elderly patients., Methods and Results: Data from the ItCABG and Mattone Outcome-BYPASS study (MO-BYPASS) have been used. ItCABG and LogEuroSCORE models were applied to the ItCABG population (n = 34,310) stratified by four age classes: < 60, 60-69, 70-79, > or = 80 years. Each model's ability to predict 30-day mortality was assessed for accuracy (Brier score and pseudo-R2), calibration (Hosmer-Lemeshow test, X(H-L)) and discrimination (area under the receiver operating characteristic curve, AUC) in age classes. To estimate the elderly risk function a logistic regression was performed on 2,255 octogenarian patients from ItCABG and MO-BYPASS. Elderly model's performance was tested. Model accuracy is fair in all age classes although the explained variance is poor. ItCABG and LogEuroSCORE models revealed good discrimination power in patients aged < (60, 60-69, and 70-79 years, but not in patients aged > or = 80 years (AUCs: 0.82, 0.77, 0.76, 0.64, and 0.78, 0.75, 0.74, 0.65, respectively). Calibration of both models is poor in patients 80 years (ItCABG: X(H-L) = 18.1, P = 0.05; LogEuroSCORE: X(H-L) = 129.7, P < 0.001). When a new model specific to octogenarian patients was built, discrimination power remained poor (AUC = 0.66), although calibration power improved (X(H-L) = 3.93, P = 0.86)., Conclusions: ItCABG and LogEuroSCORE models were poor predictors of mortality in octogenarian patients. Elderly-specific risk factors must be assessed to improve risk stratification in patients aged 80 years and older.

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.

Objective: Coronary revascularization methods are among the most common major medical procedures performed in industrialized countries. The short- and long-term comparative effectiveness of different techniques remains undetermined., Methods and Results: The study population included all adult patients (94,864 subjects) admitted for acute myocardial infarction (AMI) in 2004 in Italy, as recorded in the National Hospital Discharge Records. Invasive reperfusion therapy (coronary artery bypass graft, percutaneous coronary intervention), and standard medical treatments were compared. End points were short-term (30-day) in-hospital mortality and any combination of new revascularizations, re-AMI, stroke, or death (MACCE) occurring within 6 and 12 months from initial treatment. Risk factors and comorbidities were used to define patients' health status. The Cox model was applied to evaluate risk-adjusted hazard ratios (HR) for different approaches. Medical treatment was used as the reference category. Propensity score matching was performed to evaluate selection bias in the allocation to CABG or percutaneous coronary intervention (PCI). Both short-term mortality and 6- and 12-month MACCE risk for invasive reperfusion therapy was significantly lower than the reference (HR: 0.50, P < 0.001; 0.54, P < 0.001; 0.64, P < 0.001, respectively). In the matched population, while short-term mortality was significantly lower for PCI (HR 0.36, P < 0.001), long-term MACCE risk was lower for CABG (6-month HR 2.93, P < 0.001; 12-month HR 3.01, P < 0.001)., Conclusions: In spite of adjustments for patients' health status, medical treatment resulted in a higher mortality and increased MACCE risk. While PCI gave the best short-term results, after 1 year the risk of re-interventions or further events was significantly lower for patients undergoing CABG.

Rationale: Severe symptomatic aortic stenosis (SSAS) is the most common acquired valvular heart disease in the western world, and its prevalence is strongly linked to the phenomenon of population ageing. After symptom onset, patients with SSAS, if untreated, show very poor prognoses, unavoidably reaching complete disability status with a significant reduction in survival. Although aortic valve replacement (AVR) is the definitive therapy for this kind of patients, a new, less-invasive alternative like transcatheter aortic valve implantation (TAVI) has been considered, at least for a large proportion of patients with very high or prohibitive operative risks. OBSERVANT represents the first observational multicenter perspective study on the comparative effectiveness of TAVI, AVR, and medical therapy in the Italian population with SSAS., Materials and Methods: In the participating hospitals, to define the patient risk profile for each patient with SSAS, data on demographic characteristics, health status prior to intervention and presence of comorbidities will be collected. Moreover, complete information on the type of intervention will be gathered. Mortality within 30 days from intervention is the primary adverse outcome. Secondary outcomes include mortality within 12 and 24 months and the incidence of in-hospital major adverse cardiac and cerebrovascular events. Clinical monitoring procedures will allow assessment of the reliability and completeness of the database and help maintain constant quality control. To compare the effectiveness of AVR, TAVI, and medical treatment in terms of medium- and long-term outcomes, accounting for possible differences in patient case-mix among the three treatment groups, risk adjustment techniques will be applied., Expected Results: Short-, medium-, and long-term outcome in patients undergoing one of the three SSAS treatments; use, appropriateness, and economic and organizational impact of TAVI and AVR procedures; specific "indication criteria" to guarantee appropriate patient selection for AVR or TAVI; new pre-procedure risk score, specific for the elderly Italian population; guidelines on TAVI procedure coding and a system of administrative follow-up to be proposed to the regional health systems for managing the use of the AVR or TAVI procedures., Conclusions: The complete knowledge base derived from this study will be directly transferable to professionals and policy makers, giving them evidence-based results for use in their decision-making process.

The aim of this study is to evaluate the effect of gender and age on outcome following coronary surgery in several hospitals enrolled in a national quality assessment program. Patients undergoing isolated coronary artery bypass graft (CABG) during 2003-2005 in Italy were included in the study (n=74,577). The outcome measure was 30-day in-hospital mortality. Comorbidities recorded during previous and current hospitalizations were used to define patients' health status and to build the adjustment model. The interaction term (gender*hospital) was introduced into the model to test the effect modification of gender; if present, gender specific models were analyzed to test the effect modification of age. A significant effect modification by gender was found in 39 hospitals; the adjusted odds ratios (AdjORs) showed significant increased risk for females (AdjORs ranging from 3.7 to 21.6). In three of these hospitals a significant increased risk was found for older age (AdjORs for elderly patients ranging from 8.1 to 14.6). Two hospitals showed a significant excess risk for patients ≥75 years (AdjORs=6.6 and 13.8). The technical aspects of surgery could account for the excess risk found in female patients; differences in the entire care process (intraoperative and postoperative management) could explain the variations in outcome among elderly patients.

Background: Possible effect modifiers are often considered as confounders when applying pre-defined risk-adjustment models. The aim was to provide evidence of effect modification by gender in comparative evaluations of hospitals on 30-day in-hospital mortality after acute myocardial infarction (AMI)., Methods: Ninety-two Italian hospitals discharging more than 300 patients with a diagnosis of AMI during 2004 were considered. Patients discharged or transferred within 48 h of hospital admission were excluded. Comorbidities recorded in previous and current admissions were used to define patients' health status and to build the adjustment model, in which an interaction term (gender by hospital) was introduced to test the presence of effect modification. The end point was the 30-day in-hospital mortality after AMI., Results: The study population consists of 38,544 incident events of AMI from 92 Italian hospitals. Eleven hospitals showed a significant effect modification by gender. In one of them, the overall mortality rate was comparable with that of the reference category, but a significant excess risk for women was found [odds ratios (ORs) = 2.3; P < 0.01]. In 10 hospitals, the overall adjusted ORs presented a significant excess mortality compared with the benchmark: three had a significant excess mortality only among females (ranging from 230 to 370%), four only among males (ranging from 110 to 200%), and three among both genders., Conclusions: An effect modification by gender was found. The results suggest that in comparative hospital performances evaluation, stratification by gender is desirable to investigate possible differences in attitudes and practices of health services in the treatment of men and women.

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.

Objectives: To compare the risk-adjustment model empirically derived from the 'Italian CABG Outcome Project' with that of the additive and logistic EuroSCORE in terms of accuracy, predictive power and ability to rank hospital performances., Methods: The Italian CABG model, the logistic and additive EuroSCORE were applied to the Italian CABG population; the observed deaths/expected deaths (O/E) ratios, as obtained by the three models, were computed for each Italian cardiac surgery centre and for six classes of risk-stratified patients. The performance of the three models in predicting the 30-day mortality was formally assessed for calibration (Hosmer-Lemeshow test) and discrimination (ROC area). According to the three models, risk-adjusted mortality rates (RAMR = O/E x Italian CABG population mortality rate) were estimated for each centre; possible differences were detected in the identification of hospitals with mortality rates higher and lower than average., Results: The Italian CABG model uses fewer variables than the EuroSCORE system (14 vs 17) and exhibits the best performance in terms of discrimination and calibration. Contrary to the other tested models, the logistic EuroSCORE shows a significant Hosmer-Lemeshow test (chi(H-L)(2)=19.30, p<0.0001), indicating unsatisfactory calibration, and a clear predicted death overestimation in each of the considered risk classes (O/E = 0.4). When a proper recalibration procedure is applied, the logistic EuroSCORE performance parameters achieve acceptable levels. The Italian CABG model identified seven centres as having higher than average mortality, while the EuroSCORE identified the same seven centres plus one other. The Italian CABG model identified eight centres with lower than average mortality, five of which were identified by the additive EuroSCORE and four of which were identified by the logistic EuroSCORE. The additive EuroSCORE identified four more and the logistic EuroSCORE three more low mortality centres., Conclusions: Although this analysis reveals a satisfactory concordance between results from the three models, a detailed comparison shows that the Italian CABG model uses fewer variables and performs better than the others. Nevertheless, when properly recalibrated, the EuroSCORE model can be exported to the Italian population and used to rank hospital performance and evaluate preoperative risk of patients undergoing open-heart surgery.

Background: Hierarchical modelling represents a statistical method used to analyze nested data, as those concerning patients afferent to different hospitals. Aim of this paper is to build a hierarchical regression model using data from the "Italian CABG outcome study" in order to evaluate the amount of differences in adjusted mortality rates attributable to differences between centres., Methods: The study population consists of all adult patients undergoing an isolated CABG between 2002-2004 in the 64 participating cardiac surgery centres.A risk adjustment model was developed using a classical single-level regression. In the multilevel approach, the variable "clinical-centre" was employed as a group-level identifier. The intraclass correlation coefficient was used to estimate the proportion of variability in mortality between groups. Group-level residuals were adopted to evaluate the effect of clinical centre on mortality and to compare hospitals performance. Spearman correlation coefficient of ranks (rho) was used to compare results from classical and hierarchical model., Results: The study population was made of 34,310 subjects (mortality rate = 2.61%; range 0.33-7.63). The multilevel model estimated that 10.1% of total variability in mortality was explained by differences between centres. The analysis of group-level residuals highlighted 3 centres (VS 8 in the classical methodology) with estimated mortality rates lower than the mean and 11 centres (VS 7) with rates significantly higher. Results from the two methodologies were comparable (rho = 0.99)., Conclusion: Despite known individual risk-factors were accounted for in the single-level model, the high variability explained by the variable "clinical-centre" states its importance in predicting 30-day mortality after CABG.

The aim of the study was to determine the value of brain natriuretic peptide for the identification of diastolic dysfunction status in congestive heart failure. We studied 204 patients with stable heart failure. Brain natriuretic peptide plasma levels were correlated with echocardiographic parameters of diastolic dysfunction. Diastolic dysfunction was classified as mild (abnormal echocardiographic relaxation pattern) and severe (pseudo-normal or restrictive pattern). A significant correlation between brain natriuretic peptide levels and the other parameters was detected. Brain natriuretic peptide dosage, then, seems to be a reliable tool for the assessment of diastolic dysfunction status in patients with congestive heart failure.

Background: Whether brain natriuretic peptide (BNP), a neurohormone marker of ventricular dysfunction, correlates with an enhanced ventilatory response (EVR) during cardiopulmonary exercise test, a well-known predictor of prognosis, in systolic heart failure (HF) is currently unknown., Material/methods: Resting BNP was measured in 134 consecutive stable outpatients aged 69 +/- 11 years with mild to moderate HF and LV ejection fraction (LVEF) < 40% who performed a maximal exercise test. EVR was assessed as the slope of the relation between minute ventilation and carbon dioxide production (VE/VCO2 slope) > or = 35., Results: LVEF averaged 33 +/- 7%, BNP 350 +/- 396 pg/ml, and the VE/VCO2 slope 36 +/- 8. Fifty-six of 123 patients (45%) had EVR. BNP correlated with VE/VCO2 slope (r = 0.453; p < 0.01). By multivariate logistic regression, plasma BNP was the only independent predictor of EVR (RR: 1.004 per unit increment, 95% CI: 1.002-1.006, p < 0.0001). A BNP > or = 160 pg/ml had 86% sensitivity, 67% specificity, and 76% overall accuracy for the prediction of EVR (chi square: 37.4, RR 12.2, 95% CI: 4.96-30.3, p < 0.0001, AUC 0.815 (95%CI. 0.738-0.892))., Conclusions: In systolic HF, plasma BNP is related to an enhanced ventilatory response to exercise and offers a simple and reliable alternative to the cardiopulmonary exercise test in patients with inability or contraindications to exercise.

Objective: During the last decade, a worldwide growing interest in evaluating performance of health services through 'outcome studies' took place. This study started in early 2002 and represents the first National Health System (NHS) experience to evaluate adjusted performance indicators at national level. The aim of this study was to compare 30 days mortality after coronary artery bypass graft (CABG) between cardiac surgery centres, adjusting by confounding risk factors., Methods: All patients, aged 15-99 years, undergoing a CABG intervention after 1st January 2002 in 82 participating centres were eligible for this observational longitudinal study. For each patient, data on severity and risk factors were collected (type of procedure, haemodynamic condition, co-morbidities, recent myocardial infarction and unstable angina, ventricular function, emergency condition, vital status at 30 days). Using a multiple logistic regression analysis the best predictive model was developed for risk-adjustment; a cross-validation procedure was applied; specific risk adjusted mortality rates (RAMR) were estimated. The overall study population was used as reference standard., Results: 34,310 isolated CABG were performed in 64 of the 82 participating centres. Thirty days mortality resulted 2.61%, ranging from 0.33 to 7.63%; eight centres presented a RAMR significantly lower and seven significantly higher than the reference., Conclusions: The study provides valid measures of the heterogeneity between outcomes of the Italian cardiac surgery centres, to support decision-making by NHS management and individual patients. Although not statistically significant, RAMR dropped from year 2002 to 2004 (2.8-2.4%) suggesting that this comparative outcome assessment can contribute to the improvement of performances in cardiac surgery.

Aim: Aim of the study was to evaluate if brain natriuretic peptide (BNP) levels, a cardiac neurohormone well correlated with prognosis in chronic heart failure (CHF), are associated with enhanced ventilatory response to exercise, in ambulatory patients with intermediate peak oxygen uptake (PVO2)., Methods: Resting BNP was measured in 129 consecutive stable CHF patients with mild to moderate heart failure (90% New York Heart Association (NYHA) class II or III) and intermediate (10-18 mL/kg/min) PVO2, assessed during cardiopulmonary exercise test. Mean (SD) left ventricular ejection fraction (EF) and pulmonary systolic pressure (PAP) were 41 +/- 3% and 47 +/- 14 mmHg, respectively. The enhanced ventilatory response to exercise (EVR) was assessed as a slope of the relation between minute ventilation and carbon dioxide production (VE/VCO2 slope) > 35., Results: Thirty-three over 129 patients (26%) had EVR. Mean BNP plasma level was 394 +/- 347 pg/mL. A significant correlation between BNP and EVR (r = 0.310; p < 0.01), was observed. In the logistic multivariate model, a BNP plasma level > 100 pg/mL had an independent predictive value for EVR (95% IC 1.68 to 10.5, Odds Ratio 4.23, p = 0.02). We found a significant correlation between BNP and PAP (r = 0.390; p < 0.001), and between PAP and EVR (r = 0.511; p < 0.01)., Conclusions: In CHF patients with intermediate PVO2, plasma BNP is clearly related to the enhanced ventilatory response to exercise. In this subset, BNP levels could represent an effective alternative tool for the clinical assessment in patients with unreliable cardiopulmonary exercise test.

Background: The assessment of the burden of disease (BOD) is necessary for sensibly allocating limited health-related resources. No such assessment is available currently for Italy., Methods: Global burden of disease (GBD) methods were used to analyse in detail the years of life lost (YLLs) component of BOD for the most important diseases contributing to premature mortality in Italy in 1998. YLLs were computed with and without age-weighting and discounting. YLLs were also analysed by gender, for Italy vs. the Euro-A region (a group of 26 European countries) defined in the 2000 update of the GBD Study, and for northern, central and southern Italy, the three traditionally demarcated regions of the country., Results: The use of YLLs yields a ranking of diseases by their relative contribution to mortality burden which differs from a ranking based purely on death counts. Although males contributed 58.5% and females 41.5% of the total mortality burden in terms of YLLs, using death counts the percentages for males and females were similar (50.6% M, 49.4% F). The leading cause of mortality burden, both in terms of YLLs and death counts, was ischaemic heart disease, followed by stroke and lung cancer. Several other conditions, however, had rankings that varied depending on the measure used. While cardiovascular diseases accounted for 31.7% and 'all cancers' for 34.1% of YLLs, they were responsible, respectively, for 44.7 and 27.9% of death counts. The results for Italy generally corresponded with those obtained in GBD 2000 for EURO-A, but the proportion of the total mortality burden explained by the four leading causes is higher in Italy. For within Italy comparisons, there was a decreasing trend from north to south for 'all cancers' and for several specific cancers. Conversely, a consistent increase in YLL rates from north to south was observed for stroke and hypertensive disease., Conclusions: This analysis of Italy's mortality burden represents the first phase in identifying Italy's total BOD. Simply establishing death counts and rates is no longer sufficient for a full understanding of a country's health status.