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Introduction: Data on the early and late outcome following transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in obese patients are limited. We investigated whether TAVI may be superior to SAVR in obese patients., Material and Methods: Obese patients (body mass index ≥ 30 kg/m 2 ) who underwent either SAVR or TAVI were identified from the nationwide OBSERVANT registry, and their in-hospital and long-term outcomes were analysed. Propensity score matching was employed to identify two cohorts with similar baseline characteristics., Results: The propensity score matching provided 142 pairs balanced in terms of baseline risk factors. In-hospital and 30-day mortality did not differ between SAVR and TAVI obese patients (4.6% vs. 3.3%, p = 0.56, and 5.2% vs. 3.2%, p = 0.41, respectively). Obese SAVR patients experienced a higher rate of renal failure (12.4% vs. 3.6%, p = 0.0105) and blood transfusion requirement (60.3% vs. 25.7%, p < 0.0001) in comparison with TAVI patients. A higher rate of permanent pacemaker implantation (14.4% vs. 3.6%, p = 0.0018), and major vascular injuries (7.4% vs. 0%, p = 0.0044) occurred in the TAVI group. Five-year survival was higher in the SAVR group compared to the TAVI patient cohort ( p = 0.0046), with survival estimates at 1, 3 and 5 years of 88.0%, 80.3%, 71.8% for patients undergoing SAVR, and 85.2%, 69.0%, 52.8% for those subjected to TAVI procedures., Conclusions: In obese patients, both SAVR and TAVI are valid treatment options, although in the long term SAVR exhibited higher survival rates., Competing Interests: The authors declare no conflict of interest., (Copyright © 2019 Termedia & Banach.)

The impact of thrombocytopenia on postoperative bleeding and other major adverse events after cardiac surgery is unclear. This issue was investigated in a series of patients who underwent isolated coronary artery bypass grafting (CABG) from the prospective, multicenter E-CABG registry. Preoperative thrombocytopenia was defined as preoperative platelet count <150 × 10 9 /L and it was considered moderate-severe when preoperative platelet count was <100 × 10 9 /L. Multilevel mixed-effects regression analysis was performed to adjust the effect of thrombocytopenia on outcomes for baseline and operative covariates as well as for interinstitutional differences in patient-blood management. Among 7189 patients included in this analysis, 599 (8.3%) had preoperative thrombocytopenia. Patient with preoperative thrombocytopenia had an increased chest drainage output at 12 h (mean, 519 vs. 456 mL, adjusted coeff. 39, 95%CI 18-60) and rates of severe-massive bleeding (Universal Definition of Perioperative Bleeding (UDPB) severity grades 3-4: 12.7% vs. 8.1%, adjusted OR 1.47, 95%CI 1.11-1.93; E-CABG bleeding severity grades 2-3: 10.4% vs. 6.1%, adjusted OR 1.78, 95%CI 1.30-2.43). Thrombocytopenia was associated with an increased risk of hospital/30-day death (3.2% vs. 1.9%, adjusted OR 2.02, 95%CI 1.20-3.42), 1-year death (5.7% vs. 3.4%, adjusted HR 1.68, 95%CI 1.16-2.44), deep sternal wound infection (3.5% vs. 2.4%, adjusted OR 1.65, 95%CI 1.02-2.66), acute kidney injury (28.1% vs. 22.2%, OR 1.45, 1.18-1.78), and prolonged stay in the intensive care unit (mean, 3.6 vs 2.8 days, adjusted coeff. 0.74, 95%CI 0.40-1.09). Similar results were observed in a subset of patients with moderate-severe thrombocytopenia (51 patients, 0.7%). In particular, these patients had a markedly higher rate of acute kidney injury (40%, adjusted OR, 1.94, 95%CI 1.05-3.57), resternotomy for bleeding (7.8%, adjusted OR 3.49, 95%CI 1.20-10.21), and severe-massive bleeding (UDPB severity grades 3-4: 23.5%, adjusted OR 3.08, 95%CI 1.52-6.22; E-CABG bleeding severity grades 2-3: 23.5%, adjusted OR 4.43, 95%CI 2.15-9.15) compared to patients with normal preoperative platelet count. Mild preoperative thrombocytopenia is associated with increased risk of severe-massive bleeding, mortality, and other major adverse events after CABG. Such risks are markedly increased in patients with moderate-severe preoperative thrombocytopenia.

Background: To assess clinical outcomes of patients with concomitant severe aortic stenosis (AS) and coronary artery disease (CAD) who underwent transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) or surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG)., Methods: Data were extracted from the multicenter OBSERVANT study. For the purposes of the present analysis, we included only patients with established stable CAD meeting any of the following inclusion criteria: 1) TAVI patients with CAD undergoing staged PCI or TAVI and PCI in the same session; 2) SAVR patients undergoing combined SAVR and CABG in the same session., Results: After propensity-score matching, a total of 472 patients (236 per group) were identified. Among TAVI patients, PCI was performed prior to the procedure in 217 patients (92.0%), whereas concomitant TAVI and PCI were performed in 19 patients (8.0%). At 3-year, there was no difference in survival between the two groups (KM estimate of freedom from death for SAVR and TAVI patients of 0.742 and 0.650, respectively; log-rank p-value of 0.105). The rate of MACCE was comparable between the two groups (KM estimate of freedom from MACCE for SAVR and TAVI patients of 0.683 and 0.582, respectively; log-rank p-value of 0.115)., Conclusions: In patients with associated severe AS and CAD, percutaneous treatment (TAVR and staged or concomitant PCI) was comparable to surgical treatment (SAVR and concomitant CABG) with respect to the early and mid-term risk of death from any cause, myocardial infarction, stroke and unplanned revascularization., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Aims: No data exists on inter-institutional differences in terms of adherence to international guidelines regarding the discontinuation of antithrombotics and rates of severe bleeding in coronary artery bypass grafting (CABG)., Methods and Results: This is an analysis of 7118 patients from the prospective multicentre European CABG (E-CABG) registry who underwent isolated CABG in 15 European centres. Preoperative pause of P2Y12 receptor antagonists shorter than that suggested by the 2017 ESC guidelines (overall 11.6%) ranged from 0.7% to 24.8% between centres (adjusted P < 0.0001) and increased the rate of severe-massive bleeding [E-CABG bleeding grades 2-3, OR 1.66, 95% confidence interval (CI) 1.27-2.17; Universal Definition of Perioperative Bleeding (UDPB) bleeding grades 3-4, OR 1.50, 95% CI 1.16-1.93]. The incidence of resternotomy for bleeding (overall 2.6%) ranged from 0% to 6.9% (adjusted P < 0.0001), and surgical site bleeding (overall 59.6%) ranged from 0% to 84.6% (adjusted P = 0.003). The rate of the UDPB bleeding grades 3-4 (overall 8.4%) ranged from 3.7% to 22.3% (P < 0.0001), and of the E-CABG bleeding grades 2-3 (overall 6.5%) ranged from 0.4% to 16.4% between centres (P < 0.0001). Resternotomy for bleeding (adjusted OR 5.04, 95% CI 2.85-8.92), UDPB bleeding grades 3-4 (adjusted OR 6.61, 95% CI 4.42-9.88), and E-CABG bleeding grades 2-3 (adjusted OR 8.71, 95% CI 5.76-13.15) were associated with an increased risk of hospital/30-day mortality., Conclusions: Adherence to the current guidelines on the early discontinuation of P2Y12 receptor antagonists is of utmost importance to reduce excessive bleeding and early mortality after CABG. Inter-institutional variation should be considered for a correct interpretation of the results in multicentre studies evaluating perioperative bleeding and use of blood products.

Objectives: We compared the outcome of anaemic patients undergoing transcatheter (TAVI) and surgical aortic valve replacement (SAVR) for severe aortic valve stenosis., Methods: Anaemic patients (haemoglobin <13.0 g/dL in men and <12.0 g/dL in women) undergoing TAVI and SAVR from the OBSERVANT study were the subjects of this analysis., Results: Preoperative anaemia was an independent predictor of 3-year mortality after either TAVI (HR 1.37, 95% CI 1.12-1.68) and SAVR (HR 1.63, 95% CI 1.37-1.99). Propensity score matching resulted in 302 pairs with similar characteristics. Patients undergoing SAVR had similar 30-d mortality (3.6% versus 3.3%, p = .81) and stroke (1.3% versus 2.0%, p = .53) compared with TAVI. The rates of pacemaker implantation (18.6% versus 3.0%, p < .001), major vascular damage (5.7% versus 0.4%, p < .001) and mild-to-severe paravalvular regurgitation (47.4% versus 9.3%, p < .001) were higher after TAVI, whereas acute kidney injury (50.7% versus 27.9%, p < .001) and blood transfusion (70.0% versus 38.6%, p < .001) were more frequent after SAVR. At 3-year, survival was 74.0% after SAVR and 66.3% after TAVI, respectively (p = .065), and freedom from MACCE was 67.6% after SAVR and 58.7% after TAVI, respectively (p = .049)., Conclusions: These results suggest that TAVI is not superior to SAVR in patients with anaemia.

Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) is the first area of interventional cardiology where women are treated as often as men. In this analysis of the gender specific results of randomised controlled trials (RCTs) comparing TAVI with surgical aortic valve replacement (SAVR) we aimed to determine whether gender affects the survival comparison between TAVI and SAVR. We identified all RCTs comparing TAVI versus SAVR for severe AS and reporting 1 and/or 2year survival. Summary odds ratios (ORs) were obtained using a random-effects model. Heterogeneity was assessed using the Q statistic and I 2 . Four RCTs met the criteria, totalling 3758 patients, 1706 women and 2052 men. Amongst females, TAVI recipients had a significantly lower mortality than SAVR recipients, at 1year (OR 0.68; 95%CI 0.50 to 0.94) and at 2years (OR 0.74; 95%CI 0.58 to 0.95). Amongst males there was no difference in mortality between TAVI and SAVR, at 1year (OR 1.09; 95%CI 0.86 to 1.39) or 2years (OR 1.05; 95%CI 0.85 to 1.3). The difference in treatment effect between genders was significant at both 1year (p interaction =0.02) and 2years (p interaction =0.04). In women TAVI has a 26 to 31% lower mortality odds than SAVR. In men, there is no difference in mortality between TAVI and SAVR., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: The rapid spread of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in the last decade in Italy has led to a gradually increasing use of TAVI procedures also in patients potentially eligible for aortic valve replacement (AVR). For this subset of patients, the OBSERVANT study (2011-2012) evaluated the short- and medium term outcome of TAVI vs AVR, at least for the first generations of TAVI devices, but failed to gather information on all the technological innovations occurred in recent years. The launch of a phase II of the study will allow to recruit a new series of TAVI, with different risk profiles compared with the historical OBSERVANT TAVI cohort, in order to assess whether and how much the use of new-generation devices mitigate the differences in outcomes recorded in the OBSERVANT study., Methods: OBSERVANT II is an observational multicenter, prospective, cohort study collecting data on patients with severe symptomatic aortic stenosis undergoing TAVI in Italian hospitals since December 15, 2016, for at least 12 months. For each patient, data on demographic characteristics, health status, type of intervention and presence of comorbidities will be collected. Mortality and incidence of in-hospital major adverse cardiac and cerebrovascular events (MACCE) within 36 months of intervention will be the primary adverse outcome. Secondary outcomes will include 30-day mortality and the incidence of MACCE at 12 and 24 months. The statistical hypotheses were formulated considering the results from the OBSERVANT study. Testing these hypotheses will require the recruitment of at least 823 new TAVI. The risk/propensity-adjustment techniques will be used to comparatively evaluate the effectiveness of TAVI vs AVR., Expected Results: Safety and efficacy profiles of the new-generation TAVI prosthesis; comparative effectiveness of the new TAVI prosthesis as compared to TAVI procedures of the OBSERVANT historical cohort; comparative effectiveness of the new TAVI prosthesis as compared to AVR procedures of the OBSERVANT historical cohort., Conclusions: The results of OBSERVANT II will provide information on the effectiveness of TAVI employing new-generation devices and will be a valuable support to give professionals and policy makers evidence-based results useful for decision-making processes.

The purpose of this study was to evaluate the outcome of nonagenarians after transcatheter aortic valve replacement (TAVR) from the OBSERVANT study and to pool the results of the literature on this topic. Aortic stenosis is the most common acquired valvular heart disease in the Western countries, and its prevalence is linked to the phenomenon of population aging. TAVR can be considered as a wise approach to treat nonagenarians, but data on its safety and effectiveness are scarce. Data on 80 patients aged >90 years who underwent TAVR from OBSERVANT study were analyzed. A systematic review and meta-analysis of published data were performed. Thirty-day mortality in the OBSERVANT series was 6.3 %. None of these patients experienced stroke. Permanent pacemaker implantation was necessary in 20 % of patients. Paravalvular regurgitation was observed in 57.5 %. Survival at 1, 2, and 3 years was 79.6, 71.9, and 61.5 %. Ten series provided data on 1227 nonagenarians who underwent TAVR. Pooled 30-day mortality rate was 7.1 %, stroke 2.8 %, vascular access complication 8.8 %, and permanent pacemaker implantation 10.6 %. Paravalvular regurgitation was observed in 60.1 % of patients. Pooled 1-, 2-, and 3-year survival rates were 79.2, 68.2, and 55.6 %. Transapical TAVR was associated with a significantly higher risk of early mortality compared with transfemoral TAVR. The results of OBSERVANT study and aggregate data meta-analysis suggest that in nonagenarians, TAVR is associated with low postoperative morbidity and excellent intermediate survival. Transapical TAVR in these very elderly is associated with high postoperative mortality.

Objective: To evaluate outcomes of monitored anesthesia care (MAC) compared with general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR)., Design: Secondary analysis from the observational and prospective OBSERVANT (OBservational Study of Effectiveness of avR-taVi procedures for severe Aortic steNosis Treatment) study., Setting: Multicenter study, including Italian hospitals performing TAVR interventions., Participants: One thousand four hundred ninety-four patients with severe and symptomatic aortic stenosis., Interventions: Transfemoral TAVR under general or local anesthesia., Measurements and Main Results: A propensity score procedure was applied, and 310 pairs were matched with similar baseline characteristics (EuroSCORE II: local anesthesia 6.6±5.9% v general anesthesia 7.0±7.7%, p = 0.430). MAC was associated with similar 30-day mortality compared with GA (3.9% v 4.8%, p = 0.564). TAVR was performed under MAC without any increased risk of other adverse events. The risk of paravalvular regurgitation≥mild was similar between the study groups (MAC 49.5% v general anesthesia 57.0%, p = 0.858). Two patients receiving on MAC had severe paravalvular regurgitation, whereas this complication was not observed after GA. Permanent pacemaker implantation was 19.1% in the MAC group v 14.8% in the GA group (p = 0.168). Mean intensive care unit stay was 3.5 days for the GA group v 2.9 days for the MAC group (p = 0.086). A similar 3-year survival rate was observed (MAC 69.4% v GA 69.9%, p = 0.966)., Conclusions: Transfemoral TAVR can be performed under MAC with similar immediate and late outcomes as compared with GA. A possible risk of severe paravalvular regurgitation and pacemaker implantation with TAVR under MAC requires further investigation., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: There are scarce data on outcomes after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in patients with renal failure., Methods: We evaluated the impact of renal failure on outcomes after TAVI and SAVR and compared the results of these procedures in patients with chronic kidney disease stages 3b to 5 from the Observational Study of Effectiveness of AVR-TAVI Procedures for Severe Aortic Stenosis Treatment (OBSERVANT) study., Results: Chronic kidney disease (CKD) stages 3b to 5 was associated with an increased risk of mortality after either TAVI or SAVR compared with CKD stages 1 to 3a. Among 170 propensity score-matched pairs with CKD stages 3b to 5, patients who underwent TAVI had a significantly higher rate of permanent pacemaker implantation, vascular damage, and mild to moderate paravalvular regurgitation, and tended to have a higher 30-day mortality (7.1% versus 2.9%; p = 0.09). Thirty-day mortality after transapical TAVI was 7.1%. SAVR had a significantly higher rate of blood transfusions, stroke, and acute kidney injury. At 2 years, patients undergoing TAVI had somewhat higher all-cause mortality (31.2% versus 23.4%; p = 0.118), major cardiac and cerebrovascular events (37.2% versus 31.0%; p = 0.270), and a lower risk of dialysis (12.4% versus 21.2%; p = 0.052) compared with SAVR., Conclusions: CKD stages 3b to 5 increases the risk of mortality after TAVI and SAVR. In this subset of patients, SAVR was associated with somewhat better early and late survival. The risk of acute kidney injury was higher after SAVR. These findings suggest that CKD stages 3b to 5 does not contraindicate SAVR. Strategies to prevent severe acute kidney injury should be implemented with either SAVR or TAVI., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The aim of this study was to analyze procedural and postprocedural outcomes of patients aged ≥80 years treated by transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) as enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) Study. TAVI is offered to patients with aortic stenosis judged inoperable or at high surgical risk. Nevertheless, it is common clinical practice to treat elderly (≥80 years) patients by TAVI regardless of surgical risk for traditional SAVR. OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. Information on demographic characteristics, health status before intervention, therapeutic approach, and intraprocedural and 30-day outcomes was collected. An administrative follow-up was set up to collect data on midterm to long-term outcomes. We reviewed baseline and procedural data of patients aged ≥80 years, looking for different early and late outcome after TAVI or SAVR. Patients treated by TAVI were sicker than SAVR because of higher rate of co-morbidities, advanced illness, frailty, and Logistic EuroSCORE. After propensity matching, early and midterm mortality were comparable between the 2 groups. However, patients treated by TAVI had higher rate of vascular complications (6.0% vs 0.5%; p <0.0001), permanent pacemaker implantation (13.4% vs 3.7%; p <0.0001), and paravalvular leak (8.9% vs 2.4%; p <0.0001). Patients who underwent SAVR had more frequent bleedings needing transfusion (63.2% vs 34.5%; p <0.0001) and acute kidney injury (9.6% vs 3.9%; p = 0.0010). In conclusion, patients aged ≥80 years treated by TAVI or SAVR had similar early and midterm mortality., (Copyright © 2016 Elsevier Inc. All rights reserved.)

A few studies recently reported controversial results with transfemoral transcatheter aortic valve replacement (TF-TAVR) versus transapical transcatheter aortic valve replacement (TA-TAVR), often without adequate adjusted analysis for baseline differences. Data on patients who underwent TF-TAVR and TA-TAVR from the Observational Study of Effectiveness of avR-tavI procedures for severe Aortic stenosis Treatment study were analyzed with propensity score 1-to-1 matching. From a cohort of 1,654 patients (1,419 patients underwent TF-TAVR and 235 patients underwent TA-TAVR), propensity score matching resulted in 199 pairs of patients with similar operative risk (EuroSCORE II: TF-TAVR 8.1 ± 7.1% vs TA-TAVR, 8.4 ± 7.3%, p = 0.713). Thirty-day mortality was 8.0% after TA-TAVR and 4.0% after TF-TAVR (p = 0.102). Postoperative rates of stroke (TA-TAVR, 2.0% vs TF-TAVR 1.0%, p = 0.414), cardiac tamponade (TA-TAVR, 4.1% vs TF-TAVR 1.5%, p = 0.131), permanent pacemaker implantation (TA-TAVR, 8.7% vs TF-TAVR 13.3%, p = 0.414), and infection (TA-TAVR, 6.7% vs TF-TAVR 3.6%, p = 0.180) were similar in the study groups but with an overall trend in favor of TF-TAVR. Higher rates of major vascular damage (7.2% vs 1.0%, p = 0.003) and moderate-to-severe paravalvular regurgitation (7.8% vs 5.2%, p = 0.008) were observed after TF-TAVR. On the contrary, TA-TAVR was associated with higher rates of red blood cell transfusion (50.0% vs 30.4%, p = 0.0002) and acute kidney injury (stages 1 to 3: 44.4% vs 21.9%, p <0.0001) compared with TF-TAVR. Three-year survival rate was 69.1% after TF-TAVR and 57.0% after TA-TAVR (p = 0.006), whereas freedom from major adverse cardiovascular and cerebrovascular events was 61.9% after TF-TAVR and 50.4% after TA-TAVR (p = 0.011). In conclusion, TF-TAVR seems to be associated with significantly higher early and intermediate survival compared with TA-TAVR. The transfemoral approach, whenever feasible, should be considered the route of choice for TAVR., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objectives: The debate regarding the advantages and limitations of off-pump versus on-pump coronary artery bypass grafting (CABG) has yet to be resolved. This study was designed to compare the impact of surgical technique on long-term mortality and subsequent revascularization., Methods: The Predicting Long-Term Outcomes After Isolated Coronary Artery Bypass Surgery (PRIORITY) project was designed to evaluate the long-term outcomes of 2 large, prospective multicenter cohort studies on CABG conducted in Italy between 2002 and 2004 and in 2007 and 2008. Clinical data on isolated CABG were compiled from 2 administrative databases., Results: The study population consisted of 11,021 patients who underwent isolated CABG (27.2% off-pump CABG). Surgical strategy did not affect in-hospital mortality. Multivariate logistic regression demonstrated that on-pump CABG was the only factor that protected from in-hospital percutaneous coronary intervention after surgery (odds ratio, 0.61). Although unadjusted long-term survival was significantly worse for off-pump CABG, adjustment did not confirm off-pump CABG as a risk factor for mortality (hazard ratio, 0.96; 95% confidence interval, 0.87-1.06). The on-pump CABG group had a significantly lower hospitalization for subsequent percutaneous coronary intervention, a finding confirmed even with adjustment for confounding factors (hazard ratio, 0.70; 95% confidence interval, 0.62-0.80; P < .001). Off-pump CABG thus carried a 42% higher risk for subsequent percutaneous coronary intervention than on-pump CABG. The incidence of repeat CABG was similar between groups., Conclusions: This study demonstrated that off-pump OPCAB did not affect short- and long-term mortality, but it was a significant risk factor for rehospitalization for percutaneous coronary intervention., (Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Uncertainties on long-term outcomes after acute myocardial infarction (AMI) still exist, despite the ongoing progresses in the management of patients with AMI., Aim of the Study: Our aim was to appraise both the early prognosis and prognosis at 1-year after discharge of patients hospitalized due to AMI., Methods: This is a retrospective nationwide cohort study based on data from an administrative database on patients admitted with AMI from 2001 to 2011 in all Italian hospitals sites. Mortality and readmission rates within 30 days, 60 days and 1 year were calculated, as well as re-hospitalizations for all causes and for HF., Results: A total of 1,110,822 patients were included. Index admission mortality rate (I-MR) and total in-hospital mortality rate (T-MR) at up to 1 year both decreased respectively from 11.34% to 8.99% and from 16.46% to 14.68% in the years 2001 to 2011 (both p<0.0001), while fatal readmission rate (F-RR) at 1 year increased from 4.75% to 5.28% (p=0.0019). Patients that developed HF during the index admission had significantly higher I-MR and F-RR. I-MR, F-RR, and T-MR, however, remained low at any time point considered (30 days, 60 days and 1 year) in a subgroup of low-risk optimally-treated patients., Conclusions: The risk of fatal readmission at 1 year increased slightly over time, in spite of the remarkable improvements currently achieved in overall prognosis after AMI. The identification of patients at high risk (mainly due to HF complicating AMI), and of patients at low risk is crucial to define and support management strategies., (Copyright © 2015 Elsevier Ireland Ltd. 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.

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.

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.

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.

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.

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.