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The debate on the advantages and limitations of off-pump myocardial revascularization (OPCAB) on long-term outcomes has not still arrived to a conclusion. This study was designed to compare the impact of OPCAB vs, on-pump coronary artery bypass grafting (CABG) on long-term mortality and major adverse cardiac and cerebrovascular events (MACCEs).The PRIORITY project was designed to evaluate the long-term outcomes of two large prospective multicenter cohort studies on CABG. Data on isolated CABG were linked to two administrative datasets. The inverse probability of treatment weight was employed to balance the treatment groups. Time-to-event methods were employed to analyze endpoints.The cohort consisted of 10 988 patients who underwent isolated CABG (27.2% OPCAB). The median follow-up time was 7.9 years and was 100% complete. Unadjusted long-term survival was significantly worst for OPCAB, confirmed by weighted models (hazard ratio 1.08, 95% confidence interval (CI) 1.01-1.14, P = 0.01). OPCAB was associated to an increased risk of MACCE at 10 years (weighted hazard ratio 1.18, 95% CI 1.12-1.23, P 0.001). Inside the MACCEs, OPCAB was significantly related to increased incidence of repeat revascularization (hazard ratio 2.27, 95% CI 1.39-3.85, P 0.001, in the first 6 months, hazard ratio 1.19, 95% CI 1.09-1.32, P 0.001 afterward) and stroke (hazard ratio 1.22, 95% CI 1.10-1.35, P 0.001).The results of this study suggest that OPCAB was associated with an increased risk of mortality, repeat myocardial revascularization and stroke at 10 years compared with on-pump CABG.

OBJECTIVES Our goal was to evaluate the impact of gender on the 10-year outcome of patients after isolated coronary artery bypass grafting (CABG) included in the Italian nationwide PRedictIng long-term Outcomes afteR Isolated coronary arTery bypass surgery (PRIORITY) study. METHODS The PRIORITY project was designed to evaluate the long-term outcomes of patients who underwent CABG and were included in 2 prospective multicentre cohort studies. The primary end point of this analysis was major adverse cardiac and cerebrovascular events. Baseline differences between the study groups were balanced with propensity score matching and inverse probability of treatment. Time to events was analysed using Cox regression and competing risk analysis. RESULTS The study population comprised 10 989 patients who underwent isolated CABG (women 19.6%). Propensity score matching produced 1898 well-balanced pairs. The hazard of major adverse cardiac and cerebrovascular event was higher in women compared to men [adjusted hazard ratio (HR) 1.13, 95% confidence interval (CI) 1.03–1.23; P = 0.009]. The incidence of major adverse cardiac and cerebrovascular event in women was significantly higher at 1 year (HR 1.31, 95% CI 1.11–1.55; P CONCLUSIONS The present study documented an excess of non-fatal cardiac events after CABG among women despite comparable 10-year survival with men. These findings suggest that studies investigating measures of tertiary prevention are needed to decrease the risk of adverse cardiovascular events among women.

OBJECTIVES To compare clinical outcomes of balloon-expandable (BE) and self-expanding (SE) transcatheter aortic valves (TAVs) up to 5 years. BACKGROUND To date, no robust, comparative data of BE and SE TAVs at long-term are available. METHODS We considered a total of 1,440 patients enrolled in the multicenter OBSERVANT study and undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI) with either supra-annular SE (n = 830, 57.6%) and intra-annular BE (n = 610, 42.4%) valves. Clinical outcomes of the two groups were compared after adjustment using inverse probability of treatment weighting (IPTW) and confirmed by sensitivity analysis with propensity score matching. RESULTS Patients receiving SE valve showed a higher all-cause mortality at 5 years (Kaplan-Meier estimates 52.3% vs. 47.7%; Hazard ratio [HR] 1.18, 95% confidence interval [CI] 1.01-1.38, p = .04). Landmark analyses showed that there was a not statistically significant reversal of risk excess against the BE group starting from 3 years after TAVI (3-5 years HR 0.97, 95% CI 0.76-1.25, p = .86). Post-procedural, moderate/severe paravalvular regurgitation (PVR)(HR 1.46, 95% CI 1.14-1.87; p

OBJECTIVES We sought to develop and validate a novel risk assessment tool for the prediction of 30-day mortality after surgical aortic valve replacement incorporating a patient’s frailty. METHODS Overall, 4718 patients from the multicentre study OBSERVANT was divided into derivation (n = 3539) and validation (n = 1179) cohorts. A stepwise logistic regression procedure and a criterion based on Akaike information criteria index were used to select variables associated with 30-day mortality. The performance of the regression model was compared with that of European System for Cardiac Operative Risk Evaluation (EuroSCORE) II. RESULTS At 30 days, 90 (2.54%) and 35 (2.97%) patients died in the development and validation data sets, respectively. Age, chronic obstructive pulmonary disease, concomitant coronary revascularization, frailty stratified according to the Geriatric Status Scale, urgent procedure and estimated glomerular filtration rate were independent predictors of 30-day mortality. The estimated OBS AVR score showed higher discrimination (area under curve 0.76 vs 0.70, P CONCLUSIONS The OBS AVR risk score showed high discrimination and calibration abilities in predicting 30-day mortality after surgical aortic valve replacement. The addition of a simplified frailty assessment into the model seems to contribute to an improved predictive ability over the EuroSCORE II. The OBS AVR risk score showed a significant association with long-term mortality.

Despite the prognostic role of frailty among elderly patients undergoing transcatheter aortic valve implantation (TAVI) is known, its assessment still represents a challenge due to the multitude of scales proposed in literature. The aim of this study was to define the prognostic impact of a simple combined frailty model including both functional and metabolic parameters in a large cohort of patients undergoing TAVI with new generation devices.We examined 1-year survival of patients affected by aortic valve stenosis treated with new generation TAVI devices from the OBSERVANT II study. Frailty of patients undergoing TAVI was stratified in four groups according to a combination of functional (geriatric status scale - GSS) and metabolic (global nutritional risk index - GNRI) assessment. Among 1985 patients included in the analysis, 1008 (51%) had no significant frailty, 246 (12%) had only functional impairment, 522 (26%) had only metabolic impairment and 209 (11%) had both functional and metabolic impairment. The presence of combined functional and metabolic frailty was associated with a two-fold increased risk of 1-year all-cause mortality (HR 2.06 [95% CI 1.35-3.14]; p = 0.001). GNRI as a single parameter had a lower impact on mortality (HR 1.48 [95% CI 1.05 - 2.09]; p = 0.027), whereas GSS did not impact on mortality (HR 1.23 [95% CI 0.77-1.97]; p = 0.386).In a large real-world cohort of patients undergoing TAVI with new generation devices, combined functional and metabolic frailty had a significant and incremental impact on 1-year mortality.

Background: Bilateral internal mammary artery (BIMA) grafting largely is underutilized in patients undergoing coronary artery bypass grafting (CABG), partly because of the perceived increased complexity of the procedure. Aims: In this study, we evaluated whether BIMA grafting can safely be performed also in centers, where this revascularization strategy infrequently is adopted. Methods: Out of 6,783 patients from the prospective multicenter E-CABG study, who underwent isolated non-emergent CABG from January 2015 to December 2016, 2,457 underwent BIMA grafting and their outcome was evaluated in this analysis. Results: The mean number of BIMA grafting per center was 82 cases/year and hospitals were defined as high or low volume, according to this cutoff value. Six hospitals were considered as centers with a high volume of BIMA grafting (no. of procedures ranging from 120 to 267/year; overall: 2,156; prevalence: 62.2%) and nine hospitals as centers with a low volume of BIMA grafting (no. of procedures ranging from 2 to 39/year; overall: 301; prevalence: 9.1%). Multilevel mixed-effects regression analysis showed that the low- and high-volume cohorts had similar outcomes. Propensity score one-to-one matching analysis of 292 pairs showed that the low-volume cohort had a significantly shorter intensive care unit stay (2.2 ± 2.3 versus 2.9 ± 4.8 days, P = .020). The rates of in-hospital death (1.0% versus 0.3%, P = .625), deep sternal wound infection/mediastinitis (3.8% versus 3.1%, P = .824), and 1-year survival (98.1% versus 99.7%, P = .180) as well as other outcomes were similar between the high- and low-volume cohorts. Conclusions: BIMA grafting can be safely performed also in centers in which this revascularization strategy is infrequently performed.

In Italy the National Outcomes Evaluation Programme, (P.N.E.) is the most comprehensive comparative evaluation of healthcare outcomes at the national level. The aim of this report is to describe the P.N.E. and some of the most relevant results achieved. The P.N.E. analysed 184 indicators on quality of care in 2015–2020 period. The data sources are the Italian Health Information Systems. The indicators reported were: proportion of surgery within 2 days after hip fracture in the elderly (HF), 30-day mortality after hospital admission for acute myocardial infarction (AMI), proportion of reoperations within 90 days of breast-conserving surgery and proportion of primary caesarean deliveries. Risk adjustment methods were used to take into account patients’ characteristics. From 2010 to 2020 the proportion of interventions within 2 days after HF increased from 31.3% to 64.6%, the AMI 30-day mortality decreased from 10.4% to 8.3%, the proportion of reinterventions within 90 days of breast-conserving surgery decreased from 12.0% to 5.9% and the proportion of primary caesarean deliveries decreased from 28.4% to 22.7%. Results by area of residence showed heterogeneity of healthcare quality. We observed a general improvement in different clinical areas not always associated with a reduction of heterogeneity among areas of residence.

The outcome of patients with acute myocardial infarction (AMI) may vary substantially based on baseline risk. We aimed at analyzing the impact of gender, age and heart failure (HF) on mortality trends, based on a nationwide, comprehensive and universal administrative database of AMI.This is a nationwide cohort study of patients admitted with AMI from 2009 to 2018 in all Italian hospitals. In-hospital mortality rate (I-MR) and 1-year post-discharge mortality rate (1-Y-MR) were assessed.Among the 1,000,965 AMI events included in the analysis, 43.6% occurred in patients aged ≥75 years, 34.7% in females and 21.8% in AMI complicated by HF at the index hospitalization. Both I-MR and 1-Y-MR significantly decreased over time (from 8.87% to 6.72%; mean annual change -0.23%; confidence intervals (CI): - 0.26% to -0.20% and from 12.24% to 10.59%; mean annual change -0.18%; CI: - 0.24% to -0.13%, respectively). This trend was confirmed in younger and elderly AMI patients, in both sexes. In AMI patients complicated by HF, both I-MR and 1-Y-MR were markedly high, regardless of age and gender.This contemporary, nationwide study suggests that I-MR and 1-Y-MR are still elevated, albeit decreasing over time. Elderly patients and those with HF at the time of index admission, present a particularly high risk of fatal events, regardless of gender.

Aims The aim of this study was to compare the risk of prosthetic valve endocarditis (PVE) in patients with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Methods and results The FinnValve registry included data from 6,463 consecutive patients who underwent TAVR (n=2,130) or SAVR (n=4,333) with a bioprosthesis from 2008 to 2017. PVE was defined according to the modified Duke criteria. In this study, the incidence of PVE was 3.4/1,000 person-years after TAVR, and 2.9/1,000 person-years after SAVR. In competing risk analysis there was no significant difference in the risk of PVE between patients with TAVR and SAVR over an eight-year observational period. Male gender (HR 1.73, 95% CI: 1.04-2.89) and deep sternal wound infection or vascular access-site infection (HR 5.45, 95% CI: 2.24-13.2) were positively associated with PVE, but not type of procedure (HR 1.09, 95% CI: 0.59-2.01) in multivariate analysis. The mortality rate was 37.7% at one month and increased to 52.5% at one year. Surgical treatment was independently associated with decreased in-hospital mortality (HR 0.34, 95% CI: 0.21-0.61). Conclusions PVE is rare, and its risk is similar after TAVR and SAVR. ClinicalTrials.gov Identifier: NCT03385915. https://clinicaltrials.gov/ct2/show/NCT03385915.

Background: Sternal wound infection (SWI) is a major complication occurring often after coronary artery bypass grafting (CABG) using bilateral internal mammary artery (BIMA) grafts. The aim of this study is to assess whether such a risk may be reduced by using incision negative pressure wound therapy (INPWT). Methods: Data on patients undergoing isolated CABG using BIMA grafts at the Reims University Hospital, France, from 2013 to 2016 without or with INPWT was prospectively collected. Results: INPWT was used in 161 patients and conventional sterile wound dressing was used in 266 patients. Propensity score matching resulted in 128 pairs with similar characteristics. SWIs were similarly distributed between the conventional sterile wound dressing (10.9%) and the INPWT cohorts (10.2%) (P = 1.00). Patients treated with INPWT had a lower rate of deep SWI/mediastinitis than patients who had conventional sterile dressing (5.5% versus 10.2%, P = .210), but the difference did not reach statistical significance. Tests for interaction confirmed these findings in different patient subgroups. Conclusion: The routine use of INPWT may not significantly reduce the risk of SWI in patients undergoing BIMA grafting. In view of previous reports showing a benefit with the use of this method, a large randomized study is justified to assess the efficacy of INPWT in patients undergoing cardiac surgery.

The allocation of clinical and economic resources is an emerging issue in health management. A useful update necessarily depends on the evaluation of long-term outcomes of clinical and surgical resources that can permit emphasis on all amendable fields, improve quality of care, and reduce health costs. The PRIORITY (PRedictIng long term Outcomes afteR Isolated coronary arTery bypass surgerY) study represents the first innovative step toward the updating of health management in a selected field, surgery for coronary artery disease, which is one of the most prevalent diseases and requires allocation of high-cost resources, although information on long-term outcomes is limited. The aims of the PRIORITY study are the identification of preoperative risk factors for long-term outcomes and the development of clinical and administrative preoperative scores that can guide clinicians and the national health system to more appropriate actions for increasing quality of care and reducing costs.

OBJECTIVES We investigated whether the selective use of supracoronary ascending aorta replacement achieves late outcomes comparable to those of aortic root replacement for acute Stanford type A aortic dissection (TAAD). METHODS Patients who underwent surgery for acute type A aortic dissection from 2005 to 2018 at the Helsinki University Hospital, Finland, were included in this analysis. Late mortality was evaluated with the Kaplan–Meier method and proximal aortic reoperation, i.e. operation on the aortic root or aortic valve, with the competing risk method. RESULTS Out of 309 patients, 216 underwent supracoronary ascending aortic replacement and 93 had aortic root replacement. At 10 years, mortality was 33.8% after aortic root replacement and 35.2% after ascending aortic replacement (P = 0.806, adjusted hazard ratio 1.25, 95% confidence interval, 0.77–2.02), and the cumulative incidence of proximal aortic reoperation was 6.0% in the aortic root replacement group and 6.2% in the ascending aortic replacement group (P = 0.65; adjusted subdistributional hazard ratio 0.53, 95% confidence interval 0.15–1.89). Among 71 propensity score matched pairs, 10-year survival was 34.4% after aortic root replacement and 36.2% after ascending aortic replacement surgery (P = 0.70). Cumulative incidence of proximal aortic reoperation was 7.0% after aortic root replacement and 13.0% after ascending aortic replacement surgery (P = 0.22). Among 102 patients with complete imaging data [mean follow-up, 4.7 (3.2) years], the estimated growth rate of the aortic root diameter was 0.22 mm/year, that of its area 7.19 mm2/year and that of its perimeter 0.43 mm/year. CONCLUSIONS When stringent selection criteria were used to determine the extent of proximal aortic reconstruction, aortic root replacement and ascending aortic replacement for type A aortic dissection achieved comparable clinical outcomes.

Background There is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR). The aim of this study was to compare the mid-term outcomes after TAVR with Sapien 3 and SAVR with Perimount Magna Ease bioprostheses for severe aortic stenosis. Methods In a retrospective study, we included patients who underwent transfemoral TAVR with Sapien 3 or SAVR with Perimount Magna Ease bioprosthesis between January 2008 and October 2017 from the nationwide FinnValve registry. Propensity score matching was performed to adjust for differences in the baseline characteristics. The Kaplan-Meir method was used to estimate late mortality. Results A total of 2000 patients were included (689 in the TAVR cohort and 1311 in the SAVR cohort). Propensity score matching resulted in 308 pairs (STS score, TAVR 3.5 ± 2.2% vs. SAVR 3.5 ± 2.8%, p = 0.918). In-hospital mortality was 3.6% after SAVR and 1.3% after TAVR (p = 0.092). Stroke, acute kidney injury, bleeding and atrial fibrillation were significantly more frequent after SAVR, but higher rate of vascular complications was observed after TAVR. The cumulative incidence of permanent pacemaker implantation at 4 years was 13.9% in the TAVR group and 6.9% in the SAVR group (p = 0.0004). At 4-years, all-cause mortality was 20.6% for SAVR and 25.9% for TAVR (p = 0.910). Four-year rates of coronary revascularization, prosthetic valve endocarditis and repeat aortic valve intervention were similar between matched cohorts. Conclusions The Sapien 3 bioprosthesis achieves comparable midterm outcomes to a surgical bioprosthesis with proven durability such as the Perimount Magna Ease. However, the Sapien 3 bioprosthesis was associated with better early outcome. Trial registration ClinicalTrials.gov Identifier: NCT03385915.

Objectives: The aim of this study was to identify the risk factors associated with early mortality after postcardiotomy venoarterial extracorporeal membrane oxygenation. Methods: This is an analysis of the postcardiotomy extracorporeal membrane oxygenation registry, a retrospective multicenter cohort study including 781 patients aged more than 18 years who required venoarterial extracorporeal membrane oxygenation for cardiopulmonary failure after cardiac surgery from 2010 to 2018 at 19 cardiac surgery centers. Results: After a mean venoarterial extracorporeal membrane oxygenation therapy of 6.9 ± 6.2 days, hospital and 1–year mortality were 64.4% and 67.2%, respectively. Hospital mortality after venoarterial extracorporeal membrane oxygenation therapy for more than 7 days was 60.5% (P = 0.105). Centers that had treated more than 50 patients with postcardiotomy venoarterial extracorporeal membrane oxygenation had a significantly lower hospital mortality than lower–volume centers (60.7% vs 70.7%, adjusted odds ratio, 0.58; 95% confidence interval, 0.41–0.82). The postcardiotomy extracorporeal membrane oxygenation score was derived by assigning a weighted integer to each independent pre–venoarterial extracorporeal membrane oxygenation predictors of hospital mortality as follows: female gender (1 point), advanced age (60–69 years, 2 points; ≥70 years, 4 points), prior cardiac surgery (1 point), arterial lactate 6.0 mmol/L or greater before venoarterial extracorporeal membrane oxygenation (2 points), aortic arch surgery (4 points), and preoperative stroke/unconsciousness (5 points). The hospital mortality rates according to the postcardiotomy extracorporeal membrane oxygenation score was 0 point, 45.6%; 1 point, 40.5%; 2 points, 51.1%; 3 points, 57.8%; 4 points, 70.7%; 5 points, 68.3%; 6 points, 77.5%; and 7 points or more, 89.7% (P < 0.0001). Conclusions: Age, female gender, prior cardiac surgery, preoperative acute neurologic events, aortic arch surgery, and increased arterial lactate were associated with increased risk of early mortality after postcardiotomy venoarterial extracorporeal membrane oxygenation. Center experience with postcardiotomy venoarterial extracorporeal membrane oxygenation may contribute to improved results. PC-ECMO Study Group Collaborators of the PC-ECMO Study Group: Kristiina Pälve, MD, PhD, Vesa Anttila, MD, PhD, MD, Thomas Fux, MD, PhD, Gilles Amr, MD, Nikolaos Kalampokas, MD, Artur Lichtenberg, MD, Anders Jeppsson, MD, PhD, Marco Gabrielli, MD, Daniel Reichart, MD, Sidney Chocron, MD, PhD, Mariafrancesca Fiorentino, MD, Ugolino Livi, MD, Ivan Netuka, MD, Dieter De Keyzer, MD, Krister Mogianos, MD, Zein El Dean, MRCS, LLM, Angelo M. Dell’Aquila, MD, Nicla Settembre, MD, PhD, and Stefano Rosato, MSc.

Background. Patients with severe aortic stenosis and heart failure have poor prognosis, and their outcomes may be suboptimal even after transcatheter (TAVR) and surgical aortic valve replacement (SAVR). Methods. This is an analysis of the nationwide FinnValve registry, which included patients who underwent primary TAVR or SAVR with a bioprothesis for aortic stenosis. We evaluated the outcome of patients with acute heart failure (AHF) within 60 days prior to TAVR or SAVR. Results. The prevalence of recent AHF was 11.4% (484 of 4241 patients) in the SAVR cohort and 11.3% (210 of 1855 patients) in the TAVR cohort. In the SAVR cohort, AHF was associated with lower 30-day survival (91.3% vs 97.0%; adjusted odds ratio 1.801, 95% confidence interval [CI] 1.125-2.882) and 5-year survival (64.0% vs 81.2%; adjusted hazard ratio 1.482, 95% CI 1.207-1.821). SAVR patients with AHF had higher risk of major bleeding, need of mechanical circulatory support, acute kidney injury, prolonged hospital stay, and composite end-point (30-day mortality, stroke and/or acute kidney injury). Patients with AHF had a trend toward lower 30-day survival (crude rates 95.2% vs 97.9%; adjusted odds ratio 2.028, 95% CI 0.908-4.529) as well as significantly lower 5-year survival (crude rates 45.3% vs 58.5%; adjusted hazard ratio 1.530, 95% CI 1.185-1.976) also after TAVR. AHF increased the risk of acute kidney injury, prolonged hospital stay, and composite end-point after TAVR. Conclusions. Recent AHF is associated with increased risk of mortality and morbidity after SAVR and TAVR. These findings suggest that aortic stenosis patients should be referred for invasive treatment before the development of clinically evident heart failure.

The OBSERVANT study evaluated the medium and long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement obtaining comparative effectiveness results at least for the first-generation devices. The OBSERVANT II study enrolled a new series of TAVI procedures to evaluate whether the use of new-generation devices has modified outcome differences recorded in the OBSERVANT study. The aim of this paper is to describe the clinical characteristics of the OBSERVANT II population and compare them with those of the OBSERVANT population.OBSERVANT II is a prospective multicenter observational study, which enrolled patients with severe aortic stenosis, who underwent a TAVI procedure in 30 Italian centers from December 2016 to September 2018. Clinical, anatomical and procedural information was recorded for each patient as well as procedure characteristics and any periprocedural outcomes. An administrative follow-up will allow to obtain information on medium and long-term outcomes.The enrolled population consists of 3001 patients with a mean age similar to that recorded in OBSERVANT (81.7 ± 6.3 vs 81.9 ± 6.2 years; p=0.336). OBSERVANT II patients show a lower prevalence of several morbid conditions than OBSERVANT patients (i.e. chronic obstructive pulmonary disease, coronary artery disease, peripheral arterial disease, etc.), though having very similar mean values of EuroSCORE II (7.2 ± 7.6% vs 7.4 ± 7.9%; p=0.558). According to three EuroSCORE II risk classes (≤3; 3-7; ≥7), the in-hospital mortality rates for patients enrolled in the two studies are 1.0% vs 2.0% (p≤0.000), 1.4% vs 4.1% (p0.000) and 2.4% vs 7.7% (p0.000), respectively.The first results of the OBSERVANT II study show that patients undergoing TAVI with new-generation devices are elderly, have a lower risk profile than patients enrolled in the OBSERVANT study but comparable mean values of EuroSCORE II. The in-hospital mortality rate for patients enrolled in the OBSERVANT II study is lower than that recorded in the OBSERVANT study across all the EuroSCORE II risk classes.

Bilateral internal mammary artery (BIMA) grafting is increasingly used in the elderly without evidence of its risks or benefits compared to single internal mammary artery (SIMA) grafting. Background. Bilateral internal mammary artery (BIMA) grafting is increasingly used in elderly patients without evidence of its risks or benefits compared with single internal mammary artery (SIMA) grafting.Methods. In all, 2,899 patients aged 70 years or older (855 [29.5%] underwent BIMA grafting) operated on from January 2015 to December 2016 and included in the prospective multicenter Outcome After Coronary Artery Bypass Grafting (E-CABG) study were considered in this analysis.Results. One-to-one propensity matching resulted in 804 pairs with similar preoperative risk profile. Propensity score matched analysis showed that BIMA grafting was associated with a nonstatistically significant increased risk of inhospital death (2.7% versus 1.6%, p = 0.117). The BIMA grafting cohort had a significantly increased risk of any sternal wound infection (7.7% versus 5.1%, p = 0.031) as well as higher risk of deep sternal wound infection/mediastinitis (4.0% versus 2.2%, p = 0.048). The BIMA grafting cohort required more frequently extracorporeal membrane oxygenation (1.0% versus 0.1%, p = 0.02), and the intensive care unit stay (mean 3.6 versus 2.6 days, p < 0.001) and inhospital stay (mean 11.3 versus 10.0 days, p < 0.001) were significantly longer compared with the SIMA grafting cohort. Test for interaction showed that urgent operation in patients undergoing BIMA grafting was associated with higher risk of inhospital death (5.6% versus 1.3%, p = 0.009).Conclusions. Bilateral internal mammary artery grafting in elderly patients seems to be associated with a worse early outcome compared with SIMA grafting, particularly in patients undergoing urgent operation. Until more conclusive results are gathered, BIMA grafting should be reserved only for elderly patients with stable coronary artery disease, without significant baseline comorbidities and with long life expectancy. (C) 2018 by The Society of Thoracic Surgeons

Increasing data support transcatheter aortic valve implantation (TAVI) as a valid option over surgical aortic valve replacement (SAVR) in the treatment for severe aortic stenosis (AS) also in patients with low operative risk. However, limited data exist on the outcome of TAVI and SAVR in low-risk patients without coronary artery disease (CAD). The FinnValve registry included data on 6463 patients who underwent TAVI or SAVR with bioprosthesis between 2008 and 2017. Herein, we evaluated the outcome of low operative risk as defined by STS-PROM score3% and absence of CAD, previous stroke and other relevant co-morbidities. Only patients who underwent TAVI with third-generation prostheses and SAVR with Perimount Magna Ease or Trifecta prostheses were included in this analysis. The primary endpoints were 30-day and 3-year all-cause mortality. Overall, 1,006 patients (175 TAVI patients and 831 SAVR patients) met the inclusion criteria of this analysis. Propensity score matching resulted in 140 pairs with similar baseline characteristics. Among these matched pairs, 30-day mortality was 2.1% in both TAVI and SAVR cohorts (p = 1.00) and 3-year mortality was 17.0% after TAVI and 14.6% after SAVR (p = 0.805). Lower rates of bleeding and atrial fibrillation, and shorter hospital stay were observed after TAVI. The need of new permanent pacemaker implantation and the incidence of early stroke did not differ between groups. In conclusion, TAVI using third-generation prostheses achieved similar early and mid-term survival compared with SAVR in low-risk patients without CAD.

The OBSERVANT study (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) showed that mortality at 1 year is similar after transfemoral transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for real-world propensity-matched patients with aortic stenosis at low and intermediate risk. We report the 5-year outcomes of the Italian OBSERVANT study.The unadjusted enrolled population (N=7618) between December 2010 and June 2012 included 5707 patients on SAVR and 1911 patients on TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary end points of this analysis were death from any cause and major adverse cardiac and cerebrovascular events at 5 years. The matched population had a total of 1300 patients (650 per group). The propensity score method generated a low and intermediate-risk population (mean logistic EuroSCORE 2: 5.1±6.2% versus 4.9±5.1%, SAVR versus transfemoral TAVR; P=0.485). At 5 years, the rate of 5 death from any cause was 35.8% in the surgical group and 48.3% in the transcatheter group (hazard ratio, 1.38; 95% CI, 1.12-1.69; P=0.002). Similarly, TAVR was associated with an increased risk of major adverse cardiac and cerebrovascular events as compared with SAVR (42.5% versus 54.0%; hazard ratio, 1.35; 95% CI, 1.11-1.63; P=0.003). The cumulative incidence of cerebrovascular events, myocardial infarction, and coronary revascularization were similar in the study groups at 5 years.The present results suggest that at 5 years, in a real-world population with severe aortic stenosis and at low and intermediate risk, suggest that SAVR is associated in with lower mortality and major adverse cardiac and cerebrovascular events rates than transfemoral TAVR performed using first-generation devices. These data need to be confirmed in randomized trials using new-generation TAVR devices.

Importance: Transcatheter aortic valve replacement (TAVR) has been shown to be a valid alternative to surgical aortic valve replacement (SAVR) in patients at high operative risk with severe aortic stenosis (AS). However, the evidence of the benefits and harms of TAVR in patients at low operative risk is still scarce. Objective: To compare the short-term and midterm outcomes after TAVR and SAVR in low-risk patients with AS. Design, Setting, and Participants: This retrospective comparative effectiveness cohort study used data from the Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis of patients at low operative risk who underwent TAVR or SAVR with a bioprosthesis for severe AS from January 1, 2008, to November 30, 2017. Low operative risk was defined as a Society of Thoracic Surgeons Predicted Risk of Mortality score less than 3% without other comorbidities of clinical relevance. One-to-one propensity score matching was performed to adjust for baseline covariates between the TAVR and SAVR cohorts. Exposures: Primary TAVR or SAVR with a bioprosthesis for AS with or without associated coronary revascularization. Main Outcomes and Measures: The primary outcomes were 30-day and 3-year survival. Results: Overall, 2841 patients (mean [SD] age, 74.0 [6.2] years; 1560 [54.9%] men) fulfilled the inclusion criteria and were included in the analysis; TAVR was performed in 325 patients and SAVR in 2516 patients. Propensity score matching produced 304 pairs with similar baseline characteristics. Third-generation devices were used in 263 patients (86.5%) who underwent TAVR. Among these matched pairs, 30-day mortality was 1.3% after TAVR and 3.6% after SAVR (P = .12). Three-year survival was similar in the study cohorts (TAVR, 85.7%; SAVR, 87.7%; P = .45). Interaction tests found no differences in terms of 3-year survival between the study cohorts in patients younger than vs older than 80 years or in patients who received recent aortic valve prostheses vs those who did not. Conclusions and Relevance: Transcatheter aortic valve replacement using mostly third-generation devices achieved similar short- and mid-term survival compared with SAVR in low-risk patients. Further studies are needed to assess the long-term durability of TAVR prostheses before extending their use to low-risk patients.

Objective: To investigate the prognostic impact of red blood cell (RBC) transfusion on the outcome after transfemoral transcatheter aortic valve replacement (TAVR). Design: Nationwide, retrospective multicenter study. Setting: Five University Hospitals. Participants: The nationwide FinnValve registry included data from 2,130 patients who underwent TAVR for aortic stenosis from 2008 to 2017. After excluding patients who underwent TAVR through nontransfemoral accesses, 1,818 patients were selected for this analysis. Intervention: TAVR with or without coronary revascularization. Measurements and Main Results: RBCs were transfused in 293 patients (16.1%). Time-trend analysis showed that the rates of RBC transfusion decreased significantly from 27.5% in 2012 to 10.0% in 2017 (p

Background: We evaluated perioperative bleeding after coronary artery bypass grafting (CABG) in patients preoperatively treated with ticagrelor or clopidogrel, stratified by discontinuation of these P2Y₁₂ inhibitors. Methods: All patients from the prospective, European Multicenter Registry on Coronary Artery Bypass Grafting (E-CABG) treated with ticagrelor or clopidogrel undergoing isolated primary CABG were eligible. The primary outcome measure was severe or massive bleeding defined according to the Universal Definition of Perioperative Bleeding, stratified by P2Y₁₂ inhibitor discontinuation. Secondary outcome measures included four additional definitions of major bleeding. Propensity score matching was performed to adjust for differences in preoperative and perioperative covariates. Results: Of 2,311 patients who were included, 1,293 (55.9%) received clopidogrel and 1,018 (44.1%) ticagrelor preoperatively. Mean time between discontinuation and the operation was 4.5 ± 3.2 days for clopidogrel and 4.9 ± 3.0 days for ticagrelor. In the propensity score–matched cohort, ticagrelor-treated patients had a higher incidence of major bleeding according to Universal Definition of Perioperative Bleeding when ticagrelor was discontinued 0 to 2 days compared with 3 days before the operation (16.0% vs 2.7%, p = 0.003). Clopidogrel-treated patients had a higher incidence of major bleeding according to the Universal Definition of Perioperative Bleeding when clopidogrel was discontinued 0 to 3 days compared with 4 to 5 days before the operation (15.6% vs 8.3%, p = 0.031). Conclusions: In patients receiving ticagrelor 2 days before CABG and in those receiving clopidogrel 3 days before CABG, there was an increased rate of severe bleeding. Postponing nonemergent CABG for at least 3 days after discontinuation of ticagrelor and 4 days after clopidogrel should be considered.

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.

Background Recent studies suggested that prothrombin complex concentrate (PCC) might be more effective than fresh frozen plasma (FFP) to reduce red blood cell (RBC) transfusion requirement after cardiac surgery. Methods This is a comparative analysis of 416 patients who received FFP postoperatively and 119 patients who received PCC with or without FFP after isolated coronary artery bypass grafting (CABG). Results Mixed-effects regression analyses adjusted for multiple covariates and participating centres showed that PCC significantly decreased RBC transfusion (67.2% vs. 87.5%, adjusted OR 0.319, 95%CI 0.136–0.752) and platelet transfusion requirements (11.8% vs. 45.2%, adjusted OR 0.238, 95%CI 0.097–0.566) compared with FFP. The PCC cohort received a mean of 2.7 ± 3.7 (median, 2.0, IQR 4) units of RBC and the FFP cohort received a mean of 4.9 ± 6.3 (median, 3.0, IQR 4) units of RBC (adjusted coefficient, -1.926, 95%CI -3.357–0.494). The use of PCC increased the risk of KDIGO (Kidney Disease: Improving Global Outcomes) acute kidney injury (41.4% vs. 28.2%, adjusted OR 2.300, 1.203–4.400), but not of KDIGO acute kidney injury stage 3 (6.0% vs. 8.0%, OR 0.850, 95%CI 0.258–2.796) when compared with the FFP cohort. Conclusions These results suggest that the use of PCC compared with FFP may reduce the need of blood transfusion after CABG.

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.

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

Objectives: The aim of this study was to evaluate the prognostic impact of untreated asymptomatic carotid artery stenosis (CS) in patients undergoing isolated coronary artery bypass grafting (CABG). Methods: This was a post hoc analysis of data from a prospective multicentre observational study. Patients without history of stroke or transient ischaemic attack from the multicentre E-CABG registry who were screened for CS before isolated CABG were included. Results: Among 2813 patients screened by duplex ultrasound and who did not undergo carotid intervention for asymptomatic CS, 11.1% had a stenosis of 50–59%, 6.0% of 60–69%, 3.1% of 70–79%, 1.4% of 80–89%, 0.5% of 90–99%, and 1.1% had carotid occlusion. In the screened population post-operative stroke occurred in 25 patients (0.9%), with an incidence of 1.5% among patients with CS ≥ 50% (n = 649). Pre-operative screening had not found a relevant CS in 15 of 25 patients suffering stroke after CABG. Brain imaging identified cerebral ischaemic injury in 20 patients, which was bilateral in five patients (25%), ipsilateral to a CS ≥ 50% in six (30%), and ipsilateral to a CS ≥ 70% in three (15%). In univariable analysis, the severity of CS was associated with a significantly increased risk of stroke (CS < 50%, 0.7%; 50–59%, 1.0%; 60–69%, 0.6%; 70–79%, 1.2%; 80–89%, 5.1%; 90–99%, 7.7%; occluded, 6.7%, p < .001). In multivariable analysis, a CS of 90–99% (OR 12.03, 95% CI 1.34–108.23) and the presence of an occluded internal carotid artery (OR 8.783, 95% CI 1.820–42.40) were independent predictors of stroke along with urgency of the procedure, severe massive bleeding according to the E-CABG classification, and the presence of a porcelain ascending aorta. Conclusions: Among screened patients with untreated asymptomatic patients, CS ≥ 90% was an independent predictor of post-operative stroke. As this condition has a low prevalence and when left untreated is associated with a relatively low rate of stroke, pre-operative screening of asymptomatic CS before CABG may not be justified. Clinical Trial registration: https://clinicaltrials.gov. Unique identifier: NCT02319083.

OBJECTIVES The aim of this study was to assess the impact of frailty on the outcome after coronary artery bypass grafting (CABG) and whether it may improve the predictive ability of European System for Cardiac Operative Risk Evaluation (EuroSCORE II). METHODS The Clinical Frailty Scale (CFS) was assessed preoperatively in patients undergoing isolated CABG from the multicentre E-CABG registry, and patients were stratified into 3 classes: scores 1-2, scores 3-4 and scores 5-7. RESULTS Of the 6156 patients enrolled, 39.2% had CFS scores 1-2, 57.6% scores 3-4, and 3.2% scores 5-7. Logistic regression adjusted for multiple covariates showed that the CFS was an independent predictor of hospital/30-day mortality [CFS scores 3-4, odds ratio (OR) 3.95, 95% confidence interval (CI) 2.19-7.14; CFS scores 5-7, OR 5.90, 95% CI 2.67-13.05] and resulted in an Integrated Improvement Index of 1.3 (P

Background— The clinical impact of prior percutaneous coronary intervention (PCI) in patients requiring coronary artery bypass grafting (CABG) remains unsettled. We sought to determine whether prior PCI is associated with adverse outcome after CABG. Methods and Results— Data from the prospective E-CABG (European Multicenter Study on Coronary Artery Bypass Grafting) conducted between January 2015 and March 2016 at 16 European centres were analyzed using propensity weighted methodology to adjust for confounding. A parallel systematic review/meta-analysis (MEDLINE, Embase, SCOPUS, and Cochrane Library) through September 2017 was accomplished. Of a total of 3641 adult patients included in the E-CABG study, 685 (19%) patients had a history of PCI. At multivariable level, prior PCI was not associated with an increased hospital mortality in both unweighted and weighted patient groups (odds ratio, 0.73; 95% confidence interval, 0.29–1.38; P =0.33 and odds ratio, 0.90; 95% confidence interval, 0.39–2.08; P =0.81, respectively). Subgroup analyses confirmed that prior PCI had no impact on hospital mortality and morbidity, including reexploration for bleeding, blood transfusion, hospital resource use, and neurological, renal, and cardiac complications. The systematic review provided a total of 71 366 individuals and showed a trend toward higher in-hospital/30-day mortality (adjusted odds ratio, 1.30; 95% confidence interval, 0.99–1.70; I 2 =43.1%) in patients with prior PCI. Conclusions— Our prospective multicenter study showed that prior PCI was not associated with an increased risk of mortality or other adverse outcomes in patients undergoing CABG. In light of a trend toward increased mortality observed in the meta-analysis, further studies are needed to ascertain the prognostic impact of prior PCI in the outcome after CABG. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT02319083.

Background: Few data are available on the virological and clinical outcomes of advanced liver disease patients retreated after first-line DAA failure. Aim: To evaluate DAA failure incidence and the retreatment clinical impact in patients treated in the advanced liver disease stage. Methods: Data on HCV genotype, liver disease severity, and first and second line DAA regimens were prospectively collected in consecutive patients who reached the 12-week post-treatment and retreatment evaluations from January 2015 to December 2016 in 23 of the PITER network centers. Results: Among 3,830 patients with advanced fibrosis (F3) or cirrhosis, 139 (3.6%) failed to achieve SVR. Genotype 3, bilirubin levels >1.5mg/dl, platelet count

Perioperative bleeding is a determinant of poor outcome in patients undergoing coronary artery bypass grafting (CABG), but there is a lack of adequate stratification of its severity. The ability of the European registry of Coronary Artery Bypass Grafting (E-CABG), Universal Definition of Perioperative Bleeding (UDPB), Study of Platelet Inhibition and Patient Outcomes (PLATO), Clopidogrel and Aspirin Optimal Dose Usage to Reduce Recurrent,Events Seventh Organization to Assess Strategies in Ischemic Syndromes (CURRENT-OASIS 7), Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q Wave Coronary Events (ESSENCE), and SafeTy and Efficacy of Enoxaparin in Percutaneous coronary intervention patients, an internationaL randomized Evaluation (STEEPLE) bleeding classifications to predict early mortality, stroke, acute kidney injury (AKI) stage 3, and deep sternal wound infection/mediastinitis was investigated in 3,730.patients from the prospective, multicentre E-CABG registry. Increasing grades of the E-CABG, UDPB, PLATO, and CURRENT-OASIS 7 classifications were associated with increasing risks of early mortality, had similar receiver-operating characteristic area under the curves (>0.7), and were predictive also when adjusted for EuroSCORE II. The E-CABG and UDPB classifications had satisfactory area under the curves (>0.6) in pre,dicting stroke, AKI stage 3, and deep sternal wound infection/mediastinitis even when adjusted for EuroSCORE II. The PLATO and CURRENT-OASIS 7 classifications had similar predictive ability for stroke and AKI stage 3 as confirmed by multivariate analysis adjusted for EuroSCORE II but showed inferior ability in predicting severe wound infection compared to the E-CABG and UDPB classifications. The STEEPLE and ESSENCE classifications had a poor ability of predicting all these adverse events. Decision curve analysis showed a benefit of the ECABG bleeding classification over the other classifications in predicting all adverse events. In conclusion, the E-CABG, UDPB, PLATO, and CURRENT-OASIS 7 bleeding classifications have a satisfactory ability in predicting adverse events after CABG. Decision curve analysis showed that the E-CABG bleeding classification had the best predictive performance. (C) 2016 Elsevier Inc. All rights reserved.

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.

Background The SYNTAX score (SS) is a determinant of outcome in patients undergoing percutaneous coronary intervention. In addition, it has been recently shown that the clinical SYNTAX score (cSS), obtained by adding clinical variables to the SS, improves the predictive power of the resulting risk model. We assessed the hypothesis that the use of the cSS may predict outcomes of patients undergoing coronary artery bypass grafting (CABG). Methods We measured the SYNTAX score in 874 patients undergoing isolated first time on-pump CABG. The clinical SYNTAX score was calculated at the time of the study using age, creatinine clearance and ejection fraction, the modified ACEF score, and analyses performed for major adverse cardiac and cerebrovascular events (MACCE) and all-cause mortality at 3-year follow-up. Results The mean age of the study population was 70.9 ± 8.1 years, and the median cSS 14.2 (range 2.1–286.5). The ROC curve analysis showed that a cSS >14.5 (81.4% sensitivity and 67.8% specificity) was a reliable tool in discrimination of patients for the occurrence of MACCE (AUC 0.78) and all-cause mortality (AUC 0.74). Kaplan-Meier survival analysis confirmed that patients belonging to higher cSS quartiles have poorer 3-year survival ( P = .0001) and MACCE-free survival ( P = .0001), with respect to those with lower cSS. Conclusions This observational study has shown that the clinical SYNTAX score, incorporating the lesion-based SS and clinical-based ACEF score, predicted mid-term adverse outcomes of patients undergoing CABG and may play an important role in the risk stratification of this population. Further studies are needed to confirm these findings.

SummarySevere perioperative bleeding after coronary artery bypass grafting (CABG) is associated with poor outcome. An additive score for prediction of severe bleeding was derived (n=2494) and validated (n=1250) in patients from the E-CABG registry. Severe bleeding was defined as E-CABG bleeding grades 2–3 (transfusion of >4 units of red blood cells or reoperation for bleeding). The overall incidence of severe bleeding was 6.4 %. Preoperative anaemia (3 points), female gender (2 points), eGFR 6: 24.6 % vs 24.2 %, both pClinical Trial Registration: NCT02319083 (https://clinicaltrials.gov/ct2/show/NCT02319083)

The optimal timing of discontinuation of ticagrelor before cardiac surgery is controversial. Importance: The optimal timing of discontinuation of ticagrelor before cardiac surgery is controversial.Objective: To evaluate the safety of preoperative use of ticagrelor with or without aspirin in patients with acute coronary syndromes (ACS) undergoing isolated coronary artery bypass grafting (CABG) compared with aspirin alone.Design, Setting, and Participants: This prospective, multicenter clinical trial was performed at 15 European centers of cardiac surgery. Participants were patients with ACS undergoing isolated CABG from the European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG) registry between January and September 2015.Exposures: Before surgery, patients received ticagrelor with or without aspirin or aspirin alone.Main Outcomes and Measures: Severe bleeding as defined by the Universal Definition of Perioperative Bleeding (UDPB) and E-CABG bleeding classification criteria. A propensity score-matched analysis was performed to adjust for differences in baseline and operative covariates.Results: Of 2482 patients from the E-CABG registry, the study cohort included 786 (31.7%) consecutive patients with ACS (mean [SD] age, 67.1 [9.3] years; range, 32-88 years), and 132 (16.8%) were female. One-to-one propensity score matching provided 215 pairs, whose baseline and operative covariates had a standardized difference of less than 10%. Preoperative use of ticagrelor was associated with a similar risk of bleeding according to the UDPB and E-CABG bleeding classifications, but the incidence of platelet transfusion was higher in the ticagrelor group (13.5% [29 of 215] vs 6.0% [13 of 215]). Compared with those receiving aspirin alone, continuing ticagrelor up to the time of surgery or discontinuing its use less than 2 days before surgery was associated with a higher risk of platelet transfusion (22.7% [5 of 22] vs 6.4% [12 of 187]) and E-CABG bleeding grades 2 and 3 (18.2% [4 of 22] vs 5.9% [11 of 187]) and tended to have an increased risk of UDPB grades 3 and 4 (22.7% [5 of 22] vs 9.6% [18 of 187]). Among patients in whom antiplatelet drug use was discontinued at least 2 days before surgery, the incidence of platelet transfusion was 12.4% (24 of 193) in the ticagrelor group and 3.6% (1 of 28) in the aspirin-alone group.Conclusions and Relevance: In propensity score-matched analyses among patients with ACS undergoing CABG, the use of preoperative ticagrelor with or without aspirin compared with aspirin alone was associated with more platelet transfusion but similar degree of bleeding; in patients receiving ticagrelor 1 day before or up until surgery, there was an increased rate of severe bleeding.

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 =

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.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, P0.001; 0.54, P0.001; 0.64, P0.001, respectively). In the matched population, while short-term mortality was significantly lower for PCI (HR 0.36, P0.001), long-term MACCE risk was lower for CABG (6-month HR 2.93, P0.001; 12-month HR 3.01, P0.001).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.

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, werecomputedfor eachItaliancardiacsurgery centreandforsixclassesofrisk-stratifiedpatients.The performanceofthethreemodelsin predictingthe30-daymortalitywasformallyassessedforcalibration(Hosmer—Lemeshowtest)anddiscrimination(ROCarea).Accordingtothethree models, risk-adjusted mortality rates (RAMR = O/EItalian 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 testedmodels,thelogisticEuroSCOREshowsasignificantHosmer—Lemeshowtest(x 2� L ¼ 19:30,p < 0.0001),indicatingunsatisfactorycalibration, and a clear predicteddeath overestimationineach ofthe consideredriskclasses(O/E = 0.4). When a proper recalibrationprocedure is applied, the logistic EuroSCORE performance parameters achieve acceptable levels. The Italian CABG model identified seven centres as having higher than averagemortality,whiletheEuroSCOREidentifiedthesamesevencentresplusoneother.TheItalianCABGmodelidentifiedeightcentreswithlower than average mortality, five of which were identified by the additive EuroSCORE and four of which were identified by the logistic EuroSCORE. The additiveEuroSCOREidentifiedfourmoreandthelogisticEuroSCOREthree morelowmortalitycentres.Conclusions:Althoughthisanalysisrevealsa satisfactoryconcordancebetweenresultsfromthethreemodels,adetailedcomparisonshowsthattheItalianCABGmodelusesfewervariablesand performsbetterthantheothers.Nevertheless,whenproperlyrecalibrated,theEuroSCOREmodelcanbeexportedtotheItalianpopulationandused to rank hospital performance and evaluate preoperative risk of patients undergoing open-heart surgery. # 2007 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Background Myocardial revascularization in young patients should be durable enough to avoid new cardiovascular events or repeated revascularization procedures. The aim of this study was to evaluate the late outcomes of patients less than 50 years of age undergoing coronary artery bypass grafting (CABG) in comparison with older patients. Methods This study was a survival analysis of a pooled multicenter prospective cohort of patients who underwent CABG. Results Five percent of patients (572 of 11,087) were less than 50 years of age. The prevalence of female sex, pulmonary disease, diabetes, stroke, and extracardiac arteriopathy was lower compared with that in older patients. Left ventricular function was more well preserved in patients less than 50 years of age, but the prevalence of recent myocardial infarction and the need for emergency surgical intervention was significantly higher in young patients. Multiple propensity score–adjusted analysis showed that patients aged less than 50 years had a significantly lower risk of mortality, even when compared with the 50- to 59-year stratum. In the propensity score–matched population (544 pairs), patients less than 50 years of age had significantly better 7-year outcomes compared with patients aged 50 years or more: survival (95.6% versus 81.1%; p p = 0.009), freedom from major adverse cardiac and cerebrovascular events (MACCE) (76.6% versus 63.9%; p = 0.002). Similar freedom from myocardial infarction (90.1% versus 90.1%; p = 0.68) and repeated revascularization (87.1% versus 87.2%; p = 0.65) was observed in patients less than 50 years of age and those older than 50 years. Conclusions Patients less than 50 years of age undergoing CABG have an excellent outcome compared with elderly patients. These data indicate that despite its premature onset, coronary artery disease in young patients does not have a more aggressive course than that in older patients.

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-makingbyNHS management and individualpatients. Althoughnotstatisticallysignificant, RAMRdroppedfromyear 2002 to 2004 (2.8—2.4%) suggesting that this comparative outcome assessment can contribute to the improvement of performances in cardiac surgery. # 2005 Elsevier B.V. All rights reserved.

Uncertainties on long-term outcomes after acute myocardial infarction (AMI) still exist, despite the ongoing progresses in the management of patients with AMI.Our aim was to appraise both the early prognosis and prognosis at 1-year after discharge of patients hospitalized due to AMI.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.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 p0.0001), 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.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.

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.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.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%; p0.001). 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).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.

Aortic stenosis (AS) is common in patients with end-stage renal disease and the rate of progression is faster than in patients without end-stage renal disease. While aortic valve replacement (AVR) is the gold-standard approach for patients with symptomatic severe AS, surgical AVR (SAVR) carries

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.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 agedor = 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, P0.001). 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).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.

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 aged50 years after isolated coronary artery bypass surgery (CABG).This is a multicenter study including 2207 patients aged50 years undergoing isolated CABG at 68 Italian hospitals.The proportion of patients aged50 years in this series was 5.3% and varied significantly from 0% to 9.9% in different institutions (p0.0001). The 30-day mortality rate was 0.9%. One-to-one propensity score matching of patients aged50 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 fraction30% (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 aged50 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).The proportion of patients aged50 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.

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.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.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%).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.

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.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.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.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.

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.