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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 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.

Background: Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice. However, adequately powered randomized controlled trials comparing these two valve designs are lacking. Methods: The CENTER-study included 12,381 patients undergoing transfemoral TAVI. Patients undergoing TAVI with a BE-valve (n = 4096) were compared to patients undergoing TAVI with an SE-valve (n = 4096) after propensity score matching. Clinical outcomes including one-year mortality and stroke rates were assessed. Results: In the matched population of n = 5410 patients, the mean age was 81 ± 3 years, 60% was female, and the STS-PROM predicted 30-day mortality was 6.2% (IQR 4.0–12.4). One-year mortality was not different between patients treated with BE- or SE-valves (BE: 16.4% vs. SE: 17.0%, Relative Risk 1.04, 95%CI 0.02–1.21, p = 0.57). One-year stroke rates were also comparable (BE: 4.9% vs. SE: 5.3%, RR 1.09, 95%CI 0.86–1.37, p = 0.48). Conclusion: This study suggests that one-year mortality and stroke rates were comparable in patients with severe aortic valve stenosis undergoing TAVI with either BE or SE-valves.

Introduction: Few data on long-term follow-up of effectiveness and advantages related to the employ of double internal thoracic artery grafts (BITA) for coronary artery bypass grafting are available and the advantage of the employ of BITA have been recently questioned. Hypothesis: This observational cohort study was designed by the PRIORITY planning committee to evaluate 10-year follow-up of isolated CABG performed with and without BITA in order to evaluate the impact of BITA on long-term outcomes. Methods: The PRIORITY project was designed to evaluate the long-term outcomes of 2 large prospective multicenter cohort studies on CABG conducted between 2002-2004 and 2007-2008. Data on isolated CABG were linked to 2 administrative datasets. The primary endpoints were death and major adverse cardiac events (MACEs) at follow-up. Time-to-event data were analyzed using Kaplan-Meier estimates and Cox regression. Models generation was performed on the full dataset and the validation was performed with Montecarlo simulations. Results: The population consisted of 11021 patients who underwent isolated CABG; double thoracic internal artery grafts was employed in 23.5%. The median follow-up time was 7.9 years (interquartile range 7.4 - 10 years). After adjustment for potential confounding factors, BITA was significantly associated with better survival (HR 0.81, 95%CI 0.73-0.89, p < 0.001). Moreover, the employment of BITA reduced the incidence of MACEs at follow-up (adjusted HR 0.83, 95%CI 0.77-0.89, p < 0.001). In details, BITA was demonstrated to be a protective factor for acute myocardial infarction (adjusted HR 0.83, 95%CI 0.72-0.96, p = 0.001) and for rehospitalization for percutaneous cardiac intervention (PCI; adjusted HR 0.72, 95%CI 0.63-0.84, p < 0.001). Conclusions: The employment of double internal thoracic artery grafts for coronary artery bypass grafting has been associated to significant survival advantage at long-term. Moreover, it is a protective factor for acute myocardial infarction and rehospitalization for percutaneous cardiac intervention, reducing the hazard by 28%.

Background The debate on the advantages and limitations of off-pump (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 events (MACEs). Methods The PRIORITY project was designed to evaluate the long-term outcomes of 2 large prospective multicenter cohort studies on CABG conducted between 2002–2004 and 2007–2008. Data on isolated CABG were linked to 2 administrative datasets. Time-to-event methods were employed to analyze outcomes. Results The population consisted of 11021 patients who underwent isolated CABG (27.2% OPCAB) that were divided into development and validation datasets. The median follow-up time was 8 years (interquartile range 7.6–10 years) and was 100% complete. Unadjusted long-term survival was significantly worst for OPCAB, nonetheless the adjustment did not confirm OPCAB as a risk factor for mortality (HR 0.94, 95% CI 0.85–1.03, p=0.19). OPCAB was associated to an increased risk of MACE at 10 years (adjusted HR 1.14, 95% CI 1.06–1.23, p=0.001). Inside the MACEs, OPCAB was significantly related to increased incidence of rehospitalization for percutaneous cardiac intervention (PCI), (adjusted HR 1.33, 95% CI 1.16–1.53, p Conclusions OPCAB did not affect long-term mortality but is associated with an increased long-term risk of repeat PCI. These findings may have important implications towards health resources allocation, particularly in a climate of cost containment of healthcare expenditures. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Italian Minister of Health

Background The advantages of the employment of double internal thoracic artery grafts (BITA) for coronary artery bypass grafting have been recently questioned and no data on long-term follow-up are available. This observational retrospective cohort study was designed by the PRIORITY planning committee to evaluate 10-year follow-up of isolated CABG performed with and without BITA in order to clarify and consolidate the contrasting literature. Methods The PRIORITY project was designed to evaluate the long-term outcomes of 2 large prospective multicenter cohort studies on CABG conducted between 2002–2004 and 2007–2008. Data on isolated CABG were linked to 2 administrative datasets. Time-to-event distributions were separately analyzed accordingly to primary event-type (death, MACEs), using Kaplan-Meier estimates and Cox regression. Results The population consisted of 11021 patients who underwent isolated CABG that were divided into development and validation datasets; double thoracic internal artery grafts was employed in 24.6%. The median follow-up time was 8 years (interquartile range 7.6–10 years) and was 100% complete. After adjustment for potential confounding factors, BITA was significantly associated with better survival (HR 0.85, 95% CI 0.76–0.95, p=0.003). Moreover, the employment of BITA reduced the incidence of MACEs at follow-up (adjusted HR 0.87, 95% CI 0.80–0.94, p=0.001). In details, BITA was demonstrated to be a protective factor for acute myocardial infarction (adjusted HR 0.84, 95% CI 0.71–0.99, p=0.05) and for rehospitalization for percutaneous cardiac intervention (PCI; adjusted HR 0.82, 95% CI 0.70–0.96, p=0.013). Conclusions The employment of double internal thoracic artery grafts for coronary artery bypass grafting has been associated to survival advantage at 10-year. Moreover, it significantly decreased the incidence of acute myocardial infarction and rehospitalization for percutaneous cardiac intervention. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Italian Minister of Health

Background Diabetes mellitus (DM) is a well-known cardiovascular risk factor present in up to a third of patients undergoing transcatheter aortic valve implantation (TAVI). How DM might influence outcomes after TAVI procedures remains controversial. The aim of this study was to determine differences in outcomes after TAVI according to diabetes status. Methods The CENTER (Cerebrovascular EveNts in patients undergoing TranscathetER aortic valve implantation with balloon-expandable valves versus self-expandable valves)-collaboration was a global patient level dataset of patients undergoing transfemoral TAVI from 2007 to 2018. In this analysis, the study examined differences in baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes between DM and non-DM patients. Results Of the 11,440 patients included, 31% (n=3,550) were diabetic and 69% (n=7,890) were non-diabetic. Diabetics were younger, had a higher body mass index (BMI) and overall a worse cardiovascular risk profile than non-diabetics. There were no differences between DM and non-DM patients regarding in-hospital mortality (4.8% vs 5.3%, RR: 0.9, 95% CI: 0.7–1.1, p=0.46), myocardial infarction (0.9% vs 0.7%, RR: 1.4, 95% CI: 0.9–2.2, p=0.17), stroke (1.7% vs 2.0%, RR: 0.9, 95% CI: 0.6–1.2, p=0.36), major or life threatening bleeding (5.9% vs 6.3%, RR: 0.9, 95% CI: 0.8–1.1, p=0.44) and permanent pacemaker implantation (13.6% vs 13.4%, RR: 1.0, 95% CI: 0.9–1.1, p=0.69). Similarly, 30-day rates of all-cause mortality (5.4% vs 6.1%, RR: 0.9, 95% CI: 0.8–1.1, p=0.30) and stroke (2.0% vs 2.4%, RR: 0.8, 95% CI: 0.6–1.1, p=0.23) did not differ between diabetic and non-diabetic patients. Accordingly, in multivariate analysis, DM was not an independent predictor of mortality. Conclusions In this global collaboration, diabetic patients undergoing transcatheter aortic valve replacement had more cardiovascular comorbidities, were younger and had a higher body mass index than non-diabetics. They had similar periprocedural complications, in-hospital and 30-day mortality rates. In multivariate analysis, diabetes was not associated with increased mortality. Predicted vs observed mortality in DM Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Dutch Heart Foundation; the Netherlands Organisation for Health Research and Development

Background The debate on the benefits and limitations of off-pump (OPCAB) coronary artery bypass grafting (CABG) on long-term outcomes is not yet settled. This study aimed to compare the impact of OPCAB vs on-pump CABG on long-term outcomes and to evaluate possible public health implications linked to their use. Methods The PRIORITY project was planned to evaluate the long-term outcomes of two prospective multicenter studies on CABG conducted between 2002-2004 and 2007-2008. Data on isolated CABG were linked to administrative data in order to retrieve patients' late outcome. Time-to-event distributions were analyzed accordingly to primary event-type (death, major adverse cardiac events (MACEs)) using the Kaplan-Meier and the Cox proportional hazards methods. Results The study population consisted of 11 021 patients who underwent isolated CABG (27.2% OPCAB). The median follow-up time was 8.0 years (interquartile range 7.6-10.0 years). OPCAB had comparable late all-cause mortality to on-pump CABG (HR 0.94, 95%CI 0.85-1.03, p = 0.19), but it was associated to an increased risk of MACE (adjusted HR 1.14, 95%CI 1.06-1.23, p = 0.001). In particular, OPCAB had an increased risk of repeated revascularization with percutaneous cardiac intervention (PCI) (adjusted HR 1.33, 95%CI 1.16-1.53, p Conclusions OPCAB does not affect long-term mortality, but it significantly increases the risk of MACEs. In particular, OPCAB had an increased risk of repeated revascularization with PCI. These findings may have important implications towards health resources allocation. Key messages Off-pump coronary artery bypass grafting strategy is associated with an increased long-term risk of MACE and repeated PCI. Off-pump strategy is mainly based on operator preferences and can have important implications in terms of healthcare costs.

Background The advantages to use the bilateral internal thoracic artery grafting (BITA) technique for coronary artery bypass grafting (CABG) have been recently questioned, but data on long-term follow-up is limited. Using data from the PRIORITY project, this study aims to assess the outcome with the use of BITA grafting and its implications for public health. Methods The PRIORITY project was planned to evaluate the long-term outcomes of two prospective multicenter studies on CABG conducted between 2002-2004 and 2007-2008. Data on isolated CABG were linked to administrative data in order to retrieve patients' late outcome. Time-to-event distributions were analyzed accordingly to primary event-type (death, major adverse cardiac events (MACEs)) using the Kaplan-Meier and the Cox proportional hazards methods. Results The study population consisted of 11021 patients who underwent isolated CABG. BITA grafting was employed in 24.6% of patients. The median follow-up time was 8.0 years (interquartile range 7.6-10.0 years). After adjustment for potential confounding factors, BITA grafting was significantly associated with better survival (HR 0.85, 95%CI 0.76-0.95, p = 0.003). Moreover, using BITA grafting reduced the incidence of MACE (HR 0.87, 95%CI 0.80-0.94, p = 0.001), showing to be a protective factor for recurrent acute myocardial infarction (HR 0.84, 95%CI 0.71-0.99, p = 0.05) and for rehospitalization for percutaneous cardiac intervention (HR 0.82, 95%CI 0.70-0.96, p = 0.013). Conclusions BITA grafting during isolated CABG is associated with survival advantage at 10-year with a significantly reduced incidence of MACE. Being the choice to perform isolated CABG with or without BITA based mainly on operator personal preferences, these findings may have important implications from a public health perspective. Key messages The choice to perform CABG with or without BITA grafting is associated to different outcomes. The choice to perform CABG with or without BITA grafting is mainly based on operator preferences and may have important implications in terms of healthcare expenditures.

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.

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

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.

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.

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

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 Young patients requiring myocardial revascularization are considered at low operative risk, but data on their outcome are scarce. This study was undertaken to evaluate the prevalence and 30-day mortality of patients aged

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 prognostic impact of failed mitral valve repair (FMR) on in-hospital outcome after redo mitral valve surgery has not been thoroughly investigated. OBJECTIVES: The prognostic impact of failed mitral valve repair (FMR) on in-hospital outcome after redo mitral valve surgery has not been thoroughly investigated.METHODS: Hospital outcomes after redo mitral valve surgery because of an FMR in patients from nine European centres were reported. Logistic regressions identified predictors of mortality in combined or isolated redo mitral valve operations. Hospital outcome was compared between propensity-matched cohorts with FMR and native mitral valves in the context of redo surgery and FMR versus failed prostheses.RESULTS: A total of 246 patients with FMR yielded a 6.5% mortality rate at redo surgery. FMR per se did not impact mortality at multivariable analysis (P = 0.64). A preoperative Global Initiative for Chronic Obstructive Lung Disease (GOLD) score >= 2 chronic obstructive lung disease (COPD) (OR 15.2, P < 0.01), left ventricular ejection fraction = 2 COPD (OR 12.3, P = 0.049), age at surgery (OR 1.15 for each incremental year, P = 0.049) and cardiopulmonary bypass duration (OR 1.02, P = 0.022) predicted mortality in isolated redo mitral valve surgery for FMR. The fourth (> 68 years = 13.8% mortality) and the fifth quintiles of age (>= 73.4 years = 14.8%) reported the highest mortality (OR 3.8 and 4.2 respectively, P = 0.002) in this subgroup. Propensity-matched cohorts of FMR and native mitral valves in the context of redo surgery showed no differences in terms of mortality (P = 0.69) and major morbidity (acute myocardial infarction P = 0.31, stroke P = 0.65, acute kidney injury P = 1.0), whereas more perioperative dialysis (P = 0.04) and transfusions (P = 0.02) were noted in propensity-matched failed prostheses compared to FMR.CONCLUSIONS: A failed mitral repair does not impact hospital outcome of redo surgery. Given the role of severe left ventricular dysfunction and advanced age on hospital mortality rates, an early indication for redo surgery may improve outcome.

International audience; INTRODUCTION: This study was planned to investigate the impact of severe bleeding and blood transfusion on the development of stroke after coronary surgery.METHODS: This cohort study includes 2357 patients undergoing isolated CABG from the prospective European Coronary Artery Bypass Grafting (E-CABG) registry. Severity of bleeding was categorized according to the Universal Definition of Perioperative Bleeding (UDPB), E-CABG and PLATO definitions.RESULTS: Thirty patients (1.3%) suffered postoperative stroke. The amount of transfused red blood cell (RBC) (OR 1.10, 95%CI 1.03-1.18), preoperative use of unfractioned heparin (OR 4.49, 95%CI 1.91-10.60), emergency operation (OR 3.97, 95%CI 1.47-10.74), diseased ascending aorta (OR 4.62, 95%CI 1.37-15.65) and use of cardiopulmonary bypass (p = 0.043, OR 4.85, 95%CI 1.05-22.36) were independent predictors of postoperative stroke. Adjusted analysis showed that UDPB classes 3-4 (crude rate: 3.6% vs. 1.0%; adjusted OR 2.66, 95%CI 1.05-6.73), E-CABG bleeding grades 2-3 (crudes rate: 6.3% vs. 0.9%; adjusted OR 5.91, 95%CI 2.43-14.36), and PLATO life-threatening bleeding (crude rate: 2.5% vs. 0.6%, adjusted OR 3.70, 95%CI 1.59-8.64) were associated with an increased risk of stroke compared with no or moderate bleeding.CONCLUSIONS: Bleeding and blood transfusion are associated with an increased risk of stroke after CABG, which is highest in patients with 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.

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

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.

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 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.