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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 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.

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.

Objective: This study sought to investigate the effect of body mass index on outcomes in patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation. Methods: A total of 12,381 patients undergoing transfemoral transcatheter aortic valve implantation were divided into body mass index categories: underweight (30 kg/m2). Primary endpoints were differences in 30-day and 1-year all-cause mortality. Secondary endpoints included all other clinical endpoints such as stroke. Univariate and multivariate odds ratios were calculated using logistic and cox regression analyses. Results: Two percent (n = 205) of patients were underweight, 29% (n = 3564) were normal weight, 44% (n = 5460) were overweight, and 25% (n = 3152) were obese. Thirty-day mortality was lower in overweight (5.3%, odds ratio, 0.73; 95% confidence interval, 0.61-0.88; P =.001) and obese patients (5.2%, odds ratio, 0.74; 95% confidence interval, 0.60-0.92; P =.006), but higher in underweight (9.8%, odds ratio, 1.51; 95% confidence interval, 0.92-2.47; P =.010) as compared to normal weight patients (6.9%). After multivariate adjustment, 30-day mortality was not significantly different across body mass index categories. However, 1-year mortality was higher in underweight patients (hazard ratio, 1.52; 95% confidence interval, 1.10-2.09; P =.011). Stroke rates were comparable between body mass index groups. Conclusions: For overweight and obese patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation, there was no 30-day difference in mortality compared with patients with normal weight. However, underweight patients showed higher rates of 1-year mortality after transcatheter aortic valve implantation.

Objectives This study aimed to compare differences in patient characteristics and clinical outcomes of nonagenarians undergoing transcatheter aortic valve replacement (TAVR) versus patients younger than 90 years of age and to test the predictive accuracy of the logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), the EuroSCORE II, and the STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) for mortality after TAVR in nonagenarians. Background The prevalence of severe aortic valve stenosis is increasing due to the rising life expectancy. However, there are limited data evaluating outcomes in patients older than 90 years of age. Moreover, the predictive accuracy of risk scores for mortality has not been evaluated in nonagenarian patients undergoing transfemoral TAVR. Methods The CENTER (Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation) collaboration (N = 12,381) is an international collaboration consisting of 3 national registries, 6 local or multicenter registries, and 1 prospective clinical study, selected through a systematic online search. The primary endpoint of this study was the difference in 30-day all-cause mortality and stroke after TAVR in nonagenarians versus patients younger than 90 years of age. Secondary endpoints included differences in baseline characteristics, in-hospital outcomes, and the differences in predictive accuracy of the logistic EuroSCORE, the EuroSCORE II, and STS-PROM. Results A total of 882 nonagenarians and 11,499 patients younger than 90 years of age undergoing transfemoral TAVR between 2007 and 2018 were included. Nonagenarians had considerably fewer comorbidities than their counterparts. Nevertheless, rates of 30-day mortality (9.9% vs. 5.4%; relative risk [RR]: 1.8; 95% confidence interval [CI]: 1.4 to 2.3; p = 0.001), in-hospital stroke (3.0% vs. 1.9%; RR: 1.5; 95% CI: 1.0 to 2.3; p = 0.04), major or life-threatening bleeding (8.1% vs. 5.5%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.004), and new-onset atrial fibrillation (7.9% vs. 5.2%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.01) were higher in nonagenarians. The STS-PROM adequately estimated mortality in nonagenarians, with an observed-expected mortality ratio of 1.0. Conclusions In this large, global, patient-level analysis, mortality after transfemoral TAVR was 2-fold higher in nonagenarians compared with patients younger than 90 years of age, despite the lower prevalence of baseline comorbidities. Moreover, nonagenarians had a higher risk of in-hospital stroke, major or life-threatening bleeding, and new-onset atrial fibrillation. The STS-PROM was the only surgical risk score that accurately predicted the risk of mortality in nonagenarians.

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 Although the improvement of therapeutic strategies is leading to a dramatic decline of in-hospital acute coronary syndrome (ACS) death rates, differences in care and prognosis of ACS patients exist when age, gender and admission department are considered. Methods The national administrative hospital discharge record (HDR) system was used. Only data recorded from January 1, 2017 to Dicember 31, 2018 were analyzed. This approach allowed to identify 205775 patients reporting ACS as primary or secondary diagnosis: 122812 with non-ST-elevation ACS (NSTE-ACS) and 82963 with ST-elevation ACS (STEMI). The ACS cohort was stratified by age ( Results Among the 205775 patients hospitalized for ACS, 6% of STEMI and 8.3% of NSTE-ACS patients have been treated only in a general medicine ward and have never passed through a specific cardiology ward. For STEMI patients, the proportion becomes 4% when males are considered, increases up to 10% for females and up to 13% for elderly patients (≥75 years). During the index hospitalization, about 25% of female and more than 30% of elderly patients with STEMI do not undergo a coronary procedure or other extensive investigations; the same happens only in about 10% of male and 6% of younger patients. The proportion of improperly managed patients reaches 35% for women aged ≥75 years. Conclusions In-hospital management of women and elderly patients with ST-elevation ACS does not completely comply with the recommended guidelines and exposes them to unfavourable prognosis. Key messages Women and elderly STEMI patients are markedly less intensively investigated and treated in cardiologic departments. This medical policy could lead to unfavourable prognosis.

Background Uncertainties on long-term outcomes after acute myocardial infarction (AMI) still exist, despite the ongoing progresses in the management of patients with AMI. This study aims to appraise early and 1-year outcome of patients hospitalized due to AMI and to describe the role of heart failure (HF) as complication affecting prognoses. Methods Retrospective nationwide cohort study based on administrative data on patients with AMI admitted in all Italian hospitals from 2007 to 2017. Index admission mortality rate (I-MR), 30-day and 1-year post-discharge mortality rate (PD-MR), and 30-day and 1-year total mortality rate (T-MR) were analysed; mortality average annual changes (AC) and their 95% CI were calculated; the Cox model, adjusting for age, sex, comorbidities and length of stay, was used to analyse 1-year PD-MR Results 1,148,820 patients were considered. From 2007 to 2017, both I-MR and T-MR up to 1 year decreased significantly (from 10.9 to 8.4%; AC: -0.28%; CI: -0.31 to -0.25 and from 20.2% to 17.1%: AC: -0.33%; CI: -0.39 to -0.28, respectively). From 2010, also the rate of PD-MR decreased significantly from 11.7% to 10.4%, with such favourable trend confirmed at multivariable analyses. The HF diagnosis at the index admission is always associated with a significant increase in the risk of death (1-year T-MR average: 43% and 12% in patients with or without HF, respectively; both patients with and without HF show a constant improvement in I-MR, T-MR and PD-MR over time. Conclusions In the last decade, the remarkable improvements in the in-hospital treatment of patients with AMI and in the overall prognosis up to 1 year are confirmed by a constant decrease in both early and long-term mortality. Since complication from HF remains a dangerous condition that significantly worsens the prognosis of the AMI patient, appropriate management strategies must be identified and implemented to guarantee best results from both clinic and public health perspective. Key messages Remarkable improvements achieved in overall prognosis after AMI over the past 10 years. HF confirms to be a condition able to worsen AMI patients’ prognosis.

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.

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

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

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.

BACKGROUND Transfemoral aortic valve replacement (TAVR) is a guideline-recommended treatment option for patients with severe aortic valve stenosis. Women and men present with different baseline characteristics, which may influence procedural outcomes. OBJECTIVES This study sought to evaluate differences between women and men undergoing transfemoral TAVR across the globe during the last decade. 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 TAVR (N = 12,381) from 2007 to 2018. In this retrospective analysis, the study examined differences in baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes between female and male patients. The study also assessed for temporal changes in outcomes and predictors for mortality per sex. RESULTS We included 58% (n = 7,120) female and 42% (n = 5,261) male patients. Women had higher prevalence of hypertension and glomerular filtration rate

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.

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.

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.

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.

To calculate the impact of stroke in Italy in 1998, expressed in terms of disability adjusted life years (DALYs) according to the WHO Global Burden of Disease (GBD) Study.The data on first-ever stroke incidence (FES), remission rate and case fatality derived from the health information system and a research on post-FES disability of the Friuli Venezia-Giulia (FVG) Region, were used to compute the years of life lived with disability (YLDs), which were added to the years of life lost due to premature mortality (YLLs), calculated from stroke mortality data, to obtain the DALYs. The results were extrapolated to the rest of Italy after examination of national stroke registries data.Standardized estimated incidence of FES in FVG in 1998 was lower (135 cases of FES per 100 000 inhabitants) than that reported in other published national and international studies. Estimated case fatality rate and distribution of post-FES disability did not differ from other similar studies. About 100 000 YLLs and 273 000 YLDs due to FES were estimated in 1998 for Italy.The estimated proportion of the YLDs on total DALYs (27%) is comparable with that obtained in the EURO-A group (the European area including Italy) of the GBD 2000 Study (31%), and the Australian BoD Study (35%).

We read with interest the comments by Dr. Spadaccio and colleagues regarding the results of the OBSERVANT (Italian Observational Multicenter Registry) study, and we thank them for giving us the opportunity to clarify some of the issues raised in their letter. First, we would like to emphasize that

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

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.

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

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.

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

Transcatheter aortic valve replacement (TAVR) has being increasingly offered in low and intermediate surgical risk patients with severe aortic stenosis (AS), although the effectiveness of TAVR in this particular population has not been demonstrated yet. This analysis aims to describe 1-year clinical

nary heart disease death. The multivariate adjusted risks lor luture atrial fibrillation were 1.464old (p