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Background: Head-to-head comparisons of devices for transcatheter aortic valve implantation (TAVI) are mostly limited to 2-arm studies so far. The aim of this study was to compare simultaneously outcomes of the most used, second- and third-generation transcatheter aortic valves in a real-world population. Methods: A total of 2728 patients undergoing TAVI with different second- and third-generation devices, and enrolled in the multicenter, prospective OBSERVANT II study (Observational Study of Effectiveness of TAVI With New Generation Devices for Severe Aortic Stenosis Treatment) from December 2016 to September 2018 were compared according to the transcatheter aortic valve received. Outcomes were adjudicated through a linkage with administrative databases, and adjusted using inverse propensity of treatment weighting. The primary end point was the composite of all-cause death, stroke and rehospitalization for heart failure at 1-year. Rates were reported consecutively for Evolut R, Evolut PRO, SAPIEN 3, ACURATE neo, and Portico groups. Results: The primary end point did not differ among groups (23.9% versus 24.7% versus 21.5% versus 23.7% versus 27.4%, respectively, P =0.56). Permanent pacemaker implantation was significantly lower for patients receiving SAPIEN 3 (19.9% versus 19.3% versus 12.5% versus 14.7% versus 22.1%, respectively, P P P Conclusions: Data from real-world practice showed low and comparable rates of complications after TAVI considering all the available devices. Patients receiving SAPIEN 3 valve had lower rates of paravalvular regurgitation and permanent pacemaker implantation, but higher transprosthetic gradients.

Background Diabetes Mellitus (DM) affects a third of patients with symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). DM is a well-known risk factor for cardiac surgery, but its prognostic impact in TAVI patients remains controversial. This study aimed to evaluate outcomes in diabetic patients undergoing TAVI. Methods This multicentre registry includes data of > 12,000 patients undergoing transfemoral TAVI. We assessed baseline patient characteristics and clinical outcomes in patients with DM and without DM. Clinical outcomes were defined by the second valve academic research consortium. Propensity score matching was applied to minimize potential confounding. Results Of the 11,440 patients included, 31% (n = 3550) had DM and 69% (n = 7890) did not have DM. Diabetic patients were younger but had an overall worse cardiovascular risk profile than non-diabetic patients. All-cause mortality rates were comparable at 30 days (4.5% vs. 4.9%, RR 0.9, 95%CI 0.8–1.1, p = 0.43) and at one year (17.5% vs. 17.4%, RR 1.0, 95%CI 0.9–1.1, p = 0.86) in the unmatched population. Propensity score matching obtained 3281 patient-pairs. Also in the matched population, mortality rates were comparable at 30 days (4.7% vs. 4.3%, RR 1.1, 95%CI 0.9–1.4, p = 0.38) and one year (17.3% vs. 16.2%, RR 1.1, 95%CI 0.9–1.2, p = 0.37). Other clinical outcomes including stroke, major bleeding, myocardial infarction and permanent pacemaker implantation, were comparable between patients with DM and without DM. Insulin treated diabetics (n = 314) showed a trend to higher mortality compared with non-insulin treated diabetics (n = 701, Hazard Ratio 1.5, 95%CI 0.9–2.3, p = 0.08). EuroSCORE II was the most accurate risk score and underestimated 30-day mortality with an observed-expected ratio of 1.15 in DM patients, STS-PROM overestimated actual mortality with a ratio of 0.77 and Logistic EuroSCORE with 0.35. Conclusion DM was not associated with mortality during the first year after TAVI. DM patients undergoing TAVI had low rates of mortality and other adverse clinical outcomes, comparable to non-DM TAVI patients. Our results underscore the safety of TAVI treatment in DM patients. Trial registration The study is registered at clinicaltrials.gov (NCT03588247).

We sought to assess the clinical impact of Covid-19 infection on mortality in patients with Non-ST elevation myocardial infarction (NSTEMI) admitted during the national outbreak in Italy.We analysed a nationwide, comprehensive, and universal administrative database of consecutive NSTEMI patients admitted during lockdown for Covid-19 infection (March,11st - May 3rd, 2020) and the equivalent periods of the previous 5 years in Italy. The observed rate of 30-day and 6-month all-cause mortality of NSTEMI patients with and without Covid-19 infection during the lockdown was compared with the expected rate of death according to the trend of the previous 5 years.During the period of observation, 48.447 NSTEMI hospitalizations occurred in Italy. Among these, 4981 NSTEMI patients were admitted during the 2020 outbreak: 173 (3.5%) with and 4808 (96.5%) without a Covid-19 diagnosis. According to the 5-year trend, the 2020 expected rate of 30-day and 6-month all-cause mortality was 6.5% and 12.2%, while the observed incidence of death was 8.3% (p = 0.001) and 13.6% (p = 0.041), respectively. Excluding NSTEMI patients with a Covid-19 diagnosis, the 6-month mortality rate resulted in accordance with the prior 5-year trend. After multiple corrections, the presence of Covid-19 diagnosis resulted one of the independent predictors of all-cause mortality at 30 days [adjusted odds ratio (OR) 4.3; 95% confidence intervals (CI) 2.90-6.23; p 0.0001] and 6 months (adjusted OR 3.5; 95% CI: 2.43-5.03; p 0.0001).During the 2020 national outbreak in Italy, a concomitant diagnosis of Covid-19 in NSTEMI was associated with a significantly higher rate of mortality.

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

The long-term clinical benefits of myocardial revascularization in a contemporary, nationwide cohort of acute myocardial infarction (AMI) survivors are unclear. We aimed to compare the mortality rates and clinical outcomes at 8 years of patients admitted in Italy for a first AMI managed with or without myocardial revascularization during the index event. This is a national retrospective cohort study that enrolled patients admitted for a first AMI in 2012 in all Italian hospitals who survived at 30 days. The outcomes of interest were all-cause mortality, major cardio-cerebrovascular events (MACCE), and re-hospitalization for heart failure (HF) at 8 years. Time to events was analysed using a Cox and Fine and Gray multivariate regression model. A total of 127 431 patients with AMI were admitted to Italian hospitals in 2012. The study cohort consisted of 62 336 AMI events, of whom 63.8% underwent percutaneous or surgical revascularization ≤30 days of the index hospital admission. At 8 years, the cumulative incidence of all-cause death was 36.5% (24.6% in revascularized and 57.6% in not revascularized patients). After multiple corrections, the hazard ratio (HR) for all-cause mortality in revascularized vs. not revascularized patients was 0.61 (P

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

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

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. We sought to assess the clinical impact of COVID-19 infection on mortality in patients with ST-elevation myocardial infarction (STEMI) admitted during the national outbreak in Italy. Methods. We analysed a nationwide, comprehensive, and universal administrative database of consecutive STEMI patients admitted during lockdown for COVID-19 infection (11 March–3 May 2020) and the equivalent periods of the previous 5 years in Italy. The observed rate of 30-day and 6-month all-cause mortality of STEMI patients with and without COVID-19 infection during the lockdown was compared with the expected rate of death, according to the trend of the previous 5 years. Results. During the study period, 32.910 STEMI hospitalizations occurred in Italy. Among these, 4048 STEMI patients were admitted during the 2020 outbreak: 170 (4.2%) with and 3878 (95.8%) without a COVID-19 diagnosis. According to the 5-year trend, the 2020 expected rates of 30-day and 6-month all-cause mortality were 9.2% and 12.6%, while the observed incidences of death were 10.8% (p = 0.016) and 14.4% (p = 0.017), respectively. Excluding STEMI patients with a COVID-19 diagnosis, the mortality rate resulted in accordance with the prior 5-year trend. After multiple corrections, the presence of COVID-19 diagnosis was an independent predictor of all-cause mortality at 30 days [adjusted odds ratio (OR) 4.5; 95% confidence intervals (CI) 3.09–6.45; p < 0.0001] and 6 months (adjusted OR 3.6; 95% CI: 2.47–5.12; p < 0.0001). Conclusions.During the 2020 national outbreak in Italy, COVID-19 infection significantly increased the mortality trend in patients with STEMI.

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.

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

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

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.

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

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 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 Identifying potential tools that could help improving the standard of care and lead to a better allocation of economic resources represents a main objective of research in public health. Using data from the PRIORITY cohort, this study aims to describe inpatients costs after a discharge for isolated coronary artery bypass surgery (CABG). Methods The PRIORITY project was designed to evaluate the long-term outcomes of 2 large multicenter cohort studies on CABG conducted between 2002-04 and 2007-08. For each patient discharged alive after a CABG intervention, costs of hospitalizations were estimated as the sum of costs of all the admissions occurred during 3 years of follow-up. NHS reimbursement rates were used as standard costs (in Euros). Inpatients costs were analysed according to their baseline risk factors. Results Among the 7363 patients included in this analysis, the median 3-year hospitalization costs were 4341€ (IQR: 1865-11699). Median costs were around 4.000€ for subjects alive at the end of follow up but higher for patients dying within 1 (about 8.600€) and 2-3 years of follow up (about 20.000€). The presence of comorbidities (such as diabetes and cancer) lead to higher median hospitalization costs while the on-pump approach was associated to lower median cost. Sixteen per cent of patients were at zero cost having no re-hospitalizations during the 3 years of follow-up (97% alive). Subjects at zero cost received more frequently on-pump approach, had a lower frequency of cancer, arteriopathy and ictus, but a higher frequency of angina and infarction. Conclusions Inpatient costs after isolated CABG are affected by preoperative comorbidities and by operative variables that could be removed or managed. Identifying independent risk factors for re-hospitalization will lead to the definition of a preoperative clinical and decision-making path that will bring both a clinical advantage for the patient and an optimization of costs for the NHS. Key messages Inpatient costs after isolated CABG are affected by preoperative comorbidities and operative characteristics like the on-pump approach. Appropriate management of operative approaches mainly based on operator preferences can have important implications in terms of healthcare costs.

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 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 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.

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.

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

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

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.

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

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 =

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.