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Aims. The impact of the COVID-19 pandemic on the event rate of patients with ischemic stroke has been poorly investigated. We sought to evaluate the impact of the COVID-19 infection on mortality in patients with ischemic stroke admitted during the 2020 pandemic in Italy. Methods. We analyzed a nationwide, comprehensive, and universal administrative database of patients who were admitted for ischemic stroke during and after the national lockdown for the COVID-19 infection in 2020, and the equivalent periods over the previous 5 years in Italy. The 2020 observed hospitalization and mortality rates of stroke patients with and without COVID-19 infection were compared with the expected rates, in accordance with the trend of the previous 5 years. Results. During the period of observation, 300,890 hospitalizations for ischemic stroke occurred in Italy. In 2020, 41,302 stroke patients (1102 with concomitant COVID-19 infection) were admitted at 771 centers. The rate of admissions for ischemic stroke during the 2020 pandemic was markedly reduced compared with previous years (percentage change vs. 2015: −23.5). Based on the 5 year trend, the 2020 expected 30 day and 1 year mortality rates were 9.8% and 23.9%, respectively, and the observed incidence of death rates were 12.2% and 26.7%, respectively (both p < 0.001). After multiple corrections, higher rates of mortality were observed among patients admitted for stroke with a concomitant COVID-19 diagnosis. Conclusions. During the COVID-19 pandemic in 2020 in Italy, the rate of hospitalizations for ischemic stroke was dramatically reduced, although both the 30 day and 1 year mortality rates increased compared with the previous 5 year trend.

Purpose To evaluate the impact of individual institutions on the outcome after surgery for Stanford type A aortic dissection (TAAD). Methods This is an observational, multicenter, retrospective cohort study including 3902 patients who underwent surgery for TAAD at 18 university and non-university hospitals. Results Logistic regression showed that four hospitals had increased risk of in-hospital mortality, while two hospitals were associated with decreased risk of in-hospital mortality. Risk-adjusted in-hospital mortality rates were lower in four hospitals and higher in other four hospitals compared to the overall in-hospital mortality rate (17.7%). Participating hospitals were classified as overperforming or underperforming if their risk-adjusted in-hospital mortality rate was lower or higher than the in-hospital mortality rate of the overall series, respectively. Propensity score matching yielded 1729 pairs of patients operated at over- or underperforming hospitals. Overperforming hospitals had a significantly lower in-hospital mortality (12.8% vs. 22.2%, p p = 0.009) compared to underperforming hospitals. Aggregate data meta-regression of the results of participating hospitals showed that hospital volume was inversely associated with in-hospital mortality (p = 0.043). Hospitals with an annual volume of less than 15 cases had an increased risk of in-hospital mortality (adjusted OR, 1.345, 95% CI 1.126–1.607). Conclusion The present findings indicate that there are significant differences between hospitals in terms of early outcome after surgery for TAAD. Low hospital volume may be a determinant of poor outcome of TAAD. Trial registration ClinicalTrials.gov Identifier: NCT04831073.

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.

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: The aim of the present study was to evaluate the risk of late mortality and major adverse cardiovascular and cerebral events after coronary artery bypass grafting (CABG) in patients with prior percutaneous coronary intervention (PCI). Methods: A total of 2948 patients undergoing isolated CABGs were included in a prospective multicenter registry. Outcomes were adjusted for multiple covariates in logistic regression, Cox proportional hazards analysis and competing risk analysis. Results: In all, 2619 patients fulfilled the inclusion criteria of this analysis. Of them, 2199 (79.1%) had no history of PCI and 420 (20.9%) had a prior PCI. An adjusted analysis showed that a single prior PCI and multiple prior PCIs did not increase the risk of 30-day and 5-year mortality. Patients with multiple prior PCIs had a significantly higher risk of 5-year myocardial infarction (SHR 2.566, 95%CI 1.379–4.312) and repeat revascularization (SHR 1.774, 95%CI 1.140–2.763). Similarly, 30-day and 5-year mortality were not significantly increased in patients with prior PCI treatment of single or multiple vessels. Patients with multiple vessels treated with PCI had a significantly higher risk of 5-year myocardial infarction (SHR 2.640, 95%CI 1.497–4.658), repeat revascularization (SHR 1.648, 95%CI 1.029–2.638) and stroke (SHR 2.215, 95%CI 1.056–4.646) at 5-year. The risk for repeat revascularization was also increased with a prior single vessel PCI, but not for other outcomes. Conclusions: Among patients undergoing CABGs, multiple prior PCIs seem to increase the risk of late myocardial infarction and the need for repeat revascularization, but not the risk of mortality.

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.

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

Introduction Postcardiotomy veno-arterial extracorporeal membrane oxygenation (V-A-ECMO) is associated with significant mortality. Identification of patients at very high risk for death is elusive and the decision to initiate V-A-ECMO is based on clinical judgment. The prognostic impact of pre-V-A-ECMO arterial lactate level in these critically ill patients has been herein evaluated. Methods A systematic review was conducted to identify studies on postcardiotomy VA-ECMO for the present individual patient data meta-analysis. Results Overall, 1269 patients selected from 10 studies were included in this analysis. Arterial lactate level at V-A-ECMO initiation was increased in patients who died during the index hospitalization compared to those who survived (9.3 vs 6.6 mmol/L, p < 0.0001). Accordingly, in hospital mortality increased along quintiles of pre-V-A-ECMO arterial lactate level (quintiles: 1, 54.9%; 2, 54.9%; 3, 67.3%; 4, 74.2%; 5, 82.2%, p < 0.0001). The best cut-off for arterial lactate was 6.8 mmol/L (in-hospital mortality, 76.7% vs. 55.7%, p < 0.0001). Multivariable multilevel mixed-effect logistic regression model including arterial lactate level significantly increased the area under the receiver operating characteristics curve (0.731, 95% CI 0.702–0.760 vs 0.679, 95% CI 0.648–0.711, DeLong test p < 0.0001). Classification and regression tree analysis showed the in-hospital mortality was 85.2% in patients aged more than 70 years with pre-V-A-ECMO arterial lactate level ≥6.8 mmol/L. Conclusions Among patients requiring postcardiotomy V-A-ECMO, hyperlactatemia was associated with a marked increase of in-hospital mortality. Arterial lactate may be useful in guiding the decision-making process and the timing of initiation of postcardiotomy V-A-ECMO.

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

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

Background Recent surgical bovine pericardial prostheses are widely used despite limited data on their long-term durability. Methods This is a comparative analysis of the outcome of the Trifecta (Abbott, Abbott Park, IL) and Perimount Magna Ease (Edwards, Lifesciences Corp, Irvine, CA) bioprostheses from the FinnValve registry, a Finnish nationwide database including patients with aortic stenosis who underwent transcatheter or surgical aortic valve replacement with a bioprosthesis between 2008 and 2017. Results Overall 2216 patients (mean age, 74.1 ± 6.7 years; age Conclusions The Trifecta aortic bioprosthesis is associated with a higher occurrence of repeat aortic valve replacement for structural valve failure compared with the Perimount Magna Ease bioprosthesis. Further comparative studies with echocardiographic data on structural valve deterioration and longer follow-up are needed to confirm these findings.

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

Background: It is unclear whether peripheral arterial cannulation is superior to central arterial cannulation for postcardiotomy veno-arterial extracorporeal membrane oxygenation (VA-ECMO). Methods: A systematic review was conducted using PubMed, Scopus, and Google Scholar to identify studies on postcardiotomy VA-ECMO for the present individual patient data (IPD) meta-analysis. Analysis was performed according to the intention-to-treat principle. Results: The investigators of 10 studies agreed to participate in the present IPD meta-analysis. Overall, 1269 patients were included in the analysis. Crude rates of in-hospital mortality after central versus peripheral arterial cannulation for VA-ECMO were 70.7% vs. 63.7%, respectively (adjusted OR 1.38, 95% CI 1.08–1.75). Propensity score matching yielded 538 pairs of patients with balanced baseline characteristics and operative variables. Among these matched cohorts, central arterial cannulation VA-ECMO was associated with significantly higher in-hospital mortality compared to peripheral arterial cannulation VA-ECMO (64.5% vs. 70.8%, p = 0.027). These findings were confirmed by aggregate data meta-analysis, which showed that central arterial cannulation was associated with an increased risk of in-hospital mortality compared to peripheral arterial cannulation (OR 1.35, 95% CI 1.04–1.76, I2 21%). Conclusions: Among patients requiring postcardiotomy VA-ECMO, central arterial cannulation was associated with an increased risk of in-hospital mortality compared to peripheral arterial cannulation. This increased risk is of limited magnitude, and further studies are needed to confirm the present findings and to identify the mechanisms underlying the potential beneficial effects of peripheral VA-ECMO.

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.

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

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

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

Objective Stroke is a frequent complication occurring early and late after surgical aortic valve replacement. There is an unmet clinical need for simple tools to assess postoperative stroke risk. We sought to assess the predictive performance of Congestive heart failure; Hypertension; Age ≥75 (doubled); Diabetes mellitus; prior Stroke, transient ischemic attack or thromboembolism (doubled); Vascular disease; Age 65 to 74; Sex category (female) (CHA2DS2-VASc) score in patients undergoing surgical aortic valve replacement with a bioprosthesis. Methods Seven hundred fourteen patients undergoing isolated surgical aortic valve replacement with a bioprosthesis at 4 university hospitals were included. Data were collected retrospectively from patient records and monitored by an independent party. Results Median follow-up time was 4.8 years. Mean CHA2DS2-VASc score was 4.1 ± 1.6. Low (scores, 0-1), high (scores, 2-4), and very high (scores, 5-9) CHA2DS2-VASc scores were observed in 39 (5.5%), 400 (56.0%), and 262 (38.5%) patients, respectively. Incidences of stroke or transient ischemic attack at 1 year were 2.6%, 4.8%, and 10.7%; at 5 years incidences were 5.2%, 14.0%, and 21.9%; and at 10 years incidence were 5.2%, 20.7%, and 37.9% for patients in low, high, and very high scores, respectively. Incidences of major bleeds at 1 year were 0%, 1.8%, and 2.7%; at 5 years incidences were 0%, 5.4%, and 8.7%; and at 10 years incidences were 0%, 9.0%, and 27.1%, respectively. Competing risk analysis showed that patients with CHA2DS2-VASc score of 5 through 9 had a significantly increased risk of stroke or transient ischemic attack (hazard ratio, 4.75; 95% confidence interval, 1.09-20.6; P = .037) irrespective of preoperative or new-onset in-hospital atrial fibrillation compared with low-risk patients. Conclusions CHA2DS2-VASc is a valuable tool to identify patients with increased risk of stroke and major bleeding, and for whom alternative strategies for prevention of late neurologic complications should be adopted.

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

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

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

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 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.