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Aims Surgical aortic valve replacement has been the treatment of choice for patients with aortic valve disease before the arrival of transcatheter aortic valve replacement (TAVI), although limited by degeneration of the bioprosthesis. “Redo” intervention itself is burdened by high risk of complications and valve-in-valve (ViV) TAVI could be a valid strategy of redo for patients with comorbidities. Methods and results Two independent reviewers screened all studies investigating patients undergoing ViV TAVI. Mortality at 30 days and at 1 year was the primary end point. Of 286 studies identified, 26 articles were included in this review with a total of 1448 patients. Median age was 78.8 years, 57.7% male. Median STS score and Logistic EuroSCORE were 9.4% and 31.3% respectively. Stenosis (45%) was the leading cause of prosthesis failure. Transfemoral approach was preferred (76%), with a prevalence of balloon expandable valves (73.3%). Mean follow up was 376 days. Overall and cardiovascular mortality at 30 days was 6.5% and 5.5% respectively, while at 1 year it was 14.5% and 8.9% respectively. At meta-regression analysis study year (p Conclusions ViV TAVI offers a valid strategy to treat high risk patients with a failure of bioprosthesis with satisfying results in terms of short and mid-term mortality. Future studies are needed to find predictors of long term survival and outcomes in lower risk patients.

Objectives The aim of this prospective study was to validate an echocardiographic protocol derived from 5 HeartWare left ventricular assist device (HVAD) patients for the noninvasive evaluation of right atrial pressure (RAP) and left atrial pressure (LAP) in HVAD patients. Background Echocardiography is an invaluable tool to optimize medical treatment and pump settings and also for troubleshooting residual heart failure. Little is known about the echocardiographic evaluation of hemodynamic status in HVAD patients. Methods Right heart catheterization and Doppler echocardiography were performed in 35 HVAD patients. Echocardiography-estimated RAP (eRAP) was assessed using inferior vena cava diameter, hepatic venous flow analysis, and tricuspid E/e′ ratio. Echocardiography-estimated LAP was assessed using E/A ratio, mitral E/e′ ratio, and deceleration time. Results eRAP and estimated LAP significantly correlated with invasive RAP and LAP (respectively, r = 0.839, p Conclusions Doppler echocardiography accurately estimated hemodynamic status in HVAD patients. This algorithm reliably detected high RAP and LAP. Notably, high RAP was associated with high wedge pressure and adverse outcome. The benefit of noninvasive estimation of hemodynamic status in the clinical management of patients with left ventricular assist devices needs further evaluation.

Funding Acknowledgements Type of funding sources: None. Background Non-invasive ventilation (NIV) is an established treatment for acute decompensated heart failure (ADHF). Purpose The aim of the present analysis was to evaluate the feasibility of continuous positive airway pressure (CPAP) in patients with myocardial infarction (MI) and ADHF, during percutaneous coronary intervention (PCI). Methods Consecutive patients admitted for MI, receiving CPAP for ADHF in the cath lab during PCI were retrospectively included. The main study outcome was the feasibility of CPAP, intended as well tolerated by the patient and exclusive cardiology staff management. Results Between December 2018 and October 2020, 15 patients were included; median age was 79 (40-87 IQR) years, 8 (53%) were males, 9 (60%) presented with STEMI and 10 (67%) in cardiogenic shock. At admission median ejection fraction was 35 (20-60 IQR) % and 6 (40%) patients had severe mitral regurgitation. Mean PaO2/ FiO2 was 188.1 ± 74.9 mmHg/%, mean lactate level was 2.6 ± 1.5 mmol/L and NTproBNP 7882 (3139-35000 IQR) ng/L. The CPAP was set with a median FiO2 of 50 (35-80 IQR) % with a PEEP of 7.5 (5-10 IQR) mmHg. CPAP was feasible in 14 (93%) patients, as in only one case it was interrupted for patient’s intolerance. CPAP was always managed by nurses of the cath lab, without the support of anesthetist. One patient suffered cardiac arrest that led to CPAP interruption for resuscitation maneuvers. No patients underwent intubation in the cath lab. Post-procedural PaO2/FiO2 ratio substantially improved to 259.4 ± 96.9 mmHg/% (p = 0.03) and lactate decreased to 1.5 ± 0.5 mmol/L (p = 0.01, 42% median reduction). One patient died in-hospital due to underlying disease, unrelated to study procedure. Conclusion CPAP during PCI in patients with MI and ADHF was feasible, well tolerated and easily manageable. Larger studies are warranted to confirm these results.

Patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions but to date only one official position paper related to left circulation thromboembolism has been published. This interdisciplinary paper, prepared with the involvement of eight European scientific societies, reviews the available evidence and proposes a rationale for decision making for other PFO-related clinical conditions. In order to guarantee a strict evidence-based process, we used a modified grading of recommendations, assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements were weighed and graded according to predefined scales. Despite being based on limited and observational or low-certainty randomised data, a number of position statements were made to frame PFO management in different clinical settings, along with suggestions for new research avenues. This interdisciplinary position paper, recognising the low or very low certainty of existing evidence, provides the first approach to several PFO-related clinical scenarios beyond left circulation thromboembolism and strongly stresses the need for fresh high-quality evidence on these topics.

Introduction Accurate predictors of good clinical response after MitraClip implant in patients with heart failure (HF) are still lacking. Aim of this study was to investigate the role of regurgitant fraction >50% as a marker of disproportionate functional mitral regurgitation (FMR) in identifying best responders to Mitraclip. Methods and results Data from 58 advanced HF patients (age 66 ± 8 years, 81% males, 63% NYHA class IV, LV ejection fraction (EF) 25.5 ± 5.5%) with disproportionate and proportionate FMR who underwent successful MitraClip implant were analyzed. After MitraClip all patient achieved mild (≤ 2+/4+) MR. During 12-month follow-up 18 patients (31%) had a major adverse cardiac event (MACE, i.e. cardiac death, urgent LVAD implant or heart transplantation, HF hospitalization). Disproportionate FMR (n = 48, 83%) was associated with a better clinical outcome (p = .003) while regurgitant volume and EROA were not. TAPSE ≤14 mm was associated with worse outcome (p = .018). At multivariable analysis only disproportionate MR and TAPSE ≤14 mm showed a significant association with MACE (p = .017 and p = .02, respectively). A reverse left ventricular remodeling (i.e., reduction on LV end-diastolic diameter and end-diastolic volume) was achieved only in the disproportionate FMR group. Conclusions In conclusion, disproportionate FMR assessed by regurgitant fraction and RV dysfunction assessed by TAPSE may help the selection of HF patients candidates for MitraClip therapy.

Background Surgical aortic valve replacement has been the treatment of choice for patients with aortic valve disease before the arrival of transcatheter aortic valve replacement (TAVI), although limited by degeneration of the bioprosthesis. “Redo” intervention itself is burdened by high risk of complications and valve-in-valve (ViV) TAVI could be a valid strategy of redo for patients with comorbidities. The aim of this meta-analysis is to give an overview of the state of the art of ViV TAVI in high-risk patients, analyzing efficacy, safety, intra-hospital outcomes and 1-year outcomes and assess predictors of survival at short and mid-term follow up. Methods Two independent reviewers screened all studies investigating patients undergoing ViV TAVI. PubMed database was searched for reports published in English according to the following highly sensitive strategy: (Transcatheter[All Fields] AND “aortic”[All Fields]) AND valve-in-valve[All Fields] AND “implantation”[All Fields] NOT (review[pt] OR editorial[pt] OR letter[pt])AND “humans”[MeSH Terms]). Mortality at 30 days and at 1 year were the primary end point, while procedural and short-term outcomes and echocardiographic parameters at hospital discharge were the secondary end points. Results Of 286 studies identified, 26 articles were included, with a total of 1448 patients. Median age was 78.8 years, 57.7% of the patients were male. Median STS-predicted risk of mortality was 9.4% while median Logistic EuroSCORE was 31.3%. Median age of bioprosthesis was 10 years with 84.6% of stented valves. Stenosis (45%), followed by regurgitation (31%) and mixed defects (21%) were the causes of prosthesis failure. Diameter of the degenerated valve was ≤21 mm in 25.4%, 22–25 mm in 55% and >25mm in 11.7% of the patients. Transfemoral approach was preferred (76%), with a prevalence of balloon expandable valve (73.3%). Mean post procedural gradient was 16.7±0.8 mmHg. Mean follow up was 376 days. Overall and cardiovascular mortality at 30 days was 6.5% and 5.5% respectively, while at 1 year it was 14.5% and 8.9% respectively. Regarding short-term outcomes, overall bleeding (10.4%), pacemaker implantation (9.4%) and vascular complications (8.3%) were the most common peri-procedural complications, while stroke (2.3%), myocardial infarction (2.7%) and coronary obstruction (2.8%) were less frequent. At meta-regression analysis study year (p Conclusions Percutaneous valve-in-valve aortic valve implantation offers a valid strategy to treat high risk patients with a degenerative bioprosthesis. Short and mid-term outcomes are substantially superimposable to those of TAVI, except for coronary obstruction which appears more frequent. Future studies are needed to find predictors of long- term survival and outcomes in lower risk patients. Outcome of VIV TAVI Funding Acknowledgement Type of funding source: None

Aim: To evaluate sex difference in culprit plaque features at optical coherence tomography (OCT) and major adverse cardiovascular events at follow-up. Patients and methods: We analyse data from the OCT-FORMIDABLE (OCT-Features Of moRphology, coMposItion anD instABility of culprit and pLaquE in acute coronary syndrome [ACS] patients) registry. A total of 285 patients (20%, 58 females) were included. Results: Females with ST segment elevation myocardial infarction showed a longer ruptured area of the plaque (8.6 ± 7.6 vs 4.6 ± 5.4; p = 0.003) and a major necrotic core macrophage infiltration (43 vs 17%; p = 0.017). Females with non-ST segment elevation-ACS had less lipidic plaques (62 vs 80%; p = 0.04). No between-group sex differences in major adverse cardiovascular events emerged at follow-up (5 vs 9%; p = 0.88 in ST segment elevation myocardial infarction group and 19 vs 15%; p = 0.6 in non-ST segment elevation-ACS group). At multivariate analysis, female sex was not a major risk of plaque rupture (hazard ratio [HR]: 1.59, CI: 0.44–5.67; p = 0.48). Conclusion: Female sex seems to have no significant impact. ClincalTrial. gov registration number: NCT02486861.

Introduction and objectives For patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI), it is unclear whether angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) are associated with reduced mortality, particularly with preserved left ventricular ejection fraction (LVEF). The goal of this study was to determine the association between ACEI/ARB and mortality in ACS patients undergoing PCI, with and without reduced LVEF. Methods Data from the BleeMACS registry were used. The endpoint was 1-year all-cause mortality. The prognostic value of ACEI/ARB was tested after weighting by survival-time inverse probability and after adjustment by Cox regression, propensity score, and instrumental variable analysis. Results Among 15 401 ACS patients who underwent PCI, ACEI/ARB were prescribed in 75.2%. There were 569 deaths (3.7%) during the first year after hospital discharge. After multivariable adjustment, ACEI/ARB were associated with lower 1-year mortality, ≤ 40% (HR, 0.62; 95%CI, 0.43-0.90; P = .012). The relative risk reduction of ACEI/ARB in mortality was 46.1% in patients with LVEF ≤ 40%, and 15.7% in patients with LVEF > 40% (P value for treatment-by-LVEF interaction = .008). For patients with LVEF > 40%, ACEI/ARB was associated with lower mortality only in ST-segment elevation myocardial infarction (HR, 0.44; 95%CI, 0.21-0.93; P = .031). Conclusion The benefit of ACEI/ARB in decreasing mortality after an ACS in patients undergoing PCI is concentrated in patients with LVEF ≤ 40%, and in those with LVEF > 40% and ST-segment elevation myocardial infarction. In non–ST-segment elevation-ACS patients with LVEF > 40%, further studies are needed to assess the prognostic impact of ACEI/ARB.

Introduction: Bleeding is an independent risk factor of mortality in patients with acute coronary syndromes (ACS). BleeMACS project focuses on long-term bleeding events after hospital discharge, thus we evaluated gender-related differences in post-discharge bleeding among patients with ACS. Materials and methods: We investigated 13,727 ACS patients treated with percutaneous coronary intervention and discharged on dual antiplatelet therapy (either with clopidogrel or prasugrel/ticagrelor). Endpoint was defined as intracranial bleeding or any other bleeding leading to hospitalization and/or red blood transfusion. Results: Post-discharge bleeding was reported more frequently in females as compared with males (3.7% vs. 2.7%, log-rank P = 0.001). Females (n = 3165, 23%) were older compared to men (69.0 vs. 61.5 years, P < 0.001) and with more comorbidities. Hence, in multivariate analysis female sex was not identified as an independent risk factor of bleeding (HR 1.012, CI 0.805 to 1.274, P = 0.816). Administration of newer antiplatelet agents compared to clopidogrel was associated with over twofold greater bleeding rate in females (7.3% vs. 3.5%, log-rank P = 0.004), but not in males (2.6% vs. 2.7%, log-rank P = 0.887). Differences among females remained significant after propensity score matching (7.2% vs 2.4%, log-rank P = 0.020) and multivariate analysis confirmed that newer antiplatelet agents are independent risk factor for bleeding only in women (HR 2.775, CI 1.613 to 4.774, P < 0.001). Conclusions: Bleeding events occurred more frequently in women, but female sex itself was not independent risk factor. Administration of newer antiplatelet agents was identified as independent risk factor of bleeding after hospital discharge in female gender, but not in male patients.

Background: The prevalence and outcome of patients with cancer that experience acute coronary syndrome (ACS) have to be determined. Methods and results: The BleeMACS project is a multicentre observational registry enrolling patients with acute coronary syndrome undergoing percutaneous coronary intervention worldwide in 15 hospitals. The primary endpoint was a composite event of death and re-infarction after one year of follow-up. Bleedings were the secondary endpoint. 15,401 patients were enrolled, 926 (6.4%) in the cancer group and 14,475 (93.6%) in the group of patients without cancer. Patients with cancer were older (70.8±10.3 vs. 62.8±12.1 years, PConclusion: Cancer has a non-negligible prevalence in patients with acute coronary syndrome undergoing percutaneous coronary intervention, with a major risk of cardiovascular events and bleedings. Moreover, these patients are often undertreated from clinical despite medical therapy seems to be protective. Registration:The BleeMACS project (NCT02466854).

Resumen Introduccion y objetivos No esta clara la asociacion entre los inhibidores de la enzima de conversion de la angiotensina (IECA) o los antagonistas del receptor de la angiotensina II (ARA-II) y la mortalidad de los pacientes con sindrome coronario agudo (SCA) sometidos a intervencion coronaria percutanea (ICP) con fraccion de eyeccion del ventriculo izquierdo (FEVI) conservada. Nuestro objetivo es determinar dicha asociacion en pacientes con FEVI conservada o reducida. Metodos Se analizaron datos procedentes del registro BleeMACS. El objetivo principal fue la mortalidad a 1 ano. Se aplicaron ponderacion por la probabilidad inversa del tiempo de supervivencia y ajustes por regresion de Cox, puntuacion de propension y variables instrumentales. Resultados De los 15.401 pacientes con SCA sometidos a ICP, se prescribieron IECA/ARA-II al 75,2%. Se produjeron 569 muertes (3,7%) durante el primer ano tras el alta hospitalaria. Despues del ajuste multivariado, los IECA/ARA-II se asociaron con menor mortalidad, pero solo en los pacientes con FEVI ≤ 40% (HR = 0,62; IC95%, 0,43-0,90; p = 0,012). Con los IECA/ARA-II, la reduccion del riesgo relativo de la mortalidad estimada fue del 46,1% en los pacientes con FEVI ≤ 40% y del 15,7% en aquellos con FEVI > 40% (pinteraccion = 0,008). En los pacientes con FEVI > 40%, los IECA/ARA-II se asociaron con menor mortalidad solo por infarto agudo de miocardio con elevacion del segmento ST (HR = 0,44; IC95%, 0,21-0.93; p = 0,031). Conclusiones El beneficio de los IECA/ARA-II en mortalidad tras ICP por SCA se concentra en pacientes con FEVI ≤ 40% y aquellos con FEVI > 40% e infarto agudo de miocardio con elevacion del segmento ST. Se precisan estudios contemporaneos que analicen el impacto de los IECA/ARA-II en pacientes con SCA sin elevacion del segmento ST y FEVI > 40%.

The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions; however, the subject remains controversial and no official statements have been published. This interdisciplinary paper, prepared with involvement of eight European scientific societies, aims to review the available trial evidence and to define the principles needed to guide decision making in patients with PFO. In order to guarantee a strict process, position statements were developed with the use of a modified grading of recommendations assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements of particular management options were weighed and graded according to predefined scales. Despite being based often on limited and non-randomised data, while waiting for more conclusive evidence, it was possible to conclude on a number of position statements regarding a rational general approach to PFO management and to specific considerations regarding left circulation thromboembolism. For some therapeutic aspects, it was possible to express stricter position statements based on randomised trials. This position paper provides the first largely shared, interdisciplinary approach for a rational PFO management based on the best available evidence.

The association between prior stroke/transient ischemic attack (TIA) and clinical outcomes in patients with acute coronary syndrome (ACS) has not been well explored. We evaluated the impact of prior stroke/TIA on this specific patient population. We conducted an international multicenter study including 15 401 patients with ACS from the Bleeding Complications in a Multicenter Registry of Patients Discharged With Diagnosis of Acute Coronary Syndrome registry. They were divided into 2 groups: patients with and without prior stroke/TIA. The primary end point was death at 1-year follow-up. Prior stroke/TIA was associated with higher rate of 1-year death (8.7% vs 3.4%; P < .001). It was an independent predictor of 1-year death even after adjustment for confounding variables (odds ratio, 1.705; 95% confidence interval, 1.046-2.778; P = .032). Besides, patients with prior stroke/TIA had significantly increased 1-year reinfarction (5.6% vs 3.8%, P = .015), in-hospital bleeding (8.7% vs 5.8%, P < .001), and 1-year bleeding (5.2% vs 3.0%, P < .001). No difference of antithrombotic therapies or dual antiplatelet therapy (DAPT) types on outcomes was observed in patients with prior stroke/TIA. Prior stroke/TIA was associated with higher 1-year death for patients with ACS who underwent percutaneous coronary intervention. No benefits or harms were observed with different antithrombotic therapies or DAPT types in these patients.

Background A poor ability of recommended risk scores for predicting in-hospital bleeding has been reported in elderly patients with acute coronary syndromes (ACS). No study assessed the prediction of post-discharge bleeding in the elderly. The new BleeMACS score (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome), was designed to predict post-discharge bleeding in ACS patients. We aimed to assess the predictive ability of the BleeMACS score in elderly patients. Methods We assessed the incidence and characteristics of severe bleeding after discharge in ACS patients aged ≥ 75 years. Bleeding was defined as any intracranial bleeding or bleeding leading to hospitalization and/or red blood transfusion, occurring within the first year after discharge. We assessed the predictive ability of the BleeMACS score according to age by Fine–Gray proportional hazards regression analysis, calculating receiver-operating characteristic (ROC) curves and the area under the ROC curves (AUC). Results The BleeMACS registry included 15,401 patients of whom 3,376/15,401 (21.9%) were aged ≥ 75 years. Elderly patients were more commonly treated with clopidogrel and less often treated with ticagrelor or prasugrel. Of 3,376 elderly patients, 190 (5.6%) experienced post-discharge bleeding. The incidence of bleeding was moderately higher in elderly patients (hazard ratio [HR], 2.31, 95% confidence interval [CI], 1.92–2.77). The predictive ability of the BleeMACS score was moderately lower in elderly patients (AUC, 0.652 vs. 0.691, p = 0.001). Conclusion Elderly patients with ACS had a significantly higher incidence of post-discharge bleeding. Despite a lower predictive ability in older patients, the BleeMACS score exhibited an acceptable performance in these patients.

Background— Chronic liver disease is a known risk factor for perioperative morbidity and mortality in patients undergoing cardiac surgery. Very little data exist about such patients treated with transcatheter aortic valve replacement (TAVR). Our objective was to evaluate early and late clinical outcomes in a large cohort of patients with liver disease undergoing TAVR and to determine predictive factors of mortality among these patients. Methods and Results— This multicenter study collected data from 114 patients with chronic liver disease who underwent TAVR in 12 institutions. Perioperative and long-term outcomes were compared with a cohort of 1118 patients without liver disease after a propensity score–matching analysis (114 matched pairs). In-hospital mortality and vascular and bleeding complications were similar between matched groups. Acute kidney injury was more common in liver disease group (30.8% versus 13.5%; P =0.010). Although cardiovascular mortality was similar between groups (9.4% versus 6.5%; P =0.433) at 2-year follow-up, noncardiac mortality was higher in the liver group (26.4% versus 14.8%; P =0.034). Lower glomerular filtration rate (hazard ratio, 1.10, for each decrease of 5 mL/min in estimated glomerular filtration rate; 95% confidence interval, 1.03–1.17; P =0.005) and Child-Pugh class B or C (hazard ratio, 3.11; 95% confidence interval, 1.47–6.56; P =0.003) were the predictors of mortality in patients with chronic liver disease, with a mortality rate of 83.2% at 2-year follow-up in patients with both factors (estimated glomerular filtration rate Conclusions— These findings suggested that TAVR is a feasible treatment for severe aortic stenosis in patients with early-stage liver disease or as bridge therapy before a curative treatment of the hepatic condition. Patients with Child-Pugh class B-C, especially in combination with renal impairment, had a very low survival rate, and TAVR should be carefully considered to avoid a futile treatment. These results may contribute to improve the clinical decision-making process and management in patients with liver disease.

The aim of this prospective study was to validate an echocardiographic protocol derived from 5 HeartWare left ventricular assist device (HVAD) patients for the noninvasive evaluation of right atrial pressure (RAP) and left atrial pressure (LAP) in HVAD patients.Echocardiography is an invaluable tool to optimize medical treatment and pump settings and also for troubleshooting residual heart failure. Little is known about the echocardiographic evaluation of hemodynamic status in HVAD patients.Right heart catheterization and Doppler echocardiography were performed in 35 HVAD patients. Echocardiography-estimated RAP (eRAP) was assessed using inferior vena cava diameter, hepatic venous flow analysis, and tricuspid E/e' ratio. Echocardiography-estimated LAP was assessed using E/A ratio, mitral E/e' ratio, and deceleration time.eRAP and estimated LAP significantly correlated with invasive RAP and LAP (respectively, r = 0.839, p 0.001, and r = 0.889, p 0.001) and accurately detected high RAP and high LAP (respectively, area under the curve 0.94, p 0.001, and area under the curve 0.91, p 0.001). High eRAP was associated with high LAP (area under the curve 0.92, p 0.001) and correlated with death or hospitalization at 180 days (odds ratio: 8.2; 95% confidence interval: 1.1 to 21.0; p = 0.04). According to estimated LAP and eRAP, patients were categorized into 4 hemodynamic profiles. Fifteen patients (43%) showed the optimal unloading profile (normal eRAP and normal wedge pressure). This profile showed a trend toward a lower risk for adverse cardiac events at follow-up (odds ratio: 0.2; 95% confidence interval: 0.1 to 1.0; p = 0.05) compared with other hemodynamic profiles.Doppler echocardiography accurately estimated hemodynamic status in HVAD patients. This algorithm reliably detected high RAP and LAP. Notably, high RAP was associated with high wedge pressure and adverse outcome. The benefit of noninvasive estimation of hemodynamic status in the clinical management of patients with left ventricular assist devices needs further evaluation.

Background Accurate 1-year bleeding risk estimation after hospital discharge for acute coronary syndrome (ACS) may help clinicians guide the type and duration of antithrombotic therapy. Currently there are no predictive models for this purpose. The aim of this study was to derive and validate a simple clinical tool for bedside risk estimation of 1-year post-discharge serious bleeding in ACS patients. Methods The risk score was derived and internally validated in the BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registry, an observational international registry involving 15,401 patients surviving admission for ACS and undergoing percutaneous coronary intervention (PCI) from 2003 to 2014, engaging 15 hospitals from 10 countries located in America, Europe and Asia. External validation was conducted in the SWEDEHEART population, with 96,239 ACS patients underwent PCI and 93,150 without PCI. Results Seven independent predictors of bleeding were identified and included in the BleeMACS score: age, hypertension, vascular disease, history of bleeding, malignancy, creatinine and hemoglobin. The BleeMACS risk score exhibited a C-statistic value of 0.71 (95% CI 0.68–0.74) in the derivation cohort and 0.72 (95% CI 0.67–0.76) in the internal validation sample. In the SWEDEHEART external validation cohort, the C-statistic was 0.65 (95% CI 0.64–0.66) for PCI patients and 0.63 (95% CI 0.62–0.64) for non-PCI patients. The calibration was excellent in the derivation and validation cohorts. Conclusions The BleeMACS bleeding risk score is a simple tool useful for identifying those ACS patients at higher risk of serious 1-year post-discharge bleeding. ClinicalTrials.gov Identifier : NCT02466854

Aims: The benefit of complete or incomplete percutaneous coronary Intervention (PC in patients with myocardial infarction and multivessel disease remains debated. The aim of our study was to compare a complete vs. a "culprit only" revascularisation strategy hi patients with myocardial infarction distinguishing the different clinical subsets (STEM and NSTEMI) and to provide one-year clinical outcome from the "real-life" BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registry. Methods and results: We conducted a multicentre study including all patients with myocardial infarction and multivessel coronary disease included in the BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronae Syndrome) registry. They were divided into two groups, complete revascularisation (CR) and incomplete revascularisation (IR). The primary end-point was the death rate at one-year follow-up. Secondary end-points were in-hospital repeat myocardial infarction (re-AM1), in-hospital heart failure (111:), major adverse cardiovascular events (MACE) and myocardial infarction at one year. Four thousand five hundred and twenty patients were included in our analysis, with a diagnosis of STEMI in 67.7% and NSTEMI in 32.3%. CR was performed in 27.2% and 42.4%, respectively. At univariate analysis, in-hospital and one-year outcomes were similar between CR and IR hi STEMI patients (all p-values >0.05). In NSTEMI patients, CR was associated with a lower one-year death rate (4.5% vs. 8.5%; 1)p=0.002), re-AMI (3.7% vs. 6.6%; p=0.016) and MACE (8.1% vs. 13.9%; p=0.001). After propensity score matching, CR also reduced events in STEM patients, including one-vear mortality (5.3% vs. 13.8%; p

The impact of gender-related pathophysiologic features of severe aortic stenosis on transcatheter aortic valve implantation (TAVI) outcomes remains to be determined, as does the consistency of predictors of mortality between the genders. All consecutive patients who underwent TAVI at 6 institutions were enrolled in this study and stratified according to gender. Midterm all-cause mortality was the primary end point, with events at 30 days and at midterm as secondary end points. All events were adjudicated according to Valve Academic Research Consortium definitions. Eight hundred thirty-six patients were enrolled, 464 (55.5%) of whom were female. At midterm follow-up (median 365 days, interquartile range 100 to 516) women had similar rates of all-cause mortality compared with men (18.1% vs 22.6%, p = 0.11) and similar incidence of myocardial infarction and cerebrovascular accident. Gender did not affect mortality also on multivariate analysis. Among clinical and procedural features, glomerular filtration rate30 ml/min/1.73 m(2) (hazard ratio [HR] 2.55, 95% confidence interval [CI] 1.36 to 4.79) and systolic pulmonary arterial pressure50 mm Hg (HR 2.26, 95% CI 1.26 to 4.02) independently predicted mortality in women, while insulin-treated diabetes (HR 3.45, 95% CI 1.47 to 8.09), previous stroke (HR 3.42, 95% CI 1.43 to 8.18), and an ejection fraction30% (HR 3.82, 95% CI 1.41 to 10.37) were related to mortality in men. Postprocedural aortic regurgitation was independently related to midterm mortality in the 2 groups (HR 11.19, 95% CI 3.3 to 37.9). In conclusion, women and men had the same life expectancy after TAVI, but different predictors of adverse events stratified by gender were demonstrated. These findings underline the importance of a gender-tailored clinical risk assessment in TAVI patients.

The aim of this study was to identify predictors of 30-day and midterm mortality after transcatheter aortic valve implantation (TAVI) by means of a systemic review. TAVI was demonstrated to be safe and efficacious in patients with severe aortic stenosis. An accurate estimation of procedural risk of these patients represents an actual challenge. The PubMed and Cochrane Collaboration databases were systematically searched for studies reporting on the incidence and independent predictors of 30-day and midterm mortality. Adverse events were pooled with random effect, whereas independent predictors are reported as odds ratios (ORs) with 95% confidence intervals (CIs). A total of 25 studies with 8,874 patients were included (median age 82.5 +/- 1.5 years, 54.6% women). At 30 days, 7.5% of patients (n = 663) died. At midterm follow-up (median 365 days, interquartile range 267 to 365 days), the cumulative mortality rate was 21.6% (n = 1,917). Acute kidney injury (AM) stage >= 2 (OR 18.0, 95% CI 6.3 to 52), preprocedural hospitalization for heart failure (OR 9.4, 95% CI 2.6 to 35), periprocedural acute myocardial infarction (OR 8.5, 95% CI 2.6 to 33.5), and increased pro-brain natriuretic peptide (pro-BNP) levels (OR 5.4, 95% CI 1.7 to 16.5) were the most important independent predictors of 30-day mortality. Increased proBNP levels (OR 11, 95% CI 1.5 to 81), AKI stage 3 (OR 6.8, 95% CI 2.6 to 15.7), left ventricular ejection fraction

Coronary artery disease (CAD) negatively affects prognosis in patients undergoing surgical aortic valve replacement, being currently evaluated in the most common used risk score. Our meta-analysis aims to clarify the prognostic role of CAD on mid-term survival in patients undergoing TAVI.Studies reporting multivariate predictors of adverse outcomes in patients undergoing TAVI were systematically searched for and pooled, when appropriate, using a random-effect method. 960 citations were first screened and finally 7 studies (2472 patients) were included. Diagnosis of CAD was reported in 52%(42-65) of patients and 1169 Edwards SAPIEN and 1303 CoreValve prostheses were implanted. After a median follow up of 452 days (357-585) 24% of patients (19-33) died, and 23 (14-32) for cardiovascular death. At pooled analysis of multivariate approach, diagnosis of coronary artery disease did not increase risk of death (OR 1.0, 95% CI, confidence interval, 0.67-1.50 I(2) 0%).CAD does not affect mid-term TAVI outcome: this finding should be weighted to accurately evaluate risk and strategies for patients with severe aortic stenosis.

AIMS In patients undergoing surgical valve replacement for severe aortic stenosis, female gender was associated with worse outcomes, not persisting after multivariable adjustment for baseline clinical differences, while contrasting data are reported about TAVI. METHODS AND RESULTS From January 2007 to December 2011 all patients with severe symptomatic aortic stenosis undergoing TAVI at our institutions were included in the present study, and were divided into two cohorts according to their gender. All endpoints were adjudicated according to VARC definition. Three hundred and seventy-seven patients were included: 161 male and 216 female. Male patients reported higher rates of previous coronary revascularisation, while both ejection fraction and mean aortic gradient were higher in female patients. At 30 days, rates of cardiovascular death were similar (6.0% vs. 8.1%; p=0.793), while overall bleedings (44% vs. 25%; p=0.024) and life-threatening bleedings (21.1% vs. 12.7%, p=0.016) were higher in female patients, also after multivariate analysis (OR 3.44; 1.23-9.22, and OR 2.1; 1.1-4.0, CI: 95%, respectively). Major vascular complications showed a tendency to be higher in female patients (12.9% vs. 9.8%, p=0.449). At a mean follow-up of 490 ± 250 days, no significant difference was reported between men and women for all endpoints, and after multivariate adjustment only life-threatening bleeding was reported as a predictor of death (OR 8.2:3.8-17, CI: 95%). CONCLUSIONS TAVI can be an effective and safe strategy in high surgical risk patients, regardless of the gender; life-threatening bleedings were reported more frequently in female patients, being the only independent predictor of death.

Aims There is uncertainty on which stenting approach confers the best long-term outlook for unprotected left main (ULM) bifurcation disease. Methods and results This is a non-randomized, retrospective study including all consecutive patients with 50% stenosis of the left main involving at least 1 of the arteries stemming from the left main treated with drug-eluting stents (DES) in 9 European centers between 2002 and 2004. Patients were divided into two groups: those treated with provisional stentings vs. those treated with two stent strategy. The outcomes of interest were 10-year rates of target lesion revascularization (TLR), major adverse cardiac events (MACE), and their components (cardiovascular death, myocardial infarction [MI], or repeat revascularization), along with stent thrombosis (ST). A total of 285 patients were included, 178 (62.5%) in the provisional stenting group and 87 (37.5%) in the two stent group. After 10years, no differences in TLR were found at unadjusted analysis (19% vs 25%, p>0.05) nor after propensity score matching (25% vs 28%, p>0.05). Similar rates of MACE (60% vs 66%, p>0.05), death (34% vs 43%, p>0.05), MI (9% vs 14%, p>0.05) and ST were also disclosed at propensity-based analysis. Conclusion Even after 10year follow-up, patients treated with provisional stenting on left main showed comparable rates of target lesion revascularization compared to two stent strategy.

Background: In the setting of the Acute Coronary Syndrome (ACS), differences in response to prasugrel and ticagrelor between East Asian and European patients have not been investigated yet. Methods: This is a sub-analysis of the "BleeMACS registry". Patients admitted for ACS and underwent PCI from between 2012 and 2014 were stratified first according to their provenance, Europe vs. East Asia (China and Japan), and then by country. The adjusted rate of 1-year serious bleeding - safety end-point-and 1-year death/re-infarction -effectiveness endpoint-of the new P2Y12r inhibitors were compared. Results: Data of 10004 patients in Europe and 2332 patients in East Asia were collected. At baseline prior stroke (6% vs 9%, p

Bleeding events after an acute coronary syndrome have a negative impact on prognosis. Available risk scores are limited by suboptimal accuracy, prediction of only in-hospital events and absence of patients treated with new antiplatelet agents in the current era of widespread use of percutaneous coronary intervention. The BleeMACS (Bleeding complications in a Multicenter registry of patients discharged after an Acute Coronary Syndrome) project is a multicenter investigator-initiated international retrospective registry that enrolled more than 15 000 patients discharged with a definitive diagnosis of acute coronary syndrome and treated with percutaneous revascularization. The primary end point is the incidence of major bleeding events requiring hospitalization and/or red cell transfusion concentrates within 1 year. An integer risk score for bleeding within the first year after hospital discharge will be developed from a multivariate competing-risks regression. The BleeMACS registry collaborative will allow development and validation of a risk score for prediction of major bleeding during follow-up for patients receiving contemporary therapies for acute coronary syndrome

Objective: This study aims to assess changes in mitral regurgitation (MR) severity after transcatheter aortic valve implantation (TAVI). Background: Existing data on MR after TAVI are contradictory. Methods: Thirty-five patients with MR graded 2+ were followed after undergoing TAVI with either the Edwards Sapien or CoreValve device. Echocardiography was performed the week before and 3 months after the procedure. MR was graded on a scale of 0 to 4+, classified as organic or functional, and the effective regurgitant orifice area (EROA) and MR index were calculated. Results: At baseline, MR was graded 4+ in 4 (11.4%) patients, 3+ in 10 (28.6%), and 2+ in 21 (60%). At follow-up, MR was graded at 3+ in 4 (11.4%) patients, 2+ in 8 (22.9%), and 1+ in 19 (54.3%); 4 (11.4%) exhibited no MR. EROA (24.4 ± 11.5 mm 2 pre-TAVI vs. 11.2 ± 10.3 mm 2 post-TAVI, P < 0.001) and MR index (1.9 ± 0.3 preTAVI vs. 1.3 ± 0.7 post-TAVI, P < 0.001) were reduced with TAVI, independent of the etiology. MR decreased by at least 1 grade in 28 (80%) patients, with a reduction 2 grades in 10 (28.6%) patients; no patient showed a worsened condition. Subgroup analyses showed that the reduction in MR was significant in patients treated with the Edwards Sapien device but not in patients treated with the CoreValve device. Conclusions: This multiparametric echocardiographic evaluation showed that MR improved significantly after TAVI and that this result may be related to the type of valve implanted. (Echocardiography 2013;30:250-257)

The optimal antiaggregant therapy after coronary stenting in patients receiving oral anticoagulants (OACs) is currently debated. MEDLINE and Cochrane Library were searched for studies reporting outcomes of patients who underwent PCI and who were on triple therapy (TT) or dual-antiplatelet therapy (DAPT) with aspirin and clopidogrel or dual therapy (DT) with OAC and clopidogrel. Major bleeding was the primary end point, whereas all-cause death, myocardial infarction (MI), stent thrombosis, and stroke were secondary ones. Results were reported for all studies and separately for those deriving from randomized controlled trials or multivariate analysis. In 9 studies, 1,317 patients were treated with DAPT and 1,547 with TT. DAPT offered a significant reduction of major bleeding at 1 year for overall studies and for the subset of observational works providing adjusted data (odds ratio [OR] 0.51, 95% confidence interval [CI] 0.39 to 0.68, I 2 60% and OR 0.36, 95% CI 0.28 to 0.46) compared to TT. No increased risk of major adverse cardiac events (MACE: death, MI, stroke, and stent thrombosis) was reported (OR 0.71, 95% CI 0.46 to 1.08), although not deriving from randomized controlled trials or multivariate analysis. Six studies tested OAC and clopidogrel (1,263 patients) versus OAC, aspirin, and clopidogrel (3,055 patients) with a significant reduction of bleeding (OR 0.79, 95% CI 0.64 to 0.98), without affecting rates of death, MI, stroke, and stent thrombosis (OR 0.90, 95% CI 0.69 to 1.23) also when including clinical data from randomized controlled trials or multivariate analysis. In conclusion, compared to TT, both aspirin and clopidogrel and clopidogrel and OAC reduce bleeding. No difference in major adverse cardiac events is present for clopidogrel and OAC, whereas only low-grade evidence is present for aspirin and clopidogrel.

AIMS To describe the postprocedural and 1-year follow-up incidence of heart conduction disturbances in patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). METHODS Ninety-five patients were enrolled from 2008 to 2011 (mean age 81.8 ± 7.2 years, 63.1% women). Clinical and ECG data were recorded at admission, discharge, and 3, 6 and 12 months following TAVI. RESULTS Fifty-seven Edwards SAPIEN (31 transapical, 26 transfemoral) and 38 transfemoral CoreValve implants were used. Two (2.1%) patients died during the procedure and 11 (11.6%) patients received a pacemaker prior to discharge (7 CoreValve, 3 transapical, 1 transfemoral SAPIEN; P = 0.18). Among the surviving patients not receiving a pacemaker, TAVI increased the PQ interval (176 ± 29 vs. 188 ± 36 ms; P = 0.001), QRS width (90 ± 15 vs. 108 ± 26 ms; P

a Division of Cardiology, University of Turin, Citta Della Salute e Della Scienza, Turin, Italy b Division of Cardiology, Citta Della Salute e Della Scienza, Turin, Italy c Division of Pneumology, Department of Internal Medicine, Citta Della Salute e Della Scienza, Turin, Italy d Division of Rheumatology, Department of Internal Medicine, Citta Della Salute e Della Scienza, Turin, Italy e Department of Cardiology, Njang, China

Several clinical and procedural factors have been identified as predictors of early and midterm events after transcatheter aortic valve implantation (TAVI), but incidence and prognostic impact of diabetes mellitus (DM), especially insulin treated, on short- and midterm outcomes remain to be defined. All consecutive patients who underwent TAVI at our institutions were enrolled and stratified according to DM status. All-cause mortality at 30 days or in hospital and at follow-up was the primary end point, whereas periprocedural complications, rates of myocardial infarction, stroke, and reintervention at follow-up were the secondary ones. All end points were adjudicated according to the Valve Academic Research Consortium definitions. In all, 511 patients were enrolled: 361 without DM, 78 with orally treated DM, and 72 with insulin-treated DM. Orally treated DM patients were more frequently women, whereas insulin-treated DM patients were younger. Thirty-day Valve Academic Research Consortium mortality was not significantly higher in patients with orally treated DM and insulin-treated DM compared with patients without diabetes (6.4%, 9.7%, and 4.7%, p = 0.09). Bleedings, vascular complications, postprocedural acute kidney injury, and periprocedural strokes were not significantly different in the 3 groups. At midterm follow-up (median 400 days), patients with insulin-treated DM had a significantly higher mortality rate (33.3% vs 18.6%, p = 0.01) and higher myocardial infarction incidence (8.3% vs 1.4%, p = 0.002) if compared with patients without diabetes. Strokes and reinterventions at follow-up were similar in the 3 groups. After multivariable adjustment, insulin-treated DM was independently correlated with death (hazard ratio 2, 95% confidence interval 1.3 to 3.3) and myocardial infarction (hazard ratio 3.73, 95% confidence interval 1.1 to 13). In conclusion, DM does not significantly affect rates of complications in patients who underwent TAVI. Insulin-treated DM, but not orally treated DM, is independently associated with death and myocardial infarction at midterm follow-up and should be included into future TAVI-dedicated scores.

Chronic kidney disease (CKD) constitutes a predictor of adverse events for surgical aortic valve replacement. In patients undergoing TAVI no study was performed to evaluate outcomes according to renal clearance, which represents the most accurate instrument to assess kidney function.From January 2007 to December 2011 all TAVI patients of our institutions were prospectively divided into 3 cohorts. Preserved renal function those with clearance more or equal to 60 ml/min/1.73 m2, moderate CKD those between 30 and 60, and severe CKD those between 15 and 30. Patients with a clearance less than 15 or in dialysis were excluded. All outcomes were adjudicated according to VARC criterion.72 patients with preserved renal function, 219 with moderate and 73 with severe CKD were included; those in the latter group were older and with lower ejection fraction. At 30 days, severe CKD was associated with a trend toward a higher risk of major events than preserved and moderate CKD: cardiovascular death (2.8% vs 6.7% vs 9%; p=0.256) life threatening bleedings (10% vs 10% vs 16%; p=0.384), major stroke (1.4% vs 2.3% vs 4.1%; p=0.763). At a medium follow-up of 540 ± 250 days, cardiovascular death incidence was higher in patients with severe CKD (7% vs 8 vs 19%; p0.0001), however this difference was not consistently significant after multivariable adjustment (p=0.300). Overall, 2% of patients developed kidney failure, whereas 47.1% of patients with severe CKD improved to moderate renal impairment.Patients with severe chronic renal disease presented higher risk of adverse events, mainly driven by increased hazard of bleedings. TAVI procedures could offer kidney functional improvement in an important subset of patients.

Two different devices, 1 self-expanding and 1 balloon-expandable, have been developed for patients who underwent transcatheter aortic valve implantation with contrasting data about efficacy and safety. Pubmed, Medline, and Google Scholar were systematically searched for studies of these different devices, with data derived from randomized controlled trial or registries with multivariate analysis. All-cause death at 30 days and at follow-up were the primary end points, whereas postprocedural moderate or severe aortic regurgitation (AR), stroke, major vascular complications, bleedings, and pacemaker implantation the secondary ones. Six studies with 957 self-expanding and 947 balloon-expandable valves were included: 1 randomized controlled trial and 5 observational studies. At 30 days follow-up, rates of death did not differ between self-expanding and balloon-expandable valves (odds ratio [OR] 0.74, 95% confidence interval [CI] 0.47 to 1.17), whereas balloon expandable reduced rates of moderate or severe AR (OR 0.51, 95% CI 0.27 to 0.99) and of pacemaker implantation (OR 0.28, 95% CI 0.17 to 0.47). After a follow-up of 360 days (300 to 390), rates of all-cause death did not differ between the 2 groups. In conclusion, risks of moderate or severe AR and pacemaker implantation were lower with the balloon-expandable devices without an impact on 30 days and midterm mortality.

of CABG (β=0.28, Pb.0001) strongly correlate with SYNTAX score. A significant difference in the mean age, creatinine clearance (b70 ml/ min) and a history of CABG was also observed in intermediate to high tertiles of SYNTAX score patients as compared to low SYNTAX score patients. Furthermore, there was a significant correlation of SYNTAX score and THI (r=0.17, P=.01). The relation held true in multivariate analysis after adjusting for age, sex, and history of PCI or CABG. Mean THI in intermediate-high SYNTAX group was significantly more when compared with the low SYNTAX group (17.15±2.22 vs 12.89± 0.70, P=.038). Conclusion: Clinical factors such as age N65 yrs, male gender, congestive heart failure, a history of PCI or CABG, and a low creatinine clearance (b70 ml/min) along with THIRS correlate with SYNTAX score and can be helpful during patient selection for PCI or CABG. Baseline clinical variables and THI risk score do correlate with the angiographic SYNTAX score. The operator can assess the revascularization strategy based on clinical factors along with vessel lesion variables.

Background: TAVI is by now a valid therapeutic option in elderly patients (pts) with severe symptomatic aortic stenosis considered at high risk or with contraindication to aortic valve replacement (AVR). The impact of postprocedural leaks on mortality is still debated. Methods: Since May 2008 to July 2011, 100 consecutive pts underwent TAVI (60 Edwards Sapien Valve, 40 CoreValve). Transthoracic echocardiogram (TTE) was performed before discharge and after 3 months. Prosthesis insufficiency (PI) was considered significant if at least mild according to ASE and EAE recommendations. The aim of the study is to evaluate the effect of postprocedural periprosthetic and intraprosthetic leaks on mortality. Results: Retrograde approach was performed in 67 pts, while 33 pts benefited from the transapical access. Predischarge TTE was performed in all pts, and 24 had at least mild PI: 17 (70.8%) periprosthetic, 3 (12.5%) intraprosthetic, and 4 (16.7%) mixed. VARC mortality was 15%. At 3-month follow-up (range 36–126 days), all 85 alive pts underwent a TTE at our institution. Significant leaks were found in 24 (28.2%) pts: 18 (75%) periprosthetic, 1 (4.2%) intraprosthetic, and 5 (20.4%) mixed. The univariate analysis with Yatescorrected χ showed that postprocedural PI affects 1-year mortality (RR 2.68, IC 1.39–5.18, P=.009). Subgroups analysis showed an increased incidence of leaks in CoreValve group compared to the Edwards Sapien group (28/36 vs. 24/49, P=.02). Conclusion: Periprosthesis leaks, affected also by prosthesis choice, increase 1-year mortality in patients undergoing TAVI. These data confirm the actual limits of this procedure compared to AVR. In the near future, new technologies and devices could help to improve results.

Background: TAVI is by now a valid therapeutic option in elderly patients (pts) with severe symptomatic aortic stenosis considered at high risk or with contraindication to aortic valve replacement (AVR). The impact of postprocedural leaks on mortality is still debated. Methods: Since May 2008 to July 2011, 100 consecutive pts underwent TAVI (60 Edwards Sapien Valve, 40 CoreValve). Transthoracic echocardiogram (TTE) was performed before discharge and after 3 months. Prosthesis insufficiency (PI) was considered significant if at least mild according to ASE and EAE recommendations. The aim of the study is to evaluate the effect of postprocedural periprosthetic and intraprosthetic leaks on mortality. Results: Retrograde approach was performed in 67 pts, while 33 pts benefited from the transapical access. Predischarge TTE was performed in all pts, and 24 had at least mild PI: 17 (70.8%) periprosthetic, 3 (12.5%) intraprosthetic, and 4 (16.7%) mixed. VARC mortality was 15%. At 3-month follow-up (range 36–126 days), all 85 alive pts underwent a TTE at our institution. Significant leaks were found in 24 (28.2%) pts: 18 (75%) periprosthetic, 1 (4.2%) intraprosthetic, and 5 (20.4%) mixed. The univariate analysis with Yatescorrected χ showed that postprocedural PI affects 1-year mortality (RR 2.68, IC 1.39–5.18, P=.009). Subgroups analysis showed an increased incidence of leaks in CoreValve group compared to the Edwards Sapien group (28/36 vs. 24/49, P=.02). Conclusion: Periprosthesis leaks, affected also by prosthesis choice, increase 1-year mortality in patients undergoing TAVI. These data confirm the actual limits of this procedure compared to AVR. In the near future, new technologies and devices could help to improve results.