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The percutaneous treatment of structural, valvular, and non-valvular heart disease (SHD) is rapidly evolving. The Core Curriculum (CC) proposed by the EAPCI describes the knowledge, skills, and attitudes that define competency levels required by newly trained SHD interventional cardiologists (IC) and provides guidance for training centres. SHD ICs are cardiologists who have received complete interventional cardiology training. They are multidisciplinary team specialists who manage adult SHD patients from diagnosis to follow-up and perform percutaneous procedures in this area. They are competent in interpreting advanced imaging techniques and master planning software. The SHD ICs are expected to be proficient in the aortic, mitral, and tricuspid areas. They may have selective skills in either the aortic area or mitral/tricuspid areas. In this case, they must still have common transversal competencies in the aortic, mitral, and tricuspid areas. Additional SHD domain competencies are optional. Completing dedicated SHD training, aiming for full aortic, mitral, and tricuspid competencies, requires at least 18 months. For full training in the aortic area, with basic competencies in mitral/tricuspid areas, the training can be reduced to 1 year. The same is true for training in the mitral/tricuspid area, with competencies in the aortic area. The SHD IC CC promotes excellence and homogeneous training across Europe and is the cornerstone of future certifications and patient protection. It may be a reference for future CC for national associations and other SHD specialities, including imaging and cardiac surgery.

Background: The characteristics and risk factor profile of young patients presenting with non-ST segment elevation acute coronary syndrome (NSTEACS) and how they may have changed over time is not well reported., Methods: We identified 26,708 NSTEACS patients aged under 50 presenting to United Kingdom (UK) hospitals between 2010 and 2017 from Myocardial Ischaemia National Audit Project (MINAP). We calculated incidence of NSTEACS per 100,000 UK population, using Office of National Statistics (ONS) population estimates, prevalence of comorbidities, ethnicity, and in-hospital mortality. We formed biennial groups to enable comparison, 2010-2011, 2012-2013, 2014-2015 and 2016-2017., Results: The incidence of NSTEACS per 100,000 population showed minimal change between 2010 and 2017 (2010: 5.4 per 100,000 and 2017; 4.9 per 100,000). Rates of smoking (2010-11; 58% and 2016-17; 53%), and family history of coronary artery disease (CAD) (2010-11; 51% and 2016-17; 44%) fell, but the proportion of patients from an ethnic minority background (2010-11; 12% and 2016-17; 20%), with diabetes mellitus (DM) (2010-11; 14%, and 2016-17; 18%) and female patients (2010-11; 22% and 2016-17; 24%) increased over the study period. Mortality from NSTEACS remained unchanged (2010-11; 1% and 2016-17; 1%)., Conclusions: The incidence of NSTEACS in patients aged under fifty has not reduced despite reduction in prevalence of risk factors such as smoking hypercholesterolaemia in those admitted to UK hospitals. Despite improved rates of early invasive coronary angiography and percutaneous coronary intervention in 'young' NSTEACS patients, in-hospital mortality remains unchanged., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

The European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Heart Rhythm Association (EHRA), the European Association of Cardiovascular Imaging (EACVI), the European Society of Cardiology (ESC) Regulatory Affairs Committee and Women as One support continuous review and improvement, not only in the practice of assuring patients a high quality of care but also in providing health professionals with support documents to help them in their career and enhance gender equity. Recent surveys have revealed that radiation exposure is commonly reported as the primary barrier for women pursuing a career in interventional cardiology or cardiac electrophysiology (EP). The fear of foetal exposure to radiation during pregnancy may lead to a prolonged interruption in their career. Accordingly, this joint statement aims to provide a clear statement on radiation risk and the existing data on the experience of radiation-exposed cardiologists who continue to work in catheterisation laboratories (cath labs) throughout their pregnancies. In order to reduce the barrier preventing women from accessing these careers, increased knowledge in the community is warranted. Finally, by going beyond simple observations and review of the literature, our document suggests proposals for improving workplace safety and for encouraging equity.

Despite the increasing proportion of female medical and nursing students, there is still a significant under-representation of women working as healthcare providers in interventional cardiology, with very few of them reaching senior leadership, academic positions, or acting principal investigators, as well as actively involved in company advisory boards. In this position paper, we will describe the current status of women working in interventional cardiology across Europe. We will also provide an overview of the most relevant determinants of the under-representation of women at each stage of the interventional cardiology career path and offer practical suggestions for overcoming these challenges., Competing Interests: Conflict of interest Dr Buchanan declares travel support from Menarini. Dr Paradies declares consulting, advisory board and speaker fees from Abbott and Boston Scientific and research grant to the institution from Abbott. Dr Karam declares consulting, speaker and advisoryboard fees from Abbott, Medtronic and Edwards. Dr Holmvang declares speaker fees from Bayer. Dr Morice declares to be CEO andshare holder of CERC, a CRO not involved in the publication, and to be minor shareholder of ELECRODUCER. Dr Manzo-Silberman declares consulting and speaker fees for Bayer, Organon, Exeltis, Biotronik, Organon and BMS. Dr Petronio declares consulting and speaker fees from Boston and Abbott and from Medtronic to the Institution. Dr Mauri declares to be share holder of CERC, a CRO notinvolved in the publication. Dr Mehilli declares speaker fees from Daiichi Sankyo, Biotronik, Astra Zeneca, BMS and SIS Medical. Dr Barbato declares speaker's fees and travel grants from the following companies: BSCI, Abbott, Insight Lifetech, MicroPort. Dr Chieffo declares speaker/consulting fees from Abiomed, Boston Scientific, Biosensor, Menarini, Medtronic and Shock Wave Medical. The other authors declare no conflict of interest related to this article., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The rearrangement of healthcare services required to face the coronavirus disease 2019 (COVID-19) pandemic led to a drastic reduction in elective cardiac invasive procedures. We are already facing a "second wave" of infections and we might be dealing during the next months with a "third wave" and subsequently new waves. Therefore, during the different waves of the COVID-19 pandemic we have to face the problems of how to perform elective cardiac invasive procedures in non-COVID patients and which patients/procedures should be prioritised. In this context, the interplay between the pandemic stage, the availability of healthcare resources and the priority of specific cardiac disorders is crucial. Clear pathways for "hot" or presumed "hot" patients and "cold" patients are mandatory in each hospital. Depending on the local testing capacity and intensity of transmission in the area, healthcare facilities may test patients for SARS-CoV-2 infection before the interventional procedure, regardless of risk assessment for COVID-19. Pre-hospital testing should always be conducted in the presence of symptoms suggestive of SARS-CoV-2 infection. In cases of confirmed or suspected COVID-19 positive patients, full personal protective equipment using FFP 2/N95 masks, eye protection, gowning and gloves is indicated during cardiac interventions for healthcare workers. When patients have tested negative for COVID-19, medical masks may be sufficient. Indeed, individual patients should themselves wear medical masks during cardiac interventions and outpatient visits.

This consensus document, a summary of the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI), appraises the importance of ischaemia with non-obstructive coronary arteries (INOCA). Angina pectoris affects approximately 112 million people globally. Up to 70% of patients undergoing invasive angiography do not have obstructive coronary artery disease, more common in women than in men, and a large proportion have INOCA as a cause of their symptoms. INOCA patients present with a wide spectrum of symptoms and signs that are often misdiagnosed as non-cardiac leading to under-diagnosis/investigation and under-treatment. INOCA can result from heterogeneous mechanism including coronary vasospasm and microvascular dysfunction and is not a benign condition. Compared to asymptomatic individuals, INOCA is associated with increased incidence of cardiovascular events, repeated hospital admissions, as well as impaired quality of life and associated increased health care costs. This consensus document provides a definition of INOCA and guidance to the community on the diagnostic approach and management of INOCA based on existing evidence from research and best available clinical practice; noting gaps in knowledge and potential areas for further investigation.

The coronavirus disease 2019 (COVID-19) pandemic poses an unprecedented challenge to healthcare worldwide. The infection can be life threatening and require intensive care treatment. The transmission of the disease poses a risk to both patients and healthcare workers. The number of patients requiring hospital admission and intensive care may overwhelm health systems and negatively affect standard care for patients presenting with conditions needing emergency interventions. This position statements aims to assist cardiologists in the invasive management of acute coronary syndrome (ACS) patients in the context of the COVID-19 pandemic. To that end, we assembled a panel of interventional cardiologists and acute cardiac care specialists appointed by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and from the Acute Cardiovascular Care Association (ACVC) and included the experience from the first and worst affected areas in Europe. Modified diagnostic and treatment algorithms are proposed to adapt evidence-based protocols for this unprecedented challenge. Various clinical scenarios, as well as management algorithms for patients with a diagnosed or suspected COVID-19 infection, presenting with ST- and non-ST-segment elevation ACS are described. In addition, we address the need for re-organization of ACS networks, with redistribution of hub and spoke hospitals, as well as for in-hospital reorganization of emergency rooms and cardiac units, with examples coming from multiple European countries. Furthermore, we provide a guidance to reorganization of catheterization laboratories and, importantly, measures for protection of healthcare providers involved with invasive procedures.

Cardiovascular disease is the leading indirect cause of maternal mortality in the UK. Pregnancy increases the risk of acute MI (AMI) by three- to fourfold secondary to the profound physiological changes that place an extra burden on the cardiovascular system. AMI is not always recognised in pregnancy and there is concern among both clinicians and patients regarding catheter-based interventions due to fears of foetal irradiation and risks to the foetus. This article evaluates the current state of knowledge on AMI in pregnancy with particular emphasis on pregnancy-associated spontaneous coronary artery dissection and percutaneous coronary intervention as the revascularisation procedure for AMI. Special considerations that must be made in patients requiring percutaneous coronary intervention for pregnancy-associated spontaneous coronary artery dissection and the current recommendations on arterial access, methods of minimising radiation and stent selection are discussed., Competing Interests: Disclosure: The authors have no conflicts of interest to declare., (Copyright © 2020, Radcliffe Cardiology.)

Despite advances in the diagnosis and treatment of coronary artery disease, there remains evidence of a disparity in the outcomes for women when compared with men. This article provides a review of the evidence for this discrepancy and discusses some of the potential contributing factors., Competing Interests: Disclosure: The authors have no conflicts of interest to declare.

Background and Objectives: The majority of patients included in trials of anti-platelet therapy are male. This systematic review and meta-analysis aimed to determine whether, in addition to aspirin, P2Y12 blockade is beneficial in both women and men with acute coronary syndromes., Methods: Electronic databases were searched and nine eligible randomised controlled studies were identified that had sex-specific clinical outcomes (n=107,126 patients). Risk Ratios (RR) and 95% Confidence Intervals (CI) were calculated for a composite of cardiovascular death, myocardial infarction or stroke (MACE), and a safety endpoint of major bleeding for each sex. Indirect comparison analysis was performed to statistically compare ticagrelor against prasugrel., Results: Compared to aspirin alone, clopidogrel reduced MACE in men (RR, 0.79; 95% CI, 0.68 to 0.92; p=0.003), but was not statistically significant in women (RR, 0.88; 95% CI, 0.75 to 1.02, p=0.08). Clopidogrel therapy significantly increased bleeding in women but not men. Compared to clopidogrel, prasugrel was beneficial in men (RR, 0.84; 95% CI, 0.73 to 0.97; p=0.02) but not statistically significant in women (RR, 0.94; 95% CI, 0.83 to 1.06; p=0.30); ticagrelor reduced MACE in both men (RR, 0.85; 95% CI, 0.77 to 0.94; p=0.001) and women (RR, 0.84; 95% CI, 0.73 to 0.97; p=0.02). Indirect comparison demonstrated no significant difference between ticagrelor and prasugrel in either sex. Compared to clopidogrel, ticagrelor and prasugrel increased bleeding risk in both women and men., Conclusion: In summary, in comparison to monotherapy with aspirin, P2Y12 inhibitors reduce MACE in women and men. Ticagrelor was shown to be superior to clopidogrel in both sexes. Prasugrel showed a statistically significant benefit only in men; however indirect comparison did not demonstrate superiority of ticagrelor over prasugrel in women., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Several expert documents on sex-based differences in interventional outcomes are now available, however this is the first position paper from the EAPCI Women Committee discussing the potential influence of sex in the percutaneous treatment of coronary and structural heart disease. Despite the misconception that coronary artery disease is a 'man's disease', contemporary data shows a growing incidence in women. However, women are under-represented in randomised coronary clinical trials (~25%). The generalisation of such studies is therefore problematic in decision-making for females undergoing coronary intervention. Differences in pathophysiology between sexes exist, highlighting the need for greater awareness amongst healthcare professionals to enable best evidence-based therapies for women as well as for men. Reassuringly, women represent half of the population included in transcatheter aortic valve implantation clinical trials and may actually benefit more. Growing evidence is also emerging for other interventional atrial procedures which may well be advantageous to women. Awareness of sex disparities is increasing, and we must all work collaboratively within our profession to ensure we provide effective care for all patients with heart disease. The EAPCI Women Committee aim to highlight such issues through this position paper and through visibility within the interventional community.

Objective: To investigate the prognostic effect of newly diagnosed diabetes mellitus (NDM) and impaired glucose tolerance (IGT) post myocardial infarction (MI)., Research Design and Methods: Retrospective cohort study of 768 patients without preexisting diabetes mellitus post-MI at one centre in Yorkshire between November 2005 and October 2008. Patients were categorised as normal glucose tolerance (NGT n = 337), IGT (n = 279) and NDM (n = 152) on pre- discharge oral glucose tolerance test (OGTT). Primary end-point was the first occurrence of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal MI, severe heart failure (HF) or non-haemorrhagic stroke. Secondary end-points were all cause mortality and individual components of MACE., Results: Prevalence of NGT, impaired fasting glucose (IFG), IGT and NDM changed from 90%, 6%, 0% and 4% on fasting plasma glucose (FPG) to 43%, 1%, 36% and 20% respectively after OGTT. 102 deaths from all causes (79 as first events of which 46 were cardiovascular), 95 non fatal MI, 18 HF and 9 non haemorrhagic strokes occurred during 47.2 ± 9.4 months follow up. Event free survival was lower in IGT and NDM groups. IGT (HR 1.54, 95% CI: 1.06-2.24, p = 0.024) and NDM (HR 2.15, 95% CI: 1.42-3.24, p = 0.003) independently predicted MACE free survival. IGT and NDM also independently predicted incidence of MACE. NDM but not IGT increased the risk of secondary end-points., Conclusion: Presence of IGT and NDM in patients presenting post-MI, identified using OGTT, is associated with increased incidence of MACE and is associated with adverse outcomes despite adequate secondary prevention.

The method of revascularization for multi-vessel coronary artery disease (MVD) has traditionally been coronary artery bypass grafting (CABG), however, due to recent advances in the field of percutaneous coronary intervention (PCI), this latter technique has gained in popularity and its role in guidelines has been promoted. This review aims to address the current data available for the treatment of patients with complex coronary disease, including the specific disease subset in those with diabetes mellitus, focusing on the importance of risk stratification and review by the 'Heart Team'. The concept of complete versus incomplete revascularization and the assessment of lesions utilizing functional techniques are discussed. Over recent years, PCI has grown to become the most frequently performed therapeutic intervention in medicine and continues to grow. There are encouraging data that this is an effective and safe treatment option in selected patients, however, neither strategy alone can provide a solution for the entire spectrum of patients with MVD., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Aims: To our knowledge, no randomised study has compared rates of uncovered stent struts in everolimus (EES) vs. new-generation zotarolimus-eluting (ZES-R) stents in acute coronary syndrome (ACS). The aim of our study was to evaluate the completeness of neointimal coverage with optical coherence tomography (OCT) in ACS patients treated with drug-eluting stents (DES) comparing EES versus new-generation ZES-R., Methods and Results: All eligible ACS patients admitted to four Italian centres with a clinical indication for culprit lesion intervention were randomised 1:1 to EES or ZES-R. The primary study endpoint was the percentage of uncovered stent struts evaluated by optical coherence tomography (OCT) at six months. Secondary endpoints were the percentage of malapposed stent struts, percent neointimal hyperplasia cross-sectional area (CSA) and major adverse cardiac events (MACE) at six months. A total of 60 patients were randomised to EES (n=29) or ZES-R (n=31). No differences were observed in baseline characteristics between the two groups. Overall, 31.7% presented with STEMI, of which 68.4% were anterior. The other patients comprised 41.7% NSTEMI and 26.7% troponin-negative ACS. A mean of 1.3±0.6 lesions were treated per patient, with a mean of 1.3±0.5 stents per lesion. At 30 days there was one sudden death. Six-month OCT analysis was performed in 25 lesions in the EES group and in 24 lesions in the ZES-R group. There was no difference in the primary endpoint of uncovered stent struts between groups (EES 6.42% [3.27, 9.57] vs. ZES-R 7.07% [3.22, 10.92]; p=0.80). Furthermore, there were no differences between groups in the percentage of malapposed stent struts, either with (EES 1.19% [0.34, 2.04] vs. ZES-R 0.85% [0.40, 1.30]; p=0.49) or without coverage (EES 1.06% [0.12, 2.01] vs. ZES-R 0.24% [0.05, 0.44]; p=0.09). Percent neointima CSA was similar in both groups (EES 37.0% [18.6, 55.3] vs. ZES-R 26.6% [18.4, 34.8]; p=0.31). At six-month clinical follow-up, no additional patients died or suffered MI. There were four MACE in the EES group and one in the ZES-R group., Conclusions: In our study, in patients presenting with ACS, both EES and ZES-R had low percentages of malapposed and uncovered stent struts at six-month OCT analysis.

Women typically present with coronary artery disease later than men with more unfavorable clinical and anatomic characteristics. It is unknown whether differences exist in women undergoing treatment for unprotected left main coronary artery (ULMCA) disease. Our aim was to evaluate long-term clinical outcomes in women treated with percutaneous coronary intervention (PCI) with drug-eluting stents versus coronary artery bypass grafting (CABG). All consecutive women from the Drug-Eluting stent for LefT main coronary Artery disease registry with ULMCA disease were analyzed. A propensity matching was performed to adjust for baseline differences. In total, 817 women were included: 489 (59.8%) underwent treatment with PCI with drug-eluting stents versus 328 (40.2%) with CABG. Propensity score matching identified 175 matched pairs, and at long-term follow-up there were no differences in all-cause (odds ratio [OR] 0.722, 95% confidence interval [CI] 0.357 to 1.461, p=0.365) or cardiovascular (OR 1.100, 95% CI 0.455 to 2.660, p=0.832) mortality, myocardial infarction (MI; OR 0.362, 95% CI 0.094 to 1.388, p=0.138), or cerebrovascular accident (CVA; OR 1.200, 95% CI 0.359 to 4.007, p=0.767) resulting in no difference in the primary study objective of death, MI, or CVA (OR 0.711, 95% CI 0.387 to 1.308, p=0.273). However, there was an advantage of CABG in major adverse cardiovascular and cerebrovascular events (OR 0.429, 95% CI 0.254 to 0.723, p=0.001), driven exclusively by target vessel revascularization (OR 0.185, 95% CI 0.079 to 0.432, p<0.001). In women with significant ULMCA disease, no difference was observed after PCI or CABG in death, MI, and CVA at long-term follow-up., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate the impact of baseline activated clotting time (ACT)-guided heparin administration on major bleeding after transfemoral transcatheter aortic valve implantation (TAVI)., Background: Bleeding after TAVI is frequent and associated with unfavorable prognosis. Proper intraprocedural heparin dose administration may reduce the risk of potential overdosing in this frail study group., Methods: Of the patients who underwent transfemoral TAVI in our center from November 1, 2007 to June 31, 2012, 362 were retrospectively analyzed. Because abnormally high baseline ACT values were noted, heparin was administered at the operator's discretion, according to baseline ACT (ACT-guided, n = 174) or patient's body weight (non-ACT-guided, n = 188). The primary study objective was 30-day major bleeding as defined by the Valve Academic Research Consortium criteria. Secondary objectives were any life-threatening, and minor bleeding, and other Valve Academic Research Consortium outcomes at 30 days., Results: Bleeding occurred in 167 (46.1%) patients; of these, 76 (21.0%) had major bleeding. The ACT-guided group had a significantly lower occurrence of major (7.5% vs. 33.5%, p < 0.001), life-threatening (12.1% vs. 20.2%, p = 0.04), and any bleeding (25.9% vs. 64.9%, p < 0.001). Conversely, no differences were noted in the other study objectives. After adjustment for potential confounders, the protective odds ratio for ACT-guided therapy on major bleeding was 6.4 (95% confidence interval: 2.3 to 17.9; p < 0.001) at 30 days., Conclusions: In our experience, heparin administration according to baseline ACT was correlated with a significantly lower occurrence of major bleeding in transfemoral TAVI. This strategy might be a useful tool in reducing bleeding in this high-risk study group., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: To compare radial and femoral crossover techniques (CT) for vascular access management in transcatheter aortic valve implantation (TAVI)., Background: Femoral crossover for controlled angiography and balloon inflation of the therapeutic access site to facilitate safe vascular closure is beneficial but technically challenging in patients with complex femoral anatomy. An alternative approach should be available., Methods: Between June 2011 and March 2012, 41 transfemoral TAVI patients receiving the femoral CT were compared to 46 transfemoral TAVI patients receiving the radial CT. Outcomes were 30-day valve academic research consortium (VARC) endpoints., Results: Patients undergoing the radial CT received higher median contrast volumes (150 interquartile range [IQR]: 105-180 vs. 111 IQR: 90-139 ml; P = 0.025) but procedural radiation dose and fluoroscopy times were comparable. Thirty day all cause and cardiovascular death were similar between radial and femoral CT groups (respectively 2.4% vs. 7.9%, P = 0.258 and 0% vs. 7.9%, P = 0.063). There were no differences in major vascular complications (4.3% vs. 7.3%, P = 0.553), life threatening or major bleeding events (respectively 9.1% vs. 19.5%, P = 0.168 and 13.6% vs. 22%, P = 0.315)., Conclusion: In TAVI cases with unfavorable contralateral femoral anatomy, radial CT for vascular access management is a reasonable alternative to the femoral CT., (Copyright © 2013 Wiley Periodicals, Inc.)

Aims: To assess two-year outcomes following first vs. new-generation drug-eluting stent (DES) implantation in unprotected left main (ULMCA) percutaneous coronary intervention., Methods and Results: All eligible patients from our two-centre registry treated with first and new-generation DES from October 2006 to November 2010 were analysed. The study objective was major adverse cardiac events (MACE), defined as all-cause mortality, target vessel revascularisation (TVR) and myocardial infarction (MI) at two years. In total, 186 patients were included: 93 (50.0%) treated with first vs. 93 (50.0%) with new-generation DES. No differences were observed in baseline clinical characteristics except for higher EuroSCORE with new-generation DES (3.6±2.5 vs. 4.6±2.7; p=0.007). No significant difference was observed in stenting techniques; two stents were used respectively in 53.8% vs. 44.1% (p=0.187). Notably, intravascular ultrasound guidance was more frequent with new-generation DES (46.2% vs. 61.3%; p=0.040). At 730.0 (interquartile range 365.5-1,224.5) days, there was a trend towards improved MACE with new-generation DES (31.2% vs. 19.6%; p=0.070) and a significant reduction in TVR (23.7% vs. 12.0%; p=0.038) and MI (4.3% vs. 0%; p=0.044). Notably, there were four cases of definite stent thrombosis (ST) with first vs. none with new-generation DES (p=0.044)., Conclusions: In our study, new-generation DES had a trend for less MACE and improved results with regard to MI, TVR and definite ST at two-year follow-up.

Objectives: To explore the 2-year clinical outcomes in patients with unprotected left main coronary artery (ULMCA) disease treated with overall new drug-eluting stent (DES) options., Background: Recent available data have shown the feasibility and the safety of new DESs, mainly evaluating the everolimus-eluting stents in the setting of ULMCA disease., Methods: Patients with ULMCA disease undergoing percutaneous coronary intervention (PCI) with everolimus-, zotarolimus-, and biolimus A9-eluting stents were prospectively evaluated. The study objective was the composite of major adverse cardiac events (MACEs), consisting of all-cause mortality, myocardial infarction (MI), and target vessel revascularization (TVR) at 2-year clinical follow-up., Results: A total of 154 patients were analyzed. The mean EuroSCORE and SYNTAX scores were 4.7 ± 2.6 and 27.5 ± 8.3, respectively. Distal location was present in 126 patients (81.8%) and 96 lesions (76.3%) were true Medina bifurcations. The 2-stent technique was used in 73 cases (57.9%). Everolimus-, zotarolimus-, and biolimus A9-eluting stents were implanted in 68 patients (44.2%), 46 patients (29.9%), and 40 patients (25.9%), respectively. At a median clinical follow-up of 551.5 days (interquartile range, 360.8-1045.5 days), MACEs occurred in 29 patients (18.8%). Ten patients (6.5%) died, and 2 deaths (1.3%) were adjudicated as cardiac. No patient had myocardial infarction or definite stent thrombosis (ST). One probable and 1 possible ST were adjudicated. TVR was required in 19 patients (12.3%) and target lesion revascularization was required in only 7 patients (4.5%)., Conclusions: In our experience, despite the presence of complex distal left main lesions, new DESs in ULMCA disease appear to be promising in terms of safety and efficacy at 2-year clinical follow-up.

Background: Only limited and conflicting data on the impact of preoperative chronic kidney disease (CKD) on outcomes after transcatheter aortic valve implantation (TAVI) are available., Methods: We retrospectively analyzed pooled data from the prospective TAVI databases of 4 centers (942 patients). Valve Academic Research Consortium end point definitions were used. The outcomes were compared among patients with normal estimated glomerular filtration rate (≥90 mL/min), mild (60-89 mL/min), moderate (30-59 mL/min), and severe (<30 mL/min) CKD and those on chronic hemodialysis (HD). The primary end point was 1-year survival., Results: A total of 109 patients had a normal estimated glomerular filtration rate (11.6%); 329 (34.9%) had mild, 399 (42.5%) moderate, 72 (7.5%) severe CKD, and 33 (3.5%) were on HD. Baseline and procedural characteristics were similar among all groups except for Logistic EuroSCORE. Major stroke, life-threatening bleeding, all-cause 30-day mortality (HD 15.2%, severe CKD 8.3%, moderate CKD 8.3%, mild CKD 6.7%, normal 1.8%, P = .007) and 1-year survival (HD 54.8%, severe CKD 67.2%, moderate CKD 80.0%, mild CKD 85.2%, normal eGFR 91.4%, HD vs severe CKD P = .23, severe CKD vs moderate CKD P = .002, moderate CKD vs mild CKD P = .04, moderate CKD vs normal eGFR P = .03, by log-rank test) differed significantly across groups. Through multivariable analysis, HD and severe CKD were independently associated with an increased risk of 1-year mortality (hazard ratios 5.07 [95% CI 1.79-14.35, P = .002] and 4.03 [95% CI 1.52-10.69, P = .005], respectively)., Conclusions: Patients with CKD who undergo TAVI have a higher-risk profile and worse 30-day and 1-year outcomes. Chronic hemodialysis and severe preprocedural CKD are independently associated with an increased risk of 1-year mortality after TAVI., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Objectives: The aim of this study was to compare outcomes after transfemoral transcatheter aortic valve implantation with the Medtronic CoreValve (MCV) versus the Edwards SAPIEN/SAPIEN XT transcatheter heart valve (ESV) for severe aortic stenosis., Background: No large matched comparison study has been conducted so far evaluating both commercially available devices., Methods: The data from databases of 4 experienced European centers were pooled and analyzed. Due to differences in baseline clinical characteristics, propensity score matching was performed. Study objectives were Valve Academic Research Consortium outcomes at 30 days and 1 year., Results: In total, 793 patients were included: 453 (57.1%) treated with the MCV and 340 (42.9%) with the ESV. After propensity matching, 204 patients were identified in each group. At 30 days, there were no differences in all-cause mortality (MCV, 8.8% vs. ESV, 6.4%; hazard ratio [HR]: 1.422; 95% confidence interval [CI]: 0.677 to 2.984; p = 0.352), cardiovascular mortality (MCV, 6.9% vs. ESV, 6.4%; HR: 1.083; 95% CI: 0.496 to 2.364; p = 0.842), myocardial infarction (MCV, 0.5% vs. ESV, 1.5%; HR: 0.330; 95% CI: 0.034 to 3.200; p = 0.339), stroke (MCV, 2.9% vs. ESV, 1.0%; HR: 3.061; 95% CI: 0.610 to 15.346; p = 0.174), or device success (MCV, 95.6% vs. ESV, 96.6%; HR: 0.770; 95% CI: 0.281 to 2.108; p = 0.611). Additionally, there were no differences in major vascular complications (MCV, 9.3% vs. ESV, 12.3%; HR: 0.735; 95% CI: 0.391 to 1.382; p = 0.340) or life-threatening bleeding (MCV, 13.7% vs. ESV, 8.8%; HR: 1.644; 95% CI: 0.878 to 3.077; p = 0.120). MCV was associated with more permanent pacemakers (22.5% vs. 5.9%; HR: 4.634; 95% CI: 2.373 to 9.050; p < 0.001). At 1 year, there were no differences in all-cause (MCV, 16.2% vs. ESV, 12.3%; HR: 1.374; 95% CI: 0.785 to 2.407; p = 0.266) or cardiovascular (MCV, 8.3% vs. ESV, 7.4%; HR: 1.145; 95% CI: 0.556 to 12.361; p = 0.713) mortality., Conclusions: No differences between the 2 commercially available transfemoral transcatheter aortic valve implantation devices were observed at the adjusted analysis in Valve Academic Research Consortium outcomes except for the need for permanent pacemakers with the MCV., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transfemoral transcatheter aortic valve implantation (TF-TAVI) is a viable and safe treatment strategy for patients with symptomatic severe aortic stenosis and high operative risk and has been introduced as such in the recently updated European guidelines on the management of valvular heart disease.Our aim was to assess trends in outcome after TF-TAVI., Methods: Propensity score-matched analysis of a multicenter registry of consecutive patients undergoing TF-TAVI subdivided into 3 tertiles based on enrollment date was performed. Three tertiles of 214 propensity score-matched patients were compared., Results: With mounting experience and moving from the initial to the last cohort, procedural contrast volume and radiation time decreased. Over time, there were less major vascular complications (15% vs 7.9%, P = .023), life-threatening bleedings (17.8% vs 7.9%, P = .003), and major bleedings (22.4% vs 12.1%, P = .007). Major vascular complications and life-threatening bleedings caused by closure device failure decreased significantly (9.2% vs 3.1% [P = .01] and 5.7% vs 1 % [P = .01], respectively). The combined safety end point dropped from 31.3% in tertile (T) (T1) to 17.8% in T3 (P < .001). By multivariable analysis, the last cohort as compared with the initial cohort was associated with significant reductions in 30-day mortality (odds ratio [OR] 0.35, 95% CI 0.12-0.96), stage 3 AKI (OR 0.12, 95% CI 0.29-0.93), and the combined safety end point (OR 0.52, 95% CI 0.29-0.93). One-year survival improved significantly (T1 79% vs T3 86%, P = .016)., Conclusions: Over time, TAVI is performed with significant reductions in major vascular complications, life-threatening bleedings, and the combined clinical safety end point and improved 1-year survival., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Better outcomes have been reported after percutaneous cardiac intervention in obese patients ("obesity paradox"). However, limited information is available on the effect of the body mass index on the outcomes after transcatheter aortic valve implantation (TAVI). We, therefore, sought to determine the effect of the body mass index on the short- and long-term outcomes in patients who underwent TAVI. The population consisted of 940 patients, of whom 25 (2.7%) were underweight, 384 had a (40.9%) normal weight, 372 (39.6%) were overweight, and 159 (16.9%) were obese. Overall, the obese patients were younger (79.7 ± 6.4 years vs 81.7 ± 7.3 and 80.8 ± 7.0 years, p = 0.008) and had a greater prevalence of preserved left ventricular and renal function. On univariate analysis, obese patients had a greater incidence of minor stroke (1.3% vs 0 and 0.3%, p = 0.03), minor vascular complications (15.7% vs 9.1% and 11.6%, p = 0.028) and acute kidney injury stage I (23.3% vs 10.7% and 16.1%, p <0.001). After adjustment, body mass index, as a continuous variable, was associated with a lower risk of mortality at 30 days (odds ratio 0.93, 95% confidence interval 0.86 to 0.98, p = 0.023) and no effect on survival after discharge (hazard ratio 1.01, 95% confidence interval 0.96 to 1.07, p = 0.73). In conclusion, obesity was associated with a greater incidence of minor, but no major, perioperative complications after TAVI. After adjustment, obesity was associated with a lower risk of 30-day mortality and had no adverse effect on mortality after discharge, underscoring the "obesity paradox" in patients undergoing TAVI., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Our study objective was to assess the incidence, predictors, and implications of access site complications related to transfemoral transcatheter aortic valve implantation (TAVI). We pooled the prospective TAVI databases of 5 experienced centers in Europe enrolling only transfemoral cases for this analysis. Access site complications were defined according to the Valve Academic Research Consortium end-point definitions. The global transfemoral TAVI database contained 986 patients. Percutaneous access and closure was performed in 803 patients (81%) and a surgical strategy in 183 (19%). Incidences of major vascular complications, life-threatening/disabling bleeding, and major bleeding were 14.2%, 11%, and 17.8% respectively. In the patient cohort with a completely percutaneous access strategy, major vascular complications and life-threatening/disabling bleedings were related to closure device failure in 64% and 29%, respectively. Female gender (odds ratio 1.63, 95% confidence interval 1.12 to 2.36) and use of >19Fr system (2.87, 1.68 to 4.91) were independent predictors for major vascular complications. Female gender (odds ratio 2.04, 95% confidence interval 1.31 to 3.17), use of >19Fr system (1.86, 1.02 to 3.38), peripheral arterial disease (2.14, 1.27 to 3.61), learning effect (0.45, 0.27 to 0.73), and percutaneous access strategy (2.39, 1.16 to 4.89) were independently associated with life-threatening/disabling bleedings. In conclusion, transfemoral TAVI is associated with a >10% incidence of major vascular-related complications. A considerable number of these events is related to arteriotomy closure failure. Arterial sheath size and female gender are important determinants of major vascular complications and life-threatening/disabling bleeding., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Percutaneous balloon aortic valvuloplasty is used in high-risk patients with significant aortic stenosis, either as palliation or as a bridge to more definitive treatment. We report the case of a high-risk patient, a man aged 71 years and with multiple comorbidities, undergoing this procedure. Following the procedure, he was given protamine to aid with vascular closure. This immediately led to hemodynamic collapse and cardiopulmonary arrest with angiographic evidence of thrombus occluding the left main coronary artery. This extremely rare complication requires prompt and aggressive treatment to enable good functional recovery of the individual., (Copyright © 2012 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)