Percutaneous Valvular and Structural Heart Disease Interventions.2024 Core Curriculum of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC in collaboration with the European Association of Cardiovascular Imaging (EACVI) and the Cardiovascular Surgery Working Group (WG CVS) of the European Society of Cardiology.

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.

Percutaneous Valvular and Structural Heart Disease Interventions. 2024 Core Curriculum of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC.

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.

Data standards for transcatheter aortic valve implantation: the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart).

AIMS: Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology (ESC) aims to create pan-European data standards for cardiovascular diseases and interventions, including transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We followed the EuroHeart methodology for cardiovascular data standard development. A Working Group of 29 members representing 12 countries was established and included a patient representative, as well as experts in the management of valvular heart disease from the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Association of Cardiovascular Imaging (EACVI) and the Working Group on Cardiovascular Surgery. We conducted a systematic review of the literature and used a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition, permissible values, and categorized the variable as mandatory (Level 1) or additional (Level 2) based on its clinical importance and feasibility. In total, 93 Level 1 and 113 Level 2 variables were selected, with the level 1 variables providing the dataset for registration of patients undergoing TAVI on the EuroHeart IT platform. CONCLUSION: This document provides details of the EuroHeart data standards for TAVI processes of care and in-hospital outcomes. In the context of EuroHeart, this will facilitate quality improvement, observational research, registry-based RCTs and post-marketing surveillance of devices, and pharmacotherapies. ONE-SENTENCE SUMMARY: The EuroHeart data standards for transcatheter aortic valve implantation (TAVI) are a set of internationally agreed data variables and definitions that once implemented will facilitate improvement of quality of care and outcomes for patients receiving TAVI.

Expert Consensus on Sizing and Positioning of SAPIEN 3/Ultra in Bicuspid Aortic Valves.

Severe aortic stenosis patients with bicuspid anatomy have been excluded from the major transcatheter aortic valve replacement (TAVI) randomized clinical trials. As a result, there is no official recommendation on bicuspid TAVI. A panel of bicuspid experts was created to fill this gap. In this consensus statement, an algorithm is proposed to guide the choice of surgery or TAVI within this complex patient population, depending on aortic dilatation, age, surgical risk score, and anatomy. A step-by-step guide for sizing and positioning of the SAPIEN 3/Ultra TAVI bioprostheses is presented. Annular sizing remains the primary strategy in most bicuspid patients. However, some anatomies may require sizing at the supra-annular level, for which patients the panel recommends the circle method, a dedicated sizing and positioning approach for SAPIEN 3/Ultra. The consensus provides valuable pre-operative insights on the interactions between SAPIEN 3/Ultra and the bicuspid anatomy; understanding the valve-anatomy relationship is critical to avoid complications and to optimize outcomes for patients.

General anaesthesia or sedation for percutaneous aortic valve implantation? The questionnaire results and authors' experience.

INTRODUCTION: Over the last two decades transcatheter aortic valve replacement (TAVR) has been approved for clinical use. The anaesthetic choice for this procedure is evolving. General anaesthesia was the predominant anaesthetic technique. Growing experience and advances in technology and economic considerations have led to an increasing interest in performing TAVR under monitored sedation. AIM: The assessment of monitored sedation, called cooperative sedation, involves pharmacologically mediated suppression of consciousness and preservation of verbal contact in response to stimulation as a safe method of anaesthesia for TAVR. MATERIAL AND METHODS: Sixty out of 63 TAVR patients with femoral access received monitored sedation. Dexmedetomidine was administered in most of such cases (46 patients). A questionnaire was also carried out by staff involved in performing TAVR procedures, with more than 5 years of experience in it, concerning the method of anaesthesia and perioperative care. RESULTS: Conversion to general anaesthesia was required in 10% of patients (6 cases), only one as a patient-related complication (hypercarbia). The questionnaire carried out showed that anaesthesia and postoperative care after TAVR are underestimated. CONCLUSIONS: The preliminary results regarding anaesthetic management in TAVR procedures demonstrate that monitored sedation is safe, provided that contraindications are observed.

Poland: coronary and structural heart interventions from 2010 to 2015.

For the last five years, invasive cardiology in Poland has developed extensively. Currently, 98% of the 161 Polish cathlabs operate in 24/7 mode, 37 of them supported by cardiac surgery departments on-site. A certification curriculum for interventional cardiology operators is supported by dedicated workshops and scientific meetings during national conferences. The rise in the number of coronary angiographies and PCIs was paralleled by an increased use of drug-eluting stents, bioresorbable vascular scaffolds and physiologic assessment of coronary arteries. Radial artery access has become the default option for PCI. A rapid adoption of the EAPCI Stent for Life Initiative resulted in a significant increase in primary PCIs. Unlike coronary interventions, structural heart interventions have evolved unevenly, despite the solid network of Heart Teams set up in the 21 most experienced centres. Left atrial appendage closure is offered in an increasing number of cathlabs. MitraClip therapy remains largely underused (1 procedure/million population/year). Despite the slow growth of TAVI since 2008, the current annual number of 17.1 TAVI procedures per million population is incomparable with countries in Western Europe. A recently introduced EAPCI Valve for Life campaign was followed by a 42.6% annual increase in TAVI procedures and an improvement in patients' access to therapy in life-saving indications.

A randomised trial on platelet function-guided de-escalation of antiplatelet treatment in ACS patients undergoing PCI. Rationale and design of the Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes (TROPICAL-ACS) Trial.

Outcomes of acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) have been significantly improved with the use of potent P2Y12 receptor inhibitors like prasugrel. While most of the ischaemic risk reduction for prasugrel versus clopidogrel was demonstrated in the early treatment period, the risk of bleeding became particularly prominent during the chronic course of therapy. It may therefore be a valid approach to substitute prasugrel for clopidogrel in the early phase of chronic antiplatelet treatment after PCI. In the Testing Responsiveness To Platelet Inhibition On Chronic Antiplatelet Treatment For Acute Coronary Syndromes (TROPICAL-ACS) trial, we aim to compare standard prasugrel therapy with a de-escalating antiplatelet treatment approach guided by platelet function testing (PFT). The study is an investigator-initiated European multicentre, randomised clinical trial in biomarker-positive ACS patients after successful PCI. Two thousand six hundred patients will be randomised prior to hospital discharge in a 1:1 fashion to either receive standard prasugrel therapy (control group) or de-escalating therapy (one-week prasugrel followed by one-week clopidogrel and PFT-guided maintenance therapy from day 14 after hospital discharge, monitoring group). Patients of the monitoring group with high on-clopidogrel platelet reactivity (HPR) based on Multiplate analyzer testing (HPR: ≥ 46U per consensus definition) will be switched back to prasugrel, whereas those without HPR (<46 U) will continue clopidogrel treatment. The overall study treatment duration will be one year in both groups. The primary endpoint of the study is net clinical benefit (combined incidence of cardiovascular death, myocardial infarction, stroke and bleeding ≥ grade 2 according to BARC criteria) one-year after randomisation. TROPICAL-ACS is the first large-scale, randomised controlled trial assessing the clinical value of a PFT-guided de-escalation of antiplatelet treatment in biomarker positive ACS patients undergoing PCI.

Transcatheter aortic valve implantation for pure severe native aortic valve regurgitation.

OBJECTIVES: This study sought to collect data and evaluate the anecdotal use of transcatheter aortic valve implantation (TAVI) in pure native aortic valve regurgitation (NAVR) for patients who were deemed surgically inoperable BACKGROUND: Data and experience with TAVI in the treatment of patients with pure severe NAVR are limited. METHODS: Data on baseline patient characteristics, device and procedure parameters, echocardiographic parameters, and outcomes up to July 2012 were collected retrospectively from 14 centers that have performed TAVI for NAVR. RESULTS: A total of 43 patients underwent TAVI with the CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) at 14 centers (mean age, 75.3 ± 8.8 years; 53% female; mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), 26.9 ± 17.9%; and mean Society of Thoracic Surgeons score, 10.2 ± 5.3%). All patients had severe NAVR on echocardiography without aortic stenosis and 17 patients (39.5%) had the degree of aortic valvular calcification documented on CT or echocardiography. Vascular access was transfemoral (n = 35), subclavian (n = 4), direct aortic (n = 3), and carotid (n = 1). Implantation of a TAVI was performed in 42 patients (97.7%), and 8 patients (18.6%) required a second valve during the index procedure for residual aortic regurgitation. In all patients requiring second valves, valvular calcification was absent (p = 0.014). Post-procedure aortic regurgitation grade I or lower was present in 34 patients (79.1%). At 30 days, the major stroke incidence was 4.7%, and the all-cause mortality rate was 9.3%. At 12 months, the all-cause mortality rate was 21.4% (6 of 28 patients). CONCLUSIONS: This registry analysis demonstrates the feasibility and potential procedure difficulties when using TAVI for severe NAVR. Acceptable results may be achieved in carefully selected patients who are deemed too high risk for conventional surgery, but the possibility of requiring 2 valves and leaving residual aortic regurgitation remain important considerations.

Early translation of adipose-derived cell therapy for cardiovascular disease.

Over the past decade, cell therapy has emerged as a new approach to reversing myocardial ischemia. Several types of adult stem cells have been studied in both preclinical and clinical conditions for this purpose: bone marrow cells, circulating cells, and myoblasts. Nevertheless, the quest for the ideal "anti-ischemic" cell is still ongoing. Recently, the existence of a population of stem cells located in adipose tissue (adipose-derived stem cells) has been observed. These are able to differentiate into multiple cell lineages including cardiomyocytic differentiation. In this review we discuss the basic principles of adipose-derived stem cells (types and characteristics, harvesting, and expansion), the initial experimental studies, and the currently ongoing clinical trials.

Adipose tissue-derived stem cells: the friendly side of a classic cardiovascular foe.

Recently, the existence of a population of stem cells located in the adipose tissue has been observed. Adipose-derived stem cells are able to differentiate into multiple cell lineages including cardiac myocytes. Hence, adipose-derived cells are emerging as a new source of adult stem cells for cardiovascular repair. In this review, we discuss the basic principles of adipose-derived stem cells (types and characteristics, obtention processes, immunophenotypic characterization, and cell potency), the initial experimental studies, and the currently ongoing clinical trials.

Comparison of effectiveness of coronary artery bypass grafting versus percutaneous coronary intervention in patients with ischemic cardiomyopathy.

The REvascularization in Ischemic HEart Failure Trial (REHEAT) is a nonrandomized, case-controlled, prospective study assessing the hypothesis that surgical and percutaneous revascularizations in patients with ischemic cardiomyopathy are associated with comparable improvement in left ventricular ejection fraction (LVEF) and functional status 12 months after myocardial revascularization. The study population consisted of 141 patients with LVEFs of <40% and angiographically confirmed coronary artery disease. The primary end point was improvement in LVEF 12 months after intervention. Secondary end points were in-hospital major adverse events, length of hospitalization, exercise tolerance of treadmill stress testing after 12 months, 1-year survival, 1-year event-free survival, angina, and heart failure severity after 12 months. The case-controlled study included 55 patients who underwent percutaneous coronary intervention (PCI) and 54 who underwent coronary artery bypass grafting (CABG). The incidence of 30-day major adverse events was higher in the CABG group (40.7% vs 9%, p = 0.0003), whereas duration of hospital stay was shorter in the PCI group (6.8 +/- 3.6 vs 9.2 +/- 2.1 days, p = 0.00001). Increase in LVEF was comparable after PCI and CABG (6.0 +/- 7.2% vs 4.4 +/- 9.0% p = 0.12). Long-term functional status based on treadmill stress testing was better after PCI (Student's t test, p = 0.0003) but, according to Canadian Cardiovascular Society and New York Heart Association classifications, was similar in the 2 treatment arms (Wilcoxon test, p <0.01). Long-term survival was significantly better for patients after PCI (Wilcoxon test, p <0.01); however, major adverse event-free survival was better after CABG (Cox-Mantel test, p = 0.0013). In conclusion, PCI and CABG are associated with comparable improvements in LVEF in patients with ischemic cardiomyopathy. PCI offers a better 1-year survival rate than CABG, but the incidence of repeat revascularization is lower with CABG.