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Background: Myocardial ischemia (INOCA) and acute myocardial infarction with non-obstructive coronary artery disease (MINOCA) represent emerging entities in the landscape of interventional cardiology. These conditions have heterogeneous pathophysiological mechanisms and clinical presentations, complex diagnostics, and high prognostic significance., Methods: This survey was carried out jointly by the GISE Young Committee with the support of the SICI-GISE Society and the ICOT group with the aim of evaluating the implementation of diagnostic-therapeutic pathways in cases of suspected/confirmed INOCA and MINOCA diseases. A web-based questionnaire based on 22 questions was distributed to SICI-GISE and ICOT members., Results: The survey was distributed to 1550 physicians with 104 (7%) responses. The majority of participants included interventional cardiologists (70%), in two-thirds of cases working in centers with high volume of procedures (>1000 coronary angiographies/year), who estimated a <10% annual rate of INOCA and MINOCA cases in their case load. Approximately 25% of the participants stated that they do not have the option of performing any investigation for the evaluation of patients with suspected INOCA, and less than 50% make use of advanced invasive testing for the diagnosis of MINOCA, including physiology and intravascular imaging tests. It also turns out that about 50% of respondents reported the present and future absence of dedicated diagnostic-therapeutic pathways. Even with a high perception of the clinical relevance of these diseases, about 40% of the respondents rely on clinical experience or do not deal with their management, also reporting a low prevalence of dedicated follow-up care (20% of cases followed at dedicated outpatient clinics). Factors predominantly limiting the prevalence of appropriate diagnostic and treatment pathways included the cost of materials, lack of training and expertise of practitioners, and of solid data on the long-term clinical efficacy of treatments., Conclusions: Currently, the proper management of INOCA and MINOCA disease is widely advocated but poorly implemented in clinical practice. To reverse the trend and solve the remaining controversies, it is necessary to enhance awareness, produce robust scientific data, and implement dedicated pathways for patients.

Arterial hypertension is the most prevalent cardiovascular risk factor worldwide. Despite the availability of many and effective antihypertensive medications, the prevalence of uncontrolled blood pressure (BP) remains high. As sympathetic hyperactivity has long been recognized as a major contributor to resistant hypertension, catheter-based renal denervation (RDN) has emerged as a new strategy to reduce BP. RDN aims to interrupt the activity of renal sympathetic nerves by applying radiofrequency (RF) energy, ultrasound (US) energy, or injection of alcohol in the perivascular space. The Symplicity HTN-3 trial, the largest sham-controlled trial using the first-generation RF-based RDN device, failed to significantly reduce BP. Since then, new devices and techniques have been developed and consequently many sham-controlled trials using second-generation RF or US-based RDN devices have demonstrated the BP lowering efficacy and safety of the procedure. A multidisciplinary team involving hypertension experts, interventionalists with expertise in renal interventions and anesthesiologists, plays a pivotal role from the selection of the patient candidate for the procedure to the post-procedural care. The aim of this consensus document is to summarize the current evidence about the use of RDN in difficult to treat hypertension and to propose a management strategy from the selection of the patient candidate for the procedure to the post-procedural care.

Background: Over the past decades, the improvements in the diagnostic power and availability of non-invasive cardiac imaging techniques have led to a decline of right heart catheterization (RHC) performance. However, RHC remains the gold standard for diagnosing pulmonary hypertension and an essential tool for the evaluation of patient candidacy to heart transplantation., Methods: This survey was carried out jointly by the Young Committee of GISE, with the support of the SICI-GISE Society, and the ICOT group, with the aim of evaluating how the interventional cardiology community perform RHC. A web-based questionnaire based on 20 questions was distributed to SICI-GISE members., Results: The survey was distributed to 1550 physicians with 174 (11%) responses. Most centers perform few procedures per year (<10 RHC/year) and a dedicated cardiologist is usually lacking. Patients were frequently admitted as ordinary hospitalization regimen and the most frequent indication for RHC was the hemodynamic assessment of pulmonary hypertension, followed by diagnostics of valvular diseases and advanced heart failure/heart transplantation. Indeed, the majority of participants (86%) are involved in transcatheter procedures for structural heart disease. The average time taken to perform the RHC was approximately 30-60 min. The femoral access (60%) was the most frequently used, usually by an echo-guided approach. Two-thirds of participants discontinued oral anticoagulant therapy before RHC. Only 27% of centers assess wedge position from an integrated analysis. Furthermore, the edge pressure is detected in the end-diastolic cardiac phase in half cases and in the end-expiratory phase in only 31%. The most commonly used method for cardiac output calculation was the indirect Fick method (58%)., Conclusions: Guidance on the best practice for performing RHC is currently lacking. A more precise standardization of this demanding procedure is warranted.

In the last decades, advances in percutaneous coronary intervention (PCI) strategies have significantly reduced the risk of procedural complications and in-hospital mortality of patients with acute coronary syndromes (ACS), thus increasing the population of stable post-ACS patients. This novel epidemiological scenario emphasizes the importance of implementing secondary preventive and follow-up strategies. The follow-up of patients after ACS or elective PCI should be based on common pathways and on the close collaboration between hospital cardiologists and primary care physicians. However, the follow-up strategies of these patients are still poorly standardized. This SICI-GISE/SICOA consensus document was conceived as a proposal for the long-term management of post-ACS or post-PCI patients based on their individual residual risk of cardiovascular adverse events. We defined five patient risk classes and five follow-up strategies including medical visits and examinations according to a specific time schedule. We also provided a short guidance for the selection of the appropriate imaging technique for the assessment of left ventricular ejection fraction and of non-invasive anatomical or functional tests for the detection of obstructive coronary artery disease. Physical and pharmacological stress echocardiography was identified as the first-line imaging technique in most of cases, while cardiovascular magnetic resonance should be preferred when an accurate evaluation of left ventricular ejection fraction is needed. The standardization of the follow-up pathways of patients with a history of ACS or elective PCI, shared between hospital doctors and primary care physicians, could result in a more cost-effective use of resources and potentially improve patient's long-term outcome.

Background: During the last decade, thanks to contemporary evidence and technological improvements, the role of interventional cardiology in the field of cardiac conditions that are mainly treated conservatively has grown a lot. In such scenario, drug-resistant arterial hypertension and heart failure (HF) have a significant role, considering the huge number of involved patients and their impact on mortality and quality of life., Methods: This survey was jointly performed by the GISE Young Committee with the support of the SICI-GISE Society and the ICOT group with the aim of evaluating the view of the cardiology community on interventional therapies for arterial hypertension and HF. A web-based questionnaire based on 22 questions was distributed online to SICI-GISE members., Results: The survey was distributed to 1550 physicians with 156 (10%) responses, 58% of whom was under 35 years of age. Renal denervation was available in 49% of Centers, its principal indication was the evidence of severe adverse reactions to anti-hypertensive drugs (80%). Most participants agreed that, compared to past years, there is more understanding of anatomical characteristics and improvement of devices, thus increasing procedural safety; however, main limitations were: appropriate patients' selection criteria (45%), lack of robust evidence (41%) and regulatory (36%) and economical (33%) factors. In the field of HF, this survey enlightened a wide availability of conventional therapies (i.e. mechanical circulatory support, defibrillators, resynchronization) in Italy; on the other side, there is limited availability of innovative devices (i.e. atrial decompression systems, transcatheter left ventricular reshaping). Many participants expressed enthusiastic attitude in this new field, with a look for the need of further evidence in terms of safety and efficacy. Finally, in the treatment of both acute and chronic HF, many participants expressed a problem of limited patient access to advanced therapies, mainly associated with suboptimal networking among institutions., Conclusions: Device-based therapies for arterial hypertension and HF represent a promising option for selected patients; this survey highlights the importance of achieving good quality evidence in both fields, with the goal of proper identification of defined criteria for patients' selection and improvement of procedural and long-term safety and efficacy.

Background: Pulmonary embolism (PE) represents the third leading acute cardiovascular syndrome in the world and it is burdened with high mortality and morbidity rates. Percutaneous or catheter-based treatments of high- and intermediate-risk patients have garnered interest because of the limitations of both systemic thrombolysis and anticoagulation strategies. However, data on these techniques are heterogeneous and limited to small non-randomized evidences., Methods: This survey was jointly performed by the GISE Young Committee with the support of the SICI-GISE Society and ICOT group with the aim of evaluating the view of the cardiology community on interventional therapies for PE. A web-based questionnaire based on 19 questions was distributed to SICI-GISE and ICOT members., Results: The survey was distributed to 1550 physicians with 220 (14%) responses, 65% from North Italy. Multidisciplinary diagnostic and therapeutic pathways for patients with PE were not available in most centers (56%), and transcatheter treatment was available in 55% of centers, most of them at low volume (<5 percutaneous treatments/year). Among the devices used, mechanical thrombectomy was the predominant one (62%) in the absence of significant differences in the availability of devices within the three Italian geographic macro-areas. Respondents recognize the theoretical benefits of percutaneous treatment of PE, including: improving a prompt hemodynamic stabilization and respiratory exchange (89%) in high-risk patients, avoiding hemodynamic deterioration (39%) and right ventricular dysfunction (51%) in intermediate-risk patients, and reducing hemorrhagic complications related to systemic thrombolysis (36%). According to participants' judgement, the main factors limiting the use of percutaneous transcatheter treatment of PE in clinical practice are the lack of specific operator training (60%), lack of solid clinical data to support it (39%), difficult patient selection (34%), high costs (30%), and risk of procedural complications (26%)., Conclusions: Currently, transcatheter treatment of PE appears to be widely supported but poorly used in clinical practice. Solid evidences are needed regarding the safety and efficacy profile of the different available devices, the identification of patient selection criteria, alongside the enhancement of the availability of techniques and technologies.

Atrial fibrillation (AF) is the most common arrhythmia worldwide. Thromboembolism from the left atrial appendage (LAA) is the most feared complication in patients with AF. The cornerstone for the management of AF is oral anticoagulation to reduce the incidence of cardioembolic stroke. There is, however, a significant proportion of patients who cannot undergo long-term oral anticoagulation. Transcatheter LAA occlusion is an evolving technology with proven benefits in terms of AF-related stroke prevention, representing a valid alternative to anticoagulation for high-risk patients with contraindications for long-term oral anticoagulation. This has resulted in the development of a plethora of transcatheter devices to achieve endocardial occlusion or epicardial exclusion of the LAA.A panel of expert Italian cardiologists gathered under the aegis of the Italian Society of Interventional Cardiology (SICI-GISE) with the aim of reviewing the most relevant aspects of LAA occlusion, underlying anatomy and pathophysiology, summarizing current clinical knowledge, and discussing the practicalities of available devices and imaging techniques. Finally, the position paper highlights the importance of an adequate environment and of an appropriate organization in order to optimize all steps of the procedure.

Minimization of hospital lengths of stay has always been a key goal for healthcare systems. More so during the current COVID-19 pandemic. In fact, we have faced a reduction in no-COVID-19 admissions with the generation of huge backlogs. Low-risk patients undergoing elective percutaneous coronary intervention (PCI) can be candidate for short-term hospitalization, with consequent reduction of waiting lists. Several single-center and multicenter observational studies, multiple randomized trials and some meta-analyses have addressed this topic.In this position paper, we present a proposal for short hospitalization for elective PCI procedures in selected patients who present complications only exceptionally and exclusively immediately after the procedure, if the inclusion and exclusion criteria are met. Each Center can choose between admission in day surgery or one day surgery, extending hospital length of stay only for patients who present complications or who are candidate for urgent surgery. Short-term hospitalization considerably reduces costs even if, with the current model, it generally results in a parallel reduction in reimbursement. Hence, we present an actual model, already tested successfully in an Italian hospital, that warrants sustainability. This approach can then be tailored to single Centers.

In the last decades, the wide use of surgical aortic bioprostheses translated into an increased rate of valve degeneration and dysfunction. However, most patients are excluded from surgical re-do due to high or prohibitive operative risk. In this clinical context, valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) has been shown to be effective. Nevertheless, some relevant concerns, such as elevated residual transvalvular gradient and coronary artery obstruction, still remain. Detailed information regarding the degenerated surgical bioprosthesis and a thorough analysis of the computed tomography scan are essential for accurate pre-procedural planning and may avoid dramatic acute complications. Moreover, in difficult cases, the use of some tips and tricks may help expert operators to achieve better results.Here we report the case of a patient affected by structural degeneration of a small label size surgical aortic valve, who was excluded from surgical reintervention due to high operative risk. Therefore, we decided to perform a ViV-TAVI despite the presence of challenging features.

Coronary artery disease is a frequent comorbidity in patients with severe aortic stenosis undergoing trans-catheter aortic valve implantation (TAVI) and the need to ensure coronary access after TAVI is fundamental. This aspect is becoming increasingly relevant as TAVI indication expand to younger and lower-risk patients. Moreover, the longer life expectancy of subjects who are currently treated with TAVI could result in an increased need for TAVI-in-TAVI due to valve degeneration. As the implantation of a second transcatheter bioprosthesis might impair coronary access, TAVI-in-TAVI will be unfeasible in a significant proportion of cases, particularly if they received a tall-frame transcatheter heart valve at the time of the first intervention. Thus, patients might experience the paradox of needing surgical aortic valve replacement when they are older and frailer. Here we report the case of a patient with history of coronary artery disease and severe aortic stenosis treated with TAVI, presenting with an acute coronary syndrome 8 years after percutaneous aortic valve implantation. Thanks to the low frame height of the transcatheter aortic valve, it was possible to easily perform coronary angiography and high-risk percutaneous coronary intervention using hemodynamic support device (Impella CP). Moreover, this case highlights how the implantation of a low-frame transcatheter prosthesis can increase the possibility of achieving coronary access even after TAVI-in-TAVI, if needed.

Transcatheter aortic valve implantation (TAVI) has been a revolution in the treatment of severe aortic stenosis evolving to a high procedural success rate and low rate of complications. Embolization of the percutaneous device is a rare but potentially life-threatening complication. The spectrum of clinical manifestations ranges between incidental finding on cardiac imaging to cardiogenic shock or cardiac arrest. Data about predictors and management of transcatheter heart valve embolization are scarce and mostly anecdotical. Management strategies are related to the type, the size, the location of the embolized device, the timing of diagnosis, and the clinical presentation of the patient. According to recent data from TRAVEL registry, device embolization and migration occur in approximately 1% of the patients and is responsible for increased morbidity and mortality. However, in a considerable proportion of cases it could have been prevented, hence structural interventionalists should plan the procedures carefully and know thoroughly the risk factors for device embolization. Increased awareness of predisposing factors, preventive measures, and appropriate bail-out options and techniques are strongly advisable. This paper is a review of the incidence, and outcomes of percutaneous prosthesis embolization during TAVI. It also suggests an integrated algorithmic approach for the management of device embolization incorporating both percutaneous and surgical techniques.

Background: The coronavirus disease 2019 (COVID-19) pandemic has led to deferral of many non-urgent procedures in most healthcare systems worldwide. With this study we aimed to quantify the impact of COVID-19 on interventional treatment of structural heart disease (SHD) in Italy., Methods: Numbers of transfemoral transcatheter aortic valve replacement (TAVR), percutaneous mitral valve repair (PMVR), left atrial appendage occlusion (LAAO), patent foramen ovale (PFO) closures performed over a 4-week period during the national lockdown in Italian centers performing over 60 structural heart interventions (SHI)/year were compared with the same 4-week period in 2019. Incidence rate reductions (IRR) were estimated by zero-inflated negative binomial regression., Results: According to our nationwide analysis, SHIs were reduced by 79% as compared to the same period in 2019 (IRR 0.21, 95% confidence interval [CI] 0.15-0.29). This reduction was more substantial for PFO closure (IRR 0.03, 95% CI 0.01-0.07), LAAO (IRR 0.11, 95% CI 0.05-0.25) and PMVR (IRR 0.12, 95% CI 0.04-0.36) as compared to TAVR (IRR 0.31, 95% CI 0.22-0.47)., Conclusions: The COVID-19 pandemic caused a 79% drop in SHI volumes in Italy. PFO closure, LAAO and PMVR decreased more significantly as compared to TAVR. Further studies are needed to evaluate the impact of this reduction on outcomes of patients with SHD.

Background: The OBSERVANT study evaluated the medium and long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement obtaining comparative effectiveness results at least for the first-generation devices. The OBSERVANT II study enrolled a new series of TAVI procedures to evaluate whether the use of new-generation devices has modified outcome differences recorded in the OBSERVANT study. The aim of this paper is to describe the clinical characteristics of the OBSERVANT II population and compare them with those of the OBSERVANT population., Methods: OBSERVANT II is a prospective multicenter observational study, which enrolled patients with severe aortic stenosis, who underwent a TAVI procedure in 30 Italian centers from December 2016 to September 2018. Clinical, anatomical and procedural information was recorded for each patient as well as procedure characteristics and any periprocedural outcomes. An administrative follow-up will allow to obtain information on medium and long-term outcomes., Results: The enrolled population consists of 3001 patients with a mean age similar to that recorded in OBSERVANT (81.7 ± 6.3 vs 81.9 ± 6.2 years; p=0.336). OBSERVANT II patients show a lower prevalence of several morbid conditions than OBSERVANT patients (i.e. chronic obstructive pulmonary disease, coronary artery disease, peripheral arterial disease, etc.), though having very similar mean values of EuroSCORE II (7.2 ± 7.6% vs 7.4 ± 7.9%; p=0.558). According to three EuroSCORE II risk classes (≤3; 3-7; ≥7), the in-hospital mortality rates for patients enrolled in the two studies are 1.0% vs 2.0% (p≤0.000), 1.4% vs 4.1% (p<0.000) and 2.4% vs 7.7% (p<0.000), respectively., Conclusions: The first results of the OBSERVANT II study show that patients undergoing TAVI with new-generation devices are elderly, have a lower risk profile than patients enrolled in the OBSERVANT study but comparable mean values of EuroSCORE II. The in-hospital mortality rate for patients enrolled in the OBSERVANT II study is lower than that recorded in the OBSERVANT study across all the EuroSCORE II risk classes.

Patent foramen ovale (PFO) is implicated in the pathogenesis of different clinical syndromes in which it plays variable roles. In 2017 and 2018, four randomized clinical trials were published, allowing for the clarification of certain issues pertaining to cryptogenic stroke. Recently, eight European scientific societies collaborated to the writing of an interdisciplinary international position paper on PFO and cryptogenic stroke, based upon best available evidence, with the aim of defining the principles needed to guide decision making. Nonetheless, a tailored approach is not suitably addressed by standard position documents, considering that decisions about optimal management of PFO patients with left circulation thromboembolism are often challenging, mostly due to comorbidities and complex clinical scenarios.A panel of Italian cardiology experts gathered under the auspices of the Italian Society of Interventional Cardiology (SICI-GISE) for comprehensive discussion and consensus development, with the aim of providing practical recommendations, for both clinical and interventional cardiologists, regarding optimal management of PFO in patients with cerebral or systemic thromboembolism. In this position paper, various clinical scenarios in patients with and without high-risk PFO features are presented and discussed, including PFO patients with associated conditions (e.g. hypercoagulable states, deep vein thrombosis/pulmonary embolism, short runs of atrial fibrillation), and special subsets (e.g. patients with risk factors for atrial fibrillation, patients aged ≥65 years, patients who refused percutaneous PFO closure), with the Panel's recommendations being provided for each scenario.

Bioresorbable scaffolds have emerged as a potential breakthrough for the treatment of coronary artery lesions. The need for drug release and plaque scaffolding is temporary, and leaving a permanent stent once the process of plaque recoil and vessel healing has ended might be superfluous or even deleterious exposing the patient to the risk of very late thrombosis, eliminating vessel reactivity, impairing non-invasive imaging and precluding possible future surgical revascularization. This long-term potential limitation of permanent bare metal stents might be overcome by using a resorbable scaffold. The metallic and antithrombotic properties makes the resorbable magnesium scaffold an appealing technology for the treatment of coronary artery lesions. Notwithstanding this, its mechanical properties substantially differ from those of conventional bare metal stents, and previous experience using polymer-based scaffolds has shown that a standardized implantation technique and optimal patient and lesion selection are key factors for a successful implantation. A panel of expert cardiologists gathered to find a consensus on the best practices for Magmaris implantation in a selected patient population and to discuss the rationale for new potential future indications.

Contrast-induced acute kidney injury (CI-AKI) is a serious complication that can affect outcome and prognosis of patients undergoing percutaneous diagnostic and interventional procedures. The Italian Society of Interventional Cardiology (SICI-GISE) has promoted a consensus project on the subject of CI-AKI in order to disseminate and implement nephroprotection strategies in interventional cardiology. The initiative was conducted in partnership with the Italian Society of Nephrology (SIN).

The radiation dose received by interventional cardiologists during their activity in the catheterization laboratory is a matter of concern in terms of possible deterministic and stochastic risk. At the same time, very often, the knowledge of the effect and consequences of radiation exposure in the interventional cardiology community is limited. This document endorsed by the Italian Society of Interventional Cardiology (SICI-GISE) provides recommendations for cardiologists' radiation protection. Radiation safety considerations dedicated to women and other staff personnel working in the catheterization laboratory are also discussed.

Differently from many European and non-European countries, currently in Italy there is not an official, well-defined process for training, evaluation and certification for interventional cardiologists. Interventional Cardiology is an important branch of Cardiology with peculiarities such as to need specific theoretical and practical training. The lack of standardization of training criteria may result in disparities in the quality of care offered to patients in different locations. The Italian Society of Interventional Cardiology (SICI-GISE) has therefore developed an independent certification process for Italian interventional cardiologists. This is a first step towards the implementation of a well-defined training and certification process for both coronary and structural interventions, and for regular re-certification of established operators.The certification will be issued by SICI-GISE and will be based on the recognition of the skills attained by interventional cardiologists in the setting of coronary diagnostic and interventional procedures. This document describes the minimum eligibility criteria for the training centers, which have the task of recording and validating the training activity carried out by each interventional cardiologist, and the minimum competence requirements that should be attained by the operators to obtain the certification.

Despite improvements in the treatment and prevention of risk factors (i.e. dyslipidemia), cardiovascular disease (CVD) remains one of the leading causes of morbidity and mortality in countries with a high degree of socio-economic development. As a matter of fact, in the last decades, several trials and meta-analysis highlighted the impact of treatments targeted to lowering cholesterol levels (particularly LDL-cholesterol) on outcomes of patients affected by CVD, both in terms of primary and secondary prevention. The main international CVD guidelines recommend lifestyle modifications and optimal lipid-lowering therapy in individuals with established CVD. The aim of the present document is to describe the dimension of the problem and the available therapies, offering a practical pharmacological flow-chart useful for accurate monitoring and intensive treatment of dyslipidemias in this patient population.

In comparison with the international scenario, in Italy the penetration of several important scientific and technological innovations in the field of cardiovascular intervention appears to be inadequate both in terms of number of patients treated with respect to the actual need, and inhomogeneity between the different geographical areas of the country. One of the main institutional objectives of the Italian Society of Interventional Cardiology (SICI-GISE) is to develop a roadmap to guarantee homogeneous access throughout the whole national territory to treatments that are recommended by the major international guidelines. The present document focuses on four main areas of cardiovascular intervention: (i) transcatheter treatment of aortic valve stenosis, (ii) percutaneous mitral valve repair, (iii) prevention of cardioembolic stroke through percutaneous left atrial appendage occlusion in patients with non-valvular atrial fibrillation, (iv) optimization of coronary revascularization with the aid of the functional study of coronary lesions. The purpose of this document is to describe the clinical profile and the economic impact of the aforementioned methods, the current clinical, organizational and management barriers to treatment access in the national territory and the possible solutions for overcoming the aforementioned barriers.

Percutaneous mitral valve repair (MVR) using MitraClip system has been shown to be effective in patients with severe symptomatic mitral regurgitation deemed at high surgical risk. Atrial fibrillation is frequently observed in this setting, and the presence of a contraindication to oral anticoagulation is also very common in these patients. In this context, percutaneous left atrial appendage occlusion (LAAO) may be a valid alternative in reducing the thromboembolic risk. Since there is a large overlap between these two populations and the two procedures share some common steps, a combined approach of percutaneous MVR using the MitraClip system and LAAO may be considered a suitable strategy for patients with serious contraindications to both cardiac surgery and chronic antithrombotic therapy. Here we report the case of a patient affected by severe functional mitral regurgitation, secondary to post-infarction ventricular dilation, symptomatic for heart failure despite optimal medical therapy and cardiac resynchronization, and by atrial fibrillation with a contraindication for systemic anticoagulation due to high bleeding risk. Therefore, it was decided to perform a combined transcatheter procedure of MVR and LAAO.

Continuous improvement of technologies, devices and drugs needs a renewal and update of current recommendations and guidelines on antithrombotic strategies, especially in those fields where literature lacks of established scientific evidences. Accordingly, the aim of this consensus statement is to provide support for antithrombotic therapy based on current guidelines and the most recent scientific evidences.After an overview on the currently available devices, the appropriate therapy according to type of procedure and implanted device is discussed. The occurrence of postoperative thromboembolic and/or hemorrhagic complications is analyzed, along with the appropriate diagnostic tools and therapeutic approach. A section is dedicated to counseling to pregnancy in women with heart valve prosthesis. Finally, the role of novel oral anticoagulants is discussed, and indications are provided for the management of patients undergoing surgery or interventional procedures on oral anticoagulation therapy.

Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASD) is the gold-standard treatment, because of a comparable efficacy and less complications than heart surgery. Nevertheless, percutaneous treatment of very large ASD is still considered a challenging procedure and is discouraged for diameters larger than 38 mm, especially when atrial septal rims are absent. These patients are characterized by more frequent complications when a percutaneous approach is attempted. Hence, the treatment of choice is still debated. We report the case of a 75-year-old Caucasian male, admitted for congestive heart failure secondary to a very large ASD. After accurate sizing with transesophageal echocardiography and sizing balloon, percutaneous closure with an Amplatzer Septal Occluder was successfully performed, using few simple tricks.

Transcatheter aortic valve implantation (TAVI) has revolutionized the management of patients with symptomatic severe aortic stenosis and has become the standard of care for inoperable patients and the preferred therapy for those at increased surgical risk with peculiar clinical and anatomic features. Technology advances, growing experience and accumulating data prompted the update of the 2011 Italian Society of Interventional Cardiology (SICI-GISE) position paper on institutional and operator requirements to perform TAVI. The main objective of this document is to provide a guidance to assess the potential of institutions and operators to initiate and maintain an efficient TAVI program.

The appropriate use of dual antiplatelet therapy (DAPT) in elderly patients with acute coronary syndrome (ACS) remains a highly debated subject. In fact, achieving the correct balance between the reduction of ischemic risk and the increase in hemorrhagic events is more difficult in this population than in younger subjects, especially in the case of very potent drug therapy. As a consequence of this, despite guideline recommendations, antiplatelet therapy is currently underutilized in elderly patients with ACS.In current clinical practice, the antiplatelet drugs that can be used in combination with aspirin are clopidogrel, prasugrel and ticagrelor. The efficacy of these molecules is supported by randomized clinical trials, which gave variable results in terms of the extent of reduction in ischemic events and increase in hemorrhagic complications. The purpose of this article is to identify, based on the results of a consensus meeting, common elements in the use of DAPT in the elderly and to identify areas where further scientific evidence is required to better define the role of the individual antiplatelet agents.

Cardiogenic shock (CS) following acute myocardial infarction complicated by severe ventricular dysfunction remains the leading cause of death despite customized pharmacological therapy and optimal revascularization. The use of temporary mechanical circulatory support (MCS) devices during refractory CS might represent the only chance of survival to address the underlying systemic inflammatory response preventing the development of multiorgan failure. We report the case of a patient with a very-high-risk non-ST-elevation acute coronary syndrome and multivessel calcific coronary artery disease complicated by refractory CS undergoing complex percutaneous coronary revascularization. We show a gradual and complementary use of MCS devices tailored on hemodynamic monitoring, clinical and laboratory variables and multidisciplinary collaboration to early recognize the downward spiral that may ensue with multiorgan dysfunction or potential complications leading to death.

Newer generation of self-expandable nitinol coronary stents has proven to be useful in the treatment of bifurcations, tapered vessels, thrombotic lesions, venous grafts and ectatic segments. However, optimal device positioning can be cumbersome, due to the peculiar delivery mechanism which consists of retracting an outer sheath in order to release the stent from the distal edge. We report the case of a 53-year-old man, admitted for unstable angina. Coronary angiography showed a tight stenosis of the proximal left anterior descending coronary artery. As the lesion was located in an ectatic segment of the vessel, we chose to implant a StentysTM (Stentys S.A., Paris, France) device. During the release, the stent jumped forward, resulting in geographic miss. We describe the technique used to retrieve the stent and how we re-deployed it in the proper position; moreover, we examine the lesion characteristics which fostered the migration of the self-apposing stent along the vessel.

Background: The rapid spread of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in the last decade in Italy has led to a gradually increasing use of TAVI procedures also in patients potentially eligible for aortic valve replacement (AVR). For this subset of patients, the OBSERVANT study (2011-2012) evaluated the short- and medium term outcome of TAVI vs AVR, at least for the first generations of TAVI devices, but failed to gather information on all the technological innovations occurred in recent years. The launch of a phase II of the study will allow to recruit a new series of TAVI, with different risk profiles compared with the historical OBSERVANT TAVI cohort, in order to assess whether and how much the use of new-generation devices mitigate the differences in outcomes recorded in the OBSERVANT study., Methods: OBSERVANT II is an observational multicenter, prospective, cohort study collecting data on patients with severe symptomatic aortic stenosis undergoing TAVI in Italian hospitals since December 15, 2016, for at least 12 months. For each patient, data on demographic characteristics, health status, type of intervention and presence of comorbidities will be collected. Mortality and incidence of in-hospital major adverse cardiac and cerebrovascular events (MACCE) within 36 months of intervention will be the primary adverse outcome. Secondary outcomes will include 30-day mortality and the incidence of MACCE at 12 and 24 months. The statistical hypotheses were formulated considering the results from the OBSERVANT study. Testing these hypotheses will require the recruitment of at least 823 new TAVI. The risk/propensity-adjustment techniques will be used to comparatively evaluate the effectiveness of TAVI vs AVR., Expected Results: Safety and efficacy profiles of the new-generation TAVI prosthesis; comparative effectiveness of the new TAVI prosthesis as compared to TAVI procedures of the OBSERVANT historical cohort; comparative effectiveness of the new TAVI prosthesis as compared to AVR procedures of the OBSERVANT historical cohort., Conclusions: The results of OBSERVANT II will provide information on the effectiveness of TAVI employing new-generation devices and will be a valuable support to give professionals and policy makers evidence-based results useful for decision-making processes.

Mitral regurgitation is the most common valvular heart disease in western world, with moderate to severe mitral regurgitation having a deep impact on prognosis, mortality and rehospitalizations. Advanced congestive heart failure is frequently complicated by mitral regurgitation, a pathologic condition that is often under-diagnosed. A significant proportion of patients with severe mitral regurgitation is not eligible for surgery (mitral valve repair or replacement) because of contraindications or excessive surgical risk. Therefore, the need for a less invasive treatment has led to the development of endovascular techniques; among them the MitraClip system, which mimics Alfieri's edge-to-edge surgical technique introduced in 2003, has gained widespread acceptance. More than 35 000 patients have been treated using this technique. Evidence from clinical studies suggests that the MitraClip system is effective in improving survival and quality of life in patients with severe mitral regurgitation, also reducing rehospitalization rates with substantial social and economic advantages. At present, in Italy, undertreatment of patients with severe mitral regurgitation not amenable to surgical correction is still significantly high, and remarkable inhomogeneity among regions is observed in the availability of the MitraClip procedure.

Drug-eluting stents (DES) are the current gold standard for percutaneous treatment of coronary artery disease. However, DES are associated with a non-negligible risk of long-term adverse events related to persistence of foreign material in the coronary artery wall. In addition, DES implantation causes permanent caging of the native vessel, thus impairing normal vasomotricity and the possibility of using non-invasive coronary imaging or preforming subsequent bypass surgery. On the contrary, coronary bioresorbable stents (BRS) may provide temporary mechanical support to coronary wall without compromising the subsequent recovery of normal vascular physiology, and have the potential to prevent late adverse events related to permanent elements. Several types of BRS have been introduced into clinical practice in Europe or are being tested. However, most of available clinical data relate to a single BRS, the Absorb bioresorbable Vascular Scaffold (Absorb BVS) (Abbott Vascular, Santa Clara, CA). Despite encouraging clinical results, no societal guidelines are available on the use of BRS in clinical practice.A panel of Italian expert cardiologists assembled under the auspices of the Italian Society of Interventional Cardiology (SICI-GISE) for comprehensive discussion and consensus development, with the aim to provide recommendations on the use of bioresorbable stents in terms of clinical indications, procedural aspects, post-percutaneous coronary angioplasty pharmacologic treatment and follow-up. Based on current evidence and BRS availability in Italian cath-labs, the panel decided unanimously to provide specific recommendations for the Absorb BVS device. These recommendations do not necessarily extend to other BRS, unless specified, although significant overlap may exist with Absorb BVS, particularly in terms of clinical rationale.

Background: Significant developments have occurred in the field of percutaneous interventions for structural heart disease over the last decade. The introduction of several innovations has expanded significantly the spectrum of therapeutic applications of structural interventional cardiology. However, the translation of the most recent scientific evidence into clinical practice and the adoption of new technologies may be susceptible to large variability, even within the same geographic area. This study aimed at describing current status and changing trends of structural heart interventions within 6 Regions in Italy., Methods: Between July 2015 and October 2015, 6 regional delegations of the Italian Society of Interventional Cardiology (SICI-GISE) promoted a web-based multicenter survey concerning structural heart interventions. An ad hoc questionnaire was administered to head physicians of the cath-labs of 4 Regions of Northern Italy (Tuscany, Lombardy, Veneto and Emilia-Romagna) and 2 Regions of Southern Italy (Puglia and Campania). Also, in this study we considered previous data from a similar survey that involved Tuscany, Lombardy, Veneto and Emilia-Romagna between April 2014 and May 2014. Data from the two surveys were compared, observing the changing trends between 2014 and 2015., Results: The 2015 survey was completed in more than two thirds (68%) of the 145 eligible cath-labs. According to the survey, the application of percutaneous structural heart interventions and the availability of devices were wide and homogeneous within the 6 Regions involved. The main factors perceived as limiting the execution of structural heart interventions resulted economic (e.g. cost of procedures and devices) or organizational (e.g. limited diffusion of hybrid operating rooms)., Conclusions: In this study, which was based on the results of a recent survey conducted in 6 Italian Regions, structural heart interventions resulted widely growing throughout the investigated area. The indications for treatment and the availability of devices were relatively homogeneous between the regions involved, as well as the limiting factors, which appear to be mainly economic-organizational.

The wide availability of drugs effective in reducing cardiovascular events and the use of myocardial revascularization have greatly improved the prognosis of patients with coronary artery disease. However, the combination of antithrombotic drugs to be administered before the exact knowledge of the coronary anatomy and before the consequent therapeutic strategy can, on one hand, allow to anticipate an optimal treatment but, on the other hand, may expose the patient to a bleeding risk not always necessary. In patients with ST-elevation acute coronary syndrome with an indication to primary angioplasty, the administration of unfractionated heparin and aspirin is considered the pre-procedural standard treatment. The upstream administration of an oral P2Y12 inhibitor, even if not supported by randomized controlled trials, appears reasonable in view of the very high likelihood of treatment with angioplasty. In patients with non-ST elevation acute coronary syndrome, in which it is not always chosen an invasive strategy, the occurrence of bleeding can significantly weigh on prognosis, even more than the theoretical benefit of pretreatment. Fondaparinux is the anticoagulant with the most favorable efficacy/safety profile. Antiplatelet pretreatment must be selective, guided by the ischemic risk conditions, the risk of bleeding and the time schedule for coronary angiography.In patients with stable coronary artery disease, generally treated with aspirin, pretreatment with clopidogrel is advisable in case of already scheduled angioplasty, and it appears reasonable in case of high likelihood, at least in patients at low bleeding risk. In patients candidate to surgical revascularization, aspirin is typically maintained and the oral P2Y12-inhibitor discontinued, with i.v. antiplatelet drug bridging in selected cases.Anti-ischemic drugs are useful in controlling symptoms, but they have no specific indications with regard to revascularization procedures. Statins showed protective effects on periprocedural damage and late clinical events, when administered early. Although randomized data are lacking, it seems reasonable their pre-procedural administration, due to potential advantages without significant adverse effects.

With the ageing of the population in the Western world, an increasing proportion of patients seen in cardiology practice is represented by the elderly. Although approximately one third of patients admitted with acute coronary syndrome (ACS) are >75 years old and the mortality rate in this age group is doubled compared with younger patients, this population is underrepresented in randomized controlled trials and, consequently, clinical guidelines do not always provide clear indications for the management of elderly patients. Therefore, there is an unmet need for clinical guidance regarding this rapidly growing subset of ACS patients, also considering that decisions about optimal antithrombotic treatment strategies in the elderly are often challenging, mostly due to age-related organ dysfunction, the frequency of comorbidities and concomitant medications and an increased risk of both ischemic and bleeding events. A panel of Italian cardiology experts assembled under the auspices of the Italian Society of Interventional Cardiology (SICI-GISE) for comprehensive discussion and consensus development, with the aim to provide practical recommendations, for both clinical and interventional cardiologists, regarding optimal management of antithrombotic therapy in patients with ACS aged ≥75 years. In this position paper, various clinical scenarios in patients with ST-elevation and non-ST-elevation myocardial infarction or unstable angina are presented and discussed, including special subsets (e.g., patients aged ≥85 years, patients with chronic renal disease or previous cerebrovascular events, patients requiring triple therapy or long-term antithrombotic therapy), with the panel's recommendations being provided for each scenario.

Although rare, left main coronary artery dissection is a cause of periprocedural mortality during percutaneous coronary interventions. We report a case of iatrogenic dissection of the left main coronary artery causing cardiogenic shock, treated by extracorporeal membrane oxygenation (ECMO) support and later on by multiple balloon angioplasty and drug-eluting stent deployment, due to clinical worsening despite patent left coronary arteries with preserved good TIMI flow grade. We also reviewed the management strategies of this complication reported in the literature.

Percutaneous transluminal mitral commissurotomy (PTMC) is the procedure of choice for the treatment of severe mitral stenosis in symptomatic patients. In recent years, epidemiological changes among these patients are observed, since they more frequently are older, with several comorbidities and unfavorable mitral anatomy, all features that may contraindicate PTMC. Notwithstanding this, high rates of success and safety are achieved, following improvements in the learning curve and technique. We report the case of a 68-year-old Caucasian male, affected by chronic obstructive pulmonary disease and congenital kyphoscoliosis, admitted for acute pulmonary edema in severe mitral valve stenosis and moderate mitral regurgitation. PTMC was performed successfully, without any complications, using few simple tricks.

Background: The implementation of the latest medical innovations can vary widely within the same geographic area. This study aimed to describe the current status of recent innovations in the field of coronary interventional cardiology in 4 regions of Northern Italy., Methods: From April to May 2014, 4 regional delegations of the Italian Society of Invasive Cardiology (SICI-GISE) have promoted a multicenter survey. By means of a web-based methodology, a focused questionnaire was administered to head physicians of 97 cath-labs in 4 Italian regions within the "GISE TOLOVE" area (Lombardy, Veneto, Tuscany, Emilia-Romagna)., Results: Pharmacological and technological innovations in coronary interventional cardiology appear to be widely used in the area covered by this survey, with uniformity in application and availability of therapeutic devices and drugs within the 4 regions involved. The main limiting factors to the adoption of new technologies and drugs were economic factors or lack of scientific evidence for some specific devices or drugs., Conclusions: This survey showed widespread and consistent application of the main latest innovations in coronary interventional cardiology across 4 Italian regions of Northern Italy.

A 57-year-old man underwent myocardial revascularization for unstable angina. Cardiocirculatory arrest complicated the procedure and the patient was rapidly treated with advanced cardiac life support. After 26-min long resuscitation attempts, 5 DC-shock and cardioactive drug administration, an extracorporeal system was positioned and activated (extracorporeal membrane oxygenation, ECMO). After ECMO positioning, sinus rhythm was achieved after another DC-shock. Therapeutic hypothermia was started with a target temperature of 33°C. ECMO was removed after 12h, and therapeutic hypothermia was continued for 27h without any complications. The patient was discharged with good neurological outcome. This report shows the feasibility of treatment of a dramatic event such as refractory cardiac arrest, using modern and advanced techniques in the intensive cardiac care unit.