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Background: Whether the presence of right ventricular (RV) dysfunction may influence the clinical outcome of patients with low-flow, low-gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR) has not yet been established., Methods and Results: This study included consecutive patients with LFLG-AS undergoing TAVR at 2 high-volume Italian centers. RV dysfunction before TAVR procedure was defined as tricuspid annular plane systolic excursion assessed by transthoracic echocardiography lower than <17 mm. The primary outcome was all-cause death at 1 year. The propensity score weighting technique was implemented to account for potential selection bias between patients with and without RV dysfunction. A prespecified subgroup analysis was conducted to evaluate the consistency of the results in patients with classical and paradoxical LFLG-AS forms. This study included 392 patients; of them, 97 (24.7%) patients showed RV dysfunction before TAVR. At propensity score-weighted adjusted Cox regression analysis, RV dysfunction, according to dichotomous definition, was associated with an increased risk for the primary outcome (adjusted hazard ratio [HR], 3.11 [95% CI, 1.58-6.13]), cardiovascular death (adjusted HR, 3.26 [95% CI, 1.58-6.72]), and major adverse cardiovascular and cerebrovascular events (adjusted HR, 3.39 [95% CI, 1.76-6.53]). Conversely, no difference was detected for the risk of stroke and of permanent pacemaker implantation. No significant interaction of the classical and paradoxical LFLG-AS subgroups was detected for all the outcomes of interest., Conclusions: This study suggests that RV dysfunction echocardiographically assessed by tricuspid annular plane systolic excursion may improve the prognostic stratification of patients with LFLG-AS undergoing TAVR.

Improved expertise and technological advancements have enabled the safe and effective performance of complex and high-risk-indicated percutaneous coronary intervention (CHIP) in patients previously considered inoperable or high-risk. Mechanical circulatory support (MCS) devices play a crucial role in stabilizing hemodynamics during percutaneous coronary intervention (PCI) -related ischemia, thereby reducing the risk of major adverse events and achieving a more complete revascularization. However, the use of MCS devices in protected PCI is not without risks, including peri-procedural myocardial infarction (MI), bleeding, and access-related complications. Despite numerous observational studies, there is a significant lack of randomized clinical trials comparing different MCS devices in various CHIP scenarios and evaluating their long-term safety and efficacy profiles. This review aims to summarize the current evidence regarding the benefits of MCS devices during CHIPs, offer a practical guide for selecting appropriate devices based on clinical scenarios, and highlight the unanswered questions that future trials need to address.

The use of intravenous antiplatelet therapy during primary percutaneous coronary intervention (PPCI) is not fully standardized. The aim is to evaluate the effectiveness and safety of periprocedural intravenous administration of cangrelor or tirofiban in a contemporary ST-segment elevation myocardial infarction (STEMI) population undergoing PPCI. This was a multicenter prospective cohort study including consecutive STEMI patients who received cangrelor or tirofiban during PPCI at seven Italian centers. The primary effectiveness measure was the angiographic evidence of thrombolysis in myocardial infarction (TIMI) flow < 3 after PPCI. The primary safety outcome was the in-hospital occurrence of BARC (Bleeding Academic Research Consortium) 2-5 bleedings. The study included 627 patients (median age 63 years, 79% males): 312 received cangrelor, 315 tirofiban. The percentage of history of bleeding, pulmonary edema and cardiogenic shock at admission was comparable between groups. Patients receiving cangrelor had lower ischemia time compared to tirofiban. TIMI flow before PPCI and TIMI thrombus grade were comparable between groups. At propensity score-weighted regression analysis, the risk of TIMI flow < 3 was significantly lower in patients treated with cangrelor compared to tirofiban (adjusted OR: 0.40; 95% CI: 0.30-0.53). The risk of BARC 2-5 bleeding was comparable between groups (adjusted OR:1.35; 95% CI: 0.92-1.98). These results were consistent across multiple prespecified subgroups, including subjects stratified for different total ischemia time, with no statistical interaction. In this real-world multicenter STEMI population, the use of cangrelor was associated with improved myocardial perfusion assessed by coronary angiography after PPCI without increasing clinically-relevant bleedings compared to tirofiban., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Over the last decades, bioprosthetic heart valves (BHV) have been increasingly implanted instead of mechanical valves in patients undergoing surgical aortic valve replacement (SAVR). Structural valve deterioration (SVD) is a common issue at follow-up and can justify the need for a reintervention. In the evolving landscape of interventional cardiology, valve-in-valve transcatheter aortic valve replacement (ViV TAVR) has emerged as a remarkable innovation to address the complex challenges of patients previously treated with SAVR and has rapidly gained prominence as a feasible technique especially in patients at high surgical risk. On the other hand, the expanding indications for TAVR in progressively younger patients with severe aortic stenosis pose the crucial question on the long-term durability of transcatheter heart valves (THVs), as patients might outlive the bioprosthetic valve. In this review, we provide an overview on the role of ViV TAVR for failed surgical and transcatheter BHVs, with a specific focus on current clinical evidence, pre-procedural planning, procedural techniques, and possible complications. The combination of integrated Heart Team discussion with interventional growth curve makes it possible to achieve best ViV TAVR results and avoid complications or put oneself ahead of time from them.

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.

Background There is little evidence about the prognostic role of mitral regurgitation (MR) in patients with low-flow, low-gradient aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). The aim of this study was to assess the prevalence and outcome implications of MR severity in patients with low-flow, low-gradient aortic stenosis undergoing TAVR, and to evaluate whether MR improvement after TAVR could influence clinical outcome. Methods and Results This study included consecutive patients with low-flow, low-gradient aortic stenosis undergoing TAVR at 2 Italian high-volume centers. The study population was categorized according to the baseline MR severity and to the presence of MR improvement at discharge. The primary outcome was the composite of all-cause death and hospitalization for worsening heart failure up to 1 year. The study included 268 patients; 57 (21%) patients showed MR >2+. Patients with MR >2+ showed a lower 1-year survival free from the primary outcome ( P <0.001), all-cause death ( P <0.001), and heart failure hospitalization ( P <0.001) compared with patients with MR ≤2+. At multivariable analysis, baseline MR >2+ was an independent predictor of the primary outcome ( P <0.001). Among patients with baseline MR >2+, MR improvement was reported in 24 (44%) cases after TAVR. The persistence of MR was associated with a significantly reduced survival free from the primary outcome, all-cause death, and heart failure hospitalization up to 1 year. Conclusions In this study, the presence of moderately severe to severe MR in patients with low-flow, low-gradient aortic stenosis undergoing TAVR portends a worse clinical outcome at 1 year. TAVR may improve MR severity in nearly half of the patients, resulting in a potential outcome benefit after discharge.

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.

The impact of sex on pathophysiological processes, clinical presentation, treatment options, as well as outcomes of degenerative aortic stenosis remain poorly understood. Female patients are well represented in transfemoral aortic valve implantation (TAVI) trials and appear to derive favorable outcomes with TAVI. However, higher incidences of major bleeding, vascular complications, and stroke have been reported in women following TAVI. The anatomical characteristics and pathophysiological features of aortic stenosis in women might guide a tailored planning of the percutaneous approach. We highlight whether a sex-based TAVI management strategy might impact on clinical outcomes. This review aimed to evaluate the impact of sex from diagnosis to treatment of degenerative aortic stenosis, discussing the latest evidence on epidemiology, pathophysiology, clinical presentation, therapeutic options, and outcomes. Furthermore, we focused on technical sex-oriented considerations in TAVI including the preprocedural screening, device selection, implantation strategy, and postprocedural management.

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.

Coronary artery ectasia (CAE) is defined as a diffuse or focal dilation of an epicardial coronary artery, which diameter exceeds by at least 1. 5 times the normal adjacent segment. The term ectasia refers to a diffuse dilation, involving more than 50% of the length of the vessel, while the term aneurysm defines a focal vessel dilation. CAE is a relatively uncommon angiographic finding and its prevalence ranges between 0.3 and 5% of patients undergoing coronary angiography. Although its pathophysiology is still unclear, atherosclerosis seems to be the underlying mechanism in most cases. The prognostic role of CAE is also controversial, but previous studies reported a high risk of cardiovascular events and mortality in these patients after percutaneous coronary intervention. Despite the availability of different options for the interventional management of patients with CAE, including covered stent implantation and stent-assisted coil embolization, there is no one standard approach, as therapy is tailored to the individual patient. The abnormal coronary dilation, often associated with high thrombus burden in the setting of acute coronary syndromes, makes the interventional treatment of CAE patients challenging and often complicated by distal thrombus embolization and stent malapposition. Moreover, the optimal antithrombotic therapy is debated and includes dual antiplatelet therapy, anticoagulation, or a combination of them. In this review we aimed to provide an overview of the pathophysiology, classification, clinical presentation, natural history, and management of patients with CAE, with a focus on the challenges for both clinical and interventional cardiologists in daily clinical practice., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Esposito, Di Maio, Silverio, Cancro, Bellino, Attisano, Tarantino, Esposito, Vecchione, Galasso and Baldi.)

Objectives: The aim of this study was to describe the prevalence of coronary artery ectasia (CAE) in patients with ST-elevation myocardial infarction (STEMI) and to compare the long-term outcome of subjects with and without CAE undergoing emergent coronary angiography., Background: The prognostic impact of CAE in STEMI patients has been poorly investigated., Methods: This retrospective, single-center, study included consecutive patients with STEMI undergoing emergent coronary angiography from January 2012 to December 2017. The primary endpoint was the assessment of recurrent myocardial infarction (MI) in patients with versus those without CAE at the longest available follow-up. The propensity score weighting technique was employed to account for potential selection bias between groups., Results: From 1,674 patients with STEMI, 154 (9.2%) had an angiographic evidence of CAE; 380 patients were included in the no CAE group. CAE patients were more often males and smokers, and showed a lower prevalence of diabetes than no CAE patients. After percutaneous coronary intervention, the corrected thrombolysis in MI frame count (p < .001) and the myocardial blush grade (p < .001) were significantly lower in CAE than in no CAE patients. The mean follow-up was 1,218.3 ± 574.8 days. The adjusted risk for the primary outcome resulted significantly higher in patients with CAE compared to those without (adjusted HR: 1.84; p = .017). No differences in terms of all-cause and cardiac death were found between groups., Conclusions: In this study, STEMI patients with CAE had a distinct clinical and angiographic profile, and showed a significantly higher risk of recurrent MI than those without CAE., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Increased body mass index (BMI) is an established cardiovascular risk factor. The impact of high BMI on vascular and bleeding complications in patients undergoing transcatheter aortic valve implantation (TAVI) is not clarified. RISPEVA, a multicenter prospective database of patients undergoing TAVI stratified by BMI was used for this analysis. Patients were classified as normal or high BMI (obese and overweight) according to the World Health Organization criteria. A comparison of 30-day vascular and bleeding outcomes between groups was performed using propensity scores methods. A total of 3776 matched subjects for their baseline characteristics were included. Compared with normal BMI, high BMI patients had significantly 30-day greater risk of the composite of vascular or bleeding complications (11.1% vs 8.8%, OR: 1.28, 95% CI [1.02 to 1.61]; p = 0.03). Complications rates were higher in both obese (11.3%) and overweight (10.5%), as compared with normal weight patients (8.8%). By a landmark event analysis, the effect of high versus normal BMI on these complications appeared more pronounced within 7 days after the TAVI procedure. A significant linear association between increased BMI and vascular complications was observed at this time frame (p = 0.03). In conclusion, compared with normal BMI, both obese and overweight patients undergoing TAVI, experience increased rates of 30-day vascular and bleeding complications. These findings indicate that high BMI is an independent risk predictor of vascular and bleeding complications after TAVI., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: The study was designed to: (1) confirm safety and feasibility of mini-invasive radial balloon aortic valvuloplasty (BAV); (2) assess its impact in terms of quality of life and frailty; and (3) evaluate whether changes in frailty after BAV are associated with death in patients undergoing transcatheter aortic valve implantation (TAVI)., Methods: 330 patients undergoing BAV in 16 Italian centres were prospectively included. The primary endpoint was the occurrence of major and minor Valve Academic Research Consortium (VARC)-2 bleeding. Secondary endpoints were scales of quality of life, frailty, evaluated at baseline and 30 days, and their relationship with the occurrence of all-cause death., Results: BAV was performed by radial access in 314 (95%) patients. No VARC-2 major and six (1.8%) VARC-2 minor bleedings occurred in the study population. Quality of life, as well as frailty status, significantly improved 30 days after BAV. At 1 year, patients undergoing TAVI with baseline essential frailty toolset (EFT) <3 or achieving an EFT <3 after BAV had a comparable occurrence of all-cause death (15% vs 19%, p=0.58). On the contrary, patients with EFT ≥3 at 30 days despite BAV showed the worst prognosis (all-cause death: 40% vs 15% and 19%, p=0.006 and p=0.05, respectively)., Conclusions: Mini-invasive radial BAV is safe, feasible and associated with a low rate of vascular complications. Patients improving EFT 30 days after BAV showed a favourable outcome after TAVI., Trial Registration Number: NCT03087552., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background Transcatheter aortic valve replacement (TAVR) requires large-bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large-scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1-year follow-up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65-0.99]; P =0.043), driven by a reduction of bleeding complications (9.1% versus 11.7%, respectively; multivariate adjusted odds ratio, 0.76 [95% CI, 0.58-0.98]; P =0.046). Propensity score analysis confirmed the significant reduction of major adverse cardiovascular events and bleeding risk with ProGlide. No significant differences in the primary end point were found between the 2 vascular closure devices at 1 year of follow-up (multivariate adjusted hazard ratio, 0.88 [95% CI, 0.72-1.10]; P =0.902). Comparable results were obtained by propensity score analysis. During the procedure, compared with Prostar XL, ProGlide yielded significant higher device success (99.2% versus 97.5%, respectively; P =0.001). Conclusions ProGlide has superior efficacy as compared with Prostar XL in TAVR procedures and is associated with a greater reduction of composite adverse events at short-term, driven by lower bleeding complications. Registration Information URL: clini​caltr​ials.gov; Unique identifier: NCT02713932.

Background: Transcatheter aortic valve replacement (TAVR) has been validated for the treatment of severe symptomatic aortic stenosis in patients at high and intermediate surgical risk. Recently, TAVR has been proposed as an alternative to medical therapy in inoperable patients with severe native aortic valve regurgitation (NAVR). This multicenter international registry sought to evaluate safety and efficacy of TAVR with the self-expandable ACURATE neo valve in a cohort of patients with NAVR., Methods: A total of 24 patients with severe NAVR treated by TAVR between September 2016 and October 2018 in 13 European centers were included. Clinical, procedural and follow up data were inserted in a dedicated database. Outcomes were codified according to Valve Academic Research Consortium-2 criteria., Results: Mean age was 79.4 years, 58.4% were female. Mean EuroSCORE II and STS score were 5% and 3.9%, respectively. Device success was 87.5%. Moderate paravalvular leak (PVL) was found in two (8.3%) of patients, both with a perimeter oversizing index <10%. Implantation of a second device was necessary in three cases (12.5%), one for severe PVL and two for device displacement. New pacemaker implantation rate was 21.1%. At 30 days, stroke and all-cause mortality rates were 0% and 4.1%, respectively., Conclusions: This multicenter study suggests good feasibility and early safety of transfemoral TAVR with the self-expandable ACURATE neo device in patients with severe NAVR refused for surgery. Rates of moderate PVL, new pacemaker implantation and need for a second valve were higher than those reported for TAVR in aortic stenosis., Competing Interests: Ole de Backer: consultant for Abbott; Won-Keun Kim: received proctor fees from Symetis SA/Boston Scientific, St. Jude Medical/Abbott, lecture honoraria from Edwards Lifesciences, Symetis SA/Boston, St. Jude Medical/Abbott; Luis Nombela-Franco received proctor fees from Abbott, lecture honoraria from Edwards Lifesciences and Boston Scientific; Moritz Seiffert received lecture honorary or congress travel support from Abbott, Biotronik, Boston Scientific, Edwards Lifesciences, Medtronic and Symetis. Fausto Castriota received proctor fes from Boston Scientific. Dr. Bedogni has served as a consultant for Abbott Vascular, Medtronic, Boston Scientific, and Terumo. Lars Sondergaard: received research grants and has been consultant for Abbott, Medtronic and Boston Scientific. Giuseppe Tarantini: proctor for Boston Scientific and received lecture fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2020 The Authors.)

The treatment of cardiogenic shock in patients with Takotsubo syndrome (TTS) is challenging because it depends on the mechanisms leading to the haemodynamic instability. We report the case of a 70-year-old woman admitted for TTS complicated by cardiogenic shock. The early echocardiographic identification of left ventricular outflow tract obstruction (LVOTO) and severe mitral regurgitation (MR) prompted us to implant an Impella CP assist device as a bridge-to-recovery therapy. After device positioning, the haemodynamic status improved and LVOTO and severe MR disappeared. Because of the persistence of severe hypotension, the mechanical circulatory support was continued in intensive care unit and stopped only 5 days later, when intraventricular gradient spontaneously dropped. The patient was discharged after 1 week in stable conditions. Our case suggests that Impella circulating support may be a useful bridge-to-recovery therapeutic option in selected patients with cardiogenic shock due to TTS complicated by LVOTO and severe MR., (© 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)

Background: Significant aortic stenosis can be effectively treated with transcatheter aortic valve implantation (TAVI) in patients at high or intermediate surgical risk. Predilation is often performed to facilitate TAVI implantation, but its risk-benefit balance with new-generation devices is detabed. We aimed to appraise whether predilation is still needed with new-generation devices for TAVI., Methods/materials: We queried the prospective multicenter RISPEVA (Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea) Study, comparing patients with vs without predilation receiving Acurate, Evolut, Lotus, Portico, or Sapien3. Baseline, procedural features and early clinical and echocardiographic results were compared with unadjusted and adjusted analyses., Results: A total of 1409 subjects were included, 1055 (74.9%) receiving predilation, and 354 (25.1%) undergoing direct TAVI. Several baseline and procedural differences were evident at unadjusted analysis between the two groups, including device success, procedural success, contrast volume, procedural time, mean post-procedural gradient, and prevalence of aortic regurgitation 2+ (all p < 0.05). Adjusted analysis showed that only procedural time remained significantly impacted by predilation (average reduction in procedural time with predilation of -12.9 [95% confidence interval -21.0; -4.8] minutes, p = 0.002). Subgroup unadjusted and adjusted analysis showed that predilation was associated with shorter procedural times only when Evolut or Portico devices were used (all p < 0.05). Clinical and echocardiographic follow-up up to 1 month showed similar results irrespective of predilation at both unadjusted and adjusted analysis., Conclusion: TAVI without predilation is not associated with adverse procedural, clinical or echocardiographic results when new-generation devices are used. Predilation may however reduce procedural time with Evolut and Portico devices., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: To evaluate the safety and the feasibility of balloon aortic valvuloplasty (BAV) procedure made by trained operators in centers not performing transcatheter aortic valve implantation (TAVI)., Background: BAV is a valuable therapeutic tool for patients with symptomatic severe aortic valve stenosis (AS) at prohibitive risk for TAVI or surgery., Methods: Consecutive high-risk AS patients underwent BAV in five non-TAVI centers, where BAV operators had completed a 6-month training period in high-volume TAVI centers (Group A). All clinical, echocardiographic, and procedural data were prospectively collected and compared with data of patients treated in TAVI center (Group B)., Results: Between June 2016 and June 2017, 55 patients (83.9 ± 7.0 years) were enrolled: 25 in Group A and 30 in Group B. After BAV, a substantial reduction of the peak-to-peak aortic valve gradient was obtained in both groups (-35.3 ± 15.2 vs -28.8 ± 13.9 mmHg, P =0.25). No major bleeding or vascular complications occurred. In-hospital death was observed in three patients of Group A and two patients of Group B (P =0.493). The mean follow-up time was 303 ± 188 days; no patients were lost. The 1-year survival free from overall death (Group A 75.8% vs Group B 68.8%; P =0.682) and heart failure rehospitalization (Group A 73.0% vs Group B 66.8%; P =0.687) was similar in the two groups. At multivariable analysis, low left ventricular (LV) ejection fraction (HR: 0.943; P = 0.011) and cardiogenic shock (HR: 5.128; P = 0.002) at admission were independent predictors of mortality., Conclusions: BAV is a safe and effective procedure that can be performed by trained operators in centers not performing TAVI., (© 2018 Wiley Periodicals, Inc.)

Background: The risk of death in patients affected by ST-elevation segment myocardial infarction (STEMI) is well known, but more data are required to define the in-hospital mortality in special subsets. We sought to assess the prognostic value of indicators in patients with large anterior STEMI as a first acute coronary event, undergoing percutaneous coronary intervention (PCI) and intra-aortic balloon pump (IABP)., Methods and Results: We evaluated 48 consecutive large anterior STEMI patients admitted as first acute coronary event, undergoing in acute phase both PCI and IABP. Patient demographics, clinical, noninvasive and invasive findings, together with in-hospital complications, were collected. Moreover, findings obtained after a 24-month follow-up were reported. The primary endpoint was in-hospital mortality, whereas the secondary endpoints were out of hospital mortality, rehospitalization for heart failure or reinfarction, and New York Heart Association (NYHA) class at least 2 at follow-up visit. The univariate analysis showed a significant association with symptom to balloon, left anterior descending coronary artery, myocardial blush grade, and wall motion score index. Results of the multivariable analysis revealed the strongest predictive power for in-hospital mortality of proximal left anterior descending coronary artery (odds ratio: 6.9; 95% confidence interval: 1.1-67.7) and of myocardial blush grade 0-1 (odds ratio: 5.5; 95% confidence interval: 1.0-38.8). In-hospital death occurred in 13 patients (27% of total cases), whereas, at follow-up, the mean of survival was 66.7 ± 7.0%., Conclusion: The patients with large anterior STEMI as a first acute coronary event, undergoing PCI and IABP, had a very high in-hospital mortality, whereas the mortality rate over the follow-up period was lower. The involvement of a large territory at risk and the ineffective treatment in terms of myocardial reperfusion were the main predictors of in-hospital mortality.

Background: Nowadays the prognostic role of gender as a relevant factor after transcatheter aortic valve implantation (TAVI) is still unfair, since available data in the literature are few and uneven. The aim of this survey was to collect acute and 30-day safety and efficacy clinical data in high- and intermediate-risk women, who underwent TAVI with new-generation devices, in the Campania Region., Methods: All medium and high-volume TAVI centers in Campania have been invited to fulfill an online, ad-hoc questionnaire, collecting pre-, peri- and post-procedural data concerning female patients, treated between January and December 2016., Results: 331 women (representing the 61% of the overall population treated; mean age 83 ± 7 years) underwent TAVI in the participating Campania centers. Age >80 years (72%), high surgical risk score (63%) and frailty (55%) were found to be the top three reasons for the TAVI choice. Overall, 95% of the procedures were performed by transfemoral approach with local anesthesia; the remaining 5% (16 cases) were conducted via transapical (14, 4%) and transaortic (2, 1%) accesses, under general anesthesia. Edwards Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and Medtronic Evolut R (Medtronic Inc., Minneapolis, MN, USA) were the most frequently implanted valves (146, 44% and 132, 43%, respectively). The questioned Centers reported a mean length of hospital stay of 5.5 ± 1.1 days, 1.6 ± 0.37 of which in a cardiac care unit. The most prevalent in-hospital complication was pacemaker implantation (15%), followed by life-threatening vascular complications (3%). The 30-day VARC-2 composite endpoint occurred in 7% of cases, all-cause death in 4%, and stroke in 1%., Conclusions: This survey, the first representative of women undergoing TAVI in Campania, appears to confirm the good safety and efficacy profile of this procedure, also in the high- and intermediate-risk settings, probably favored by a prevalent use of new-generation devices and a low rate prevalence of significant patient comorbidities.

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.