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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.

Introduction: Recent studies have shown gender differences in cardiovascular outcomes after left atrial appendage closure (LAAC), highlighting different complication rates and adverse events, particularly in short-term assessments. As a result, there remains a significant knowledge gap on how these differences directly impact the efficacy and safety of LAAC procedures. The aim of this retrospective study was to investigate the clinical outcomes of LAAC in women and men using the Watchman FLX device., Methods: This retrospective, multicenter study analyzes gender-specific outcomes in 650 patients who underwent LAAC with the Watchman FLX device between March 2019 and May 2022, drawn from the ITALIAN-FLX registry., Results: The results show comparable rates of all-cause mortality, stroke, transient ischemic attack and major bleeding in men and women 12 months after the procedure. Notably, no significant gender differences were found for periprocedural complications., Conclusion: In conclusion, this study shows that LAAC with the Watchman FLX device has comparable clinical outcomes between genders at both short-term and long-term follow-up., Competing Interests: SB has been a consultant for Abbot and Boston Scientific Inc. The remaining 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. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (© 2024 Bonanni, Frazzetto, Nardone, Meucci, Musto, Quaranta, Saccà, Bedogni, Maffeo, Ugo, Guarracini, Bocuzzi, Durante, Granatelli, Tumminello, Eusebio, Grasso, De Marco, Cortese, Mariani and Berti.)

(1) Background : This single-center retrospective study aimed to evaluate whether sodium-glucose cotransporter-2 inhibitors (SGLT2-i) therapy may have a nephroprotective effect to prevent contrast-induced acute kidney injury (CI-AKI) in patients with heart failure (HF) undergoing iodinated contrast medium (ICM) invasive procedures. (2) Methods : The population was stratified into SGLT2-i users and SGLT2-i non-users according to the chronic treatment with gliflozins. The primary endpoint was CI-AKI incidence during hospitalization. Secondary endpoints were all-cause mortality and the need for continuous renal replacement therapy (CRRT). (3) Results : In total, 86 patients on SGLT2-i and 179 patients not on SGLT2-i were enrolled. The incidence of CI-AKI in the gliflozin group was lower than in the non-user group (9.3 vs. 27.3%, p < 0.001), and these results were confirmed after propensity matching analysis. Multivariable logistic regression showed that only SGLT2-i treatment was an independent preventive factor for CI-AKI (OR: 0.41, 95% CI: 0.16-0.90, p = 0.045). The need for CRRT was reported only in five patients in the non-SGLT2-i-user group compared to zero patients in the gliflozin group ( p = 0.05). (4) Conclusions : SGLT2-i therapy was associated with a lower risk of CI-AKI in patients with HF undergoing ICM invasive procedures.

Introduction: Both cone-beam computed tomography (CBCT) and surface-guided radiotherapy (SGRT) are used for breast patient positioning verification before treatment delivery. SGRT may reduce treatment time and imaging dose by potentially reduce the number of CBCT needed. The aim of this study was to compare the displacements resulting in positioning from the Image Guided Radiation Therapy (IGRT) 3D and SGRT methods and to design a clinical workflow for SGRT implementation in breast radiotherapy to establish an imaging strategy based on the data obtained., Methods: For this study 128 breast cancer patients treated with 42.5 Gy in 16 fractions using 3D conformal radiotherapy with free breathing technique were enroled. A total of 366 CBCT images were evaluated for patient setup verification and compared with SGRT. Image registrations between planning CT images and CBCT images were performed in mutual agreement and in online mode by three health professionals. Student's paired t-test was used to compare the absolute difference in vector shift, measured in mm, for each orthogonal axis (x, y, z) between SGRT and CBCT methods. The multidisciplinary team evaluated a review of the original clinical workflow for SGRT implementation and data about patients treated with the updated workflow were reported., Results: Comparison of the shifts obtained with IGRT and SGRT for each orthogonal axis (for the x-axes the average displacement was 0.9 ± 0.7 mm, y = 1.1 ± 0.8 mm and z = 1.0 ± 0.7 mm) revealed no significant statistical differences (p > 0.05). Using the updated workflow the difference between SGRT and IGRT displacements was <3 mm in 91.4 % of patients with a reduction in total treatment time of approximately 20 %, due to the reduce frequency of the CBCT images acquisition and matching., Conclusions: This study has shown that IGRT and SGRT agree in positioning patients with breast cancer within a millimetre tolerance. SGRT can be used for patient positioning, with the advantages of reducing radiation exposure and shorter overall treatment time., (Copyright © 2023. Published by Elsevier Inc.)

Background: The right comprehension of ischemic stroke pathogenesis guarantees the best prevention therapy. The term "patent foramen ovale (PFO) related stroke" has been proposed for those events where PFO is supposed to be pathogenetic, but their definition is challenging. A multidisciplinary evaluation in a "Heart & Brain" team (HBteam) including stroke neurologists and interventional cardiologists was therefore highly recommended in the recent guidelines of secondary stroke prevention., Objective: We aimed at describing the organization of the HBteam of Careggi-University-Hospital of Florence (Italy), and the results of the first seven years of activity., Methods: In 2016 Interventional Cardiologists and Stroke Neurologists set up an outpatient clinic for the joined evaluation of patients with PFO and other cardio/neurological conditions. A specific diagnostic-therapeutic hospital plan was produced for PFO patients. Patient empowerment was guaranteed by a hospital explicative webpage, a booklet regarding risks/benefits of PFO closure and a 3D heartmodel to simulate the intervention. Data were collected in a dedicated registry., Results: We evaluated 594 patients for PFO, 40 for left atrial appendage closure and 38 for other conditions. In 20% of PFO-patients, HBteam diagnosis was discordant from that of referring physicians, 14% were stroke misdiagnoses. We advised against closure in 53% of patients. At follow-up 94% of closed patients had no/minimum residual shunt; 3 patients had a cerebral ischemic event., Conclusions: A dedicated HBteam represents a unique opportunity to share decisions with patients after a thorough empowerment process. The joining of cardioneurological skills allows a better classification of PFO-patients, reducing futile interventions., (© 2023. Fondazione Società Italiana di Neurologia.)

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.

Competing Interests: One of the authors has received research or educational grants from Abbott, Amgen, Asahi Inteec., AstraZeneca, Boston Scientific, Cardinal Health, CSL Behring, Chiesi, Daiichi Sankyo, Edwards, Medtronic, Menarini, Pfizer, Sanofi, Shockwave, Teleflex and Volcano/Philips; another author reports receiving speaker and consultation fees from Medtronic, Edwards and Boston Scientific. The other authors have no conflict of interest to declare.

Introduction: In 2020, the SARS-CoV-2 pandemic outbreak required restrictive measures to limit the spread of the virus. This study aimed to assess how changes in dietary habits and lifestyle associated with such measures have affected the characteristics of patients with acute coronary syndromes (ACS) in the post-lockdown period. In particular, we evaluated if the incidence of ACS was higher in younger patients, who were more negatively affected by lockdown measures., Methods: We analysed 609 ACS patients and compared the clinical, laboratory, and angiographic characteristics of those admitted six months before lockdown (n = 312) and those admitted in the same six-month period after lockdown. Moreover, we compared several anthropometric and laboratory data between pre- and post-lockdown in younger (≤55 years old) and older patients., Results: The incidence of ACS in young adults (≤55 years) was significantly higher in the post- vs. pre-lockdown period (17.5% vs. 10.9%, p = 0.019). A trend to a higher percentage of ST-elevation myocardial infarction (STEMI) was observed in the post-lockdown period together with a significantly lower incidence of non-STEMI (p = 0.033). Moreover, in the post-lockdown period, we observed in younger patients a significant increase in weight, body mass index, admission glycaemia, and triglycerides while in older patients, these parameters were significantly reduced., Conclusion: The lockdown may have negatively affected cardiovascular risk, thus increasing the incidence of ACS, particularly in younger patients who probably underwent more relevant lifestyle changes, with several consequent anthropometric and metabolic alterations. Such evidence should be considered to take preventive measures in case a new state of emergency occurs., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Capobianco et al.)

Backgrounds: Two recent randomized controlled trials (RCTs), the PROTECT-AF and the PREVAIL, showed that in atrial fibrillation (AF) patients, left atrial appendage closure (LAAC) is comparable to oral anticoagulants (OAC) in the prevention of stroke and could also possibly reduce mortality. Nevertheless, this net clinical benefit was not confirmed in the most recent RCT comparing LAAC vs. OAC, the PRAGUE-17 trial., Aim: aim of the present study was to evaluate the efficacy and safety of LAAC compared with OAC among available high-quality studies., Methods: A systematic search of electronic databases (Medline, Scopus, Embase and the Cochrane Library) was performed to identify eligible RCTs and observational studies with propensity score matching (PSM) analysis. PRISMA guidelines were used for abstracting data and assessing data quality and validity. Outcomes of interest were the occurrence of cardiovascular death (CVD), all-cause death, all-type stroke, and major bleedings., Results: A total of 3 RCTs and 7 PMS studies involving 25,700 patients were identified. 12,961 patients received LAAC while 12,739 received OAC therapy. After a median follow-up of 2.6 years (IQR 2-4.4), patients who received LAAC had lower risk of CVD (RR = 0.62; 95%CI, 0.51-0.74, I 2  = 0%), all-cause death (RR = 0.67; 95% CI, 0.57-0.78, I 2 68%) and major bleedings (RR = 0.68; 95%CI, 0.48-0.95 I 2  = 87%) compared with patients on OAC. No difference was found between the two groups regarding strokes incidence (RR = 0.94; 95% CI, 0.77-1.15, I 2  = 0%)., Conclusions: According to this meta-analysis, LAAC has comparable efficacy in the prevention of stroke compared with OAC and a reduced risk of major bleedings, all-cause death and CVD that may be even larger with longer follow-up., Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display&#95;record.php?RecordID=269768, identifier CRD42021269768., 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., (© 2023 Franchin, Piroli, Demola, Mantovani, Iannaccone, Manfredi, D'Ascenzo, Fortuni, Ugo, Meucci, Navazio and Boccuzzi.)

Given the increasing population eligible for transcatheter aortic valve implantation (TAVI), resource utilization has become an important focus in this setting. We aimed to estimate the change in the financial burden of TAVI therapy over 2 different periods. A probabilistic Markov model was developed to estimate the cost consequences of increased center experience and the introduction of newer-generation TAVI devices compared with an earlier TAVI period in a cohort of 6,000 patients. The transition probabilities and hospitalization costs were retrieved from the OBSERVANT (Observational Study of Effectiveness of AVR-TAVI procedures for severe Aortic steNosis Treatment) and OBSERVANT II (Observational Study of Effectiveness of TAVI with new generation deVices for severe Aortic stenosis Treatment) studies, including 1,898 patients treated with old-generation devices and 1,417 patients treated with new-generation devices. The propensity score matching resulted in 853 pairs, with well-balanced baseline risk factors. The mean EuroSCORE II (6.6% vs 6.8%, p = 0.76) and the mean age (82.0 vs 82.1 y, p = 0.62) of the early TAVI period and new TAVI period were comparable. The new TAVI period was associated with a significant reduction in rehospitalizations (-30.5% reintervention, -25.2% rehospitalization for major events, and -30.8% rehospitalization for minor events) and a 20% reduction in 1-year mortality. These reductions resulted in significant cost savings over a 1-year period (-€4.1 million in terms of direct costs and -€19.7 million considering the additional cost of the devices). The main cost reduction was estimated for rehospitalization, accounting for 79% of the overall cost reduction (not considering the costs of the devices). In conclusion, the introduction of new-generation TAVI devices, along with increased center experience, led to significant cost savings at 1-year compared with an earlier TAVI period, mainly because of the reduction in rehospitalization costs., Competing Interests: Declaration of Competing Interest Dr. Barbanti is consultant for Boston Scientific, Medtronic, and Edwards Lifesciences. Dr. Tamburino is consultant for Medtronic. The remaining authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: The Cocoon patent foramen ovale (PFO) Occluder is a new generation nitinol alloy double-disk device coated with nanoplatinum, likely useful in patients with nickel hypersensitivity. Early results and mid-term outcomes of this device in percutaneous PFO closure are missing., Aims: To assess the preliminary efficacy and safety profile of PFO closure with Cocoon device in an Italian multi-center registry., Methods: This is a prospective registry of 189 consecutive adult patients treated with the Cocoon PFO Occluder at 15 Italian centers from May 2017 till May 2020. Patients were followed up for 2 years., Results: Closure of the PFO with Cocoon Occluder was carried out successfully in all patients, with complete closure without residual shunt in 94.7% of the patients and minimal shunt in 5.3%. Except from a case of paroxysmal supraventricular tachycardia and a major vascular bleeding, no procedural and in-hospital device-related complications occurred. No patient developed cardiac erosions, allergic reactions to nickel, or any other major complications during the follow-up. During the follow-up period, 2 cases of new-onset atrial fibrillation occurred within thirty-day., Conclusions: Percutaneous closure of PFO with Cocoon Occluder provided satisfactory procedural and mid-term clinical follow-up results in a real-world registry., Competing Interests: GC was employed by GVM Care and Research. The remaining 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 © 2023 Testa, Popolo Rubbio, Squillace, Albano, Cesario, Casenghi, Tarantini, Pagnotta, Ielasi, Popusoi, Paloscia, Durante, Maffeo, Meucci, Valentini, Ussia, Cioffi, Cortese, Sangiorgi, Contegiacomo and Bedogni.)

Background: The PARTNER 3 trial demonstrated clinical benefits of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device, over surgical aortic valve replacement (SAVR) in patients with severe symptomatic aortic stenosis (sSAS) at low risk of surgical mortality. Using PARTNER 3 outcomes and Italy-specific costs data, this cost-utility analysis from the perspective of the Italian National Health System aimed to determine the cost-effectiveness of SAPIEN 3 TAVI versus SAVR in low risk sSAS patients in Italy., Methods: A two-stage cost-utility model was developed to estimate changes in both direct healthcare costs and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. Early adverse events associated with TAVI were captured utilising the PARTNER 3 dataset. These data fed into a Markov model that captured longer-term outcomes of patients, following TAVI or SAVR intervention., Results: Analysis findings estimated that TAVI with SAPIEN 3 offers benefits over SAVR in terms of increased quality-adjusted life years (QALYs) with only a small increase in costs, representing an incremental cost-effectiveness ratio/QALY gained of €2989 per patient. The results were robust, with TAVI with SAPIEN 3 remaining cost-effective across several scenarios and in probabilistic sensitivity analyses., Conclusions: This model demonstrated that TAVI with SAPIEN 3 is likely to be cost effective compared with SAVR for the treatment of patients with sSAS who are at low risk of surgical mortality. These findings can inform policy makers to facilitate policy development in Italy on intervention selection for this patient population., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: The presence of severe calcific atherosclerosis at the iliofemoral axis may preclude transcatheter aortic valve implantation (TAVI) by the transfemoral (TF) approach. Intravascular lithotripsy (IVL) is a novel technology that fractures intimal/medial calcium and increases vessel compliance allowing TF TAVI in selected patients with peripheral artery disease (PAD)., Aims: The aim of this study was to report on the safety and efficacy of IVL-assisted TF TAVI in an all-comers population., Methods: Clinical, imaging and procedural data on all consecutive patients treated by IVL-assisted TF TAVI in six high-volume European centres (2018-2020) were collected in this prospective, real-world, multicentre registry., Results: IVL-assisted TF TAVI was performed in 108 patients, increasing from 2.4% to 6.5% of all TAVI from 2018 to 2020, respectively. The target lesion was most often localised at the common and/or external iliac artery (93.5% of cases; average TL-MLD 4.6±0.9 mm with 318 degrees of calcium arc). Transfemoral aortic valve delivery was successful in 100% of cases; final procedural success in 98.2% (two conversions to cardiac open surgery for annular rupture and valve migration). Complications of the IVL-treated segments consisted of 1 perforation and 3 major dissections requiring stent implantation (2 covered stents and 2 BMS). Access-site-related complications included 3 major bleedings. Three in-hospital deaths were recorded (2.8%, 1 failed surgical conversion after annular rupture, 1 cardiac arrest after initial valvuloplasty, 1 late hyperkalaemia in renal dysfunction)., Conclusions: IVL-assisted TF TAVI proved to be a safe and effective approach, which helps to expand the indications for TF TAVI in patients with severe calcific PAD. However, these patients continue to have a higher-than-average incidence of periprocedural complications.

Catheter-based treatment of structural heart diseases (SHD) has seen tremendous advances in the past decades, thanks to the development of new devices and advances in imaging techniques. Today, we have an extensive armamentarium of imaging tools for preprocedural planning, intraprocedural guidance and follow-up of SHD. Intraprocedural guidance is based mainly on transoesophageal echocardiography; however, other imaging modalities are used as complementary or alternative techniques, each of them with its strengths and weaknesses. Thus, a multimodality imaging approach provides added values in this setting. As the field of imaging parallels the continuous technical improvements, this review will describe the state of the art imaging techniques, focusing on echocardiography during procedural guidance of the most common catheter-based interventions, providing tips and tricks for interventional cardiologists: in particular, how to guide transseptal crossing; left atrial appendage closure; transcatheter mitral or tricuspid valve repair or replacement; percutaneous closure of patent foramen ovale and atrial defects; and percutaneous closure of paravalvular leaks. Open challenges for the near future are the need for physicians with specific technical skills and competencies in SHD imaging, more attention to high levels of radiation exposure, and optimisation of intraprocedural and post-procedural evaluation.

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.

Background: Patent foramen ovale (PFO) closure is superior to medical therapy alone to prevent stroke recurrence in selected patients. Small cortical infarcts and large right to left shunts seem to identify patients who will benefit most from closure. We aimed to study the correlation between the size of the PFO and the volume of cerebral ischemic lesions in young patients with cryptogenic ischemic stroke., Methods: PFO dimensions and acute ischemic lesion volume of 20 patients, aged<55 years, were analyzed with transesophageal echocardiography and brain magnetic resonance imaging, respectively. The association between the volume of ischemic lesions with the length of PFO, maximum separation between septum primum and septum secundum, and the combination of the twos was explored., Results: A direct statistically significant correlation was found between cerebral lesion volume and maximum separation of septum primum and septum secundum (p=0.047). Length of PFO showed a non-significant trend towards an inverse correlation with lesion volume (p=0.603). Multiple linear regression analysis showed that cerebral lesion volume was dependent directly on maximum separation and inversely on length of PFO (regression coeff. -0,837; p= 0.057; 2,536, p=0.006, respectively)., Conclusions: These data suggest that even small PFO might be pathogenetic in case of small cerebral infarcts and that large cerebral infarcts might be PFO related if the shunt is large. If confirmed, the combination of detailed characteristics of PFO with the volume of cerebral infarct could be integrated in a new score to select patients who would take real advantage from a percutaneous closure., (© 2021. The Author(s).)

Objectives: To assess the cost-effectiveness (CE) of transcatheter aortic valve implantation (TAVI) in Italy, considering patient groups with different surgical risk., Methods: A Markov model with a 1-month cycle length, comprising eight different health states, defined by the New York Heart Association functional classes (NYHA I-IV), with and without stroke plus death, was used to estimate the CE of TAVI for intermediate-, high-risk and inoperable patients considering surgical aortic valve replacement or medical treatment as comparators according to the patient group. The Italian National Health System perspective and 15-year time horizon were considered. In the base-case analysis, effectiveness data were retrieved from published efficacy data and total direct costs (euros) were estimated from national tariffs. A scenario analysis considering a micro-costing approach to estimate procedural costs was also considered. The incremental cost-effectiveness ratio (ICER) was expressed both in terms of costs per life years gained (LYG) and costs per quality adjusted life years (QALY). All outcomes and costs were discounted at 3% per annum. Univariate and probabilistic sensitivity analyses (PSA) were performed to assess robustness of results., Results: Over a 15-year time horizon, the higher acquisition costs for TAVI were partially offset in all risk groups because of its effectiveness and safety profile. ICERs were €8338/QALY, €11,209/QALY and €10,133/QALY, respectively, for intermediate-, high-risk and inoperable patients. ICER values were slightly higher in the scenario analysis. PSA suggested consistency of results., Conclusions: TAVI would be considered cost-effective at frequently cited willingness-to-pay thresholds; further studies could clarify the CE of TAVI in real-life scenarios., (© 2021. The Author(s).)

A little is known about long-term hemodynamic performance of the transcatheter heart valves (THVs). The aim of the present study was to assess hemodynamic outcome, structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) in patients treated with transcatheter aortic valve replacement (TAVR) five or more years ago. All consecutive patients treated at Bologna and Florence University Hospitals with TAVR between January 2008 and December 2013 were analyzed in a retrospective registry with regards to demographic, procedural and outcome data as well as follow-up data on mortality and echocardiographic characteristics. Standardized definitions were used to define outcomes and durability of the THVs. 400 patients were included in the study, mostly treated with transfemoral TAVR (71.8%), using first generation balloon-expandable (37%) or self-expanding (63%) devices. The 1-year mortality was 21.8% (87 patients) and 5-year mortality was 53.8% (215 patients). Median follow-up was 45.5 months (14.0-68.9) totaling 1516.7 patient/years, with the longest follow-up being 10.25 years. At least one follow-up echocardiogram was available for 320 patients (80%), SVD occurred in 19 of these patients (5.94%): moderate in 17 patients (5.31%) and severe in two patients (0.63%). The hemodynamic presentation was stenosis in most of the cases (12 patients). Late BVF was registered in 10 patients (3.13%) and this was mainly driven by transcatheter paravalvular leak closure (six patients) with subsequent good long-term outcome. Our results confirm that TAVR appears to be a long-lasting treatment strategy with low rates of structural valve degeneration and valve failure., (© 2021. Società Italiana di Medicina Interna (SIMI).)

A longtime aspiration of interventional cardiologists remains to improve the long-term impact of stent permanence in coronaries to restore original vessel patency and physiological endothelium response. Bioresorbable vascular scaffolds were considered revolutionary in coronary devices, but several trials were disappointing; thus, the challenge in this field remains. DESolve is a novolimus-eluting poly-L-lactide-based polymer scaffold that dissolves through a bio-reabsorption mechanism, vanishing completely in 2 years. Its ability to supply the necessary radial strength to support the vessel for the critical early months after delivery is an important feature showing a unique self-correction property, which reduces incomplete stent apposition. Overexpansion has a good, safe margin with DESolve. This review aims to provide an overview of this controversial topic.

Transcatheter aortic valve implantation (TAVI) has become the leading technique for aortic valve replacement in symptomatic patients with severe aortic stenosis with conventional surgical aortic valve replacement (SAVR) now limited to patients younger than 65-75 years due to a combination of unsuitable anatomies (calcified raphae in bicuspid valves, coexistent aneurysm of the ascending aorta) and concerns on the absence of long-term data on TAVI durability. This incredible rise is linked to technological evolutions combined with increased operator experience, which led to procedural refinements and, accordingly, to better outcomes. The article describes the main and newest technical improvements, allowing an extension of the indications (valve-in-valve procedures, intravascular lithotripsy for severely calcified iliac vessels), and a reduction of complications (stroke, pacemaker implantation, aortic regurgitation).

THV aortic embolization can be managed percutaneously by snaring the prosthesis in a stable position in ascending aorta. We report two cases of embolized Acurate NEO with extreme mobility of devices in ascending aorta in which a bailout supra-aortic trunk stenting with consistent aortic protrusion were performed stabilizing the devices., Competing Interests: Declaration of competing interest The performance of this study was supported exclusively by internal institutional funds. With regards to the present manuscript, Dr. F. Bedogni and Dr. F. De Marco are proctors and consultant for Boston Scientific. All other authors have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

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.

Coronary artery calcifications are always challenging scenarios for interventional cardiologists. Calcium content in coronary tree directly correlates with male sex, age, Caucasian ethnicity, diabetes, and chronic kidney disease. Intracoronary imaging is useful and necessary to understand calcific lesion features and plan the best percutaneous coronary intervention strategy. Thus, accurate evaluation of patient and lesion characteristics is crucial. For this reason, definition of calcific arc, length, and thickness can suggest the best procedure before stenting and final optimization. In our modern era, different devices are available and all are surprisingly promising., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: Aim of this study is to evaluate safety, feasibility, and mid-term outcome of transcatheter aortic valve implantation (TAVI) in cardiogenic shock (CS)., Background: Balloon aortic valvuloplasty in patients with severe aortic valve stenosis (SAS) complicated by CS is indicated but associated with a grim prognosis. TAVI might be a more reasonable treatment option in this setting but data are scant., Methods: From March 2008 to February 2019, 51 patients with severe aortic valvulopathy (native SAS or degenerated aortic bioprosthesis) and CS treated by TAVI in 11 European centers were included in this multicenter registry. Demographic, clinical, and procedural data were collected, as well as clinical and echocardiographic follow-up., Results: The mean age of our study population was 75.8 ± 13, 49% were women, and mean Society of Thoracic Surgeons (STS) score was 19 ± 15%. Device success was achieved in 94.1%, with a 5% incidence of moderate/severe paravalvular leak. The 30-day events were mortality 11.8%, stroke 2.0%, vascular complications 5.9%, and acute kidney injury 34%. Valve Academic Research Consortium-2 early safety endpoint was reached in 35.3% of cases. At 1-year of follow-up, the mortality rate was 25.7% and the readmission for congestive heart failure was 8.6%., Conclusions: TAVI seems to be a therapeutic option for patients with CS and SAS or degenerated aortic bioprosthesis in terms of both safety and efficacy at early and long-term follow-up., (© 2020 Wiley Periodicals LLC.)

Background: In spite of the increased use of Trans-catheter Aortic Valve Implantation (TAVI) due to the better patient selection, well-trained operators and improved technology, the choice of the best anesthesia regimen remains an open question. In particular, it remains to be clarified whether deep sedation (DS) in spontaneous breathing or femoral local anesthesia (LA) is best., Objective: This study compared the hemodynamic variations determined by deep sedation (DS) with spontaneous breathing and local femoral anesthesia (LA) in 2 groups of patients submitted to TAVI with two different kinds of anesthesia, using a beat-by-beat pulse contour method (MostCare ®-UP )., Methods: 82 patients with severe aortic stenosis and similar baseline characteristics and indications underwent trans-femoral TAVI: 50 with LA and 32 with DS. All patients were submitted to minimally invasive hemodynamic monitoring. The following parameters were measured: pressure indexes : systolic, diastolic, mean (SysP, DiaP, MAP) and dicrotic (DicP) pressures; flow indexes : cardiac output (CO), stroke volume (SV); ventriculo-arterial coupling indexes (VAC): peripheral arterial elastance (Ea P ), systemic vascular resistance (SVR); cardiovascular system performance : cardiac cycle efficiency (CCE), dP/dt max&#95;rad ., Results: The TAVI procedure was successful in 89% of patients (VARC-2 criteria) with no difference between the 2 groups. Anesthesia induction determined a higher decrease of pressures in DS than in LA (P<0.01) with no differences in CO. The VAC parameters (Ea P , SVR) decreased (P<0.01) in DS with an improvement in CCE (P<0.001); these parameters did not change in LA. The post-TAVI flow and VAC parameters, especially Ea, increased (P<0.05) more significantly in the LA group than in the DS group (P<0.001). Using logistic regression, the occurrence of the post-TAVI aortic regurgitation was correctly associated with the pressure gradient MAP-DicP in 63% of the study population (P=0.033). This association was more effectively detected in the LA group (78%, P=0.011) with a ROC AUC=0.779, than the DS group., Conclusion: The use of the pulse contour method to track the fast-hemodynamic changes during the TAVI procedure proved suitable for the aim. As expected, LA and DS induced different pre-TAVI hemodynamic conditions, which influenced the post-TAVI hemodynamic changes. The hemodynamic conditions induced by LA, enabled the occurrence of post-TAVI aortic regurgitation to be detected more effectively., Competing Interests: S.M. Romano is owner of the PRAM method patent. D. Payen received grant from Vygon Ltd (Ecouen, France) for clinical study and development on PRAM system. Other authors have no conflict of interests to declare., (AJCD Copyright © 2020.)

Background: Calcified coronary lesions still represent a challenge for coronary angioplasty, with sub-optimal acute PCI results causing more frequent late stent failure., Purpose: The study aimed at the evaluation of the immediate procedural outcome in a real-world consecutive population of a selective use of lithotripsy based on the intravascular imaging assessment with IVUS or OCT., Methods and Results: Thirty-one calcified stenoses (28 patients) out of a total of 455 lesions (370 patients) treated between November 2018 and May 2019 received IVL under intravascular imaging guidance. The majority of the IVL lesions had angiographically severe calcifications and were selected after intravascular imaging. A smaller group was identified by poor expansion after high-pressure balloon dilatation, in one case despite preliminary small burr Rotablation. After IVL, when OCT was performed calcium fractures were observed in 71% of cases. After OCT/IVUS guided stent optimization a satisfactory lumen enlargement (minimal stent area 7.09 ± 2.77 mm 2 ) was observed with good stent expansion (residual area stenosis<20% in 29 lesions, 93.5%) Peri-procedural complications were limited to one dissection at the distal edge requiring an additional stent and 3 peri-procedural myocardial infarctions. There were no periprocedural coronary perforations or pericardial effusions, and no in-hospital or 30 days stent thrombosis. When patients were divided into two subgroups according to a calcium arc ≤180° (Group A: 10 lesions, calcium arc 140 ± 24°; Group B: 21 lesions, calcium arc 289 ± 53°), at OCT Group B presented also a higher number of calcium fractures post IVL than group A (group A: 38% vs group B: 92%, p = 0.03). The in-stent minimum lumen diameter (MSD), the in stent minimal lumen area (MSA) and the acute gain, however, were similar between the two groups (acute gain group A: 1.22 ± 0.29 mm; group B: 1.31 ± 0.52 mm, p = 0.63)., Conclusions: A standardized algorithm applying intravascular imaging guidance of IVL facilitated second generation DES expansion delivers excellent immediate lumen expansion and patient outcome, both in concentric and eccentric calcifications., (Copyright © 2020. Published by Elsevier Inc.)

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.

Purpose of Review: In recent years, transcatheter aortic valve replacement (TAVR) and percutaneous mechanical circulatory support (MCS) systems have seen a widespread diffusion. These devices require the insertion of large femoral sheaths in a population of patients often presenting with calcific peripheral artery disease. Small and severely calcified iliac vessels are associated with increased risk of vascular complications or strategy changes such as the use of an alternative subclavian or transapical approach for TAVR or a conversion to surgery. Intravascular lithotripsy (IVL) technology applies mechanical pressure waves to modify vessel calcifications. It has been applied both in coronary and peripheral calcific disease with promising results. The use in vessel preparation before the insertion of large sheaths is an emerging application of this device., Recent Findings: After case reports and presentations of isolated cases, two multicenter registries collected 42 and 12 patients treated with peripheral IVL before TAVR and MCS insertion. In most cases, the largest balloons were used in the iliac arteries with success achieved directly or using a separate insertion sheath in all cases. Low-pressure dilatation during energy delivery avoided dissections or vessel ruptures with no need of postprocedural stent implantation or emergency surgical repair. IVL can successfully modify the arterial compliance and facilitate transfemoral delivery of TAVR or MCS in patients with calcified iliofemoral vessels, reducing the need for alternative TAVR access routes and allowing to perform high-risk coronary procedures with adequate support.

Heavily calcified lesions may be difficult to dilate adequately with conventional balloons and stents, which causes frequent periprocedural complications and higher rates of target lesion revascularisation (TLR). High-pressure non-compliant balloon angioplasty may be of insufficient force to modify calcium and, even when successful, may be limited in its ability to modify the entire calcified lesion. Scoring and cutting balloons hold theoretical value but data to support their efficacy are lacking and, because of their high lesion crossing profile, they often fail to reach the target lesion. Rotational and orbital atherectomy target superficial calcium; however, deep calcium, which may still impact on vessel expansion and luminal gain, is not affected. Intravascular lithotripsy (IVL), based on lithotripsy for renal calculi, is a new technology which uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue. Energy is delivered via a balloon catheter, analogous to contemporary balloon catheters, with transmission through diluted ionic contrast in a semi-compliant balloon inflated at low pressure with sufficient diameter to achieve contact with the vessel wall. With coronary and peripheral balloons approved in Europe, peripheral balloons approved in the USA and multiple new trials beginning, we review the indications for these recently introduced devices, summarise the clinical outcomes of the available trials and describe the design of ongoing studies.

Degenerative mitral regurgitation in elderly patients and functional mitral regurgitation secondary to severe left ventricular dysfunction are not easy options for conventional surgery. Recently, a new percutaneous approach has been proposed with the MitraClip ® , based on the Alfieri edge-to-edge repair technique. The aim of the study is to report, compare and discuss the results of two multicenter randomized trials: MITRA.FR and COAPT in light of the current practice. In both trials patients with functional mitral regurgitation grade 3/4+ or 4/4+ were randomly assigned, in 1:1 ratio, to undergo percutaneous repair and optimal medical therapy or optimal medical therapy alone. Other baseline characteristics reflecting severity of mitral regurgitation and of left ventricular impairment were statistically different, such as the effective regurgitant orifice area (0.31 cm 2 in MITRA.FR vs 0.41 cm 2 in COAPT) and the indexed LVEDV (135 ± 37 ml/m 2 in MITRA.FR vs 101 ± 34 ml/m 2 in COAPT). A 24 months follow-up and a 12 months follow-up have been completed, respectively, in COAPT and MITRA.FR. Out of the 307 patients enrolled in the MITRA.FR, 152 were randomized to percutaneous treatment but only in 138 (95.8%) the MitraClip ® was actually implanted. At the end of the follow-up a residual mitral regurgitation of at least grade 3+ has been observed in 17% of the patients. A composite of death from any cause or unplanned hospitalizations for heart failure at 12 months respectively occurred in 83 patients (54.6%) treated percutaneously and 78 patients (51.3%) treated with medical therapy only. A total of 614 patients have been enrolled in the COAPT and 293 underwent transcatheter treatment. A successful implantation of the MitraClip ® was achieved in 287 patients (98.0%). Hospitalization for heart failure at 24 months occurred in 160 patients in the device group and in 283 in the control group, with an annualized ratio of 35.8% and 67.9%, respectively (p > 0.001). The conflicting results of the two trials may have many explanations, but probably the main cause is the most stringent inclusion criteria in COAPT. The effective reduction of mitral regurgitation and improvement in exercise capacity already observed in registries including more than 70,000 patients was confirmed in a randomized trial with improvement observed in hard end-points. This has already led to an extension of FDA approval to functional regurgitation and a more liberal use across the world.

: In recent years, three-dimensional modelling and printing techniques have improved diagnosis and preprocedural planning during percutaneous interventions or surgery in cardiovascular disease. The raw data for the whole process are obtained through medical imaging, where regions of interest, that is heart chambers, valves, aorta, coronary vessels etc., are segmented and converted into three-dimensional digital models, which are then reproduced in physical replica by a three-dimensional printer. In the current article, a freeware patient-specific three-dimensional modelling and printing step-by-step procedure for preprocedural planning for complex heart diseases is presented and applied on four patients. Finally, a general discussion on the potential and future developments of personalized three-dimensional modelling and rapid prototyping for preprocedural planning is also presented.

Background: Residual aortic regurgitation (AR) complicates a not negligible number of transcatheter aortic valve replacement (TAVR) procedures, and its entity is not always clear at intraprocedural angiographic and echocardiographic control. We applied a minimally invasive hemodynamic monitoring system (Pressure Recording Analytical Method, PRAM) in the setting of TAVR, with the aim of identifying parameters that may help in detection and quantification of residual AR., Methods: We performed hemodynamic monitoring with PRAM in 43 patients undergoing trans-femoral TAVR. Investigated parameters were systolic (Psys, mm Hg), diastolic (Pdia, mm Hg), mean (MAP, mm Hg) and dicrotic pressure (Pdic, mm Hg), cardiac output (CO, L/min), stroke volume (SV, mL), cardiac cycle efficiency (CCE, Units), dP/dt max&#95;rad (mm Hg/ms), MAP-Pdic (mm Hg)., Results: Procedural success was achieved in 86% of the patients; vascular complications occurred in 3 (6.9%), death in 2 (4.7%). Twenty (46.5%) patients had at least mild residual AR. CO, SV, CCE and dP/dt max&#95;rad changed significantly (p < 0.001) between baseline and end of procedure in the overall population, with more evident modifications in the subgroup without residual AR. MAP-Pdic variations were statistically significant only in the subgroup without AR (p = 0.05)., Conclusions: TAVR determined an improvement in hemodynamic parameters such as CO, SV, CCE, dP/dt max&#95;rad . MAP-Pdic was able to discriminate patients with significant residual AR. Hemodynamic monitoring with PRAM system during TAVR is easy and fast to obtain and may help in clinical decision-making in controversial cases., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Percutaneous patent foramen ovale (PFO) closure is an intervention aimed to prevent cardioembolic stroke. It recently proved to be superior to antiplatelet therapy in preventing recurrent strokes in a well-selected population of patients with a previous cryptogenic cerebral ischemic event. A large part of the clinical advantage of PFO transcatheter therapy derives from the very high efficacy and safety of the maneuver. Various types of devices with different characteristics are currently available for the use of the interventionists. Recently, a direct PFO suture device has been added to the device list, allowing for PFO closure without implanting any prosthesis. This article describes the procedure of PFO closure with a particular focus on the main characteristics of the various devices available. A road-map of choice among the various prostheses is also provided, keeping in mind the patient's clinical features and the various PFO anatomies.