BACKGROUND:Long-term clinical outcomes are lacking for patients treated with sirolimus-eluting balloons (SEBs). We sought to evaluate long-term clinical outcomes of the SELUTION SLR (Selution; MedAlliance; Nyon, Switzerland) SEB in various clinical settings. METHODS:From 2021 to 2025, we included patients treated with the Selution SEB. Patients were divided into 3 groups: drug-eluting stent in-stent restenosis (DES-ISR), small vessel (SV; diameter < 3 mm) and big vessel (BV). Inverse probability of treatment weighting analysis was used to account for baseline differences. The primary end point was target lesion failure, defined as the composite of cardiovascular death, target vessel myocardial infarction, and target lesion revascularization. RESULTS:A total of 495 patients were included in the study. Of these, 33.1% were included for DES-ISR, 40.4% for de novo SV lesions, and 26.5% for de novo BV lesions. In patients treated for de novo lesions, bail out stenting occurred in 16.6% of patients. Up to 3 years, there were no significant differences in any end points between DES-ISR and SV, nor between DES-ISR and BV. A significantly lower bail out rate was observed in the second half of patients included in the registry (12.6%) compared with the early inclusion group (20.5%; P = 0.049), without an increase in clinical events. CONCLUSIONS:Patients treated with the Selution SEB were associated with favourable clinical outcomes at mid- and long-term follow-up. There were no significant differences in any end points between DES-ISR and SV, nor between DES-ISR and BV.

Background/Objectives: Bail-out stenting remains a procedural challenge for percutaneous coronary intervention (PCI) performed with drug-coated balloons (DCBs). No dedicated bedside tool is currently available to predict this event. We aimed to develop and internally validate a bedside Bail-Out Risk Score. Methods: We analyzed patients treated with DCBs between 2021 and 2025. Predictors of bailout stenting were identified through univariate analysis, and variables with p < 0.10 were entered into a multivariable logistic regression model. Regression coefficients were then transformed into integer points using the Sullivan method. Model performance was evaluated by AUC-ROC, calibration, and bootstrap internal validation (B = 1000). Results: A total of 352 patients (399 de novo lesions) were treated with DCB-only PCI. Bail-out stenting occurred in 14.5% of lesions (58/399). Independent predictors of bail-out stenting were prior CABG (OR 4.29, p = 0.002), proximal lesion location (OR 2.99, p = 0.003), and diffuse disease (OR 2.18, p = 0.018). Prior PCI (OR 0.44, p = 0.009) and lipid-lowering therapy (OR 0.42, p = 0.029) were protective, while LAD involvement showed a non-significant trend (OR 1.57, p = 0.137). The model demonstrated moderate discrimination (AUC = 0.734; optimism-corrected AUC = 0.704) and excellent calibration (intercept = 0.000, slope = 1.000). The final score (range -4 to +8) stratified lesions into low (≤-1), intermediate (0-3), and high (≥3) risk groups, with progressively higher predicted probabilities (≤9%, 13-37%, and ≥49%). Conclusions: The Bail-Out Risk Score provides a practical and reliable bedside tool to estimate procedural risk during stentless PCI.

BACKGROUND:Sirolimus-coated balloon (SCB) is a potential treatment option for peripheral arterial disease (PAD). However, evidence is limited on the durability of the treatment effect in the longer term. AIMS:The aim of our study was to assess the long-term efficacy and safety of SELUTION SCB in the treatment of the femoropopliteal steno-occlusive disease. METHODS:This is a single-center, all-comers, observational registry in which 80 consecutive patients undergoing SELUTION SCB-angioplasty due to femoropopliteal steno-occlusive lesions were enrolled from February 2021 to March 2022. Assessments through 3 years included: primary patency (primary efficacy outcome), defined as freedom from restenosis determined by a duplex ultrasound peak systolic velocity ratio (PSVR) ≤ 2.4; freedom from clinically-driven target lesion revascularization (CD-TLR) and secondary patency, defined as freedom from new restenosis following the CD-TLR (secondary efficacy outcomes); freedom from major adverse limb events (MALEs, primary composite safety outcome); change in median ankle-brachial index (ABI) and Rutherford classification (functional outcomes). RESULTS:At 3 years, primary patency was 74.7% and freedom from CD-TLR was 85.3%. The rate of CD-TLR was 14.7% (11 patients). Among them, one patient experienced a new restenosis (failure of CD-TLR), therefore secondary patency was 90.9%. Freedom from MALEs was 94.7%. Median ABI increased significantly from 0.4 ± 0.2 at baseline to 0.7 ± 0.3 at 36 months postprocedure, as well as Rutherford classification data improved. CONCLUSIONS:These 3-year findings suggest long-term efficacy and safety of SELUTION SCB in the setting of femoropopliteal steno-occlusive endovascular treatment. Larger cohorts and randomized controlled trials will be needed to confirm these results.

BACKGROUND:Transradial arterial access (TRA) using 5 French (5F) devices is a new option to manage percutaneous aorto-iliac interventions, potentially reducing the rate of vascular complications and the length of hospital stay. However, evidence is limited on the efficacy and safety of this approach. The aim of our study was to assess the feasibility, efficacy and safety of TRA 5F approach, using Micro device portfolio by Qualimed, for the treatment of aorto-iliac artery lesions up to 12-month follow-up. METHODS:This is a single-center, all-comers, observational registry in which 60 consecutive patients undergoing transradial angioplasty due to aorto-iliac steno-occlusive disease were prospectively enrolled from April 2022 to September 2024. We assessed: procedural success of angioplasty using at least 1 TRA (primary efficacy outcome); primary patency at 12 months; length of hospital stay (secondary efficacy outcomes); freedom from major adverse events (MAEs) (primary safety outcome); and freedom from access-related vascular complications (secondary safety outcome). RESULTS:Procedural success of aorto-iliac angioplasty using at least one 5F transradial access was achieved in 58 of 60 patients (96.7%). In 66.7% of the cases, an additional transfemoral approach was required, whereas in 2 of 60 patients an unplanned switch from radial to femoral access occurred. Primary patency was 95.0%, since 3 patients underwent target vessel revascularization due to restenosis/thrombosis. Mean hospital stay was 2 days. As for safety, no MAEs were reported. Freedom from (radial) access-related vascular complications was 100% during index hospital stay and 88.3% after12-month follow-up, since 7 radial occlusions occurred. CONCLUSIONS:These 12-month findings suggest mid-term efficacy and safety of transradial aorto-iliac artery interventions using 5F Micro devices by Qualimed, even in the setting of complex lesions (ie, TASC II classification ≥ C). Larger cohorts and randomized controlled trials will be needed to confirm these results.Clinical ImpactThe study suggests that 5F transradial access for aorto-iliac interventions is a feasible and safe alternative to the traditional femoral approach. The high procedural success, absence of major adverse events, and short hospital stay support its integration into routine practice. For clinicians, this technique may reduce access-site complications and facilitate faster patient mobilization without compromising technical outcomes. The main innovation lies in the availability of a complete 5F device platform, enabling treatment of complex lesions previously unsuitable for radial access. If confirmed in larger studies, this approach may shift practice toward safer, minimally invasive endovascular strategies.

BACKGROUND:Lower extremity arterial disease is a prevalent vascular condition leading to ischemic symptoms and increased risk of cardiovascular events. Drug-eluting stents have improved outcomes by reducing restenosis, with sirolimus emerging as a promising alternative to paclitaxel due to its safer profile. This study evaluates the efficacy and safety of novel polymer-free Amphilimus™ formulation (Sirolimus + fatty acid) eluting self-expanding stent in the treatment of femoropopliteal disease in a real-world population. METHODS:A prospective, single-center study was conducted from November 2022 to January 2024, including 78 patients with femoropopliteal artery disease. Patients underwent percutaneous transluminal angioplasty with stent implantation and follow-up at discharge, 30 days, 6 and 12 months. The primary endpoints were overall and device related major adverse events and primary patency at 12 months. Secondary endpoints included freedom from clinically driven target lesion revascularization and the presence of the HALO effect on ultrasound. RESULTS:The mean age of patients was 68.5±9.4 years and mean target lesion length was 151±75 mm. The occlusions were 39% while 48.1% of patients had chronic limb threatening ischemia. Device and clinical success were obtained in all cases. At 12 months, primary patency was 87%, freedom from clinically driven target lesion revascularization was 92.2% and overall freedom from major adverse events was 89%. No HALO effect was observed. CONCLUSIONS:These findings suggest that using a novel polymer-free sirolimus self-expanding stent is a safe and effective treatment option for femoropopliteal lesions, supporting its use in routine clinical practice.

The interventional treatment of coronary artery disease (CAD) has undergone significant improvements thanks to technological innovations. Nowadays, percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is the standard of care for the treatment of CAD. Nevertheless, the non-negligible incidence of in-stent restenosis (ISR) and suboptimal results in various anatomical settings has led to the development of drug-coated balloons (DCBs). DCBs are catheter-based balloons whose surface is coated with an anti-proliferative drug (mainly Paclitaxel or Sirolimus) loaded onto the balloon surface with different technologies and dose concentrations. In the beginning, these devices were used for the treatment of ISR showing an excellent efficacy profile in the inhibition of intimal hyperplasia. Subsequently, several studies evaluated their use in other angiographical and clinical contexts such as de novo lesions, small vessel disease, diffuse coronary disease, bifurcation lesions, acute coronary syndromes, high-bleeding risk and diabetic patients. This comprehensive review aims to describe the main DCB platforms on the market, their fields of application with the main supporting studies and their future perspectives.

BACKGROUND:Despite the use of two crossed Perclose ProGlide™ (Abbott Vascular Devices) is the most widespread technique to close the main arterial access in transfemoral transcatheter aortic valve implantation (TF-TAVI), the safest and most effective strategy still remains much debated. AIMS:The aim of the present study was to evaluate the performance of a single Perclose ProGlide suture-mediated closure device to obtain femoral hemostasis after sheathless implantation of self-expanding transcatheter heart valves through their 14 F-equivalent fix delivery systems. METHODS:This prospective observational study included 439 patients undergoing TF-TAVI at the "Montevergine" Clinic of Mercogliano, Italy. All patients underwent hemostasis of the large-bore access using a single Perclose ProGlide with preclose technique, after sheathless implantation of self-expanding transcatheter heart valves through 14 F-equivalent fix delivery systems. A multidetector computed tomography analysis of size, tortuosity, atherosclerotic, and calcification burdens of the ilio-femoral access route was made by a dedicated corelab. Vascular complications (VCs), percutaneous closure device (PCD) failure, and bleedings were adjudicated by a clinical events committee. RESULTS:A total of 81 different VCs were observed in 60 patients (13.7%); among these, 41 (5% of patients) were categorized as major. PCD failure occurred in 14 patients (3.2%). At the logistic regression analysis, no predictors of PCD failure have been identified. CONCLUSION:This registry suggests that the use of a single suture-mediated closure device could be considered a safe and efficient technique to achieve access site hemostasis in patients undergoing TF-TAVI through 14 F-equivalent fix delivery systems.

Over the last few decades, endovascular revascularization techniques have revolutionized the treatment of peripheral artery disease, offering a less invasive alternative to surgery. However, the successful treatment of heavily calcified lesions is often compromised by various vascular complications, including recoils, dissections, and the need for target vessel reinterventions. This has prompted the development of several tools for lesion preparation, with the aim of achieving better procedural outcomes. This review aims to summarize the main characteristics and current evidence related to the available devices for preparing severely calcified peripheral lesions.

BACKGROUND:The primary patency rate of superficial femoral artery (SFA) after percutaneous transluminal angioplasty (PTA) has improved with the use of self-expanding stents. However, occurrence of in-stent restenosis (ISR) still represents a frequent problem. Despite different studies have assessed the role of atherectomy and drug coated balloons (DCBs), no long-term data exist about combined use. The aim of this study was to evaluate safety and efficacy of combined treatment with Jetstream (Boston Scientific Corp., Marlborough, MA, USA) atherectomy and DCB for SFA intrastent restenosis (ISR) at 2-year follow-up.METHODS:30 patients treated with PTA from November 2018 to September 2019 at Montevergine Clinic (Mercogliano, Avellino, Italy) were included in this analysis. All patients underwent PTA of SFA-ISR with Jetstream Atherectomy System followed by paclitaxel eluting balloon treatment. Patients were evaluated at 30 days, and every 3 months up to 24.RESULTS:Technical and procedural success was achieved in every patient. No in-hospital major adverse cardiac and cerebrovascular events occurred. No acute and sub-acute(in-hospital) procedure related complications occurred. During follow-up, 1 patient died due to stroke. Primary patency rate at 12 months was 93.4%. Primary patency rate at 24 months was 83.4%. Secondary patency rate at 24 months was 96.7%. One minor amputation, planned before treatment, was performed in the first 30 days.CONCLUSIONS:Our data suggest that combined therapy with Rotational Atherectomy and DCBs for SFA-ISR represents a safe and effective procedure with a high rate of primary patency at 2-year follow-up.

Background: Cardiac fibrosis represents a key element in the pathophysiology of heart failure with preserved ejection fraction (HFpEF), a condition highly prevalent amongst geriatric patients, especially if diabetic. The microRNA 181c (miR-181c) has been shown to be associated with the response to exercise training in HFpEF patients and has been also linked to diabetic cardiovascular complications. However, the underlying mechanisms have not been fully elucidated.Objective: To measure circulating miR-181c in elderly patients with HFpEF and diabetes mellitus (DM) and identify gene targets pathophysiologically relevant in HFpEF.Methods: We quantified circulating miR-181c in frail older adults with a confirmed diagnosis of HFpEF and DM, and, as control, we enrolled age-matched subjects without HFpEF and without DM. We validated in human cardiac fibroblasts the molecular mechanisms linking miR-181c to a pro-fibrotic response.Results: 51 frail patients were included :34 patients with DM and HFpEF and 17 age-matched controls. We observed that miR-181c was significantly upregulated (p < 0.0001) in HFpEF patients vs controls. We confirmed in vitro that miR-181c is targeting PRKN and SMAD7.Conclusions: We demonstrate that miR-181c levels are significantly increased in frail elderly adults with DM and HFpEF and that miR-181c targets PRKN and SMAD7 in human cardiac fibroblasts.

Background: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is a frequent complication associated with adverse outcomes and mortality. Various scores have been developed to predict this complication in the coronary setting. However, none have ever been tested in a large TAVI population. This study aimed to evaluate the power of four different scores in predicting AKI after TAVI. Methods: Overall, 1535 consecutive TAVI patients from the observational multicentric "Magna Graecia" TAVI registry were included in the analysis. Of the study population, 235 (15.31%) developed AKI early. The Mehran, William Beaumont Hospital, CR4EATME3AD3, and ACEF scores were calculated retrospectively. Results: The patients who developed TAVI-related AKI had significantly higher absolute values of all risk scores than those who did not. The receiver-operating characteristic analysis also showed a significant correlation between these four scores and AKI, but without a significant difference among all of them (p value = 0.176). Nevertheless, based on their area under the curve values (<0.604 for all), none had adequate diagnostic accuracy in predicting TAVI-related AKI. Importantly, multivariate analysis identified myocardial revascularization close to the TAVI procedure and implantation of self-expanding prostheses, as well as atrial fibrillation, low-osmolar contrast media administration, corrected contrast medium volume, and any transfusion (p value < 0.05 for all) as independent risk factors for AKI. Conclusions: Although high values of current AKI risk scores are significantly associated with the development of this complication, these are not sufficiently accurate. Further studies are needed so that a TAVI-dedicated AKI risk score may be created. (c) 2022 Hellenic Society of Cardiology. Publishing services by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

BackgroundAortic valve stenosis (AS) is the most common valvular heart disease worldwide. When timely intervention is performed, aortic valve replacement can improve patients' quality and duration of life. Load-independent left ventricular (LV) functional assessments, such as myocardial work indices (MWIs) and LV diastolic function parameters, could help clinicians decide on the optimal timing of intervention. AimsTo evaluate the reliability of MWI in AS patients and the changes in MWI and LV diastolic function after transcatheter aortic valve replacement (TAVR). MethodsWe enrolled 53 consecutive patients with severe AS undergoing TAVR admitted between March 2021 and November 2021. MWIs and LV diastolic function were assessed before and after TAVR for each patient. ResultsAll MWIs and LV diastolic function indices improved after TAVR. The degree of MWIs improvement was higher in patients with lower prior-TAVR MWI values, while the more severe the impairment of diastolic function, the greater the post-TAVR benefit. ConclusionThe introduction of myocardial work parameters into the routine assessment of patients with AS could improve our understanding of cardiac performance and aid in identifying the optimal timing for surgical or percutaneous treatment.

OBJECTIVE:Ischemia with nonobstructive coronary arteries (INOCA) is a prevailing finding in patients with angina. However, the main factors underlying the risk of being rehospitalized for chest pain in patients with INOCA remain mostly unknown. RESEARCH DESIGN AND METHODS:We evaluated INOCA patients referred to the "Casa di Cura Montevergine" in Mercogliano (Avellino), Italy, from January 2016 to January 2021 for percutaneous coronary intervention (PCI). In these subjects, we assessed the impact of the stress hyperglycemia ratio (SHR), defined as the ratio of mmol/L blood glucose and % HbA1c, on the risk of rehospitalization for chest pain. RESULTS:A total of 2,874 patients with INOCA successfully completed the study. At the 1-year follow-up, the risk of rehospitalization for chest pain was significantly higher (P < 0.001) in INOCA patients with SHR >1 compared to patients with SHR ≤1. These findings were confirmed by multivariable analyses (adjusting for potential confounders, including age, BMI, blood pressure, heart rate, chronic kidney disease, and cholesterol), propensity score matching, and inverse probability of treatment weighting. CONCLUSIONS:Our data indicate, to our knowledge for the first time, that SHR on hospital admission significantly and independently increases the risk of rehospitalization for chest pain in INOCA patients.

Figure 1The peptides constituting the proteomic classifier used to predict coronary artery disease (CAD) are involved in diverse pathways associated with atherosclerosis, including inflammation, lipid metabolism, and collagen turnover.