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The incorporation of artificial intelligence (AI) in health care offers revolutionary enhancements in patient diagnostics, clinical processes, and overall access to services. Nevertheless, this technological transition brings forth various new, intricate risks that pose challenges to current safety and ethical norms. This research explores the ability of enterprise risk management as an all-encompassing framework to tackle these arising risks, providing both a forward-looking and responsive strategy designed for the health care industry. At the core of this method are instruments that together seek to proactively uncover and address AI-related weaknesses like algorithmic bias, system failures, and data privacy issues. On the reactive side, it incorporates incident reporting systems and root cause analysis, tools that enable health care providers to quickly address unexpected events and consistently improve AI implementation procedures. However, some application difficulties still exist. The unclear, "black box" characteristics of numerous AI models hinder transparency and responsibility, prompting inquiries about the clarity of AI-generated choices and their adherence to ethical benchmarks in patient treatment. The research highlights that with the progress of AI technologies, the enterprise risk management framework also needs to evolve, addressing these new complexities while promoting a culture focused on safety in health care settings., (© 2025 The Author(s). Journal of Health Care Risk Management published by Wiley Periodicals LLC on behalf of American Society for Health Care Risk Management.)

Introduction: Temporal lobe epilepsy is the most common form of focal epilepsy, often associated with cognitive impairments, particularly in memory functions, and depression. Sex and APOE ε4 genotype play a crucial role in modulating cognitive outcomes and depression in various neurological conditions like Alzheimer's disease. However, the combined effects of APOE genotype and sex on cognitive performance and depression in temporal lobe epilepsy have not been previously investigated., Objective: This study aims to (i) identify impaired cognitive performance and clinically relevant depression; (ii) explore the interaction between sex and APOE ε4 genotype on cognitive performance and depression in individuals with temporal lobe epilepsy., Methods: We used a comprehensive battery of neuropsychological tests to assess domains such as learning and memory, attention, executive functions, language, and visuo-spatial constructional skills and the Hamilton Depression Rating Scale. We also performed APOE genotyping to assess its role in the study. The final sample was composed by fifty-four patients (53.7% female). Cognitive performance and depression were analyzed using normative cut-off scores. To examine the main effects and interactions of sex and APOE ε4 carrier status on neuropsychological test scores and the Hamilton Depression Rating Scale, we also conducted a two-way Analysis of Variance (ANOVA)., Results: Female APOE ε4 carriers compared to normative cut-offs, exhibited poor performance on multiple test scores, including the MMSE, The Rey Auditory Verbal Learning Test (immediate and delayed recall), The Corsi Block-Tapping Task, The Verbal Fluency Test, The Raven's Standard Progressive Matrices and The Pentagon-copying Test. Males showed impairment only in visuo-spatial short-term memory. ANOVA analysis revealed significant main effects of APOE ε4 status and sex on the MMSE, The Rey Auditory Verbal Learning Test, The Verbal Fluency, The Raven's Standard Progressive Matrices and The Pentagon-copying Test scores. Specifically, female APOE ε4 carriers performed consistently worse than other groups on many tasks. For depression, only an effect of sex emerged. Females scored higher besides APOE genotype., Conclusions: These findings underscore the importance of considering both sex and APOE genotype when assessing cognitive performance in patients with temporal lobe epilepsy. The significant cognitive deficits we observed among females carrying the APOE ε4 allele highlight previously unexplored genetic and sex-related influences on cognition. This has potential implications for personalized therapeutic strategies, emphasizing the need for targeted assessment and intervention., 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 © 2025 Bruno, Spadafora, Veltri, Cuconati, Condino, Cerantonio, De Benedittis, Greco, Di Palma, Gallo, Citrigno, Qualtieri, Cundari and Cavalcanti.)

Introduction: Adverse events in hospitals significantly compromise patient safety and trust in healthcare systems, with medical errors being a leading cause of death globally. Despite efforts to reduce these errors, reporting remains low, and effective system changes are rare. This systematic review explores the potential of artificial intelligence (AI) in clinical risk management., Methods: The systematic review was conducted using the PRISMA Statement 2020 guidelines to ensure a comprehensive and transparent approach. We utilized the online tool Rayyan for efficient screening and selection of relevant studies from three different online bibliographic., Results: AI systems, including machine learning and natural language processing, show promise in detecting adverse events, predicting medication errors, assessing fall risks, and preventing pressure injuries. Studies reveal that AI can improve incident reporting accuracy, identify high-risk incidents, and automate classification processes. However, challenges such as socio-technical issues, implementation barriers, and the need for standardization persist., Discussion: The review highlights the effectiveness of AI in various applications but underscores the necessity for further research to ensure safe and consistent integration into clinical practices. Future directions involve refining AI tools through continuous feedback and addressing regulatory standards to enhance patient safety and care quality., 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 © 2025 De Micco, Di Palma, Ferorelli, De Benedictis, Tomassini, Tambone, Cingolani and Scendoni.)

Background: Mycotoxin exposure during pregnancy has been associated with adverse birth outcomes and poor infant growth. We assessed multiple biomarkers and metabolites of exposure to mycotoxins at birth and their associations with birth outcomes and infant growth in 274 newborns in rural Burkina Faso., Methods: Whole-blood microsamples were analyzed for mycotoxin concentrations in newborns in the Biospecimen substudy nested in the MIcronutriments pour la SAnté de la Mère et de l'Enfant-III trial using ultra-performance liquid chromatography coupled with tandem mass spectrometry. Unadjusted and adjusted associations between mycotoxin exposure, and birth outcomes and infant growth at 6 mo were estimated using linear regression models for continuous outcomes and linear probability models with robust variance estimation for binary outcomes. Infant growth trajectories from birth to 6 mo were compared by exposure status using mixed-effects models with a random intercept for the individual infant and a random slope for the infant's age., Results: Ochratoxin A (OTA) exposure was detected in 38.3% of newborns, with other mycotoxins being detected in the range of 0.36% and 4.01%. OTA exposure was significantly associated with adverse birth outcomes, such as lower birth weight [β (95% CI): -0.11 kg (-0.21, 0.00); P = 0.042] and ponderal index [β (95% CI): -0.62 gm/cm 3 (-1.19, -0.05); P = 0.034], and a marginally significant lower length growth trajectories during the first 6 mo [β (95% CI): -0.08 cm/mo (-0.15, 0.0); P = 0.057]., Conclusions: OTA exposure was prevalent among newborns and also associated with lower growth at birth and during the first 6 mo. The results emphasize the importance of nutrition-sensitive strategies to mitigate dietary OTA, as well as adopting food safety measures in Burkina Faso during the fetal period of development., Competing Interests: Conflicts of interest The authors report no conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction : The frozen section intra-operative consultation is a pathology procedure that provides real-time evaluations of tissue samples during surgery, enabling quick and informed decisions. In the pre-analytical phase, errors related to sample collection, transport, and identification are common, and tools like failure mode, effects, and criticality analysis help identify and prevent risks. This study aims to enhance patient safety and diagnostic quality by analyzing risks and optimizing sample management. Materials and Methods : The failure mode, effects, and criticality analysis was conducted by a multidisciplinary team to analyze the workflow of frozen section sample handling from collection in the operating theater to acceptance at the pathology lab. Six steps were identified, each assigned tasks and responsibilities, with risks assessed through the risk priority number, calculated from severity, occurrence, and detectability. Severity was classified based on the WHO framework, ranging from "No Harm" to "Death", to prioritize risks effectively. Results : The study identified 12 failure modes across 11 sub-processes, prioritized by risk. Key failures included missing patient identification, incorrect sample retrieval, missing labels, misdirected samples, and samples sent to the wrong lab. Discussion : Pre-analytical errors in pathology pose risks to diagnosis and patient care, with most errors occurring in this phase. A multidisciplinary team identified key issues, such as sample mislabeling and delays due to staff unavailability, and implemented corrective actions, including improved signage, staff re-training, and sample tracking systems. Monitoring and regular checks ensured ongoing adherence to protocols and reduced the risks of misidentification, transport delays, and procedural errors. Conclusions : The frozen section intra-operative consultation is vital in surgical pathology, with the pre-analytical phase posing significant risks due to potential errors in sample handling and labeling. Failure mode, effects, and criticality analysis has proven effective in identifying and prioritizing these failures, despite resource demands, by allowing corrective actions that enhance patient safety and healthcare quality.

Pathogenic variants localized in the gene coding for the Fukutin-Related Protein (FKRP) are responsible for Limb-Girdle Muscular Dystrophy type 9 (LGMDR9), Congenital Muscular Dystrophies type 1C (MDC1C), Walker-Warburg Syndrome (WWS), and Muscle-Eye-Brain diseases (MEBs). LGMDR9 is the fourth most common hereditary Limb Girdle Muscular Dystrophy in Italy. LGMDR9 patients with severe disease show an overlapping Duchenne/Becker phenotype and may have secondary dystrophin reduction on muscle biopsy. We conducted a molecular analysis of the FKRP gene by direct sequencing in 153 patients from Southern Italy (Calabria) with Duchenne/Becker-like phenotypes without confirmed genetic diagnosis. Mutational screening of the patients (112 men and 41 women, aged between 5 and 84 years), revealed pathogenic variants in 16 subjects. The most frequent variants identified were c.427C > A, p.R143S, and c.826C > A, p.L276I (NM_024301.5). The results obtained show that the Duchenne/Becker-like phenotype is frequently determined by mutations in the FKRP gene in our cohort and highlight the importance of considering LGMDR9 in the differential diagnosis of dystrophinopathies in Calabria. Finally, this study, which, to our knowledge, is the first conducted on Calabrian subjects, will contribute to the rapid identification and management of LGMDR9 patients.

The integration of robotics and artificial intelligence into medical practice is radically revolutionising patient care. This fusion of advanced technologies with healthcare offers a number of significant benefits, including more precise diagnoses, personalised treatments and improved health data management. However, it is critical to address very carefully the medico-legal challenges associated with this progress. The responsibilities between the different players concerned in medical liability cases are not yet clearly defined, especially when artificial intelligence is involved in the decision-making process. Complexity increases when technology intervenes between a person's action and the result, making it difficult for the patient to prove harm or negligence. In addition, there is the risk of an unfair distribution of blame between physicians and healthcare institutions. The analysis of European legislation highlights the critical issues related to the attribution of legal personality to autonomous robots and the recognition of strict liability for medical doctors and healthcare institutions. Although European legislation has helped to standardise the rules on this issue, some questions remain unresolved. We argue that specific laws are needed to address the issue of medical liability in cases where robotics and artificial intelligence are used in healthcare., 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 © 2024 De Micco, Grassi, Tomassini, Di Palma, Ricchezze and Scendoni.)

In the professional realm, the healthcare sector stands out as one of the most susceptible to violence. One notable manifestation of this is violence among colleagues, commonly referred to as horizontal violence, which has garnered significant attention in recent times. To delve deeper into this phenomenon across various categories of healthcare professionals, a comprehensive search was conducted on PubMed, Scopus, and CINAHL, resulting in the inclusion of 13 articles. The findings of this narrative review illuminate how horizontal violence can manifest in both physical and psychological forms and how it often becomes normalized among the healthcare professionals who endure it. Particularly vulnerable to such occurrences are recent graduates and those with limited professional experience. Furthermore, it has been observed that horizontal violence has detrimental effects on the well-being of those subjected to it, as well as on the quality of patient care delivered. Considering preventive measures, numerous studies emphasize the pivotal role of effective departmental leadership in fostering a harmonious work environment. Despite the largely underreported nature of this phenomenon, the conclusions drawn in this study advocate for a deeper exploration of the dynamics surrounding horizontal violence, with the goal of devising targeted strategies to mitigate its occurrence.

Mitochondrial DNA (mtDNA) is a 16,569 base pairs, double-stranded, circular molecule that contains 37 genes coding for 13 subunits of the respiratory chain plus 2 rRNAs and 22 tRNAs. Mutations in these genes have been identified in patients with a variety of disorders affecting every system in the body. The advent of next generation sequencing technologies has provided the possibility to perform the whole mitochondrial DNA sequencing, allowing the identification of disease-causing pathogenic variants in a single platform. In this study, the whole mtDNA of 100 patients from South Italy affected by mitochondrial diseases was analyzed by using an amplicon-based approach and then the enriched libraries were deeply sequenced on the ION Torrent platform (Thermofisher Scientific Waltham, MA, USA). After bioinformatics analysis and filtering, we were able to find 26 nonsynonymous variants with a MAF <1% that were associated with different pathological phenotypes, expanding the mutational spectrum of these diseases. Moreover, among the new mutations found, we have also analyzed the 3D structure of the MT-ATP6 A200T gene variation in order to confirm suspected functional alterations. This work brings light on new variants possibly associated with several mitochondriopathies in patients from South Italy and confirms that deep sequencing approach, compared to the standard methods, is a reliable and time-cost reducing strategy to detect all the variants present in the mitogenome, making the possibility to create a genomics landscape of mitochondrial DNA variations in human diseases., Competing Interests: Declaration of competing interest The authors declare no conflict of interest., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Metal-organic frameworks offer a diverse landscape of building blocks to design high performance materials for implications in almost every major industry. With this diversity stems complex crystallization mechanisms with various pathways and intermediates. Crystallization studies have been key to the advancement of countless biological and synthetic systems, with MOFs being no exception. This review provides an overview of the current theories and fundamental chemistry used to decipher MOF crystallization. We then discuss how intrinsic and extrinsic synthetic parameters can be used as tools to modulate the crystallization pathway to produce MOF crystals with finely tuned physical and chemical properties. Experimental and computational methods are provided to guide the probing of MOF crystal formation on the molecular and bulk scale. Lastly, we summarize the recent major advances in the field and our outlook on the exciting future of MOF crystallization.

Materials are needed to increase the stability and half-life of therapeutic proteins during delivery. These materials should be biocompatible and biodegradable. Here, we demonstrate that enzymes and immunoproteins can be encapsulated inside cyclodextrin based metal-organic frameworks using potassium as the metal node. The release profile can be controlled with the solubility of the cyclodextrin linker. The activity of the proteins after release is determined using catalytic and in vitro assays. The results show that cyclodextrin metal-organic framework-based protein biocomposites are a promising class of materials to deliver therapeutic proteins.

Background: Stent underexpansion increases the risk of cardiac adverse events. At present, there are limited options to treat refractory stent underexpansion. In this context, the intravascular lithotripsy (IVL) system might be a safe and effective strategy., Aims: We aimed to evaluate the safety and efficacy of IVL in addressing resistant stent underexpansion due to heavy underlying calcification., Methods: This was an international multicentre registry including patients receiving IVL therapy to treat stent underexpansion from December 2017 to August 2020. Angiographic and intracoronary imaging data were collected. The efficacy endpoint was device success (technical success with a final percentage diameter stenosis <50%). The safety endpoint was in-hospital major adverse cardiac events (MACE)., Results: Seventy patients were included, the mean age was 73±9.2 years and 76% were male. The median time from stent implantation to IVL therapy was 49 days (0-2,537). Adjuvant treatment with non-compliant balloon dilatations pre- and post-IVL was performed in 72.3% and 76.8% of patients, respectively, and additional stenting was performed in 22.4%. Device success was 92.3%. Minimum lumen diameter increased from 1.49±0.73 mm to 2.41±0.67 mm (p<0.001) and stent expansion increased by 124.93±138.19% (p=0.016). No IVL-related procedural complications or MACE were observed. The use of bailout IVL therapy directly after stenting and the presence of ostial underexpanded lesions negatively predicted lumen diameter gain., Conclusions: Coronary lithotripsy is safe and effective in increasing lumen and stent dimensions in underexpanded stents secondary to heavily calcified lesions.

Mutations in the DYSF gene, encoding dysferlin, are responsible for Limb Girdle Muscular Dystrophy type R2/2B (LGMDR2/2B), Miyoshi myopathy (MM), and Distal Myopathy with Anterior Tibialis onset (MDAT). The size of the gene and the reported inter and intra familial phenotypic variability make early diagnosis difficult. Genetic analysis was conducted using Next Gene Sequencing (NGS), with a panel of 40 Muscular Dystrophies associated genes we designed. In the present study, we report a new missense variant c.5033G>A, p.Cys1678Tyr (NM&#95;003494) in the exon 45 of DYSF gene related to Limb Girdle Muscular Dystrophy type R2/2B in a 57-year-old patient affected with LGMD from a consanguineous family of south Italy. Both healthy parents carried this variant in heterozygosity. Genetic analysis extended to two moderately affected sisters of the proband, showed the presence of the variant c.5033G>A in both in homozygosity. These data indicate a probable pathological role of the variant c.5033G>A never reported before in the onset of LGMDR2/2B, pointing at the NGS as powerful tool for identifying LGMD subtypes. Moreover, the collection and the networking of genetic data will increase power of genetic-molecular investigation, the management of at-risk individuals, the development of new therapeutic targets and a personalized medicine.

Background and objectives: Pre-existing atrial fibrillation (AF) is a frequent comorbidity in hospitalized patients with COVID-19; however, little is still known about its prognostic role in infected patients. The aim of our study was to evaluate whether the pre-existing AF as comorbidity would contribute to increase the risk for severe forms of COVID-19, worse prognosis, or even higher mortality. Materials and Methods: We retrospectively evaluated all consecutive COVID-19 patients admitted to the emergency department of nine Italian Hospitals from 1 March to 30 April 2020.The prevalence and the type of pre-existing AF have been collected. The correlation between the history and type of AF and the development of severe ARDS and in-hospital mortality has been evaluated. Results: In total, 467 patients (66.88 ± 14.55 years; 63% males) with COVID-19 were included in the present study. The history of AF was noticed in 122 cases (26.1%), of which 12 (2.6%) with paroxysmal, 57 (12.2%) with persistent and 53 (11.3%) with permanent AF. Among our study population, COVID-19 patients with AF history were older compared to those without AF history (71.25 ± 12.39 vs. 65.34 ± 14.95 years; p < 0.001); however, they did not show a statistically significant difference in cardiovascular comorbidities or treatments. Pre-existing AF resulted in being independently associated with an increased risk of developing severe ARDS during the hospitalization; in contrast, it did not increase the risk of in-hospital mortality. Among patients with AF history, no significant differences were detected in severe ARDS and in-hospital mortality between patients with permanent and non-permanent AF history. Conclusions: Pre-existing AF is a frequent among COVID-19 patients admitted to hospital, accounting up to 25% of cases. It is independently associated with an increased risk of severe ARDS in hospitalized COVID-19 patients; in contrast, it did not affect the risk of death. The type of pre-existing AF (permanent or non-permanent) did not impact the clinical outcome.

The current commentary describes the possible existing link between metabolic diseases such as diabetes type 2 and the degenerative patterns of bones via the molecular mechanism that inhibits the mesenchymal stem cells' differentiation into osteoblasts and osteocytes., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Since their introduction Drug Coated Balloons (DCBs) have slowly gained their spot into everyday cath-lab practice, first for treatment of in-stent restenosis (ISR), more recently for small vessels disease; today a growing body of evidence start supporting their use in more complex lesions, from bifurcations, to large vessels, to acute lesions. Although the new generation of DCBs showed a better performance and safety than the older one, the drug of choice has always been the Paclitaxel; last year some concerns were raised on the safety of Paclitaxel devices, in particular the balloons mining their use. Recently Sirolimus ventured in the DCBs world, making its appearance on cath-lab shelves and becoming a good alternative to Paclitaxel (DCB)., Competing Interests: The authors declare no conflict of interest. Bernardo Cortese is serving as one of the Guest editors of this journal. We declare that Bernardo Cortese had no involvement in the peer review of this article and has no access to information regarding its peer review. Full responsibility for the editorial process for this article was delegated to Marco Zimarino., (© 2021 The Author(s). Published by IMR Press.)

Here we present room-temperature spin-dependent charge transport measurements in single-molecule junctions made of metalloporphyrin-based supramolecular assemblies. They display large conductance switching for magnetoresistance in a single-molecule junction. The magnetoresistance depends acutely on the probed electron pathway through the supramolecular wire: those involving the metal center showed marked magnetoresistance effects as opposed to those exclusively involving the porphyrin ring which present nearly complete absence of spin-dependent charge transport. The molecular junction magnetoresistance is highly anisotropic, being observable when the magnetization of the ferromagnetic junction electrode is oriented along the main molecular junction axis, and almost suppressed when it is perpendicular. The key ingredients for the above effect to manifest are the electronic structure of the paramagnetic metalloporphyrin, and the spinterface created at the molecule-electrode contact., (© 2021 The Authors. Angewandte Chemie International Edition published by Wiley-VCH GmbH.)

Purpose: We aimed to investigate the clinical performance of edoxaban for the treatment of pulmonary embolism (PE) in hospitalized COVID-19 patients., Methods: We conducted a retrospective analysis selecting hospitalized patients with COVID-19 admitted to our Institution from 20 May 2020 to 20 November 2020 with computer tomography (CT) detected PE at admission, treated with edoxaban after initial parenteral therapy. Clinical outcomes were compared between patients with and without ARDS at admission and between those with and without CT confirmed PE resolution., Results: 50 patients were included. Mean follow-up was 42.5 ± 10 days. No baseline differences were found between patients with ARDS (30%) and those without ARDS at admission. Patients with PE resolution (84%) were younger ( P = 0.03 ), had a shorter duration of fondaparinux therapy (9.9 ± 3.8 vs 15.8 ± 7.5 days; P = 0.0015) and length of hospitalization (36 ± 8 vs 46 ± 9 days: P =  0.0023) compared with those without PE resolution. 2 patients experienced major bleedings. At multivariate analysis the time to edoxaban switch was the only predictor of the PE resolution (HR: 0.92; 95% C.I. 0.86 to 0.99 ) ., Conclusion: Edoxaban was an effective and safe treatment for acute PE in COVID-19 setting.

Aim: To compare the long-term outcomes of patients implanted with Absorb bioresorbable scaffold (BRS) with optimal versus suboptimal technique., Methods and Results: All patients who received an Absorb between March 2012 and January 2016 were selected from 19 Italian centers databases to assess the impact of an optimal implantation technique (CIAO criteria) on long-term device-oriented composite end-point (DOCE) - including cardiac death (CD), target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) - on its single components and on scaffold thrombosis (ScT). CIAO criteria consist of predilation (balloon/vessel ratio 1:1), correct sizing (BRS/proximal reference vessel diameter -RVD- ratio 0.8-1.2) and high-pressure postdilation with non-compliant (NC) balloon (≥20 atm for balloon/BRS ratio 1:1 or ≥16 atm for a 0.25-0.5 mm oversized balloon). Among the 1.434 patients analyzed, 464 (32.4%) fulfilled all CIAO criteria for every BRS implanted (CIAO 3 group), while 970 (67.6%) did not in at least one of the received BRS (CIAO 0-1-2 group). At 31.0 (interquartile range -IQR- 24.8-38.5) months follow-up, CIAO criteria did not impact on DOCE (8.2% vs. 8.0%, p = 0.92), ID-TLR (6.9% vs. 7.1%, p = 0.72) or ScT (1.9% vs. 1.8%, p = 0.80) in the overall population. At multivariate analysis overall BRS length (p = 0.001), severely calcified lesions (p = 0.03) and absence of CIAO criteria (CIAO 0, p = 0.005) were independent predictors of DOCE in long-term follow-up., Conclusion: Our data suggest that strict application of an optimal Absorb implantation technique doesn't improve long-term DOCE or ScT but may mitigate the worse outcome of patients with calcific lesions., Competing Interests: Declaration of competing interest B.C., A.S.P. and F.R. report being member of the advisory board of Abbott Vascular and speakers' honoraria from Abbott Vascular; E.C., M.D.C. and F.V. reports speakers' honoraria from Abbott Vascular. The other authors have no conflict of interest to declare., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: Our study sought to compare the 12-month clinical outcome of patients treated with paclitaxel-coated balloons (PCB) vs. sirolimus-coated balloons (SCB) during coronary angioplasty., Background: Drug-coated balloons represent an established therapeutic tool for percutaneous coronary interventions (PCI). A comparison between PCB and SCB is still lacking., Methods: We performed an indirect comparison between two cohorts of patients previously included into two investigator-driven registries with clinical primary endpoints, 494 treated with the Elutax SV PCB (AR Baltic, Lithuania) from the DCB RISE registry, and 596 treated with the Magic Touch SCB (Concept Medical, India) from the EASTBOURNE registry. The primary endpoint was the rate of major adverse cardiovascular events (MACE) at 12-month clinical follow-up., Results: After propensity score matching, a total of 580 patients were well matched for baseline clinical and procedural characteristics and were analyzed. At 12 months there was no significant difference between the matched DCB RISE and EASTBOURNE cohorts in terms of the primary endpoint MACE (10.3% DCB RISE vs. 10.7% EASTBOURNE, p = 0.892). No significant difference was observed also regarding the rate of TLR (7.9% DCB RISE vs. 8.3% EASTBOURNE; p = 0.879, respectively). By multivariate analysis, insulin-dependent diabetes was the only predictor of MACE., Conclusions: In the SIRPAC study, the first indirect comparison between paclitaxel-coated and sirolimus coated balloons, no significant difference in clinical endpoints were found at 12-month follow-up. Randomized studies are necessary to confirm these findings., Competing Interests: Declaration of competing interest Authors have no competing interest for this manuscript and no relationship with industry., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Optimal treatment of renal artery "in-stent restenosis" (ISR) is still debated; drug eluting stents (DES), drug coated balloons (DCB) and scoring balloons have all been used, with mixed long term results. The shockwave lithotripsy for the treatment of heavily calcified atherosclerotic plaques has proven to be an effective tool and preliminary data support its use in case of underexpanded stents. Here we present the case of a 60 year old male with a known significant atherosclerotic renal artery stenosis and refractory hypertension who already underwent bilateral renal angioplasty with bare metal stents (BMS) in 2011 and angioplasty with DCB in 2012 for right renal artery ISR. In May 2020 he presented with worsening hypertension and CT scan showed total occlusion of the right with critical ISR of the left renal artery. Because of the high calcium burden he underwent balloon lithotripsy for plaque modification and subsequent renal angioplasty with sirolimus and paclitaxel DCB, with a good angiographic result. This is the first case of recurrent renal ISR successfully treated with Shockwave IVL and double-drug DCB therapy., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Carotid artery stenting (CAS) is a valid and effective alternative to endoatherectomy when performed by experienced operators. The conventional approach used is the transfemoral one, but in the last 10 years a transradial (TR) approach, the standard access for cardiac catheterization, became widely adopted for peripheral vascular interventions, included the extracranial carotids. Preliminary experiences suggest this approach as safe and effective, especially in specific anatomical and clinical settings that have been shown to be associated with high risk of complications from the femoral route. Lacking international guidelines, this document, promoted by the Italian Society of Interventional Cardiology - Gruppo Italiano Studi Emodinamici (SICI-GISE), was drawn-up by a panel of interventional cardiologists with a documented experience on the subject, focusing on the indications, techniques and materials that should be used for this type of intervention and the most recent literature on the subject., (© 2021 Wiley Periodicals LLC.)

Background: During the outbreak of coronavirus disease 2019 (COVID-19), allocating intensive care beds to patients needing acute care surgery became a very difficult task. Moreover, since general anesthesia is an aerosol-generating procedure, its use became controversial. This strongly restricted therapeutic strategies. Here, we report a series of undeferrable surgical cases treated with awake surgery under neuraxial anesthesia. Contextual benefits of this approach are deepened., Methods: During the first pandemic surge, thirteen patients (5 men and 8 women) with a mean age of 80 years, needing undelayable surgery due to abdominal emergencies, underwent awake open surgery at our Hospital. Prior to surgery, all patients underwent nasopharyngeal swab tests for COVID-19 diagnosis. In all cases, regional anesthesia (spinal, epidural, or combined spinal-epidural anesthesia) was performed. Intraoperative and postoperative pain intensities have been monitored and regularly assessed. A distinct pathway has been set up to keep patients of uncertain COVID-19 diagnosis separated from all other patients. Postoperative course has been examined., Results: The mean operative time was 87 minutes (minimum 60 minutes; maximum 165 minutes). In one case, conversion to general anesthesia was necessary. Postoperative pain was always well controlled. None of them required postoperative intensive care support. No perioperative major complications (Clavien-Dindo ≥3) occurred. Early readmission after surgery never occurred. All nasopharyngeal swabs resulted negative., Conclusions: In our experience, awake laparotomy under regional anesthesia resulted feasible, safe, painless, and, in specific cases, was the only viable option. This approach allowed prevention of the need of postoperative intensive monitoring during the COVID-19 era. In such a peculiar time, we believe it could become part of an ICU-preserving strategy and could limit viral transmission inside theatres., Competing Interests: The authors declare that there are no conflicts of interest regarding the publication of this article., (Copyright © 2021 Andrea Romanzi et al.)

Aims: The purpose of the EASTBOURNE registry is to evaluate the immediate and long-term clinical performance of a novel sirolimus-coated balloon (SCB) in a real-world population of patients with coronary artery disease. We here present the prespecified interim analysis after the enrollment of the first 642 patients who obtained 1-year clinical follow-up., Methods: EASTBOURNE is a prospective, international, multicenter, all-comer investigator-driven clinical registry, which is enrolling consecutive patients treated with SCB at 42 European and Asiatic centers. Primary study endpoint is target-lesion revascularization (TLR) at 12 months. Secondary endpoints are procedural success and major adverse cardiac events through 36 months., Results: Diabetes mellitus was present in 41% of patients. Acute coronary syndrome was present in 45% of patients and de novo lesions were 55%; 83% of the in-stent restenosis (ISR) patients had drug-eluting stents restenosis. Lesion predilatation was performed in 95% of the cases and bailout stenting occurred in 7.5%. So far, 642 patients have a complete 12-month follow-up. TLR occurred in 2.5%, myocardial infarction in 2.3%, total death in 1% and major adverse cardiac events in 5.8% of patients. A prespecified analysis of comparison between ISR and de-novo lesions showed a significantly higher occurrence of TLR in the ISR population (5.4 vs. 0.2%, P = 0.0008)., Conclusion: The current interim analysis of 12-month follow-up of the EASTBOURNE registry shows good immediate performance and an adequate and encouraging safety profile through 12 months for this novel SCB., (Copyright © 2020 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Objectives: This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in patients with de novo lesions., Background: Small vessel coronary artery disease (SVD) represents one of the most attractive fields of application for DCB. To date, several devices have been compared with drug-eluting stents in this setting, with different outcomes., Methods: The PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) trial was an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo SVD lesions were randomized to DCB or EES. Primary study endpoint was in-lesion late lumen loss (LLL) at 6 months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12 months., Results: Between May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers. After a median of 189 (interquartile range: 160 to 202) days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17 mm; p = 0.001 for noninferiority; p = 0.03 for superiority). Percent diameter stenosis and minimal lumen diameter were not significantly different. At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p = 0.55). There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%; p = 0.23) and vessel thrombosis (1.8% vs. 0%; p = 0.15) in the DES arm., Conclusions: In this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generation DCB was found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinical outcome. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818)., Competing Interests: Author Disclosures This is an investigator-driven study with the Italian Society of Interventional Cardiology (GISE) as a sponsor. The role of GISE was to coordinate the centers and submit the protocol to the ethics committees. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020. Published by Elsevier Inc.)

Objectives: To test the long-term efficacy of a sirolimus-coated balloon (SCB)., Background: Nanoluté was a prospective registry to evaluate the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of de novo coronary lesions and in-stent restenosis (ISR). We here present the 24 months clinical data., Methods: All patients treated with SCB for any type of coronary indication between July 2012 and September 2015 were enrolled at Indian centers and clinically followed up to 24 months. Primary endpoints were major adverse cardiovascular events (MACE) defined as a composite of cardiac death, target lesion revascularization (TLR), and target vessel-myocardial infarction (MI)., Results: A total of 484 SCBs were used in 408 patients to treat 435 lesions. In detail, the SCB was used for 183 patients with ISR, 185 with de novo small vessel disease, and 40 with de novo large vessel disease. Mean balloon length and diameter (average ± SD) were 22.3 ± 7.1 mm and 2.7 ± 0.40 mm, respectively. All patients with 24 months follow-up were included. Overall MACE rate was 4.2% (n = 17) with three cardiac deaths (0.7%), 13 TLR (3.2%), and one MI (0.2%)., Conclusion: The Nanoluté prospective registry is the first long-term clinical evidence of the safety and feasibility of this type of SCB, both in patients with ISR or de novo lesions., (© 2020 Wiley Periodicals, Inc.)

Background and Aims: There is poor knowledge on characteristics, comorbidities and laboratory measures associated with risk for adverse outcomes and in-hospital mortality in European Countries. We aimed at identifying baseline characteristics predisposing COVID-19 patients to in-hospital death., Methods and Results: Retrospective observational study on 3894 patients with SARS-CoV-2 infection hospitalized from February 19th to May 23rd, 2020 and recruited in 30 clinical centres distributed throughout Italy. Machine learning (random forest)-based and Cox survival analysis. 61.7% of participants were men (median age 67 years), followed up for a median of 13 days. In-hospital mortality exhibited a geographical gradient, Northern Italian regions featuring more than twofold higher death rates as compared to Central/Southern areas (15.6% vs 6.4%, respectively). Machine learning analysis revealed that the most important features in death classification were impaired renal function, elevated C reactive protein and advanced age. These findings were confirmed by multivariable Cox survival analysis (hazard ratio (HR): 8.2; 95% confidence interval (CI) 4.6-14.7 for age ≥85 vs 18-44 y); HR = 4.7; 2.9-7.7 for estimated glomerular filtration rate levels <15 vs ≥ 90 mL/min/1.73 m 2 ; HR = 2.3; 1.5-3.6 for C-reactive protein levels ≥10 vs ≤ 3 mg/L). No relation was found with obesity, tobacco use, cardiovascular disease and related-comorbidities. The associations between these variables and mortality were substantially homogenous across all sub-groups analyses., Conclusions: Impaired renal function, elevated C-reactive protein and advanced age were major predictors of in-hospital death in a large cohort of unselected patients with COVID-19, admitted to 30 different clinical centres all over Italy., Competing Interests: Declaration of Competing Interest All Authors declare no competing interests., (Copyright © 2020 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

Aims: To assess the long-term outcomes of patients treated with sirolimus-eluting Stentys stent in a real-life setting., Background: Few data regarding the safety and effectiveness of self-apposing sirolimus-eluting Stentys stent are available., Methods: 278 patients (30% stable coronary artery disease, 70% acute coronary syndromes, and 54% on unprotected left main) treated with sirolimus eluting Stentys stent were retrospectively included in the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease multicenter registry. Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis) were the primary end-point, single components of MACE were the secondary ones., Results: After 13 months (interquartile range 5-32), MACE was 14%. Stent thrombosis occurred in 3.9% of the patients (2.5% definite stent thrombosis and 1.4% probable stent thrombosis), 66% of them presenting with ST-segment elevation myocardial infarction (STEMI) at admission. Cardiovascular death, target lesion revascularization and myocardial infarction was 4.7%, 8.3%, and 7.2%, respectively. At multivariate analysis, risk of MACE was increased by diabetes (hazard ratios 4.76; P = 0.002) but was not affected by the indication leading to sirolimus-eluting Stentys stent implantation (marked vessel tapering vs. coronary ecstasies, hazard ratios 0.74, P = 0.71)., Conclusion: Sirolimus-eluting Stentys stent may represent a potential solution for specific coronary anatomies such as bifurcation, ectasic, or tapered vessels. Risk of stent thrombosis appears related to clinical presentation with STEMI and to anatomic features, stressing the importance of the use of intracoronary imaging for self-expandable stents implantation.

Background: Radial artery approach is currently the most common access site for coronary angiography and percutaneous coronary intervention. It rarely results in complications, improves patient comfort, and reduces the duration of hospitalization., Case Presentation: A 91-year-old woman presented to our institution with ST-segment elevation myocardial infarction (STEMI). The right radial access was chosen for the performance of percutaneous coronary intervention. After the introduction of 6 F sheath, there was difficulty in the advancement of 0.035 J wire that was exchanged with a Terumo hydrophilic wire. After the procedure and before sheath removal, radial arteriography was done and revealed perforation. Protamine sulfate was administered and prolonged balloon inflation was attempted but failed to seal the perforation, so a 7-F-long vascular sheath was inserted to internally tamponade the vessel, and the patient was sent to the coronary care unit for monitoring. Over the next 3 days, serial radial angiographies were done revealing the persistence of the perforation, and on the fourth day, angiography revealed multiple thrombi. Thrombus aspiration was done using Pronto V4 extraction catheter (Vascular Solutions, USA) and was followed by the deployment of a covered stent. The stent was dislodged and successfully snared. Finally, the perforation was sealed spontaneously and there were no signs of intra-arterial thrombi., Conclusion: Despite the very low complication rate of radial approach, the interventional cardiologist should be aware of any possible complication, and how to avoid or, eventually, manage it.

Aims: To evaluate the angiographic performance of a novel sirolimus-coated balloon (SCB) in de novo coronary lesions., Methods: Out of an all-comer prospective registry of patients treated with the SCB at our center from April 2016 to September 2017, we selected those treated for a de novo stenosis on a native vessel, with a scheduled angiographic control at at least 4 months after the index procedure. We performed a centralized, blinded core-lab adjudicated quantitative coronary angiography analysis. Primary endpoint was late lumen loss. Secondary endpoints were binary restenosis and target-lesion revascularization., Results: A total of 27 patients with native coronary arteries treated with SCB and with angiographic follow-up entered the study; seven patients were excluded because a stent was implanted at the lesion site during the index procedure. The degree of calcification (assessed with coronary angiography) was high in six patients (30%) and the average lesion length was 20.52 ± 6.88 mm. The reference vessel diameter was 2.32 ± 0.44 mm and the percentage diameter stenosis was 67 ± 12. Procedural success was obtained in all patients. After a median of 6.6 ± 2.5 months, late lumen loss was 0.09 ± 0.34 mm and the percentage diameter stenosis was 31 ± 18. We observed two cases (10%) of binary restenosis which underwent subsequent target-lesion revascularization: in one a drug-eluting stent was implanted, whereas the other patient was treated with paclitaxel-coated balloon. No myocardial infarction or death was observed during follow-up., Conclusion: The use of a novel SCB in native coronary arteries was associated with good angiographic outcome at 6-month follow-up.

The ability to design surfaces with reversible, high-affinity protein binding sites represents a significant step forward in the advancement of analytical methods for diverse biochemical and biomedical applications. Herein, we report a dynamic supramolecular strategy to directly assemble proteins on surfaces based on multivalent host-guest interactions. The host-guest interactions are achieved by one-step nanofabrication of a well-oriented β-cyclodextrin host-derived self-assembled monolayer on gold (β-CD-SAM) that forms specific inclusion complexes with hydrophobic amino acids located on the surface of the protein. Cytochrome c, insulin, α-chymotrypsin, and RNase A are used as model guest proteins. Surface plasmon resonance and static time-of-flight secondary ion mass spectrometry studies demonstrate that all four proteins interact with the β-CD-SAM in a specific manner via the hydrophobic amino acids on the surface of the protein. The β-CD-SAMs bind the proteins with high nanomolar to single-digit micromolar dissociation constants ( K D ). Importantly, while the proteins can be captured with high affinity, their release from the surface can be achieved under very mild conditions. Our results expose the great advantages of using a supramolecular approach for controlling protein immobilization, in which the strategy described herein provides unprecedented opportunities to create advanced bioanalytic and biosensor technologies.

Background: The aim of the Nanoluté registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB) (Concept Medical Research Private Limited, India) for the treatment of coronary de-novo and restenotic lesions., Methods: All patients treated with SCB between July 2012 and September 2015 were enrolled at Indian centres and clinically followed for 1, 3, 6 and 12 months post-procedure. Primary endpoints were procedural success and device-oriented adverse cardiac events (DOCE) at 12 months. DOCE were defined as a composite of cardiac death, target lesion revascularization (TLR) and target vessel-myocardial infarction., Results: A total of 394 SCB were used in 332 patients to treat 356 lesions. In-stent restenosis and small coronary vessel disease occurred in 46% and 43% of the patients respectively. Mean balloon length and diameter (average ± SD) were 21.83 ± 6.70 mm and 2.69 ± 0.45 mm respectively. All patients with 1 year follow-up were included. Overall DOCE rate was 4.2% (n = 14) which included death 0.3% (n = 1), TLR 3.6% (n = 12) and myocardial infarction 0.3% (n = 1)., Conclusion: The Nanoluté prospective registry, is the first clinical evidence of the safety and feasibility of this type of SCB, both in patients with in-stent restenosis or de novo lesions., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Kinesins are a family of proteins for anterograde transport of the molecules from the neuronal cell body and their impairment has been widely associated with neurodegeneration of the motor neurons. KIF5A gene causes autosomal dominant spastic paraplegia 10, a neurological disorder characterized by spasticity and weakness of the lower limbs (SPG10). We carried out a screening of KIF5A gene in 50 subjects affected by HSP negative to diagnostic test for SPG4, ATL1 and REEP1. We identified a novel variation p.Ile255Met in a 58-year-old man who developed progressive gait disturbance due to spastic paraparesis complicated by axonal neuropathy.

Background: In the recent years percutaneous treatment of the left main stem (LM) has gained a precise role as a result of consistent scientific evidence vs. coronary artery bypass. A self-apposing stent offers an improved adaptation to the vessel wall, especially in case of tapered vessels; aim of this study was to investigate the role of a novel self-apposing, sirolimus-eluting stent (Stentys, France) for the treatment of LM coronary artery disease., Methods and Results: MATISSE is a retrospective, multicenter registry, which enrolled 151 patients treated with the device at 17 international centers. Primary study endpoint was the occurrence of major adverse cardiovascular events (MACE), a composite endpoint of cardiac death, target lesion revascularization (TLR) and target-vessel myocardial infarction, at 9months clinical follow-up. Secondary endpoints included procedural success, the single determinants of MACE and stent thrombosis. Lesions were located in distal LM bifurcation in 84% of the patients. Procedural success was achieved in 150 patients. The average follow-up length was 348±52days. MACE occurred in 14 (9.3%) patients with 2 (1.3%) cardiac deaths. TLR occurred in 8 patients (5.3%). There were 2 cases of definite stent thrombosis, 1 acute and 1 very late., Conclusions: A self-apposing stent, when used for LM PCI in a real world, high risk population, showed good immediate procedural results with low rates of adverse events at mid-term follow-up., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Drug-coated balloons (DCB) have been developed in recent years to overcome some of the drug-eluting stents limitations. There is an established indication for the use of DCB in the treatment of in-stent restenosis and they are also variably used in various setting, in particular small coronary vessels and bifurcations. Until 2016, all DCBs available in Europe eluted paclitaxel, a highly lipophilic drug with narrow therapeutic window. In April 2016 a new sirolimus-coated balloon (Magic Touch®, Envision Scientific PVT, Bhatpore, India) obtained the CE Mark. This device shares a new-generation delivery system and is able to release in a few seconds an effective dosage of sirolimus.

Background: Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non-SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern., Objective: We aimed to compare outcomes of Absorb BVS versus a 2nd-generation metallic everolimus-eluting stents (EES) in the SVD setting, by pooling patients from three large, prospective studies., Methods: Patients with SVD (reference vessel diameter ≤2.75 mm by QCA) and treated with Absorb BVS were identified in the Italian RAI and the MAASSTAD-Absorb registries. EES controls were identified in the COMPARE II Trial. We performed a propensity-score matching using several clinical and angiographic variables. Implantation technique was not object of matching, being device-specific., Results: Out of 4635 enrolled subjects, 1147 belonged to the SVD population. After matching, we obtained 337 pairs of patients. High clinical and angiographic complexity was found in both groups. Predilation and postdilation rates were significantly higher in BVS patients. No differences were found in terms of the device-oriented composite end-point at 1-year (HR = 1.08, 95%CI 0.5-2.3, P = .8) and 2-years (HR = 1.28, 95% CI: 0.68-2.43, P = .5). Notwithstanding, higher incidence of definite/probable stent thrombosis was observed in the BVS group at 1 year (HR 4.7, 95%CI 0.8-31.4, P = .08) and 2-years (HR = 8.34 95%CI 1.1-60.2, P = .04)., Conclusion: In this propensity-matched analysis pooling SVD patients of three large prospective studies, incidence of composite device-related events was comparable between BVS and EES up to 2 years follow-up. However, higher rates of stent thrombosis were found in the BVS group., (© 2018 Wiley Periodicals, Inc.)

Coronary Sinus Reducer (Neovasc, Inc., Richmond B.C., Canada) has shown to be an effective and safe treatment option for the treatment of refractory angina. Until now, a few number of complications related to its implantation have been reported. Coronary sinus perforation is a rare complication, more often related to cardiac surgery procedures. We report the first case of coronary sinus perforation after a sinus Reducer implantation., (© 2018 Wiley Periodicals, Inc.)

Percutaneous treatment of the unprotected left main trunk (ULM), defined as a vessel without patent bypass graft either to the left circumflex (LCX) or left anterior descending (LAD) artery, has gained a precise role thanks to recent scientific evidence. Although new generation drug-eluting stents have already proven to be safer, there is still a consistent risk of restenosis and late adverse events. The optimal management of a ULM restenosis is still debated. Here we aim at presenting a review of the available data in literature and show our choice for treating it., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Aims: Drug-coated balloons (DCBs) are a recognized alternative to stents for the treatment of in-stent restenosis (ISR), and there is some initial clinical evidence about their efficacy for the treatment of small coronary vessels. Newer-generation DCBs were developed to overcome the reduced deliverability of the previous generation, also warranting a more effective drug delivery to vessel wall. However, the vast majority of new-generation DCBs still lack of reliability due to paucity of clinical data., Methods: Between 2012 and 2015, all patients treated with Elutax SV DCB (Aachen Resonance, Germany) at nine Italian centers were enrolled in this retrospective registry. Primary outcome was the occurrence of target-lesion revascularization (TLR) at the longest available follow-up. Secondary endpoints were procedural success and occurrence of device-oriented adverse cardiovascular events including cardiac death, target-vessel myocardial infarction, stroke, and TLR. A minimum 6-month clinical follow-up was required., Results: We enrolled 544 consecutive patients treated at 583 sites. Fifty-three per cent of the patients had ISR, and the rest native vessel coronary artery disease. Procedural success occurred in 97.5%. At the longest available clinical follow-up (average 13.3 ± 7.4 months), 5.9% of the patients suffered a TLR and 7.1% a device-oriented adverse cardiovascular event. We did not register cases of target-vessel abrupt occlusion. At multivariate analysis, severe calcification at the lesion site was the first determinant for the occurrence of TLR., Conclusion: This registry on the performance of a new-generation DCB shows an adequate profile of safety and efficacy at mid-term clinical follow-up.