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Background: Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR) procedures. Current preventive strategies are suboptimal., Objectives: The aim of this study was to describe bench testing and clinical experience with a novel device that splits valve leaflets that are at risk for causing coronary obstruction after TAVR, allowing normal coronary flow., Methods: The ShortCut device was initially tested in vitro and preclinically in a porcine model for functionality and safety. The device was subsequently offered to patients at elevated risk for coronary obstruction. Risk for coronary obstruction was based on computed tomography-based anatomical characteristics. Procedure success was determined as patient survival at 30 days with a functioning new valve, without stroke or coronary obstruction., Results: Following a successful completion of bench testing and preclinical trial, the device was used in 8 patients with failed bioprosthetic valves (median age 81 years; IQR: 72-85 years; 37.5% man) at 2 medical centers. A total of 11 leaflets were split: 5 patients (63.5%) were considered at risk for left main obstruction alone, and 3 patients (37.5%) were at risk for double coronary obstruction. All patients underwent successful TAVR without evidence of coronary obstruction. All patients were discharged from the hospital in good clinical condition, and no adverse neurologic events were noted. Procedure success was 100%., Conclusions: Evaluation of the first dedicated transcatheter leaflet-splitting device shows that the device can successfully split degenerated bioprosthetic valve leaflets. The procedure was safe and successfully prevented coronary obstruction in patients at risk for this complication following TAVR., Competing Interests: Funding Support and Author Disclosures Dr Dvir is a consultant to Edwards Lifesciences, Medtronic, Abbott, and Pi-Cardia. Dr Leon has received institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and is a consultant and member of the steering committee for Pi-Cardia, with direct compensation in the form of stock options that can be exercised in the future. Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Phoenix for echocardiography core laboratory analyses and research studies in the field of transcatheter valve therapies, for which he received no personal compensation. Dr Leipsic has provided computed tomography core laboratory services to Pi-Cardia. Dr Gerckens has received honoraria for clinical proctoring and/or consultancy fees from Medtronic, Boston Scientific, and Pi-Cardia. Dr Manoharan is a consultant and proctor for Medtronic, Abbott Medical, and Pi-Cardia. Dr Abdel-Wahab’s hospital has received speaker honoraria and/or consultancy fees on his behalf from Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Despite intensive efforts, there is no effective remedy for COVID-19. Moreover, vaccination efficacy declines over time and may be compromised against new SARS-CoV-2 lineages. Therefore, there remains an unmet need for simple, accessible, low-cost and effective pharmacological anti-SARS-CoV-2 agents. ArtemiC is a medical product comprising artemisinin, curcumin, frankincense and vitamin C, all of which possess anti-inflammatory and anti-oxidant properties. The present Phase II placebo-controlled, double-blinded, multi-centred, prospective study evaluated the efficacy and safety of ArtemiC in patients with COVID-19. The study included 50 hospitalized symptomatic COVID-19 patients randomized (2:1) to receive ArtemiC or placebo oral spray, twice daily on Days 1 and 2, beside standard care. A physical examination was performed, and vital signs and blood tests were monitored daily until hospital discharge (or Day 15). A PCR assessment of SARS-CoV-2 carriage was performed at screening and on last visit. ArtemiC improved NEWS2 in 91% of patients and shortened durations of abnormal SpO 2 levels, oxygen supplementation and fever. No treatment-related adverse events were reported. These findings suggest that ArtemiC curbed deterioration, possibly by limiting cytokine storm of COVID-19, thus bearing great promise for COVID-19 patients, particularly those with comorbidities., (© 2022 The Authors. Journal of Cellular and Molecular Medicine published by Foundation for Cellular and Molecular Medicine and John Wiley & Sons Ltd.)

Objectives: This study was planned for evaluating the safety and efficacy of SPAS (stent positioning assistance system) device in first-in-human procedures., Background: SPAS is a novel device that can be used for improved positioning of coronary stents., Methods: Consecutive patients underwent percutaneous coronary intervention (PCI) with the SPAS device. Device-related adverse and serious adverse events were evaluated in addition to a dedicated questionnaire completed by operators immediately after using SPAS., Results: The SPAS device was deployed in 55 PCI procedures, comprising of heavily calcified lesions (33.3%), totally occluded (7.4%), and severely tortuous vessels (7.4%). In these procedures, nonbifurcation and nonostial (53.7%), bifurcation (22.2%), and edge-to-edge (24.1%) stenting techniques were employed. Analysis of the pooled scores for the five satisfaction-related questions gave an average score of 5.6 ± 1.5, with 40 (75.5%) operators providing an average satisfaction grade of >5; the average operator-rated SPAS device accuracy performance scores exceeded 6 out of 7 (on visual analog score). The time spent for positioning the stent with the SPAS device averaged 41 ± 68.0 seconds. The SPAS device was rated as easy to use (6.1 ± 1.6) and reliable (6.1 ± 1.7). No device-related adverse events were reported., Conclusion: This stent positioning device was evaluated in a consecutive cohort of standard and complex PCI procedures. The device was shown to be safe, easy, and precise to use, both in standard and complex cases., Competing Interests: All authors declare that they have no conflicts of interest., (Copyright © 2022 Elias Hellou et al.)

Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Coronary artery stenting is the treatment of choice for patients requiring coronary angioplasty. We describe the major advancements with this technology. There have been significant developments in the design of stents and adjunctive medical therapies. Newer-generation drug-eluting stents (DES) have almost negligible restenosis rates and, when combined with proper anti-platelet treatment and optimal deployment, a low risk of stent thrombosis. The introduction of newer-generation DES with thinner stent struts, novel durable or biodegradable polymer coatings, and new antiproliferative agents has further improved the safety profile of early-generation DES. In parallel the effectiveness has been kept, with a significant reduction in the risk of target lesion revascularization compared with the early-generation DES. However, to date, the development of completely bioresorbable vascular scaffolds has failed to achieve further clinical benefits and has been associated with increased thrombosis. Newer-generation DES-including both durable polymer as well as biodegradable polymer-have become the standard of care in all patient and lesion subsets, with excellent long-term results.

Background: The aim of this study was to report the impact of patients' baseline characteristics on the incidence of acute kidney injury (AKI) after nephron-sparing surgery (NSS) for localized kidney cancer., Patients and Methods: Data from our kidney cancer database were retrospectively extracted to include 402 patients who underwent NSS between March 2000 and June 2016, and had sufficient data. Definition of AKI was based on the postoperative serum creatinine levels and estimated glomerular filtration rate (eGFR) magnitude, which were measured during the 72 h after surgery., Results: Based on RIFLE and AKIN criteria, the overall rate of postoperative AKI was 35%. The average decrease in eGFR among patients who developed AKI was 20% as compared with the non-AKI subgroup (2%). In univariate analysis, variables that were associated with AKI included right-sided tumors ( p = 0.014), male sex ( p = 0.01), hypertension ( p = 0.003), baseline eGFR ( p = 0.009) and history of nephrolithiasis ( p = 0.039). However, multivariate analysis revealed that the only independent predictors of postoperative AKI were hypertension ( p = 0.009) and cigarette smoking ( p = 0.024)., Conclusion: AKI is a common complication of NSS affecting about one-third of the patients. The most important risk factors are hypertension and smoking., Competing Interests: Conflict of interest statement: The authors declare that there is no conflict of interest.

Nonalcoholic fatty liver disease (NAFLD) has become one of the most common causes of liver disease worldwide and has been recognized as a major health burden. The prevalence of NAFLD has grown proportionally with the rise in obesity, sedentary lifestyle, unhealthy dietary pattern, and metabolic syndrome. Currently, there is no drug therapy that can be formulated for treating NAFLD. A combination of dietary modifications and increased physical activity remains the mainstay of NAFLD management. It is hard to maintain this mode of management; however, it seems to have significant long-term benefits. Furthermore, NAFLD patients, whether obese or not, should be educated that a healthy diet and physical activity have benefits beyond weight reduction. Further large controlled randomized trials are needed in order to identify the best dietary regimen and physical activity in the management of NAFLD patients. This review highlights the role of diet and lifestyle modifications in the management of NAFLD, and focuses on human studies regarding dietary modifications and physical activity.

Diabetes mellitus disrupts all phases of the wound repair cascade and leads to development of chronic wounds. We previously showed that topical erythropoietin (EPO) can promote wound repair in diabetic rats. Fibronectin (FN) has a critical role throughout the process of wound healing, yet it is deficient in wound tissues of diabetic patients. Therefore, we investigated the effect of topical treatment of both EPO and FN (EPO/FN) on wound repair in diabetic mice. Full-thickness excisional skin wounds in diabetic and nondiabetic mice were treated with a cream containing vehicle, EPO, FN, or EPO/FN. We assessed the rate of wound closure, angiogenesis, apoptosis, and expression of inflammatory cytokines, endothelial nitric oxide synthase (eNOS) and β1-integrin, in the wound tissues. We also investigated the effect of EPO, FN, and EPO/FN on human dermal microvascular endothelial cells and fibroblasts cultured on fibrin-coated plates, or in high glucose concentrations. EPO/FN treatment significantly increased the rate of wound closure and this effect was associated with increased angiogenesis, increased eNOS and β1-integrin expression, and reduced expression of inflammatory cytokines and apoptosis. Our findings show that EPO and FN have an additive effect on wound repair in diabetic mice.

Wound healing in diabetic patients is slower than in healthy individuals. Erythropoietin (EPO) has non-hemopoietic targets in the skin, and systemically administered EPO promotes wound healing in experimental animals. This study investigated the effect of topical EPO treatment on defective wound repair in the skin of diabetic rats. Full-thickness excisional skin wounds were made in 38 rats, of which 30 had diabetes. The wounds were then treated topically with a cream that contained either vehicle, 600 IU ml(-1) EPO (low dose), or 3,000 IU ml(-1) (high dose) EPO. We assessed the rate of wound closure during the 12-day treatment period, and microvascular density (MVD), vascular endothelial growth factor (VEGF), and hydroxyproline (HP) contents, and the extent of apoptosis in wound tissues at the end of the 12-day treatment period. Topical EPO treatment significantly reduced the time to final wound closure. This increased rate of closure of the two EPO-treated wounds in diabetic rats was associated with increased MVD, VEGF, and HP contents, and a reduced extent of apoptosis. In light of our finding that topical EPO treatment promotes skin wound repair in diabetic rats, we propose that topical EPO treatment is a therapeutically beneficial method of treating chronic diabetic wounds.