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Optimizing the longevity of vascular access in hemodialysis patients remains a critical aspect of patient care, given the significant role of arteriovenous fistulas (AVFs) and arteriovenous grafts (AVGs) in enabling effective dialysis. Vascular access complications, such as stenosis, thrombosis, and cannulation-related damage, continue to challenge both the functionality and the sustainability of these access points. Recent advancements underscore the importance of a robust follow-up strategy, integrating clinical evaluations with diagnostic tools like color Doppler ultrasound (CDU) and emerging interventional approaches such as drug-coated balloon (DCB) angioplasty. Regular CDU surveillance has shown promise in identifying asymptomatic stenosis, providing an opportunity for early intervention and reducing the risk of thrombotic events. This non-invasive imaging modality allows for detailed evaluation of hemodynamic changes within the vascular access, enabling timely detection and monitoring of stenotic lesions. Furthermore, the use of DCBs - angioplasty balloons coated with antiproliferative agents such as paclitaxel - offers a targeted approach to manage intimal hyperplasia and reduce restenosis rates in vascular access sites. Studies indicate that DCBs can mitigate neointimal proliferation, prolonging patency and enhancing long-term access outcomes. In this paper, we explore the synergistic role of clinical follow-up, ultrasound-based diagnostics, and drug-coated technologies in the preservation of vascular access. By examining the impact of these strategies, we aim to provide a comprehensive approach to vascular access maintenance, emphasizing the need for structured surveillance protocols and interventional techniques to optimize the lifespan of hemodialysis access points.

Background: The long-term efficacy of drug-coated balloon (DCB) angioplasty for large bifurcation lesions, particularly those involving the left main trunk (LMT), remains unclear., Aims: This study aimed to evaluate the long-term outcomes of directional coronary atherectomy followed by DCB (DCA/DCB) for large bifurcation lesions., Methods: This retrospective multicenter study analyzed 129 cases from the DCA/DCB registry, with 80.4% involving LMT bifurcation lesions. Building on previously reported 12-month outcomes, this study assessed long-term results. The primary endpoint was clinically driven (CD) target lesion revascularization (TLR) at 36 months. Secondary endpoints included CD target vessel revascularization (TVR); CD target vessel failure (TVF); and adverse events, such as all-cause mortality, cardiac death, target vessel acute myocardial infarction (AMI), and the need for coronary artery bypass grafting (CABG), at 24 and 36 months., Results: The mean follow-up was 53.4 ± 23.9 months. The CD-TLR rate was 5.0% at 24 months, and the primary endpoint was 5.9% at 36 months. CD-TVR rates were 14.0% at 24 months and 15.0% at 36 months, while CD-TVF rates were 14.9% at 24 months and 16.7% at 36 months. Adverse events included all-cause mortality rates of 0.8% at 24 months and 1.8% at 36 months, and cardiac death rates of 0.8% at both 24 and 36 months. No target vessel AMI or CABG procedures were reported., Conclusion: The consistently low CD-TLR rate at 36 months supports the efficacy of the DCA/DCB strategy for large bifurcation lesions, including LMT, indicating its sustained effectiveness. These findings highlight the viability of this treatment approach., (© 2024 Wiley Periodicals LLC.)

Purpose: To assess the effectiveness and safety of drug-eluting embolic (DEE) bronchial arterial chemoembolization (BACE) in lung cancer and compare its outcomes with those of conventional BACE (cBACE)., Materials and Methods: A comprehensive search was conducted across PubMed, Embase, Cochrane Library, Web of Science, CNKI, VIP, and Wanfang databases. Random-effects model analysis was applied when I 2 was ≥50%; otherwise, fixed-effects model analysis was used. Subgroup analysis was performed for I 2 values of ≥50%. Eighteen studies involving 681 patients were included, with 501 patients receiving DEE-BACE and 110 patients undergoing cBACE., Results: Among patients with lung cancer treated with DEE-BACE, the pooled objective response rates (ORRs) at 1 and 6 months were 64.4% and 50.3%, respectively; the disease control rates (DCRs) at 1, 3, and 6 months were 93.4%, 74.4%, and 71.7%, respectively. The 1-year overall survival and progression-free survival rates were 48.2% and 22.5%, respectively. The incidences of adverse events such as cough, fever, chest discomfort, nausea, fatigue, and leukopenia were reported at 30.7%, 22.8%, 22.4%, 29.6%, 7.4%, and 21.8%, respectively. Compared with the cBACE group, the DEE-BACE group exhibited higher 1-month DCR (pooled relative risk [RR], 1.236; 95% confidence interval [CI], 1.028-1.486) and 6-month ORR (pooled RR, 2.036; 95% CI, 1.226-3.383) and DCR (pooled RR, 1.824; 95% CI, 1.249-2.662). Both DEE-BACE and cBACE exhibited similar rates of adverse events., Conclusions: DEE-BACE presents a favorable effectiveness and safety profile for lung cancer treatment compared with cBACE, particularly for nonresectable cases or when chemotherapy or radiation therapy options are limited. However, the lack of direct comparisons with standard treatments requires cautious interpretation of these results., (Copyright © 2024 SIR. Published by Elsevier Inc. All rights reserved.)

Introduction: To evaluate the efficacy and safety of paclitaxel-coated balloon angioplasty in the treatment of thrombosed arteriovenous fistulas., Methods: This prospective, randomized, controlled study investigated the use of drug-eluting balloons in the treatment of the thrombosis of arteriovenous fistulas (AVFs) at our center between January 2018 and January 2023. A total of 246 patients were included in the study. The mean age of the patients was 61.3 ± 11.5 years. Of the patients, 150 (61%) were male and 96 (39%) were female. Angioplasty was performed using a plain balloon (PB) in 126 patients (51.2%) and a drug-coated balloon (DCB) in 120 (48.8%). The control images of the patients were obtained at the sixth and 12th months. Patency was evaluated during the follow-up., Results: There was no significant difference between the two groups in terms of age, gender, hypertension, hyperlipidemia, diabetes, fistula location, or stenosis length. No significant difference was observed between the groups regarding the number of complications observed during and after the procedure. At the end of the sixth month, the patency rate was found to be 86.7% in the DCB group and 78.6% in the PB group. The 12th-month patency rate was 77.5% in the DCB group and 57.9% in the PB group. A significant difference was detected between the two groups in relation to the 6th- and 12th-month patency rates (p = 0.034 and p = 0.046, respectively)., Conclusion: Drug-coated balloon angioplasty is an effective approach to the treatment of thrombosed AVFs, especially in terms of prolonging primary patency and reducing the need for secondary procedures., (© 2024 International Society for Apheresis and Japanese Society for Apheresis.)

Purpose: To report the outcomes of below-the-knee (BK) bypass surgery using heparin-bonded expanded polytetrafluoroethylene (ePTFE) grafts, performed in two centers since its launch in Japan., Methods: We conducted a retrospective analysis of databases from two medical centers, evaluating 51 limbs in 42 consecutive patients with peripheral arterial disease (PAD), who underwent BK bypass surgery using heparin-bonded ePTFE grafts between October, 2013 and April, 2023., Results: Thirty-three limbs (64.7%) were classified as Rutherford category 4-6 and 33 limbs (64.7%) had a history of ipsilateral revascularization. Technical success was achieved in 98% of the patients. The 30 day mortality rate was 2.4% (n = 1) and the overall 30 day complication rate was 9.5% (n = 4). The median follow-up period was 38 (interquartile range 13-67) months. Three patients required major amputation and 14 died during follow-up. Primary patency rates at 1, 3, and 5 years were 67.8%, 57.5%, and 46.5%, respectively, while secondary patency rates for these periods were 84.6%, 70.0%, and 66.0%, respectively. Overall survival rates at 1, 3, and 5 years were 90.1%, 74.5%, and 70.9%, respectively., Conclusions: BK bypass surgery using heparin-bonded ePTFE graft is a viable and durable option for patients with PAD, who are deemed unsuitable for autologous vein bypass surgery., Competing Interests: Declarations. Conflict of interest: We have no conflicts of interest to declare., (© 2024. The Author(s) under exclusive licence to Springer Nature Singapore Pte Ltd.)

Purpose: This systematic review aimed to compare covered stent (CS) and bare-metal stent (BMS) implantation in treating aortoiliac occlusive disease., Materials and Methods: Comprehensive searches were conducted in the MEDLINE, Embase, and Cochrane Library databases for all pertinent studies. The end points included primary patency, secondary patency, freedom from target lesion revascularization (TLR), technical success, ankle-brachial index (ABI) improvement, periprocedural adverse events, major amputation, and mortality. Odds ratios (OR) or risk differences with 95% CIs were used to estimate the binary variables. The continuous variables were presented as mean difference (MD) with 95% CI., Results: Ten studies involving 1,861 limbs were included. For overall outcomes, compared with BMS, CS showed significantly superior in freedom from TLR (OR, 3.00; 95% CI, 1.05-8.51; P = .04) and ABI (MD, 0.03; 95% CI, -0.00 to 0.06; P = .04). No significant differences were found in technical success, primary patency (at 12, 24, 36, and 60 months), secondary patency, periprocedural adverse events, major amputation rates, and early mortality. Subgroup analyses favored CS in ABI improvement (MD, 0.06; 95% CI, 0.02-0.11; P = .01) after propensity score matching, and covered balloon-expandable stents demonstrated certain advantages in freedom from TLR (OR, 4.60; 95% CI, 1.79-11.81; P = .002). Additionally, no significant difference in primary patency at 36 months between the 2 groups with Trans-Atlantic Inter-Society Consensus D or severe calcification lesions., Conclusions: Compared with BMS, CS presented advantages in reducing TLR and enhancing ABI improvement. Meanwhile, CS demonstrated comparable technical success, primary patency, secondary patency, periprocedural adverse events, major amputation rates, and early mortality., (Copyright © 2024 SIR. Published by Elsevier Inc. All rights reserved.)

Purpose: To develop a porcine model for arteriovenous fistula (AVF) venous stenosis (VS) treated with percutaneous transluminal angioplasty (PTA), and to compare outcomes of plain ordinary balloon angioplasty (POBA) to paclitaxel drug-coated balloon (DCB) angioplasty., Materials and Methods: Twelve castrated male Yorkshire pigs (4-5 months, 35-45 kg) underwent renal artery embolization to induce chronic kidney disease (CKD). Twenty-eight days later, AVF was created by anastomosing the left external jugular vein to left common carotid artery. The pigs were divided into a pilot group (n = 6) for optimizing the AVF technique (euthanized at Day 4) and a definitive group (n = 6) for validating PTA outcomes (euthanized at Day 42). Stenosis developed at juxta-anastomosis 28 days later and was treated with POBA (pilot group, n = 6; definitive group, n = 3) or DCB (definitive group only, n = 3). The definitive group underwent biweekly 4-dimensional flow magnetic resonance (MR) imaging., Results: All animals developed CKD, with significant increases in the levels of blood urea nitrogen (increase of median from 2.6 to 3.2 mmol/L; P < .001) and creatinine (increase of median from 10 to 187 μmol/L, P < .001). In the pilot group, 1 animal had an infected fistula, and AVF patency was 1/5. In the definitive group, the patency was 5/6 because the AVF technique was modified by resecting the sternomastoid muscle and increasing the spatulation. At Day 42 after PTA, the DCB-treated AVF outflow vein showed increasing but statistically insignificant blood flow compared with POBA (DCB, 209.8 mm 2 ± 64.4, vs POBA, 170.9 mm 2 ± 95.5; P = .934)., Conclusions: A porcine model of AVF VS treated with PTA was developed, with blood flow trends favoring DCB over POBA., (Copyright © 2024. Published by Elsevier Inc.)

Moyamoya disease (MMD) is a rare, progressive steno-occlusive disease of the intracranial carotid arteries. Coronary artery disease associated with MMD has been described in several cases. Coronary artery bypass grafting and percutaneous coronary intervention (PCI) with stent implantation were performed mainly for MMD patients with myocardial ischemia caused by coronary stenotic lesions. However, there have been no reports of coronary revascularization with a drug-coated balloon in MMD patients. We present the first case report of intravascular imaging guidance of PCI with a drug-coated balloon for a young patient with left anterior descending artery chronic total occlusion and a history of MMD. The left anterior descending artery remained patent after the 7-month follow-up, and there was no chest pain., (© 2024 Wiley Periodicals LLC.)

There is a growing trend of patients with significant comorbidities among those referred for percutaneous coronary intervention (PCI). Consequently, the number of patients undergoing complex high risk indicated PCI (CHIP) is rising. CHIP patients frequently present with factors predisposing to extensive drug-eluting stent (DES) implantation, such as bifurcation and/or heavily calcified coronary lesions, which exposes them to the risks associated with an increased stent burden. The drug-coated balloon (DCB) may overcome some of the limitations of DES, either through a hybrid strategy (DCB and DES combined) or as a leave-nothing-behind strategy (DCB-only). As such, there is a growing interest in extending the application of DCB to the CHIP population. The present review provides an outline of the available evidence on DCB use in CHIP patients, which comprise the elderly, comorbid, and patients with complex coronary anatomy. Although the majority of available data are observational, most studies support a lower threshold for the use of DCBs, particularly when multiple CHIP factors coexist within a single patient. In patients with comorbidities which predispose to bleeding events (such as increasing age, diabetes mellitus, and hemodialysis) DCBs may encourage shorter dual antiplatelet therapy duration-although randomized trials are currently lacking. Further, DCBs may simplify PCI in bifurcation lesions and chronic total coronary occlusions by reducing total stent length, and allow for late lumen enlargement when used in a hybrid fashion. In conclusion, DCBs pose a viable therapeutic option in CHIP patients, either as a complement to DES or as stand-alone therapy in selected cases., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Purpose: Tibial open shaft fractures are very common and susceptible to infection, which can lead to significant morbidity especially infection and non-union. Antibiotic coated nail is one option for fixing open shaft tibial fractures to minimise infection. This study aimed to compare the clinical outcome of Gentamicin-coated tibial nails versus regular unreamed interlocking tibial nails in the treatment of type I and II tibial open fractures., Methods: Between 2013 and 2020, in a retrospective study of 124 patients with Gustilo type I and II tibial fractures compared non-antibiotic-coated nails (62 patients) with gentamicin-coated nails (62 patients) over 12 months. This study assessed infection rates, duration of hospital stays, fracture union time, and complications., Results: The antibiotic nail group had significantly lower postoperative infection rates (3.2%) than the regular nail group (17.7%), (χ2 = 4.64, p = 0.031). At the 6-month follow-up, significant differences were observed in ESR (p = 0.031), CRP (p = 0.019), leukocyte count (p = 0.0241), and blood culture (p = 0.018), but not in hemoglobin levels (p = 0.067). The Gentamicin-coated nail group demonstrated better fracture union rates at 6 and 12 months, (p = 0.0267) and lower overall complication rates., Conclusion: A tibial nail coated with Gentamicin is an effective method for preventing infection in type I and II open fracture shafts of the tibia. It allows, shortens hospital stay and healing time, prevents infection, and thus reduces the chance of a second surgery., Level of Evidence: Level III, a retrospective study., Design: Retrospective analytical study., Hypothesis: We hypothesized that Gentamicin-coated nail is effective in preventing infection in Gustilo type I and II open fractures compared to non-antibiotic-coated regular nails., Competing Interests: Declarations. Ethics approval and consent to participate: The research followed the guidelines outlined in the Declaration of Helsinki. The Ethics Committee of the institution granted approval (ERC MHA/ EC/Ortho/03/2021, dated 01 Jan 2021). All patients signed an informed consent to before enrolling in the study. Consent for publication: All authors expressed their agreement to the publication of this study. Competing interests: The authors declare no competing interests., (© 2025. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Background: First-generation bioresorbable scaffolds (BRS) increased risks of stent thrombosis and adverse events. The Bioheart scaffold is a new poly-L-lactic acid-based BRS., Objectives: This study sought to evaluate the efficacy and safety of the BRS in patients with coronary artery disease., Methods: This was a prospective, multicenter, randomized, noninferiority trial comparing the Bioheart BRS with a cobalt-chromium everolimus-eluting stent (CoCr-EES) in patients with coronary artery disease. Angiography was planned at 12 months in all patients. The primary endpoint was 12-month in-segment late loss. The key secondary endpoint was the 12-month proportion of covered struts assessed on optical coherence tomography. Three-year clinical follow-up was completed., Results: A total of 434 patients from 22 Chinese sites were included (Bioheart BRS, n =218; CoCr-EES, n = 216). One-year in-segment late loss was 0.17 ± 0.38 mm with the Bioheart BRS vs 0.14 ± 0.24 mm with CoCr-EES; the 1-sided 97.5% upper confidence limit of the difference was 0.10 mm (P for noninferiority < 0.0001). The proportion of covered struts was 97.9% in the Bioheart BRS and 98.5% in the CoCr-EES (difference 0.02%; 95% CI: -0.3% to 0.26%; P for noninferiority < 0.0001; P for superiority = 0.91). Clinical outcomes at 3 years were similar in the 2 groups, as were the rates of target lesion failure (5.6% vs 5.2%; P = 0.84)., Conclusions: In this multicenter randomized trial, the Bioheart BRS was noninferior to the CoCr-EES for 1-year in-segment late loss, and resulted in a comparable 3-year clinical outcome. (Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System Clinical Study; NCT03284255)., Competing Interests: Funding Support and Author Disclosures The study was sponsored by Bioheart Biological Technology (Shanghai, China). The sponsor had no role in data collection, data analysis, data interpretation, writing of the manuscript, or the decision to submit the manuscript for publication. There was no funding of grants, contracts, and other forms of financial support. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Side branch stenting is often required during provisional stenting, leading to suboptimal results. Drug-coated balloons (DCB) for the compromised side branch have emerged as an attractive strategy. However, the benefit of DCB for coronary bifurcations remains unclear., Objectives: This study aimed to investigate whether DCB, compared with a noncompliant balloon (NCB), for the pinched side branch improves the outcomes of provisional stenting in patients with simple, true coronary bifurcations., Methods: In this multicenter, randomized controlled trial, patients with true coronary bifurcations who had side branch diameter stenosis of ≥70% after main vessel stenting at 22 centers in China, Indonesia, Italy, and Korea were randomly assigned to either DCB or NCB intervention. The primary endpoint was major adverse cardiac events, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target-lesion revascularization at the 1-year follow-up., Results: Between September 8, 2020, and June 2, 2023, 784 patients with true coronary bifurcation lesions undergoing main vessel stenting and having a severely compromised side branch were randomly assigned to the DCB (n = 391) or NCB (n = 393) group. One-year follow-up was completed in all patients. The primary endpoint occurred in 28 patients in the DCB group and 49 patients in the NCB group (Kaplan-Meier rate: 7.2% vs 12.5%; HR: 0.56; 95% CI: 0.35-0.88; P = 0.013), driven by a reduction in myocardial infarction. There were no significant differences between groups in procedural success, crossover to a 2-stent approach, all-cause death, revascularization, or stent thrombosis., Conclusions: In patients with simple and true coronary bifurcation lesions undergoing provisional stenting, main vessel stenting with a DCB for the compromised side branch resulted in a lower 1-year rate of the composite outcome compared with an NCB intervention for the side branch. The high rates of periprocedural myocardial infarction, which occurred early and did not lead to revascularization, are of unclear clinical significance., Competing Interests: Funding Support and Author Disclosures This trial was funded by the National Key Research and Development Plan (2022YFC2503503), the Chinese Society of Cardiology (grant number CSCF 2019-A0003), the National Natural Scientific Foundation of China (grant numbers NSFC 91639303, 81770441, and 82121001), and the Jiangsu Provincial and Nanjing Municipal Clinical Trial Project (grant number BE 2019615) and jointly supplied by B Braun Medical (Melsungen, German), Shenqi Medical (Shanghai, China), Yinyi Medical (Dalian, China), Yingsheng Medical (Shanghai, China), and Kaidenuo Medical (Wuhan, China). The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: We report the 5-year study closeout results for the ROBUST I trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) for men with short, recurrent bulbar urethral strictures., Materials and Methods: Adult men with recurrent bulbar urethral strictures ≤ 2 cm long and lumen < 12F were included in the study and treated with the Optilume DCB. Outcome measures included symptom questionnaires, maximum urinary flow rate, postvoid residual, and freedom from repeat intervention. Functional success was defined as improvement in International Prostate Symptom Score ≥ 50% without re-treatment., Results: Fifty-three men were enrolled and treated, and 31 subjects completed all follow-up. Functional success was achieved in 58% (25/43) patients at 5 years. Average International Prostate Symptom Score improved from a mean of 25.2 at baseline to 7.2 at 5 years ( P < .001). Freedom from repeat intervention was maintained through 5 years at 71.7% estimated by Kaplan-Meier. Maximum urinary flow rate improved from 5.0 mL/s at baseline to 19.9 ( P < .01), and average postvoid residual was reduced from 141.4 mL to 59.5 mL ( P < .01) at 5 years of follow-up. Erectile function remained unaffected. There were no serious treatment-related adverse events., Conclusions: In this challenging cohort of men with failed prior endoscopic treatment, the Optilume DCB shows sustained improvement in subjective and objective voiding parameters at 5 years. Optilume is a safe and effective treatment option for appropriately selected men with recurrent bulbar urethral stricture who wish to avoid urethroplasty. Results are in line with the ROBUST III randomized controlled trial that will continue follow-up through 5 years., Clinical Trial No.: NCT03014726.

Background and Purpose: Flow diversion has become a key treatment option for complex intracranial aneurysms. Recent advancements include coated flow diverters (FDs), designed to potentially reduce the need for dual antiplatelet therapy, thereby removing the associated secondary risks while maintaining patency and low complication rates. Comparing coated and uncoated FDs may offer insights into long-term outcomes and treatment optimization., Method: In this retrospective single-center study, we investigated the data of 21 consecutive patients with cerebral aneurysms, treated between 2021 and 2023 with the coated Derivo 2heal Embolization Device and the uncoated Derivo Embolization Device (both Acandis). We described the procedure and analyzed clinical and radiological data, along with long-term outcomes after 18 months of follow-up., Results: Nine patients (42.9%) had incidental, while 12 (57.1%) had symptomatic aneurysms, including 10 with World Federation of Neurosurgical Societies classification IV subarachnoid hemorrhages. Aneurysm locations included mostly the internal carotid (n = 9) and the vertebral artery (n = 7). All FDs were successfully deployed: 11 patients received the coated and 10 the uncoated device. After 18 months, 73.3% of patients had favorable outcomes (modified Rankin Score 0-2). One coated FD occluded asymptomatically after 6 months, and one uncoated FD occluded immediately but could be recanalized., Conclusions: We observed favorable occlusion rates for both coated and uncoated FDs. The role of dual antiplatelet therapy remains debated. Large multicenter studies are essential to evaluate the patency of coated compared to uncoated FDs and determine whether they can reduce thrombogenicity, potentially allowing for less or no antiplatelet therapy in emergencies., (© 2024 The Author(s). Journal of Neuroimaging published by Wiley Periodicals LLC on behalf of American Society of Neuroimaging.)

Drug-coated balloon (DCB) catheters offer an alternative to drug-eluting stents (DES) by delivering anti-proliferative drugs directly to vessel walls, avoiding implantation of a permanent metallic structure. While DCBs have shown efficacy for in-stent restenosis, evidence for their application in de novo coronary disease and chronic total occlusion (CTO) PCI is growing. We present a case of a 49-year-old male with multivessel chronic total and subtotal occlusions who had complete percutaneous revascularisation using a DCB only strategy. Each lesion had unique characteristics involving its length and location, bifurcation anatomy, and vessel diameter for which this stent-free approach was favored. DCB use in CTO PCI may be promising in select cases and lesions, and further studies are warranted to ascertain long-term efficacy in this setting., (© 2024 Wiley Periodicals LLC.)

Objective: To compare one year outcomes after atherectomy, intravascular lithotripsy vs. plain balloon angioplasty before application of drug coated balloons for treating femoropopliteal atherosclerotic disease., Data Sources: MEDLINE, EMBASE, and Cochrane Library were screened until May 2023 for randomised controlled trials., Review Methods: This was a systematic review and network meta-analysis. The inclusion criteria were patients with claudication and those with critical limb threatening ischaemia with lesion characteristics of all lengths, stenosis, calcification, and occlusions. The primary outcome was freedom from target lesion re-intervention at one year. Secondary outcomes were rate of bailout stenting, major amputation, and all cause mortality at one year. Pooled point estimates were calculated with a standard random effects model. Further sensitivity analyses were completed with a mixed treatment Bayesian model. Risk of bias was assessed by the Revised Cochrane Risk of Bias tool 2 (RoB2) and certainty of evidence assessed via the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework., Results: Four RCTs comprising 549 patients (two studies evaluating directional atherectomy, one evaluating rotational atherectomy, one evaluating intravascular lithotripsy against plain balloon angioplasty) were included. The weighted mean length of femoropopliteal lesions was 103.4 ± 6.67 mm. Results of the mixed treatment Bayesian analysis were consistent with pooled analysis for all outcomes. There were no significant differences in freedom from target lesion revascularisation (GRADE, high) (RoB2, low), major amputation (GRADE, low), or mortality (GRADE, moderate). Bailout stenting rates were significantly reduced with intravascular lithotripsy and atherectomy compared with plain balloon angioplasty (RR 0.25, 95% CI 0.07 - 0.89) (GRADE, moderate) (RoB2, low)., Conclusion: This review found that intravascular lithotripsy or atherectomy did not appear to incur a statistically significant advantage in freedom from target lesion revascularisation, major amputation, or mortality rate at one year. There was moderate certainty of evidence that bailout stenting is significantly reduced after vessel preparation with intravascular lithotripsy and atherectomy., (Crown Copyright © 2024. Published by Elsevier B.V. All rights reserved.)

Background: Few studies investigated the implications of post-PCI QFR and post-PCI ΔQFR (absolute increase of QFR) in de novo lesions of small coronary disease after drug-coated balloon (DCB)., Objectives: We sought to investigate the prognostic implications of post-PCI QFR and post-PCI ΔQFR in patients who received DCB only., Methods: Patients were divided according to the optimal cutoff value of the post-PCI QFR and the post-PCI ΔQFR. The primary outcome was major adverse cardiovascular events (MACE), including target vessel revascularization (TVR), cardiac death, and myocardial infarction (MI)., Results: The optimal cutoff values of QFR and ΔQFR for the MACE rate were 0.86 and 0.57, respectively. There were 175 patients (61.2%) with a high QFR (≥ 0.86) and 113 patients (39.5%) with a high ΔQFR (≥ 0.57) after PCI. The MACE rate was significantly higher in patients with a low QFR compared to a high QFR (5.7% vs. 27.0%, hazard ratio [HR]: 3.632, 95% confidence interval [CI]: 1.872 to 7.044, P < 0.001). The MACE rate was higher in patients with a low ΔQFR increase compared to those with high ΔQFR (4.4% vs. 20.2%, HR: 4.700, 95%CI: 2.430 to 9.089, P = 0.001). In multivariable model, a low post-PCI QFR and a low post-PCI ΔQFR was independent predictor of MACE (adjusted HR: 4.071, 95%CI: 2.037 to 8.135, P = 0.001)., Conclusions: After DCB in de novo lesions of small coronary disease, both post-PCI QFR and ΔQFR showed similar prognostic implications in MACE., Competing Interests: Declarations. Ethics approval and consent to participate: This study was approved by the ethical committee of Beijing Anzhen hospital and informed consent was provided by all of the patients according to hospital guidelines. All the experiment was conducted according to the Helsinki Declaration. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

Objective: This study aimed to analyze the safety and mid-term outcomes of a hybrid treatment method combining rotational atherectomy (RA) with drug-coated balloon (DCB) angioplasty in patients with femoropopliteal artery in-stent restenosis (ISR)., Methods: This single-center retrospective study enrolled patients from January 2018 to March 2022 who had femoropopliteal artery in-stent restenosis treated by RA and DCB. Preoperative demographics, operative details, and postoperative 12-month follow-up outcomes were analyzed statistically., Results: 38 consecutive patients (31 men; mean age 69.55 ± 9.18 years, range 54-91 years) with Tosaka II (n = 8) and III (n = 30) ISR were treated with RA Most patients had a high prevalence of typical vascular comorbidities. Overall, 50% of patients had chronic limb-threatening ischemia, and the average lesion length was 155.0 ± 54.8 mm. The primary patency rate, assessed by duplex ultrasound at 12 months, was 86.7%; 7.9% (3/38) of patients underwent target lesion revascularization (TLR). The overall mortality rate was 2.6% (1/38), and the ulcer healing rate reached 83.3% (5/6), with none of these patients requiring amputation. Subgroup analysis based on target lesion length (≥ 200 mm) showed that the 12-month primary patency rate was 75.0% for the ≥ 200 mm group and 95.5% for the < 200 mm group. Cox univariate regression analysis did not identify any risk factors affecting primary patency rate and freedom from clinically driven TLR (CD-TLR) at 12 months., Conclusions: Rotarex ® S combined with DCB seems safe and provides acceptable 12-month primary patency and TLR rates in femoropopliteal in-stent restenosis. Well-designed comparative or large registry studies are necessary to provide high quality and long-term data on this technique to provide firm conclusions on the efficacy of Rotarex ® S and DCB in ISR in the femoropopliteal area., Competing Interests: Declarations. Competing interests: The authors declare no competing interests. Ethical approval number: [2022] 054. Clinical trial number: Because this was a retrospective study clinical trial numbers were not applicable., (© 2024. The Author(s).)

Early debridement of partial-thickness burns and coverage with skin substitutes is currently the standard of care in children, although there is currently no "gold standard" skin substitute. Our aim is to compare the effectiveness of three different skin substitutes, analyzing the medium- and long-term outcomes., Methods: A retrospective study was conducted on burn patients under 18 years admitted to our Burn Unit between 2015 and 2021, who were divided into 3 groups according to the type of skin substitute used (EZ-derm®, Biobrane®, and Suprathel®). Demographic and clinical data and short- and long-term outcomes were analyzed. Effectiveness was analyzed by escharectomy and grafting rate during acute management and long-term follow-up reintervention rate. A total of 378 patients were included (179 EZ-derm® group, 107 Biobrane® group, and 92 Suprathel® group). No differences in demographics or burn characteristics were observed between the groups. Patients treated with Suprathel® had a significantly shorter hospital stay (median 4 days (IQR 2-9)), a lower rate of escharectomy and grafting during acute management (21.1%), and a lower long-term follow-up reintervention rate (18.5%) when compared to the EZ-derm® group (median stay 9 days (IQR 6-13); escharectomy and graft 24.6% and reintervention 26.8%) and to the Biobrane® group (median stay 9 days (IQR 7-14); escharectomy and graft 32.1% and reintervention 26.2%)., Conclusion: Treatment of partial-thickness burns with Suprathel® is associated with a shorter hospital stay, lower need for escharectomy and grafting, and lower need for long-term reintervention. Therefore, it should be considered the treatment of choice for pediatric partial-thickness burns., What Is Known: • Different types of skin substitutes are available for the treatment of skin burns in paediatric patients., What Is New: • Suprathel® is linked to a reduction in hospital stays, a lower need for escharectomy and grafting, and a lower likelihood of requiring long-term re-interventions., Competing Interests: Declarations. Ethics approval: The protocol of the study obtained the approval of La Paz Hospital Institutional Review Board (IRB number PI-5041) and complied with the guidelines of the Declaration of Helsinki (as revised in 2013). Conflict of interest: The authors declare no competing interests., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Paclitaxel can inhibit smooth muscle cell proliferation and migration, and reduce the risk of vascular restenosis after balloon dilation. Our study investigated the safety and efficacy of paclitaxel-coated balloon (PCB) treatment for diabetic subpatellar artery disease. In this study, 140 patients with diabetic subknee arterial disease treated in our hospital from January 2022 to December 2023 were selected as the study objects, and were divided into the control group (conventional balloon interventionization angioplasty) and the observation group (PCB interventionization angioplasty), with 70 cases in each group according to the differences in previous balloon interventionization. The safety and efficacy of the 2 treatments were compared. There was no significant difference in the primary patency rate 6 months after operation between the 2 groups (P > .05). There was significant difference in restenosis rate at 12 months after operation (P < .05). There was no significant difference in ankle-brachial index between the 2 groups before and 6 months after operation (P > .05). At 12 months after operation, ankle-brachial index of observation group was higher than that of control group, and the differences were statistically significant (P < .05). The improvement rate of walking impairment and 6 minutes walking distance in the observation group were significantly better than those in the control group, the difference was statistically significant (P < .05). There was no significant difference in the occurrence of adverse events between the 2 groups after operation (P > .05). For diabetic patients with subknee arterial disease, PCB treatment can ensure safety and improve clinical symptoms, and has good practical value., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.)

Background: This study aims to evaluate the long-term outcomes of patients with large coronary arteries (LCA, reference vessel diameter more than 3.0 mm) de novo lesions treated by drug-coated balloon (DCB) versus second-generation drug-eluting stent (sDES) in real-world clinical practice., Methods: Between January 2020 and June 2021, 2857 consecutive patients with equal number of LCA de novo lesions, including 708 lesions treated with paclitaxel DCB-only (DCB-only cohort) and 2149 lesions with sDES-only (sDES-only cohort), were enrolled in this retrospective study. The primary outcome was the clinically driven target lesion revascularization (CD-TLR) rate at two years. After propensity score matching, 708 patients treated with DCB-only and another 704 patients with sDES-only were successfully matched to study adjusted associations between treatment strategy and outcomes., Results: CD-TLR rate was higher in the DCB-only group than sDES-only group (DCB: 5.5%, sDES: 3.1%, P = 0.028). However, lower major bleeding rate was observed in the DCB-only group compared to sDES-only group (0.8% vs. 3.0%, P = 0.003), which benefited from its short duration of antiplatelet therapy. Multivariate logistic regression analysis revealed that hypercholesteremia [odds ratio (OR), 2.516], diabetes (OR, 2.773), severe calcified lesions (OR, 5.184) and residual stenosis>30% (OR, 8.676) were risk predictors (P<0.01) of CD-TLR for DCB-only strategy; meanwhile, diabetes (OR, 3.255) and severe calcified lesions (OR, 2.152) were risk predictors (P<0.01) of CD-TLR for sDES strategy., Conclusions: DCB-only strategy is feasible for LCA de novo lesions in patients with high bleeding risk, but not suitable in other patients, who should first choose intended stenting strategy especially with unmanageable hypercholesteremia, severe calcified lesions or non-ideal residual stenosis after preprocessing., Competing Interests: Declarations. Ethics approval and consent to participate: This study was approved by the institutional ethics committee of Fuwai Central China Cardiovascular Hospital, Zhengzhou University (Zhengzhou, China) (No. 2021 [13]). All participants confirmed informed consent forms and follow-up agreements before enrolling. Consent for publication: Not applicable. Clinical trial number: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

Background: Balloon angioplasty with drug-coated balloons (DCBs) is frequently used during percutaneous coronary intervention for in-stent restenosis. Despite its frequent use, there is a lack of long-term data on the efficacy of DCB angioplasty. We conducted an investigation on the long-term efficacy outcome of in-stent restenosis, comparing DCBs, drug-eluting stents, and plain old balloon angioplasty., Methods and Results: We conducted a nationwide analysis from the SCAAR (Swedish Coronary Angiography and Angioplasty Registry) including in-stent restenosis lesions undergoing coronary angiography between June 11, 2013, and January 14, 2022. The primary outcome of this study was target-lesion revascularization within a 5-year follow-up. Secondary outcomes included all-cause death, cardiovascular death, myocardial infarction, and any percutaneous coronary intervention. The outcomes were analyzed using a multivariable Cox proportional hazard model or Poisson regression, as appropriate. A total of 10 561 lesions from 9062 patients were included. Compared with plain old balloon angioplasty, the use of DCB angioplasty was associated with less target-lesion revascularization (risk ratio, 0.69 [95% CI, 0.57-0.82]), all-cause death (risk ratio, 0.72 [95% CI, 0.59-0.88]), and cardiovascular death (hazard ratio [HR], 0.59 [95% CI, 0.45-0.78]). No difference was observed for myocardial infarction or any percutaneous coronary intervention. Compared with drug-eluting stents, the use of DCBs was associated with higher rates of target-lesion revascularization (HR, 1.20 [95% CI, 1.06-1.37]). No difference was observed for all-cause death, cardiovascular death, myocardial infarction, or any percutaneous coronary intervention., Conclusions: In this long-term nationwide analysis, the use of DCB angioplasty showed superior outcomes compared with plain old balloon angioplasty within 5 years but higher rates of repeat revascularizations compared with drug-eluting stents.

Objectives: Intravascular lithotripsy (IVL) followed by drug-coated balloon (DCB) angioplasty might be a valuable alternative to surgery for calcified common femoral artery (CFA) atherosclerotic disease. Nonetheless, the 12 months performance of this treatment strategy remains unknown. This study reports on the 12 months outcomes of IVL with adjunctive DCB angioplasty for calcified CFA lesions., Methods: This is a retrospective single-center, single-arm study. Consecutive patients treated by IVL and DCB for calcified CFA disease between February 2017 and September 2020 were evaluated. The primary measure outcome of this analysis was primary patency. Procedural technical success (<30% stenosis), freedom from target lesion revascularization (TLR), secondary patency, and overall mortality were additionally analyzed., Results: Thirty-three (n=33) patients were included in this study. The majority presented with lifestyle limiting claudication (n=20, 61%), 52% (n=17) of the patients had chronic kidney disease (CKD) and 33% (n=11) had diabetes. The procedural technical success was 97% (n=32). A flow-limiting dissection post IVL was observed in 2 patients (6%) and a peripheral embolization in a single patient (3%), while the bail-out stenting rate amounted to 12% (n=4). No perforation was observed. The median length of hospital stay was 2 days (interquartile range 2-3). At 12 months, the primary patency was 72%. The freedom from TLR and the secondary patency rates were 94% and 88%, respectively. The 12-month survival amounted to 100% and 75% (n=25) of the patients were asymptomatic or presented with mild claudication. The presence of chronic limb-threatening ischemia (CLTI) (hazard ratio [HR], 0.92; confidence interval (CI); 0.18-4.8, p=0.7) or CKD (HR, 1.30; 95% CI, 0.29-5.8; p=0.72), as well as the use of a 7 mm IVL catheter (HR, 0.59; 95% CI, 0.13-2.63; p=0.49) or of high-dose DCB (HR, 0.68; 95% CI, 0.13-3.53; p=0.65) did not influence the primary patency., Conclusions: In this study, the combination of IVL and DCB angioplasty for calcified CFA disease was associated with low risk for periprocedural complications, acceptable 12 months clinical outcomes, and low rates of reinterventions., Clinical Impact: Intravascular lithotripsy in combination with DCB angioplasty can be an alternative to surgery in highly selected patients with CFA atherosclerotic disease. In this Cohort the combination therapy lead to acceptable clinical results and low reintervention rates at 12 months., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Konstantinos Stavroulakis has received consulting fees for Phillips, Shockwave, Boston Scientific, and Terumo, and received Honoraria from Medtronic, Bentley, and Biotronik, Giovanni Torsello has received consulting fees for Medtronic and Boston Scientific, and received grants from Medtronic, Gore, Cook, and Cordis, Theodosios Bisdas has received consulting fees for Boston Scientific, Medtronic, BARD, and COOK Medical.

Background: Despite the improvements in drug eluting stents (DES) technology, suboptimal results have been observed in certain higher-risk subsets of patients, as in diabetes mellitus (DM). Drug-coated balloons (DCB) could represent an alternative to DES in complex populations and anatomies, as in DM., Aims: The present meta-analysis aimed at assessing the role of DCBs in patients with diabetes mellitus., Methods: Studies comparing DCB versus percutaneous coronary revascularization (PCI) with/without DES for PCI in high-risk populations (>30% DM) were included. The primary efficacy endpoint was overall mortality, secondary endpoints were myocardial infarction, target lesion revascularization (TLR), and major adverse cardiovascular events (MACE)., Results: We included 10 studies, comprising 2026 patients. Among them, 1002 patients (49.5%) were treated with DCB and 1024 with DES implantation. Among the included studies, 6 only enrolled diabetic patients and 2 had a prevalence of diabetes of 50%. At a mean follow-up of 15.3 months, mortality rate was 3.8% (82 patients), significantly lower with DCB (3.2% vs. 4.9% with DES; odds ratio [OR] [95% confidence interval {CI}] = 0.61 [0.38, 0.97], p = 0.04 p het  = 0.34. A similar reduction in favor of DCB was observed for MACE (13.6% vs. 17.6%; OR [95% CI] = 0.79 [0.61, 1.04], p = 0.09, p het  = 0.25), while TLR was significantly reduced only in the diabetic-restricted sub-analysis., Conclusion: In the present meta-analysis, we showed a significant survival benefit and an absolute reduction in MACE and TLR with a DCB-based strategy as compared to DES in high-risk patients, mostly with DM. Future large-scale randomized trials, dedicated to this population, are deserved to confirm our findings., What Is Known: Complex coronary anatomies and diabetes mellitus (DM) represent the pitfall of drug eluting stents (DES), mainly due to inflammatory and thrombotic complications, which should be reduced with drug-coated balloons (DCB)., What Is New: We confirmed a significant advantage of DCB versus DES in the treatment of de novo lesions in high-risk patients and mainly in DM, reducing overall mortality, MACE and target lesion revascularization., (© 2024 Wiley Periodicals LLC.)

Background: To investigate the long-term efficacy of the paclitaxel-eluting Legflow balloon catheter in the treatment of "real-world" long and complex femoropopliteal lesions., Methods: The REFLOW study was a prospective, multi-national, non-randomized, single arm study evaluating the long-term safety and efficacy of the Legflow paclitaxel-eluting balloon dilatation catheter in the treatment of stenotic or occlusive lesions >150 mm long in the femoropopliteal arteries of symptomatic patients (Rutherford 2-5). A total of 120 study subjects were enrolled in a period of 30 months, between October 2015 and May 2018. The mean age was 71.1 years and 79 patients were men (65.8%). Mean lesion length was 216.1 mm. 45.0% of the lesions were occluded, whereas 55.0% were stenotic. For this extended study follow-up, 100 out of 120 patients agreed to participate. The primary endpoint was primary patency at 24 months, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 24 months., Results: Primary patency was 70.50% at 2 year. Freedom from TLR was 76.10% at 2 year., Conclusions: Longer term follow-up confirms there is no safety-concern on this paclitaxel device. The excellent results of the newer drug-eluting devices, and the Legflow paclitaxel-eluting balloon in particular, is a valid and effective alternative to treat long and complex "real-world" femoropopliteal lesions.

Objective: Flow diverters (FDs) carry the risk of thromboembolic complications associated with the device and bleeding complications associated with dual antiplatelet therapy. We hypothesize that an antithrombotic surface-coated FD (ASCFD) would have less acute thrombus formation and better endothelialization on the device surface compared with uncoated FD., Methods: A ASCFD was developed. Acute clot formation and chronic endothelialization over the device were assessed in 8 rabbit models compared with its prototype FD (PFD) at 2 hours and 1 month by scanning electron microscopy (SEM) and histologic images. Nonparametric score data, including thrombus, injury, endothelialization, adventitial inflammation, intramural bleeding, and intimal hyperplasia were compared between ASCFD and PFD using the Kendall coefficient of rank correlation., Results: Parent artery and branch artery were patent on digital subtraction angiography in 8 ASCFDs and 6 PFDs. There was 1 intrastent thrombosis in PFDs at 2 hours and 1 intrastent stenosis in PFDs at 1 month. SEM at 2 hours showed that a large number of blood cells adhered to the surface of all 4 PFDs, and no blood cells were found on the surface of all 4 ASCFDs. At SEM and histologic analysis of 1 month, there was less inflammation (Kendall τ-B -0.818; P ＝ 0.022), less vessel wall injury (Kendall τ-B = -0.764; P ＝ 0.032), and better endothelialization (Kendall τ-B = 0.818; P ＝ 0.022) in ASCFDs., Conclusions: In the rabbit model, the ASCFD is associated with less thrombus formation at the acute stage, less inflammation, less vessel injury, and better endothelialization on the device surface compared with the PFD., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Drug-coated balloons (DCB) can be used as an alternative to drug-eluting stents (DES) in patients with de novo small vessel coronary artery disease. This study aims to assess the efficacy and safety of solely using DCB versus DES in percutaneous coronary intervention (PCI) for de novo coronary lesions in large vessels., Method: A database search was conducted using PubMed, EMBASE, Cochrane Library, and http://Clinicaltrials.gov for trials comparing DCB only with DES in treating de novo coronary lesions in large vessels. Efficacy outcomes included coronary angiography (CAG), follow-up minimal lumen diameter (MLD), and late luminal loss (LLL). Safety outcomes included target lesion failure [TLF: cardiac death, myocardial infarction (MI), target lesion revascularization (TLR)] and their individual components., Results: We included seven randomized control trials (RCTs) with 816 patients, of which 422 and 394 patients were in the DCB and DES groups, respectively. MLD measured during the 6-12 months follow-up in the DCB group was statistically significantly smaller than in the DES group (MD -0.21, 95% CI -0.34 to -0.07, P = 0.003, I 2 = 52%). LLL measured at 6-12 months follow-up was statistically significantly lower in the DCB group than in the DES group (MD -0.13, 95% CI -0.22 to -0.05, P = 0.003, I 2 = 60%). TLF, cardiac death, MI, and TLR, were not statistically significantly different between the two groups., Conclusion: Use of DCB was associated with less LLL at 6-12 months than DES and was not associated with any increase in adverse clinical events. This data suggests DCB are as effective in treating de novo coronary lesions in large vessels as DES., Competing Interests: Declarations. Ethics Approval: Not applicable. Consent to Participate: Not required. Consent for Publication: Not required. Conflicts of Interest: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Balloon angioplasty achieves luminal enlargement by fracturing the atherosclerotic intima at its point of least resistance, thereby creating a dissection plane and space with dehiscence of the intima from the media. This barotraumatic dissection triggers an inflammatory and proliferative reaction, resulting in a restenosis process at medium-term. In the era of plain old balloon angioplasty, quantitative angiographic studies at follow-up demonstrated that - the greater the acute luminal gain was after balloon angioplasty, the greater the late luminal loss was at follow-up. The interventional cardiologists coined the following motto "the more you gain, the more you lose". However, in the current era of drug coated balloon (DCB), it appears that this vexing conundrum could have been abrogated. A recently published DCB study in small de novo vessel has demonstrated that there was a slightly negative correlation between the volume of dissection assessed by optical coherence tomography and the angiographic late luminal loss (now gain) after Paclitaxel coated balloon treatment. In other words, the barotraumatic dissection does not necessarily herald a restenosis process in the era of DCB. This article revisits the mechanism of balloon angioplasty and explores how DCB with Paclitaxel may change the paradigm of balloon angioplasty as default treatment in CAD percutaneous treatment., Competing Interests: Declaration of competing interest Patrick W Serruys: Consultancy fees for SMT, Novartis, Meril Life Sciences, Xeltis, and Philips. Akihiro Tobe: Grant from Fukuda Foundation for medical technology. Scot Garg: Honoraria or consultation fees from Biosensors. Aloke V Finn: Research grants from Boston Scientific, Medtronic, Abbott, Edwards, BD, Advanced Nanotherapies, Reflow, Amgen, Terumo. Consulting fees from Medtronic, Terumo and Advanced Nano. Lecture fees from Boston Scientific, Concept Medical and Cordis. Bernardo Cortese is a consultant for B. Braun and Concept Medical. Sandeep Basavarajaiah: Honoraria for lectures from Concept Medical, Cordis and Shockwave. Support for attending meetings from Concept Medical., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Currently, there is often a lack of suitable small-caliber graft vessels for treating cardiovascular diseases because of thrombosis and intimal hyperplasia. Tissue engineered vascular grafts (TEVGs) promise a potential solution to this issue. Acellular vascular matrix with good mechanical properties and biocompatibility is commonly used as a tissue engineered scaffold. In this study, acellular rat aortas were preloaded with heparin and hepatocyte growth factor (HGF) to fabricate small diameter TEVGs. In terms of the biomechanical properties, this scaffold was similar to native rat aortas. We implanted this scaffold into a rat abdominal aorta, and the acellular aorta with heparin only was used as control. The patency at 6 months of the two groups was 100%. At 1 month, a complete layer of endothelial cells could be seen on the surface of the vascular lumen of the scaffold with heparin and HGF. The results also showed that the intimal thickness was significantly reduced in the grafts coated with HGF compared to the control grafts. In conclusion, the small-diameter TEVGs constructed by acellular vascular scaffolds coated with heparin and HGF have a promising clinical application prospect., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: This systematic literature review compares the clinical outcomes of heparin-bonded expanded polytetrafluoroethylene with autologous saphenous vein in the management of patients undergoing below-the-knee bypass to treat peripheral arterial disease., Methods: An electronic literature search was conducted in MEDLINE and Embase to identify comparative studies in patients who underwent below-the-knee surgical bypass. Studies were screened at abstract and full text review using predefined inclusion criteria by two independent reviewers and critically appraised for risk of bias. Meta-analyses were conducted using Review Manager 5 software (Nordic Cochrane Centre)., Results: Eight retrospective cohort studies were identified. Meta-analysis of primary patency demonstrated no significant difference between heparin-bonded expanded polytetrafluoroethylene and autologous saphenous vein grafts after 1 (odds ratio: 0.91, 95% confidence interval: [0.52-1.59]; P = .74), 2 (1.12 [0.60-2.10]; P = .77), 3 (0.62 [0.26-1.48]; P = .28), and 4 years (0.70 [0.36-1.39]; P = .31). Similarly, for secondary patency, no significant difference was detected at 1 (0.62 [0.33-1.15]; P = .13), 2 (0.83 [0.32-2.13]; P = .69), 3 (0.60 [0.27-1.32]; P = .20), and 4 years (0.66 [0.32-1.36]; P = .26). There was no significant difference between autologous veins and heparin-bonded expanded polytetrafluoroethylene for limb salvage and mortality at all time points. A sensitivity analysis to compare outflow vessels was conducted in only tibial bypass and identified no differences. All analyses were considered at high-risk bias because of heterogeneity in study populations and attrition in follow-up., Conclusions: This meta-analysis demonstrates similar outcomes between autologous saphenous vein and heparin-bonded expanded polytetrafluoroethylene for patency, limb salvage, and mortality through 4 years. The use of heparin-bonded expanded polytetrafluoroethylene synthetic grafts is a satisfactory option to prevent amputation, particularly when autologous saphenous vein grafts are not available. Controlled clinical studies are needed to further inform future decision-making and economic modeling related to the choice of conduit for below-the-knee graft construction., Competing Interests: Disclosures D.J.D. is a clinical investigator for Gore Medical. F.O. is a former employee of W. L. Gore and Associates. R.F.N is on the WL Gore Scientific Advisory Board., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the effect of drug-coated balloon (DCB) with high-dose paclitaxel for the treatment of restenotic dysfunctional arteriovenous fistulae (AVFs)., Materials and Methods: In this single-arm, multicenter, prospective, observational study, 334 patients who underwent DCB angioplasty using IN.PACT AV (Medtronic, Plymouth, Minnesota) for the first time for restenotic lesions of dysfunctional AVFs between April 2021 and March 2022 were registered. Outcomes were compared with the outcomes of plain angioplasty performed previously, leading up to the restenosis., Results: Procedural success, defined as <30% residual stenosis, was achieved in 96.7% of cases. During a median follow-up of 7.4 months, 179 target lesion reinterventions (TLRs) were observed, and the 6-month freedom from TLR was 73.2% (68.2%-78.2%). When compared with the previous plain angioplasty, the median time to reintervention was significantly longer with DCB (9.1 [8.0-10.6] vs 3.2 [3.0-3.4] months; P < .001). Baseline characteristics that were independently associated with TLR were as follows: months from the last intervention (adjusted hazard ratio, 0.50 [95% confidence interval, 0.40-0.62] per doubling; P < .001), partial lesion coverage by DCB (2.13 [1.10-4.12]; P = .024), and residual stenosis after DCB (2.19 [1.53-3.12] per 15% increase; P < .001) with its time interaction (0.91 [0.86-0.97] per month; P = .003). Of the 179 TLRs, 84 used DCB once again. The median time to reintervention was significantly longer for TLR using DCB (7.1 [6.2-9.7] vs 3.3 [3.1-4.0] months; P < .001)., Conclusions: DCB with high-dose paclitaxel is effective at both the initial treatment of restenotic lesions of dysfunctional AVFs and during TLR after DCB use. Partial lesion coverage by DCB and residual stenosis may compromise patency., (Copyright © 2024 SIR. Published by Elsevier Inc. All rights reserved.)

Background: A recent meta-analysis of randomized control trials demonstrated a significantly higher risk of major amputation in patients treated with drug-coated balloons (DCBs) compared with standard treatment, especially in high-dose paclitaxel-coated DCBs. Distal particulate embolization after DCB use was considered a potential cause of the higher incidence of major amputation. The current study aimed to histologically and biologically compare biologic drug effect and distal particulate embolization in 3 DCBs (a high-dose paclitaxel-coated DCB [IN.PACT Admiral] and 2 low-dose paclitaxel-coated DCBs [Ranger and Lutonix])., Methods and Results: The DCBs were inflated in the healthy descending aortas of 18 rabbits, followed by euthanasia 28 days after the procedure. The treated descending aorta and distal skeletal muscles were histopathologically evaluated, and paclitaxel concentrations were measured. The paclitaxel concentration of the treated lesion was highest for Ranger, followed by IN.PACT and Lutonix (Ranger vs IN.PACT vs Lutonix: 1089 [745-2170] pmol/mg vs 638 [160-2075] pmol/mg vs 25 [10-304] pmol/mg, respectively; p<0.0001). In the histopathological evaluation, the angle of severe medial smooth muscle cell loss was largest for Ranger followed by IN.PACT and Lutonix (12.8 [8.0-20.4] degree vs 1.4 [1.2-5.2] degree vs 0.8 [0.5-2.5] degree, respectively), with significant differences for Ranger vs IN.PACT (p=0.007) and Ranger vs Lutonix (p=0.002). However, paclitaxel concentrations of distal skeletal muscles were lowest for Lutonix, followed by Ranger and IN.PACT (12 [1-58] pmol/mg vs 15 [13-21] pmol/mg vs 42 [19-108] pmol/mg, respectively, p<0.0001). The numbers of arteries with downstream DCB effects were highest for IN.PACT, followed by Ranger and Lutonix (Ranger vs IN.PACT vs Lutonix, 3 [3-4] vs 4 [3-7] vs 2 [1-2], respectively), which was consistent with the measured tissue paclitaxel concentrations., Conclusion: These findings suggest that Ranger demonstrates the strongest paclitaxel effect, as well as the second-best effect regarding distal particulate embolization, making it a good treatment option for patients with peripheral artery disease among the 3 DCBs evaluated in the current study. Further clinical head-to-head comparisons with larger numbers of patients are needed to explore which DCB is the most effective and safe treatment option.Clinical Impact:The findings of the current preclinical study suggests that Ranger demonstrates the strongest paclitaxel effect, as well as the second-best effect regarding distal particulate embolization making it a good treatment for patients with intermittent claudication and chronic limb-threatening ischemia., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: This study was sponsored by Boston Scientific Japan (Tokyo, Japan). S.T. received research grants from Abbot Vascular Japan, Boston Scientific Japan, Medtronic, and received honoraria from Boston Scientific Japan. G.N. is a consultant for Boston Scientific, Abbott Vascular, Terumo Corp., and Japan Medical Device Technology Co., Ltd, and received research grants from Boston Scientific, Abbott Vascular, Terumo Corp., and Japan Medical Device Technology Co., Ltd.

Cochlear implant users with residual hearing benefit synergistically from combined electrical stimulation via the cochlear implant and preserved residual hearing after surgery. However, direct mechanical trauma and subsequent inflammation may deteriorate hearing function. AC102, a novel otoprotective pyridoindole with anti-apoptotic and anti-oxidative properties significantly improved hearing recovery following cochlear implantation when administered intratympanically prior to surgery. Additionally, AC102 exerts neurotrophic effects, possibly aiding in the preservation of auditory nerve fibers and spiral ganglion neurons. Rapid clearance of the drug, however, might be a limiting factor to further attenuate the inflammatory response and maintain neuronal health. The aim of the current study was to design an AC102-loaded electrode array for sustained drug delivery and investigate its effects in hearing preservation cochlear implantation. First, the release-kinetics of AC102 were investigated in vitro and modelled by the Higuchi equation of drug release. An electrode array coated with 10 % AC102 was manufactured, its release kinetics evaluated, and subsequently tested in vivo. 20 normal hearing Mongolian gerbils were unilaterally implanted with an AC102-loaded or an unloaded control electrode. Compound action potentials were measured prior to cochlear implantation and serially over 28 days. Hair cells, inner hair cell synapses, and auditory nerve fibers were quantified in cochlear whole-mounts by immunofluorescence staining. AC102 release from silicone coating could be predictably modelled by the Higuchi equation of drug release. The electrode array with an AC102-silicone depot enabled non-linear sustained drug release with initially higher release concentrations. In vivo, the AC102-loaded electrode array significantly recovered auditory threshold shifts near the maximum insertion depth over 28 days. In the apical region, a significant recovery was noticed only until day 14, after which threshold shifts aligned between groups. Histologically, AC102-loaded electrodes significantly preserved outer hair cells apical of the maximum insertion depth and inner hair cells and neuronal structures at the tip of the inserted electrode. In conclusion, the drug-loaded electrode arrays could predictably release AC102 over a period of 28 days. AC102 enabled the restoration of auditory thresholds near the area of maximum insertion, which is the desired region to be preserved in cochlear implant recipients with residual hearing., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: When dealing with complex femoropopliteal lesions, there is a growing preference for the utilization of drug-coated balloons (DCBs) or stents. However, in real-world scenarios, a greater number of elderly patients with longer lesion lengths are encountered. The purpose of our study was to compare the efficacy and safety of different interventional strategies, including the utilization of Supera stent and DCB, in a real-world setting., Methods: This was a retrospective study that collected treatment and follow-up data of patients with complex femoropopliteal artery lesions treated between January 2019 and March 2022. All patients were categorized into 3 groups: "non-Supera stent group," "Supera stent group," and "Supera stent + DCB group." The primary effectiveness outcome was primary patency at 12 months, defined as duplex ultrasound peak systolic velocity ratio < 2.5 at the 12-month visit. Other outcomes included improvements in Rutherford categories and safety., Results: A total of 162 patients were enrolled in this study. Compared with non-Supera group (47.6%) in the primary patency rate at 12 months, Supera group (58.7%) or Supera + DCB group (60.0%) showed no significant difference. There were no significant differences in all-cause death, major amputation of the target limb, and target lesion revascularization between the groups. Supera group showed a significant improvement in Rutherford category without target lesion revascularization at 12 months compared with non-Supera group (73.3% vs. 54.8%, P = 0.041). In 12-month follow-up, more than 65% of patients maintained a Rutherford category of 3 or in the following, particularly in Supera group where 74.7% of patients had mild symptoms., Conclusions: The Supera stent has demonstrated its efficacy and safety in treating complex peripheral artery disease. However, combining Supera stent with DCB did not provide a significant advantage. Furthermore research is necessary to validate these findings in a larger patient population., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Introduction: The presence of severe arterial calcification is associated with less favorable outcomes in terms of procedural and clinical success as well as higher rates of major adverse limb events. Recent studies incorporating rotational atherectomy for effective preparation of severely calcified lesions demonstrate beneficial procedural outcomes by obtaining maximal luminal gain and improved long-term outcomes., Methods: This prospective single-center, observational study includes patients with severely calcified femoropopliteal lesions with chronic limb ischemia Rutherford 1-5 between January 2017 and July 2019, who underwent atherectomy using the Jetstream Atherectomy system, followed by drug-coated balloon angioplasty. Lesion calcification was categorized by the Peripheral Arterial Calcium Scoring System (PACSS), whereas lesion complexity was classified by the Transatlantic Inter-Society Consensus (TASC). Safety and efficacy aspects in terms of vessel injury, thromboembolism, and clinical success were systematically analyzed up to 12 months of follow-up (FU)., Results: In 162 consecutive patients, 210 non-stented and 22 stented lesions were treated. Twelve (7.4%) patients received bail-out stenting. Mean lesion length was 24.2±4.8 cm; 51% were chronic total occlusions (mean occlusion length 18.2±5.1 cm). TASC C lesions were present in 38 patients (23.5%) and TASC D lesions in 124 patients (76.5%). The mean PACCS score was 3.3±0.9. Device success was achieved in 88%; procedural success was noted in 99% of the lesions. Embolic protection device was used in 11.7%. Perforation or dissection occurred in none of the cases. Asymptomatic peripheral embolization was noted in 10 patients (6.2%). Clinical FU at 12 months was available in 157 of 162 patients (96.9%). At 12 month FU, (1) mean Rutherford classification at baseline of 3.7±0.6 significantly dropped to 1.0±0.9 (p<0.05), (2) baseline mean anke-brachial index (ABI) of 0.4±0.1 significantly increased to 0.8±0.2 (p<0.05), (3) 92.6% were free from target lesion revascularization (TLR), (4) 95.1% were free from target vessel revascularization (TVR), and (5) binary restenosis measured by duplex occurred in 22 patients (13.6%). Multivariate analyses showed lesion length as predictive of stent placement (p=0.02), whereas both lesion length (p=0.006) and PACCS score (p=0.02) are predictive of clinical success., Conclusion: Rotational atherectomy in combination with drug-coated balloon (DCB) can be safely performed in long, calcified (non-) occlusive lesions with a relatively low rate of bail-out stenting and favorable clinical mid-term results., Clinical Impact: In this prospective, single arm study we demonstrated that combination treatment using rotational atherectomy and DCB is safe and effective in complex and calcified TASC C/D femoropopliteal lesions in patients with claudication or CLTI in a real-world clinical setting. Despite mean lesion length of >20cm and a relatively high rate of chronic total occlusions, the rate of bail-out stenting was surprisingly low (7.4%), whereas the rates of freedom from TLR and TVR were surprisingly high. Thus, our study may encourage vascular specialists to choose an endovascular -first approach even in such complex and calcified femoropopliteal lesions and occlusions in daily clinical practice., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Since the advent of coronary stents, two of the most common long-term complications after percutaneous coronary intervention (PCI) are in-stent restenosis (ISR) and stent thrombosis (ST). Although the rates of ST have been nearly abolished and ISR rates have declined with the current gold-standard second-generation drug-eluting stents (DES), late ISR of DES remains a valid concern in the field of interventional cardiology. The drug-coated balloon (DCB) is a non-stent technology that relies on the concept of targeted homogeneous drug delivery from an inflated balloon to restore luminal vascularity, treat atherosclerosis, and overcome some limitations of PCI, including ISR and prolonged dual antiplatelet therapy to prevent ST by leaving nothing behind. Most clinical evidence on coronary DCBs predominantly comes from small, randomized data and registries using paclitaxel DCBs for ISR and de novo lesions in the coronary space. Since 2014, outside the United States, DCBs have been approved for the treatment of ISR, with a class I recommendation by the European Society of Cardiology. The Food and Drug Administration very recently approved the Agent DCB to treat ISR in patients with coronary artery disease in the US. Additionally, recent randomized clinical data also showed DCB's safety and efficacy for the treatment of de novo small-vessel disease and high-bleeding-risk patients, while their role for other clinical situations including acute coronary syndrome, large-vessel disease, bifurcation lesions, and long-diffuse distal lesions is currently under investigation. Herein, we review the evidence-based role of DCBs in the treatment of coronary lesions and offer future perspectives., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Append Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional/SIS Medical AG, Transmural Systems Inc.; Institutional Grant Support: Biotronik, Medtronic, Philips IGT; Investor: Transmural Systems Inc. All other authors – None., (Copyright © 2024. Published by Elsevier Inc.)

Background: Treatment of patients with in-stent restenosis (ISR) remains challenging. In this setting the use of drug-coated balloons (DCB) represents an attractive approach to avoid adding another metal layer to the coronary wall., Aims: The Chansu Vascular Technologies (CVT)-ISR trial aimed to evaluate the safety and efficacy of a novel everolimus-DCB (CVT-DCB) using a new coating formulation and crystalline everolimus., Methods: The CVT-ISR trial was a prospective, multicenter, open, single-arm, first-in-man (FIM) study. A total of 51 patients (mean age 69.2 years, 74.5% male) with single ISR coronary lesions (≤24 mm in length) were enrolled at nine sites in Europe., Results: The primary safety endpoint, freedom from target lesion failure (TLF) at 180 days, was 92.2%, with the lower bound of the 95% confidence interval (81.1%), above the protocol-defined objective performance criterion (OPC) (65% for conventional balloon angioplasty, P  < 0.05). At 1 year freedom from TLF was 90.2%. The primary efficacy endpoint, in-stent late lumen loss at 180 days (evaluated in a predefined subgroup of 25 patients scheduled for late angiography), was 0.40 mm (median 0.30 mm), lower than the protocol-defined OPC of the plain balloon angioplasty historical control (0.80 mm, P  < 0.001)., Conclusion: This FIM study demonstrated the superior efficacy of the new everolimus CVT-DCB compared with conventional balloon angioplasty in the treatment of patients with ISR., Clinical Trials Registration: NCT05731700., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Drug-coated balloon (DCB) angioplasty and drug-eluting stents (DES) are two widely used treatments for in-stent restenosis (ISR). Focal and non-focal types of ISR affect the clinical outcomes. The present study aims to compare DES reimplantation versus DCB angioplasty in acute coronary syndrome (ACS) patients with focal ISR and non-focal ISR lesions., Methods: Patients with ISR lesions underwent percutaneous coronary intervention (PCI) were retrospectively evaluated and divided into DES group and DCB group. The primary endpoint was the incidence of target lesion failure (TLF) at 24 months follow up. Propensity score matching (PSM) was conducted to balance the baseline characteristics., Results: For focal ISR, TLF was comparable in the DES and DCB groups at 24 months of follow-up (Before PSM, hazard ratio [HR]: 0.70; 95% confidence interval [CI]: 0.39-1.27; p = 0.244; After PSM, HR: 0.83; 95% CI: 0.40-1.73; p = 0.625). For non-focal ISR, TLF was significantly decreased in DES compared with DCB group (Before PSM, HR: 0.43; 95% CI: 0.29-0.63; p < 0.001; After PSM, HR: 0.33; 95% CI: 0.19-0.59; p < 0.001), which was mainly attributed to the lower incidence of clinically indicated target lesion revascularization (CD-TLR) (Before PSM, HR: 0.39; 95% CI: 0.26-0.59; p < 0.001; After PSM, HR: 0.28; 95% CI: 0.15-0.54; p < 0.001)., Conclusions: The clinical outcomes for DES and DCB treatment are similar in focal type of ISR lesions. For non-focal ISR, the treatment of DES showed a significant decrease in TLF which was mainly attributed to a lower incidence of CD-TLR., Competing Interests: Declaration of competing interest The authors declare that they have no competing interests., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Introduction: Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in complex coronary artery disease (CAD) has been established as the standard of care, but stent-related events are not uncommon. Sirolimus-Coated Balloon (SCB)-based angioplasty is an emerging technology, although it needs to be thoroughly evaluated compared with DES in the complex PCI setting. This study aimed to investigate the safety and efficacy of SCB-based angioplasty compared with new-generation DES in complex PCI., Methods: Net adverse cardiovascular events (NACE: all-cause death, target lesion revascularization, non-fatal myocardial infarction, and major bleedings according to BARC classification), as a primary study endpoint was compared between SCB and new-generation DES for complex coronary lesions., Results: Among 1782 patients with complex CAD, 1076 were treated with a sirolimus-coated balloon (EASTBOURNE Registry) and 706 with new-generation DES (COMPLEX Registry). After propensity score matching, a total of 512 patients in both groups were analyzed. NACE occurred more significantly in the DES group during the 1-year follow-up (10.5% vs. 3.9%, p = 0.003), mainly due to a higher risk of bleeding (6.6% vs. 0.4%, p = 0.001). The Cox model adjusted for lesion length showed a significantly lower hazard of NACE (HR: 0.23, CI [0.10, 0.52], p < 0.001) and all-cause mortality (HR: 0.07, CI [0.01, 0.66], p = 0.020) in SCB compared to DES group., Conclusions: SCB angioplasty has an advantage over DES for the treatment of complex CAD regarding NACE, significantly reducing the incidence of major bleeding without increasing ischemic endpoints. SCB may be an alternative to DES in selected patients with complex coronary lesions., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Biomaterials used in fracture healing hold a significant place in orthopedics. This study aimed to develop biomaterials coated with hydroxyapatite (HA), boric acid (BA), and magnesium (Mg) and investigate their effects on fracture healing., Methods: Sixty female Wistar Albino rats were included in the study. The subjects were randomized into five groups. Cytotoxicity tests were performed on HA, BA, and Mg, and cell viability rates were calculated. Coatings were applied to Kirschner (K) wires at determined ratios. Group I was the control group with a steel K wire, Group II used HA-coated K wires, Group III used HA + BA-coated K wires, Group IV used HA + BA + Mg-coated K wires, and Group V used HA + Mg-coated K wires. A fracture was induced in the right femur of the subjects, followed by fixation with intramedullary K wires. The subjects were randomly divided into equal numbers and sacrificed at 6 and 12 weeks. Radiological and histopathological evaluations were performed., Results: In direct cytotoxicity tests, the highest viability rate was observed in Group IV, while in indirect cytotoxicity tests, it was highest in Group II. In radiological evaluation at the 6th week, the highest scores were in Groups IV and V, while the lowest was in Group III. At the 12th week, the highest scores were in Groups II and V, while the lowest was in Group I. No significant differences were found between the groups (p = 0.837, p = 0.0479). In histopathological evaluation, a significant difference was observed between the groups (p < 0.001), with the highest scores in Group V. A correlation was found between the radiological and histopathological scores (p < 0.001, r = 0.438)., Conclusion: It was found that HA + Mg significantly improved histological outcomes in fracture healing. Good histological results can be achieved with the use of Mg-containing implants in both early and late-stage fracture healing. Coating the biomaterials used in fracture fixation with Mg may lead to positive outcomes in fracture healing., Competing Interests: Declarations Ethics approval and consent to participate The study, referenced as AKUHADYEK-25-21, received ethical approval from the Afyon Kocatepe University Local Animal Experiments Ethics Committee (HADYEK) under decision number 49533702/30. The study was conducted at Afyon Kocatepe University Animal Husbandry and Research Experimental Animals Center. Consent for publication Not applicable. Competing interests The authors declare no competing interests., (© 2024. The Author(s).)

Background: Drug-coated balloons (DCB) have promising results in the management of in-stent restenosis (ISR), still their role remains a major challenge, and not well established in contemporary clinical practice., Aims: To provide a comprehensive appraisal of the efficacy and safety of DCBs in patients with in-stent restenosis (ISR)., Methods: We searched PubMed, Scopus, web of Science, Ovid, and Cochrane Central from inception until 30 March, 2023. We included randomized controlled trials (RCTs) that compared DCB versus DES in ISR patients. Our primary endpoints were major adverse cardiac events (MACE) and late lumen loss (LLL). Secondary clinical endpoints were all-cause death, cardiac death, MI, TLR, TVR, and stent thrombosis, and angiographic outcomes were MLD, and in-stent binary restenosis., Results: Ten RCTs comprising 1977 patients were included in this meta-analysis. The incidence of MACE was 15.57% in the DCB group compared to 14.13% in the DES group, with no significant difference in the risk of MACE following DCB (odds ratio [OR] 1.04, 95% confidence interval [CI]: 0.87 to 1.44). Compared with the DES intervention, the risk of LLL was comparable to the DCB intervention (mean difference [MD] -0.08, 95% CI: -0.18 to 0.02), while the incidence of TLR was increased in the DCB intervention (OR: 1.54, 95% CI: 1.2 to 1.99)., Conclusion: DCB was comparable to DES implantation is ISR patients regarding clinical outcomes, however it showed an increase in TLR events. Moreover, a RCT with large sample size and longer follow-up duration is warrened to validate these results., (© 2024. The Author(s).)

Background: Paclitaxel-coated balloons (PCB) are a viable alternative to drug-eluting stents in the treatment of de novo coronary lesions. Whether sirolimus represents an alternative to paclitaxel for drug-coated balloons remains elusive., Aims: This randomised, controlled, multicentre, non-inferiority trial investigated a novel sirolimus-coated balloon (SCB) with a crystalline coating versus a PCB in de novo coronary lesions., Methods: To compare a novel SCB with a clinically proven PCB, 70 patients with de novo coronary lesions were enrolled at 4 centres in Germany and Switzerland. The primary endpoint was non-inferiority regarding angiographic late lumen loss (LLL) at 6 months, with a predefined margin of δ=0.35 mm. Secondary endpoints included procedural success, major adverse cardiac events, and individual clinical endpoints., Results: Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months, in-segment LLL was 0.04±0.39 mm in the PCB group versus 0.11±0.37 mm in the SCB group (non-significant), respectively. The mean difference between SCB and PCB was 0.07 mm (95% confidence interval: -0.12 to 0.26). Non-inferiority at the predefined margin of 0.35 was shown. Clinical event rates up to 12 months were not different between the groups (3 target lesion revascularisations in the PCB group versus 2 in the SCB group, no myocardial infarctions, no deaths)., Conclusions: The novel SCB showed similar angiographic outcomes in the treatment of de novo coronary disease as compared with a clinically proven PCB (ClinicalTrials.gov: NCT03908450).

Background: Ceramic endosseous implant coatings have gained esteem due to their favorable osteoinductive and osteoconductive properties. However, such a layer may be prone to failure under in vivo conditions, which necessitates its modification., Objectives: The aim of the present study was to modify an electrodeposited hydroxyapatite (HA) coating on titanium (Ti) with ultrashort-pulsed lasers for the incorporation of the ceramic into the sample surface and the texturing of the metal surface. The obtained surface was planned for application on the endosseous implant surface to enhance osseointegration. To our knowledge, such laser modification of a HA coating has not been performed previously., Material and Methods: Four different HA coatings were created (A-D). Each coating was conditioned with 4 different laser irradiations (1-4 to 4-4), carried out using different power, velocity and frequency settings. The surface features of the laser-irradiated coatings were analyzed., Results: The laser modifications of the HA coatings resulted in 2 kinds of surfaces. Laser-induced periodic surface structure (LIPSS) texturing could be observed on quadrants 1-4 to 3-4, with parallel grooves and HA crystals melted and sintered into spherical structures. The 4-4 laser surface conditioning did not altered the needle-like morphology of the HA coating. The LIPSS-fusion modification decreased the water contact angle of the samples., Conclusions: The ultrashort-pulsed laser modification of the HA coating for regimes 1-4 to 3-4 resulted in the LIPSS texturing of the Ti surface with HA sinterization. Further biological analyses are necessary to evaluate the cell and tissue response to such laser-modified HA coating on Ti.

The effect of drug-coated balloons (DCB) on hemodialysis (HD) in patients with femoropopliteal (FP) disease remains uncertain. This study aimed to investigate the outcomes of DCB therapy in patients with FP artery disease on HD. A total of 185 patients with FP lesions (140 HD patients) who underwent DCB treatment were included in the study. The incidence of restenosis and target lesion revascularization (TLR) at 12 months were measured. Risk factors for TLR were also investigated. The mean age was 71.7 years, and diabetes was observed in 82.3% of patients. The mean duration of receiving dialysis was 8.8 years. The mean lesion length was 11.0 cm, and approximately half of the lesions were severely calcified. Severe dissection after DCB therapy was observed in 19.5% of patients. During the follow-up period, 74 restenosis, 68 TLRs, 8 major amputations, and 28 deaths were observed. The freedom rates from restenosis and TLR at 12 months were 63.8% and 71.3%, respectively. The freedom rates after low- and high-dose DCB at 12 months were 61.9% and 70.6% for restenosis (P = 0.49) and 66.4% and 79.4% for TLR (P = 0.095), respectively. Independent risk factors for TLR at 12 months of age were diabetes, chronic limb-threatening ischemia, and severe calcification. When patients were divided into four groups according to the number of these three risk factors, the rates of freedom from TLR at 12 months were 100%, 94.8%, 76.7%, and 30.3% in the groups with no risk factors, any one risk factor, any two risk factors, and all risk factors, respectively (P < 0.0001). Clinical outcomes after endovascular therapy in HD patients with FP disease remain unsatisfactory, even if they are treated with DCB. In particular, patients on HD with diabetes, chronic limb-threatening ischemia, and severe calcification have poor outcomes., (© 2024. Springer Nature Japan KK, part of Springer Nature.)

Background: We previously showed non-inferiority of a low-dose paclitaxel-coated balloon (PCB) with citrate excipient (Agent PCB) as compared to normal-dose iopromide excipient (SeQuent Please PCB) in terms of angiographic and clinical endpoints at 12 months. The long-term clinical efficacy and safety of Agent PCB is not defined., Methods: 262 patients (323 DES-ISR lesions) were enrolled in this study and treated with either Agent PCB (125 patients, 151 lesions) in the ISAR-DESIRE 3a trial or with SeQuent Please PCB (137 patients, 172 lesions) in the setting of the randomized ISAR-DESIRE 3 trial with similar in- and exclusion criteria serving as historical control arm. The follow-up period was extended to 7 years. The efficacy and safety endpoints of this analysis were target-lesion revascularization (TLR), death, myocardial infarction (MI) and target lesion thrombosis (TLT) at 7 years., Results: At 7 years, 206 patients (78.6%) were alive. The risks of TLR (hazard ratio [HR]: 1.29, 95% confidence interval [CI]: 0.87-1.90; p = 0.205), death (HR: 1.38, 95% CI: 0.82-2.35; p = 0.227), MI (HR: 1.10, 95% CI: 0.39-3.15; p = 0.852) and TLT (HR: 2.18, 95% CI: 0.20-24.10; p = 0.523) were comparable between Agent PCB and SeQuent PCB. Multivariate analysis showed comparable risks of TLR, death and MI between both PCB devices., Conclusions: In patients treated for DES-ISR by angioplasty with Agent PCB and SeQuent Please PCB, there was no statistically significant difference in TLR at 7 years. Randomized trials with standardized lesion preparation and long-term follow-up are warranted to further evaluate comparative efficacy of both devices. (ClinicalTrials. gov Identifier: NCT02367495)., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: After drug-coated balloon (DCB) treatment of the femoropopliteal artery in-stent restenosis (ISR), a certain proportion of patients also experience target lesion restenosis. The purpose of this study was to explore the efficacy and safety of rivaroxaban combined with aspirin in the treatment of ISR after DCB intervention., Methods: Patients who underwent DCB treatment for ISR after femoropopliteal artery intervention at our center from March 2017 to February 2022 were included consecutively. According to the drug treatment after DCB intervention of ISR, the patients were divided into rivaroxaban and aspirin group (RA Group) and dual antiplatelet therapy (DAPT) group. The outcomes of 2 groups during the 12-month follow-up after DCB intervention were compared., Results: A total of 92 patients were included in final analysis, with 43 in RA group and 49 in DAPT group. During 12-month follow-up, a total of 15 cases of recurrent ISR were detected, and the recurrence rate of ISR and clinically driven target lesion revascularization in the RA group were lower than those in the DAPT group (P < 0.05). The vascular patency rate in the RA group was higher than that in the DAPT group at 6 and 12 months of follow-up (P < 0.05). During the follow-up, there were no adverse events such as death, myocardial infarction, stroke, amputation, or major bleeding, and only a total of 5 cases of minor bleeding occurred., Conclusions: Compared with the standard DAPT regimen, rivaroxaban combined with aspirin can safely improve the follow-up outcome after DCB for femoropopliteal ISR., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: Residual dissection is a concern in endovascular treatment with a DCB, and there is limited knowledge of hemodynamics at a dissection lesion. Therefore, the objective of this study is to evaluate the mean pressure gradient (MPG) and fractional flow reserve (FFR) at a residual dissection after DCB angioplasty for the superficial femoral artery (SFA)., Methods: A total of 59 cases with residual SFA dissection treated with DCB angioplasty at a single center were analyzed retrospectively. The dissection was classified into 6 types (A-F). The primary endpoints were MPG and FFR at a residual dissection lesion after DCB angioplasty, using evaluation with a pressure wire., Results: The median lesion length was 70 (40-130) mm with 24% popliteal involvement, and 11 cases (18%) had chronic total occlusion. A completion angiogram revealed dissection of types A (n = 33, 56%), B (n = 18, 31%), C (n = 7, 12%), and D (n = 1, 2%). The median MPGs in type A, B, and C cases were 0 (0-2), 0 (0-4), and 3 (0-6) mmHg, with a significant lower in type C cases than in type A cases (A vs C, P = .021). The median FFRs in type A, B, and C cases of 1.0 (.98-1.00), 1.0 (.96-1.00), and .98 (.95-1.00) did not differ significantly among dissection types (A vs B, P = .86; A vs C, P = .055; B vs C, P = .15)., Conclusions: This is the first report of hemodynamics at a SFA dissection. The results suggest that low-grade dissection (types A or B) does not affect MPG and FFR at a SFA lesion. This indicates that a bailout stent may be unnecessary for patients with dissection of types A or B. A further investigation is needed to determine whether a scaffold is required for a SFA lesion with type C dissection., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Introduction: There are several types of surface treatments (coatings) aimed at improving the biocompatibility of cardiopulmonary bypass (CPB) circuit. Some coatings appear to require higher doses of heparin to maintain anticoagulation goals, and some of them might induce postoperative coagulopathy. In this study, we compared the amount of heparin required, postoperative bleeding, and inflammatory response according to three types of coatings., Method: We retrospectively included 300 consecutive adult patients who underwent cardiac surgery with CPB and received one of three coatings (Phisio®, Trillium®, and Xcoating™). Our primary objective was to compare, according to coating, the amount of heparin required to maintain an ACT > 400s during CPB. Our secondary objectives were to compare postoperative bleeding for 48 h and CRP rate., Results: Baseline characteristics were comparable between groups except for age and preoperative CRP. We did not find a significant difference between the 3 coatings regarding the amount of heparin reinjected. However, we found less postoperative bleeding with the Xcoating™ circuit compared to the Phisio® circuit (-149 mL [-289; -26.5]; p = 0.02) and a lower elevation of CRP with the Phisio® circuit (2.8 times higher than preoperative CRP) compared to Trillium® (4.9 times higher) and Xcoating™ (6.4 times higher); p < 10 -3 ., Conclusion: The choice of coating did not influence the amount of heparin required during CPB; however, the post-CPB inflammatory syndrome may be impacted by this choice., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.