Search Results (82)

Background and Objective: Benign prostatic hyperplasia (BPH) and urethral stricture (US) are common causes of lower urinary tract symptoms in ageing men, often requiring repeated interventions. Conventional treatments of US, such as urethrotomy and mechanical dilation, have high recurrence rates. The Optilume drug-coated balloon catheter system, which combines mechanical dilation with paclitaxel delivery, has emerged as a minimally invasive alternative. This systematic review assesses its efficacy and safety in the management of BPH and US. Methods: A systematic search of PubMed was conducted for studies published between August 2020 and October 2023. Eligible studies included randomised controlled trials (RCTs), cohort studies, and case reports evaluating Optilume’s therapeutic effects. Key outcomes analysed included symptom relief, urinary flow improvement, recurrence rates, and adverse events. Results: Seven studies met the inclusion criteria, including five on US and two on BPH. The ROBUST trial series demonstrated sustained improvements in urinary flow rates and symptom scores in US patients over follow-up periods of up to four years. The EVEREST-1 and PINNACLE trials reported significant symptom relief and preserved sexual function in BPH patients, with a favourable safety profile and minimal complications. Conclusions: Optilume appears to be a promising alternative to conventional endoscopic treatments for US and BPH, offering durable symptom relief with a low complication rate. Further long-term studies are required to confirm its efficacy and cost-effectiveness in routine clinical practice. Full article

Background: Although contemporary stent technology has significantly evolved, a substantial number of patients present with stent failure (SF), the clinical expression of which is either in-stent restenosis (ISR) or stent thrombosis (ST). Methods: In this observational, single-center study, we aimed to compare the clinical characteristics, clinical presentation, angiographic findings and subsequent management of patients who underwent percutaneous coronary intervention (PCI) for SF, either ISR or ST, with patients who had PCI for de novo lesions. Results: Over a period of two years (September 2022–October 2024), 1120 patients underwent PCI, of whom 9% had SF. Of the 101 SF cases, the majority (76 cases, 75%) had ISR, while the rest (25 cases, 25%) had ST. Regarding baseline characteristics, patients who underwent PCI for SF had a higher incidence of diabetes mellitus (53% vs. 29%; p < 0.001), dyslipidemia (88% vs. 50%; p < 0.001) as well as prior coronary artery bypass grafting surgery (7.9% vs. 3.7%; p = 0.043), while they were less likely to be current smokers (33% vs. 52%; p < 0.001). SF PCI patients presented more frequently with unstable angina (17% vs. 8.9%; p = 0.010). A new stent was implanted in less than half of SF cases (i.e., stent implantation, 44% vs. 91%; p < 0.001). On the other hand, in the clinical setting of SF, drug-coated balloons (44% vs. 5.3%; p < 0.001) and plain balloon angioplasty (8.9% vs. 0.7%; p < 0.001) was applied more frequently compared with de novo lesions. Furthermore, the usage of cutting/scoring balloons and lithotripsy was significantly higher in the SF group (8.9% vs. 0.4% and 12% vs. 3%, respectively; p < 0.001 for both). Intracoronary imaging guidance was more commonly used in the SF group (33% vs. 13%; p < 0.001). Stent malapposition (44%) and neoatherosclerosis (67%) were the most common mechanisms of ST and ISR, respectively, as identified by intravascular imaging modalities. Finally, the success rates were comparable (96% vs. 98%; p = 0.150) between the two groups. Conclusions: Approximately one of ten patients underwent PCI because of the failure of a previously implanted stent. Use of intracoronary imaging is significantly higher in the clinical context of SF. While DES implantation remains the standard of practice for de novo lesions, DCBs are a popular alternative, especially for ISR cases. Interventional cardiologists who are involved in the treatment of SF cases should be familiar with interpreting intravascular imaging to guide the use of the adjunctive device required to ensure that optimal procedural results in SF cases are obtained. Full article

Coronary artery disease is the most common cause of mortality worldwide. Percutaneous coronary intervention represents an important method of treatment. Over time, the methods have been refined to improve safety and efficacy. With the development of drug-eluting stents, in-stent restenosis has importantly decreased, but it remains a relevant concern in terms of the need for additional revascularization procedures or recurrent coronary events. Different platforms, polymers, and anti-proliferative agents have been tested, mostly demonstrating non-inferiority when compared. Additional devices, such as drug-coated balloons, bioresorbable scaffold systems, gene-eluting stents and bioadaptor implants have been developed. As none of the aforementioned methods demonstrated considerable superiority over the others, the search for the ideal treatment method continues. Based on currently available data, the ideal treatment method could be a personalized approach combining different revascularization methods. Additional research with subpopulation group studies, different associated diseases or vessels affected, and longer follow-up are required to determine better subgroups of patients that would benefit most from specific treatment methods. Full article

The evolution of percutaneous coronary intervention (PCI) has led to significant advances in drug-coated balloon (DCB) technology, offering a stent-free alternative for treating coronary artery disease. While paclitaxel-coated balloons (PCBs) have been the standard, sirolimus-coated balloons (SCBs) are emerging as a viable alternative with distinct pharmacokinetic and clinical benefits. This review explores the mechanisms of action of paclitaxel and sirolimus, their impact on different plaque morphologies, and the clinical implications of DCB selection. Paclitaxel facilitates positive vascular remodeling and is particularly effective in fibrotic and lipid-rich plaques, but its poor penetration in calcified lesions remains a limitation. Sirolimus, with its homogeneous tissue distribution and anti-inflammatory properties, is better suited for unstable, lipid-rich, and inflammatory plaques, where it promotes plaque stabilization. Recent randomized trials and meta-analyses have compared SCBs vs. PCBs in both de novo lesions and in-stent restenosis, showing non-inferior outcomes. Additionally, DCBs demonstrate comparable efficacy to DES in small vessel disease, reducing the need for permanent metallic scaffolds. This review summarizes the current evidence on DCB selection based on plaque characteristics and highlights areas for further investigation in personalized PCI strategies. Given the narrative review design, the authors conducted a comprehensive literature search using databases such as PubMed and MEDLINE. Keywords included “drug-coated balloon”, “paclitaxel-coated balloon”, “sirolimus-coated balloon”, “in-stent restenosis”, and “plaque morphology”. Studies were selected based on relevance, including randomized controlled trials, registries, and meta-analyses. No formal inclusion/exclusion criteria or systematic screening were applied due to the nature of narrative synthesis. Full article

The current management of patients with acute coronary syndrome (ACS) and bleeding disorders, such as hemophilia, is supported by small retrospective studies or expert consensus documents. Moreover, people with hemophilia are less likely to receive invasive treatments like percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for ACS compared to those without hemophilia, which could affect their cardiovascular outcomes. A multidisciplinary team with an expert hematologist is essential to properly define the therapeutic strategy, which should balance both the thrombotic and bleeding risks. We report a clinical case that illustrates an alternative revascularization strategy for hemophilic patients presenting with ACS and with a pattern of diffuse coronary atherosclerotic disease (CAD), encompassing drug-coated balloons (DCBs) in combination with spot stenting. The proposed approach might avoid a full-length drug-eluting stent (DES) implantation and also allow a short dual antiplatelet therapy (DAPT) regimen that is desirable in patients at a very high bleeding risk (HBR) like hemophiliacs. Furthermore, we have provided a review of the available literature on this topic and a focus on the main recommendations for managing ACS, in response to the presented clinical case. Finally, this article aims to share information and develop more confidence in the current guidelines on the treatment of hemophiliacs who need myocardial revascularization. Full article

Background/Objectives: Drug-coated balloons (DCBs) are emerging as a promising treatment for peripheral artery disease; however, current technologies lack flexibility in customizing drug release profiles and composition, limiting their therapeutic potential. This study aims to develop a Gelatin (Gel) and Sodium Alginate (Alg) bioink loaded with apolipoprotein A-I (apoA-I) for controlled drug delivery by using additive manufacturing technologies. Methods: We developed and printed via rapid freeze prototyping (RFP) a Gel and Alg bioink loaded with different concentrations of apoA-I. Mechanical properties related to compressional and tensile forces have been studied, as well as the structural stability and active release from the 3D structure of apoA-I (cholesterol efflux assays). The biological behavior of HUVEC cells with and without ApoA-I was assessed by proliferation assay, metabolic activity analysis, and fluorescence imaging. Results: The 3D structures presented breakpoint stress values consistent with the mechanical requirements for integration within a DCB, and the ability to effectively promote cholesterol transport in J774 cells. Moreover, in vitro studies on HUVECs revealed that the scaffolds exhibited no cytotoxic effects, leading to increased ATP levels and enhanced metabolic activity over time, confirming the possibility to obtain RFP-printed Alg/Gel scaffolds able to provide a stable structure capable of controlled apoA-I release. Conclusions: These findings support the potential of Alg/Gel+apoA-I scaffolds as biocompatible drug delivery systems for vascular applications. Their ability to maintain structural integrity while enabling controlled biomolecular release positions them as promising candidates for personalized cardiovascular therapy, facilitating the rapid customization of bioprinted therapeutic platforms. Full article

With the advancement of interventional coronary procedures, drug-coated balloons have become an increasingly common alternative to drug-eluting stents in the treatment of various lesions. This paradigm shift stems from several advantages that DCBs entail, including a reduction in stent length burden, the possibility of late vessel positive remodeling, and the preservation of bifurcation anatomy. Conversely, several studies compared the efficacy of DCB treatment to stents or POBA in various scenarios. In this review, we will discuss the areas in which a DCB can be of paramount importance. We will begin by examining the role of DCBs in in-stent restenosis, for which the current practice guidelines do not clearly state the role of this technology, as opposed to the previous ones, in which it was mentioned as a first-line armamentarium. We will then discuss the indications and advantages of using DCBs in de novo lesions, concerning both small and large vessels, with growing emphasis on diffuse lesions. Lastly, we will address the current data on the use of DCBs in special scenarios such as the treatment of chronic total occlusion and left main and bifurcation lesions, without forgetting the primordial role of drug-eluting stents in all these lesions. Full article

Drug-coated balloons (DCBs) have emerged as a compelling alternative to drug-eluting stents in the treatment of coronary artery disease (CAD), offering the advantage of local drug delivery without permanent vascular scaffold implantation. Initially developed for managing in-stent restenosis, DCBs seem appealing for broader indications, particularly in small vessel disease and bifurcation lesions. While paclitaxel-based DCBs remain the most investigated, newer limus formulations are showing promise and appear to be a valid alternative in early trials. Evidence from recent randomized clinical trials (RCTs) and meta-analyses highlights DCBs as a safe and effective option in selected patients, with potential benefits including lower restenosis rates, reduced need for dual antiplatelet therapy, and avoidance of late stent-related complications. As new large-scale trials near completion, DCBs are poised to take on a broader role in the treatment of CAD, particularly in patients where “leaving nothing behind” offers a clinical advantage. This review offers an overview of the DCB platforms commercially available, showing pharmacological differences, providing current indications in practical guidelines, and analyzing the most recent and impactful RCTs and meta-analyses in the field. Full article

Drug-coated balloons (DCBs) have emerged as a promising alternative therapeutic strategy to traditional drug-eluting stent (DES) implantation in various coronary artery lesion scenarios, aiming to minimize complications associated with permanent metallic scaffolds, such as chronic inflammation, delayed vessel healing, and stent thrombosis. This review systematically evaluates the current clinical evidence supporting the use of DCBs across diverse anatomical and clinical contexts, including small-vessel disease, in-stent restenosis, bifurcation lesions, diffuse coronary lesions, acute coronary syndromes, and chronic total occlusions, as well as in special patient populations such as individuals with diabetes mellitus or at high bleeding risk. The literature analysis incorporated recent randomized controlled trials, observational studies, and real-world registries, highlighting the clinical efficacy, safety profiles, and specific advantages of DCB angioplasty. The findings consistently demonstrated non-inferior clinical outcomes of DCBs compared to DESs across multiple lesion types, with particular benefits observed in special populations, including reduced restenosis rates and comparable major adverse cardiac events (MACEs). Nevertheless, clinical data gaps remain, emphasizing the need for larger, longer-term randomized trials to refine patient selection and procedural techniques. In conclusion, DCB angioplasty represents a viable and effective alternative to conventional stenting, particularly advantageous in complex lesions and specific patient subsets, pending further definitive evidence. Full article

Background/Objectives: We sought to confirm the performance and safety of the Pantera Lux paclitaxel-coated balloon (pDCB) when used as per the instructions for use at a single high-volume center. Methods: In this retrospective analysis, 386 consecutive patients were categorized into three groups: the treatment of drug-eluting stent in-stent restenosis (DES-ISR) lesions (n = 191), bare-metal stent in-stent restenosis (BMS-ISR) lesions (n = 127), and de novo lesions (n = 68). The primary endpoint at 12 months was target-lesion revascularization (TLR). Secondary endpoints were device success, target-vessel myocardial infarction (TV-MI), and cardiac death. Results: The baseline characteristics were balanced between the groups, with a median age of 71.3 years, 25% being female, 32% being diabetic. The majority presented with chronic coronary syndrome (82.9%). Type C lesions were more often observed in the DES-IRS group as compared with the BMS-IRS and de novo groups (15.6% vs. 7.9% vs. 7.4%, p < 0.001). Cutting balloons were more often used in the DES-IRS group (41.0% vs. 19.7% vs. 1.5%, p < 0.001). The residual stenosis rate was 7.6% vs. 3.3% vs. 7.3% (p = 0.002). The TLR at 12 months was 8.9% vs. 2.4% vs. 1.5% (p = 0.013). Device success was achieved in 98.8% vs. 98.5% vs. 100% of cases (p = 0.8). TV-MI occurred in 3.2% vs. 0.8% vs. 1.5% (p = 0.5) and cardiac death in 2.6% vs. 0.0% vs. 2.9% (p = 0.13) in DES-IRS vs. BMS-IRS vs. de novo lesions. Conclusions: In this single-center observation, we confirmed the safety and efficacy of the Pantera Lux paclitaxel-coated balloon for the treatment of DES-IRS, BMS-IRS, and de novo lesions with low TLR rates at 12 months. Full article

Urethral strictures significantly impact patients’ quality of life, with endoscopic treatments such as direct vision internal urethrotomy (DVIU) and dilatation showing high recurrence rates. Drug-coated balloon (DCB) treatment, which delivers paclitaxel locally after dilation, is an innovative, minimally invasive approach aimed at reducing fibrosis and stricture recurrence. Paclitaxel’s antiproliferative and antifibrotic properties inhibit excessive collagen deposition, improving long-term outcomes. DCB treatment is now included in guidelines for managing recurrent bulbar strictures less than 3 cm in length. Recent studies, including the ROBUST trials, have demonstrated the efficacy of Optilume in improving the International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax). DCB has also shown a significant reduction in reintervention rates compared with endoscopic treatments in long-term studies, confirming its safety profile. However, the durability of DCB in complex or longer strictures remains uncertain, and its role as a salvage therapy post-urethroplasty requires further investigation. DCB represents a promising, cost-effective advancement in managing recurrent bulbar urethral strictures, particularly for patients unsuitable for urethroplasty. Future research should focus on refining patient selection criteria and exploring indications for other anatomical sites. Full article

Background and Objectives: We aimed to assess the outcomes of upfront Optilume drug-coated balloon (DCB) dilation in patients after failed treatment for complex recurrent urethral stricture disease. All patients presented with acute urinary retention and were treated with DCB dilation regardless of stricture site and length. Materials and Methods: We retrospectively evaluated patients with acute urinary retention and known complex recurrent urethral strictures. Patients presented at the urology emergency room of our tertiary centre with an inability to void or a post-void residual (PVR) volume exceeding 400 mL between August 2021 and February 2024. Urethrography and/or endoscopic imaging confirmed the diagnosis. Patients with urinary tract infection/sepsis and those with neurological disease were excluded. Urethral dilation to 20 Fr was performed, followed by DCB dilation (30 Fr, 10 bar, 10 min). The primary endpoints were anatomical success (≥14 Fr by cystoscopy/calibration) at 12 months and freedom from repeat interventions. Results: Thirty-one consecutive male patients were evaluated, with twenty-six patients followed for ≥12 months (mean age 65 ± 16.8 years). The stricture sites included seven bulbopenile, seven bulbomembranous, seven anastomotic, three bladder neck, one penile, and one panurethral stricture. The median number of prior urethral/surgical interventions was 2 [IQR: 1–3] (range: 1–31). The median stricture length was 3 [IQR: 2–4] cm (range: 1–8). At 12 months, 65.4% (17/26) of subjects voided satisfactorily and were free of recurrence and reoperation. Conclusions: Timely DCB dilation may offer a viable treatment option for patients with complex recurrent urethral strictures and urinary retention, particularly those who are unable or unwilling to undergo surgical reconstruction and prefer to avoid indwelling catheters. Full article

Background: A drug-coated balloon (DCB) is an emerging treatment technology for percutaneous coronary intervention (PCI). However, the prognostic factors of PCI with a DCB remain fully determined. Chronic kidney disease (CKD) is an independent predictor of adverse outcomes in patients with coronary artery disease (CAD) who underwent PCI. The aim of this present study was to clarify the impact of CKD on prognosis in CAD patients who underwent PCI with a DCB. Methods: We enrolled 252 consecutive patients with CAD who underwent PCI with a DCB from 2015 to 2023. The endpoints of this study were composite events including all-cause death, myocardial infarction, target vessel revascularization, stroke, and major bleeding. Results: The prevalence rate of CKD was 48%. Patients with CKD were older and had higher prevalence of hypertension and diabetes mellitus than those without. Kaplan–Meier analysis revealed a significantly higher composite event rate in patients with CKD (log-rank test, p = 0.003). In the multivariate Cox proportional hazards analysis, CKD was independently associated with composite events after adjusting for confounding factors (adjusted hazard ratio 1.985, 95% confidence intervals 1.157–3.406, p = 0.013), mainly driven by all-cause deaths. Conclusions: CKD was associated with unfavorable outcomes in CAD patients who underwent PCI with a DCB. Full article

Drug-coated balloons (DCBs) are designed to deliver an anti-proliferative drug to the stenotic vessel to combat restenosis after an angioplasty treatment. However, significant drug loss can occur during device navigation toward the lesion site, thus reducing the delivery efficiency and increasing the off-target drug loss. In this framework, this study aimed to design a novel in vitro setup to estimate the drug loss due to blood flow–coating interaction during tracking. The system consists of a millifluidic chamber, able to host small drug-coated flat patches representative of DCBs, connected at the inlet to a syringe pump able to provide an ad hoc flow and, at the outlet, to a vial collecting the testing fluid with possible drug removed from the specimen. Unlike other studies, the device presented here uniquely evaluates flow-related drug loss from smaller-scale DCB samples, making it a precise, easy-to-use, and efficient assessment tool. In order to define proper boundary conditions for these washing off tests, computational fluid dynamics (CFD) models of a DCB in an idealized vessel were developed to estimate the wall shear stresses (WSSs) experienced in vivo by the device when inserted into leg arteries. From these simulations, different target WSSs were identified as of interest to be replicated in the in vitro setup. A combined analytical–CFD approach was followed to design the testing system and set the flow rates to be imposed to generate the desired WSSs. Finally, a proof-of-concept study was performed by testing eight coated flat specimens and analyzing drug content via high-performance liquid chromatography (HPLC). Results indicated different amounts of drug loss according to the different imposed WSSs and confirmed the suitability of the designed system to assess the washing off resistance of different drug coatings for angioplasty balloons. Full article

Background: While various techniques for the surgical correction of urethral strictures exist, data on their trends and perioperative outcomes are limited. Methods: Data from the German Nationwide Inpatient Data (GRAND) registry (2005–2023) were used to estimate the trends, baseline characteristics, and perioperative outcomes of the surgical techniques for urethral stricture correction. Results: A total of 500,937 patients underwent surgery. Internal urethrotomy was the most frequently performed procedure (n = 413,095, 82%), followed by urethral dilatation (n = 39,619, 8%), meatoplasty (n = 30,774, 6%), urethroplasty with buccal mucosa (n = 12,351, 2%), urethral excision with primary anastomosis (n = 3428, 0.7%), urethroplasty with preputial skin (n = 1585, 0.3%), and drug-coated balloon dilatation (n = 85, <0.1%). In recent years, internal urethrotomy declined; urethroplasty was relatively stable, and drug-coated balloon dilatation emerged as a promising treatment modality. Internal urethrotomy and urethral dilatation were predominantly performed in older patients (median age of 71 years), while urethroplasty was performed in younger (56 years). Preputial skin urethroplasty had a shorter hospital stay compared to buccal mucosa (−0.4 days, p = 0.02), with no significant differences in transfusion or sepsis rates. Conclusions: Internal urethrotomy remains the most frequently used technique despite declining utilization. Preputial skin urethroplasty presents similar perioperative outcomes compared to buccal mucosa urethroplasty. Full article