Search Results (13)

Chronic rhinosinusitis (CRS) is a prevalent inflammatory condition of the nasal and paranasal mucosa that significantly impacts the quality of life. Postoperative inflammation and polyp recurrence remain common despite advances in endoscopic sinus surgery (ESS), prompting interest in localized corticosteroid delivery systems. This review analyzes bioresorbable steroid-releasing implants and corticosteroid-impregnated nasal dressings, focusing on their pharmacologic mechanisms, safety, and clinical outcomes. A synthesis of findings from randomized trials and observational studies was performed, with emphasis on devices such as Propel™, NasoPore, Merocel, SinuBand FP, and gel-based dressings. The Propel implant demonstrated robust evidence for reducing adhesions and inflammation with negligible systemic absorption. NasoPore and Merocel provided structural support and localized steroid delivery but lacked controlled-release kinetics. Gel-based dressings and SinuBand FP offered anatomic adaptability, with limited systemic effects. Some methods showed systemic steroid exposure in cortisol monitoring. Corticosteroid-releasing devices enhance ESS outcomes through localized therapy. While Propel is the most validated, other devices remain viable alternatives in specific clinical contexts. Comprehensive safety monitoring and standardized trials are essential to optimize their integration into postoperative care. 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

Background and Objectives: Percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) is often associated with longer total stent length. Our aim was to evaluate the long-term safety and effectiveness of bioresorbable scaffold (BRS) implantation in CTO to avoid using a full metal jacket. Materials and Methods: We conducted a single-center prospective longitudinal case study including 34 patients who underwent PCI of CTO with at least one BRS and drug-eluting stent (DES) implantation (n = 27) or BRS-only at the Latvian Centre of Cardiology between 2016 and 2018. Quantitative coronary angiography (QCA) and intravascular ultrasound were performed during the index procedure and long-term follow-up. Results: Of 34 patients with a mean age of 60.6 ± 9.5 years, 76.5% were male. The most common CTO artery was the right coronary artery (73.5%, n = 25). The median length of occlusion was 23.0 mm (interquartile range (IQR) = 13.9–32.7), with a total mean BRS/DES length of 49.6 ± 20.4 mm. During the median follow-up of 5.6 years (IQR = 5.0–5.9), the primary endpoint of target vessel re-occlusion occurred in 5.9% (n = 2) of patients. Target lesion revascularization (TLR) was performed in 35.3% (n = 12) of patients, with a mean time to TLR of 62.5 (95% confidence interval (CI), 53.9–71.2) months. Through QCA, there was a statistically significant increase in median residual diameter stenosis (20.1–31.4%, p < 0.01) and residual length of stenosis (5.2–7.1%, p = 0.04) compared with the index procedure. Conclusions: Our study demonstrates that BRS is a safe and feasible option for PCI of CTO, allowing for the avoidance of long segment stenting and ensuring long-term patency of the coronary artery. Full article

Background: The acute coronary syndrome (ACS) continues to be a fundamental indication for revascularization by percutaneous coronary intervention (PCI). Drug-eluting stent (DES) implantation remains a part of contemporary practice but permanent caging of the vascular structure with the metallic stent structure may increase the rate of device-related adverse clinical events. As an alternative to classic metallic DESs, the bioresorbable scaffolds (BRSs) have emerged as a temporary vascular support technology. We evaluated the mid-term outcomes of two generations of bioresorbable scaffolds—Absorb (Abbott-Vascular, Chicago, IL, USA) and Magmaris (Biotronik, Germany)—in patients with non-ST-elevation ACS. Methods: The study cohort consisted of 193 subjects after Magmaris implantation and 160 patients following Absorb implantation in large-vessel lesions. Results: At 2 years, a significantly lower rate of a primary outcome (cardiac death, myocardial infarction, stent thrombosis) was observed with Magmaris (5.2% vs. 15%; p = 0.002). In addition, we observed a significantly lower rate of MI in the target vessel (2.6% vs. 9.4%; p = 0.009) and a lower rate of scaffold thrombosis (0% vs. 3.7%; p = 0.008). The TLF rate between the two groups was not significantly different. Conclusion: Magmaris demonstrated a good safety profile and more favorable clinical outcomes when compared to Absorb in patients with non-ST-elevation ACS. Full article

Prostate cancer is the second most common cancer in males. In the case of locally advanced prostate cancer radical prostatectomy is one of the first-line therapy. However, recurrence after resection of the tumor can appear. Drug-eluting bioresorbable implants acting locally in the area of the tumor or the resection margins, that reduce the risk of recurrence would be advantageous. Electrospinning offers many benefits in terms of local delivery so fiber-forming polyesters and polyestercarbonates which are suitable to be drug-loaded were used in the study to obtain CTX or DTX-loaded electrospun patches for local delivery. After a fast verification step, patches based on the blend of poly(glycolide-ε-caprolactone) and poly(lactide-glycolide) as well as patches obtained with poly(lactide-glycolide- ε-caprolactone) were chosen for long-term study. After three months, 60% of the drug was released from (PGCL/PLGA) + CTX and it was selected for final, anticancer activity analysis with the use of PC-3 and DU145 cells to establish its therapeutic potential. CTX-loaded patches reduced cell growth to 53% and 31% respectively, as compared to drug-free patches. Extracts from drug-free patches showed excellent biocompatibility with the PC-3 cell line. Cabazitaxel-loaded bioresorbable patches are a promising drug delivery system for prostate cancer therapy. Full article

Background: The long-term efficacy and safety of bioresorbable vascular scaffolds (BVS) in real world clinical practice including Magmaris need to be elucidated to better understand performance of this new and evolutive technology. The aim of this study was to evaluate long-term performance of Magmaris, drug-eluting bioresorbable metallic scaffold, in all-comers patients’ population. Methods: We included in this prospective registry first 54 patients (54 ± 11 years; male 46) treated with Magmaris, with at least 30 months of follow-up. Diabetes mellitus and acute coronary syndrome were present in 33 (61%) and 30 (56%) of the patients, respectively. Patients were followed for device- and patient-oriented cardiac events during a median follow-up of 47 months (DOCE–cardiac death, target vessel myocardial infarction, and target lesion revascularization; POCE–all cause death, any myocardial infarction, any revascularization). Results: Event-free survivals for DOCE and POCE were 86.8% and 79.2%, respectively. The rate of DOCE was 7/54 (13%), including in total target vessel myocardial infarction in two patients (4%), target lesion revascularization in six patients (11%), and no cardiac deaths. The rate of POCE was 11/54 (21%), including in total any myocardial infarctions in 3 patients (6%), any revascularization in 11 patients (20%), and no deaths. Definite Magmaris thrombosis occurred in two patients (3.7%), and in-scaffold restenosis developed in five patients (9.3%). Variables associated with DOCE were implantation of ≥2 Magmaris BVS (HR: 5.4; 95%CI: 1.21–24.456; p = 0.027) and total length of Magmaris BVS ≥ 40 mm (HR: 6.4; 95%CI: 1.419–28.855; p = 0.016), whereas previous PCI was the only independent predictor of POCE (HR: 7.4; 95%CI: 2.216–24.613; p = 0.001). Conclusions: The results of the long-term clinical outcome following Magmaris implantation in patients with complex clinical and angiographic features were acceptable and promising. Patients with multi-BVS and longer multi-BVS in lesion implantation were associated with worse clinical outcome. Full article

Background: Diabetes mellitus (DM) is one of the major risk factors contributing to Acute Coronary Syndromes (ACS) and is associated with an increased risk of adverse clinical outcomes following percutaneous coronary intervention (PCI), even when the second generation of drug-eluting stents (DES) is used. In order to overcome the disadvantages of permanent caging of a vessel with metallic DES, bioresorbable scaffold (BRS) technology has been recently developed. However, the prognosis of patients with DM and ACS treated with PCI via subsequent implantation of Magmaris (Biotronik, Berlin, Germany)—a novel magnesium-bioresorbable scaffold—is poorly investigated. Methods: A total of 193 consecutive subjects with non-ST elevation acute coronary syndrome (NSTE-ACS) who, from October 2016 to March 2020, received one or more Magmaris scaffolds were enrolled in this study. The diabetic group was compared with non-diabetic subjects. Results: There were no significant differences in the occurrence of primary endpoints (cardiovascular death, myocardial infarction, and in-stent thrombosis) and principal secondary endpoints (target-lesion failure, scaffold restenosis, death from any reason, and other cardiovascular events) between the two compared groups in a 1-year follow-up period. Conclusions: The early 1-year-outcome of magnesium bioresorbable scaffold (Magmaris) seems to be favorable and suggests that this novel BRS is safe and effective in subjects with NSTE-ACS and co-existing DM. Full article

One of the leading causes of morbidity and mortality worldwide is coronary artery disease, a condition characterized by the narrowing of the artery due to plaque deposits. The standard of care for treating this disease is the introduction of a stent at the lesion site. This life-saving tubular device ensures vessel support, keeping the blood-flow path open so that the cardiac muscle receives its vital nutrients and oxygen supply. Several generations of stents have been iteratively developed towards improving patient outcomes and diminishing adverse side effects following the implanting procedure. Moving from bare-metal stents to drug-eluting stents, and recently reaching bioresorbable stents, this research field is under continuous development. To keep up with how stent technology has advanced in the past few decades, this paper reviews the evolution of these devices, focusing on how they can be further optimized towards creating an ideal vascular scaffold. Full article

Percutaneous coronary interventions with stent-based restorations of vessel patency have become the gold standard in the treatment of acute coronary states. Bioresorbable vascular scaffolds (BVS) have been designed to combine the efficiency of drug-eluting stents (DES) at the time of implantation and the advantages of a lack of foreign body afterwards. Complete resolution of the scaffold was intended to enable the restoration of vasomotor function and reduce the risk of device thrombosis. While early reports demonstrated superiority of BVS over DES, larger-scale application and longer observation exposed major concerns about their use, including lower radial strength and higher risk of thrombosis resulting in higher rate of major adverse cardiac events. Further focus on procedural details and research on the second generation of BVS with novel properties did not allow to unequivocally challenge position of DES. Nevertheless, BVS still have a chance to present superiority in distinctive indications. This review presents an outlook on the available first and second generation BVS and a summary of results of clinical trials on their use. It discusses explanations for unfavorable outcomes, proposed enhancement techniques and a potential niche for the use of BVS. Full article

The limitations of the first-generation everolimus-eluting coronary bioresorbable vascular scaffolds (BVS) have been demonstrated in several randomized controlled trials. Little data are available regarding the outcomes of patients receiving hybrid stenting with both BVS and drug-eluting stents (DES). Of 3144 patients prospectively enrolled in the GABI-Registry, 435 (age 62 ± 10, 19% females, 970 lesions) received at least one BVS and one metal stent (hybrid group). These patients were compared with the remaining 2709 (3308 lesions) who received BVS-only. Patients who had received hybrid stenting had more frequently a history of cardiovascular disease and revascularization (p < 0.05), had less frequently single-vessel disease (p < 0.0001), and the lesions treated in these patients were longer (p < 0.0001) and more frequently complex. Accordingly, the incidence of periprocedural myocardial infarction (p < 0.05) and that of cardiovascular death, target vessel and lesion failure and any PCI at 24 months was lower in the BVS-only group (all p < 0.05). The 24-months rate of definite and probable scaffold thrombosis was 2.7% in the hybrid group and 2.8% in the BVS-only group, that of stent thrombosis in the hybrid group was 1.86%. In multivariable analysis, only implantation in bifurcation lesions emerged as a predictor of device thrombosis, while the device type was not associated with this outcome (p = 0.21). The higher incidence of events in patients receiving hybrid stenting reflects the higher complexity of the lesions in these patients; in patients treated with a hybrid strategy, the type of device implanted did not influence patients´ outcomes. Full article

Bioresorbable scaffolds (BRS) were introduced in clinical practice to overcome the long-term limitations of newer-generation drug-eluting stents. Despite some initial promising results of the Absorb BRS, safety concerns have led to the discontinuation of the commercialization of this device. Several retrospective studies have assessed the impact of the so-called Pre-dilation, Sizing and Post-dilation (PSP) technique concluding that an optimal PSP technique can improve clinical outcomes following BRS implantation. In this article, the definition of the PSP technique, and the current evidence of its impact on clinical outcomes are put in perspective. Additionality, the relationship between the PSP technique and the dual-antiplatelet therapy to prevent scaffold thrombosis is addressed. Finally, the future perspectives of BRS technology in clinical practice are commented. Full article

Coronary artery disease is the leading cause of death worldwide. Conventional balloon angioplasty is associated with high rates of complications such as coronary dissection and vessel recoil. The deployment of bare-metal stents (BMSs) can overcome these problems and achieve a better patency rate than simple balloon angioplasty. It has been shown that the stent design including structure platform, size, length, and strut thickness has a major influence on the clinical results. Even though angioplasty with BMS implantation is widely used in coronary interventions, the restenosis rate due to neointimal hyperplasia remains high. Therefore, drug-eluting stents (DESs) coated with anti-proliferative agents and polymers have been developed to reduce the restenosis rate and improve the clinical outcomes. Although the repeat revascularization rate of DESs is lower than that of BMSs, the long-term stent thrombosis rate is higher than for BMSs. Therefore, new and emerging generations of stents, in which, for example, thinner struts and bioresorbable polymers are used, are available for clinical use. However, there are only a limited number of clinical trials, in which these newer stents have been compared with BMSs and first- and second-generation DESs. The purpose of this review was to provide up-to-date information on the evolution of coronary artery stents from BMSs to DESs to bioresorbable stents (BRSs). Full article

The introduction of metallic drug-eluting stents has reduced the risk of restenosis and widened the indications of percutaneous coronary intervention in treatment of coronary artery disease. However, this medical device can induce hypersensitive reaction that interferes with the endothelialization and healing process resulting in late persistent or acquired malapposition of the permanent metallic implant. Delayed endotheliaization and malapposition may lead to late and very late stent thrombosis. Bioresorbable scaffolds (BRS) have been introduced to potentially overcome these limitations, as they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage. Magnesium is an essential mineral needed for a variety of physiological functions in the human body and its bioresorbable alloy has the strength-to-weight ratio comparable with that of strong aluminum alloys and alloy steels. The aim of this review is to present the new developments in Magnesium BRS technology, to describe its clinical application and to discuss the future prospects of this innovative therapy. Full article