Search Results (2,044)

Restenosis is the main cause of failure after stent implantation during angioplasty. The localized, sustained delivery of an antirestenotic drug may reduce smooth muscle cell (SMCs) proliferation and thereby limit neointimal hyperplasia. The aim of this study was to develop degradable sirolimus-eluting polymer coatings that can be applied on bioresorbable polymer-based scaffolds via an ultrasonic coating system. This is a novel approach because the detailed analysis of the coating procedure on bioresorbable polymeric scaffolds with the use of an ultrasonic system has not been reported thus far. It has been observed that the ultrasonic technique facilitates formation of a smooth coating, well-integrated with the scaffold. However, the drug dose is affected by the concentration of the coating solution and the number of layers. Therefore, these parameters can be used for tailoring the drug dose and release process. Although all types of the developed coatings provided sirolimus elution for at least 3 months, a more uniform, diffusion-controlled release profile was observed from coatings obtained from the 1.0% polymeric solution. The released drug showed antiproliferative activity against vascular SMCs, without any hemolytic or thrombogenic effects. The results of the study may be advantageous for further progress in the development and medical translation of polymeric vascular scaffolds with antirestenotic activity. Full article

Polyetheretherketone (PEEK) is a semi-crystalline thermoplastic polymer which, due to its very high mechanical properties and high chemical resistance, has found application in the automotive, aerospace, chemical, food and medical (biomedical engineering) industries. Owing to the use of additive technologies, particularly the Fused Filament Fabrication (FFF) method, this material is the most widely used plastic to produce skull reconstruction implants, parts of dental implants and orthopedic implants, including spinal, knee and hip implants. PEEK enables the creation of personalized implants, which not only have greater elasticity compared to implants made of metal alloys but also resemble the physical properties of the cortical layer of human bone in terms of their mechanical properties. Therefore, the aim of this article is to characterize polyether ether ketone as an alternative material used in the manufacturing of implants in orthopedics and dentistry. Full article

Total knee replacement (TKR) is a common procedure for pain relief and restoration of the mobility of the knee joint in patients with severe knee joint problems. Despite this, some patients still suffer from stiffness, instability, or pain caused by soft tissue imbalance, malalignment, or implant-related issues. Previously, surgeons have had to use their experience and visual judgment to balance the knee, which has resulted in variability of outcomes. Smart knee implants are addressing these issues by using sensor technology to provide real-time feedback on joint motion, pressure distribution, and loading forces. This enables more accurate intra-operative adjustment, enhancing implant positioning and soft tissue balance and eliminating post-operative adjustment. These implants also enable post-operative monitoring, simplifying the ability to have more effective individualized rehabilitation programs directed at optimizing patient mobility and minimizing complications. While the patient pool for smart knee implantation remains not commonly documented, it was found in a study that 83.6% of the patients would opt to have the monitoring device implemented, and nearly 90% find reassurance in monitoring their healing indicators. As the number of knee replacements is likely to rise due to aging populations and the rising prevalence of joint disease, smart implants are a welcome development in orthopedics, optimizing long-term success and patient satisfaction. Smart knee implants are built with embedded sensors such as force, motion, temperature, and pressure detectors placed within the implant structure. These sensors provide real-time data during surgery and recovery, allowing earlier detection of complications and supporting tailored rehabilitation. The design aims to improve outcomes through better monitoring and personalized care. Full article

Background and Objectives: Transcatheter heart valve (THV) selection is challenging as self-expanding valves (SEVs) are associated with lower post-procedural mean aortic gradients, while balloon-expandable valves (BEVs) have lower rates of paravalvular leak (PVL) and permanent pacemaker implantation (PPI). We aimed to compare the 30-day and 1-year outcomes following Myval BEV (Meril Life Sciences, Vapi, Gujarat, India) and intra-annular Portico SEV (Abbott, St. Paul, MN, USA) implantation. Materials and Methods: We retrospectively analyzed the data from the all-comer TAVI registry of the University Medical Centre Ljubljana, Slovenia, from October 2017 to August 2023. Safety and efficacy outcomes following Myval BEV and Portico SEV implantation were compared overall and after propensity score matching. Results: Of the total 1152 THVs implanted, 97 patients (8%) received a Myval BEV and 47 (4%) a Portico SEV. After propensity score matching, there were no significant differences between the two patient cohorts regarding 30-day (Myval 0.0% vs. Portico 2.9%, p = 1.000) and 1-year mortality (Myval 0.0% vs. Portico 5.9%, p = 0.492). Likewise, the rates of new PPI, device failure (mean aortic gradient and more than mild PVL), and periprocedural in-hospital complications were comparable between the two groups. Conclusions: In this retrospective analysis of two intra-annular THVs, the Myval BEV was associated with comparable short- and mid-term outcomes as the Portico SEV. Full article

Biofilms are structured communities of microorganisms encased in a self-produced extracellular matrix, and they represent one of the most widespread forms of microbial life on Earth. Their presence poses serious challenges in both environmental and clinical settings. In natural and industrial systems, biofilms contribute to water contamination, pipeline corrosion, and biofouling. Clinically, biofilm-associated infections are responsible for approximately 80% of all microbial infections, including endocarditis, osteomyelitis, cystic fibrosis, and chronic sinusitis. A particularly critical concern is their colonization of medical devices, where biofilms can lead to chronic infections, implant failure, and increased mortality. Implantable devices, such as orthopedic implants, cardiac pacemakers, cochlear implants, urinary catheters, and hernia meshes, are highly susceptible to microbial attachment and biofilm development. These infections are often recalcitrant to conventional antibiotics and frequently necessitate surgical revision. In the United States, over 500,000 biofilm-related implant infections occur annually, with prosthetic joint infections alone projected to incur revision surgery costs exceeding USD 500 million per year—a figure expected to rise to USD 1.62 billion by 2030. To address these challenges, surface modification of medical devices has emerged as a promising strategy to prevent bacterial adhesion and biofilm formation. This review focuses on recent advances in chemical surface functionalization using non-antibiotic agents, such as enzymes, chelating agents, quorum sensing quenching factors, biosurfactants, oxidizing compounds and nanoparticles, designed to enhance antifouling and mature biofilm eradication properties. These approaches aim not only to prevent device-associated infections but also to reduce dependence on antibiotics and mitigate the development of antimicrobial resistance. Full article

The growing demand for sustainable materials has led to increased interest in biodegradable polymer fibers and nonwoven mats due to their eco-friendly characteristics and potential to reduce plastic pollution. This review highlights how mechanical properties influence the performance and suitability of biodegradable polymer fibers across diverse applications. This covers synthetic polymers such as polylactic acid (PLA), polyhydroxyalkanoates (PHAs), polycaprolactone (PCL), polyglycolic acid (PGA), and polyvinyl alcohol (PVA), as well as natural polymers including chitosan, collagen, cellulose, alginate, silk fibroin, and starch-based polymers. A range of fiber production methods is discussed, including electrospinning, centrifugal spinning, spunbonding, melt blowing, melt spinning, and wet spinning, with attention to how each technique influences tensile strength, elongation, and modulus. The review also addresses advances in composite fibers, nanoparticle incorporation, crosslinking methods, and post-processing strategies that improve mechanical behavior. In addition, mechanical testing techniques such as tensile test machine, atomic force microscopy, and dynamic mechanical analysis are examined to show how fabrication parameters influence fiber performance. This review examines the mechanical performance of biodegradable polymer fibers and fibrous mats, emphasizing their potential as sustainable alternatives to conventional materials in applications such as tissue engineering, drug delivery, medical implants, wound dressings, packaging, and filtration. Full article

Combined trabeculectomy–phacoemulsification is known to provoke more inflammation and yield a poorer long-term efficacy than trabeculectomy alone. This study evaluates whether a similar trend exists for Ahmed glaucoma valve implantation when performed with or without concurrent phacoemulsification. We retrospectively analyzed 51 eyes from patients who underwent either Ahmed-Alone (n = 25) or PhacoAhmed (n = 26) surgery over a 5-year period. The primary outcomes included intraocular pressure (IOP), the use of IOP-lowering medications, and the need for further surgical intervention. Absolute success was defined as IOP reduction > 20% and IOP < 21 mmHg without medication; relative success allowed for continued pharmacologic therapy. Both groups showed a significant IOP reduction, with similar final mean IOP values (Ahmed-Alone: 14.02 ± 4.76 mmHg; PhacoAhmed: 13.89 ± 4.17 mmHg; p = 0.99) and comparable reductions in medication use (p = 0.52). Reinterventions occurred less frequently and later in the PhacoAhmed group (12% vs. 27.3%; median time: 27.1 vs. 12 months). Absolute success was not achieved in any PhacoAhmed case but occurred in 9.3% of Ahmed-Alone cases; relative success rates were similar (83.3% vs. 81.4%; p = 0.291). These findings suggest that combining phacoemulsification with Ahmed valve implantation does not significantly alter efficacy or safety profiles. Additional prospective studies are warranted to assess long-term outcomes. Full article

Introduction and Objectives: Risk-sharing agreements (RSAs) have emerged as a key strategy for financing high-cost medical technologies while ensuring financial sustainability. These payment mechanisms mitigate clinical and financial uncertainties, optimizing pricing and reimbursement decisions. Despite their widespread adoption globally, Latin America has reported limited implementation, particularly for high-cost medical devices. This study aims to share insights from designing RSAs in the form of Outcome Protection Programs (OPPs) for medical devices in Latin America from the perspective of a medical devices company. Methods: The report follows a structured approach, defining key OPP dimensions: payment base, access criteria, pricing schemes, risk assessment, and performance incentives. Risks were categorized as financial, clinical, and operational. The framework applied principles from prior models, emphasizing negotiation, program design, implementation, and evaluation. A multidisciplinary task force analyzed patient needs, provider motivations, and payer constraints to ensure alignment with health system priorities. Results: Over two semesters, a panel of seven experts from the manufacturer designed n = 105 innovative payment programs implemented in Argentina (n = 7), Brazil (n = 7), Colombia (n = 75), Mexico (n = 9), Panama (n = 4), and Puerto Rico (n = 3). The programs targeted eight high-burden conditions, including Coronary Artery Disease, atrial fibrillation, Heart Failure, and post-implantation arrhythmias, among others. Private providers accounted for 80% of experiences. Challenges include clinical inertia and operational complexities, necessitating structured training and monitoring mechanisms. Conclusions: Outcome Protection Programs offer a viable and practical risk-sharing approach to financing high-cost medical devices in Latin America. Their implementation requires careful stakeholder alignment, clear eligibility criteria and endpoints, and robust monitoring frameworks. These findings contribute to the ongoing dialogue on sustainable healthcare financing, emphasizing the need for tailored approaches in resource-constrained settings. Full article

Plaque erosion (PE) is now recognized as a common and clinically significant cause of acute coronary syndromes (ACSs), accounting for up to 40% of cases. Unlike plaque rupture (PR), PE involves superficial endothelial loss over an intact fibrous cap and occurs in a low-inflammatory setting, typically affecting younger patients, women, and smokers with fewer traditional risk factors. The growing recognition of PE has been driven by high-resolution intracoronary imaging, particularly optical coherence tomography (OCT), which enables in vivo differentiation from PR. Identifying PE with OCT has opened the door to personalized treatment strategies, as explored in recent trials evaluating the safety of deferring stent implantation in selected cases in favor of intensive medical therapy. Given its unexpectedly high prevalence, PE is now recognized as a common pathophysiological mechanism in ACS, rather than a rare exception. This growing awareness underscores the importance of its accurate identification through OCT in clinical practice. Early recognition and a deeper understanding of PE are essential steps toward the implementation of precision medicine, allowing clinicians to move beyond “one-size-fits-all” models toward “mechanism-based” therapeutic strategies. This narrative review aims to offer an integrated overview of PE, tracing its epidemiology, elucidating the molecular and pathophysiological mechanisms involved, outlining its clinical presentations, and placing particular emphasis on diagnostic strategies with OCT, while also discussing emerging therapeutic approaches and future directions for personalized cardiovascular care. Full article

Background: Cardiac implantable electronic device (CIED) infections necessitate extraction and subsequent pacing interventions. Conventional methods after removing the infected CIED system involve temporary or semi-permanent pacing followed by delayed permanent pacemaker (PPM) implantation. Leadless pacemakers (LPs) may offer an alternative, allowing immediate PPM implantation without increasing infection risks. Our objective is to evaluate the safety and cost-effectiveness of LP implantation during the same procedure of CIED extraction, compared to conventional two-stage approaches. Methods: Pacemaker-dependent patients with systemic or pocket infection undergoing device extraction and LP implantation during the same procedure at Sheba Medical Center, Israel, were compared to a historical group of patients undergoing a semi-permanent (SP) pacemaker implantation during the procedure, followed by a permanent pacemaker implantation. Results: The cohort included 87 patients, 45 undergoing LP implantation and 42 SP implantation during the extraction procedure. The LP group demonstrated shorter intensive care unit stay (1 ± 3 days vs. 7 ± 12 days, p < 0.001) and overall hospital days (11 ± 24 days vs. 17 ± 17 days, p < 0.001). Rates of infection relapse and one-year mortality were comparable between groups. Economic analysis revealed comparable total costs, despite the higher initial expense of LPs. Conclusions: LP implantation during CIED extraction offers significant clinical and logistical advantages, including reduced hospital stays and streamlined treatment, with comparable safety and cost-effectiveness to conventional approaches. Full article

Background: Aortic stenosis (AS) is the most common valvular heart disease, associated with poor outcomes if left untreated. Current guidelines recommend that transcatheter aortic valve implantation (TAVI) procedures be performed in hospitals with an on-site cardiac surgery unit due to potential complications requiring surgical intervention. Objective: Based on our experience, we evaluated the feasibility and outcomes of implementing a TAVI program in a cardiology department without an on-site cardiac surgery unit, in collaboration with a remote hospital for surgical backup. Methods: The TAVI program involved pre- and post-procedural evaluations conducted at Meir Medical Center (Kfar Saba, Israel) with a remote surgical team available. The study population included 149 consecutive patients with severe aortic stenosis treated at the Meir valve clinic between November 2019 and December 2023. Procedures were performed by the center’s interventional cardiology team. Results: The mean age of the 149 patients was 80 ± 6 years, and 75 (50%) were female. The average STS score was 4.3, and the EuroSCORE II was 3.1. Among the patients, 68 (45%) were classified as New York Heart Association (NYHA) class III-IV. The valve types used included ACURATE neo2 (57 patients, 38%), Edwards SAPIEN 3 (43 patients, 28%), Evolut-PRO (41 patients, 27%), and Navitor (7 patients, 4%). There were no cases of moderate to severe paravalvular leak and no elevated post-implantation gradients, and there was no need for urgent cardiac surgery. One case of valve embolization was successfully managed percutaneously during the procedure. In-hospital follow-up revealed no deaths and only one major vascular complication. At one-year follow-up, six patients had died, with only one death attributed to cardiac causes. Conclusions: Our findings support the safe and effective performance of transfemoral TAVI in cardiology departments without on-site cardiac surgery, in collaboration with a remote surgical team. Further prospective, multicenter studies are warranted to confirm these results and guide broader clinical implementation of this practice. Full article

Cardiogenic shock (CS) in the setting of severe aortic stenosis (AS) presents a critical and high-risk scenario with limited therapeutic options and poor prognosis. Transcatheter aortic valve implantation (TAVI), initially reserved for inoperable or high-risk surgical candidates, is increasingly being considered in patients with CS due to improvements in device technology, operator experience, and supportive care. This review synthesizes current evidence from large registries, observational studies, and meta-analyses that support the feasibility, safety, and potential survival benefit of urgent or emergent TAVI in selected CS patients. Procedural success is high, and early intervention appears to confer improved short-term and mid-term outcomes compared to balloon aortic valvuloplasty or medical therapy alone. Critical factors influencing prognosis include lactate levels, left ventricular ejection fraction, renal function, and timing of intervention. The absence of formal guidelines, logistical constraints, and ethical concerns complicate decision-making in this unstable population. A multidisciplinary Heart Team/Shock Team approach is essential to identify appropriate candidates, manage procedural risk, and guide post-intervention care. Further studies and the development of TAVI-specific risk models in CS are anticipated to refine patient selection and therapeutic strategies. TAVI may represent a transformative option for stabilizing hemodynamics and improving outcomes in this otherwise high-mortality group. Full article

Background: Transforaminal lumbar interbody fusion (TLIF) with static cages is a frequently performed procedure. Larger series focusing on the use of expandable TLIF spacers are less common. Methods: This retrospective, single-center observational cohort study reviewed consecutive patients treated by TLIF using expandable titanium interbody implants (ALTERA™, Globus Medical Inc., Audubon, PA, USA) for degenerative pathologies from L2-S1 between 11/2018 and 09/2023. Surgical parameters, adverse events, radiological outcomes (fusion rate, segmental lordosis, spinopelvic parameters), and clinical outcomes were analyzed through a mean postoperative follow-up of 12 months. Results: This study identified 270 patients (mean age 65 years, 50.4% female) who underwent TLIF with expandable interbody spacers at 324 levels. Clinical outcomes were good or excellent in 74.1% of patients at 3 months and 71.8% at 12 months. Radiographic fusion was achieved in 73.1% of assessable segments at 12 months. Segmental lordosis increased significantly from 17.8° preoperatively to 20.0° at 12 months (p < 0.001). Adverse event (AE) rates were acceptable across all timepoints, with no device failures or device-associated complications observed. Conclusions: This study demonstrates that TLIF with expandable titanium interbody implants was safe, associated with high fusion rates, and enabled significant restoration of segmental lordosis that was maintained during follow-up. Full article

Spinal cord injury (SCI) is a major disability that, to this day, does not have a permanent cure. The spinal cord extends caudally through the body structure of the vertebral column and is part of the central nervous system (CNS). The spinal cord enables neural communication and motor coordination, so injuries can disrupt sensation, movement, and autonomic functions. Mechanical and traumatic damage to the spinal cord causes lesions to the nerves, resulting in the disruption of relayed messages to the extremities. Various forms of treatment for the spinal cord include functional electrical stimulation (FES), epidural electrical stimulation (EES), ‘SMART’ devices, exoskeleton and robotic systems, transcranial magnetic stimulation, and neuroprostheses using AI for the brain–computer interface. This research is going to analyse and review these current treatment methods for spinal cord injury and identify the current gaps and limitations in these, such as long-term biocompatibility, wireless adaptability, cost, regulatory barriers, and risk of surgery. Future advancements should work on implementing wireless data logging with AI algorithms to increase SCI device adaptability, as well as maintaining regulatory and health system integration. Full article

This study evaluated the effects of low-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) coating in combination with vacuum plasma treatment on titanium implants, aiming to enhance osseointegration and bone regeneration while minimizing the adverse effects associated with high-dose rhBMP-2. In vitro analyses demonstrated that plasma treatment increased surface energy, promoting cell adhesion and proliferation. Additionally, it facilitated sustained rhBMP-2 release by enhancing protein binding to the implant surface. In vivo experiments using the four-beagle mandibular defect model were conducted with the following four groups: un-treated implants, rhBMP-2–coated implants, plasma-treated implants, and implants treated with both rhBMP-2 and plasma. Micro-computed tomography (micro-CT) and medical CT analyses revealed a significantly greater volume of newly formed bone in the combined treatment group (p < 0.05). Histological evaluation further confirmed superior outcomes in the combined group, showing significantly higher bone-to-implant contact (BIC), new bone area (NBA), and inter-thread bone density (ITBD) compared to the other groups (p < 0.05). These findings indicate that vacuum plasma treatment enhances the biological efficacy of low-dose rhBMP-2, representing a promising strategy to improve implant integration in compromised conditions. Further studies are warranted to determine the optimal clinical dosage. Full article