Search Results (2,852)

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

Background: Neurogenic bladder (NB) in children may lead to recurrent urinary tract infections (UTIs), renal deterioration, and a reduced quality of life. Clean intermittent catheterization (CIC) is the standard of care, but in some patients, CIC may be unfeasible due to anatomical, sensory, or compliance issues. Button cystostomy (BC) has emerged as a minimally invasive, bladder-preserving alternative. This study aimed to assess the feasibility, safety, and outcomes in the long-term of BC in pediatric NB patients. Methods: Retrospective analysis was conducted on children with NB who underwent endoscopic BC placement between January 2020 and December 2024 in a tertiary pediatric center. Demographic data, operative time, complications, and follow-up outcomes were collected. All procedures used an endoscopic approach with cystoscopic guidance for safe device placement. Results: Thirty-three patients (25 males; median age 7.96 years) underwent BC placement. Most had spinal dysraphism (63.6%). The mean operative time was 48.5 ± 6 min. During a mean follow-up of 2.1 ± 1.4 years, five patients (15.2%) had febrile UTIs and two had minor leakage. No major complications occurred. Four buttons were removed due to clinical improvement (N = 1), the fashioning of a continent derivation (N = 1) and implantation of a sacral neuromodulator (N = 2); two patients accepted CIC. Satisfaction was reported by 93.9% of families. Conclusions: BC is an effective, minimally invasive alternative for urinary drainage in children with NB, even when compared to continent diversion techniques such as the Mitrofanoff, due to its lower invasiveness, greater feasibility, and lower complication rate. Broader adoption may be warranted, but prospective studies are needed to confirm long-term outcomes. 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 aim of this review is to investigate the possibility of fabricating coatings functionalized with bioactive molecules. These coatings are interesting when applied to biomedical devices, particularly in the orthopedic field. In fact, the application of calcium phosphate-based coatings on the surface of implanted devices is an effective strategy to increase their osteoinductive and osseointegrative properties. Several coating fabrication technologies are presented, including chemical deposition and physical methods. The application of bioactive molecules in combination with calcium phosphate coatings may improve their osteointegrative, antibacterial, and antitumor properties, therefore increasing the performance of implantable devices. Full article

Background: Despite the survival benefit of ICDs in patients with HFrEF, most recipients do not receive appropriate therapy during follow-up. Existing risk models based on echocardiographic and clinical parameters show limited predictive accuracy for arrhythmic events. This study aimed to assess whether ECG-derived markers outperform conventional measures in predicting appropriate ICD shocks. Methods: This retrospective observational study included 375 patients with HFrEF who underwent ICD implantation for primary prevention at least six months before study enrollment. Twelve-lead surface ECGs were analyzed for a QTc interval, Tp-e/QT ratio, frontal QRS-T angle, and maximum deflection index (MDI). Clinical, echocardiographic, and arrhythmic event data obtained from device interrogations were evaluated. Receiver operating characteristic (ROC) curve analysis and multivariate logistic regression were performed to identify independent predictors of appropriate ICD shocks. Results: Patients who experienced appropriate ICD shocks had significantly higher rates of a complete bundle branch block, digoxin use, QRS duration, QTc, Tp-e/QT ratio, frontal QRS-T angle, MDI, and right-ventricular pacing ratio. Conversely, beta-blocker use was significantly lower in this group. In multivariate analysis, independent predictors of appropriate shocks included the patient’s digoxin use (OR = 2.931, p = 0.003), beta-blocker use (OR = 0.275, p = 0.002), frontal QRS-T angle (OR = 1.009, p < 0.001), QTc interval (OR = 1.020, p < 0.001), and Tp-e/QT ratio (OR = 4.882, p = 0.050). The frontal QRS-T angle had a cutoff value of 105.5° for predicting appropriate ICD shocks (sensitivity: 73.6%, specificity: 85.2%, AUC = 0.758, p < 0.001). Conclusions: Electrocardiographic markers, particularly the frontal QRS-T angle, QTc interval, and Tp-e/QT ratio, demonstrated superior predictive power for appropriate ICD shocks compared to conventional echocardiographic and clinical measures. These easily obtainable, non-invasive ECG parameters may improve current risk stratification models and support more individualized ICD implantation strategies. Full article

Background: Cardiac surgery patients with pre- or post-operative atrial fibrillation are at an increased risk for thromboembolic stroke, often due left atrial appendage (LAA) thrombus. Surgical LAA exclusion (LAAE) can be performed and must be complete to avoid increased thrombus formation. Methods: This prospective, multi-center, post-market study (NCT05101993) evaluated the long-term safety and performance of the epicardial V-shape AtriClip device. Patients ≥18 years who had received V-shape AtriClip devices during non-emergent cardiac surgery consented to a prospective 12-month follow-up visit and LAA imaging. The primary performance was LAAE without residual left atrium-LAA communication, assessed by imaging at the last follow-up visit. The primary safety was device- or implant procedure-related serious adverse events (SAEs) (death, major bleeding, surgical site infection, pericardial effusion requiring intervention, myocardial infarction) within 30 days. Results: Of 155 patients from 11 U.S. centers, 151 patients had evaluable imaging. Complete LAAE was obtained in all patients. Primary performance in the intent-to-treat population was met, with 97% (95% CI 93.52%, 99.29%; p = 0.0001) complete LAAE. Primary safety was met, with 100% (95% CI 97.75%, 100%; p < 0.0001) of patients free from pre-defined SAEs within 30 days. One device-related SAE was reported, which resolved intraprocedurally. Conclusions: AtriClip V-Clip showed safe and successful LAAE through 12 months of follow-up. 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

Anodal capture, characterized by a different QRS morphology compared to cathodal capture, is a well-known issue in cardiac resynchronization therapy (CRT). Left bundle branch area pacing (LBBAP), a novel physiological pacing technique, is also used as a bailout strategy following failed conventional CRT implantation. In LBBAP, QRS transition, defined by a change in paced QRS morphology, serves as a key marker of successful lead placement. This case report is the first to document both high-output anodal capture and LBBAP-induced QRS transition in a single individual receiving LBBAP with an implantable cardioverter–defibrillator (ICD) as a bailout strategy for failed cardiac resynchronization therapy with defibrillator (CRT-D) implantation. Their coexistence underscores unique device optimization challenges in this emerging approach. 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

Molecular sensor systems, e.g., implantables and wearables, provide extensive health-related monitoring. Glucose sensor systems have historically prevailed in wearable bioanalysis applications due to their continuous and reliable glucose monitoring, a feat not yet accomplished for other biomarkers. However, the advancement of reagentless detection methodologies may facilitate the creation of molecular sensor systems for multiple analytes. Improving the sensitivity and selectivity of molecular sensor systems is also crucial for biomarker detection under intricate physiological circumstances. The term multidomain molecular sensor systems is utilized to refer, in general, to both biological and chemical sensor systems. This review examines methodologies for enhancing signal amplification, improving selectivity, and facilitating reagentless detection in multidomain molecular sensor devices. The review also analyzes the fundamental components of multidomain molecular sensor systems, including substrate materials, bodily fluids, power, and decision-making units. The review article further investigates how extensive data gathered from multidomain molecular sensor systems, in conjunction with current data processing algorithms, facilitate biomarker detection for precision medicine. 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

Tricuspid regurgitation (TR) is a well-recognized factor contributing to adverse outcomes and mortality. Recent developments in transcatheter valve repair techniques, with the emergence of tricuspid transcatheter edge-to-edge repair (TEER) devices, have altered the treatment algorithm of TR and now offer a safe and feasible alternative for the effective management of the disease and an improvement in patient symptoms. Evidence from large studies and registries showcases the benefit of tricuspid interventions in terms of heart failure hospitalization and quality of life; however, most studies do not report a significant benefit in terms of hard outcomes. Even though longer-term follow-up may be needed to identify such differences, it is important to also identify distinct patient phenotypes that would benefit the most from such interventions, moving from pure anatomical criteria to an overall assessment of the patient’s clinical status. Therefore, the aim of this review is to provide updates on potential moderators of the effect of tricuspid TEER, focusing on novel anatomical criteria, right cardiac function, and renal physiology, in order to guide patient selection and provide an insightful discussion on the optimal patient phenotype for future trial design. 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

Background and Objectives: Implantation of cardiac implantable electronic devices (CIEDs) is increasingly performed in elderly and comorbid patients, for whom minimizing perioperative complications—including pain and systemic drug use—is critical. Traditional local infiltration often provides insufficient analgesia. The ultrasound-guided PECS II block, an interfascial regional technique, offers promising analgesic benefits in thoracic wall procedures but remains underutilized in cardiac electrophysiology. Materials and Methods: We conducted a prospective, controlled, non-randomized clinical study including 106 patients undergoing de novo CIED implantation. Patients were assigned to receive either a PECS II block (n = 53) or standard lidocaine-based local anesthesia (n = 53). Pain intensity was assessed using the numeric rating scale (NRS) intraoperatively and at 1, 6, and 12 h postoperatively. Secondary outcomes included the need for rescue analgesia, procedural duration, length of hospitalization, and patient satisfaction. Results: Patients in the PECS II group reported significantly lower NRS scores at all time points (mean intraoperative score: 2.1 ± 1.2 vs. 5.7 ± 1.6, p < 0.001; at 1 h: 2.5 ± 1.5 vs. 6.1 ± 1.7, p < 0.001). Rescue analgesia (metamizole sodium) was required in only four PECS II patients (7.5%) vs. 100% in the control group within 1 h. Hospital stay and procedural time were also modestly reduced in the PECS II group. Patient satisfaction scores were significantly higher in the intervention group. Conclusions: The ultrasound-guided PECS II block significantly reduces perioperative pain and the need for additional analgesia during CIED implantation, offering an effective, safe, and opioid-sparing alternative to conventional local infiltration. Its integration into clinical protocols for device implantation may enhance procedural comfort and recovery. Full article