Search Results (2,345)

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

Heart failure (HF) is a major global health challenge, characterized by high morbidity, mortality, and frequent hospital readmissions. Despite the advent of guideline-directed medical therapies (GDMTs), the burden of HF continues to grow, necessitating a shift toward comprehensive, multidisciplinary care models. Heart Failure Disease Management Programs (HF-DMPs) have emerged as structured frameworks that integrate evidence-based medical therapy, patient education, telemonitoring, and support for social determinants of health to optimize outcomes and reduce healthcare costs. This review outlines the key components of HF-DMPs, including patient identification and risk stratification, pharmacologic optimization, team-based care, transitional follow-up, remote monitoring, performance metrics, and social support systems. Incorporating tools such as artificial intelligence, pharmacist-led titration, and community health worker support, HF-DMPs represent a scalable approach to improving care delivery. The success of these programs depends on tailored interventions, interdisciplinary collaboration, and health equity-driven strategies. Full article

Background: This study aimed to evaluate prognostic factors of early filtering blebs using anterior segment swept-source optical coherence tomography (AS SS-OCT) in patients with uveitic and neovascular glaucoma. Methods: This retrospective cohort study included 22 eyes from 22 patients who underwent trabeculectomy (11 eyes each with uveitic or neovascular glaucoma). Intrableb characteristics were assessed using AS SS-OCT at 1 month, postoperatively. Surgical success was defined as intraocular pressure (IOP) ≤ 18 mmHg and ≥30% IOP reduction without medication at 12 months. Logistic regression was used to identify the prognostic factors associated with IOP control. Results: Sixteen eyes (72.7%) achieved surgical success, while six (27.3%) were unsuccessful. Eyes with successful IOP control at 12 months showed thicker and less reflective bleb walls with microcysts compared with unsuccessful cases of IOP control, in the early postoperative phase (all p < 0.033). However, IOP at the time of OCT did not significantly differ between the groups (p = 0.083). Multivariate logistic regression analysis revealed that higher bleb wall reflectivity at 1-month post-trabeculectomy was significantly associated with a higher surgical failure rate at 12 months after trabeculectomy (hazard ratio = 1.072, p = 0.032). Conclusions: Early intrableb assessment using AS SS-OCT may be beneficial for managing filtering blebs after trabeculectomy in uveitic and neovascular glaucoma. Higher bleb wall reflectivity in the early post-trabeculectomy phase may indicate poor features of the filtering bleb, suggesting the need for timely interventions for refractory cases. Full article

The aim of the present observational study was to evaluate the early effect of free-form essential amino acid (EAA) supplementation on cardiac and muscular performance in elderly patients with chronic heart failure (HF) with reduced ejection fraction (HFrEF) and sarcopenia, as add-on to the optimized medical therapy (OMT) for HF. The present study included 60 elderly Caucasian patients suffering from HFrEF and sarcopenia. At the baseline and at follow-up, all patients underwent complete physical examination with the determination of the main anthropometric and hemodynamic parameters. After 6 months of supplementation with EAAs, we observed significant improvements in the parameters of sarcopenia. In addition, there was a significant improvement in glycol-metabolic parameters, and in inflammatory index as high sensitivity C-reactive protein (hs-CRP). In accordance with these results, significant decreases were observed in circulating levels of oxidative stress biomarkers Nox-2 (p < 0.001) and 8-Isoprostane (p < 0.001), and platelet aggregation biomarkers such as sP-Selectin (p < 0.001) and Gp-VI (p < 0.001). Of particular interest, after 6 months’ follow-up, there was a significant improvement in LVEF and global longitudinal strain (GLS). In conclusion, this study demonstrates that targeted nutritional intervention with EEAAs represents a viable therapeutic strategy for addressing the complex interplay between cardiac dysfunction and skeletal muscle wasting in elderly HF patients. Full article

CT scanners are essential tools in modern medical imaging. Sudden failures of their X-ray tubes can lead to equipment downtime, affecting healthcare services and patient diagnosis. However, existing prediction methods based on a single model struggle to adapt to the multi-stage variation characteristics of tube lifespan and have limited modeling capabilities for temporal features. To address these issues, this paper proposes an intelligent prediction architecture for CT tubes’ remaining useful life based on a dual-branch neural network. This architecture consists of two specialized branches: a residual self-attention BiLSTM (RSA-BiLSTM) and a multi-layer dilation temporal convolutional network (D-TCN). The RSA-BiLSTM branch extracts multi-scale features and also enhances the long-term dependency modeling capability for temporal data. The D-TCN branch captures multi-scale temporal features through multi-layer dilated convolutions, effectively handling non-linear changes in the degradation phase. Furthermore, a dynamic phase detector is applied to integrate the prediction results from both branches. In terms of optimization strategy, a dynamically weighted triplet mixed loss function is designed to adjust the weight ratios of different prediction tasks, effectively solving the problems of sample imbalance and uneven prediction accuracy. Experimental results using leave-one-out cross-validation (LOOCV) on six different CT tube datasets show that the proposed method achieved significant advantages over five comparison models, with an average MSE of 2.92, MAE of 0.46, and R² of 0.77. The LOOCV strategy ensures robust evaluation by testing each tube dataset independently while training on the remaining five, providing reliable generalization assessment across different CT equipment. Ablation experiments further confirmed that the collaborative design of multiple components is significant for improving the accuracy of X-ray tubes remaining life prediction. 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

Aims: Sinus tachycardia after heart transplantation (HTX) due to cardiac graft denervation is associated with reduced post-transplant survival and requires adequate treatment. We analyzed the long-term effects of heart rate control with ivabradine or metoprolol succinate in HTX recipients. Methods: This observational retrospective single-center study analyzed the ten-year results of 110 patients receiving ivabradine (n = 54) or metoprolol succinate (n = 56) after HTX. Analysis included comparison of demographics, medications, heart rates, blood pressure values, echocardiographic features, cardiac catheterization data, cardiac biomarkers, and post-transplant survival including causes of death. Results: Both groups showed no significant differences concerning demographics or medications (except for ivabradine and metoprolol succinate). At 10-year follow-up, HTX recipients with ivabradine showed a significantly lower heart rate (72.7 ± 8.5 bpm) compared to baseline (88.8 ± 7.6 bpm; p < 0.001) and to metoprolol succinate (80.1 ± 8.1 bpm; p < 0.001), a significantly lower NT-proBNP level (588.4 ± 461.4 pg/mL) compared to baseline (3849.7 ± 1960.0 pg/mL; p < 0.001) and to metoprolol succinate (1229.0 ± 1098.6 pg/mL; p = 0.005), a significantly lower overall mortality (20.4% versus 46.4%; p = 0.004), and mortality due to graft failure (1.9% versus 21.4%; p = 0.001). Multivariate analysis showed a significantly decreased risk of death within 10 years after HTX in patients with post-transplant use of ivabradine (HR 0.374, CI 0.182–0.770; p = 0.008). Conclusions: In this single-center trial, patients with ivabradine revealed a significantly more pronounced heart rate reduction, a lower NT-proBNP level, and a superior 10-year survival after HTX. Full article

Background: Pain is a complex phenomenon characterized by unpleasant experiences with profound heterogeneity influenced by biological, psychological, and social factors. According to the National Health Interview Survey, 50.2 million U.S. adults (20.5%) experience pain on most days, with the annual cost of prescription medication for pain reaching approximately USD 17.8 billion. Theranostic pain nanomedicine therefore emerges as an attractive analgesic strategy with the potential for increased efficacy, reduced side-effects, and treatment personalization. Theranostic nanomedicine combines drug delivery and diagnostic features, allowing for real-time monitoring of analgesic efficacy in vivo using molecular imaging. However, clinical translation of these nanomedicines are challenging due to complex manufacturing methodologies, lack of standardized quality control, and potentially high costs. Quality by Design (QbD) can navigate these challenges and lead to the development of an optimal pain nanomedicine. Our lab previously reported a macrophage-targeted perfluorocarbon nanoemulsion (PFC NE) that demonstrated analgesic efficacy across multiple rodent pain models in both sexes. Here, we report PFC-free, biphasic nanoemulsions formulated with a biocompatible and non-immunogenic plant-based coconut oil loaded with a COX-2 inhibitor and a clinical-grade, indocyanine green (ICG) near-infrared fluorescent (NIRF) dye for parenteral theranostic analgesic nanomedicine. Methods: Critical process parameters and material attributes were identified through the FMECA (Failure, Modes, Effects, and Criticality Analysis) method and optimized using a 3 × 2 full-factorial design of experiments. We investigated the impact of the oil-to-surfactant ratio (w/w) with three different surfactant systems on the colloidal properties of NE. Small-scale (100 mL) batches were manufactured using sonication and microfluidization, and the final formulation was scaled up to 500 mL with microfluidization. The colloidal stability of NE was assessed using dynamic light scattering (DLS) and drug quantification was conducted through reverse-phase HPLC. An in vitro drug release study was conducted using the dialysis bag method, accompanied by HPLC quantification. The formulation was further evaluated for cell viability, cellular uptake, and COX-2 inhibition in the RAW 264.7 macrophage cell line. Results: Nanoemulsion droplet size increased with a higher oil-to-surfactant ratio (w/w) but was no significant impact by the type of surfactant system used. Thermal cycling and serum stability studies confirmed NE colloidal stability upon exposure to high and low temperatures and biological fluids. We also demonstrated the necessity of a solubilizer for long-term fluorescence stability of ICG. The nanoemulsion showed no cellular toxicity and effectively inhibited PGE2 in activated macrophages. Conclusions: To our knowledge, this is the first instance of a celecoxib-loaded theranostic platform developed using a plant-derived hydrocarbon oil, applying the QbD approach that demonstrated COX-2 inhibition. Full article

Background: Right ventricular (RV) dysfunction is associated with poor clinical outcomes in critically ill sepsis patients, but its pathophysiology and predictors are incompletely characterized. We aimed to investigate the predictors of RV dysfunction and its outcomes in sepsis patients admitted to the intensive care unit (ICU). Methods: This is a single-center retrospective cohort study of adult patients admitted to the ICU for sepsis who had echocardiography within 72 h of diagnosis. Patients with acute coronary syndrome, acute decompensated heart failure, or significant valvular dysfunction were excluded. RV dysfunction was defined as the presence of RV dilation, hypokinesis, or both. Demographics and clinical outcomes were obtained from electronic medical records. Results: A total of 361 patients were included in our study—47 with and 314 without RV dysfunction. The mean age of the population was 66.8 years and 54.6% were females. Compared to those without RV dysfunction, patients with RV dysfunction were more likely to require mechanical ventilation (63.8% vs. 43.9%, p = 0.01) and vasopressor support (61.7% vs. 36.6%, p < 0.01). On multivariate logistic regression analysis, increasing age (OR 1.03, 95% C.I. 1.00–1.06), a history of HIV infection (OR 5.88, 95% C.I. 1.57–22.11) and atrial fibrillation (OR 4.34, 95% C.I. 1.83–10.29), and presence of LV systolic dysfunction (OR 14.40, 95% C.I. 5.63–36.84) were independently associated with RV dysfunction. Patients with RV dysfunction had significantly worse 30-day survival (Log-Rank p = 0.023). On multivariate Cox regression analysis, older age (HR 1.02, 95% C.I. 1.00–1.04) and peak lactate (HR 1.16, 95% C.I. 1.11–1.21) were independent predictors of 30-day mortality. Conclusions: Among other findings, our data suggests a possible association between a history of HIV infection and RV dysfunction in critically ill sepsis patients, and this should be investigated further in future studies. Patients with evidence of RV dysfunction had poorer survival in this population; however this was not an independent predictor of mortality in the multivariate analysis. A larger cohort with a longer follow-up period may provide further insights. Full article

This study focuses on analyzing progressive Type-II right censoring competing risks datasets. The latent causes of failures are assumed to follow independent generalized linear exponential distributions. The maximum likelihood and maximum product of spacing methods are employed to estimate the unknown parameters and survival indices. Furthermore, approximate confidence intervals are derived using the asymptotic normality of the maximum likelihood and the maximum product of spacing estimators. Additionally, bootstrap methods are employed to construct confidence intervals. A comprehensive simulation study is carried out to evaluate the effectiveness of these estimation approaches. Finally, real-world datasets are analyzed to illustrate the practical applicability of the proposed model. Full article

Background/Objectives: Anti-tumour necrosis factor (anti-TNF) medications were historically commonly prescribed as the first-line biologic treatment for chronic inflammatory pouch conditions. However, their use in these conditions is mainly based on retrospective studies of relatively small numbers of patients with short follow up periods. We aimed to describe the long-term outcomes of first-line anti-TNF therapy in a large, multi-centre, multi-national patient cohort with chronic inflammatory pouch conditions. Methods: This was an observational, retrospective, multi-centre, multi-national study. We included patients with chronic inflammatory pouch conditions initially treated with anti-TNF drugs infliximab (IFX) or adalimumab (ADA), who had a follow up of at least 1 year. The primary outcome was anti-TNF treatment persistence, defined as continuation of anti-TNF throughout the study period. The secondary outcome was pouch failure, defined by the need for a defunctioning ileostomy or pouch excision. Results: We recruited 98 patients with chronic inflammatory pouch conditions initially treated with anti-TNF medications—63 (64.3%) treated with IFX and 35 (35.7%) treated with ADA. Average follow up length was 94.2 months (±54.5). At the end of the study period only 22/98 (22.4%) patients were still on anti-TNF treatment. In those in whom the first-line anti-TNF was discontinued, the median time to discontinuation was 12.2 months (range 5.1–26.9 months). The most common cause for anti-TNF discontinuation was lack of efficacy despite adequate serum drug levels and absence of anti-drug antibody formation (30 patients, 30.6%). Loss of response due to anti-drug antibody formation was the cause for discontinuation in 18 patients (18.4%), while 12 patients (12.2%) stopped treatment because of adverse events or safety concerns. Out of the 76 patients discontinuing anti-TNF treatment, 34 (34.7% of the cohort) developed pouch failure, and 42 (42.8% of the cohort) are currently treated with a different medical therapy. Conclusions: First-line anti-TNF therapy for chronic pouch inflammatory conditions is associated with low long-term persistence rates. This is due to a combination of lack of efficacy and adverse events. A significant percentage of patients initially treated with anti-TNF therapy develop pouch failure. 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

The development of severe SARS-CoV-2 pneumonia is characterized by extensive lung inflammation, which, in turn, leads to respiratory distress and a decline in blood oxygen levels. Hospital admission, along with intensive care or ventilator usage, becomes necessary because this condition leads to serious respiratory problems. This review aims to provide a comprehensive overview of the pathophysiological mechanisms, diagnostic methods, and current therapeutic options for pneumonia caused by the SARS-CoV-2 virus. The pathophysiological process of severe pneumonia due to SARS-CoV-2 infection is characterized by direct lung damage from viral replication, an excessive immune system response, inflammation, impaired gas exchange, and multi-organ failure. The coexistence of various medical conditions leads to substantial lung impairment, resulting in hypoxia and respiratory failure, which can ultimately lead to fatal outcomes. The diagnosis of severe SARS-CoV-2 pneumonia is made through a combination of clinical, radiologic, and laboratory findings. A multifaceted approach integrating antiviral therapy, corticosteroids, oxygen supplementation, ventilatory management, and immunomodulation is imperative to control inflammation and enhance clinical outcomes. Early intervention, meticulous monitoring, and personalized care are paramount for enhancing survival and mitigating complications in critically ill patients with COVID-19 pneumonia. Full article

Background: Human metapneumovirus (hMPV) is a respiratory pathogen that causes illness ranging from mild upper respiratory tract infections to severe pneumonia, particularly in individuals with comorbidities. Fatal cases of hMPV-induced hemorrhagic pneumonia are rare and likely under-reported. Diagnosis is often delayed due to overlapping symptoms with other respiratory viruses and the rapid progression of the disease. Case presentation: We report the case of a 55-year-old man with a complex medical history, including liver cirrhosis and diabetes mellitus, who developed acute viral pneumonia. Initial symptoms appeared three days before a sudden clinical deterioration marked by shortness of breath, hemoptysis, and respiratory failure. A nasopharyngeal swab taken on the third day of illness tested positive for hMPV by qRT-PCR. The patient died the following day. Postmortem molecular testing confirmed hMPV in lung tissue and alveolar contents. Autopsy revealed bilateral hemorrhagic pneumonia with regional lymphadenopathy. Histopathological examination showed alveolar hemorrhage, multinucleated cells, neutrophilic infiltration, activated autophagy in macrophages, and numerous cytoplasmic eosinophilic viral inclusions. Conclusions: This is the first documented case of fatal hMPV pneumonia in Armenia. It highlights the potential severity of hMPV in adults with chronic health conditions and emphasizes the need for timely molecular diagnostics. Postmortem identification of characteristic viral inclusions may serve as a cost-effective histopathological marker of hMPV-associated lung pathology. Full article