Asundexian versus Apixaban in Patients with Atrial Fibrillation.

BACKGROUND: Stroke prevention with direct-acting oral anticoagulant agents in patients with atrial fibrillation confers a risk of bleeding and limits their use. Asundexian, an activated factor XI (XIa) inhibitor, is an oral anticoagulant that may prevent strokes with less bleeding. METHODS: In a phase 3, international, double-blind trial, we randomly assigned high-risk patients with atrial fibrillation in a 1:1 ratio to receive asundexian at a dose of 50 mg once daily or standard-dose apixaban. The primary efficacy objective was to determine whether asundexian is at least noninferior to apixaban for the prevention of stroke or systemic embolism. The primary safety objective was to determine whether asundexian is superior to apixaban with respect to major bleeding events. RESULTS: A total of 14,810 randomly assigned patients were included in the intention-to-treat population. The mean (±SD) age of the patients was 73.9±7.7 years, 35.2% were women, 18.6% had chronic kidney disease, 18.2% had a previous stroke or transient ischemic attack, 16.8% had received oral anticoagulants for no more than 6 weeks, and the mean CHA2DS2-VASc score (range, 0 to 9, with higher scores indicating a greater risk of stroke) was 4.3±1.3. The trial was stopped prematurely at the recommendation of the independent data monitoring committee. Stroke or systemic embolism occurred in 98 patients (1.3%) assigned to receive asundexian and in 26 (0.4%) assigned to receive apixaban (hazard ratio, 3.79; 95% confidence interval [CI], 2.46 to 5.83). Major bleeding occurred in 17 patients (0.2%) who received asundexian and in 53 (0.7%) who received apixaban (hazard ratio, 0.32; 95% CI, 0.18 to 0.55). The incidence of any adverse event appeared to be similar in the two groups. CONCLUSIONS: Among patients with atrial fibrillation at risk for stroke, treatment with asundexian at a dose of 50 mg once daily was associated with a higher incidence of stroke or systemic embolism than treatment with apixaban in the period before the trial was stopped prematurely. There were fewer major bleeding events with asundexian than with apixaban during this time. (Funded by Bayer; OCEANIC-AF ClinicalTrials.gov number, NCT05643573; EudraCT number, 2022-000758-28.).

Comparing New Smartphone-Connected Handheld Ultrasound Device vs. Traditional Ultrasound in Vitreo-Retinal Disease Diagnosis.

(1) Background: Ocular emergencies account for 1.5-3% of emergency department (ED) visits and require urgent diagnosis to prevent serious complications. Ultrasonography is a crucial, non-invasive diagnostic tool for these conditions but traditionally lacks portability and integration with modern electronic smart devices. The purpose of this study was to assess the accuracy and performance of a new handheld ultrasound device in comparison to a conventional cart-based sonographic machine in patients attending to the ED for vitreo-retinal diseases. (2) Methods: three specialists in ophthalmology, with at least 4-year experience in vitreo-retinal diseases and eye ultrasound, evaluated images of 50 eyes with both portable and traditional ultrasound probes. Each specialist made the diagnosis based on the images captured with both probes and then rated their overall image quality and confidence of diagnosis with a five-point Likert scale. The concordance of diagnosis between the two probes was evaluated. (3) Results: The sample comprised 42 patients. Twenty (40%) healthy eyes and thirty eyes with the following vitreo-retinal interface conditions were examined: 12 retinal detachment (24%), 8 vitreous hemorrhage (16%), and 10 posterior vitreous detachment (20%). The overall accuracy of the two devices appeared to be comparable (70.7% vs. 69.3%). The Butterfly iQ+ probe showed similar sensitivity in retinal detachment diagnosis (91.7% vs. 94.4% of the Accutome B-scan Pro), while it showed poor performance in diagnosing posterior vitreous detachment (sensitivity = 27.2%); (4) Conclusions: The Butterfly iQ+ device demonstrated high sensitivity in the diagnosis of retinal detachment. Significant adjustments are still needed to improve the resolution of the vitreous body.

Innovative Bioscaffolds in Stem Cell and Regenerative Therapies for Corneal Pathologies.

Corneal diseases, which can result in substantial visual impairment and loss of vision, are an important worldwide health issue. The aim of this review was to investigate the novel application of bioscaffolds in stem cell and regenerative treatments for the treatment of corneal disorders. The current literature reports that organic and artificial substances create bioscaffolds that imitate the inherent structure of the cornea, facilitating the attachment, growth, and specialization of stem cells. Sophisticated methods such as electrospinning, 3D bioprinting, and surface modification have been reported to enhance the characteristics of the scaffold. These bioscaffolds have been shown to greatly improve the survival of stem cells and facilitate the regrowth of corneal tissue in both laboratory and live animal experiments. In addition, the incorporation of growth factors and bioactive compounds within the scaffolds can promote a favorable milieu for corneal regeneration. To summarize, the advancement of these groundbreaking bioscaffolds presents a hopeful treatment strategy for the regeneration of the cornea, which has the potential to enhance the results for individuals suffering from corneal disorders. This study highlights the possibility of utilizing the fields of biomaterials science and stem cell treatment to tackle medical demands that have not yet been satisfied in the field of ophthalmology.

The Impact of Frailty and Gender Differences on Hospitalization and Complications in Proximal Femoral Pathological Fractures: A Cross-Sectional Study.

BACKGROUND: Frailty associated with aging increases the risk of falls, disability, and death. The aim of this study is to explore gender-related disparities in the survival outcomes of pathological femoral fractures in older frail patients, while analyzing potential specific prognostic factors. METHODS: This study is a retrospective observational analysis conducted at a single medical center. It enrolled all patients aged 65 and above who were admitted to our emergency department between 2016 and 2020 with a diagnosis of pathological femur fracture requiring surgical intervention. The primary study endpoint was evaluating gender-related differences in survival outcomes. The secondary endpoint involves investigating gender-specific prognostic factors through the analysis of clinical and laboratory parameters. RESULTS: The average Charlson Comorbidity Index (CCI) was slightly lower in men, but the difference was not statistically significant (p = 0.53). The Clinical Frailty Scale (CFS) showed similar results, with men and women 5.23 (SD 1.46), also not significant (p = 0.83). An evaluation comparing patients aged 75 years or younger to those older than 75 years found significant differences in health metrics. The average CCI was higher in the over 75 group compared to the under 75 group, with a p-value of 0.001. Similarly, the CFS average was also greater in the over 75 group than in the under 75 group, with a p-value of 0.0001. Complications were more frequent in patients over 75 and those with lower educational qualifications. The evaluation analyzed cardiac patients compared to a control group, revealing that the average age of cardiac patients was 75.22 years, while the control group was younger at 73.98 years (p = 0.5119). The CCI for cardiac patients averaged 6.53, significantly higher than 4.43 for non-cardiac patients (p = 0.0003). CONCLUSION: Frailty assessment is therefore essential in patients with pathological fracture of the proximal femur and is an important predictor of both gender differences and hospital complications. Enhancing gender analysis in this field is crucial to gather more robust evidence and deeper comprehension of potential sex- and gender-based disparities.

Ocular Implications of COVID-19 Infection and Vaccine-Related Adverse Events.

The COVID-19 pandemic, caused by SARS-CoV-2, has significantly impacted various organ systems, including the eyes. Initially considered a primarily respiratory disease, it is now evident that COVID-19 can induce a range of ocular symptoms. Recognizing these ocular manifestations is crucial for eye care practitioners as they can serve as early indicators of the disease. This review consolidates current evidence on the ocular effects of COVID-19, identifying manifestations such as conjunctivitis, scleritis, uveitis, and retinopathy. The increasing prevalence of these symptoms highlights the importance of thorough eye examinations and detailed patient histories in COVID-19 cases. Potential routes of viral entry into ocular tissues and the underlying mechanisms, including direct infection, immune responses, and vascular involvement, are explored. Additionally, this review addresses ocular side effects associated with COVID-19 vaccines, such as corneal graft rejection, uveitis, and retinal issues. These findings emphasize the need for ongoing surveillance and research to ensure vaccine safety.

Cognitive and morphometric features of mild cognitive impairment reversion in early patients with Parkinson's disease.

INTRODUCTION: Mild cognitive impairment is a common feature of Parkinson's disease (PD-MCI), even at the earliest disease stages. Growing evidence supports the instability of PD-MCI over time, without a consistent linear evolution to dementia, and in some patients, the potential of reversion to normal cognition. However, which features are associated with reversion from PD-MCI to normal cognition in early PD-MCI are not fully known. METHODS: In our longitudinal study of early drug naïve PD patients, 65 of 134 (48 %) patients had PD-MCI at baseline. Study participants underwent comprehensive assessments at baseline and 1-year follow-up. Sixteen (24.6 %) patients with PD-MCI reverted to normal cognition (Reverters), and 49 (75.4 %) had persistent PD-MCI (Non-Reverters) after 1-year follow-up. We performed single- and multiple-variable logistic regression analyses to identify baseline variables predicting reversion of PD-MCI to normal cognition after 1-year. We also compared brain morphometric measures (cortical thickness and volumes) at baseline between the PD-MCI Reverters and Non-Reverters. RESULTS: Higher educational level and better performance on measures of attention and memory at baseline predicted the reversion to normal cognition at 1-year follow-up. Reverters had greater cortical thickness in the left inferior temporal gyrus than Non-Reverters. CONCLUSIONS: Our results show PD-MCI with a higher chance of reverting to normal cognition over time have a higher educational level, better frontotemporal-related cognitive function, and increased thickness of the inferior temporal lobe gyrus. These findings may potentially help researchers to select the candidates for clinical trials focusing on the treatment of cognitive impairment in the early stages of PD.

Association between Mediterranean Diet and Advanced Glycation End Products in University Students: A Cross-Sectional Study.

The aim of this study was to evaluate the association between the Mediterranean diet (MD) and the accumulation of advanced glycation end products (AGEs) measured by skin autofluorescence. This cross-sectional study included 1016 healthy students from the University of Split, Croatia. Participants completed a self-administered questionnaire. Adherence to the MD was assessed using the Mediterranean Diet Serving Score (MDSS), and tissue AGEs accumulation was measured using the AGE Reader mu (DiagnOptics). Multivariate linear regression was used in the analysis. Students' age and female gender were associated with higher levels of AGEs, which was likewise found for greater coffee intake, adequate olive oil consumption, smoking, and lower levels of physical activity. Higher consummation of vegetables and eating breakfast regularly were associated with lower AGEs levels. The overall MD adherence was not associated with AGEs, possibly due to very low overall compliance to the MD principles among students (8.3% in women and 3.8% in men). Health perception was positively associated with the MD and nonsmoking and negatively with the perceived stress level, while AGEs did not show significant association with self-rated students' health. These results indicate that various lifestyle habits are associated with AGEs accumulation even in young and generally healthy people. Hence, health promotion and preventive measures are necessary from an early age.

Intrinsic capacity and recent falls in adults 80 years and older living in the community: results from the ilSIRENTE Study.

BACKGROUND: Falls in older adults significantly impact overall health and healthcare costs. Intrinsic capacity (IC) reflects functional reserve and is an indicator of healthy aging. AIMS: To explore the association between IC and recent falls (≤ 90 days) in community-dwelling octogenarians from the Aging and Longevity in the Sirente geographic area (IlSIRENTE) study. METHODS: The Minimum Data Set for Home Care (MDS-HC) and supplementary questionnaires and tests were used to assess the five IC domains: locomotion, cognition, vitality, psychology, and sensory. Scores in each domain were rescaled using the percent of maximum possible score method and averaged to obtain an overall IC score (range 0-100). RESULTS: The study included 319 participants (mean age 85.5 ± 4.8 years, 67.1% women). Mean IC score was 80.5 ± 14.2. The optimal IC score cut-off for predicting the two-year risk of incident loss of at least one activity of daily living (ADL) was determined and validated in a subset of 240 individuals without ADL disability at baseline (mean age 84.7 ± 4.4 years, 67.1% women). Participants were then stratified into low (< 77.6) and high (≥ 77.6) IC categories. Those with high IC (63.9%) were younger, more often males, and had lower prevalence of recent falls, disability, multimorbidity, and polypharmacy. Logistic regression models including IC as a continuous variable revealed a significant association between higher IC and lower odds of falls. This association was significant in the unadjusted (odds ratio [OR] 0.96, 95% confidence interval [CI] 0.94-0.98, p < 0.001), age- and sex-adjusted (OR 0.96, 95% CI 0.94-0.98, p < 0.001), and fully adjusted models (OR 0.96, 95% CI 0.93-0.99, p = 0.003). When considering IC as a categorical variable, unadjusted logistic regression showed a strong association between high IC and lower odds of falls (OR 0.31, 95% CI 0.16-0.60, p < 0.001). This association remained significant in both the age- and sex-adjusted (OR 0.30, 95% CI 0.15-0.59, p < 0.001) and fully adjusted models (OR 0.33, 95% CI 0.16-0.82, p = 0.007). The locomotion domain was independently associated with falls in the unadjusted (OR 0.98, 95% CI 0.97-0.99, p < 0.001), age- and sex-adjusted (OR 0.97, 95% CI 0.96-0.99, p < 0.001), and fully adjusted model (OR 0.98, 95% CI 0.96-0.99, p < 0.001). DISCUSSION: This is the first study using an MDS-HC-derived instrument to assess IC. Individuals with higher IC were less likely to report recent falls, with locomotion being an independently associated domain. CONCLUSIONS: Lower IC is linked to increased odds of falls. Interventions to maintain and improve IC, especially the locomotion domain, may reduce fall risk in community-dwelling octogenarians.

Novel Approaches for Early Detection of Retinal Diseases Using Artificial Intelligence.

BACKGROUND: An increasing amount of people are globally affected by retinal diseases, such as diabetes, vascular occlusions, maculopathy, alterations of systemic circulation, and metabolic syndrome. AIM: This review will discuss novel technologies in and potential approaches to the detection and diagnosis of retinal diseases with the support of cutting-edge machines and artificial intelligence (AI). METHODS: The demand for retinal diagnostic imaging exams has increased, but the number of eye physicians or technicians is too little to meet the request. Thus, algorithms based on AI have been used, representing valid support for early detection and helping doctors to give diagnoses and make differential diagnosis. AI helps patients living far from hub centers to have tests and quick initial diagnosis, allowing them not to waste time in movements and waiting time for medical reply. RESULTS: Highly automated systems for screening, early diagnosis, grading and tailored therapy will facilitate the care of people, even in remote lands or countries. CONCLUSION: A potential massive and extensive use of AI might optimize the automated detection of tiny retinal alterations, allowing eye doctors to perform their best clinical assistance and to set the best options for the treatment of retinal diseases.

Thyroid Eye Disease: Advancements in Orbital and Ocular Pathology Management.

Thyroid Eye Disease (TED) is a debilitating autoimmune condition often associated with thyroid dysfunction, leading to significant ocular and orbital morbidity. This review explores recent advancements in the management of TED, focusing on both medical and surgical innovations. The introduction of Teprotumumab, the first FDA-approved drug specifically for TED, marks a pivotal development in medical therapy. Teprotumumab targets the insulin-like growth factor-1 receptor (IGF-1R), effectively reducing inflammation and tissue remodeling. Clinical trials demonstrate its efficacy in reducing proptosis and improving quality of life, making it a cornerstone in the treatment of active, moderate-to-severe TED. Surgical management remains critical for patients with chronic TED or those unresponsive to medical therapy. Advancements in orbital decompression surgery, including image-guided and minimally invasive techniques, offer improved outcomes and reduced complications. Innovations in eyelid and strabismus surgery enhance functional and cosmetic results, further improving patient satisfaction. The management of TED necessitates a multidisciplinary approach involving endocrinologists, ophthalmologists, oculoplastic surgeons, radiologists, and other specialists. This collaborative strategy ensures comprehensive care, addressing the diverse aspects of TED from thyroid dysfunction to ocular health and psychological well-being. Future directions in TED treatment include emerging pharmacological therapies targeting different aspects of the disease's pathophysiology and advanced surgical techniques aimed at enhancing precision and safety. This review underscores the importance of a personalized, multidisciplinary approach in managing TED, highlighting current advancements, and exploring potential future innovations to improve patient outcomes and quality of life.

Periprocedural Management and Multidisciplinary Care Pathways for Patients With Cardiac Implantable Electronic Devices: A Scientific Statement From the American Heart Association.

The rapid technological advancements in cardiac implantable electronic devices such as pacemakers, implantable cardioverter defibrillators, and loop recorders, coupled with a rise in the number of patients with these devices, necessitate an updated clinical framework for periprocedural management. The introduction of leadless pacemakers, subcutaneous and extravascular defibrillators, and novel device communication protocols underscores the imperative for clinical updates. This scientific statement provides an inclusive framework for the periprocedural management of patients with these devices, encompassing the planning phase, procedure, and subsequent care coordinated with the primary device managing clinic. Expert contributions from anesthesiologists, cardiac electrophysiologists, and cardiac nurses are consolidated to appraise current evidence, offer patient and health system management strategies, and highlight key areas for future research. The statement, pertinent to a wide range of health care professionals, underscores the importance of quality care pathways for patient safety, optimal device function, and minimization of hemodynamic disturbances or arrhythmias during procedures. Our primary objective is to deliver quality care to the expanding patient cohort with cardiac implanted electronic devices, offering direction in the era of evolving technologies and laying a foundation for sustained education and practice enhancement.

Sex differences in achieving guideline-recommended heart rate control among a large sample of patients at risk for sudden cardiac arrest.

Background: Despite known clinical benefits, guideline-recommended heart rate (HR) control is not achieved for a significant proportion of patients with HF with reduced ejection fraction. The wearable cardioverter-defibrillator (WCD) provides continuous HR monitoring and alerts that could aid medication titration. Objective: This study sought to evaluate sex differences in achieving guideline-recommended HR control during a period of WCD use. Methods: Data from patients fitted with a WCD from 2015 to 2018 were obtained from the manufacturer's database (ZOLL). The proportion of patients with adequate nighttime resting HR control at the beginning of use (BOU) and at the end of use (EOU) were compared by sex. Adequate HR control was defined as having a nighttime median HR <70 beats/min. Results: A total of 21,440 women and a comparative sample of 17,328 men (median 90 [IQR 59-116] days of WCD wear) were included in the final dataset. Among patients who did not receive a shock, over half had insufficient HR control at BOU (59% of women, 53% of men). Although the proportion of patients with resting HR ≥70 beats/min improved by EOU, 43% of women and 36% of men did not achieve guideline-recommended HR control. Conclusion: A significant proportion of women and men did not achieve adequate HR control during a period of medical therapy optimization. Compared with men, a greater proportion of women receiving WCD shocks had insufficiently controlled HR in the week preceding ventricular tachyarrhythmia/ventricular fibrillation and 43% of nonshocked women, compared with 36% of men, did not reach adequate HR control during the study period. The WCD can be utilized as a remote monitoring tool to record HR and inform adequate uptitration of beta-blockers, with particular focus on reducing the treatment gap in women.

Radiation Exposure, Training, and Safety in Cardiology.

Exposure to ionizing radiation is an inherent occupational health hazard in clinical cardiology. Health risks have been reported previously, including predilection to cancer. In addition, orthopedic injury due to prolonged wearing of heavy protective lead aprons, which are mandatory to reduce radiation risk, have been extensively documented. Cardiology as a specialty has grown with rising volumes of increasingly complex procedures. This includes electrophysiological, coronary, and structural intervention, advanced heart failure/transplant management, and diagnostic imaging. Both the operator as well imaging specialists are exposed to radiation, particularly in structural interventions where interventional cardiologists and structural imagers work closely. Increasingly, women interested in cardiology may deselect the field due to radiation concerns. This expert document highlights the risks of radiation exposure in cardiology, including practical tips within various subspecialty fields such as interventional/structural cardiology, electrophysiology, imaging, advanced heart failure, and pediatric cardiology.

Immediate Sequential Bilateral Implantable Collamer Lens Surgery Is Safe and Effective.

PURPOSE: To assess the clinical outcomes and safety profiles of patients who underwent immediate sequential bilateral phakic lens surgery. METHODS: This retrospective multicenter study included 254 consecutive patients (508 eyes) who underwent bilateral same-day Implantable Collamer Lens (ICL) (STAAR Surgical) surgery. The authors focused on 1-year postoperative clinical outcomes and adverse events. RESULTS: In the initial cohort, 176 patients (352 eyes) met inclusion criteria. Of these, 335 eyes underwent myopic ICL placement, and 17 eyes received a hyperopic ICL. Notably, 87% of eyes achieved ±0.50 diopters (D) and 95% achieved ±1.00 D of the intended refraction. One year postoperatively, 78% of eyes demonstrated optimal vaulting (250 to 750 µm), with a significant 19% reduction in vaulting observed over the 12 months (P < .001). Only minor adverse events, including early cataract formation (1 case), secondary toric ICL rotation (3 cases), and ICL exchange due to inappropriate vaulting (6 cases), were noted. CONCLUSIONS: The findings corroborate the safety and efficacy of immediate sequential bilateral phakic lens surgery and indicate its potential as a treatment option. The low incidence of minor adverse events further reinforces its favorable safety profile. [J Refract Surg. 2024;40(5):e313-e320.].

Corrigendum: Infertility in Fabry's disease: role of hypoxia and inflammation in determining testicular damage.

[This corrects the article DOI: 10.3389/fendo.2024.1340188.].