Safety Trends Research Articles

Three‐Year Clinical and Hemodynamic Evaluation of the Hydra Self‐Expanding Transcatheter Aortic Valve in Patients With Severe Aortic Stenosis

ABSTRACTBackgroundThe Hydra CE study revealed 1‐year favorable efficacy of TAVR, showing a large effective orifice area (EOA), low gradient, and acceptable complication rates.AimsWe evaluated the 3‐year clinical and hemodynamic outcomes of Hydra self‐expanding transcatheter aortic valve (manufactured by Vascular Innovations Co Ltd, Nonthaburi, Thailand; a subsidiary of Sahajanand Medical Technologies Limited, India) in patients with symptomatic severe aortic stenosis at high or extremely high surgical risk.MethodsThe Hydra CE study was a prospective, multicenter, single‐arm study. A total of 157 patients were enrolled in the study, out of whom 54 patients from two centers (Lithuania and Poland) had provided consent for long‐term follow‐up at recruitment, with a planned 5‐year follow‐up period. The primary endpoint was all‐cause mortality, and patients were followed up for up to 3 years, with an assessment of clinical and echocardiographic outcomes.ResultsAmong the 54 patients, the average age was 81.0 ± 4.1 years. The mean STS score was 3.2 ± 2.0%. At 3 years, all‐cause mortality had occurred in 14.8% of patients, including 3.7% cardiovascular deaths and 1.9% device‐related deaths. There was a progressive enhancement in EOA that is, 0.68 ± 0.15 cm2 at baseline to 1.97 ± 0.52 cm2 at 3 years (p < 0.001) as well as significant improvement in the mean aortic valve gradient that is, 53.4 ± 14.24 mmHg at baseline to 8.6 ± 2.80 mmHg at 3 years (p < 0.001). New permanent pacemaker implantation rates up to 3‐year follow‐up was 12.9%.ConclusionThe 3‐year results of the Hydra CE study demonstrated consistent improvements in hemodynamics over time. The study also revealed favorable safety and efficacy trends, along with low occurrences of new permanent pacemaker implantations and paravalvular leaks.

Nationwide trends in utilization and safety of ventricular arrythmia ablation in patients with hypertrophic cardiomyopathy

Abstract Background Catheter ablation for ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular complexes (PVC) is increasingly utilized across the nation, while data on its safety in Hypertrophic Cardiomyopathy (HCM) patients is sparse. Purpose To analyze the nationwide trends in utilization and complications of inpatient ventricular arrhythmia ablations in patients with HCM. Methods This study is a retrospective analysis of hospitalizations, in HCM patients 18 years of age and older, who underwent an inpatient VA ablation in the U.S., between 2016 and 2020. We drew data from the National Inpatient Sample (NIS) database. Patients without HCM undergoing the CA for VA were used as controls. Baseline sociodemographic and clinical data, procedural complications, mortality and length of stay were analyzed. Multivariable analysis was performed to identify independent predictors of procedural complications. Results Among a weighted total of 2880 patients hospitalized between 2016 and 2020, who underwent VA ablations, the median age was 67 years (IQR 56-74), 60% were male, and 73% were white. The HCM group had similar age distribution but more women (64.5% vs 33.6%, p<0.001) and more African Americans (13.2% vs. 7.3%, p=0.03). The non-HCM cohort had significantly higher rates of prior myocardial infarction (22% vs 12.4%, p=0.026), ischemic cardiomyopathy (30.1% vs 0.8%, p<0.001), heart failure (70.5% vs 39.7%, p<0.001), and peripheral vascular disease (PVD, 42.9% vs 18.2%, p<0.001). This was reflected in higher Deyo Comorbidity Index in the non-HCM cohort (score of ≥ 2 in 66.6% vs 43%, p<0.001). Overall, the real-world peri-procedural complication rate in the entire cohort was 15.3%, including 6.4% hemorrhagic, 4.5% pericardial, and 2.3% vascular complications. There was a trend for lower complication rate in the HCM group (9.9% vs. 16.7%, p = 0.08). The in-hospital mortality didn’t defer (1.7% vs. 4.2%, p=0.28) and the length of stay was shorter in the HCM group (3.5 vs. 6.4 days, p < 0.001). Multivariable logistic regression analysis showed obesity (OR 2.06; 95%CI: 1.59 - 2.67; p<0.001) and PVD (OR 2.19; 95%CI: 1.34-3.53; p=0.001) to be independent predictors of complications while HCM was not (OR 0.76, 95% CI 0.51-1.14, p = 0.195). Conclusion Real-world data from a nationwide inpatient database shows comparable safety for VA ablation in HCM patients with similar mortality and lower length of stay, compared to non-HCM patients.

Evolution of the use, effectiveness and safety of bismuth-containing quadruple therapy for Helicobacter pylori infection between 2013 and 2021: results from the European registry on H. pylori management (Hp-EuReg)

BackgroundBismuth quadruple therapies (BQTs) including bismuth, a proton pump inhibitor (PPI) and two antibiotics have been shown to be highly effective for treating Helicobacter pylori infection even in areas of...

Safety Trends in the Automobile Industry in India

The automobile industry in India has experienced significant advancements in recent years, driven by rapid technological innovations and evolving consumer expectations. Safety has emerged as a critical focus area, with stakeholders ranging from government bodies to manufacturers and consumers increasingly emphasizing the need for stringent safety measures. This paper explores the key safety trends shaping the Indian automotive sector, including the adoption of advanced driver-assistance systems (ADAS), the implementation of new crash test standards, and the increased integration of passive and active safety features in vehicles. Additionally, it highlights the regulatory changes brought forth by the Indian government, such as the Bharat New Vehicle Safety Assessment Program (BNVSAP) and mandatory safety norms like airbags and anti-lock braking systems (ABS). The study also examines the role of technological innovations, including connected vehicle technologies and the potential of autonomous driving in enhancing road safety. By analyzing these trends, the paper aims to provide insights into how safety measures in the Indian automobile industry are evolving to meet global standards and reduce the rising number of road accidents in the country.

Trends in Antidiabetic Drug Use and Safety of Metformin in Diabetic Patients with Varying Degrees of Chronic Kidney Disease from 2010 to 2021 in Korea: Retrospective Cohort Study Using the Common Data Model.

This study aimed to investigate trends in antidiabetic drug use and assess the risk of metformin-associated lactic acidosis (MALA) in patients with chronic kidney disease (CKD). A retrospective observational analysis based on the common data model was conducted using electronic medical records from 2010 to 2021. The patients included were aged ≥18, diagnosed with CKD and type 2 diabetes, and had received antidiabetic medications for ≥30 days. MALA was defined as pH ≤ 7.35 and arterial lactate ≥4 mmol/L. A total of 8318 patients were included, with 6185 in CKD stages 1-2 and 2133 in stages 3a-5. Metformin monotherapy was the most prescribed regimen, except in stage 5 CKD. As CKD progressed, metformin use significantly declined; insulin and meglitinides were most frequently prescribed in end-stage renal disease. Over the study period, the use of SGLT2 inhibitors (13.3%) and DPP-4 inhibitors (24.5%) increased significantly, while sulfonylurea use decreased (p < 0.05). Metformin use remained stable in earlier CKD stages but significantly decreased in stage 3b or worse. The incidence rate (IR) of MALA was 1.22 per 1000 patient-years, with a significantly increased IR in stage 4 or worse CKD (p < 0.001). Metformin was the most prescribed antidiabetic drug in CKD patients in Korea with a low risk of MALA. Antidiabetic drug use patterns varied across CKD stages, with a notable decline in metformin use in advanced CKD and a rise in SGLT2 inhibitor prescriptions, underscoring the need for further optimized therapy.

Quality, Safety, and Security Systems in the Greek Port Industry: Over Twenty Years of Research, Empirical Evidence, and Future Perspectives

Background: Quality, Safety and Security are embedded in all aspects of port operations and are crucial for port industry stakeholders. Over the past decades, numerous assurance systems, codes, and regulations for quality, safety, and security have been developed and implemented in ports world-wide. This paper examines key insights for the implementation those systems in ports, reviewing over 20 years of empirical research on the impact and outcomes of such systems in Greek ports and internationally. Methods: It compares and discusses evidence from two empirical surveys spanning the first two decades of the 21rst century. The first survey was conducted in 2011 (with evidence from 2000 to 2011) including 12 major Greek ports (SAs) and the second one was conducted up to 2022–2023, including 23 over 25 Greek ports (the same SAs and other ones from the Greek TEN-T network). Results: The higher-level scope of this paper is to investigate critical perspectives on and trends in quality, safety, and security systems in the port industry. Conclusions: This investigation aims to strengthen the assumption that quality, safety, and security play a pivotal role in shaping the image, performance, and growth of ports.

The dark side of beauty: an in-depth analysis of the health hazards and toxicological impact of synthetic cosmetics and personal care products.

Over the past three decades, the popularity of cosmetic and personal care products has skyrocketed, largely driven by social media influence and the propagation of unrealistic beauty standards, especially among younger demographics. These products, promising enhanced appearance and self-esteem, have become integral to contemporary society. However, users of synthetic, chemical-based cosmetics are exposed to significantly higher risks than those opting for natural alternatives. The use of synthetic products has been associated with a variety of chronic diseases, including cancer, respiratory conditions, neurological disorders, and endocrine disruption. This review explores the toxicological impact of beauty and personal care products on human health, highlighting the dangers posed by various chemicals, the rise of natural ingredients, the intricate effects of chemical mixtures, the advent of nanotechnology in cosmetics, and the urgent need for robust regulatory measures to ensure safety. The paper emphasizes the necessity for thorough safety assessments, ethical ingredient sourcing, consumer education, and collaboration between governments, regulatory bodies, manufacturers, and consumers. As we delve into the latest discoveries and emerging trends in beauty product regulation and safety, it is clear that the protection of public health and well-being is a critical concern in this ever-evolving field.

Huaxi integrated blood management reduces the red blood cell transfusion for on-pump cardiac surgery: A quasi-experimental study

ObjectiveAs many as half of patients undergoing on-pump cardiac surgery require red blood cell transfusion, emphasizing the need for effective strategies that can reduce this need. We conducted this analysis to assess the effectiveness of Huaxi Integrated Blood Management strategy at our medical center. DesignBefore and after study. ParticipantsPatients who underwent on-pump cardiac surgery were included from January 2019 to December 2021. Two cohorts were compared, one before implementation of the strategy (1 January 2019 until 31 May 2020) and one after implementation (1 June 2020 until 31 December 2021). MeasurementsWe evaluated temporal trends in blood transfusion, safety, and efficacy of this strategy. Primary outcomes were the incidence and volume of intra- and postoperative blood transfusions of packed red blood cells. Secondary outcomes are intraoperative and postoperative transfusion of other blood products, all-cause mortality during hospitalization, and incidence of new-onset complications. Main resultsOur results demonstrated that this integrated strategy effectively decreased both the perioperative packed red blood cell transfusion volume and incidence for patients who underwent the on-pump cardiac surgery. Following the implementation, the incidence of packed red blood cell transfusions decreased by 8.1% during the intraoperative period and by 12.3% during the postoperative period. The mean volume of such transfusions decreased by 0.28 units during the intraoperative period and by 0.49 units during the postoperative period. Hemoglobin concentrations were significantly higher after implementation, and the maximal mean increase was 4.72 g/l on postoperative day 1. Similar benefit of the strategy was observed across subgroups of patients who underwent different types of surgery. ConclusionsThe Huaxi Integrated Blood Management strategy may be effective at reducing the need for packed red blood cell transfusion and enhancing patient care.

Construction of a Food Safety Evaluation System Based on the Factor Analysis of Mixed Data Method.

Food safety evaluation, which aims to reflect food safety status, is an important part of food safety management. Traditional food evaluation methods often consider limited data, and the evaluation process is subjective, time-consuming, and difficult to popularize. We developed a new food safety evaluation system that incorporates simple qualification degrees, food consumption, project hazard degrees, sales channels, food production regions, and other information obtained from food safety sampling and inspection to reflect the food safety situation accurately, objectively, and comprehensively. This evaluation model combined the statistical method and the machine learning method. The optimal distance method was used to calculate the basic qualification degree, and then expert elicitation via a questionnaire and the factor analysis of mixed data method (FADM) was applied to modify the basic qualification degree so as to obtain the food safety index, which indicates food safety status. Then, the effectiveness of this new method was verified by calculating and analyzing of the food safety index in region X. The results show that this model can clearly distinguish food safety levels in different cities and food categories and identify food safety trends in different years. Thus, this food safety evaluation system based on the FADM quantifies the real food safety level, screens out cities and food categories with high food safety risks, and, finally, helps to optimize the allocation of regulatory resources and provide technical and theoretical support for government decision-making.

Mapping of Latest Methods and Trends in K3 Emergency Response on Toll Roads: Literature Review

As the industrial era develops around the world, the government is rapidly developing infrastructure including toll roads. The construction industry, which provides construction services, plays an important role in this development. Toll roads are dangerous workplaces and the risk of occupational injuries is high. Workplace accidents can result in property loss, death, and delays in the production process. The management of occupational safety and health (OHS) on toll roads is a major concern to prevent industrial accidents and increase productivity. The management of occupational safety and health (OHS) on toll roads is a major concern to prevent industrial accidents and increase productivity. However, in the face of OHS emergencies on toll roads,. However, in dealing with OHS emergencies on toll roads, there is a gap between expectations and the actual situation. This research maps the latest methods and trends in Occupational Safety and Health (OHS) emergency response on toll roads through a literature review. The results show that the application of real-time monitoring technology and predictive analytics significantly improves the effectiveness of OHS emergency response. These technologies enable early detection and rapid response to incidents and help identify potential hazards and assess risks more accurately, allowing for more targeted preventive measures.

Near miss prediction in commercial aviation through a combined model of grey neural network

Owing to unprecedented level of safety management, there have been few commercial aviation accidents recently, obstructing accurate prediction of safety trends. The innovative approach of proactive safety management was employed to replace reactive safety management for predicting commercial aviation near misses. In light of positive correlation between flight time and commercial aviation near-miss with different severity levels, this study aims to predict total / serious / non-serious near-miss per million flight hours. Considering grey system theory is good at prediction without adequate data, and artificial neural networks can handle nonlinear data well, the combined models of grey neural networks were developed for forecasting three data sequences over time respectively. Based on the empirical results of commercial aviation near-miss forecasting, BP neural network had the potential to enhance accuracy of grey prediction model. The three statistical measures of MAE/MSE/MAPE denoted the combined model of grey neural network outperformed the single model of GM (1, 1) or BP neural network. Predictions with a high degree of accuracy is beneficial to determining actual trends of commercial aviation near-misses at present or in future. Quantitative data will be offered for making specific decisions on maintaining preventive measures or promoting commercial aviation safety performance by introducing additional management actions.

NALYSIS OF FOREIGN TRENDS IN THE FIELD OF OCCUPATIONAL SAFETY AND HEALTH

In this article, the author analyzes current trends in occupational safety and health in Japan, South Korea and the United States, including the development of a compliance strategy, staff training, provision of appropriate equipment, ensuring safe performance of work duties, accident reporting and reduction of injuries and morbidity. Thus, the author identifies several key aspects on which the enterprises of the above-mentioned countries focus. In the course of the study, the author came to the conclusion that an active labor protection policy not only ensures the safety of employees, but also allows enterprises to function optimally even in difficult times and conditions. The author also emphasizes that policies aimed at identifying and eliminating workplace hazards before they lead to injury or illness are not only necessary in many jurisdictions, but also provide value by increasing trust between employers and employees, improving safety and communication, leading to an overall improvement in operational performance. The author argues that the successful implementation of workplace health and safety policies should continue to be a top priority for employers, employees, other stakeholders and governments around the world. Based on the analysis, the article also provides recommendations on the partial implementation of foreign experience into domestic practice.

Enzymatic chemonucleolysis for lumbar disc herniation—an assessment of historical and contemporary efficacy and safety: a systematic review and meta-analysis

Lumbar disc herniation (LDH) is often managed surgically. Enzymatic chemonucleolysis emerged as a non-surgical alternative. This systematic review and meta-analysis aims to assess the efficacy and safety of chemonucleolytic enzymes for LDH. The primary objective is to evaluate efficacy through “treatment success” (i.e., pain reduction) and severe adverse events (SAEs) rates. Additionally, differences in efficacy and safety trends among chemonucleolytic enzymes are explored. Following our PROSPERO registered protocol (CRD42023451546) and PRISMA guidelines, a systematic search of PubMed and Web of Science databases was conducted up to July 18, 2023. Inclusion criteria involved human LDH treatment with enzymatic chemonucleolysis reagents, assessing pain alleviation, imaging changes, and reporting on SAEs, with focus on allergic reactions. Quality assessment employed the Cochrane Source of Bias and MINORS tools. Meta-analysis utilized odds ratios (OR) with 95% confidence intervals (CI). Among 62 included studies (12,368 patients), chemonucleolysis demonstrated an 79% treatment success rate and significantly outperformed placebo controls (OR 3.35, 95% CI 2.41–4.65) and scored similar to surgical interventions (OR 0.65, 95% CI 0.20–2.10). SAEs occurred in 1.4% of cases, with slightly higher rates in chymopapain cohorts. No significant differences in “proceeding to surgery” rates were observed between chemonucleolysis and control cohorts. Limitations include dated and heterogeneous studies, emphasizing the need for higher-quality trials. Further optimization through careful patient selection and advances in therapy implementation may further enhance outcomes. The observed benefits call for wider clinical exploration and adoption. No funding was received for this review.

Cured or fresh? Between fish maturation trends in restaurants and food safety: The case of dry-aged rainbow trout

The application of dry aging on fish is increasing in restaurants worldwide. This process determines fluid loss, changes in muscle texture, and the development of a more concentrated flavour appreciated by consumers. Despite the growing popularity in the foodservice industry, there is a lack of data on potential risks and quality conditions of dry-aged fish. This study was aimed at assessing the safety for consumption of whole rainbow trout subjected to dry aging in a local restaurant (Turin, Italy). Quantitative microbiological analyses and detection of foodborne pathogens were performed on dorsal, ventral muscles, and skin samples at day 0, 3, 6, 10, and 14 of dry aging. Changes in water activity (aw), pH, colour, and biogenic amines in muscle were checked at each sampling point. Almost all the microbiological indicators were below the quantification limits in muscle until day 6 of dry aging, while higher but still acceptable loads were observed at day 10. At day 14, yeasts and moulds exceeded the acceptable level in one case (3.3 ± 0.4 log10 CFU/g) in ventral muscle and counts of Pseudomonas spp. (from 6.1 ± 0.8 to 6.4 ± 0.5 log10 CFU/g), total mesophilic (from 4.4 ± 0.3 to 5.3 ± 0.7 log10 CFU/g), and psychrophilic (from 5.4 ± 0.1 to 5.8 ± 0.3 log10 CFU/g) bacteria indicated the approaching of spoilage. Detection of Listeria monocytogenes and Staphylococcus aureus was always negative during the trials. Minimal changes of pH and colour were observed, while aw values followed a decreasing trend during dry aging. Putrescine was the only detectable amine, with a maximum concentration of 2.05 ± 0.02 mg/kg at day 14. In this study, dry-aged rainbow trout was safe for consumption and 10 days was the most appropriate curing time with 3 °C and 78% of relative humidity. Further studies at different environmental conditions and on other fish species are needed for a comprehensive risk assessment of this fast-growing practice in the restaurant sector.

Road Safety Evaluation during the COVID-19 Pandemic: An Exploratory Analysis on Brazilian Federal Highways

Because of the increase in the number of cases of COIVD-19, government authorities needed to contain the spread and implemented several measures, including restricting hours of operation and social distancing measures, such as isolation. This leads to a considerable decrease in urban mobility and, consequently, to an effect on road safety. Therefore, the problem question arises: What is the impact of the COVID-19 pandemic on road safety on Brazilian federal highways? Thus, the objective of this paper is to evaluate the safety trends during the COVID-19 pandemic in 2020. This paper used the crash database from the Brazilian Federal Highway Police (PRF), was analyzed, which enabled identifying changes in crash occurrence in 2020 when compared to the previous years (2011 - 2019). A decrease in the number of crashes on federal highways was observed, which might not have a direct relationship with the COVID-19 pandemic.

P.045 Trofinetide for the treatment of Rett syndrome: long-term safety and efficacy results from the open-label LILAC and LILAC-2 studies

Background: Trofinetide significantly improved core symptoms of Rett syndrome (RTT) with an acceptable safety profile in LAVENDER. Here, we report the safety and efficacy results of LILAC and LILAC-2, open-label extension studies of LAVENDER. Methods: Females with RTT, aged 5–21 years, received twice-daily, oral trofinetide in LILAC for 40 weeks. Participants who completed LAVENDER and LILAC continued trofinetide in LILAC-2, a 32-month extension study. Safety assessments included the incidence of adverse events (AEs). Efficacy endpoints included the Rett Syndrome Behaviour Questionnaire (RSBQ) and the Clinical Global Impression–Improvement (CGI-I) scale. Results: Overall, 154 patients were enrolled in LILAC. The most common AEs were diarrhea (74.7%) and vomiting (28.6%). The mean (standard error [SE]) change from the LAVENDER baseline to Week 40 in the LILAC study in RSBQ was -7.3 (1.62) and -7.0 (1.61) for participants treated with trofinetide and placebo in LAVENDER, respectively. Mean (SE) CGI-I scores compared with the LILAC baseline at Week 40 were 3.1 (0.11) and 3.2 (0.14) for patients treated with trofinetide and placebo in LAVENDER, respectively. Similar safety and efficacy trends were observed in LILAC-2. Conclusions: Trofinetide continued to improve symptoms of RTT in LILAC and LILAC-2 with a safety profile consistent with LAVENDER.

Safety and myocardio-necrosis laboratory data trend in patients undergoing atrial fibrillation catheter ablation: pulsed field ablation vs. radiofrequency ablation

Abstract Background Pulsed Field Ablation (PFA) is an innovative technology to perform atrial fibrillation (AF) catheter ablation. No form of thermal energy is used, but an irreversible electroporation mechanism that causes selective cardiomyocytes death, sparing the cells of adjacent tissues. There are few data in the literature about peri-procedural trend of myocardium-necrosis laboratory data in patients undergoing PFA versus those with radiofrequency (RF). Purpose Compare the short-term safety and the peri-procedural trend of myocardium-necrosis laboratory data in patients undergoing PFA with those undergoing standard-power (40W) RF catheter ablation. Methods 50 patients undergoing paroxysmal AF catheter ablation with pulmonary veins isolation were retrospectively enrolled, 25 treated with PFA and 25 with RF (matched for age, sex, BMI, left atrium size). The PFA protocol involved four two-second deliveries with the penta-spline catheter in the "basket" and in the "flower" configuration; about RF ablation, circular lesions were carried out at the antrum of each pulmonary vein. All patients underwent serial blood samples including troponin I (TnI, n.v. 0-50 ng/L) and CKMB (n.v 0-5 ng/mL) at time 0 and at 3, 24 and 48 post-procedure hours. Complication were evaluated at pre-discharge visit and at 3-month follow-up. Results The clinical and echocardiographic patient’s characteristics are summarized in Table 1. The TnI and CKMB baseline values were within normal range for all patients, both those treated with PFA and those treated with RF, and there were no statistically significant differences between the two group. Regarding the TnI and CKMB values temporal increase, a statistically significant increase was observed in patients treated with PFA (Table 2). The TnI percentage decrease over the 48 hours in RF-treated patients, although not statistically significant, is slower compared to patients treated with PFA. This data could be explained by considering that PFA causes acute damage (myocardiocytes necrosis by electroporation) with less inflammation and a less progressive nature, while RF causes damage with greater irritation and progression (coagulative necrosis) that may result in myocardial necrosis even in the subsequent hours. Despite evidence of greater myocardial necrosis, there were not procedural complications in those treated with PFA. Therefore, the TnI increase is indicative of selective myocardial damage, likely more antral. Conclusion The increase of myocardio-necrosis laboratory data appears to be higher using PFA compared to RF, and it is not associated with greater adverse events. The trend of the myocardio-necrosis laboratory data shows different reduction curves between PFA and RF, probably related to different ablation power source; these data will need to be re-analysed with a greater number of cases.Table 1Table 2

Photodynamic therapy in the treatment of non-melanoma skin cancer: A literature review

Objective: The following study aims to analyze the mechanism of action, efficacy, safety and recent trends in the use of photodynamic therapy (PDT) as a therapeutic approach in the treatment of non-melanoma skin cancer. In addition, it seeks to provide a comprehensive overview of the current state of knowledge on the subject, highlighting its use and availability in the Brazilian scenario. Methods: The research was carried out using a literature review based on data published in Periódicos CAPES, Biblioteca Virtual de Saúde (BVS) and UpToDate. Results: PDT is a technique that has already been consolidated globally and has several advantages in the treatment of non-melanoma skin cancer, as well as actinic keratoses, even in comprehensive cases. PDT is considered a non-invasive, fast, safe method, with few side effects, providing rapid recovery and being well tolerated by patients. It has a significant cure rate and excellent aesthetic results, differing from other treatments often cited for their disadvantages, such as undesirable scars. Conclusion: It is crucial to further explore the benefits of PDT, considering its application in different subtypes of non-melanoma skin cancer and optimizing protocols to expand its clinical application. As a promising innovation, the technology has the prospect of contributing to improving the quality of life of patients affected by this specific type of skin cancer.

Trends in safety of catheter-based electrophysiology procedures in the last 2 decades: A meta-analysis

BackgroundRapid technologic development and expansion of procedural expertise have led to widespread proliferation of catheter-based electrophysiology procedures. It is unclear whether these advances come at cost to patient safety. ObjectiveThis meta-analysis aimed to assess complication rates after modern electrophysiology procedures during the lifetime of the procedures. MethodsA comprehensive search was performed to identify relevant data published before May 30, 2023. Studies were included if they met the following inclusion criteria: prospective trials or registries, including comprehensive complications data; and patients undergoing atrial fibrillation ablation, ventricular tachyarrhythmia ablation, leadless cardiac pacemaker implantation, and percutaneous left atrial appendage occlusion. Pooled incidences of procedure-related complications were individually assessed by random effects models to account for heterogeneity. Temporal trends in complications were investigated by clustering trials by publication year (2000–2018 vs 2019–2023). ResultsA total of 174 studies (43,914 patients) met criteria for analysis: 126 studies of atrial fibrillation ablation (n = 24,057), 25 studies of ventricular tachyarrhythmia ablation (n = 1781), 21 studies of leadless cardiac pacemaker (n = 8896), and 18 studies of left atrial appendage occlusion (n = 9180). The pooled incidences of serious procedure-related complications (3.49% [2000–2018] vs 3.05% [2019–2023]; P < .001), procedure-related stroke (0.46% vs 0.28%; P = .002), pericardial effusion requiring intervention (1.02% vs 0.83%; P = .037), and procedure-related death (0.15% vs 0.06%; P = .003) significantly decreased over time. However, there was no significant difference in the incidence of vascular complications over time (1.86% vs 1.88%; P = .888). ConclusionDespite an increase in cardiac electrophysiology procedures, procedural safety has improved over time.

Feasibility and Acceptability of a Mobile App-Based TEAM-CBT (Testing Empathy Assessment Methods-Cognitive Behavioral Therapy) Intervention (Feeling Good) for Depression: Secondary Data Analysis.

The Feeling Good App is an automated stand-alone digital mobile mental health tool currently undergoing beta testing with the goal of providing evidence-informed self-help lessons and exercises to help individuals reduce depressive symptoms without guidance from a mental health provider. Users work through intensive basic training (IBT) and ongoing training models that provide education regarding cognitive behavioral therapy principles from a smartphone. The key objective of this study was to perform a nonsponsored third-party academic assessment of an industry-generated data set; this data set focused on the safety, feasibility, and accessibility of a commercial automated digital mobile mental health app that was developed to reduce feelings associated with depression. The Feeling Good App development team created a waitlist cohort crossover design and measured symptoms of depression and anxiety using the Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, and an app-specific measure of negative feelings called the 7 Dimension Emotion Slider (7-DES). The waitlist cohort crossover design divided the participants into 2 groups, where 48.6% (141/290) of the participants were given immediate access to the apps, while 51.4% (149/290) were placed on a 2-week waitlist before being given access to the app. Data collected by the Feeling Good App development team were deidentified and provided to the authors of this paper for analysis through a nonsponsored university data use agreement. All quantitative data were analyzed using SPSS Statistics (version 28.0; IBM Corp). Descriptive statistics were calculated for demographic variables. Feasibility and acceptability were descriptively assessed. All participants included in the quantitative data were given access to the Feeling Good App; this study did not include a control group. In terms of safety, there was no statistically significant change in suicidality from preintervention to postintervention time points (t288=0.0; P>.99), and there was a statistically significant decrease in hopelessness from preintervention to postintervention time points (F289=30.16; P<.01). In terms of acceptability, 72.2% (166/230) of the users who started the initial 2-day IBT went on to complete it, while 34.8% (80/230) of the users who started IBT completed the entirety of the apps' 4-week protocol (150/230, 65.22% dropout rate over 4 weeks). This study is the first reported proof-of-concept evaluation of the Feeling Good App in terms of safety, feasibility, and statistical trends within the data set. It demonstrates a feasible and novel approach to industry and academic collaboration in the process of developing a digital mental health technology translated from an existing evidence-informed treatment. The results support the prototype app as safe for a select nonclinical population. The app had acceptable levels of engagement and dropouts throughout the intervention. Those who stay engaged showed reductions in symptom severity of depression warranting further investigation of the app's efficacy.