Adv Ther. 2025 Feb 3. doi: 10.1007/s12325-025-03107-9. Online ahead of print.
NO ABSTRACT
PMID:39899224 | DOI:10.1007/s12325-025-03107-9
Adv Ther. 2025 Feb 3. doi: 10.1007/s12325-024-03089-0. Online ahead of print.
ABSTRACT
INTRODUCTION: Vigabatrin (VGB) is intended for use by caregivers of infants (1 month to 2 years old) diagnosed with infantile spasms (IS). Commercially available vigabatrin powders require caregiver reconstitution prior to oral administration. This study compared the ability of caregivers to accurately provide a targeted dose of vigabatrin using a ready-to-use (RTU) vigabatrin oral solution (VGB-RTU solution) and SABRIL® (vigabatrin) powder for oral solution, Lundbeck LLC, (vigabatrin powder) without instruction from a healthcare professional.
METHODS: A crossover comparative usability study with 30 lay users (15 caregivers with vigabatrin powder experience and 15 oral-syringe/medication preparation naïve users) which required users to deliver a single dose of both VGB-RTU surrogate solution and vigabatrin powder to a sample collection bottle was performed. Doses were measured analytically with a primary endpoint to deliver doses within ± 10% of the target dose of 1125 mg.
RESULTS: All 30 participants administered VGB-RTU solution doses within ± 5% of the target, while only 23/30 of the vigabatrin powder doses were within ± 10%. All naïve users delivered vigabatrin doses using VGB-RTU solution within ± 5% of the target; whereas only 13/15 delivered doses within ± 10% for vigabatrin powder. All experienced vigabatrin users delivered calculated vigabatrin doses using VGB-RTU solution within ± 3%; whereas only 10/15 delivered doses within ± 10% for vigabatrin powder. Users were equally able to accurately deliver the prescribed volumes of both products. Calculated doses of VGB-RTU solution (mg) were significantly less variable (p < 0.0001) and more accurate (p < 0.01) than doses of vigabatrin powder.
CONCLUSION: Caregivers delivered more accurate and less variable doses of the ready-to-use solution compared to solutions prepared from vigabatrin powders for oral solution. These differences were shown to be due to caregiver errors in reconstituting vigabatrin powders for oral solution.
PMID:39899223 | DOI:10.1007/s12325-024-03089-0
Infection. 2025 Feb 3. doi: 10.1007/s15010-024-02465-w. Online ahead of print.
ABSTRACT
BACKGROUND: Invasive fungal infections (IFI) represent a significant contributor to mortality among sepsis patients in the Intensive Care Unit (ICU). Early diagnosis of IFI is challenging, and currently, there are no predictive tools for identifying sepsis patients who may develop IFI. Our study aims to develop a predictive scoring system to assess the risk of IFI in patients with sepsis admitted to the ICU.
METHODS: A retrospective collection of data from a total of 549 patients was conducted. Data-driven, clinically knowledge-driven, and decision tree models were used to identify predictive variables for risk of IFI in ICU patients with sepsis. Demographic data, vital signs, laboratory values, comorbidities, medication use, and clinical outcomes were all collected. The optimal model was selected based on model performance and clinical utility to establish a risk score.
RESULTS: Among adult patients with sepsis admitted to the ICU, 127 patients (23.1%) developed IFI. The final data-driven model included four predictive factors, the clinically knowledge-driven model included three predictive factors, and the decision tree model included two. Based on the good performance and clinical utility of the clinically knowledge-driven model, it was chosen as the optimal risk scoring model (C-statistics: 0.79 (95% confidence interval (CI): 0.75-0.83); Hosmer-Lemeshow (H-L) test P = 0.884). The ICU sepsis patient invasive fungal infection risk (AMI) score, created based on the clinically knowledge-driven model, includes mechanical ventilation, application of immunosuppressants, and the types of antibiotics used. The C-statistics for this risk score was 0.79 (95% CI:0.75-0.84) with good calibration (H-L test P = 0.992 and see calibration curve: Fig. 2). Moreover, in terms of clinical utility, the decision curve analysis for AMI showed a favorable net benefit.
CONCLUSIONS: The application of the AMI score can effectively distinguish whether ICU sepsis patients will develop IFI, which is beneficial for clinicians to formulate targeted and timely preventive and treatment measures based on the risk of IFI.
PMID:39899210 | DOI:10.1007/s15010-024-02465-w
Indian J Gastroenterol. 2025 Feb 3. doi: 10.1007/s12664-024-01723-x. Online ahead of print.
ABSTRACT
BACKGROUND: Anti-human epidermal growth factor receptor-2 (Her-2/neu) target therapy has substantially improved the disease outcome of patients with breast and gastric/gastroesophageal cancers characterized by Her-2/neu overexpression and/or amplification. Consequently, evaluating Her-2/neu expression in other cancers to predict response to Her-2/neu targeting agents emerges as a crucial approach. We aimed at investigating the positivity rate of this receptor in gallbladder cancer (GBC) and assess the relationship between Her-2/neu status, clinicopathological parameters and survival to identify patients who would benefit most from anti-Her-2/neu-targeted therapy. The Her-2/neu expression was correlated with clinicopathological parameters and survival of GBC cases.
METHODS: Total 235 surgically resected and histopathologically proven primary GBC cases were collected over a five-year period from January 1, 2017, and December 31, 2020. Her-2/neu expression in these cases was analyzed using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH).
RESULTS: Employing testing algorithms (IHC scoring based on gastric cancer criteria, followed by FISH in equivocal cases), Her-2/neu positivity was identified in 43 (18.29%) GBC cases and was significantly associated with grade I tumors, tumor stage > T2, perineural invasion, surgical margin positivity and advanced TNM stage. The mean survival time for Her-2/neu-positive cases was 14 months (SE, 1.1; 95%CI, 11.7-16.06), while it was 20 months (SE, 0.69; 95%CI, 18.1-20.9) for Her-2-negative cases (p < 0.001).
CONCLUSIONS: Her-2/neu is expressed in about one-fifth of GBC patients and is significantly associated with tumor behavior and patient survival. Utilizing novel targeted agents may hold the key to improving the prognosis of these patients.
PMID:39899204 | DOI:10.1007/s12664-024-01723-x
Egypt Heart J. 2025 Feb 3;77(1):19. doi: 10.1186/s43044-025-00613-7.
ABSTRACT
BACKGROUND: New type of arrhythmia called atrial high-rate episodes (AHREs) has been discovered thanks to the ability of cardiac electronic implantable devices to track, record, and analyze complex arrhythmias. The aim is to determine factors associated with AHRE in HFrEF/CRT patients and the effect of AHRE on functional capacity and quality of life (QoL).
RESULTS: We interrogated 100 patients’ devices to gauge the incidence and burden of AHRE, then assessed their functional capacity using the standard 6-min walk test (6MWT), and evaluated their QoL using the Minnesota Living with HF questionnaire (MLHFQ) score. 34% of patients had AHRE, and 91.2% of them had AF. By multivariate logistic regression analysis, smoking (OR 9.426, 95% CI [1.33, 66.65], P 0.025), higher BMI (OR 1.336, 95% CI [1.09, 1.635], P 0.005), and increased LAVI (OR 1.16, 95% CI [1.063, 1.262], P < 0.001) are independent predictors for AHRE. There was a significant correlation between AHRE and the distance walked during 6MWT when compared to the distance expected for an equivalent healthy individual (82.02 ± 17.22% in the non-AHRE group vs. 75.15 ± 15.78% in the AHRE group, P < 0.001). It was found that AHRE was statistically linked to a higher total MLHFQ score (46.76 ± 9.82 in the AHRE group vs. 36.97 ± 7.76 in the non-AHRE group, P 0.032), with higher physical scores in the AHRE group.
CONCLUSION: AHRE significantly reduces functional status and perceived quality of life in HFrEF patients receiving CRT. Longer than five minutes of AHRE was associated with a higher MLHFQ score and worse performance on the 6MWT. In that patient population, smoking, obesity, and elevated LAVI were independent predictors of AHRE.
PMID:39899192 | DOI:10.1186/s43044-025-00613-7
Int J Comput Assist Radiol Surg. 2025 Feb 3. doi: 10.1007/s11548-025-03327-y. Online ahead of print.
ABSTRACT
Purpose Federated training is often challenging on heterogeneous datasets due to divergent data storage options, inconsistent naming schemes, varied annotation procedures, and disparities in label quality. This is particularly evident in the emerging multi-modal learning paradigms, where dataset harmonization including a uniform data representation and filtering options are of paramount importance.Methods DICOM-structured reports enable the standardized linkage of arbitrary information beyond the imaging domain and can be used within Python deep learning pipelines with highdicom. Building on this, we developed an open platform for data integration with interactive filtering capabilities, thereby simplifying the process of creation of patient cohorts over several sites with consistent multi-modal data.Results In this study, we extend our prior work by showing its applicability to more and divergent data types, as well as streamlining datasets for federated training within an established consortium of eight university hospitals in Germany. We prove its concurrent filtering ability by creating harmonized multi-modal datasets across all locations for predicting the outcome after minimally invasive heart valve replacement. The data include imaging and waveform data (i.e., computed tomography images, electrocardiography scans) as well as annotations (i.e., calcification segmentations, and pointsets), and metadata (i.e., prostheses and pacemaker dependency).Conclusion Structured reports bridge the traditional gap between imaging systems and information systems. Utilizing the inherent DICOM reference system arbitrary data types can be queried concurrently to create meaningful cohorts for multi-centric data analysis. The graphical interface as well as example structured report templates are available at https://github.com/Cardio-AI/fl-multi-modal-dataset-creation .
PMID:39899185 | DOI:10.1007/s11548-025-03327-y
Eat Weight Disord. 2025 Feb 3;30(1):12. doi: 10.1007/s40519-025-01718-3.
ABSTRACT
PURPOSE: Intuitive exercise may foster healthier engagement in physical activity, leading to enhanced well-being and more intuitive eating habits. The Intuitive Exercise Scale (IEXS) was originally developed to assess this construct in English speakers. The IEXS is composed of four scales addressing distinct facets of intuitive exercise: emotional exercise, body trust, exercise rigidity, mindful exercise. The present study aimed to validate an Italian translation of the IEXS, exploring its factorial structure, invariance, internal consistency, and convergent validity.
METHODS: A sample of 1140 women and men (age: M = 45.25, SD = 11.64, range 22-76 years) was recruited from the Italian general population; 61.8% were physically active. Inclusion criteria were being an Italian native speaker and being at least 18 years. The sample was randomly split in two equal halves for the Exploratory Factor Analysis (n = 570; women: 50%; physically active: 61.8%) and the Confirmatory Factor Analysis (n = 570; women: 50%; physically active: 61.8%). Multi-group confirmatory factor analyses were performed to assess invariance among women and men and physically and non-physically active individuals. McDonald’s omega was used to assess internal consistency. Pearson’s correlations were utilized to assess convergent validity.
RESULTS: The Italian IEXS replicated a four-factor structure and showed good invariance among women and men. Invariance among physically and non-physically active individuals was only partially supported. Excellent internal consistency and adequate convergent validity were achieved.
CONCLUSIONS: The IEXS demonstrated to be a valid measure to examine intuitive exercise in the Italian population, replicating and expanding the findings of the English version. Level of evidence Level V, Cross-sectional, Psychometric study.
PMID:39899175 | DOI:10.1007/s40519-025-01718-3
J Am Heart Assoc. 2025 Feb 3:e029950. doi: 10.1161/JAHA.123.029950. Online ahead of print.
ABSTRACT
BACKGROUND: The impact of sex-related differences in coronary atheroma and flow impairment severity on clinical events and costs remains unclear.
METHODS AND RESULTS: This is a secondary analysis of patients with stable coronary artery disease who underwent both coronary computed tomography angiography and fractional flow reserve derived from computed tomography as part of the FORECAST (Fractional Flow Reserve Derived From Computed Tomography Coronary Angiography in the Assessment and Management of Stable Chest Pain) trial, investigating (1) the relationship between coronary stenosis severity on coronary computed tomography angiography and fractional flow reserve derived from computed tomography FFRCT by sex and (2) the association with revascularization, resource usage, and adverse clinical events. A total of 212 patients (64 female participants [32.1%]) and 1245 vessels were included. There was no significant sex difference in the frequencies of significant coronary artery disease (38.2% of women versus 51.3% of men; P=0.073), but female participants had significantly less coronary flow impairment, according to the presence of at least 1 fractional flow reserve derived from computed tomography≤0.8 (47.0% versus 71.5%; P=0.008). Female subjects underwent fewer revascularization procedures (23.5% versus 42.3%; P=0.014), less coronary artery bypass graft surgery (2.9% versus 13.1%; P=0.025) and were less likely to be on statin treatment (72.0% versus 84.7%; P=0.022) by 9-month follow-up. This resulted in lower overall health care costs for female participants compared with male counterparts (median total cost, £1276 versus £2051; P=0.014). In multivariable Cox analysis the presence of significant coronary artery disease (hazard ratio [HR], 2.91; 95% CI, 1.30-6.51) and having a positive fractional flow reserve derived from computed tomography (HR, 4.11; 95% CI, 1.15-14.69) were independent predictors of major adverse cardiovascular events at 9 months, whereas sex was not statistically significant (p=0.13).
CONCLUSIONS: There are significant sex differences in the anatomico-functional assessment of coronary artery disease leading to differences in clinical management, costs, and adverse events.
PMID:39895531 | DOI:10.1161/JAHA.123.029950
J Am Heart Assoc. 2025 Feb 3:e037567. doi: 10.1161/JAHA.124.037567. Online ahead of print.
ABSTRACT
BACKGROUND: Using machine learning for the phenotyping of patients with heart failure with preserved ejection fraction (HFpEF) has emerged as a novel approach to understanding the pathophysiology and stratifying the patients. Our objective is to perform phenotyping of patients with HFpEF in stable phase and to investigate the phenotypic trajectory from acute worsening phase to stable phase.
METHODS: The present study is a post hoc analysis of the PURSUIT-HFpEF (Prospective Multicenter Observational Study of Patients with Heart Failure with Preserved Ejection Fraction) study. We applied the latent class analysis to the discharge data of patients hospitalized for acute decompensated heart failure.
RESULTS: We finally included patient data of 1100 cases and 63 features in the latent class analysis. All patients were subclassified into 5 phenogroups as follows: Phenotype 1, characterized by better renal function and lower NT-proBNP (N-terminal pro-B-type natriuretic peptide) level [N=325 (29.5%)]; Phenotype 2, higher blood pressure, sinus rhythm, and poor renal function. [N=242 (22.0%)]; Phenotype 3, higher prevalence of atrial fibrillation, higher tricuspid pressure gradient, and lower tricuspid annular plane systolic excursion [N=214 (19.5%)]; Phenotype 4, higher C-reactive protein level and higher tricuspid pressure gradient [N=245 (22.3%)]; and Phenotype 5, poor nutritional status, poor renal function, and higher NT-proBNP level [N=74 (6.7%)]. A particular phenotype observed at the time of discharge was correlated with a distinct phenotype of acute worsening.
CONCLUSIONS: We identified 5 distinct stable phase phenotypes of the patients with HFpEF from the data at discharge. A specific phenotype at discharge was associated with a particular phenotype of acute worsening. This grouping can be a basis for future precision medicine of patients with HFpEF.
REGISTRATION: URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000021831.
PMID:39895530 | DOI:10.1161/JAHA.124.037567
J Am Heart Assoc. 2025 Feb 3:e038484. doi: 10.1161/JAHA.124.038484. Online ahead of print.
ABSTRACT
BACKGROUND: Coronary microvascular dysfunction (CMD), which mimics symptoms of obstructive coronary artery disease, has significant prognostic implications. While epicardial adipose tissue normally has a protective role, increased epicardial adipose tissue is associated with inflammation and may contribute to CMD. However, a direct correlation remains unclear. We aimed to investigate this association.
METHODS AND RESULTS: The CMDR (Coronary Microvascular Disease Registry) is a prospective, 2-center registry that is enrolling patients with angina and nonobstructive coronary artery disease who underwent invasive hemodynamic assessment of the coronary microvasculature. Patients with chest computed tomography within 1 year of CMD evaluation were included. We measured epicardial fat volume (EFV) and calculated the EFV index. Logistic regression analysis was used to investigate the association between EFV and EFV index to CMD. Our study included 130 CMDR patients with associated chest CT; 35 were diagnosed with CMD. The CMD-negative patients were younger than the CMD-positive patients (58.52±11.97 versus 63.37±9.56 years; P=0.033), with numerically fewer women (64.2% versus 74.3%; P=0.279). Univariate regression analysis demonstrated a statistically significant association between EFV index and CMD diagnosis (odds ratio, 1.037 [95% CI, 1.014-1.063]; P=0.003), while no significance was observed for EFV (odds ratio, 1.006 [95% CI, 0.995-1.017]; P=0.292).
CONCLUSIONS: Our results suggest a strong association between EFV index (a significant risk factor) and the presence of CMD. Future studies involving larger cohorts are needed to confirm the association of epicardial adipose tissue with CMD and investigate therapeutic targets to prevent CMD.
REGISTRATION: URL: https://www.clinicaltrials.gov; unique identifier: NCT05960474.
PMID:39895522 | DOI:10.1161/JAHA.124.038484