Associations of Abnormal Maternal Glucose Regulation in Pregnancy with Offspring Adiposity, Insulin Resistance, and Adipokine Markers During Childhood and Adolescence.

OBJECTIVE: To examine the associations of abnormal maternal glucose regulation in pregnancy with offspring adiposity, insulin resistance, adipokine, and inflammatory markers during childhood and adolescence. STUDY DESIGN: Project Viva is a prospective prebirth cohort (n = 2128 live births) initiated from 1999 through 2002 in Eastern Massachusetts, US. During the second trimester of pregnancy, clinicians used 2-step oral glucose challenge testing to screen for gestational diabetes mellitus. In the offspring, we measured anthropometry, insulin resistance, adipokines, lipids, and inflammatory markers in mid-childhood (n = 1107), early adolescence (n = 1027), and mid-adolescence (n = 693). We used multivariable linear regression models and generalized estimating equations adjusted for child age and sex, and for maternal age, race/ethnicity, education, parity, and smoking during pregnancy; we further adjusted for prepregnancy body mass index (BMI). RESULTS: In mid-adolescence (17.1 [0.8] years of age), offspring of mothers with gestational diabetes mellitus (n = 27) had a higher BMI z-score (ß; 95% Cl; 0.41 SD; 0.00, 0.82), sum of skinfolds (8.15 mm; 2.48, 13.82), homeostatic model assessment for insulin resistance (0.81 units; 0.13, 1.50), leptin z-score (0.40 SD; 0.01, 0.78), and leptin/adiponectin ratio z-score (0.51 SD; CI 0.09, 0.93) compared with offspring of mothers with normoglycemia (multivariable-adjusted models). The associations with BMI, homeostatic model assessment for insulin resistance, and adiponectin seemed stronger in mid-adolescence compared with earlier time points. The associations were attenuated toward the null after adjustment for maternal prepregnancy BMI. CONCLUSION: Exposure to gestational diabetes mellitus is associated with higher adiposity, insulin resistance, and altered adipokines in mid-adolescence. Our findings suggest that the peripubertal period could be a key time for the emergence of prenatally programmed metabolic abnormalities.

Evaluation of the Prime Diet Quality Score from Early Childhood Through Mid-Adolescence.

BACKGROUND: Few diet quality indices have been developed and validated for use among children and adolescents. Additionally, many available indices require completion of burdensome dietary assessments. OBJECTIVES: We aimed to calculate and evaluate the performance of a modified version of the food-based Prime Diet Quality Score (PDQS) derived from different diet assessment methods conducted at 4 time points in a single study population from childhood through adolescence. METHODS: Among 1460 child participants in the Project Viva cohort, we calculated the PDQS in early and mid-childhood and early and mid-adolescence using dietary data obtained from food frequency questionnaire (early childhood: parent report), PrimeScreen (mid-childhood: parent report; early adolescence: self-report) and 24-h recall (mid-adolescence: self-report). We evaluated construct and relative validity and internal reliability of the score in each life stage. RESULTS: The PDQS showed a range of scores at all life stages and higher scores were associated with intake of many health-promoting macronutrients and micronutrients (e.g., protein, fiber, and vitamins) in early childhood and mid-adolescence. The PDQS performed similarly to the Youth Healthy Eating Index/Healthy Eating Index (Spearman r = 0.63-0.85) in various assessments. Higher PDQS was associated with expected characteristics including more frequent breakfast eating, family dinners, and vigorous physical activity; with less frequent TV viewing and fast food intake; and with more sleep and higher maternal diet scores during pregnancy. Cross-sectional associations of the PDQS with various anthropometric measurements and biomarkers were inconsistent but generally in the expected directions (e.g., higher PDQS associated with lower triglycerides and insulin and higher HDL cholesterol). Internal reliability was consistent with what has been found for other diet quality indices. CONCLUSIONS: The PDQS can be calculated from data collected using different and brief dietary assessment methods and appears to be a valid and useful measure of overall diet quality in children and adolescents. Project Viva was registered at clinicaltrials.gov as NCT02820402.

One-year initial efficacy and safety outcomes of the premounted dry-pericardium Vienna self-expandable transcatheter aortic valve system: A first-in-human VIVA feasibility study.

BACKGROUND: The dry-pericardium Vienna transcatheter aortic valve system is repositionable and retrievable, already premounted on the delivery system, eliminating the need for assembly and crimping of the device before valve implantation. METHODS: The VIVA first-in-human feasibility study, a prospective, nonrandomized, single-center trial, evaluated the Vienna aortic valve in 10 patients with severe symptomatic aortic stenosis, who were at intermediate or high surgical risk. This study, registered at ClinicalTrials.gov (NCT04861805), focused on the safety, feasibility, clinical and hemodynamic performance of the Vienna system up to 1-year follow-up. RESULTS: The mean patient age was 79 ± 5 years, 60% male. Valve sizes used: 26 mm (10%), 29 mm (30%), 31 mm (60%). Key hemodynamic improvements were significant: mean aortic valve pressure gradient (mmHg) decreased from 48.7 to 8.1, aortic valve area (cm2) increased from 0.75 to 1.91, and maximum jet velocity through the aortic valve (m/s) decreased from 4.41 to 1.95 (p < 0.0001). No moderate/severe paravalvular leakage was observed, and computed tomography scans revealed no evidence of hypo-attenuated leaflet thickening. The study recorded one life-threatening bleeding event, two cases requiring postprocedural pacemaker implantation, and three ischemic events, with only one causing lasting neurological impairment. Importantly, there were no cases of cardiovascular mortality and only one noncardiovascular death, which was confirmed as unrelated to the device. CONCLUSIONS: The study indicates the Vienna valve as a potential option for severe symptomatic aortic stenosis, designed to streamline the procedure and potentially lower healthcare costs by reducing resource and equipment needs, also procedural errors. Further research is essential to thoroughly evaluate its safety and efficacy.

Structured viva validity, reliability, and acceptability as an assessment tool in health professions education: a systematic review and meta-analysis.

BACKGROUND: The viva, or traditional oral examination, is a process where the examiners ask questions and the candidate answers them. While traditional viva has many disadvantages, including subjectivity, low validity, and low reliability, it is advantageous for assessing knowledge, clinical reasoning, and self-confidence, which cannot be assessed by written tests. In order to overcome these disadvantages, structured viva was invented and is claimed to be highly valid, reliable, and acceptable, but this was not confirmed by an overall systematic review or meta-analysis of the studies. The research aims to investigate the studies to reach an overall decision regarding the quality of structured viva as an assessment tool according to the agreed standards in medical education in terms of validity, reliability, and acceptability. METHODS: This systematic review was done following the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. PubMed, Best Evidence Medical Education (BEME) website reviews, Google Scholars, and ScienceDirect databases were searched for any article addressing the research questions from inception to December 2022. Data analysis was done by the OpenMeta Analyst open-source app, version Windows 10. RESULTS: A total of 1385 studies were identified. Of them, 24 were included in the review. Three of the reviewed studies showed higher validity of structured viva by a positive linear correlation coefficient compared with MCQs, MCQs and Objective Structured Clinical Examination (OSCE), and structured theory exam. In the reviewed studies, the reliability of structured viva was high by Cronbach alpha α = 0.80 and α = 0.75 in two different settings, while it was low α = 0.50 for the traditional viva. In the meta-analysis, structured viva was found to be acceptable by overall acceptability of (79.8%, P < 0.001) out of all learners who participated in structured viva as examinees at different levels in health professions education using the available numeric data of 12 studies. The heterogeneity of the data was high (I^2 = 93.506, P < 0.001) thus the analysis was done using the binary random-effects model. CONCLUSION: Structured viva or structured oral examination has high levels of validity, reliability, and acceptability as an assessment tool in health professions education compared to traditional viva.

Clinical learning for pre-registration nursing students: a viva voce approach during COVID-19.

The COVID-19 pandemic restricted face-to-face contact between students and educators, limiting continual assessment of student's clinical skill development. This led to rapid transformational online adaptations to nursing education. This article will present and discuss the introduction of a clinical 'viva voce' approach, which has been used at one university to formatively assess students' clinical learning and reasoning skills using virtual methods. The Virtual Clinical Competency Conversation (V3C) was developed using the 'Think aloud approach' and involved facilitated one-to-one discussion based on two questions from a bank of 17 predefined clinically focused questions. A total of 81 pre-registration students completed the formative assessment process. Overall, feedback from students and academic facilitators was positive and facilitated both learning and consolidation in a safe and nurturing way. Further local evaluation is continuing to measure the impact of the V3C approach on student learning now that some aspects of face-to-face education have resumed.

The use of the conservation of living force before Helmholtz.

In his recent authoritative Helmholtz and the Conservation of Energy, Kenneth Caneva has claimed that earlier authors had invoked the principle of conservation of living force only in cases of a system returning to an earlier state, or of one without Newtonian forces. Relaying on texts in the tradition of the French Analytical Mechanics form Lagrange to Coriolis, I argue that this was not the case, and that the principle had been formulated and used for cases where living force proper (mv2) was not conserved but its sum with an integral function (refers today as potential) was constant. In addition. I show that contrary to Caneva's claim, the principle had been connected to the impossibility of creating power out of nothing. The two points indicate a stronger link between the analytical tradition and Helmholtz and his readers than usually portrayed, and the significant contribution of mechanics to the emergence of energy conservation. On a methodological level the use of living force shows that a common term and even a concept, like energy, is not always needed for its successful employment.

Early-Life Factors Are Associated with Vitamin D Status in Early and Mid-Childhood and May Differ between White and Black Children.

BACKGROUND: Suboptimal vitamin D (VitD) status has been associated with poor bone health and other adverse health outcomes and is common among children. Various early-life factors are associated with child VitD, yet few studies have examined multiple factors simultaneously in a single study population. OBJECTIVES: We aimed to characterize relations of early-life factors with plasma 25-hydroxyvitamin D [25(OH)D] concentrations in early and mid-childhood, and to explore potential differences in these associations between white and black children. METHODS: We identified associations of various early-life factors with 25(OH)D concentrations in early and mid-childhood among 961 children in Project Viva using linear regression models. All variables associated with 25(OH)D were included together in final multivariable models at each outcome time point: 1 in the overall sample and additional models for children whose mothers identified them as being white or black. RESULTS: Overall mean ± SD 25(OH)D concentrations were 86 ± 29 nmol/L in early childhood and 68 ± 21 nmol/L in mid-childhood. After accounting for other predictors, children who took VitD supplements (compared with those who did not) had 25(OH)D concentrations 5.6 nmol/L (95% CI: 2.0, 9.2 nmol/L) higher in early childhood and 8.2 nmol/L (95% CI: 4.8, 11.6 nmol/L) higher in mid-childhood. Other factors consistently associated with higher 25(OH)D were blood collection in summer or fall, white race, nonfall birth season, prenatal exposure to higher 25(OH)D, and higher dietary intake of VitD. Greater waist circumference was associated with lower 25(OH)D in early childhood (ß: -3.8; 95% CI: -7.4, -0.2 per 1-SD increase) among black children only. CONCLUSIONS: Our findings may help clinicians better target children at risk of lower 25(OH)D for screening and/or intervention and may inform research focused on associations of 25(OH)D with different exposures and outcomes or causal effects of early-life factors on later VitD status.This trial was registered at clinicaltrials.gov as NCT02820402.

Weight Trajectories After Delivery are Associated with Adiposity and Cardiometabolic Markers at 3 Years Postpartum Among Women in Project Viva.

BACKGROUND: Postpartum weight trajectories and its implications on later cardiometabolic health are not entirely understood. OBJECTIVES: Our objectives were: 1) to characterize maternal weight trajectories from 1 to 24 mo postpartum, 2) to determine the association of prepregnancy BMI, gestational weight gain (GWG), and pregnancy behaviors with the trajectories, and 3) to evaluate the association of weight trajectories with BMI, waist circumference (WC), lipid profile, glucose, insulin resistance, blood pressure, and inflammatory markers at 3 y postpartum. METHODS: We studied 1359 mothers from the prospective cohort Project Viva. Using weights at 1, 6, 12, and 24 mo postpartum, we characterized weight trajectories using a latent class growth model. For objectives 2 and 3, we used multinomial logistic regression and multiple linear regression models, respectively. RESULTS: Around 85% of women fell into a trajectory of sustained weight loss (1-12 mo) + maintenance (12-24 mo) (reference), 5.7% followed a trajectory characterized by fast weight loss + slight gain, and 9.7% fell into a trajectory of little weight loss + slight gain. Prepregnancy overweight and obesity increased the odds of falling into the fast weight loss + slight gain trajectory, compared with the reference. Prepregnancy overweight [OR 1.57 (95% CI: 1.01, 2.46)] and a higher total GWG rate [3.69 (2.90, 4.68)] increased the odds of falling into the little weight loss + slight gain trajectory, whereas a higher Prudent dietary pattern score was protective [0.73 (0.54, 0.98)]. Women in this trajectory had higher BMI, WC, weight gain from prepregnancy, low-density lipoprotein cholesterol, and inflammatory markers at 3 y postpartum. CONCLUSIONS: Women following a trajectory of little weight loss + slight gain during the first 2 y postpartum had an adverse cardiometabolic profile 3 y after delivery. Targeting diet and GWG during pregnancy and facilitating postpartum weight loss could improve women's long-term health.

VIVA (vinorelbine, ifosfamide, vincristine, actinomycin-D): A new regimen in the armamentarium of systemic therapy for high-risk rhabdomyosarcoma.

The study reports the treatment feasibility, and secondly efficacy, of a novel chemotherapy regimen, which adds vinorelbine to the ifosfamide-vincristine-actinomycin-D combination (VIVA regimen), used in four patients with high-risk rhabdomyosarcoma. All patients received nine cycles of the VIVA regimen followed by maintenance chemotherapy with vinorelbine and cyclophosphamide. All patients experienced significant hematological toxicity, but no other major complications (in particular neurotoxicity) or required treatment dose modifications. We observed a major response after three cycles in all patients, and they remained alive after a median follow up of 11 months from diagnosis.

Plasma CCN2 is independently related to subsequent need for abdominal aorta aneurysm repair.

The objective of this study was to determine if plasma CCN2 is associated with abdominal aorta aneurysm (AAA), and future need for AAA repair, and further to assess the potential clinical value of CCN2 in predicting disease outcome. CCN2 was quantified in plasma samples obtained from a cohort of 679 men aged 65-74 at initial ultrasound screening for AAA in the Viborg Vascular (VIVA) screening trial. Plasma CCN2 was correlated with need for future surgical repair in the whole study population (HR = 1.457 (1.081-1.962), p = .013) and in the AAA group alone (HR = 1.431 (1.064-1.926), p = .018), yet the predictive value (CCN2 > 0 and <0 of 0.52 and 0.55, respectively) disqualified its use in clinically relevant AAA repair prediction. In conclusion, CCN2 is independently related to subsequent need for AAA repair, but has negligible predictive power for clinical use.

Plasma Cystatin B Association With Abdominal Aortic Aneurysms and Need for Later Surgical Repair: A Sub-study of the VIVA Trial.

OBJECTIVE/BACKGROUND: The development of an abdominal aortic aneurysm (AAA) involves extensive extracellular matrix remodelling, leading to aortic wall weakening. This process is mediated by proteases, including cysteinyl cathepsins. Cystatins are their endogenous inhibitors. This study tested whether plasma cystatin B levels in patients with AAA differed from those of healthy controls. METHODS: Plasma samples from patients with AAA and age matched controls were selected from the Viborg Vascular (VIVA) screening trial for AAA. Enzyme linked immunosorbent assay determined plasma cystatin B. T-test, logistic regression, Pearson's correlation and Cox regression tested whether plasma cystatin B correlates with AAA size and growth rate, or serves as a marker for AAA. RESULTS: Plasma cystatin B levels were significantly higher in patients with AAA than in controls (p < 0.001). Logistic regression analysis showed that cystatin B tertile at baseline was associated with the presence of AAA before (odds ratio [OR] 1.656; p < 0.001) and after adjustment for peripheral arterial disease (PAD), chronic obstructive pulmonary disease (COPD), and previous ischaemic events (OR 1.526; p < 0.001). A t-test showed a significant association between cystatin B and PAD at screening, hospital diagnosis of COPD, previous atherosclerotic events, and use of low dose aspirin. Pearson's correlation test showed positive and significant associations between cystatin B and AAA size (r = 0.15; p < 0.001). Cox regression test showed that plasma cystatin B tertile at baseline was associated with later AAA surgical repair before (hazard ratio [HR] 1.387; p < 0.001) and after adjustment for PAD, COPD, previous ischaemic event, and maximum infrarenal aortic diameter (HR 1.523; p < 0.001). CONCLUSION: In contrast to prior studies that showed that cystatin C is negatively associated with AAA development, this study demonstrated a positive association between cystatin B and AAA size and associations between cystatin B tertile at baseline and AAA presence and need for later surgical repair. It is possible that these two cystatins inhibit cathepsin activity and participate in AAA with different mechanisms.

Émilie Du Châtelet's interpretation of the laws of motion in the light of 18th century mechanics.

Émilie Du Châtelet is well known for her French translation of Newton's Philosophiae Naturalis Principia Mathematica. It is the first and only French translation of Newton's magnum opus. The complete work appeared in 1759 under the title Principes mathématiques de la philosophie naturelle, par feue Madame la Marquise Du Chastellet. Before translating Newton's Principia, Du Châtelet worked on her Institutions de physique. In this book she defended the Leibnizian concept of living forces - vis viva. This paper argues that both of these works were part of a critical transformation and consolidation of post-Newtonian mechanics in the early 18th century, beyond Newton and Leibniz. This will be shown by comparing Du Châtelet's translation of Newton's axioms with her own formulations of the laws of motion in light of Thomas Le Seur's and François Jacquier's Geneva edition which holds a special place among the several editions of the Principia that appeared in the early 18th century.

Higher Maternal Protein Intake during Pregnancy Is Associated with Lower Cord Blood Concentrations of Insulin-like Growth Factor (IGF)-II, IGF Binding Protein 3, and Insulin, but Not IGF-I, in a Cohort of Women with High Protein Intake.

Background: Prenatal exposure to dietary protein may program growth-regulating hormones, consequently influencing early-life growth patterns and later risk of associated chronic diseases. The insulin-like growth factor (IGF) axis is of particular interest in this context given its influence on pre- and postnatal growth and its sensitivity to the early nutritional environment.Objective: Our objective was to examine associations of maternal protein intake during pregnancy with cord blood concentrations of IGF-I, IGF-II, IGF binding protein-3 (IGFBP-3), and insulin.Methods: We studied 938 mother-child pairs from early pregnancy through delivery in the Project Viva cohort. Using multivariable linear regression models adjusted for maternal race/ethnicity, education, income, smoking, parity, height, and gestational weight gain and for child sex, we examined associations of second-trimester maternal protein intake [grams per kilogram (weight before pregnancy) per day], as reported on a food frequency questionnaire, with IGF-I, IGF-II, IGFBP-3, and insulin concentrations in cord blood. We also examined how these associations may differ by child sex and parity.Results: Mothers were predominantly white (71%), college-educated (64%), and nonsmokers (67%). Mean ± SD protein intake was 1.35 ± 0.35 g ⋅ kg-1 ⋅ d-1 Each 1-SD increment in second-trimester protein intake corresponded to a change of -0.50 ng/mL (95% CI: -2.26, 1.26 ng/mL) in IGF-I and -0.91 µU/mL (95% CI: -1.45, -0.37 µU/mL) in insulin. Child sex and parity modified associations of maternal protein intake with IGF-II and IGFBP-3: protein intake was inversely associated with IGF-II in girls (P-interaction = 0.04) and multiparous mothers (P-interaction = 0.05), and with IGFBP-3 in multiparous mothers (P-interaction = 0.04).Conclusions: In a cohort of pregnant women with relatively high mean protein intakes, higher intake was associated with lower concentrations of growth-promoting hormones in cord blood, suggesting a pathway that may link higher protein intake to lower fetal growth. This trial was registered at clinicaltrials.gov as NCT02820402.

Inhibitory Growth of Oral Squamous Cell Carcinoma Cancer via Bacterial Prodigiosin.

Chemotherapy drugs for oral cancers always cause side effects and adverse effects. Currently natural sources and herbs are being searched for treated human oral squamous carcinoma cells (OSCC) in an effort to alleviate the causations of agents in oral cancers chemotherapy. This study investigates the effect of prodigiosin (PG), an alkaloid and natural red pigment as a secondary metabolite of Serratia marcescens, to inhibit human oral squamous carcinoma cell growth; thereby, developing a new drug for the treatment of oral cancer. In vitro cultured human OSCC models (OECM1 and SAS cell lines) were used to test the inhibitory growth of PG via cell cytotoxic effects (MTT assay), cell cycle analysis, and Western blotting. PG under various concentrations and time courses were shown to effectively cause cell death and cell-cycle arrest in OECM1 and SAS cells. Additionally, PG induced autophagic cell death in OECM1 and SAS cells by LC3-mediated P62/LC3-I/LC3-II pathway at the in vitro level. These findings elucidate the role of PG, which may target the autophagic cell death pathways as a potential agent in cancer therapeutics.

Viva Delay.

The time delay between submission of a thesis and Viva Voce is intolerable for students. This letter tries to draw the readers' attention to the effect of choosing the right examiner, in order to reduce the Viva Voce delay.

The use of environmental DNA in invasive species surveillance of the Great Lakes commercial bait trade.

Over 180 non-native species have been introduced in the Laurentian Great Lakes region, many posing threats to native species and ecosystem functioning. One potential pathway for introductions is the commercial bait trade; unknowing or unconcerned anglers commonly release unused bait into aquatic systems. Previous surveillance efforts of this pathway relied on visual inspection of bait stocks in retail shops, which can be time and cost prohibitive and requires a trained individual that can rapidly and accurately identify cryptic species. Environmental DNA (eDNA) surveillance, a molecular tool that has been used for surveillance in aquatic environments, can be used to efficiently detect species at low abundances. We collected and analyzed 576 eDNA samples from 525 retail bait shops throughout the Laurentian Great Lake states. We used eDNA techniques to screen samples for multiple aquatic invasive species (AIS) that could be transported in the bait trade, including bighead (Hypophthalmichthys nobilis) and silver carp (H. molitrix), round goby (Neogobius melanostomus), tubenose goby (Proterorhinus marmoratus), Eurasian rudd (Scardinius erythrophthalmus), and goldfish (Carassius auratus). Twenty-seven samples were positive for at least one target species (4.7% of samples), and all target species were found at least once, except bighead carp. Despite current regulations, the bait trade remains a potential pathway for invasive species introductions in the Great Lakes region. Alterations to existing management strategies regarding the collection, transportation, and use of live bait are warranted, including new and updated regulations, to prevent future introductions of invasive species in the Great Lakes via the bait trade.

Feasibility study of intubation in lateral position using Viva-sight double-lumen tube combined with video laryngoscope in patients undergoing pulmonary lobectomy.

BACKGROUND: Double-lumen tube (DLT) intubation in lateral decubitus position is rarely reported. We designed this study to evaluate the feasibility of VivaSight double-lumen tube (VDLT) intubation assisted by video laryngoscope in lateral decubitus patients. METHODS: Patients undergoing elective video-assisted thoracoscopic surgery (VATS) for lung lobectomy were assessed for eligibility between January 2022 and December, 2022. Eligible patients were randomly allocated into supine intubation group (group S) and lateral intubation group (group L) by a computer-generated table of random numbers. The prime objective was to observe whether the success rate of VDLT intubation in lateral position with the aid of video laryngoscope was not inferior to that in supine position. RESULTS: A total of 116 patients were assessed, and 88 eligible patients were randomly divided into group L (n = 44) and group S (n = 44). The success rate of the first attempt intubation in the L group was 90.5%, lower than that of S group (97.7%), but there was no statistical difference (p > 0.05). Patients in both groups were intubated with VDLT for no more than 2 attempts. The mean intubation time was 91.98 ± 26.70 s in L group, and 81.39 ± 34.35 s in S group (p > 0.05). The incidence of the capsular malposition in the group L was 4.8%, less than 36.4% of group S (p < 0.001). After 24 h of follow-up, it showed a higher incidence of sore throat in group S, compared to that in group L (p = 0.009). CONCLUSION: Our study shows the comprehensive success rate of intubation in lateral decubitus position with VDLT assisted by video laryngoscope is not inferior to that in supine position, with less risk of intraoperative tube malposition and postoperative sore throat. TRIAL REGISTRATION: Chinese Clinical Trail Register (ChiCTR2200062989).

Comparison of whole-blood sirolimus concentrations measured by EMIT-based Siemens Viva-ProE® System and LC-MS/MS in Chinese transplant patients.

Sirolimus (SRL) is commonly used in transplant patients to prevent organ transplant rejection. The current guidelines recommend to perform SRL therapeutic drug monitoring regularly to improve treatment outcomes and avoid adverse effects. Consequently, a precise and accurate method for determining SRL is crucial in clinical practice. Currently, liquid chromatography-tandem mass spectrometry (LC-MS/MS) and immunoassays have been widely adopted for determining SRL concentrations. However, previous studies have shown that immunoassays exhibit a positive bias compared to LC-MS/MS. As the new updated version of the EMIT-based Viva-E® System (SVPS), this study aims to compare SRL blood concentrations measured by the SVPS and LC-MS/MS. The residual whole-blood samples obtained from transplant patients were simultaneously analyzed using the SVPS and LC-MS/MS, respectively. The correlation between the two assays was analyzed using the linear regression analysis and Deming linear regression. The Pearson correlation coefficient and Intraclass correlation coefficient (ICC) analysis were executed. The Paired Wilcoxon test and Bland-Altman analysis were performed to assess the concordance between the two methods. The SVPS considerably increased SRL concentration value by 46.62 % as compared to the LC-MS/MS method. When SRL concentrations measured by the SVPS were above 4.0 ng/mL, there was no significant difference between the corrected SVPS concentrations after using the Deming linear regression equation, indicating their interchangeability. Given the significant disparities observed between EMIT and LC-MS/MS, it is crucial to indicate the methodology and instruments in both TDM reports and future clinical guidelines. Our study also provides the conversion formulas between the SVPS and LC-MS/MS, which can be applied as a reference for different clinical centers.

Early Safety and Performance of the Premounted Dry-Pericardium Vienna Self-Expandable Transcatheter Aortic Valve System: 30-Day Outcomes of the First-in-Human VIVA Feasibility Study.

The purpose of this first-in-human (FIH) study was to determine the safety and feasibility of the transfemoral premounted dry-pericardium Vienna Self-Expandable Supra-Annular Aortic Valve System. This novel system is repositionable and retrievable and comes already premounted on the delivery system, eliminating the need for assembly and crimping of the device before valve implantation. This is a prospective, nonrandomized, single-arm, single-center, first-stage FIH feasibility study, which will be followed by a second-stage pivotal, multicenter, multinational study in symptomatic patients with severe aortic stenosis. The first-stage FIH study evaluated the safety and feasibility of the device in 10 patients with severe aortic stenosis based on recommendations by the Valve Academic Research Consortium-2 for transcatheter aortic valve implantations. The mean patient age was 79 ± 5 years, 60% were male, and all patients were in New York Heart Association functional class II to III. The primary safety end point was successful when all patients were alive at 30-day follow-up. Device and technical success were observed in all patients. Two patients had a stroke, 1 of which occurred 5 days after the procedure. New permanent pacemakers were implanted in 2 patients (22.2%), of which only 1 was because of complete heart block. Only 1 patient (10%) had moderate paravalvular leak at 30 days. After the procedure, the mean aortic valve gradient decreased from 48.7 ± 10.8 mm Hg to 8.8 ± 4.3 mm Hg. In conclusion, this FIH feasibility study demonstrates successful procedural feasibility, with no 30-day mortality and favorable valve hemodynamic performance, leading to an improvement in quality of life. ClinicalTrials.gov identifier NCT04861805.

How much does the injury risk between average female and average male anthropometry differ? - A simulation study with open source tools for virtual crash safety assessments.

Differences in injury risk between females and males are often reported in field data analysis. The aim of this study was to investigate the differences in kinematics and injury risks between average female and male anthropometry in two exemplary use cases. A simulation study comprising the newly introduced VIVA+ human body models (HBM) was performed for two use cases. The first use case relates to whiplash associated disorders sustained in rear impacts and the second to femur fractures in pedestrians impacted by passenger cars as field data indicates that females have higher injury risk compared to males in these scenarios. Detailed seat models and a generic vehicle exterior were used to simulate crash scenarios close to those currently tested in consumer information tests. In the evaluations with one of the vehicle seats and one car shape the injury risks were equal for both models. However, the risk of the average female HBM for whiplash associated disorders was 1.5 times higher compared to the average male HBM for the rear impacts in the other seat and 10 times higher for proximal femur fractures in the pedestrian impacts for one of the two evaluated vehicle shapes.. Further work is needed to fully understand trends observed in the field and to derive appropriate countermeasures, which can be performed with the open source tools introduced in the current study.