Present Analysis Research Articles

Analysis of interventional treatment options of the common femoral artery - a retrospective single center experience.

Background: Due to the rapid development of treatment techniques of peripheral arterial disease (PAD) treatment is nowadays predominantly interventional. An exception are lesions of the common femoral artery (CFA), which should be treated surgically according to vascular guidelines. However, recent evidence has shown that endovascular techniques, e.g. stenting, have comparable clinical outcomes while causing fewer complications. The aim of the present analysis was to evaluate the therapeutic success of endovascular therapy of CFA lesions in a single center, all - comers registry. Patients and methods: All patients who were treated for a CFA lesion at the Department of Internal Medicine I of the University Hospital Jena in the period from 01/2017 to 12/2020 were included. Treatment success was determined by evaluating the ankle-brachial-index (ABI) pre- and post-interventional as well as after follow-up (FU), measuring walking distance (WD) and by target revascularization rate (TLR) and primary patency rate (PPR). Results: The analysis included 109 patients with a mean age of 73.4 years, with 67% (73) of those being men. 72 patients received interventional treatment, whereas 33 were treated surgically and 4 conservatively. Resting ABI in the overall cohort showed an increase from 0.5 to 0.7 post intervention (p=<0.05; mean FU-time: 6.5 months). In the interventional cohort ABI increases from 0.6 to 0.8 (p=<0.05; mean FU-time: 5,8 months) at FU and from 0.3 to 0.6 (p=<0.05; mean FU-time: 8,8 month) in the surgically treated group. The WD improved in the whole collective from 116.5 meter (m) to 152.5 m (p=<0.05). The TLR showed no significant difference with 8.1% after interventional treatment and 6.1% after vascular surgery in the present analysis (p=0.72) as well as PPR with 89.8% after EVT and 90.9% after surgical approach (p=0.87). The intra-/postinterventional complication rate was 5.5% in the intervention group, compared to postoperative complication rate of 15.2% in the surgically treated group. Conclusions: The present analysis demonstrates that even in a real-world, all-comers collective, interventional therapy for CFA lesions was safe and equally effective as the surgically treated patient cohort. Continuing to generate registry data is important to eventually initiate a paradigm shift.

AirCore Observations at Northern Tibetan Plateau During the Asian Summer Monsoon

AbstractWe present data and analysis of a set of balloon‐borne sounding profiles, which includes co‐located O3, CO, CH4, and particles, over the northern Tibetan Plateau during an Asian summer monsoon (ASM) season. These novel measurements shed light on the ASM transport behavior near the northern edge of the anticyclone. Joint analyses of these species with the temperature and wind profiles and supported by back trajectory modeling identify three distinct transport processes that dominate the vertical chemical structure in the middle troposphere, upper troposphere (UT), and the tropopause region. The correlated changes in profile structures in the middle troposphere highlight the influence of the strong westerly jet. Elevated constituent concentrations in the UT identify the main level of convective transport at the upstream source regions. Observed higher altitude maxima for CH4 characterize the airmasses' continued ascent following convection. These data complement constituent observations from other parts of the ASM anticyclone.

Numerical simulation of neutral gas dynamics in the W7-X sub-divertor

Abstract The present work presents a 2D and 3D modelling of the neutral gas flow in the sub-divertor region of the W7-X. The investigations have been done using the DIVGAS code. The complex 2D and 3D geometries of the divertor components in the sub-divertor region have been considered and the Standard and High-Iota magnetic configurations have been numerically simulated. The main objective of this study is to investigate the dynamics of neutral particles in the sub-divertor region including the effects due to geometry and toroidal and poloidal leakages located at the divertor targets and baffles on the achieved pumping efficiency. A sensitivity analysis has been performed for the effect of various geometrical and flow parameters on the pumping performance, under different plasma scenarios. The considered incoming fluxes in the sub-divertor range between 1020 to 1022 (H2/s). The main conclusions, which can be extracted from the present numerical analysis could be summarized as follows; a large fraction of incoming neutral particle flux i.e. &gt; 70% on the low iota side and &gt; 40% for the high iota side is leaked back to the main divertor region, while higher incoming neutral fluxes facilitate the increase of the pumped flux as well as the decrease of the outflux. It has been estimated that a small fraction ~3-4% of the incoming neutral flux is being pumped via the turbo-molecular pumps. The closure of the toroidal leakages as well as the inclination of the pumping gap panel by 9 o facilitate the increase of the pumped flux, but considering the all the engineering constraints, the latter option seems to be more easy to be implemented. For low incoming neutral fluxes (~1020 H2/s) and for the case of AEH section, free molecular flow conditions are estimated and therefore neutral-neutral collisions could be neglected. For higher incoming neutral fluxes and for both AEH and AEP sections neutral-neutral collisions play a significant role in the flow establishment. A comparison with available experimental measurements of the neutral pressure in the sub-divertor has been performed for Standard and High-Iota plasma discharges. The 3D DIVGAS simulations predict qualitatively the experimental data with relative deviation between 25 and 63%. All the above numerical findings will actively support the optimization of the W7-X particle exhaust, in view of the experimental campaign OP2.

Acute kidney injury in acute decompensated heart failure related cardiogenic shock: data from the Alt-Shock2 registry

Abstract Funding Acknowledgements None. Background Acute kidney injury (AKI) is one of the most common complications in patients with cardiogenic shock (CS), proving the strict relationship between heart and kidney (the so-called cardio-renal syndrome). AKI is a marker of shock severity, but also independently associated with worse outcomes. Purpose Many data are available on the prevalence of AKI in acute heart failure, but very few studies assessed the role of AKI in CS and they were mainly focused on acute myocardial infarction (AMI)-related CS. Aim of our study was to analyze the impact of AKI on acute decompensated heart failure (ADHF)-CS. Methods Between March 2020 and August 2022, we prospectively enrolled 375 CS patients from a Cardiac Intensive Care Units Network of 12 centers. Among these patients 121 (33.9% of the whole cohort) with ADHF-CS were included for the present analysis. AKI was defined according to KDIGO 2012 criteria as serum creatinine increase ≥ 0.3 mg/dl or 1.5 times compared to admission value, or urinary output &amp;lt; 0.5 ml/kg/h. Results Table 1 shows the baseline characteristics of the cohort. Patients with AKI were older (70 years old [55.5; 76] vs 61 [54; 69], p&amp;lt;0.05), had more comorbidities and a worse CS profile on admission. On multivariable analysis, SCAI stage D-E on admission was independently associated with a higher risk of AKI 24 hours after admission (OR 5.54 and p = 0.01). Treatment with mechanical circulatory support did not prevent AKI (OR 0.84 and p = 0.8). Notably, patients with a greater reduction in central venous pressure (CVP) 24 hours after admission had a lower risk of AKI (deltaCVP in AKI group 0 [-3;0] versus deltaCVP in no-AKI group -3 [-6;0], p = 0.025). Kaplan-Meier curves showed significantly worse survival in patients with AKI (Figure 1A). Cox regression analysis confirmed an association between AKI and increased risk of death (HR 2.14, CI 95% 1.16-3.96, p = 0.01). Notably, this association was even more pronounced in patients with SCAI stages A-B-C (HR 2.81, CI 95% 1.30-6.09, p = 0.01). Finally, in patients treated with renal replacement therapy (RRT) there was no association with lower survival at 180-days follow up (Figure 1B). Conclusions Our study confirms that AKI is a predictor of adverse outcomes in patients with ADHF-CS. Effective decongestion 24 hours after admission was associated with a lower risk of AKI. Considering that AKI had a negative impact even at lower SCAI stages, our findings underscore the importance of early identification of renal injury to promptly target decongestion with pharmacologic therapy and, ultimately, early use of RRT.

Biomedical and therapeutic potential of marine-derived Pseudomonas sp. strain AHG22 exopolysaccharide: A novel bioactive microbial metabolite

Abstract Microbial exopolysaccharides (EPSs) are gaining interest as alternatives to chemical antioxidants and pharmaceuticals. This study mines the promising biomedical and antimicrobial potential of a marine bacterium, a prolific EPS producer, isolated from the Red Sea. Pseudomonas sp. strain AHG22 generated an EPS weighing 6.98 g·L−1, coded EPSF8, subjected to FT-IR and HPLC chemical analysis. EPSF8 was then investigated for antioxidant assessment by 2,2-diphenyl-1-picrylhydrazyl (DPPH), H2O2, ABTS˙ + , nitric oxide, total antioxidant capacity (TAC), and ferric reducing antioxidant power (FRAP). EPSF8 had an IC50 of 46.99 μg·mL−1 in the DPPH antioxidant assay and antioxidant capacities of 219.45 μg·mg−1 ascorbic acid equivalent (AAE) in the TAC assay and 54.15 μg·mg−1 AAE in the FRAP assay. The in vitro anti-inflammatory effect of EPSF8 was tested against 5-lipoxygenase (5-LOX) and cyclooxygenase-2 (COX-2) enzymes and compared with the drugs ibuprofen and celecoxib used as controls. The IC50 values of 5-LOX, COX-2, ibuprofen, and celecoxib were found to be 14.82, 15.49, 1.5, and 0.28 μg·mL−1, respectively. Additionally, EPSF8 revealed antidiabetic activity toward α-amylase and α-glucosidase, and the IC50 values were 93.1 and 127.28 μg·mL−1, compared to those of acarbose (50.93 and 4.13 μg·mL−1, respectively). Anti-obesity activity of EPSF8 by lipase inhibition revealed IC50 = 56.12 μg·mL−1 compared to orlistat (IC50 = 20.08 μg·mL−1) as a control. EPSF8 displayed antibiofilm and bactericidal activity against Gram-positive (G +ve) and Gram-negative (G −ve) ATCC pathogenic bacterial strains. It had a minimum bactericidal concentration/minimum inhibitory concentration ratio ≤2, indicating a broad bactericidal spectrum. Furthermore, EPSF8 is evidenced to have a promising anti-butyrylcholinesterase activity for the control of Alzheimer’s disease. The findings of the present analysis suggest that the isolated Pseudomonas sp. strain AHG22 EPS can potentially be explored as a promising green therapeutic compound.

Stability of plane Couette flow with constant wall transpiration

Plane Couette flow with constant wall transpiration, i.e., constant blowing from below and constant suction from above, is a solution of the Navier-Stokes equations in terms of exponentials. It is characterized by two Reynolds numbers Re and ReV, where Re parametrizes the moving wall and ReV describes the influence of the transpiration. For this flow the modified Orr-Sommerfeld equation admits one of the very few exact solutions in terms of hypergeometric functions. Based on this, we solve the stability problem, though for the main part focus on temporal stability. For small wall-transpiration rates up to ReV≃6.71, the flow remains unconditionally stable, analogous to the classical Couette flow for arbitrary Reynolds numbers Re. By further increasing ReV an instability sets in and a minimum critical Reynolds number of Re=668350.491 is reached at ReV=9.799. Hence, around this point, the destabilizing effect of blowing outweighs the stabilizing effect of suction. By further increasing the transpiration rate beyond this point, the corresponding critical Reynolds number Re increases again and continues to grow. This limiting case is accompanied by the development of a strong boundary-layer-like velocity profile near the upper wall and the flow transitions to the asymptotic suction boundary layer (ASBL). Thus, the present analysis comprises the whole range from classical Couette flows extended by transpiration to the ASBL, which is known to have a strongly stabilizing effect. Published by the American Physical Society 2024

The impact of food production on ecological footprint in Turkey: an analysis across agriculture, livestock, and aquaculture

AbstractThe ecological footprint (ECF), which has been frequently examined recently, offers a comprehensive analysis of the environment and has started to be used in Turkey. However, although it is a significant area of study in the world, food production, that raise the ECF the most, has not been the subject of much research in Turkey. In the present analysis, food production’s impacts on the ECF in Turkey are analyzed with yearly statistics for the period 1961–2018. Within the frame of this analysis, both food production as a whole and agriculture, livestock, and aquaculture production, which are the components of food, were analyzed individually. In this context, four different models were constructed, and the Autoregressive Distributed Lag method was used to analyze. According to the outcomes of the analysis, food, agriculture, and livestock production raise the ECF while aquaculture production diminishes. The largest coefficient among the three sub-sectors belongs to the agriculture sector. In addition, while the use of fertilizers, agricultural land, GDP, population, and life expectancy at birth increases the ECF, the age dependency ratio decreases, and the effect of rural population differs in the models.

Incidence and management of BPH surgery-related urethral stricture: results from a large U.S. database.

Urethral stricture (US) is a well-known complication after surgical treatment of benign prostatic hyperplasia (BPH). This study aimed to evaluate the contemporary incidence of the US after different types of BPH surgery, to identify associated risk factors and to assess its management. A retrospective analysis was conducted using the PearlDiver™ Mariner database, containing de-identified patient records compiled between 2011 and 2022. Specific International Classification of Diseases (ICD) and Current Procedural Terminology (CPT) codes were employed to identify population characteristics and outcomes. All the most employed surgical procedures for BPH treatment were considered. Multivariable logistic regression was employed to evaluate factors associated with diagnosis of post-operative US. Among 274,808 patients who underwent BPH surgery, 10,918 developed post-operative US (3.97%) within 12 months. Higher incidence of US was observed following TURP (4.48%), Transurethral Incision of the Prostate (TUIP) (3.67%), Photoselective Vaporization of the Prostate (PVP) (3.92%), HoLEP/ThuLEP (3.85%), and open Simple Prostatectomy (SP) (3.21%). Lower incidence rates were observed after laparoscopic\robot-assisted SP (1.76%), Aquablation (1.59%), Prostatic Urethral Lift (PUL) (1.07%), Rezum (1.05%), and Prostatic Artery Embolization (PAE) (0.65%). Multivariable analysis showed that patients undergoing PUL, Rezum, Aquablation, PAE, and PVP were associated with a reduced likelihood of developing US compared to TURP. US required surgical treatment in 18.95% of patients, with direct visual internal urethrotomy (DVIU) and urethroplasty performed in 14.55% and 4.50% of cases, respectively. Urethral dilatation (UD) in an outpatient setting was the primary management in most cases (76.7%). The present analysis from a contemporary large dataset suggests that the incidence of US after BPH surgery is relatively low (<5%) and varies among procedures. Around 94% of US cases following BPH surgery are managed using minimally invasive treatment approaches such as UD and DVIU.

A Higher Adherence to the ALINFA Nutritional Intervention Is Effective for Improving Dietary Patterns in Children

Food patterns are deteriorating and, consequently, not meeting nutritional recommendations. Learning about the adherence to a diet is crucial for understanding children’s dietary habits. The objective of the present analysis was to assess the degree of compliance with the ALINFA nutritional intervention and the effectiveness of adherence groups, and to evaluate potential baseline factors predicting a higher adherence to the intervention. A total of 44 children aged 6 to 12 years-old participated in the eight-week intervention. A two-week dietary plan was specifically designed, providing participants with food products, ready-to-eat dishes, and recipes. An intake of 75% of calories of the prescribed diet was defined to divide the participants into high- and low-adherence groups (HA/LA, respectively). From the 44 participants, 24 showed a LA to the intervention, whereas 20 of them were in the HA group. Diet quality improved in both groups (p &lt; 0.001), mainly by increasing cereals and nuts, and reducing pastries. A decrease in BMI z-score was observed (LA: p &lt; 0.001; HA: p = 0.021). Fat mass (p = 0.002), LDL-c (p = 0.036), and CRP (p = 0.023) reductions were only achieved in the HA group, whereas leptin decreased only in the LA group (p = 0.046). All participants ameliorated their dietary habits, but those with better diet quality at baseline experienced greater enhancements in their nutritional status.

Development of Oral Healthcare Plan for Children with Congenital Anomalies

Development of Oral Healthcare Plan for Children with Congenital Anomalies

Association between Prenatal Dietary Toxicants and Infant Neurodevelopment: The Role of Fish

More research is needed to understand how the maternal consumption of fish and fish-borne toxicants impacts infant neurodevelopment. The present analysis was conducted over 460 mother–infant pairs within the ECLIPSES study. Dietary intake of metals and persistent organic pollutants from fish (including white fish, blue fish, and seafood) was estimated in pregnant women. The infants underwent cognitive, language, and motor function assessments using the Bayley Scales of Infant Development-III at the 40-day postpartum. Associations between dietary toxicants and outcomes were assessed using multivariable linear regression models. Estimated prenatal exposure to fish-borne toxicants, such as arsenic, inorganic arsenic, methylmercury, dioxin-like polychlorinated biphenyls (DL-PCBs), and non-DL-PCBs, was associated with poorer language functions in infants, whereas no significant associations were found with motor or cognitive functions. Maternal fish consumption exceeding the Spanish recommendation of no more than 71 g per day was linked to these adverse effects on language abilities without affecting motor or cognitive development. This highlights the importance of vigilant monitoring of environmental toxicants and the provision of dietary guidance for pregnant women, with potential implications for public health and child development.

Effect of morphology on the performance of MnOx catalysts for selective catalytic reduction of NO with NH3

Modulating the physicochemical properties of catalysts through the construction of special crystal structures or microscopic morphology provides new insights for developing high-performance low-temperature denitrification catalysts. This paper explores the effect of morphology structure on catalyst performance and identifies the dominant driving factors. The catalyst activity sequence was found to be MnOx spiny nanospheres (Mn-SNS) > MnOx nanowires (Mn-N) > MnOx nanospheres (Mn-NS) > MnOx nanoparticles (Mn-P). Among these, the Mn-SNS catalyst prepared by the hydrothermal method exhibited the best catalytic activity and the good resistance to water and sulfur. It achieved over 70% NOx conversion at 150 °C, and maintained 100% at 200–350 °C. In the presence of SO2 and H2O, the NOx conversion was maintained at 87%. The spherical structure consisting of nanospikes provides the Mn-SNS catalysts with a large specific surface area, more (Mn4++Mn3+), abundant acid sites, and stronger reducibility, thus exhibiting excellent performance through the "fast-SCR" pathway. It also inhibits oxide crystallization and provides more sites for the adsorption activation of NOx and NH3. The nanowire structures can provide a large specific surface area and a high concentration of Mn3+ and Mn4+ for MnOx catalyst. Characterization analyses revealed that the specific surface area, the ratio of (Mn4++Mn3+)/Mn, and the number of Lewis acid sites (L-NH3) are the most important factors affecting the catalytic activity. This present empirical analysis provides new ideas for designing high-performance catalysts with a large specific surface area.

Combining Ability Analysis of Yield and Quality Traits in Pumpkin [Cucurbita moschataduch. Ex Poir]

The present analysis was carried out with aims to estimate the general and specific combining ability of pumpkin involving six parents namely, Arka Chandan (P1), Ambili (P2), Arka Suryamukhi(P3), Pusa Vishwas (P4), CO 2 (P5) and CO 1 (P6) and 30 F1 hybrids obtained through full diallel analysis in randomized block design with three replication. The observation were recorded for eighteen traits viz., vine length, node number at which first male flower anthesis, node number at which first female flower anthesis, number of primary branches vine-1, days to first male flower anthesis, days to first female flower anthesis, number of male flowers vine-1, number of female flowers vine-1, sex ratio, number of fruits vine-1, fruit weight, polar diameter of fruit, equatorial diameter of fruit, flesh thickness, 100 seed weight, carotene content, total soluble solids and yield vine-1.. The analysis of variance for combining ability among various traits in pumpkin revealed that there were significant differences for all the traits. Among the parents, Ambili was the best general combiner for number of fruits vine-1, yield vine-1 and yield contributing traits. The highest desirable SCA were obtained from a cross of Ambili x Arka Suryamukhi for yield and attributing traits, which was the best and promising hybrid.

Timing of Red Blood Cell Transfusions and Occurrence of Necrotizing Enterocolitis

Observational studies often report that anemia and red blood cell (RBC) transfusions are associated with a higher risk of necrotizing enterocolitis (NEC) among extremely low-birthweight (ELBW) infants. To evaluate whether there is a temporal association between 72-hour hazard periods of exposure to RBC transfusions and NEC among ELBW infants randomized to either higher or lower hemoglobin transfusion thresholds. This post hoc secondary analysis of 1690 ELBW infants who survived to postnatal day 10 enrolled in the Transfusion of Prematures (TOP) randomized multicenter trial between December 1, 2012, and April 12, 2017, was performed between June 2021 and July 2023. First, the distribution of RBC transfusions and the occurrence of NEC up to postnatal day 60 were examined. Second, 72-hour posttransfusion periods were categorized as hazard periods and the pretransfusion periods of variable duration as control periods. Then, the risk of NEC in posttransfusion hazard periods was compared with that in pretransfusion control periods, stratifying the risk based on randomization group (higher or lower hemoglobin transfusion threshold group). The primary outcome was incidence of NEC stage 2 or 3. Secondary outcomes included the incidence rates of NEC within five 10-day intervals, taking into account the number of days at risk. Of 1824 ELBW infants randomized during the TOP trial, 1690 were included in the present analysis (mean [SD] gestational age, 26.0 [1.5] weeks; 899 infants [53.2%] were female). After categorizing 4947 hazard periods and 5813 control periods, we identified 133 NEC cases. Fifty-nine of these cases (44.4%) occurred during hazard periods. Baseline and clinical characteristics of infants with NEC during hazard periods did not differ from those of infants with NEC during control periods. The risk of NEC was 11.9 per 1000 posttransfusion hazard periods and 12.7 per 1000 control periods (adjusted risk ratio, 0.95; 95% CI, 0.68-1.32; P = .74). This risk did not differ significantly between randomization groups, but the incidence rate of NEC per 1000 days peaked between postnatal days 20 and 29 in the lower hemoglobin transfusion threshold group. The findings of this post hoc analysis suggest that, among ELBW infants with the hemoglobin ranges occurring in the TOP trial, exposure to RBC transfusions was not temporally associated with a higher risk of NEC during 72-hour posttransfusion hazard periods. Given that the incidence rate of NEC peaked between postnatal days 20 and 29 among infants with lower hemoglobin values, a more in-depth examination of this at-risk period using larger data sets is warranted. ClinicalTrials.gov Identifier: NCT01702805.

Toxicity burden patterns of MET-selective tyrosine kinase inhibitors: evidence from real-world pharmacovigilance.

MET exon 14 skipping alterations and MET amplifications are recognized as oncogenic and targetable genetic changes in cancer patients. The treatment of MET-selective tyrosine kinase inhibitors (TKIs) in this specific population has shown encouraging therapeutic results. However, a comprehensive understanding of the potential toxicities linked to these agents is still lacking.The present pharmacovigilance analysis was carried out using the FDA Adverse Event Reporting System database to assess notable adverse events associated with MET-selective TKIs.Gastrointestinal disorders, respiratory toxicity, hepatotoxicity, and disturbances in metabolism and nutrition demonstrated a substantial prevalence and significance among the adverse event (AE) categories. Particularly notable were the occurrences of peripheral oedema, nausea, dysphagia, fatigue, and dyspnoea, which emerged as the foremost five reported AEs. The majority of these AEs were observed within the initial months of initiating treatment with MET-selective TKIs and persistently thereafter. Notably, our investigation unveiled a significant correlation between the usage of capmatinib and the incidence of hearing loss and difficulty in swallowing.Diligent monitoring and the implementation of supportive care strategies are essential in managing the toxicities associated with MET-selective TKIs, particularly those related to gastrointestinal disorders, respiratory toxicity, hepatotoxicity, and ototoxicity.

Synthesis, Biological and Molecular Docking Studies of Thiazole-Thiadiazole derivatives as potential Anti-Tuberculosis Agents.

Tuberculosis remains a global health threat, with increasing infection rates and mortality despite existing anti-TB drugs. The present work focuses on the research findings regarding the development and evaluation of thiadiazole-linked thiazole derivatives as potential anti-tuberculosis agents. We present the synthesis data and confirm the compound structures using spectroscopic techniques. The current study reports twelve thiazole-thiadiazole compounds (5a-5l) for their anti-tuberculosis and related bioactivities. This paper emphasizes compounds 5g, 5i, and 5l, which exhibited promising MIC values, leading to further in silico and interaction analysis. Pharmacophore mapping data included in the present analysis identified tubercular ThyX as potential drug targets. The compounds were evaluated for anti-tubercular activity using standard methods, revealing significant MIC values, particularly compound 5l, with the best MIC value of 7.1285 µg/ml. Compounds 5g and 5i also demonstrated moderate to good MIC values against M. tuberculosis (H37Ra). Structural inspection of the docked poses revealed interactions such as hydrogen bonds, halogen bonds, and interactions containing Pi electron cloud, shedding light on conserved interactions with residues like Arg 95, Cys 43, His 69, and Arg 87 from the tubercular ThyX enzyme.

Three-dimensional Effects on Gap-Resonances in Twin-Hull Vessels in Time-Harmonic Vertical Oscillations

Three-dimensional effects induced by dimensional ratios on the gap resonances happening in twin hull vessels oscillating in forced vertical motion have been analyzed. They can lead to relevant consequences, such as the amplification of the inner radiated waves or the generation of standing waves in between the demi-hulls, that can have a direct effect on the operating profile of the vessel. The response of twin hull vessels in waves can be strongly affected by these resonant phenomena. Also, some of these behaviors can be exploited in the framework of wave energy conversion systems. The present analysis is carried out by using an open-source, linear, Boundary Element Method (BEM), based on the Green function approach. Mathematical backgrounds of the added mass and damping coefficients computation for a floating body under harmonic vertical oscillation are provided as well as details of the numerical discretization used in the BEM. A panel mesh sensitivity study is carried out and the numerical prediction is validated by comparison against available experimental data, another CFD solution obtained by a high-fidelity viscous solver based on the open-source libraries Open-FOAM and approximate analytic formulations. The effect of the beam ratio and the length-to-beam ratio on the resonant phenomena has been analyzed. This has been achieved by systematic variations of the geometric dimensions of the hull, focusing on the trends of the hydrodynamic coefficients, the amplitude of the radiated waves, and the location of the resonant frequencies over the analyzed range.

Abstract PO1-03-02: Impact of Body Mass Index (BMI) on the efficacy of different adjuvant chemotherapy schedules in patients with breast cancer: analysis from the randomized phase III GIM2 trial

Abstract Background: The long-term results of the Italian randomized phase III GIM2 study showed that, in women with node-positive breast cancer (BC), dose-dense (DD) chemotherapy significantly improved both disease-free survival (DFS) and overall survival (OS) compared with standard-interval (SI) chemotherapy. Obesity has been identified as an independent poor prognostic factor in patients with BC, with a potential negative impact on the efficacy and toxicity of systemic therapies. Nevertheless, the specific influence of body mass index (BMI) on the efficacy of different adjuvant chemotherapy schedules (DD or SI) remains a subject of debate. This analysis aimed to investigate this hypothesis in patients enrolled in the GIM2 trial. Methods: GIM2 was a randomized multicentric phase III trial that compared different chemotherapy schedule (DD vs SI) and regimen (FEC-P vs EC-P) in 2091 node-positive early breast cancer patients. BMI (kg/m2) was categorized as follows: &amp;lt; 18.5 (underweight), 18.5 to &amp;lt; 25 (lean), 25 to &amp;lt; 30 (overweight), and ≥ 30 (obese). The primary endpoint was to assess association between BMI and DFS and OS. Survival estimates were compared using the Kaplan-Meier method and log-rank test. Univariate and multivariable Cox proportional hazard models, adjusted for relevant prognostic factors, were used. Results: A total of 1925 patients were included in the present analysis, of whom 31.6% (n=632) were overweight and 19.3% (n=386) obese. Median age was 52 years. Overweight-obesity condition was significantly associated with postmenopausal status, greater representation of T2-T4 tumors with N &amp;gt; 2 in both patients in the DD and SI arm. After a median follow-up of 15.0 years (IQR 8.4-16.3), compared to patients with normal BMI, those who were overweight or obese at diagnosis had a higher risk of experiencing a DFS event (Hazard Ratio [HR] 1.11 95% CI 0.94-1.31 and HR 1.37 95%CI 1.14-1.65, respectively, p=0.003) and OS event (HR 1.11 95% CI 0.89-1.38 and HR 1.59 95%CI 1.26-2.01, respectively, p=0.0003). No significant interaction was found between BMI and treatment schedule in terms of DFS (p for interaction=0.56) nor OS (p for interaction=0.19). At the multivariate analysis, in the DD arm, adjusted HR (aHR) for DFS and for OS were 1.01 (95% CI 0.75- 1.35) and 1.04 (95% CI 0.72-1.52) for obese vs. normal BMI groups, and 0.88 (95% CI 0.68- 1.15) and 0.77 (95%CI 0.54-1.10) for overweight vs. normal BMI groups, respectively. In the SI arm, aHRs for DFS and OS were 1.24 (95% CI 0.94- 1.63) and 1.35 (95%CI 0.96- 1.90) for obese vs. normal BMI groups, and 1.04 (95%CI 0.82- 1.33) and 1.01 (95% CI 0.74-1.40) for overweight vs. normal BMI groups, respectively. Similar results were observed when considering hormone receptor-positive and negative BC separately. Conclusion: In the GIM2 trial, BMI was prognostic but not predictive of different benefit to adjuvant chemotherapy. In high-risk patients, DD schedule should be considered the preferred schedule irrespective of BMI. Citation Format: Francesca Poggio, Eva Blondeaux, Marco Tagliamento, Marta Perachino, Simone Nardin, Benedetta Conte, Sabino De Placido, Mario Giuliano, Valeria Forestieri, Michelino De Laurentiis, Adriano Gravina, Giancarlo Bisagni, Anita Rimanti, Anna Turletti, Cecilia Nisticò, Angela Vaccaro, Francesco Cognetti, Alessandra Fabi, Simona Gasparro, Ornella Garrone, Ylenia Urracci, Maria Grazia Alicicco, Mauro Mansutti, Paola Poletti, Pierpaolo Correale, Claudia Bighin, Fabio Puglisi, Filippo Montemurro, Giuseppe Colantuoni, Luca Boni, Matteo Lambertini, Lucia Del Mastro. Impact of Body Mass Index (BMI) on the efficacy of different adjuvant chemotherapy schedules in patients with breast cancer: analysis from the randomized phase III GIM2 trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-03-02.

Abstract GS02-06: Recurrence-free survival following sentinel node-positive breast cancer without completion axillary lymph node dissection – first results from the international randomized SENOMAC trial

Abstract Background The omission of a completion axillary lymph node dissection (cALND) after a positive sentinel lymph node (SLN) biopsy in patients with clinically node-negative breast cancer has been demonstrated to yield survival outcomes non-inferior to routine cALND in breast-conserving surgery followed by whole-breast irradiation (ACOSOG Z0011 and IBCSG 23-01 trials), and to axillary radiotherapy (RT) regardless of breast surgery (EORTC AMAROS trial). Mainly due to the under-representation of mastectomy patients, and a limited number of observed events compromising statistical power, the international randomized SENOMAC trial was initiated in 2015. The main aim of this non-inferiority trial was to address knowledge gaps relating to individuals treated by mastectomy, those with larger tumors and those with SLN extracapsular extension. Method The SENOMAC trial (NCT 02240472) enrolled patients with cT1-3cN0 primary breast cancer and 1-2 SLN macrometastases at 67 sites in five countries between January 27, 2015, and December 31, 2021. Participants were randomized 1:1 between cALND (standard) and omission of cALND (intervention). Stratification was per country. Breast-conserving surgery and mastectomy were eligible surgical interventions. Preoperative axillary ultrasound was mandatory; patients with non-palpable suspicious axillary lymph nodes, even if proven metastatic by biopsy, were eligible. SLN extracapsular extension was allowed. Adjuvant radiotherapy was dictated by national guidelines and not by the trial protocol. Statistical sample size calculation was based on the primary outcome overall survival. Non-inferiority was defined as a 5-year overall survival not worsened by more than 2.5% when refraining from cALND after the observation of 190 all-cause deaths in a target sample size of 3000 included patients. In the present analysis, the pre-specified secondary outcome of recurrence-free survival is reported. Results Out of 2766 randomized individuals, 2539 comprised the per-protocol population: 1204 in the standard and 1335 in the intervention group. Median follow-up was 37.1 months (1.5-75.0) and median age at inclusion 61 years (range 20-94). Most tumors belonged to the luminal subtype (93.6%); tumor stage was T1 in 1358 (53.5%), T2 in 1034 (40.7%) and T3 in 146 participants (5.8%). Out of 347 participants with suspicious lymph nodes on ultrasound, 36 had confirmed non-palpable metastasis. SLN extracapsular extension was reported in 866 (34.1%). The breast was conserved in 1621 (63.8%) and a mastectomy performed in 918 (36.2%) patients. Most patients (2127, 83.8%) received radiotherapy including nodal target volumes. In 34.1% of the standard group, additional non-SLN metastases were identified on cALND. Overall, 104 recurrences were reported, 54 (4.5%) in the standard and 50 (3.7%) in the intervention group. Of these, 11 recurrences were found in the ipsilateral axilla: 5 (0.4%) and 6 (0.5%), respectively. Recurrence-free survival did not differ between groups (country-adjusted HR 0.89, 95% CI 0.65-1.20). Conclusion Despite extended inclusion criteria, there was no difference in recurrence-free survival whether cALND was omitted (intervention) or not (standard). Patients undergoing mastectomy will specifically be addressed in subgroup analyses. Long-term follow-up is crucial considering the high proportion of luminal cancers. Citation Format: Jana de Boniface, Tove Tvedskov, Bergkvist Leif, Jan Frisell, Yvette Andersson, Sara Alkner, Malin Sund, Roger Olofsson Bagge, Dan Lundstedt, Oreste Davide Gentilini, Michalis Kontos, Toralf Reimer, Birgitte Offersen, Thorsten Kühn, Lisa Rydén, Peer Christiansen. Recurrence-free survival following sentinel node-positive breast cancer without completion axillary lymph node dissection – first results from the international randomized SENOMAC trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr GS02-06.

Abstract PO2-11-06: Anti-Müllerian hormone in Young women with breast CAncer to predict permanent loss of ovarian function after chemotherapy and anti-HER2 therapy (AMYCA): a biomarker analysis of the BETH and KAITLIN trials

Abstract Background: The ability to predict and identify ovarian function loss accurately after anticancer treatment is important for appropriate oncofertility counseling and to aid in therapy decision making for young women with early breast cancer (eBC). Anti-Müllerian hormone (AMH) has been proposed as both a pre- and post-treatment predictor of subsequent permanent loss of ovarian function. The present biomarker analysis conducted within two randomized controlled trials (RCTs) in a large and well-characterized patient population with HER2+ eBC receiving homogeneous treatment aimed to assess AMH use, alone and in combination with other hormonal biomarkers, for predicting loss of ovarian function at 36 months from randomization, i.e. approximately 2 years after end of therapy. Methods: BETH (NCT00625898) and KAITLIN (NCT01966471) were RCTs investigating adjuvant chemotherapy (CT) plus anti-HER2 therapy in high-risk HER2+ eBC patients. For the purpose of the present analysis, only samples of patients receiving currently adopted treatments were used, i.e. cohort 1A (6 cycles of docetaxel/carboplatin+trastuzumab (T)) and cohort 2A (3 cycles of docetaxel plus T followed by 3 cycles of anthracycline- and cyclophosphamide-based CT) of BETH trial, and arm 1 (3-4 cycles of anthracycline- and cyclophosphamide-based CT followed by 3-4 cycles of taxane plus T plus pertuzumab (P)) of KAITLIN trial. Women selected for this analysis were ≤45 years with known premenopausal status, available serum samples at baseline (pre-treatment) and/or end of therapy and 36 months (± 6 months) from randomization (i.e. min of 2 samples in all cases). Selected samples were centrally tested measuring AMH, follicle stimulating hormone (FSH) and estradiol (E2) using Roche Elecsys assays. Permanent ovarian loss was defined as FSH &amp;gt;25 IU/L and E2 &amp;lt; 110 pmol/L at 36 months. Results: Of 194 included patients, 62 were from BETH and 132 from KAITLIN. 139 (71.6%) received both taxane and anthracycline- and cyclophosphamide-based CT and 55 (28.4%) taxane only. Pertuzumab was used in addition to trastuzumab in 132 (68.0%) patients. AMH values declined from baseline median 8.44 pmol/L to undetectable levels in many women at end of therapy (median 0.08 pmol/L), with partial recovery at 36 months (median 0.14 pmol/L). Ovarian loss at 3 years was observed in 56 women with AMH available at baseline (29.5%) and in 52 women with AMH available at end of therapy (29.7%). For prediction of ovarian loss, in ROC analysis, AMH measured at baseline showed AUC 0.784 (internally validated using bootstrap: 0.783). While age influenced risk of ovarian loss, addition to AMH only slightly improved AUC to 0.800 (internal validation: 0.795) while addition of baseline FSH and E2 did not improve prediction. AMH measured at the end of therapy showed AUC 0.741 (internal validation: 0.742), which increased slightly to 0.785(internal validation: 0.781) with addition of age but without improved prediction with the addition of FSH and E2. The combination of AMH at baseline and end of therapy increased prediction slightly to 0.808 (internal validation 0.806) and with addition of age added to 0.820 (internal validation: 0.806). Conclusions: These results support the use of pretreatment measurement of AMH in predicting loss of ovarian function in women withHER2+ eBC aged ≤45 receiving CT and anti-HER2 therapy. Measurement of AMH at end of treatment was comparably valuable to pretreatment and added slightly to the value of pretreatment sampling. Inclusion of ovarian function assessment by measuring AMH before commencing treatment can inform subsequent risk of ovarian function loss with value for fertility preservation counselling and treatment decisions. Further validation is required in larger cohorts. Citation Format: Matteo Lambertini, Deirdre Allegranza, Ruediger Laubender, Nadia Harbeck, Sandra Swain, Charles Geyer, Dennis Slamon, Gabriella Bobba, Chiara Lambertini, Sanne Lysbet De Haas, Eleonora Restuccia, Ines Vaz Luis, David Cameron, Ian Krop, Eric Winer, Richard Anderson. Anti-Müllerian hormone in Young women with breast CAncer to predict permanent loss of ovarian function after chemotherapy and anti-HER2 therapy (AMYCA): a biomarker analysis of the BETH and KAITLIN trials [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-11-06.