Prospective Evaluation Research Articles

Post-transplant cyclophosphamide with post-engraftment anti-thymocyte globulin reduce moderate to severe chronic graft-versus-host disease in peripheral stem cell transplantation from HLA-matched unrelated and haploidentical donors.

Post-transplantation cyclophosphamide (PTCy) has unique advantages for graft-versus-host disease (GVHD) prophylaxis after allogeneic hematopoietic stem cell transplantation (allo-HSCT). In this single-center retrospective landmark analysis, we evaluated chronic GVHD (cGVHD) and clinical outcomes in patients receiving PTCy, tacrolimus, and post-engraftment low-dose anti-thymocyte globulin (PTCy-ATG) as GVHD prophylaxis after HLA-matched unrelated or haploidentical donor transplantation. Two historical patient groups receiving calcineurin inhibitor-based GVHD prophylaxis were used as control groups. A total of 71 patients with myeloid malignancies undergoing allo-HSCT with myeloablative conditioning regimens were included in the analysis. The 3-year cumulative incidences of cGVHD and moderate to severe cGVHD (M/S cGVHD) were 39.2% (95%CI 27.4%-51.0%) and 11.5% (95%CI 4.1%-18.9%), respectively, in the PTCy-ATG group, and only one instance of bronchiolitis obliterans (BO) was observed. The disease-free survival (DFS), overall survival (OS), and GVHD-free and relapse-free survival rates were 94.0% (95%CI 88.3%-99.7%), 93.0% (95%CI 87.1%-98.9%) and 83.8% (95%CI 75.0%-92.6%) respectively. Of note, the PTCy-ATG group presented with a significantly lower incidence of M/S cGVHD and BO, which translated into superior OS in multivariate analysis. In this retrospective analysis, we observed that PTCy-ATG-based GVHD prophylaxis was associated with a lower incidence of M/S cGVHD and better transplantation outcomes beyond day 100, which invites prospective evaluation.

A prototype early warning system for diarrhoeal disease to combat health threats of climate change in the asia-pacific region

Abstract Ongoing climate variability and change are increasing the burden of diarrhoeal disease worldwide. Meaningful early warning systems with adequate lead times (weeks to months) are needed to guide public health decision–making and enhance community resilience against health threats posed by climate change. Toward this goal, we trained various machine-learning models to predict diarrhoeal disease rates in Nepal (2002–2014), Taiwan (2008–2019), and Vietnam (2000–2015) using temperature, precipitation, previous disease rates, and El Niño Southern Oscillation phases. We also compared the performance of shallow time-series neural network (NN), Random Forest Regressor, artificial nn, gradient boosting regressor, and long short-term memory–based methods for their effectiveness in predicting diarrhoeal disease burden across multiple countries. We evaluated model performance using a test dataset and assessed the accuracy of predicted diarrhoeal disease incidence rates for the last year of available data in each district. Our results suggest that even in the absence of the most recent disease surveillance data, a likely scenario in most low- and middle-income countries, our NN-based early warning system using historical data performs reasonably well. However, future studies are needed to perform prospective evaluations of such early warning systems in real-world settings.

Prospective evaluation of extended reality for neonatal intubation education

Purpose360° immersive videos may be useful in procedure-based healthcare settings. We hypothesized that extended reality (XR) neonatal intubation education is a feasible alternative to live demonstration in skill and knowledge transfer.MethodsThis was a prospective single center evaluation of an educational XR intubation video using Premature Anne™ (Laerdal Medical, Stavanger, Norway) comparing to a live demonstration. Participants were randomly allocated to either live demonstration or XR group. Each group received 20 min of teaching from the pediatric respiratory care education specialist, either in person or in video format. Intubation success, knowledge and skill acquisition were measured using a questionnaire and checklist.ResultsWe had a total of 23 participants, XR (n = 11) and live demonstration (n = 12). The groups were heterogeneous in experience level.The XR group was successful at intubating 73% of the time (n = 8), which was not significantly different to the live demonstration group 58% (n = 7) (p = 0.667). For patients who achieved intubation, there was no difference between groups in the mean time to successful intubation; 98 s (SD 73) for the XR group and 65 s (SD 22) for the live demonstration group (p = 0.685).When comparing scores between groups there were no statistically significant differences regarding knowledge scores (p = 0.514), skill scores (p = 0.826) and total scores (p = 0.926).ConclusionThese preliminary findings indicated no significant differences between the XR and live demonstration groups in terms of intubation success, knowledge acquisition, skill performance, total scores or time to successful intubation.

Prospective Adoptive Parent Psychological Evaluations: A Proposal for Required Content Areas

Current psychological evaluation processes for prospective adoptive parents lack standardization, leading to inconsistent assessments, potential placement issues, and adverse effects on adopted children well into adulthood. This brief proposes a structured framework for evaluations that includes 10 essential content areas and highlights the risks of inconsistent criteria. By standardizing the content areas of such evaluations, a pathway to more effective and consistent adoption practices can be implemented to improve parent readiness and enhance the well-being of adopted individuals throughout their lifespan.

The impact of nutritional intervention on quality of life and outcomes in patients with head and neck cancers undergoing chemoradiation.

Chemoradiotherapy in head and neck cancer patients has a curative intent but often deteriorates nutritional status leading to sarcopenia and cachexia. In this observational and single-centered study, a prospective evaluation of several biochemical and anthropometrical parameters, weight loss, handgrip strength, visual analogue scale of appetite, questionnaires associated with malnutrition & quality of life and body composition (obtained by Bioelectrical Impedance Vector Analysis) was performed before and after high-dose cisplatin chemotherapy combined with radiotherapy in 60 patients affected by head and neck cancer. Oral nutritional supplements were used to reach the correct number of daily calories and proteins. All patients completed radiotherapy as planned and the 96,4% of them did not interrupt chemotherapy for toxicity, reaching a total dose of at least 200mg/m2. Despite a rapid deterioration of body composition during treatment, nutritional support helped patients to maintain (or in some cases improve) anthropometric parameters from the end of chemoradiotherapy to the following 3 months. Low prealbumin and albumin pre-treatment led to higher risk of toxicities with consequent reduction of cisplatin dose intensity, whereas weight at the end of the treatment seems to be an interesting predicting factor for disease free and overall survival (p=0.007; p=0.015).

Role of gastrograffin in adhesive bowel obstruction after unsuccessful conservative treatment: a prospective evaluation

Background: Water soluble gastrograffin (GG) administration via nasogastric (NG) tube has shown to resolve the obstructive features and reduced the need for surgery and reduced hospital stay in the patients presenting with adhesive small bowel obstructions (ASBOs). Thus the use of GG in patients who did not improve after 48 hours of conservative treatment was found to be very useful in the management of ASBOs. Methods: 77 patients presenting with the features of ASBOs in Department of General Surgery, Bir Hospital were included in the study which took place from July 2021 to April 2022. Those patients who presented with the signs of strangulation, peritonitis, complete obstruction and clinical signs of large bowel obstruction were excluded from the study. Results: The mean time at which the symptoms of abdominal pain resolved was 17.45 hours, 28.5 hours and 23.06 hours in patients improved with conservative management, with GG and who undergone surgery respectively. The mean time for passage of flatus was 57.42 hours in patients treated with GG. The mean time in which the patients passed stool was 36.92 hours, 66 hours and 74.8 hours in patients treated with conservative treatment, GG and operated respectively. It took 50.81 hours, 81.68 and 95.4 hours for improvement with conservative management, GG and surgery respectively. Conclusions: The administration of GG in ASBOs after the failure of the initial 48 hours conservative management of ASBOs reduced the need for operative procedures and number of hospital days as most of them did not require surgery.

Optimised treatment of patients with enlarged lateral lymph nodes in rectal cancer: protocol of an international, multicentre, prospective registration study after extensive multidisciplinary training (LaNoReC)

IntroductionInadequate treatment of enlarged lateral lymph nodes (LLNs) in rectal cancer patients is associated with an increased lateral local recurrence (LLR) risk, despite neoadjuvant treatment and total mesorectal excision (TME)...

Prospective evaluation of PI-RADSv2.1 using multiparametric and biparametric MRI for detecting clinically significant prostate cancer based on MRI/US fusion-guided biopsy.

To evaluate the cancer detection rates for each category of Prostate Imaging-Reporting and Data System version 2.1 (PI-RADSv2.1) using multiparametric magnetic resonance imaging (mpMRI) and biparametric MRI (bpMRI) based on MRI/ultrasound (US)-fusion biopsy. This prospective study included participants who underwent mpMRI or bpMRI with a PI-RADSv2.1 interpretation and subsequently received MRI/US-fusion biopsy between August 2022 and December 2023. The lesion-based detection rates of clinically significant prostate cancer (csPCa) in each PI-RADSv2.1 category and the correlation between PI-RADSv2.1 categories and International Society of Urological Pathology (ISUP) grade groups were analyzed. The diagnostic performance of PI-RADSv2.1 in predicting csPCa was evaluated, and diagnostic performance of mpMRI and bpMRI was compared using cut-offs, with PI-RADSv2.1 categories ≥ 3 or ≥ 4 defined as positive. A total of 247 lesions from 216 participants were included in this study. A total of 157 patients underwent mpMRI and the remaining 59 underwent bpMRI. The csPCa detection rates for each PI-RADSv2.1 category of mpMRI and bpMRI were as follows: category 1, 0% (0/11); 2, 13% (3/23); 3, 16% (5/31); 4, 60% (43/72); 5, 65% (26/40), in mpMRI; category 1, 0% (0/4); 2, 33% (1/3); 3, 25% (3/12); 4, 61% (19/31); 5, 75% (15/20) in bpMRI. PI-RADSv2.1 categories were significantly positively associated with csPCa detection rates in both mpMRI and bpMRI (p < 0.0001 and p = 0.00048, respectively). PI-RADSv2.1 categories correlated with ISUP grade groups for mpMRI and bpMRI (p < 0.0001 for both). There were no significant differences in the detection rates between mpMRI and bpMRI for PI-RADS v2.1 positive and negative lesions. PI-RADSv2.1 using mpMRI and bpMRI could stratify the risk of csPCa, and the csPCa detection rate of bpMRI was compatible with that of mpMRI using cut-offs of PI-RADSv2.1 categories ≥ 3 or ≥ 4.

Using a novel PSMA-PET and PSA-based model to enhance the diagnostic accuracy for clinically significant prostate cancer and avoid unnecessary biopsy in men with PI-RADS ≤ 3 MRI.

The diagnostic evaluation of men with suspected prostate cancer (PCa) yet inconclusive MRI (PI-RADS ≤ 3) presents a common clinical challenge. [68Ga]Ga-labelled prostate-specific membrane antigen ([68Ga]Ga-PSMA) positron emission tomography/computed tomography (PET/CT) has shown promise in identifying clinically significant PCa (csPCa). We aim to establish a diagnostic model incorporating PSMA-PET to enhance the diagnostic process of csPCa in PI-RADS ≤ 3 men. This study retrospective included 151 men with clinical suspicion of PCa and PI-RADS ≤ 3 MRI. All men underwent [68Ga]Ga-PSMA PET/CT scans and ultrasound/MRI/PET fusion-guided biopsies. csPCa was defined as Grade Group ≥ 2. PRIMARY-scores from PSMA-PET scans were evaluated. A diagnostic model incorporating PSMA-PET and prostate-specific antigen (PSA)-derived parameters was developed. The discriminative performance and clinical utility were compared with conventional methods. Internal validation was conducted using a fivefold cross-validation with 1000 iterations. In this PI-RADS ≤ 3 cohort, areas-under-the-curve (AUCs) for detecting csPCa were 0.796 (95%CI, 0.738-0.853), 0.851 (95%CI, 0.783-0.918) and 0.806 (95%CI, 0.742-0.870) for PRIMARY-score, SUVmax and routine clinical PSMA-PET assessment, respectively. The diagnostic model comprising PRIMARY-score, SUVmax and serum free PSA/total PSA (fPSA/tPSA) achieved a significantly higher AUC of 0.906 (95%CI, 0.851-0.961) compared to strategies based on PRIMARY-score or SUVmax (P < 0.05) and markedly superior to conventional strategies typically based on PSA density (P < 0.001). The average fivefold cross-validated AUC with 1000 iterations was 0.878 (95%CI, 0.820-0.954). Theoretically, using a threshold of 21.6%, the model could have prevented 78% of unnecessary biopsies while missing only 7.8% of csPCa cases in this cohort. A novel diagnostic model incorporating PSMA-PET derived metrics-PRIMARY-score and SUVmax-along with serum fPSA/tPSA, has been developed and validated. The integrated model may assist clinical decision-making with enhanced diagnostic accuracy over the individual conventional metrics. It has great potential to reduce unnecessary biopsies for men with PI-RADS ≤ 3 MRI results and warrants further prospective and external evaluations.

Chemotherapy-induced cognitive impairment and its long-term development in patients with breast cancer: results from the observational CICARO study.

Chemotherapy-induced cognitive impairment (CICI) is a well-recognized side effect of breast cancer treatment. However, prospective long-term evaluations of CICI using standardized neuropsychological tests are scarce. This prospective longitudinal cohort study investigated cognitive dysfunction and its impact on quality of life and everyday functioning in patients with breast cancer receiving first-line chemotherapy compared to patients with breast cancer without chemotherapy. Assessment occurred prior to chemotherapy, postchemotherapy (median 6 months), and 2-3 years later. We used standardized neuropsychological tests, questionnaires, and scales to assess patients' quality of life and functioning. Additionally, serum analysis for neurodegenerative markers and autoantibodies was conducted. We included n = 53 patients. Overall cognitive function declined statistically significantly (P = .046) postchemotherapy compared to control patients, mostly driven by a reduced figural memory (P = .011). Patients who received chemotherapy showed a greater reduction in quality of life (increased fatigue symptoms, P = .023; reduced Karnofsky index, P<.001); however, without a statistically significant effect on cognitive decline. The neurodegenerative markers Neurofilament light chain (NfL) and phosphorylated Neurofilament heavy chain (pNfH) increased statistically significantly (P<.001) postchemotherapy and pNfH correlated with overall cognitive function. After 2-3 years, both cognitive performance and quality of life were comparable between chemotherapy-treated and control patients. Our findings suggest that chemotherapy statistically significantly contributes to overall cognitive dysfunction in patients with breast cancer, which disappears after 2-3 years, indicating a recovery in both objectively measurable cognitive function and subjective quality of life. Future research should examine larger sample sizes and explore screening indicators, particularly pNfH.

25 years of experience on the management of enterococcal infective endocarditis an observational study.

As they are effective and well tolerated, aminopenicillins are still the cornerstone for the treatment of enterococcal infections. Current treatment guidelines for infective endocarditis (IE) recommend combination treatments, which carry a higher risk of adverse effects and are based on limited in vitro and experimental data. The aim of this study was therefore to evaluate the treatments of enterococcal IE in real-life practice. A total of 4121 episodes of enterococcal bloodstream infections, occurring between 1994 and 2019, were screened for the evidence of IE. Baseline characteristics, risk factors for complicated infections and treatment information were assessed and analyzed using Cox regression analysis. Overall, 80 (3.9%) IE episodes were identified of which 78 were included in the final analysis. Treatment regimens in our cohort comprised aminopenicillin-monotherapy (n = 20), teicoplanin-monotherapy (n = 26), other monotherapies (OMT) (n = 8), as well as combinations of ampicillin plus daptomycin (n = 8), ampicillin plus gentamicin (n = 4) or other combinations (n = 9). Overall mortality at 28-days was low (9 of 75) and increased to (19 of 75) after 6-months. Frequency of moderate to severe valve regurgitation (p = 0.89), or signs of uncontrolled infection (p = 0.5) and vegetation size ≥ 10mm (p = 0.11) were similar in the treatment groups. None of the treatment groups was associated with increased hazard for IE-related mortality. This retrospective study complements previous evidence, demonstrating that monotherapy regimens may be a suitable and effective option for the treatment of IE and supports the need for a prospective evaluation of aminopenicillin-monotherapy for initial and subsequent therapy in these patients.

The foresight methodology for transitional shale gas reservoirs prediction based on a knowledge graph

The sedimentary environment in the eastern Ordos area of China is complex and contains a large number of transitional facies environments. Yet, there are many characteristics such as large vertical lithology changes, complex lateral sedimentary environment changes, small monolith thickness and large organic matter content changes, which lead to large uncertainty in the prediction of favorable areas for transitional shale gas. As the intricate reservoirs continue to unfold, the conventional linear prediction methods find themselves facing an arduous path to meet the demands of development. The ever-evolving complexity of these reservoirs has outpaced the capabilities of these traditional approaches. It becomes apparent that a more comprehensive and adaptable approach is necessary to navigate the intricacies of these reservoirs and unlock their hidden potential. Therefore, we put forward a method of introducing knowledge graph into transitional shale gas reservoir prediction in the eastern Ordos region by using big data technology. Because artificial intelligence big data relies heavily on data tags, it is particularly important for the construction of tags. Firstly, a top-down knowledge graph in the field of reservoir prediction is constructed to determine the key parameters used in prediction, namely porosity, total organic carbon and brittleness index. Secondly, the decision tree knowledge graph optimization label is constructed in a bottom-up way. The key parameter of this prediction is the knowledge graph obtained according to the professional knowledge of reservoir prediction, so as to optimize the school label of U-net and reduce the workload of artificial judgment. The results of the combination of the two methods are applied to 11 wells in Daji area of Ordos, and the experimental results are consistent with the actual situation of the reservoir. Based on the foundation of theoretical knowledge, this method enhances the efficiency and accuracy of interpretation and evaluation. It provides fundamental and technical support for the selection of favorable areas in shale gas exploration and the evaluation of exploration and development prospects, particularly in transitional shale gas areas, which is innovative and advanced in the field.

Pain in recessive dystrophic epidermolysis bullosa (RDEB): findings of the Prospective Epidermolysis Bullosa Longitudinal Evaluation Study (PEBLES)

BackgroundPain is common in the genetic skin fragility disorder epidermolysis bullosa (EB), from skin and mucosal injury and inflammation as well as extra-mucocutaneous sites. Individuals living with EB have identified pain as a priority for better treatments.ObjectivesThe Prospective EB Longitudinal Evaluation Study (PEBLES) is a prospective register study exploring the natural history of RDEB across all ages from birth to death. Here, we investigated the characteristics and treatment of pain in different RDEB subtypes.MethodsInformation was collected from individuals with different RDEB subtypes over an 8-year period. Data included visual analogue scale (VAS) ratings of background and procedural pain, its location, intensity and impact on sleep, as well as pain medication. Disease severity scores and quality of life measures were correlated to pain scores.ResultsSixty-one participants (13 children, 48 adults) completed a total of 361 reviews. Pain was common, experienced by 93% of participants at index review, with 80% suffering both background and procedural pain. Across all RDEB patients, the median VAS for background pain was 40 (out of 100) [interquartile range 20,60] and for those having regular dressing changes, median procedural pain was 52 [40,80]. Severe (RDEB-S) and pruriginosa (RDEB-Pru) groups had the greatest increase in procedural compared to background pain of 20 and 22 VAS points, respectively. Correlations between disease severity and quality of life impairment were observed across most groups, particularly RDEB-S. Over half of those studied experienced pain frequently or constantly, and in one third pain disturbed sleep at least 4 nights per week. Skin was the commonest source of pain in all subtypes except inversa RDEB where the mouth was the main site. Despite frequent and severe pain, one third of participants used no medication for pain and, in those that did, pain levels remained high suggesting ineffectiveness of current pain management approaches and a significant unmet need in RDEB.ConclusionThe frequency, severity, and impact of pain in all RDEB patients is significant, particularly in RDEB-S and RDEB-Pru. Our findings highlight that current RDEB pain management is poorly effective and that further research is needed to address this symptom.

Association of tear osmolarity and corneal nerves structure in dry eye disease: an in vivo study.

To evaluate the structural changes in corneal sub-basal nerves of dry eye disease (DED) patients with tear hyperosmolarity versus normosmolar tears. A prospective evaluation of the tear film (keratograph 5M), tear osmolarity, and sub-basal corneal nerves (laser scanning in-vivo confocal microscopy) was performed in a cohort of 53 DED patients (106 eyes) diagnosed as per DEWS II criteria. Patients with tear hyperosmolarity (Group 1, n = 48 eyes) were compared with DED patients without tear hyperosmolarity (Group 2, n = 58 eyes). Of 53 patients (27 females), 28 had Sjogren's syndrome, and the rest had meibomian gland dysfunction. There were more SS patients (21 vs 7) and females in Group 1. The two groups were similar in age, TMH, NIBUT, meibomian gland loss, bulbar redness, and corneal staining, except for Schirmer I (p < 0.001), and tear osmolarity (p < 0.001; worse in group 1). The groups did not differ in dendritic cell density, whether immature (53.8 vs. 38) or mature (2.7 vs. 0). The significantly different corneal nerve parameters were nerve fiber length (p = 0.005), density (p = 0.01), and branching density (p = 0.04), with lower values observed in group 1. Only tear osmolarity had a weak negative correlation with corneal nerve fiber length (r, -0.38), density (r, -0.32), and branching (r, -0.28). SS patients with hyperosmolar tears had reduced nerve fiber length and branching compared to SS patients with normosmolar tears. Tear hyperosmolarity is associated with reduced nerve branching, fiber density, and fiber length despite similar levels of conjunctival congestion, tear film stability, and meibomian gland loss in DED patients. What is known • Corneal nerves are reduced in density and length in dry eye disease patients. • Laboratory studies have shown fragmentation of corneal nerves on exposure to hyperosmolar solutions. What is new • Tear hyperosmolarity is associated with reduced nerve branching, fiber density, and fiber length in dry eyes compared to normosmolar tears. • The effect is independent of dendritic cell density.

Prospect evaluation of the Paleogene Sokor-1 reservoirs in Fana Field, Termit Basin (Niger Republic) using geophysical well logs and sedimentological data

Prospect evaluation of the Paleogene Sokor-1 reservoirs in Fana Field, Termit Basin (Niger Republic) using geophysical well logs and sedimentological data

Comparison of 4-week versus 8-week dietitian-led FODMAP diet group education sessions in tertiary care clinical practice for irritable bowel syndrome: A service evaluation.

The implementation of the fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet for irritable bowel syndrome (IBS) can be effectively delivered by dietitians in group settings. The initial FODMAP restriction phase is recommended to be followed for 4 weeks; however, limited efficacy data exist for 4-week FODMAP restriction in group education clinical practice. We aimed to compare 4-week versus 8-week FODMAP group treatment pathways on clinical outcomes using a prospective service evaluation design of IBS patients attending FODMAP restriction (baseline) and reintroduction (follow-up) group sessions (between 2015 and 2019). Clinical outcomes included global symptom question (GSQ) measuring satisfactory relief, gastrointestinal symptom rating scale (GSRS), stool frequency (SF), stool consistency using Bristol stool form scale (BSFS), diet acceptability, patient satisfaction with group sessions and dietary adherence. Logistic regression was used to test for differences in treatment effects when clinical outcomes were compared between groups. Patients (n = 284) included were aged 18 to 86 years (mean ± SD [standard deviation], 44.6 ± 15.5), 80% female, and were split into 4-week (41%, 117/284) versus 8-week (59%, 167/284) pathways with no differences in baseline characteristics. Mean ± SD time gap between baseline and follow-up was 4.6 ± 0.9 weeks in the 4-week pathway and 9.6 ± 3.3 weeks in the 8-week pathway. When groups were compared at follow-up, no statistical differences were observed in any measures (GSQ, GSRS, SF, BSFS, dietary adherence, diet acceptability and patient satisfaction). A 4-week dietitian-led group FODMAP treatment pathway is as clinically effective and maintains patient acceptability when compared to 8-weeks and should be considered as part of routine clinical practice.

Evaluation of wind potential and economic prospects in the southern regions of Morocco with MERRA-2 and ERA5

Meteorological reanalyses are generating interest in the modelling of wind energy production. This study provides a comparison between ERA5 and MERRA-2. Two regions in Morocco were studied: Laayoune-Sakia-El-Hamra (22 sites) and Dakhla-Oued-Eddahab (17 sites). Among the 150 wind turbines tested, the two most efficient ones were identified for each site. The results show that MERRA-2 outperforms ERA5 in several aspects, including scatter plots and R2 correlation. Wind potential and economic viability were evaluated for each of the 39 sites, incorporating a loss factor of 26.71% and applying Weibull parameters to precisely characterize each site. The analysis reveals that a few sites stand out for their high wind speeds, significant power densities and a capacity factor reaching 54.37%. Economically, the cost of electricity, ranging between $ 0.012 and $ 0.023 per kWh, is particularly favourable for wind energy production.

Genetic family studies and prospective evaluation for multisystem involvement are needed in LHON patients.

Genetic family studies and prospective evaluation for multisystem involvement are needed in LHON patients.

Tubeless ureteroenteric anastomosis in robot-assisted radical cystectomy with intracorporeal urinary diversion does not increase the risk of anastomotic stenosis or postoperative complications.

The objective is to demonstrate that omitting ureteral stent placement in robotic intracorporeal urinary diversion does not lead to increased risk of perioperative complications, namely ureteral strictures or anastomotic leaks. We retrospectively reviewed the records of 68 consecutive patients who underwent robotic radical cystectomy with ileal conduit creation or orthotopic neobladder by a single surgeon between January 2020 and September 2023. Chronologically, the first cohort of patients had ureteral stents placed to bridge the ureteroenteric anastomosis, and in the second cohort, stenting was omitted. Cohort 1 consisted of 28 patients with surgeries performed between January 2020 and April 2021, while cohort 2 had 40 patients who underwent surgery from April 2021 to September 2023. The cohorts were well matched with regard to patient age, gender, ASA score and rate of neoadjuvant chemotherapy. The choice of urinary diversion was left to surgeon and patient preference, and there was no significant difference in the proportion of ileal conduits versus orthotopic neobladders within each cohort. Estimated blood loss, total operative time, inpatient length of stay and pathologic T and N staging did not statistically differ between the cohorts. Overall, there was no difference in the rates of postoperative ileus, ureteral stricture, anastomotic leak, infectious complications, and 30-day readmission rates between the groups. Tubeless ureteroenteric anastomosis in patients undergoing robotic radical cystectomy with intracorporeal diversion does not appear to increase the risk of anastomotic strictures or postoperative complications. Further prospective evaluation is warranted.

A-004 Clinical and Laboratory Validation of the Atellica® vTLi Analyzer for Diagnosis of Myocardial Infarction Through High Sensitivity Cardiac Troponin I (hs-cTnI) Measurement

Abstract Background Most deaths resulting from Acute Myocardial Infarction (AMI) occur within the initial hours following the onset of clinical symptoms. Troponins serve as the preferred biomarkers and can be utilized for screening individuals presenting with chest pain, referring them towards appropriate clinical interventions based on the 0-hour/1-hour algorithm. The Atellica® vTLi Patient-side analyzer (POC), employing the methodology based Magnotech™ Technology, allows the quantification of hs-cTnI levels using a small sample volume. This capability enables the prompt evaluation and management of patients with chest pain. Use POCT troponin assays may allow for faster decision-making in this high-risk population and reduce the burden on emergency facilities. This study evaluated the analytical and clinical performance of a POCT hs-cTnI from Atellica® VTLi compared to hs-cTnT Roche Diagnostics and hs-cTnI Atellica® IM 1300. Objectives Clinical and analytical validation of the Atellica® vTLi analyzer for the measurement of hs-cTnI in patients with suspected AMI compared to the reference methodologies on the market. Methods The study is being conducted in the department of critically patient, the Cardiology program and the clinical laboratory of the Hospital Israelita Albert Einstein. In the first phase of the study, samples from 108 volunteers were analyzed for analytical comparability between hs-cTnI of the Analyzer Atellica® vTLi and hs-cTnT Cobas®. A study was then carried out of precision with samples of commercial controls with three evaluation levels, with five replicates, for 5 days in the Analyzer Atellica® vTLi. The second phase of the study was performed with samples from 51 patients who report to the emergency department with chest pain for a clinical prospective evaluation and correlation between the hs-cTnI assays of the Analyzer Atellica® vTLi, hs-cTnT Cobas® and Atellica IM 1300. Results The results show a great correlation (Pearson’s correlation greater than 0.75, p&amp;lt;0.0001) between the Atellica® vTLi, hs-cTnT Cobas® platforms in the sample group. Of the patients included in the second phase of study, the average age was 61 years, with 60% of patients having systemic arterial hypertension, 35% diabetics, 53% dyslipidemic patients and none of the patients were smokers. When assessing cardiovascular risk using the heart score, 55% of patients were at moderate or high risk. In this group there was also a strong correlation between the Atellica® vTLi platforms, hs-cTnT Cobas® serum, hs-cTnT Cobas® plasma, Atellica IM 1300 serum and Atellica IM 1300 plasma in the second phase (p&amp;lt;0.0001 in all cases. Pearson correlation), considering the reference values for laboratory stratification in the rapid chest pain protocol (time 0 h and 1 h) and the biochemical differences of troponin I and troponin T molecules. Conclusions In the present study, the Siemens POCT Atellica® vTLi device showed excellent performance in laboratory validation and strong correlation with the high-sensitivity TnT assay in different troponin concentration ranges. Additionally, Atellica® vTLi demonstrated a strong clinical correlation between hs-cTnI Atellica® IM 1300 and hs-cTnT Cobas® platforms present in a central laboratory, being considered safe for use in 0-1h protocols in patients with chest pain and suspected heart attack.