Single-center Prospective Study Research Articles

Predictors of quality of life, economic impact, and loss to follow-up after open tibial shaft fractures in Ghana.

Open tibia fractures are associated with substantial morbidity and impact on quality of life. Despite increasing incidence in low-resource settings, most open tibia fracture research comes from high-resource settings. This study aimed to assess the impact of socioeconomic status on treatment modality and evaluate predictors of health-related quality of life following open tibia fractures in Ghana. A single-center prospective observational study was conducted in Kumasi, Ghana, from May 2020 to April 2022. Adults with open tibial shaft fractures presenting within 2 weeks of injury were eligible. Demographics, comorbidities, socioeconomic factors, and hospital course were collected at enrollment. Follow-up was scheduled at 8, 12, 26, and 52 weeks. A telephone survey assessing reasons for loss to follow-up was initiated on enrollment completion. A total of 180 patients were enrolled. Most patients were employed before injury (79.9%), had government insurance (67.2%), and were from rural areas (59.4%). Fracture classification was primarily Gustilo-Anderson type 3A (49.1%). No relationship between socioeconomic predictors and treatment modality was identified. The largest barriers to follow-up were preference for bonesetter treatment (63.1%), treatment cost (48.8%), and travel cost (29.8%). Of the lost to follow-up patients contacted, 67 (79.8%) reported receiving traditional bonesetter care. Reasons for seeking traditional bonesetter care included ease of access (83.6%), lower cost (77.6%), and familial influence (50.7%). No association was identified between socioeconomic predictors and choice of treatment. Bonesetter treatment plays a substantial role in the care of open tibia fractures in Ghana, largely because of ease of access and lower cost.

Myeloperoxidase and N-terminal pro-atrial natriuretic peptide as predictors for atrial fibrillation recurrence in patients undergoing redo ablation

BackgroundAtrial fibrillation (AF) is a progressively developing arrhythmia. Electroanatomic remodeling may play an important role, both in the development of the disease as well as in the perpetuation and thus in the recurrence of AF. ObjectiveThis study aimed to investigate potential biomarkers Myeloperoxidase (MPO), N-terminal pro-atrial natriuretic peptide (NT-proANP), intercellular adhesion molecule-1 (ICAM-1), and matrix metalloproteinase-2 (MMP-2) and their predictive value for AF recurrence in patients undergoing redo ablation. MethodsIn this single-center prospective cohort study 50 consecutive patients underwent ultra-high-density mapping and redo ablation. Biomarkers were determined before ablation and at 6 months follow-up. Seven-day Holter was conducted to check for AF recurrence (>30 seconds). ResultsEleven (22%) patients showed AF recurrence after redo ablation. ROC analysis revealed venous MPO and NT-proANP (AUC 0.755, 95% CI 0.599 – 0.912, p=0.010 and AUC 0.752, 95% CI 0.551 – 0.953, p=0.011) as acceptable predictors for intermediate AF recurrence, whereas MMP-2, ICAM-1, and established cardiovascular biomarkers such as NT-proBNP, Troponin T, and C-reactive protein were not (all AUC <0.600). MPO and NT-proANP correlated with AF burden (ρ 0.365, p=0.005 and ρ 0.362, p=0.005). While MPO was associated with atrial fibrosis in the endocardial map (ρ 0.280, p=0.024), NT-proANP correlated with left atrial volume index (ρ 0.256, p=0.037). There were no significant differences in biomarkers concentrations with regard to venous and coronary sinus samples. ConclusionMPO and NT-proANP are of predictive value for AF recurrence in patients undergoing redo ablation. While MPO correlated with endocardial fibrosis, NT-proANP was associated with left atrial volume.

371. ENDOFLIP: THE FUTURE OF DYSPHAGIA DIAGNOSIS AND MANAGEMENT

Abstract Background High-resolution manometry (HRM) is the gold standard for characterizing esophageal motility disorders, but it’s frequently associated with poor patient tolerance. A newer diagnostic tool, the Endoscopic Functional Lumen Imaging Probe (EndoFLIP), has emerged to assess esophagogastric junction (EGJ) distensibility and distension-mediated peristalsis. Also, for motility disorders such as EGJ outflow obstruction (EGJOO), HRM-isolated features aren’t enough for the diagnosis. The diagnosis also requires symptom correlation and additional investigations like EndoFLIP. Methods We conducted a single-center prospective cohort study for patients with dysphagia and inconclusive or intolerant to HRM. The inclusion criteria were patients with an elevated median integrated relaxation pressure (IRP) on HRM and patients with an inconclusive or intolerant to HRM. Patients with isolated IRP on HRM were included, as this isolated finding does not allow for the definitive diagnosis of EGJOO. These patients underwent EndoFLIP testing from January 2022 to February 2024 at a tertiary center. Results We performed EndoFLIP on 42 patients (50% male; 50% female), 23,8% with EGJOO diagnosis on HRM, 21,4% with inconclusive HRM, and 54,8% patients intolerant to HRM. Twenty-three patients intolerant to HRM underwent EndoFLIP, enabling diagnosis in all cases. Four patients were diagnosed with EGJOO, 6 with achalasia, and 4 with ineffective esophageal motility (IEM). On 88% of patients, the EndoFLIP allowed a correct diagnosis and treatment, with 29% undergoing endoscopic treatment during the same procedure. 9 patients with inconclusive HRM were diagnosed after EndoFLIP: 3 were diagnosed with EGJOO, 4 with IEM, and 3 with achalasia. We report a significant discordance between EGJOO diagnosis on HRM and EndoFLIP results. 50% of patients diagnosed with EGJOO on HRM showed normal EndoFLIP results, with only 20% confirming the diagnosis, while 20% raised the possibility of the diagnosis being achalasia. 43,8% of patients diagnosed with EGJOO confirmed by EndoFLIP underwent endoscopic therapy with botulinum toxin or balloon dilation during the same procedure, resulting in clinical improvement for all patients. Discussion The discordance between HRM and EndoFLIP may arise from HRM's tendency to overdiagnose EJGOO, leading to unnecessary testing and treatments for EGJOO. Many EGJOO HRM diagnoses don't require therapy, as symptoms often resolve spontaneously or with dietary education, casting doubt on the isolated HRM finding's clinical significance. It's particularly beneficial for patients with inconclusive/intolerance to HRM, allowing correct diagnosis and treatment in cases of obstructive symptoms. These results support EndoFLIP as a screening tool for patients undergoing endoscopy, enabling better selection of those benefiting from subsequent HRM.

Development and Validation of a Contrast-Enhanced US VI-RADS for Evaluating Muscle Invasion in Bladder Cancer.

Background Contrast-enhanced US (CEUS) can be used preoperatively for evaluating muscle invasion in bladder cancer, which is important for determining appropriate treatment. However, diagnostic criteria for assessing this at CEUS have not been standardized. Purpose To develop and validate a CEUS Vesical Imaging Reporting and Data System (VI-RADS) for evaluating muscle invasion in bladder cancer. Materials and Methods This single-center prospective study consecutively enrolled patients with suspected bladder cancer. Participants underwent transabdominal or intracavity CEUS between July 2021 and May 2023. Participants were divided into a training set and a validation set at a 2:1 ratio based on the chronologic order of enrollment. The training set was used to identify major imaging features to include in CEUS VI-RADS, and the likelihood of muscle invasion per category was determined using a pathologic reference standard. The optimal VI-RADS category cutoff for muscle invasion was determined with use of the maximum Youden index. The validation set was assessed by novice and expert readers and used to validate the diagnostic performance and interreader agreement of the developed system. Results Overall, 126 participants (median age, 64 years [IQR, 57-71 years]; 107 male) and 67 participants (median age, 64 years [IQR, 56-69 years]; 49 male) were included in the training and validation set, respectively. In the training set, the optimal CEUS VI-RADS category cutoff for muscle invasion was VI-RADS 4 or higher (Youden index, 0.77). In the validation set, CEUS VI-RADS achieved good performance for both novice and expert readers (area under the receiver operating characteristic curve, 0.80 [95% CI: 0.70, 0.90] vs 0.88 [95% CI: 0.80, 0.97]; P = .09). The interreader agreement regarding the evaluation of CEUS VI-RADS category was 0.77 (95% CI: 0.65, 0.85) for novice readers, 0.87 (95% CI: 0.79, 0.92) for expert readers, and 0.78 (95% CI: 0.70, 0.84) for all readers. Conclusion The developed CEUS VI-RADS showed good performance and interreader agreement for the assessment of muscle invasion in bladder cancer. Chinese Clinical Trial Registry no. ChiCTR2100049435 © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Morrell in this issue.

Reduction of peritoneal dialysis associated infections using a novel exit-site care practice.

Peritoneal dialysis (PD) related infections are a significant obstacle leading to PD discontinuation. Since catheter related infections (CRI), defined as exit site infections and/or tunnel infection, can progress to peritonitis, vigorous efforts are implemented in CRI prevention. Following an increased CRI rate in our institution, partially related to environmental organisms found in water distribution systems, we hypothesized that exit site care that includes prevention of water exposure-related pathogens may reduce CRI. In this prospective single center study, we compared a contemporary cohort consisting of PD patients who implemented the modified exit-site care protocol, mainly including water avoidance during shower with stoma bag usage and local Mupirocin ointment against a historical control group before the protocol implementation. The historical cohort was allowed water exposure and used local gentamicin ointment. The primary outcome was the development of a CRI. Secondary outcomes were PD associated peritonitis and infection related outcomes. There were 55 patients in contemporary cohort and 58 in historical group. The CRI rate was significantly lower in study group (0.11/episodes per patient year [EPP]) compared to control group (0.71 EPP), p < 0.001. A multivariate Cox regression analysis demonstrated a protective effect of being in the contemporary cohort compared to historical group (HR for first CRI = 12.0 95%CI: 4.0-35.7, p < 0.001). Peritonitis rate was significantly lower in contemporary cohort (0.19/EPP) compared to the historical group (0.40/EPP), p = 0.011. Transfer to hemodialysis was significantly lower in contemporary cohort than historical group (7.3% vs 31.0% in contemporary and historical group respectively, HR = 0.2, 95%CI; 0.05-0.6, p = 0.001). An exit site care protocol that includes water avoidance and local Mupirocin use reduced substantially both CRI and peritonitis rate in patients treated with PD.

Efficacy and safety of serrapeptase on ankle sprain cases: A single center prospective comparative study

BackgroundNon-steroid anti-inflammatory drugs (NSAIDs) rank among the frequently prescribed medications for addressing pain and inflammation. Although they are powerful pain relievers, their side effects are indisputable. Serrapeptase, a serine protease, exhibits anti-inflammatory and anti-oedemic activity without the side effects of NSAIDs. We aim to assess the efficacy and safety of serrapeptase in the treatment of pain and edema in ankle sprains. MethodsIn a single-centre prospective comparative study, 76 patients aged 18–53 with Grade II ankle sprains were assigned to either a serrapeptase intervention group (n = 38) receiving 5 mg serrapeptase (two tablets, three times per day) for ten days, or a control group (n = 38) receiving 500 mg paracetamol (three times per day) for the same duration. Ankle joint edema was assessed using both Figure-of-Eight and water-displacement methods. Pain was assessed with Visual Analogue Scale (V.A.S.). Within-groups and between-groups analyses were performed in the 3rd and 10th day. ResultsBoth groups exhibited reduced edema and pain over time. Serrapeptase demonstrated a superior reduction in ankle joint edema on the third and tenth day compared to paracetamol, while pain management did not differ significantly. ConclusionSerrapeptase exhibited better efficacy than paracetamol in reducing ankle joint edema, highlighting its potential as an alternative treatment. Level of evidenceLevel II, prospective comparative trial without randomization.

Development of a new scale for self-reported procedural patient comfort during endovascular therapy for acute stroke.

In stroke patients with acute large vessel occlusion, endovascular therapy (EVT) may be performed with or without sedation. Our aim is to describe self-reported intraprocedural comfort in patients undergoing EVT depending on sedation type. We performed a prospective observational single-center study of patients undergoing EVT. Patients were systematically interviewed on the day following intervention using a structured questionnaire addressing five domains (nausea/vomiting, pain of any kind, physical discomfort, emotional discomfort, and medical team interaction). Each domain scored 0 to 2 points for a maximum total of 10 points (a higher score indicating greater discomfort). In addition, satisfaction with procedural comfort was rated on a visual analog scale (VAS), and patients reported whether they would have preferred more, less, or the same amount of sedation. Patients who underwent EVT without sedation (local anesthesia, LA) were compared to those who received procedural sedation (conscious sedation, CS). Seventy-seven questionnaires were completed: 37 (48%) patients underwent EVT with CS while 40 (52%) were treated under LA. Median scores on the self-reported discomfort scale (1[0-2] vs 1[0-2], p = 0.70) and mean scores on VAS (76 ± 25 vs 81 ± 24, p = 0.37) were similar between the CS and the LA group. The proportion of patients who were satisfied with the adopted sedation strategy was similar between groups. EVT without prior sedation seems to be well tolerated. Systematic self-evaluation of patient comfort appears feasible and may become integrated into routine clinical care. Patient-oriented outcomes should be included in future trials of sedation during thrombectomy.

Loss of Heterozygosity and Mutations in the RAS-ERK Pathway Genes in Tumor Cells of Various Loci in Multiple Myeloma.

Multiple myeloma (MM) is a disease characterized by spatiotemporal heterogeneity of tumor clones. Different genetic aberrations can be observed simultaneously in tumor cells from different loci, and as the disease progresses, new subclones may appear. The role of liquid biopsy, which is based on the analysis of tumor DNA circulating in the blood plasma, continues to be explored in MM. Here, we present an analysis of the STR profiles and mutation status of the KRAS, NRAS, and BRAF genes, evaluated in plasma free circulating tumor DNA (ctDNA), CD138+ bone marrow cells, and plasmacytomas. The prospective single-center study included 97 patients, with a median age of 55 years. Of these, 94 had newly diagnosed symptomatic MM, and three had primary plasma cell leukemia. It should be noted that if mutations were detected only in ctDNA, "non-classical" codons were more often affected. A variety of adverse laboratory and clinical factors have been associated with the detection of rare KRAS or NRAS gene mutations in bone marrow or ctDNA, suggesting that these mutations may be factors of an unfavorable prognosis for MM. Liquid biopsy studies provide undeniable fundamental information about tumor heterogeneity and clonal evolution in MM. Moreover, we focus on using liquid biopsy to identify new high-risk factors for MM.

Insights into Iron Metabolism Parameters in Ischemic Stroke: A Single-Center Prospective Cohort Study.

The hemojuvelin-hepcidin regulatory axis may play a key role in the iron metabolism both systemically and locally. There is a pressing need to evaluate this tightly regulated network of iron parameters and their potential impact on the development of ischemic stroke (IS). We aimed to assess iron metabolism biomarkers in patients after IS, evaluating changes over time and considering their clinical features. We studied 45 patients diagnosed with IS. We assessed major iron metabolism parameters, such as hepcidin, soluble hemojuvelin (sHJV), soluble transferrin receptor (sTfR), and ferritin, using immunoenzymathic methods at two time points: on admission and on the 7th day post IS. We found increased ferritin levels on the 7th day post IS compared to admission, and this was observed in the entire study group (p = 0.03) and in the subgroup treated with thrombolysis (p = 0.02). The hepcidin levels, on the other hand, showed a significant decrease on the 7th day, though this difference was only evident in the entire study group (p = 0.04). We also discovered significantly elevated sHJV levels in patients with PACI stroke compared to other stroke locations, both on admission and on the 7th day post IS (p < 0.05). Significantly higher sHJV levels were observed in patients treated with thrombolysis compared to those receiving conventional treatment, regardless of the time point (p < 0.0001 and p = 0.0002, respectively). Our study revealed changes in the iron metabolism parameters during stroke. The patients with anterior cerebral infarction and those treated with thrombolysis presented significantly elevated sHJV levels.

Carbapenem resistance in Enterobacterales: Predicting clinical outcomes in bloodstream infections

PurposeCarbapenem-resistant Enterobacterales (CRE) are a global concern due to their high mortality rates and limited therapeutics. CRE-caused bloodstream infections (BSIs) are challenging to manage, especially in healthcare settings. This study aimed to investigate the predictors of mortality in BSI patients caused by CRE. MethodsA single center prospective study to examine the characteristics of BSI caused by CRE in a large academic hospital over 15 months. The main outcomes were microbiological characteristics and clinical outcomes of patients at 28 days based on a step-wise regression analysis. ResultsA total of 76 episodes of BSI due to CRE were included. The study found that the most common type of carbapenemase was OXA-48 (69.7 %, n = 53), followed by the co-existence of OXA-48 and MBL (26.3 %, n = 20), with Klebsiella pneumoniae being the most common (90 %, n = 69). Patients with OXA-48-BSI were more likely to have a urinary source of infection, while patients with MBL-BSI were more likely to have a non-urinary source of infection. All cases (100 %) had medical devices. Around 30.3 % of patients received effective empirical treatment, while 61.8 % received adequate therapy at 48 h. The overall mortality rate was 42.1 % (n = 32), and the main predictors of mortality in this study were the presence of sepsis and inadequate initial therapy, while age >65 predicted mortality in the linear regression but not the stepwise regression model. ConclusionCRE-BSIs are a serious health threat. The study highlights the need for preventive strategies focused on high-risk patients and proper device management to reduce BSI.

The FLARE Score and Circulating Neutrophils in Patients with Cancer and COVID-19 Disease.

Inflammation and neutrophils play a central role in both COVID-19 disease and cancer. We aimed to assess the impact of pre-existing tumor-related inflammation on COVID-19 outcomes in patients with cancer and to elucidate the role of circulating neutrophil subpopulations. We conducted a multicenter retrospective analysis of 524 patients with cancer and SARS-CoV-2 infection, assessing the relationship between clinical outcomes and circulating inflammatory biomarkers collected before and during COVID-19 infection. Additionally, a single-center prospective cohort study provided data for an exploratory analysis, assessing the immunophenotype of circulating neutrophils and inflammatory cytokines. The primary endpoints were 30-day mortality and the severity of COVID-19 disease. Prior to COVID-19, 25% of patients with cancer exhibited elevated dNLR, which increased to 55% at the time of COVID-19 diagnosis. We developed the FLARE score, incorporating both tumor- and infection-induced inflammation, which categorized patients into four prognostic groups. The poor prognostic group had a 30-day mortality rate of 68%, significantly higher than the 23% in the favorable group (p < 0.0001). This score proved to be an independent predictor of early mortality. This prospective analysis revealed a shift towards immature forms of neutrophils and higher IL-6 levels in patients with cancer and severe COVID-19 infection. A pre-existing tumor-induced pro-inflammatory state significantly impacts COVID-19 outcomes in patients with cancer. The FLARE score, derived from circulating inflammatory markers, emerges as an easy-to-use, globally accessible, effective tool for clinicians to identify patients with cancer at heightened risk of severe COVID-19 complications and early mortality who might benefit most from immediate and intensive treatment strategies. Furthermore, our findings underscore the significance of immature neutrophils in the progression of COVID-19 in patients with cancer, advocating for further investigation into how these cells contribute to both cancer and COVID-19 disease.

Impact of ultrasound-guided high-intensity focused ultrasound for the treatment of uterine fibroids on ovarian reserve and quality of life: a single-center prospective cohort study

BackgroundWe aimed to evaluate changes in ovarian reserve and quality of life in women treated with ultrasound-guided high-intensity focused ultrasound (USgHIFU) for uterine fibroids.MethodsIn this single-center prospective study, a total of 69 patients with uterine fibroids treated with USgHIFU from October 2018 to November 2021 were enrolled. Fibroid volume, anti-Müllerian hormone (AMH) levels, uterine fibroid symptom scores, and uterine fibroid symptoms and quality of life (UFS-QOL) questionnaire scores before and 1, 3, and 6 months after USgHIFU treatment were analyzed. Correlations between AMH levels and age, fibroid type, and fibroid location were assessed.ResultsData from 54 of the 69 patients included in the present study were analyzed. The UFS-QOL scores at baseline and at 1 month and 6 months after USgHIFU treatment were 70 (50.75–87.50), 57 (44.75–80.00), and 52 (40.75–69.00) points, respectively (p < 0.001). The rate of fibroid volume reduction increased significantly at the 3-month follow-up compared with the 1-month follow-up (p < 0.001), and no significant change was observed between the 3-month and 6-month follow-ups (p > 0.99). The median AMH levels before and at 1, 3 and 6 months after treatment were 1.22 (0.16–3.28) ng/ml, 1.12 (0.18–2.52) ng/ml, 1.15 (0.19–2.08) ng/ml and 1.18 (0.36–2.43) ng/ml, respectively (p = 0.2). Multivariate linear regression analyses revealed that age was independently associated with AMH levels.ConclusionsUSgHIFU treatment for uterine fibroids can significantly improve quality of life with minimal adverse effects on ovarian function.

Safety and efficacy of bilateral superselective adrenal arterial embolization for treatment of idiopathic hyperaldosteronism: a prospective single-center study

ObjectiveThis study aimed to assess the efficacy and safety of bilateral superselective adrenal arterial embolization (SAAE) in patients with bilateral idiopathic hyperaldosteronism (IHA), a subtype of PA.MethodsNinety-eight patients with bilateral IHA underwent bilateral SAAE between August 2022 and August 2023. Sixty-eight patients were followed up for up to 12 months. The study outcomes were evaluated using the criteria provided by the Primary Aldosteronism Surgical Outcome (PASO) guidelines.ResultsThe mean reductions in systolic and diastolic blood pressure were 27.4 ± 21.3 mmHg and 23.1 ± 17.4 mmHg, respectively (p < 0.001). The rates of clinical success and biochemical success after adrenal artery ablation were 63.2% (43/68) and 39.7% (27/68), respectively. Overall, there were significant reductions in daily defined doses (DDD), aldosterone/renin ratio (ARR), and plasma aldosterone levels (p < 0.001). Plasma renin levels increased by a mean value of 10.4 ± 39.0 pg/mL (p = 0.049), and potassium levels increased by 0.40 ± 0.63 mmol/L (p < 0.001). No significant adverse events were reported during SAAE or the follow-up period of up to one year. Additionally, no abnormalities were detected by adrenal 68Ga-Pentixafor PET/CT scans before or after SAAE.ConclusionBilateral SAAE appears to lead to sustained improvements in blood pressure and biochemical parameters in patients with bilateral PA, with minimal adverse effects. This suggests that bilateral SAAE could serve as an effective alternative approach for treating bilateral IHA, potentially curing this condition.

Oral Levodopa Stimulates Copeptin Secretion in Children and Adolescents with Intact Posterior Pituitary Function

BackgroundCopeptin stimulation tests can be used in the differential diagnosis of polyuria polydipsia syndrome. Current stimulation methods rely on intravenous or subcutaneous administration. Oral stimulus can further simplify the diagnostic approach. The levodopa stimulation test is widely used in the evaluation of growth hormone deficiency (GHD), and the dopamine pathway was reported to be associated with arginine vasopressin secretion. The study aimed to investigate the effect of oral levodopa on copeptin secretion. MethodsThe study was a prospective observational single-center cohort study. Patients < 18 years old with short stature and no symptoms of polyuria or polydipsia undergoing levodopa stimulation test for suspected GHD were recruited from May 2023 to Nov 2023. Copeptin and growth hormone (GH) were measured at 0, 30, 60, 90, and 120min in the levodopa test. The insulin tolerance test with copeptin and GH measured at the same time points was conducted in part of patients. ResultsForty-four participants were included in the final analysis. In the levodopa stimulation test, the median (interquartile range, IQR) copeptin concentration increased from 5.20 (3.51, 8.25) pmol/L to maximum 19.36 (8.97, 108.08) pmol/L (P < 0.001), 3.94 (1.41, 13.88) times of the baseline (P < 0.001). Compared with insulin tolerance test, peak copeptin in the levodopa test was significantly higher (34.61 (13.67, 98.96) vs 8.88 (7.14, 15.42) pmol/L, P = 0.009). Higher copeptin was associated with larger dose of levodopa. ConclusionsOral levodopa could be used to stimulate copeptin.

Pentoxifylline ameliorates subclinical atherosclerosis progression in patients with type 2 diabetes and chronic kidney disease: a randomized pilot trial

BackgroundDiabetic kidney disease (DKD) is associated with a higher risk of cardiovascular disease (CVD). Pentoxifylline (PTF), a nonselective phosphodiesterase inhibitor with anti-inflammatory, antiproliferative, and antifibrotic actions, has demonstrated renal benefits in both clinical trials and meta-analyses. The present work aimed to study the effects of PTF on the progression of subclinical atherosclerosis (SA) in a population of patients with diabetes and moderate to severe chronic kidney disease (CKD).MethodsIn this open-label, randomized controlled, prospective single-center pilot study the evolution of carotid intima-media thickness (CIMT) and ankle-brachial index (ABI) were determined in 102 patients with type 2 diabetes mellitus and CKD assigned to PTF, aspirin or control groups during 18 months. We also determined the variations in the levels of inflammatory markers and Klotho (KL), a protein involved in maintaining cardiovascular health, and their relationship with the progression of SA.ResultsPatients treated with PTF presented a better evolution of CIMT, increased KL mRNA levels in peripheral blood cells (PBCs) and reduced the inflammatory state. The progression of CIMT values was inversely related to variations in KL both in serum and mRNA expression levels in PBCs. Multiple regression analysis demonstrated that PTF treatment and variations in mRNA KL expression in PBCs, together with changes in HDL, were significant determinants for the progression of CIMT (adjusted R2 = 0.24, P < 0.001) independently of traditional risk factors. Moreover, both variables constituted protective factors against a worst progression of CIMT [OR: 0.103 (P = 0.001) and 0.001 (P = 0.005), respectively].ConclusionsPTF reduced SA progression assessed by CIMT variation, a beneficial effect related to KL gene expression in PBCs.Trial registrationThe study protocol code is PTF-AA-TR-2009 and the trial was registered on the European Union Drug Regulating Authorities Clinical Trials (EudraCT #2009–016595–77). The validation date was 2010-03-09.

[68 Ga]Ga-CXCR4 PET/CT imaging in high-grade glioma for assessment of CXCR4 receptor expression

PurposeGliomas account for 75 % of primary malignant CNS tumors. High-grade glioma (CNS WHO grades 3 and 4) have an unfavorable treatment response and poor outcome. CXCR4 is a G protein-coupled receptor that plays an important part in the signaling pathway between cancer cells and tumor microenvironment. CXCR4 overexpression has been shown in a variety of cancers. In this study, we evaluate the potential value of [68Ga]Ga-Pentixafor as a PET/CT CXCR4-probe for in vivo assessment of CXCR4 expression in patients with high-grade glioma and its correlation with tumor grade. Materials and Methods[68Ga]Ga-CXCR4 PET/CT was performed in the prospective single-center study in treatment-naïve biopsy-proven patients with high-grade glioma. The acquired images were analyzed qualitatively and semi-quantitatively. ResultA total of 26 patients (mean age: 53.3±14.4 years, 11 women, 15 men) were enrolled. CNS WHO grade 3 pathology was seen in 19 % (5/26) of the sample. The patient-based sensitivity of 68Ga-CXCR4 was 96.2 %. Overall, 28 pathologic lesions were detected, leading to a lesion-based sensitivity of 96.4 %. The median (IQR) SUVmax of grade 4 lesions was substantially greater than the grade 3(3.03(2.5–3.7) vs. 1.51(1.2–1.8), p = 0.0145).). The highest tracer activity of organs −beside bladder as the main excretion reservoir-was in lymphoid tissue of Waldeyer’s ring (mean SUVmax: 7.41), and spleen (mean SUVmax: 6.62). ConclusionIn conclusion, this new application for [68Ga]Ga-Pentixafor PET tracer exhibits excellent visual and semi-quantitative diagnostic properties. Further studies are warranted.

Contemporaneous symptom networks analysis in lymphoma patients during chemotherapy: protocol for a single-centre prospective cross-sectional study

BackgroundSymptom networks offer a theoretical basis for developing personalised and precise symptom management strategies. However, symptom networks in lymphoma patients during chemotherapy have been rarely reported. This study intends to...

Does two dimensional templating allow for the use of reduced-size ancillaries in total hip arthroplasty?

Rising costs in healthcare for total hip arthroplasty (THA) mean that new solutions must be considered, such as the use of single-use ancillaries (SUA). The goal of this study was to assess the accuracy of 2D templating in primary THA for the use of reduced-size SUA. Our hypothesis was that the accuracy of 2D templating in primary THA would be higher than 95%, give or take two sizes. This single-centre prospective study included all primary THAs performed over two years. Templating was carried out using 2D templating on anteroposterior pelvic X-rays. The template sizes were compared to the implant sizes. The primary endpoint was the rate of coincidence between digitally templated estimates and the actual implant sizes. The secondary endpoint was the difference of accuracy based on patient parameters. We analysed 512 cases of THA. Accuracy within two sizes was 96.9% for acetabular implants and 98.5% for femoral implants. Accuracy was below the 95% threshold only in patients under 55 and over 85 years old. A BMI above 30.0kg/m2 significantly reduced accuracy but did not fall below the 95% threshold. The operated hip, the type of implant, and the operative indication did not significantly influence templating accuracy. Using reduced-size SUA with five rasps and five reamers depending on template sizes means that THA can be performed in more than 95% of cases allowing the use of compact single use ancillaries.

Butyrylcholinesterase levels correlate with surgical site infection risk and severity after colorectal surgery: a prospective single-center study.

Surgical site infections (SSIs) after colorectal surgery remain a significant concern, which warrants effective predictive markers for prompt diagnosis and treatment. Butyrylcholinesterase (BChE), a non-specific cholinesterase enzyme, has been correlated with the risk of hepatic dysfunction progression and, more recently, infectious diseases and septic shock with ongoing research into the utility of BChE in multiple systemic inflammatory conditions. Whether these preliminary results can be translated into predicting infection after colorectal surgery remains in remains in question. This prospective study aimed to assess BChE's potential as a predictive marker for surgical site infections and anastomotic leaks after colorectal surgery. This single-center prospective study (11/2019-05/2023) enrolled 402 patients who underwent colorectal surgery. BChE levels were measured at four postoperative time points. The primary endpoints focused on BChE's association with complications, particularly surgical site infections (SSIs). Further known predictors of SSI were utilized to construct multivariable models to assess for independent association with SSI development. During the third and fifth day postsurgery, SSI patients had significantly lower mean BChE levels (3.90 KU/L vs. 4.54 KU/L p-value < 0.05, and 4.14 KU/L vs. 4.73 KU/L, p-value < 0.05; t-test, respectively). However, multivariate analysis revealed that when adjusted for other factors, low BChE levels on the first postoperative day were associated with 2.6 times higher odds of developing SSI (OR: 2.6, 95%CI: 1.3-3.9, p-value < 0.05). Similar results were found for low BChE levels on the third postoperative day as they were associated with a. 2.53 times higher odds for developing SSI (OR: 2.5, 95%CI: 1.27-3.87, p-value < 0.05) when adjusted for other factors. In conclusion, in this prospective observational study, low levels in the first and third postsurgery were associated with an increased risk for the development of SSIs but not sepsis.

Higher Accuracy of Arthroscopy Compared to MRI in the Diagnosis of Chondral Lesions in Acute Ankle Fractures: A Prospective Study.

Even after successful surgery for acute ankle fractures, many patients continue having complaints. A possible explanation is the presence of concomitant chondral lesions. The aim of this study is to investigate the accuracy of MRI compared to that of arthroscopy in the assessment of chondral lesions in acute ankle fractures. In this prospective single-center study, patients presenting with acute ankle fractures over a period of three years were identified. A preoperative MRI was performed within a maximum of 10 days after trauma. During surgery, ankle arthroscopy was also performed. The International Cartilage Repair Society (ICRS) cartilage lesion classification was used to grade the detected chondral lesions. To localize the chondral lesions, the talar dome was divided into eight zones and the tibial/fibular articular surfaces into three zones. In total, 65 patients (28 females) with a mean age of 41.1 ± 15 years were included. In the MRI scans, 70 chondral lesions were detected (69.2% of patients) affecting mostly the tibial plafond (30%) and mostly graded as ICRS 3. The mean lesion area measured was 20.8 mm2. In the arthroscopy, 85 chondral lesions were detected (70.8% of patients) affecting mostly the medial surface of the talar dome (25.9%) and mostly graded ICRS 3. The mean lesion area measured was 43.4 mm2. The highest agreement between the two methods was observed in the size estimation of the chondral lesions. The present study shows the reduced accuracy of MRI when compared to arthroscopy in the assessment of traumatic chondral lesions in the setting of acute ankle fractures especially regarding lesion size. MRI remains an essential instrument in the evaluation of such lesions; however, surgeons should take this discrepancy into consideration, particularly the underestimation of chondral lesions' size in the preoperative planning of surgical treatment and operative technique.