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    Prognostic Value of Serum Albumin in Aortic Aneurysm Patients Undergoing Graft Replacement of Ascending Aorta and Aortic Arch

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    Background: Hypoalbuminemia is a marker of poor overall health with influences from protein energy malnutrition, systemic inflammation and hepatic and renal disease. Albumin has been reported to have a prognostic impact in various cohorts. This study investigated whether preoperative serum albumin levels could be used to predict mortality in patients with aortic aneurysms undergoing graft replacement of ascending aorta and aortic arch. Methods: We retrospectively reviewed 183 patients who underwent graft replacement of ascending aorta and aortic arch between January 2010 and December 2020. The exclusion criteria included patients with traumatic aortic injuries (n=2), previous aortic repair within 6 months (n=2), ruptured aortic aneurysms (n=14), or a lack of preoperative laboratory data or medical records (n=10). The remaining 87% eligible patients were divided into two groups based on their preoperative serum albumin levels. The lower albumin group was defined as having serum albumin levels ≤3.5 g/dL, while the higher albumin group was defined as having albumin levels >3.5 g/dL. The incidence of mortality was compared between the two groups, and a logistic regression analysis was performed to evaluate the predictors of mortality. Results: The incidence of 1-year mortality was higher in the lower albumin group than in the higher albumin group (3.4% vs. 23.5%, p=0.006). The optimal cut-off value of albumin to predict 1-year mortality was 4.0 g/dL (area under the curve 0.885, 95% CI 0.821–0.949, p<0.001), with a sensitivity and specificity of 90.0% and 80.3%, respectively. Preoperative serum albumin levels (OR = 0.116, 95% CI 0.021-0.641, p=0.014) and diabetes mellitus (OR = 5.757, 95% CI 1.018-32.565, p=0.048) remained independent predictors of mortality. Conclusion: Preoperative serum albumin levels were an independent predictor of 1-year mortality after the graft replacement of ascending aorta and aortic arch. These findings underscore that the optimization of patients' nutritional status before surgery may be warranted and should be further explored in this high-risk population.ope

    A Study on the Improvement of Domestic Medical Device Product Classification through Analysis of Medical Device Classification System in the U.S. and Europe

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    The purpose of this study is to derive medical devices with different management systems through com- parison of domestic and overseas medical device product classification systems and to propose management con- version measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety’s regulations on medical device products and grades, 21 CFR part 860-892 and product code clas- sification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification sys- tems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under med- ical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.ope

    Fabrication of 3D-Printed Implant for Two-Stage Ear Reconstruction Surgery and Its Clinical Application

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    Purpose: Ear reconstruction is one of the most difficult areas in the field of reconstructive surgery. Due to limitations of the cur rent practice, a novel method of auricular reconstruction is needed. Major advancements in three-dimensional (3D) printing technique have rendered the process of ear reconstruction more favorable. Herein, we present our experience in designing and clinically using 3D implants in both 1st and 2nd stage ear reconstruction surgery. Materials and Methods: After obtaining 3D CT data from each patient, a 3D geometric ear model was created using mirroring and segmentation processes. The 3D-printed implant design resembles but does not exactly match the normal ear shape, and can be inserted in harmony with the currently used surgical technique. The 2nd stage implant was designed to minimize dead space and support the posterior ear helix. The 3D implants were finally fabricated with a 3D printing system and used in ear re construction surgery in our institute. Results: The 3D implants were manufactured for application to the currently used two-stage technique while maintaining the shape of the patient’s normal ear. The implants were successfully used for ear reconstruction surgery in microtia patients. A few months later, the 2nd stage implant was used in the 2nd stage operation. Conclusion: The authors were able to design, fabricate, and apply patient-specific 3D-printed ear implants for 1st and 2nd stage ear reconstruction surgeries. This design, combined with 3D bioprinting technique, may be a future alternative for ear reconstruction.ope

    Acute coronary syndrome in antineutrophil cytoplasmic antibody-associated vasculitis: a Korean single-centre cohort study

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    Objective: This study investigated the incidence and patterns of the acute coronary syndrome (ACS) after AAV diagnosis and searched for the predictors of ACS in a single-centre cohort of Korean patients diagnosed with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Methods: A total of 262 patients with AAV were included in this study. ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), and unstable angina (UA) were defined as ACS in this study. Only ACS that occurred during or after AAV diagnosis was counted. Results: The incidence of ACS in patients with AAV was 2.7% (7 patients), and the most common type of ACS was NSTEMI regardless of the affected site or the number of coronary arteries. Five patients with ACS were diagnosed with microscopic polyangiitis (MPA) and all of them had myeloperoxidase (MPO)-ANCA (or perinuclear [P]-ANCA), whereas the remaining two patients were diagnosed with eosinophilic granulomatosis with polyangiitis (EGPA). Of the seven patients, 2 patients experienced ACS within the first year after AAV diagnosis, and 2 experienced ACS 5 years after AAV diagnosis. Among clinical variables, only the male sex was a predictor of ACS during the follow-up period in patients diagnosed with AAV. Conclusion: The incidence of ACS was 2.7%, and the most common type of ACS was NSTEMI in Korean patients with AAV.ope

    Inhibition of PD‑L1 and tumor growth in triple‑negative breast cancer using a magnetic nanovector with microRNA34a

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    Background Clinical applications of RNA interference for cancer treatment and immune therapy require the development of simultaneous therapy and imaging systems for microRNA. This research was performed to fabricate the miRNA34a-loaded magnetic nanoparticles and investigate its anticancer effects against triple-negative breast cancer (TNBC) in mice model. Results Using two types of polymers to improve their water dispersibility and gene delivery, iron oxide magnetic nanoparticles were prepared for delivery of miRNA34a. The iron oxide magnetic nanoparticles were delivered to TNBC cells, and their efficacy was evaluated in vitro and in vivo. Delivery of miRNA34a reduced TNBC cell migration and decreased the expression of PD-L1 at the mRNA and protein levels. In animal experiments, delivery of miRNA34a reduced tumor growth, and immunostaining and algorithmic analysis confirmed the decrease in PD-L1 expression. Conclusion This study is the first to modulate PD-L1 by delivering miRNA34a with magnetic nanoparticles, and the results suggest that miRNA34a can be delivered effectively using magnetic nanoparticles and has potential as a molecular imaging contrast agent.ope

    DNA double-strand break-free CRISPR interference delays Huntington's disease progression in mice

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    Huntington’s disease (HD) is caused by a CAG repeat expansion in the huntingtin (HTT) gene. CRISPR-Cas9 nuclease causes double-strand breaks (DSBs) in the targeted DNA that induces toxicity, whereas CRISPR interference (CRISPRi) using dead Cas9 (dCas9) suppresses the target gene expression without DSBs. Delivery of dCas9-sgRNA targeting CAG repeat region does not damage the targeted DNA in HEK293T cells containing CAG repeats. When this study investigates whether CRISPRi can suppress mutant HTT (mHTT), CRISPRi results in reduced expression of mHTT with relative preservation of the wild-type HTT in human HD fibroblasts. Although both dCas9 and Cas9 treatments reduce mHTT by sgRNA targeting the CAG repeat region, CRISPRi delays behavioral deterioration and protects striatal neurons against cell death in HD mice. Collectively, CRISPRi can delay disease progression by suppressing mHtt, suggesting DNA DSB-free CRISPRi is a potential therapy for HD that can compensate for the shortcoming of CRISPR-Cas9 nuclease.ope

    Dietary zinc intake and sources among Koreans: findings from the Korea National Health and Nutrition Examination Survey 2016-2019

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    BACKGROUND/OBJECTIVES: Zinc is an essential trace mineral which is important for the growth and development of the human body and immunological and neurological functions. Inadequate zinc intake may cause zinc deficiency with its adverse consequences. In this study, we aimed to estimate the dietary zinc intake levels and sources among Koreans. SUBJECTS/METHODS: For this secondary analysis, we obtained data from the Korea National Health and Nutrition Examination Survey (KNHANES) 2016–2019. Individuals aged ≥ 1 yr who had completed a 24-h recall were included. The dietary zinc intake of each individual was calculated by applying data from a newly developed zinc content database to the KNHANES raw data. We also compared the extracted data with the sex-, age-specific reference values suggested in the Korean Dietary Reference Intakes 2020. The prevalence of adequate zinc intake was then evaluated by the proportion of the individuals who met the estimated average requirement (EAR). RESULTS: The mean zinc intake of Koreans aged ≥ 1 yr and adults aged ≥ 19 yrs were 10.2 and 10.4 mg/day, equivalent to 147.4% and 140.8% of the EAR, respectively. Approximately 2 in 3 Koreans met the EAR for zinc, but the zinc intake differed slightly among the different age and sex groups. In children aged 1–2 yrs, 2 out of 5 exceeded the upper level of intake, and nearly half of the younger adults (19–29 yrs) and the elders (≥ 75 yrs) did not meet the EAR. The major contributing food groups were grains (38.9%), meats (20.4%), and vegetables (11.1%). The top 5 food contributors to zinc intake were rice, beef, pork, egg, and baechu kimchi, which accounted for half of the dietary intake. CONCLUSION: The mean zinc intake among Koreans was above the recommended level, but 1 in 3 Koreans had inadequate zinc intake and some children were at risk of excessive zinc intake. Our study included zinc intake from diet only, thus to better understand zinc status, further research to include intake from dietary supplements is needed.ope

    Validation of the simplified magnetic resonance index of activity by using DWI without gadolinium enhancement to evaluate bowel inflammation in Crohn's disease

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    Objectives To validate the modified simplified magnetic resonance index of activity (sMARIA) score using DWI on noncontrast magnetic resonance enterography (MRE) to evaluate active inflammation in patients with Crohn’s disease (CD), compared to the original sMARIA scoring system, with and without contrast enhancement. Methods This retrospective study included 275 bowel segments from 55 CD patients who underwent ileocolonoscopy and MRE within a 2-week period. Two blinded radiologists evaluated original sMARIA on both conventional MRE (CEsMARIA) and non-contrast MRE (T2-sMARIA). Modified sMARIA was then evaluated using non-contrast MRE, replacing ulcerations with DWI grades. Three scoring systems were compared for diagnostic accuracy of active inflammation, correlation with simple endoscopic score (SES)-CD, and interobserver reproducibility. Results The AUC of modified sMARIA for detecting active inflammation (0.863, 95% confidence interval [0.803–0.923]) was significantly higher than T2-sMARIA (0.827 [0.773–0.881], p = 0.017), and comparable to CE-sMARIA (0.908 [0.857–0.959], p = 0.122). CE-sMARIA, T2-sMARIA, and modified sMARIA all showed moderate correlation with SES-CD (r = 0.795, 0.722, and 0.777, respectively). Interobserver reproducibility of diffusion restriction (κ, 0.686 [0.602–0.770]) was significantly better than ulcers on conventional MRE (κ, 0.382 [0.212–0.552]; p = 0.001) and T2-weighted image (κ, 0.312 [0.034–0.590]; p = 0.012). Conclusions Modified sMARIA using DWI can improve the diagnostic performance of sMARIA on non-contrast MRE, showing comparable performance to sMARIA using contrast-enhanced MRE. Key Points • DWI can improve the diagnostic performance of non-contrast magnetic resonance enterography (MRE) for assessing active inflammation in patients with Crohn’s disease. • Modified simplified magnetic resonance index of activity (sMARIA) using DWI grades in place of ulcers showed comparable diagnostic performance to sMARIA using conventional MRE with contrast-enhanced sequences.restrictio

    Mediating Effect of Illness Perception on Psychological Distress in Patients With Newly Diagnosed Gastric Cancer: Based on the Common-Sense Model of Self-regulation

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    Background A cancer diagnosis is a life-threatening event, but studies on psychological distress in patients with cancer after diagnosis are relatively limited, particularly those in early-stage cancer. Objectives On the basis of Leventhal's common-sense model of self-regulation, this study examined the mediating effects of illness perception on psychological distress and identified the factors influencing illness perception in patients with newly diagnosed gastric cancer. Methods A cross-sectional survey was conducted, and a mediation analysis was performed to determine the role of illness perception in the relationship between social support, the presence of physical symptoms, satisfaction with patient education, and psychological distress. Results Participants were 184 patients with recently diagnosed early gastric cancer who are waiting for surgery in a tertiary hospital in Seoul, Korea. The population had a moderate level of psychological distress. Social support, physical symptoms, and satisfaction with patient education significantly influenced illness perception (β = −0.14, P = .048; β = 0.18, P = .015; β = −0.17, P = .019, respectively), and illness perception had a full mediation effect between these 3 variables and psychological distress (β = 0.66, P < .001). Conclusion Healthcare providers need to focus on patients' psychological distress following a diagnosis of cancer because this distress could be easily overlooked in clinical settings, even in patients with early-stage cancer. Implication for Practice Healthcare providers might alleviate patients' psychological distress by improving unrealistic illness perceptions, alleviating physical symptoms, and providing clear and sufficient patient education in patients with cancer after diagnosis.ope

    Prognostic value of preoperative left ventricular global longitudinal strain for predicting postoperative myocardial injury and mortality in patients undergoing major non-cardiac surgery (SOLOMON study)

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    Background: The usefulness of preoperative measurement of left ventricular global longitudinal strain (LVGLS) for predicting prognosis in patients undergoing non-cardiac surgery has not been evaluated. We analyzed the prognostic value of LVGLS in predicting postoperative 30-day cardiovascular events and myocardial injury after non-cardiac surgery (MINS). Methods: This prospective cohort study was conducted in two referral hospitals and included 871 patients who underwent non-cardiac surgery <1 month after preoperative echocardiography. Those with ejection fraction <40%, valvular heart disease, and regional wall motion abnormality were excluded. The co-primary endpoints were the (1) composite incidence of all-cause death, acute coronary syndrome (ACS), and MINS and (2) com-posite incidence of all-cause death and ACS. Results: Among the 871 participants enrolled (mean age: 72.9 years; female: 60.8%), there were 43 cases of the primary endpoint (4.9%): 10 deaths, 3 ACS, and 37 MINS. Participants with impaired LVGLS (<= 16.6%) had a higher incidence of the co-primary endpoints (log-rank P < 0.001 and 0.015) than those without. The result was similar after adjustment with clinical variables and preoperative troponin T levels (hazard ratio = 1.30, 95% confidence interval [CI] = 1.03-1.65; P = 0.027). In sequential Cox analysis and net reclassification index, LVGLS had an incremental value for predicting the co-primary endpoints after non-cardiac surgery. Among the 538 (61.8%) participants who underwent serial troponin assay, LVGLS predicted MINS independently from the traditional risk factors (odds ratio = 3.54, 95% CI = 1.70-7.36; P = 0.001). Conclusions: Preoperative LVGLS has an independent and incremental prognostic value in predicting early postoperative cardiovascular events and MINS. Clinical Trial Registration: URL: https://trialsearch.who.int/. Unique identifiers: KCT0005147.ope

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