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Purpose@#The starting time for probiotic supplementation in preterm infants after birth varies widely. This study aimed to investigate the optimal time for initiating probiotics to reduce adverse outcomes in preterm or very low birth weight (VLBW) infants. @*Methods@#Medical records of preterm infants born at a gestational age (GA) of <32 weeks or VLBW infants in 2011–2020 were reviewed respectively. The infants who received Saccharomyces boulardii probiotics within 7 days of birth were grouped into an early introduction (EI) group, and those who received supplemented probiotics after 7 days of birth were part of the late introduction (LI) group. Clinical characteristics were compared between the two groups and analyzed statistically. @*Results@#A total of 370 infants were included. The mean GA (29.1 weeks vs. 31.2 weeks, p<0.001) and birth weight (1,235.9 g vs. 1491.4 g, p<0.001) were lower in the LI group (n=223) than in the EI group. The multivariate analysis indicated that factors affecting the LI of probiotics were GA at birth (odds ratio [OR], 1.52; p<0.001) and the enteral nutrition start day (OR, 1.47; p<0.001). The late probiotic introduction was associated with a risk of late-onset sepsis (OR, 2.85; p=0.020), delayed full enteral nutrition (OR, 5.44; p<0.001), and extrauterine growth restriction (OR, 1.67; p=0.033) on multivariate analyses after adjusting for GA. @*Conclusion@#Early supplementation of probiotics within a week after birth may reduce adverse outcomes among preterm or VLBW infants.
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Background@#The coronavirus disease-2019 (COVID-19) pandemic has contributed to the change in the epidemiology of many infectious diseases. This study aimed to establish the pre-pandemic epidemiology of pediatric invasive bacterial infection (IBI). @*Methods@#A retrospective multicenter-based surveillance for pediatric IBIs has been maintained from 1996 to 2020 in Korea. IBIs caused by eight bacteria (Streptococcus pneumoniae, Haemophilus influenzae, Neisseria meningitidis, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pyogenes, Listeria monocytogenes, and Salmonella species) in immunocompetent children > 3 months of age were collected at 29 centers. The annual trend in the proportion of IBIs by each pathogen was analyzed. @*Results@#A total of 2,195 episodes were identified during the 25-year period between 1996 and 2020. S. pneumoniae (42.4%), S. aureus (22.1%), and Salmonella species (21.0%) were common in children 3 to 59 months of age. In children ≥ 5 years of age, S. aureus (58.1%), followed by Salmonella species (14.8%) and S. pneumoniae (12.2%) were common. Excluding the year 2020, there was a trend toward a decrease in the relative proportions of S. pneumoniae (rs = −0.430, P = 0.036), H. influenzae (rs = −0.922, P 3 months of age. These findings can be used as the baseline data to navigate the trend in the epidemiology of pediatric IBI in the post COVID-19 era.
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Background and Objectives@#It is well recognized that early detection and intervention are most important for the prevention of neonatal hearing loss. The national support policy in Korea for newborn hearing screening has been changed since October 2018; however, parent awareness of the change still needs to be increased. This study investigated how well parents, who have underwent national infant checkups of their children, were aware of the Korean national policy for neonatal and infant hearing loss in parents.Subjects and Method A survey of neonatal hearing tests and national support policies conducted for 353 parents was analyzed. The survey included questions about parent awareness of the neonatal hearing screening test period, confirmatory test period, national support for these expenses, and hearing aid support. Also evaluated were the necessity of national guidance and management system for neonatal hearing. @*Results@#The test time of neonatal hearing screening was correctly recognized by 82.2% of the parents. The percentage increased after the national insurance coverage started in October 2018 in Korea, and the rate was higher for parents who visited an otolaryngology clinic rather than a pediatric clinic. The test time of the confirmatory test was correctly recognized only by 20.4%. National support policy for neonatal hearing screening tests, confirmatory hearing tests, and hearing aids were acknowledged by 50.7%, 43.1%, and 56.1% of the parents, respectively. @*Conclusion@#These results indicate the necessity of efforts to increase the awareness of neonatal hearing tests and relevant support policies in Korea to ultimately achieve early hearing detection and intervention of neonates and infants in Korea.
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A measles outbreak with 20 confirmed cases occurred at a local children’s hospital in Daejeon from March 28 to April 21, 2019. The index patient was a 7-month-old girl with a recent history of travel to Vietnam. Contact tracing, active surveillance, and post-exposure prophylaxis were conducted by health authorities. Among the 20 patients, 11 (55%) were infants (0–11 months of age), three (15%) were aged 1–3 years, one (5%) was aged 4 years, and five (25%) were adults. Fifteen (75%) patients did not have a history of measles vaccination, and five (25%) had received only one vaccine dose. This study described the importance of prompt application of infection control measures in susceptible environments, including hospitals. Age-appropriate vaccination and providing information on infectious diseases to international travelers and multicultural families in Korea is vital.
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Colonoscopic polypectomy is effective in decreasing the incidence and mortality of colorectal cancer (CRC). Premalignant polyps discovered during colonoscopy are associated with the risk of metachronous advanced neoplasia. Postpolypectomy surveillance is the most important method for managing advanced metachronous neoplasia. A more efficient and evidence-based guideline for postpolypectomy surveillance is required because of the limited medical resources and concerns regarding colonoscopy complications. In these consensus guidelines, an analytic approach was used to address all reliable evidence to interpret the predictors of CRC or advanced neoplasia during surveillance colonoscopy. The key recommendations state that the high-risk findings for metachronous CRC following polypectomy are as follows: adenoma ≥10 mm in size; 3 to 5 (or more) adenomas; tubulovillous or villous adenoma; adenoma containing high-grade dysplasia; traditional serrated adenoma; sessile serrated lesion containing any grade of dysplasia; serrated polyp of at least 10 mm in size; and 3 to 5 (or more) sessile serrated lesions. More studies are needed to fully comprehend the patients who are most likely to benefit from surveillance colonoscopy and the ideal surveillance interval to prevent metachronous CRC.
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Background/Aims@#Endoscopic submucosal dissection is a widely used treatment for gastric epithelial neoplasms. Accurate delineation of the horizontal margins is necessary for the complete resection of gastric epithelial neoplasms. Recently, image-enhanced endoscopy has been used to evaluate horizontal margins of gastric epithelial neoplasms. The aim of this study was to investigate whether I-SCAN-optical enhancement (I-SCAN-OE) is superior to chromoendoscopy in evaluating the horizontal margin of gastric epithelial neoplasms. @*Methods@#This was a multicenter, prospective, and randomized trial. The participants were divided into two groups: I-SCAN-OE and chromoendoscopy. For both groups, we first evaluated the horizontal margins of early gastric cancer or high-grade dysplasia using white-light imaging, and then evaluated, the horizontal margins using I-SCAN-OE or chromoendoscopy. We devised a unique scoring method based on the pathological results obtained after endoscopic submucosal dissection to accurately evaluate the horizontal margins of gastric epithelial neoplasms. The delineation scores of both groups were compared, as were the ratios of positiveegative horizontal margins. @*Results@#In total, 124 patients were evaluated for gastric epithelial neoplasms, of whom 112 were enrolled in the study. A total of 112 patients participated in the study, and 56 were assigned to each group (1:1). There was no statistically significant difference in the delineation scores between the groups (chromoendoscopy, 7.80±1.94; I-SCAN-OE, 8.23±2.24; p=0.342). @*Conclusions@#I-SCAN-OE did not show superiority over chromoendoscopy in delineating horizontal margins of gastric epithelial neoplasms.
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Background/Aims@#There are limited studies on the management of hepatic hemangiomas (HHs). We investigated the proportion and predictors of surgical resection and analyzed HH growth rates in addition to associated factors. @*Methods@#A retrospective case-control study of patients treated in 2 centers was conducted. Thirty-six patients who underwent surgical resection were assigned to the case group. Patients who did not undergo surgical treatment were randomly sigselected at a 1:10 ratio and assigned to the control group (n = 360). Baseline characteristics, clinical course and surgical outcomes were analyzed. @*Results@#The proportion of surgically treated HH patients was 0.3% (36 per 11,049). The longest diameter at diagnosis (mean ± standard deviation) was 7.7 ± 5.2 cm in the case group and 2.4 ± 1.8 cm in the control group (p 10 cm (OR 10.50, 95% CI 1.06–103.77, p = 0.04). The subgroup analysis showed substantial growth in 41.3% with an overall mean annual growth rate of 0.14 cm. @*Conclusions@#Approximately one in 300 patients with an HH underwent surgical treatment. Multiple HHs and a growth rate of more than 4.8%/year were indications for surgical treatment. Nearly half of the HHs showed growing pattern in our study.
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Owing to their superior pharmacokinetic and pharmacodynamic profiles, potassium-competitive acid blockers (P-CABs) score over proton pump inhibitors (PPIs) in the treatment of gastric acid-related disorders and may provide clinical benefit in the management of these conditions. Previous studies have compared P-CABs with PPIs for treatment of gastric acid-related disorders, and current data show that P-CABs are non-inferior to PPIs in the treatment of erosive esophagitis and as maintenance therapy. P-CABs are useful for effective healing and as maintenance medications in patients with severe esophagitis. These drugs also aid with healing of peptic ulcers and artificial ulcers secondary to gastric endoscopic submucosal dissection (ESD). Few studies have discussed prevention of delayed ulcer bleeding after gastric ESD and ulcers associated with long-term nonsteroidal anti-inflammatory drug administration. Well-controlled, large-scale prospective studies are warranted in future to compare P-CABs with PPIs.
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In this study, we investigated the clinical characteristics of acute kidney injury (AKI) in patients with glyphosate surfactant herbicide (GSH) poisoning. Methods: This study was performed between 2008 and 2021 and included 184 patients categorized into the AKI (n = 82) and nonAKI (n = 102) groups. The incidence, clinical characteristics, and severity of AKI were compared between the groups based on the Risk of renal dysfunction, Injury to the kidney, Failure or Loss of kidney function, and End-stage kidney disease (RIFLE) classification. Results: The incidence of AKI was 44.5%, of which 25.0%, 6.5%, and 13.0% of patients were classified into the Risk, Injury, and Failure categories, respectively. Patients in the AKI group were older (63.3 ± 16.2 years vs. 57.4 ± 17.5 years, p = 0.02) than those in the non-AKI group. The length of hospitalization was longer (10.7 ± 12.1 days vs. 6.5 ± 8.1 days, p = 0.004) and hypotensive episodes occurred more frequently in the AKI group (45.1% vs. 8.8%, p < 0.001). Electrocardiographic (ECG) abnormalities on admission were more frequently observed in the AKI group than in the non-AKI group (80.5% vs. 47.1%, p < 0.001). Patients in the AKI group had poorer renal function (estimated glomerular filtration rate at the time of admission, 62.2 ± 22.9 mL/min/1.73 m2 vs. 88.9 ± 26.1 mL/min/1.73 m2 , p < 0.001) on admission. The mortality rate was higher in the AKI group than in the non-AKI group (18.3% vs. 1.0%, p < 0.001). Multiple logistic regression analysis showed that hypotension and ECG abnormalities upon admission were significant predictors of AKI in patients with GSH poisoning. Conclusion: The presence of hypotension on admission may be a useful predictor of AKI in patients with GSH intoxication.
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Background and Objectives@#This study aimed to evaluate the voice of patients with vocal cord palsy using the Praat compared to Speech tool.Materials and Method The medical record of the patients with vocal cord palsy from 2013 to 2021 was analyzed retrospectively to validate Praat as a voice evaluation modality compared to the speech tool. Total 60 patients were enrolled in this study. Thirty control and 30 vocal cord palsy patients were selected to undergo recording of voice samples. The voice samples, /a/ and “Sancheck” were evaluated both groups and cepstral peak prominence was analyzed with both modalities; Praat and speech tool. @*Results@#Statistically significant differences were observed between the control and vocal cord palsy groups in the speech tool and Praat. There was also a significant difference between pre- and post-treatment values in the vocal cord palsy group. A similar change in the voice value was observed using both methods. The Praat showed a lower value in 1st visit of patients with vocal cord palsy in the vowel test. The Praat vowel test may sensitively represent voice problems in patients with vocal cord palsy. This could contribute to decision-making regarding the treatment modality for vocal cord palsy. @*Conclusion@#Praat is open-access software that is freely available. It can be easily and sufficiently used for voice evaluation in patients with vocal cord palsy.
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Methemoglobinemia (MetHb), which is characterized by an increased methemoglobin level, is a rare but potentially fatal disorder caused by congenital enzyme deficiencies or exposure to oxidizing agents, including dapsone. Elevation in the methemoglobin level impairs the oxygen-carrying capacity of hemoglobin, produces functional anemia, and induces tissue hypoxia. Such hypoxia results in microcirculation injury and hypoperfusion in the tissue and organs, including the kidney, and is a risk factor for acute kidney injury (AKI). This paper reports a case of AKI caused by dapsone-induced MetHb in a patient with chronic kidney disease, in which the patient ingested approximately 1,500 mg of dapsone in a suicide attempt, which was treated with aggressive management, including methylene blue, ascorbic acid, and transfusion.
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Background@#Tuberculosis (TB) exposure in congregate settings related to neonates is a serious medical and social issue. TB exposure happens during the neonatal period, but contact investigations for exposed infants are usually conducted after the neonatal period.Generally, recommendations for screening and managing close contact are different for neonates and children. Thus, there are challenges in contact investigations. We aimed to report contact investigations with a single tuberculin skin test (TST) on infants exposed to infectious TB in a postpartum care center. @*Methods@#The index case was a healthcare worker with active pulmonary TB: sputum acidfast bacilli smear negative, culture positive, and no cavitary lesion. All exposed infants underwent medical examinations and chest X-ray. After TB disease was ruled out, contacts received window period prophylaxis with isoniazid (INH) until three months after the last exposure. TST was performed only once after completing the prophylaxis. @*Results@#A total of 288 infants were selected as high-priority contacts. At the initial contact investigation, the age of infants ranged from 8 to 114 days. None of these exposed infants had TB disease. The prevalence of latent TB infection (LTBI) was 25.3% (73/288; 95% confidence interval [CI], 20.7–30.7). There were no serious adverse events related to the window period prophylaxis or LTBI treatment with INH. During the 1-year follow-up period, no infants progressed to overt TB disease. The size of TST induration in infants vaccinated with percutaneous Bacillus Calmette-Guérin (BCG) vaccine was significantly larger than that of infants vaccinated with intradermal BCG vaccine (median, 8 mm vs. 5 mm; P = 0.002). In multiple logistic regression analysis, independent factors associated with TST positivity (≥ 10 mm induration) were male (adjusted odds ratio [aOR], 2.98; 95% CI, 1.6–5.64), percutaneous BCG vaccination (aOR, 3.30; 95% CI, 1.75–6.48), TST reading between 60 and 72 hours after injecting purified protein derivative (aOR, 2.87; 95% CI, 1.53–5.49), and INH prophylaxis more than four weeks (aOR, 0.49; 95% CI, 0.25–0.94). @*Conclusion@#A single TST at three months after the last TB exposure with INH prophylaxis could be used as a main protocol in contact investigations for infants exposed to infectious TB during the neonatal period in congregate settings in Korea.
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Background@#The purpose of this study was to evaluate the effect of vanishing twin (VT) on maternal serum marker concentrations and nuchal translucency (NT). @*Methods@#This is a secondary analysis of a multicenter prospective cohort study in 12 institutions. Serum concentrations of pregnancy-associated plasma protein-A in the first trimester and alpha-fetoprotein (AFP), total human chorionic gonadotrophin, unconjugated estriol, and inhibin A in the second trimester were measured, and NT was measured between 10 and 14 weeks of gestation. @*Results@#Among 6,793 pregnant women, 5,381 women were measured for serum markers in the first or second trimester, including 65 cases in the VT group and 5,316 cases in the normal singleton group. The cases in the VT group had a higher median multiple of the median value of AFP and inhibin A than the normal singleton group. The values of other serum markers and NT were not different between the two groups. After the permutation test with adjustment,AFP and inhibin A remained significant differences. The frequency of abnormally increased AFP was also higher in the VT group than in the normal singleton group. @*Conclusion@#VT can be considered as an adjustment factor for risk assessment in the secondtrimester serum screening test.
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As nucleocapsid protein of severe acute respiratory syndrome coronavirus 2 is immunogenic but not targeted in vaccines, it could be useful in distinguishing natural infection from vaccination. We aimed to investigate the clinical utility of sero-immunological responses against the nucleocapsid protein. Nucleocapsid antibody immunoassay study with 302 coronavirus disease 2019 (COVID-19) patients showed lower titers in immunocompromised patients (P < 0.001), higher titers in higher severity (P = 0.031), and different seroconversion rates and titers according to variants of concern. Longitudinal evaluation of nucleocapsid antibodies using 513 samples from 291 COVID-19 patients revealed that it could persist up to 556 days from symptom onset. Interferon gamma release assay against the nucleocapsid protein showed poor response, precluding the deduction of a cut-off for the nucleocapsid protein. In conclusion, nucleocapsid antibody provides instructive clues about the immunogenicity of nucleocapsid proteins by different seroconversion rates and titers according to the severity of infection, host immune status, and different variants of concern.
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Background@#Prostate-specific antigen-based routine screening is not recommended for the general population due to conflicting results with mortality reduction. We aimed to develop a web-based decision aid (DA) for informed decision making for prostate cancer screening. @*Methods@#Using the International Patient Decision Aid Standards (IPDAS) development process model, we developed our DA based on patient and clinician interviews and multidisciplinary expert discussions. The prototype consisted of predicting individual prostate cancer risk and informed decision-making, including knowledge, risk and benefit, cost, personal value, and decision making. We conducted a pilot study on 101 healthy men, evaluating the effectiveness of DA by measuring knowledge, attitude, and intention to screen before and after using the DA, as well as decisional conflict and usefulness after using the DA. @*Results@#Of the 101 participants (median age 60 [50–69] years), 84% had not undergone screening for prostate cancer in the past two years. After using the DA, knowledge on prostate cancer screening increased (mean score [of 10] before versus after: 6.85 ± 1.03 versus 7.57 ± 1.25; P < 0.001), and intention to not screen increased from 27.7% to 51.5% (P < 0.001), but attitude toward screening did not change (P = 0.564). After use of the DA, 79 participants reported no decisional conflict, and the usefulness score was high (mean score [of 100] 77.35 ± 7.69), with 85% of participants reporting that the DA helped with decision making. @*Conclusion@#Our web-based DA yielded increased knowledge, decreased screening intention, and high perceived usefulness. These findings indicate potential clinical relevance, especially among younger individuals.
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Tixagevimab/cilgavimab is a monoclonal antibody used to prevent coronavirus disease 2019 among immunocompromised hosts and maintained neutralizing activity against early omicron variants. Omicron BN.1 became a dominant circulating strain in Korea early 2023, but its susceptibility to tixagevimab/cilgavimab is unclear. We conducted plaque reduction neutralization test (PRNT) against BN.1 in a prospective cohort (14 patients and 30 specimens). BN.1 PRNT was conducted for one- and three-months after tixagevimab/ cilgavimab administration and the average PRNT ND 50 of each point was lower than the positive cut-off value of 20 (12.9 ± 4.5 and 13.2 ± 4.2, respectively, P = 0.825). In the paired analyses, tixagevimab/cilgavimab-administered sera could not actively neutralize BN.1 (PRNT ND 50 11.5 ± 2.9, P = 0.001), compared with the reserved activity against BA.5 (ND 50 310.5 ± 180.4). Unlike virus-like particle assay, tixagevimab/cilgavimab was not active against BN.1 in neutralizing assay, and would not be effective in the present predominance of BA.2.75 sublineages.
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Purpose@#The purpose of this study is to confirm the relationship between nursing students’ nursing professionalism and ethical decision-making confidence, and to clarify the mediating effect of moral sensitivity which has a mutual influence on nursing professionalism and ethical decision-making confidence. @*Methods@#The data collection for this study was conducted from January 23 to February 1, 2021 with junior and senior nursing students enrolled in five nursing departments in two regions. The data collected in this study were analyzed using the IBM SPSS statistics version 23.0 program. @*Results@#Through this study, it was found that nursing professionalism (β=.47) and moral sensitivity (β=.32) acted as important influencing factors on the ethical decision-making confidence of nursing students, with an explanatory power of 31.2%. In addition, it was confirmed that there was a partial mediating effect of moral sensitivity in the relationship between the nursing professionalism and ethical decision-making confidence of nursing students, and the mediating effect coefficient of moral sensitivity was .16. @*Conclusion@#Based on the results of the study, it is suggested to prepare a plan to increase ethical decision-making confidence and moral sensitivity when planning interventions to improve nursing professionalism in nursing students.
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Purpose@#Liver grafts from donors with HBV infection contributed to expanding the donor pool under the hepatitis B immunoglobulin and antiviral agents (nucleos(t)ide analogues) in the HBV-endemic area. We report long-term outcomes of liver transplantations (LTs) using grafts from donors with active or chronic HBV infection. @*Methods@#Overall, 2,260 LTs performed in 3 major hospitals in Seoul from January 2000 to April 2019 were assessed for inclusion. Twenty-six grafts (1.2%) were obtained from HBsAg (+), HBeAb (+), or HBcAb (+) donors, and recipient outcomes were retrospectively reviewed. Donor and recipient demographics and transplantation outcomes were analyzed. @*Results@#Sixteen deceased donor LTs were performed using active HBsAg (+) grafts. Ten other LTs were sourced from 10 living donors. There was no significant difference in survival in patients who received deceased donor LTs compared with that in those who underwent LT with non–hepatitis virus-infected grafts. Fourteen patients who were followed up for >5 years were stable, and no difference in hepatocellular carcinoma recurrence rate was observed 5 years after transplantation between transplants from donors with and those without HBV. @*Conclusion@#Considering long-term outcomes, liver grafts from donors with active HBV replication can be safely used for LT.
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Purpose@#We assessed prenatal detection rates of congenital heart disease (CHD) and associations between maternal serum biomarkers and non-chromosomal CHD in singleton pregnancies. @*Materials and Methods@#This study was conducted as a secondary analysis of data obtained during a multicenter prospective cohort study that investigated the cost-effectiveness of prenatal testing for fetal aneuploidy. We analyzed the prenatal detection rate and accuracy for CHD screening via ultrasound during the second trimester, as well as associations between serum biomarkers and CHDs, in singleton newborns without chromosomal abnormalities. @*Results@#Among 6715 women, 142 (2.1%) newborns were born with CHDs, of which 67 (1.0%) newborns had major CHDs. The prenatal detection rate for all CHDs and major CHDs were 34.5% and 58.2%, respectively. After excluding isolated ventricular septal defects, the detection rate for critical CHDs was 85.9%. Women with low pregnancy-associated plasma protein A (PAPP-A) (<0.4 multiples of the median, MOM) face increased risks of non-chromosomal CHDs [adjusted odds ratio (aOR) 2.76; 95% confidence interval (CI) 1.36–5.13] and major CHDs (aOR 7.30; 95% CI 3.18–15.59), compared to those without CHDs. A higher inhibin A level (≥2.5 MOM; aOR 4.84; 95% CI 1.42–12.46) was associated with non-chromosomal major CHDs. @*Conclusion@#Ultrasonography performed during the second trimester by obstetricians detected over 85% of critical CHDs. Low maternal serum PAPP-A or high inhibin-A was associated with non-chromosomal CHDs. These results may contribute to an improvement in prenatal diagnosis of CHDs.
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Background/Aims@#Pulmonary hypertension (PH) in patients with heart failure contributes to a poor prognosis. However, the role of PH in the long-term clinical outcome is unclear in those with acute myocardial infarction (AMI). The clinical significance of elevated right ventricular systolic pressure (RVSP) on routine echocardiography is underestimated. @*Methods@#This study enrolled 2,526 AMI patients (65.1 ± 12.7 years; 1,757 males [69.6%]) from the Korean AMI registry who underwent successful percutaneous coronary intervention and pre-discharge transthoracic echocardiography (TTE). The patients were divided into four groups according to the RVSP on TTE: normal RVSP (RVSP < 35 mmHg, n = 1,695), mild PH (35 ≤ RVSP < 45 mmHg, n = 601), moderate PH (45 ≤ RVSP < 70 mmHg, n = 211), and severe PH (RVSP ≥ 70 mmHg, n = 19). Major adverse cardiac events (MACE) were compared among the four groups. @*Results@#During the 3-year clinical follow-up period, MACE occurred in 562 patients (22.2%), including 321 (18.9%), 145 (24.1%), 83 (39.3%), and 13 patients (68.4%) in the normal RVSP and mild, moderate, and severe PH groups, respectively. On multivariate analysis, independent factors for MACE were moderate or severe PH, age ≥ 65 years, Killip class ≥ III, left ventricular ejection fraction < 40%, hypertension, and diabetes. @*Conclusions@#Measuring RVSP is useful for stratifying the risk of patients with AMI; MACE occurred in patients with moderate or severe PH.