Pilot study of the Korean national breast implant registry: Experiences and lessons learned.

BACKGROUND: To improve the safety and early detection of unexpected breast implant-related complications, the Korean Breast Implant Registry (K-BIR) was launched in 2020 in cooperation with the Korean Society of Plastic and Reconstructive Surgeons and the Korean Ministry of Food and Drug Safety, and a pilot study was conducted. OBJECTIVE: This article provides an overview of our pilot study and experiences of the K-BIR. METHODS: The dataset to be used in the pilot form of K-BIR was constructed by holding online surveys and meetings focusing on the global breast device registry's minimum dataset. A pilot study was implemented from April 1, 2020, to July 31, 2020, with six university teaching hospitals and four private clinics. RESULTS: During the pilot study period, 325 patients, 451 procedures, and 366 implants were entered into the K-BIR. The most common procedure registered was augmentation mammaplasty (30%) for cosmetic indications, followed by direct-to-implant breast reconstruction (27%). Smooth silicone implant was the most common type (73%) of implant used. A feedback survey after the pilot study included questions about the registration rate compared with an actual procedure, entry time, reasons for difficulty in entry, and additional data needed. CONCLUSIONS: The continuous maintenance and development of K-BIR will require an effective dataset, a strengthened legal system for an opt-out registry and personal data protection, various incentives for increasing participation rates, and an electronic platform that patients, manufacturers, and clinicians can easily access. K-BIR has the potential to provide quality assurance and outcomes for research and post-market surveillance systems for breast implants as well as methods for enhancing patient safety.

Association between serum immunoglobulin E levels and knee osteoarthritis in Korean adults.

OBJECTIVE: The objective of this study was to examine whether osteoarthritis (OA) in the knees was associated with total immunoglobulin E (IgE), allergen-specific IgE, or allergic sensitizations in a nationally representative population. METHODS: The study population comprised of 785 adults aged 50 years or more in the Korea National Health and Nutrition Examination Survey 2010. OA was diagnosed as radiographic (rOA) and symptomatic osteoarthritis (sxOA). We performed multivariable logistic regression analyses to investigate relationships of OA in a knee with serum total IgE, allergen (Dermatophagoides farinae, cockroach, and dog allergens)-specific IgE, and allergic sensitizations. RESULTS: Participants with the highest tertile of the total IgE had 92% and 242% increased risk of knee rOA and sxOA, respectively. Those with D. farinae-specific IgE had 2.2 times increased risk of knee sxOA compared to the lowest tertile. Participants with high total IgE (>150kU/L) had a 60% increased risk of knee rOA. Those with D. farinae-specific sensitization (>0.35kU/L) had 2.0 times increased risk of knee sxOA in compared to those without sensitization. Population-attributable fractions of knee rOA caused by high total IgE and knee sxOA caused by D. farinae-specific sensitization were 9.8% and 15.3%, respectively. CONCLUSIONS: Total IgE and D. farinae-specific IgE were significantly associated with OA in knees of Korean adults. High total IgE and D. farinae-specific sensitization were also associated with their OA.

Tuberculosis is frequently diagnosed within 12 months of diabetes mellitus.

BACKGROUND: Evidence regarding the effects of tuberculosis (TB) screening among patients with diabetes mellitus (DM) in intermediate TB burden countries is insufficient, and the most appropriate time point for TB screening is unclear. OBJECTIVE: To investigate trends in TB incidence among newly diagnosed DM patients. DESIGN: A retrospective cohort study of the claims database of the Health Insurance Review and Assessment Service in Korea was performed. Participants were newly diagnosed with type 2 DM in 2009. The study outcome was TB incidence between 2009 and 2011 among participants according to duration of type 2 DM. RESULTS: A cohort of 331,601 patients with newly diagnosed type 2 DM in 2009 was identified. During the 3-year follow-up period, 1533 patients were diagnosed with TB. The estimated incidence of TB among newly diagnosed type 2 DM patients was 18/10,000 patient-years (py) (95%CI 17.5-19.4). TB incidence was 33/10,000 py (95%CI 30.0-35.6) in the first 6 months, and 19/10,000 py (95%CI 16.5-20.6) in the following 6-month period. CONCLUSIONS: The risk of developing TB was increased among DM patients, particularly during the first 12 months after DM diagnosis.

The effects of statin use on the development of tuberculosis among patients with diabetes mellitus.

OBJECTIVE: To evaluate whether statin use affects the development of tuberculosis (TB) among patients with diabetes mellitus (DM). METHODS: This is a retrospective cohort study of patients with newly diagnosed type 2 DM based on the South Korean nationwide claims database. The participants were type 2 DM patients aged 20-99 years who were newly treated with anti-diabetic drugs between 1 January 2007 and 31 December 2010. Patients who had statin prescriptions before a diagnosis of diabetes or were diagnosed with TB before diabetes were excluded. RESULTS: Of 840,899 newly diagnosed type 2 DM patients, 281,842 (33.5%) patients were statin users and 559,057 (66.5%) were non-users. During the study period, 4075 [corrected] individuals were diagnosed with TB; the estimated incidence of TB in our cohort was 251/100,000 patient-years (95%CI 243-258). In comparison to non-TB patients, statin users were less frequent among TB patients (19.2% vs. 33.6%). After adjustment for potential baseline confounders, statin use was not associated with the development of TB in DM patients (aHR 0.98; 95%CI 0.89-1.07). CONCLUSIONS: TB development among newly diagnosed type 2 DM was considerable, and statin use among these diabetics was not associated with a protective effect on TB incidence.

Polyethylene glycol bowel preparation does not eliminate the risk of acute renal failure: a population-based case-crossover study.

BACKGROUND AND STUDY AIMS: Polyethylene glycol (PEG) bowel preparations are regarded as effective and safe for colonoscopy; however, recent reports have indicated a risk of acute renal failure (ARF). This population-based case-crossover study evaluated the association between PEG and ARF in screening colonoscopy patients aged ≥ 50 years. PATIENTS AND METHODS: Korean Health Insurance Review and Assessment Service (HIRA) claims data from 1 January 2005 to 31 December 2009 were used in the study. The study population consisted of patients aged ≥ 50 years who were first hospitalized for ARF following colonoscopy involving PEG bowel preparation. For each patient, PEG use in a 1-, 2-, or 4-week period prior to the first hospital admission date for ARF (hazard period) was compared with PEG use in four earlier 1-, 2-, or 4-week control periods. Conditional logistic regression analysis was used to estimate odds ratios (ORs) and 95 % confidence intervals (CIs), adjusting for concomitant medications that could induce ARF. RESULTS: The total number of study patients was 1064 (59 % were male). A greater proportion of patients used PEG during the hazard period than during the control periods (for 4-week time window: 8.8 % vs. 3.2 %). The adjusted ORs for ARF incidence when applying the 1-, 2-, and 4-week periods were 3.1 (95 %CI 2.06 - 4.73), 2.5 (95 %CI 1.76 - 3.53), and 2.1 (95 %CI 1.61 - 4.85), respectively. CONCLUSIONS: The use of PEG was associated with the risk of ARF. Adequate hydration and renal function monitoring should be assured before and after colonoscopy, regardless of the bowel preparation regimen used.

Construction of an open-access QT database for detecting the proarrhythmia potential of marketed drugs: ECG-ViEW.

Information about the QT interval from surface electrocardiograms (ECGs) is essential for surveillance of the proarrhythmia potential of marketed drugs. However, ECG records obtained in daily practice cannot be easily used for this purpose without labor-intensive manual effort. This study was aimed at constructing an open-access QT database, the Electrocardiogram Vigilance with Electronic Data Warehouse (ECG-ViEW). This longitudinal observational database contains 710,369 measurements of QT and associated clinical data from 371,401 patients. The de-identified database is freely available at http://www.ecgview.org.

Detection of adverse drug reaction signals using an electronic health records database: Comparison of the Laboratory Extreme Abnormality Ratio (CLEAR) algorithm.

Electronic health records (EHRs) are expected to be a good source of data for pharmacovigilance. However, current quantitative methods are not applicable to EHR data. We propose a novel quantitative postmarketing surveillance algorithm, the Comparison of Laboratory Extreme Abnormality Ratio (CLEAR), for detecting adverse drug reaction (ADR) signals from EHR data. The methodology involves calculating the odds ratio of laboratory abnormalities between a specific drug-exposed group and a matched unexposed group. Using a 10-year EHR data set, we applied the algorithm to test 470 randomly selected drug-event pairs. It was found possible to analyze a single drug-event pair in just 109 ± 159 seconds. In total, 120 of the 150 detected signals corresponded with previously reported ADRs (positive predictive value (PPV) = 0.837 ± 0.113, negative predictive value (NPV) = 0.659 ± 0.180). By quickly and efficiently identifying ADR signals from EHR data, the CLEAR algorithm can significantly contribute to the utilization of EHR data for pharmacovigilance.

Use of bisphosphonate and risk of atrial fibrillation in older women with osteoporosis.

UNLABELLED: Concerns have been raised among clinicians and patients whether or not bisphosphonates increase the risk of atrial fibrillation. In this large cohort study, increased risk of atrial fibrillation was not found to be associated with bisphosphonate. In fact, bisphosphonate even showed a protective effect against cardiac arrhythmia compared to other osteoporosis medications. INTRODUCTION: Increased risk of atrial fibrillation among bisphosphonate users has been reported; however, the results from these studies are controversial. The purpose of this study was to evaluate the risk of atrial fibrillation associated with bisphosphonate use in older women. METHODS: We used the Korean Health Insurance Review and Assessment Service claims database from May 1, 2005 to June 30, 2006. Retrospective cohort analysis was conducted on women 65 years or older with newly diagnosed cases of osteoporosis (ICD 10 code: M80, M81) who had not previously taken any medications for osteoporosis. Bisphosphonate-exposed and non-exposed patients were followed until they were either diagnosed with atrial fibrillation (ICD 10 code: I48) or until the end of the study. The Cox proportional hazards model was used to calculate hazard ratios and the 95% confidence intervals. RESULTS: Atrial fibrillation was reported in 626 of the 120,319 patients (0.52%) treated with bisphosphonates and 66 of 9,863 patients (0.67%) treated with other osteoporosis medications. Overall hazard ratio for developing atrial fibrillation in the bisphosphonate-treated group was 0.52 (95% CIs, 0.29-0.91). In patients with a medication possession ratio greater than 0.7, the hazard ratio was lower (HR 0.41, 95% CIs 0.23-0.75). In the subgroup analysis, alendronate showed a statistically significant protective effect against the risk of atrial fibrillation with a hazard ratio of 0.75 (95% CI, 0.58-0.97). CONCLUSION: Among older Korean women with osteoporosis, bisphosphonate was found to have a protective effect against atrial fibrillation.

Short-acting nifedipine and risk of stroke in elderly hypertensive patients.

OBJECTIVES: Short-acting nifedipine is frequently prescribed in elderly hypertensive patients, despite warnings of possible harmful cardiovascular effects. We conducted a case-crossover study to estimate the risk of stroke episodes associated with use of short-acting nifedipine in elderly hypertensive patients. METHODS: We used the Korea Health Insurance Review & Assessment Service database. Cases included elderly hypertensive patients with hospitalization or emergency department visits for first stroke (International Classification of Diseases-10, I60-I64) between July 1, 2005, and June 30, 2006. Patients with prior stroke-related hospital admission or any visit related to TIA were excluded. Exposure to a short-acting nifedipine formulation was assessed within 7 days before the incident stroke episode (case period) and within a 7-day period preceding 60 days before the episode (control period). Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated by conditional logistic regression, with adjusting for antihypertensives, anticoagulants, antiplatelet agents, and pneumonia. RESULTS: A total of 16,069 stroke patients with a mean (±SD) age of 68.3 (±2.1) years were studied, of whom 8,573 (53.3%) were female. Short-acting nifedipine was prescribed at least once to 301 (1.9%) patients during the case period. An increased risk of stroke associated with use of short-acting nifedipine within 7 days (adjusted OR 2.56; 95% CI 1.96-3.37) was observed. Patients who were newly prescribed nifedipine within the recent 7 days showed an OR of 4.17 (95% CI 2.93-5.93) compared with nonusers. CONCLUSION: Use of short-acting nifedipine was associated with increased risk of stroke occurrence in elderly hypertensive patients.

Peritransplant monitoring of immune cell function in adult living donor liver transplantation.

PURPOSE: We evaluated the clinical utility of peritransplant in vitro assays of immune cell function in adult living donor liver transplant (LDLT) recipients. METHODS: In particular, we measured immune cell function, using the ImmuKnow assay, in 107 adult LDLT recipients and 200 potential living liver donors (control group) admitted to our center between July 2008 and January 2009. RESULTS: In the control group, the mean proportion of T-helper/inducer cells was 36.8% ± 8.2%. The degree of immune response was strong in 12%, moderate in 77%, and low in 11%. In the study group, the degree of immune response within the first month was strong in 4.6%, moderate in 38.2%, and low in 57.2%, thus significantly lower than in the control group (P < .001). ImmuKnow results and tacrolimus levels did not show a significant correlation (r(2) = .002, P = .392). Although six patients showed biopsy-proven acute cellular rejection, none showed a strong immune response. Patients with overt infection showed a lower immune response. CONCLUSIONS: These results indicate that peritransplant assessment of immune response using the ImmuKnow assay does not reliably predict the occurrence of acute rejection. Additional studies are necessary to accurately assess the clinical utility of immune response monitoring.

Living-donor liver transplantation in patients with concurrent active tuberculosis at transplantation.

SETTING: Although active tuberculosis (TB) is a contraindication for liver transplantation (LT), LT may be the only possible treatment option in patients with irreversible liver failure and concurrent TB. OBJECTIVES: To assess the outcome of LT in patients with concurrent TB and liver failure. METHODS: We retrospectively evaluated the clinical outcomes of nine LT recipients with concurrent TB in Korea, an intermediate TB burden country. RESULTS: The primary causes of living-donor LT (LDLT) in nine patients were anti-tuberculosis drug-induced fulminant hepatic failure (n = 4) and end-stage liver disease (n = 5). The sites of active TB were the lungs (n = 5), lymph nodes (n = 3) and pleura (n = 1). After LDLT, most patients were treated with less hepatotoxic drugs, including fluoroquinolones, ethambutol and cycloserine; none was treated with pyrazinamide. One patient experienced acute rejection, probably attributable to an interaction between rifampicin and cyclosporine. All nine patients, including one taking rifabutin, successfully completed anti-tuberculosis treatment and have been followed up for a median of 926 days after LDLT, without relapse of TB. CONCLUSION: When properly managed, the prognosis of LDLT recipients with concurrently active TB at transplantation is very favourable. The current protocol, which considers active TB an absolute contraindication for LT, should be modified or relaxed, particularly for patients with LDLT.

An increase in deceased donor incidence alleviated the need for urgent adult living donor liver transplantation in a Korean high-volume center.

PURPOSE: This study analyzed the effects of a recent increase in deceased donors on the pattern of adult liver transplantation (OLT) in a high-volume center in Korea. METHODS: OLT patterns relative to pretransplant recipient status were analyzed for 112 deceased donor LTs (DDLT) and 743 living donor OLT (LDLT) in a single center as compared to nationwide Korean data over 3 years from 2006 to 2008. RESULTS: During the study period, the annual proportion of institutional urgent OLT was relatively invariable (20% to 25.2%), but the annual proportion of DDLTs to all OLT increased from 8.9% to 19.9%, as did the annual rate of DDLTs among those undergoing urgent OLT, from 18.6% to 65.8%, with a reciprocal decrease in the proportion of urgent LDLTs. Korean nationwide data also showed a noticeable increase in deceased liver graft allocation for urgency from 39.8% to 62.2% over the same time period. CONCLUSION: An increase in deceased donors up to 5 per million enabled an increase in urgent adult DDLTs, alleviating the need for urgent adult LDLTs in Korea.

Bioelectrical impedance analysis for evaluation of donor hepatic steatosis in living-donor liver transplantation.

OBJECTIVE: To assess whether bioelectrical impedance analysis (BIA) can be used to evaluate the degree of hepatic steatosis in potential living liver donors. MATERIAL AND METHODS: From May 2008 to April 2009, BIA was measured in 302 living donor candidates. Correlations among body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), total fatty changes at percutaneous needle liver biopsy, and BIA-derived fat composition were assessed. RESULTS: The median (range) BIA-derived fat proportion was 19.4% (4.8%-35.3%), BMI was 24 (17-39), and hepatic steatosis at liver biopsy was 2% (0%-75%). Crude correlations were observed between BIA-derived fat proportion and hepatic steatosis (r(2) = 0.14; P = .000), between BMI and hepatic steatosis (r(2) = 0.27; P = .000), and between BMI and BIA-derived fat proportion (r(2) = .25; P = .000). Receiver operating characteristic curve analysis revealed that the area under the curve of BIA-derived fat proportion was smaller than that of BMI, and no significant cutoff value was identified. CONCLUSIONS: These results suggest that BIA-derived fat composition alone cannot be used to accurately determine the degree of hepatic steatosis. However, a combination of BMI and BIA-derived fat composition may increase clinical ability to assess hepatic steatosis.

Alendronate affects cartilage resorption by regulating vascular endothelial growth factor expression in rats.

This study was performed to determine effects of alendronate on the tibial proximal epiphyseal cartilage undergoing endochondral ossification and the expression of vascular endothelial growth factor (VEGF) from the cartilage. Alendronate was injected subcutaneously every other day in postnatal Day 1 Sprague Dawley rats. The rats were sacrificed 3, 5, 7, and 10 days after the first injection. The effect of alendronate treatment for 10 days was demonstrated from the morphological change that the area of the secondary ossification center in the epiphysis was significantly smaller in the alendronate group than that in the control group (P < 0.05). Strong immunoreactivity to VEGF was observed in the hypertrophied chondrocytes and some proliferating chondrocytes in the epiphyseal cartilage at postnatal Day 5 and was decreased after the alendronate treatment for 5 days. Immunoreactivity was observed in not only hypertrophied cells but also the peripheral cartilaginous matrix adjacent to the vascular canals invading into the central portion of the cartilage at postnatal Day 7. This reactivity was also reduced considerably by the alendronate treatment for 7 days. The level of VEGF expression was reduced by the alendronate treatment at both the transcription and translation levels. However, the transcriptional level of the flt-1 and flk-1 receptors was relatively unaltered by the treatment. These results suggest that VEGF expression is required for vascular invasion into the developing cartilage and alendronate can affect its resorption by downregulating VEGF expression.

Weight gain within the normal weight range predicts ultrasonographically detected fatty liver in healthy Korean men.

OBJECTIVES: We performed a prospective study to determine whether weight gain predicts future ultrasonographically detected fatty liver (USFL) in a lean adult population. METHODS: Among 15,347 Korean male workers, aged 30-59 years, who participated in a health check-up programme in 2002, a USFL-free cohort of 4246 non-diabetic men was followed until September 2007. Alcohol consumption was assessed by a questionnaire. Weight change for each subject was calculated as the difference between baseline and subsequent measurements. Biochemical tests for liver and metabolic function were done. The primary outcome was ultrasound-diagnosed fatty liver. A standard Cox proportional hazards model and time-dependent Cox model were performed. RESULTS: During 16,829.7 person-years of follow-up, 622 participants developed USFL. After adjusting for age, the period from visit 1 to visit 2, BMI, HDL-C, triglyceride, uric acid, alanine aminotransferase, and HOMA-IR, the risk for USFL increased with increasing quartiles of weight change (p for trend <0.001). This association remained significant when weight change and covariates, except age and the period from visit 1 to visit 2, were modelled as time-dependent variables. Subjects in the fourth quartile (weight gain > or =2.3 kg) were at significantly elevated risk for USFL (adjusted hazard ratio (aHR), 1.26; 95% CI, 1.01 to 1.58). These associations did not change, even in normal weight men with a baseline BMI between 18.5 and 22.9 kg/m(2) (n = 2186). CONCLUSION: Weight gain per se appears to increase the risk for developing USFL. Thus, avoiding weight gain, even among lean adult individuals, can be helpful in preventing this disease.

A study on the eruption timing of primary teeth in Korean children.

The objectives of this study were to clarify the eruption time and sequence of primary teeth in Korean children. A random sample of 1070 children from ages of four to thirty-six months was examined: 567 were males and 503 were females. The median values to measure the eruption time of the primary teeth were used. The results show that the primary teeth of boys erupt earlier than those of girls. As to the eruption sequence of primary teeth, the mandibular central incisor and second molar erupted earlier than their maxillary counterparts. For the lateral incisor, the canine and the first molar, the maxillary teeth erupted before the mandibular ones.

A case of retroperitoneal teratoma with nephroblastoma.

We present a case of retroperitoneal teratoma in a 4-year-old girl in which a Wilms' tumor-like element was predominant, unlike the usual pattern of the immature or malignant teratoma. Mature elements were composed of adipose tissue, neural plexus and ganglia, cartilage, smooth and skeletal muscles, and glandular epithelium of the respiratory and gastrointestinal types. Three months after complete excision of the mass, a recurrent tumor developed. It consisted of only nephroblastomatous elements without teratomatous components. Theories for the histogenesis of this rare tumor are discussed.