Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.
Equipment and Supplies ; Equipment Safety ; In Vitro Techniques ; Indicators and Reagents ; Korea* ; Licensure ; Magnets ; Needles

BACKGROUND AND OBJECTIVES: Metabolic syndrome and high sodium intake are associated with frequent cardiovascular events. Few studies have estimated sodium intake in subjects with metabolic syndrome by 24-hour urine sodium excretion. We evaluated sodium intake in individuals with metabolic syndrome. SUBJECTS AND METHODS: Participants were recruited by random selection and through advertisement. Twenty four-hour urine collection, ambulatory blood pressure measurements, and blood test were performed. Sodium intake was estimated by 24-hour urine sodium excretion. Participants receiving antihypertensive medications were excluded from analysis. RESULTS: Among the 463 participants recruited, subjects with metabolic syndrome had higher levels of 24-hour urine sodium excretion than subjects without metabolic syndrome (p=0.0001). There was a significant relationship between the number of metabolic syndrome factors and 24-hour urine sodium excretion (p=0.001). The proportion of subjects with metabolic syndrome was increased across the tertile groups of 24-hour urine sodium excretion (p<0.0001). The association of high sodium intake and metabolic syndrome was significant only among women. Among the factors related to metabolic syndrome, body mass index had an independent association with 24-hour urine sodium excretion (p<0.0001). CONCLUSION: Women with metabolic syndrome exhibited significantly higher sodium intake, suggesting that dietary education to reduce sodium consumption should be emphasized for women with metabolic syndrome.
Blood Pressure ; Body Mass Index ; Education ; Female ; Hematologic Tests ; Humans ; Hypertension ; Sodium* ; Sodium, Dietary ; Urine Specimen Collection

Colorectal polyps of mesenchymal origin are a rare group of colorectal disorders. A "mucosal Schwann-cell hamartoma," which is one type of polypoid lesion that originates from the mesenchyme, is a newly-proposed disease entity to be distinguished from the neurofibromas found in type-1 neurofibromatosis. This lesion is composed of pure Schwann-cell proliferation in the lamina propria and shows diffuse immunoreactivity for the S-100 protein. We report a case of a polypoid lesion of the colon with the features of this recently-proposed disease entity.
Colon ; Hamartoma ; Mesoderm ; Mucous Membrane ; Neurofibroma ; Neurofibromatoses ; Neuroma ; Polyps ; S100 Proteins ; Schwann Cells ; SNARE Proteins

BACKGROUND AND OBJECTIVES: Microalbuminuria (MAU) and decreased estimated glomerular filtration rate (eGFR) are risk factors for cardiovascular disease (CVD) in patients with hypertension. However, in hypertensive patients with normal or minimally reduced eGFR (> or =60 mL/min/1.73 m2) and with normo- or MAU, the value of combined estimation of eGFR and urine microalbumin for the risk assessment has not been widely reported. We evaluated the association between arterial stiffness and the combined estimation of eGFR and urine microalbumin. SUBJECTS AND METHODS: Subjects with never treated hypertension and normal or minimally reduced eGFR were evaluated (n=491, 50.1+/-10.4 years). eGFR was calculated by the simplified Modification of Diet in Renal Disease formula. Urinary albumin-to-creatinine ratio (UACR) was assessed with spot urine. Arterial stiffness was assessed with heart-femoral pulse wave velocity (hfPWV). All subjects were divided into four groups; group 1, eGFR > or =90 mL/min/1.73 m2 (normal eGFR) and normo-albuminuria (NAU); group 2, eGFR 89.9-60 mL/min/1.73 m2 (minimally reduced eGFR) and NAU; group 3, normal eGFR and MAU; group 4, minimally reduced eGFR and MAU. RESULTS: Group 1 had the lowest hfPWV (964.6+/-145.4; group 2, 1013.5+/-168.9; group 3, 1058.2+/-238.0; group 4, 1065.8+/-162.9 cm/sec). Analysis adjusting age, sex, body mass index, heart rate and mean arterial pressure showed significantly lower hfPWV of group 1 compared to group 2 (p=0.032) and 3 (p=0.007). Multiple regression analysis showed a significant association of hfPWV with logUACR {beta=0.096, 95% confidence interval (CI) 8.974-60.610, p=0.008} and eGFR (beta=-0.069, 95% CI -1.194 - -0.005, p=0.048). CONCLUSION: Minimally reduced eGFR or MAU is independently associated with increased arterial stiffness, indicating greater CVD risk.
Arterial Pressure ; Body Mass Index ; Cardiovascular Diseases ; Diet ; Glomerular Filtration Rate ; Heart Rate ; Humans ; Hypertension ; Pulse Wave Analysis ; Renal Insufficiency ; Risk Assessment ; Risk Factors ; Vascular Stiffness

BACKGROUND AND OBJECTIVES: Associations have been reported between the serum uric acid (SUA) level, metabolic syndrome (MS), and atherosclerosis. We have determined the relationship between the SUA level, MS, and arterial stiffness in Korean. SUBJECTS AND METHODS: Cross-sectional data from 1,276 adults who underwent routine laboratory tests and pulse wave velocity (PWV) measurements during a health check-up were analyzed in a gender-specific manner. None of the participants had atherosclerotic cardiovascular disease, diabetes, renal disease, or systemic disease, or were under treatment which would affect SUA levels, or taking medications for hypertension or dyslipidemia. RESULTS: After adjustment for age, smoking status, total cholesterol (TC), and creatinine, the odds ratios (ORs, 95% confidence interval) of gender-specific quartiles of SUA for MS were 1.0, 1.28 (0.66-2.47), 1.46 (0.76-2.82), and 2.21 (1.15-4.26) in females, and 1.0, 1.33 (0.82-2.17), 1.60 (0.96-2.66), and 2.03 (1.21-3.40) in males. However, after adjustment for waist circumference, there were no significant differences in the ORs among the SUA quartile groups in females and males (both, p=NS). The Pearson's correlation coefficients for the relationship between SUA levels and heart-femoral (hf) PWVs or brachial-ankle (ba) PWVs were not significant in females and males (r=0.054 and r=0.015, respectively, in females; r=-0.036 and r=-0.015, respectively, in males; all, p=NS). CONCLUSION: An elevated SUA level is associated with abdominal obesity among the MS components, but the SUA level is not associated with PWV in females or males.
Adult ; Atherosclerosis ; Cardiovascular Diseases ; Cholesterol ; Creatinine ; Dyslipidemias ; Electrolytes ; Female ; Humans ; Hypertension ; Male ; Obesity, Abdominal ; Odds Ratio ; Pulse Wave Analysis ; Smoke ; Smoking ; Uric Acid ; Vascular Stiffness ; Waist Circumference

BACKGROUND AND OBJECTIVES: High aerobic exercise capacity and sport-related physical activity are reported to be inversely associated with arterial stiffness in healthy young adults. However, it is unknown whether increased physical activity and/or high aerobic exercise capacity attenuate arterial stiffness in patients with untreated hypertension. SUBJECTS AND METHODS: We studied subjects with never-treated hypertension {n=84 (55 males); mean age+/-SD, 49+/-7 years; age range, 36-65 years}. We excluded subjects with a history of diabetes, angina, myocardial infarction, major arrhythmia, or cerebrovascular diseases and those who were taking any cardiovascular medications, including lipid-lowering agents. Carotid intima-media thickness (IMT) and heart-femoral pulse wave velocity (hfPWV) were measured before exercise testing was performed. Physical activity was estimated using a modified Baecke questionnaire. Aerobic exercise capacity was measured with maximal cardiopulmonary exercise testing (maximum oxygen uptake, Vo2max). RESULTS: Linear regression analysis showed a significant inverse correlation between sport-index and hfPWV (r=-0.404; p<0.001), which multiple linear regression analysis showed to be independent of the individual variables of age, gender, body mass index, mean arterial pressure, total cholesterol, fasting blood glucose, and heart rate (beta=-0.277; p=0.004). However, the work- and leisure-indices and Vo2max were not associated with hfPWV (p>0.05). Carotid IMT was not associated with physical activity indices or Vo2max. CONCLUSION: In patients with untreated hypertension, increased sport activity was associated with lower aortic stiffness, but high aerobic exercise capacity was not. These results suggest that regular daily exercise, but not exercise capacity, is an important determinant of aortic stiffness in patients with untreated hypertension.
Arrhythmias, Cardiac ; Arterial Pressure ; Blood Glucose ; Body Mass Index ; Carotid Intima-Media Thickness ; Cholesterol ; Exercise ; Exercise Test ; Fasting ; Heart Rate ; Humans ; Hypertension ; Linear Models ; Motor Activity ; Myocardial Infarction ; Oxygen ; Pulse Wave Analysis ; Sports ; Vascular Stiffness ; Young Adult ; Surveys and Questionnaires

BACKGROUND AND OBJECTIVES : Pulse wave velocity (PWV) is an ideal indicator of arterial stiffness. This study investigated arterial stiffness of different vascular regions in patients suffering with Behcet's disease (BD), and we assessed whether arterial stiffness was affected by the clinical parameters of BD. Subjects and METHODS : This study included 53 BD patients (mean age: 38+/-8 years) and 65 healthy controls (mean age: 38+/-8 years) who were without any known cardiovascular diseases. After recording the clinical parameters of the BD patients, pulse wave velocity was measured with an automated device in the heart-femoral, heart-carotid, heart-brachial and femoral-ankle segments. RESULTS : Patients with BD had significantly higher PWV values than did the controls in all the regional arterial segments. The PWV values were not correlated with the duration of the disease, corticosteroid use or the presence of active disease at the time of examination. The clinical variables related to severe BD manifestations, which included severe disease, male gender, vascular lesions or immunosuppressant use, were partly associated with increased PWV on the univariate analysis, but any statistical significance for these clinical variables was lost in all the regional arterial segments on multivariate analysis. In addition, multivariate regression analysis revealed that age and the mean arterial pressure were independently associated with increased PWV in most regional arterial segments for BD patients. CONCLUSION : The patients with BD had significantly increased arterial stiffness in all the regional arterial segments when compared with the healthy controls. Longitudinal studies that employ a large population are required to determine the pathophysiologic and prognostic implications of increased arterial stiffness in BD.
Arterial Pressure ; Arteries ; Cardiovascular Diseases ; Humans ; Longitudinal Studies ; Male ; Multivariate Analysis ; Pulse Wave Analysis ; Vascular Stiffness*

Stent thrombosis is generally a fatal complication after percutaneous coronary intervention. Combined antiplatelet therapy is recommended to prevent stent thrombosis in those patients who have undergone stenting. However, there are conflicting opinions on the appropriate duration of instituting antiplatelet treatment, especially after intracoronary radiation therapy or drug-eluting stent implantation, which are two situations closely associated with an increased risk of stent thrombosis. We report here on 2 cases of late stent thrombosis that occurred despite giving combined antiplatelet therapy, and these maladies developed more than 4 years after intracoronary brachytherapy.
Angioplasty ; Brachytherapy* ; Coronary Thrombosis ; Drug-Eluting Stents* ; Humans ; Learning* ; Percutaneous Coronary Intervention ; Radiotherapy ; Stents* ; Thrombosis*

BACKGROUND: We analysed the characteristics of anastomotic sites after coronary artery bypass grafting (CABG) using coronary angiographies (CAGs) performed at one and five years postoperatively in the same patient population. MATERIAL AND METHOD: Among the 219 patients who underwent isolated CABGs between January 1995 and December 1997, follow-up coronary angiograms were performed in 149 (75.3%) patients at one year and in 115 (58.1%) patients at five years postoperatively. FitzGibbon grading system was used to evaluate the anastomotic sites. RESULT: The patency rates of arterial grafts at one- and five-year were 96.5% (192/199) and 93.1% (134/144), which were higher than those of saphenous vein grafts (SVGs) (82.9% (224/270) and 77.5% (141/182), respectively) (p=0.01). Although there were significant decreases in the patency rates between one- and five-year CAGs of both arterial and venous grafts, the proportion of FitzGibbon grade B among the SVGs was increased from 5.2% (one-year) to 8.2% (five-year), suggesting the progression of vein graft disease (p<0.01). CONCLUSION: The patency rate of the arterial graft was higher than that of SVG in both one- and five-year CAGs. The attrition rate of saphenous vein graft was higher than arterial grafts.
Angiography* ; Coronary Angiography ; Coronary Artery Bypass* ; Coronary Vessels* ; Follow-Up Studies* ; Humans ; Saphenous Vein ; Transplants ; Veins

BACKGROUND AND OBJECTIVES: Aortic stiffness is believed to be an important risk factor of coronary artery atherosclerosis (CAA), as it directly affects coronary perfusion. The following aspects of the invasively measured aortic pulse wave velocity (PWV) were assessed in relation to CAA: The effect of cardiovascular risk factors on PWV, the effect of PWV on the severity of CAA and on the development of the restenosis after drug-eluting stent (DES) implantation. SUBJECTS AND METHODS: 371 subjects who had undergone coronary angiography were enrolled, with all undergoing an invasive aortic PWV measurement also. 112 patients, who had undergone a DES implantation, were prospectively investigated for the effect of PWV in relation to the subsequent risk of major adverse cardiac events (MACE). RESULTS: Among the conventional cardiovascular risk factors, an age >60 (10.79+/-4.92 vs. 8.35+/-4.02, p=0.0006), diabetes (10.97+/-4.66 vs. 9.26+/-4.70 m/sec, p=0.0118) and dyslipidemia (10.38+/-4.97 vs. 9.47+/-4.55m/sec, p=0.0421) were significantly associated with an increased PWV, but sex, smoking and hypertension were not associated with an increased PWV. The PWV was shown to be significantly associated with the severity of CAD. The odds ratio (OR) of 1m/sec increment in the PWV for an increased vessel score was 1.08 (95% confidence interval (CI): 1.03-1.13, p=0.0017). There were no differences in the incidence of MACE and the changes in the angiographic parameters between the high (>10 m/sec) and low PWV groups. CONCLUSION: The invasively measured aortic PWV was affected by age (>60), diabetes and dyslipidemia, and also showed a strong association with the severity of CAD. The aortic PWV was not a significant risk factor for restenosis following a DES implantation.
Atherosclerosis ; Coronary Angiography ; Coronary Artery Disease* ; Coronary Restenosis ; Coronary Vessels* ; Drug-Eluting Stents ; Dyslipidemias ; Humans ; Hypertension ; Incidence ; Odds Ratio ; Perfusion ; Prospective Studies ; Pulse Wave Analysis ; Risk Factors ; Smoke ; Smoking ; Vascular Stiffness*