• International Journal of Heart Failure
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• v.6 no.2
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• pp.76-81
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• 2024

Background and Objectives: Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)'s Manufacturers and User Defined Experience (MAUDE) database. Methods: We reviewed the FDA's MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians. Results: A total of 1,512 adverse events were identified in 453 "injury and death" reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453). The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%). Conclusions: Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.

• Strategy21
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• s.39
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• pp.82-113
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• 2016

This paper analyzes the contents and the effects of the UNSC 2270, and its implications to South Korea's defense strategy and navy. The UN Security Council passed strong sanctions against North Korea which punish North Korea's 4^th nuclear test. The sanctions compared to the previous ones require international society to take practical actions such as comprehensive trade bans as well as diplomatic isolation which will put significant pains on North Korea. Especially, these measures would greatly hamper economic development policy of Kim Joung-un regime. Because Kim Jung-un regime has inherent legitimacy problems which stems from the third family succession of the power, economic difficulties may play an important cause on the regime instability in the long term. In fact, the United States sees this possibility as an option to coerce North Korea in which North Korea choose denuclearization for its regime survival. Nevertheless, the prospects of the UN sanctions are not so optimistic. Considering North Korea's willingness for nuclear development and its level of nuclear technology, North Korea will try to play a gambit with the US and South Korea by exploiting its strategic advantages. North Korea's response will have three following strategies. First, it would actively pursue political and economic survival strategy by using China's support for the regime, strengthening its power grip in the name of countering US hostile policy, and enhancing peace propaganda. Second, North Korea will accelerate efforts to position its status as a nuclear de facto state. For this purpose, it could create nuclear crisis on the peninsula. Third, it would exploit local provocations as an exit strategy to get over the current situation. In order to counter North Korea's actions and punish North Korea's behavior strongly, South Korea needs following strategies and efforts. It should first make all the efforts to implement the UN sanctions. Strong and practical nuclear deterrence strategy and capability with the U.S. should be developed. Effective strategy and capabilities for the prevention and deterrence of North Korea's provocation should be prepared. For this purpose, North Korea's provocation strategy should be thoroughly reviewed. Active international cooperation is needed to punish and coerce North Korea's behavior. Finally, South Korea should prepare for the possible occurrence of North Korea's contingency and make use of the situation as an opportunity to achieve unification. All these strategies and efforts demand the more active roles and missions of South Korea's navy and thus, nullify North Korea's intention militarily.

• Radiation Oncology Journal
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• v.31 no.3
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• pp.118-124
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• 2013

Purpose: The optimal treatment of advanced maxillary sinus cancer has been challenging for several decades. Intra-arterial chemotherapy (IAC) for head and neck cancer has been controversial. We have analyzed the long-term outcome of neoadjuvant IAC followed by radiation therapy (RT) and surgery. Materials and Methods: Twenty-seven patients with advanced maxillary sinus cancer were treated between 1989 and 2002. Five-fluorouracil (5-FU, $500mg/m^2$) was infused intra-arterially, and followed by RT (total 50.4 Gy/28 fractions). A planned surgery was performed 3 to 4 weeks after completion of IAC and RT. Results: At a median follow-up of 77 months (range, 12 to 169 months), the 5-year rates of overall survival in all patients were 63%. The 5-year rates of overall survival of stage T3/T4 patients were 70.0% and 58.8%, respectively. Seven of fourteen patients with disease recurrence had a local recurrence alone. The 5-year actuarial local control rates in patients with stage T3/T4, and in all patients were 20.0%, 32.3%, and 27.4%, respectively. Overall response rate after the completion of IAC and RT was 70.3%. During the follow-up, seven patients (25.9%) showed mild to moderate late complications. The tumor extent (i.e., the involvement of either orbit and/or base of skull) appeared to be related with local recurrence. Conclusion: Neoadjuvant IAC with 5-FU followed by RT and surgery may be effective to improve local tumor control in the patients with advanced maxillary sinus cancer. However, local failure was still the major cause of death. Further investigations are required to determine the optimal treatment schedule, radiotherapy techniques and chemotherapy regimens.

• Journal of Hospice and Palliative Care
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• v.1 no.1
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• pp.30-38
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• 1998

Background : Hepatocellular carcinomoma is the 3rd most common malignancy and the 2nd most common cause of death in Korea. The prediction of life-expectancy in terminal cancer patients is a major problem for patients, families, and physicians. We would like to investigate the prognostic factors of hepatocellular carcinoma, and therefore contribute to the prediction of the survival time of patients with hepatocellular carcinoma. Methods : A total of 91 patients(male 73, female 18) with hepatocellular carcinoma who were admitted to the hospital between January and lune 1995 were entered into the study, and data were collected prospectively on 28 clinical parameters through medical obligation record. We surveyed an obligation and local district office records, and confirmed the surivival of patients till July, 1996. Using Cox-proportional hazard model, give the significant variables related to survival. These determined prognostic factors. Life regressional analysis was used, there were calculated predicted survival day based on combinations of the significant prognostic factors. Results : 1) Out of 91 patients, 73 were male, and 18 were female. The mean age was $56.7{\pm}10.6$ ears. During the study, except for 16 patients who could not follow up, out of 75 patients, the number of deaths was 57(76%) and the number of survivals was 18(24%). 2) Out of the 28 clinical parameters, the prognostic factors related to reduced survival rate were prothrombin time<40%(relative risk:10.8), weight loss(RR:4.4), past history of hypertension (RR:3.2), ascites(RR:2.8), hypocalcemia(RR:2.5)(P<0.001). 3) Out of five factors, the survival day is 1.7 in all of five, $4.2{\sim}10.0$ in four, $10.4{\sim}41.9$ in three, $29.5{\sim}118.1$ in two, $124.0{\sim}296.6$ in one, 724.0 in none. Conclusion : In hepatocellular carcinoma we found that the prognostic factors related to reduce survival rate were prolonged prothrombin time(<40%), weight loss, past history of hypertension, ascites, and hypocalcemia(<8.7mg/dl). The five prognostic factors enabled the prediction of life-expectancy in patients with hepatocellular carcinoma and may assist in managing patients with hepatocellular carcinomal.

• Clinical and Experimental Pediatrics
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• v.51 no.4
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• pp.383-390
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• 2008

Purpose : This study was aimed to analyze the clinical characteristics of patients with acute interstitial pneumonia who had presented similar clinical patterns from March to June, 2006 and to describe our experience of treatment and to identify risk factors associated with prognosis. Methods : The clinical characteristics, radiologic and histopathologic findings and response to steroids of 15 patients (non-survival group [n=7] and survival group [control, n=8]) with acute interstitial pneumonia were investigated through the review of medical records. Results : The mean age of the patients was 26 (range: 3-48) months. Cough, cyanosis and fever were frequent symptoms. The most frequent radiologic findings on admission were pneumomediastium and extensive ground glass opacity. Surgical lung biopsy was performed on 8/15 (53.3%) patients and diffuse alveolar damage was found. Mechanical ventilation was applied for 9/15 (60.0%) patients for 40 (range: 1-99) days. Five patients in survival group received steroid treatment and 7 patients in non-survivial group (P=0.20). One patient in survival group received steroid pulse treatment and 4 patients in non-survival group (P=0.12). Seven patients died all of respiratory failure. The survival rate was 53.4%. Conclusion : The patients with acute interstitial pneumonia which occurred on spring 2006 showed high mortality because of rapidly and extensively progressing pulmonary fibrosis and air leakage. Therefore, we should consider surgical lung biopsy and steroid application earlier. We should recognize this acute interstitial pneumonia occurring on spring in domestics and need to investigate the cause and treatment in large scale.

• Annals of Occupational and Environmental Medicine
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• v.34
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• pp.40.1-40.9
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• 2022

Background: According to the occupational accident status analysis in 2020, of 1,180 occupational deaths, 463 were caused by cardiovascular disease (CVD). Workers should be assessed for CVD risk at regular intervals to prevent work-related CVD in accordance with the rules on occupational safety and health standards. However, no previous study has addressed risk and mortality. Therefore, this longitudinal study was conducted to evaluate the relationship between 10-year cardiovascular risk of the general health checkup and mortality. Methods: The study included 545,859 participants who visited Kangbuk Samsung Total Healthcare Centers from January 1, 2002, to December 31, 2017. We performed 10-year cardiovascular risk assessment for the participants and the risk was divided into 4 groups (low, moderate, high, and very high). The study used death data from the Korea National Statistical Office for survival status as an outcome variable by December 31, 2019, and the cause of death based on the International Classification of Diseases, 10^th Revision (ICD-10) was identified. Statistical analysis was performed using Cox proportional hazards regression analysis, and the sum of the periods from the first visit to the date of death or December 31, 2019, was used as a time scale. We also performed a stratified analysis for age at baseline and sex. Results: During 5,253,627.9 person-years, 4,738 overall deaths and 654 cardiovascular deaths occurred. When the low-risk group was set as a reference, in the multivariable-adjusted model, the hazard ratios (HRs) (95% confidence interval [CI]) for overall mortality were 3.36 (2.87-3.95) in the moderate-risk group, 11.08 (9.27-13.25) in the high-risk group, and 21.20 (17.42-25.79) in the very-high-risk group, all of which were statistically significant. In cardiovascular deaths, the difference according to the risk classification was more pronounced. The HRs (95% CI) were 8.57 (4.95-14.83), 38.95 (21.77-69.69), and 78.81 (42.62-145.71) in each group. As a result of a subgroup analysis by age and sex, the HRs of all-cause mortality and cardiovascular mortality tended to be higher in the high-risk group. Conclusions: This large-scale longitudinal study confirmed that the risk of death increases with the 10-year cardiovascular risk of general health checkup.

• Korean Journal of Radiology
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• v.21 no.7
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• pp.880-890
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• 2020

Objective: Patients with chronic obstructive pulmonary disease (COPD) are known to be at risk of osteoporosis. The purpose of this study was to evaluate the association between thoracic vertebral bone density measured on chest CT (D_Thorax) and clinical variables, including survival, in patients with COPD. Materials and Methods: A total of 322 patients with COPD were selected from the Korean Obstructive Lung Disease (KOLD) cohort. D_Thorax was measured by averaging the CT values of three consecutive vertebral bodies at the level of the left main coronary artery with a round region of interest as large as possible within the anterior column of each vertebral body using an in-house software. Associations between D_Thorax and clinical variables, including survival, pulmonary function test (PFT) results, and CT densitometry, were evaluated. Results: The median follow-up time was 7.3 years (range: 0.1-12.4 years). Fifty-six patients (17.4%) died. D_Thorax differed significantly between the different Global Initiative for Chronic Obstructive Lung Disease stages. D_Thorax correlated positively with body mass index (BMI), some PFT results, and the six-minute walk distance, and correlated negatively with the emphysema index (EI) (all p < 0.05). In the univariate Cox analysis, older age (hazard ratio [HR], 3.617; 95% confidence interval [CI], 2.119-6.173, p < 0.001), lower BMI (HR, 3.589; 95% CI, 2.122-6.071, p < 0.001), lower forced expiratory volume in one second (FEV₁) (HR, 2.975; 95% CI, 1.682-5.262, p < 0.001), lower diffusing capacity of the lung for carbon monoxide corrected with hemoglobin (DL_CO) (HR, 4.595; 95% CI, 2.665-7.924, p < 0.001), higher EI (HR, 3.722; 95% CI, 2.192-6.319, p < 0.001), presence of vertebral fractures (HR, 2.062; 95% CI, 1.154-3.683, p = 0.015), and lower D_Thorax (HR, 2.773; 95% CI, 1.620-4.746, p < 0.001) were significantly associated with all-cause mortality and lung-related mortality. In the multivariate Cox analysis, lower D_Thorax (HR, 1.957; 95% CI, 1.075-3.563, p = 0.028) along with older age, lower BMI, lower FEV₁, and lower DL_CO were independent predictors of all-cause mortality. Conclusion: The thoracic vertebral bone density measured on chest CT demonstrated significant associations with the patients' mortality and clinical variables of disease severity in the COPD patients included in KOLD cohort.

• Journal of Chest Surgery
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• v.38 no.10 s.255
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• pp.675-679
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• 2005

Background: Clinical reports on replacement of all three (AV + MV + TV) valves are rare. Material and Method: From January 1992 to December 2003, 38 patients received triple valve replacement (aortic, mitral, tricuspid) at Yonsei Cardiovascular Center. Mean age of patients was $49.5\pm10.7 (28\~69)$ years, and 24 patients $(63.1\%)$ were female. Rheumatic valve disease was the most common cause of operation (n=37). Preoperative New York Heart Association functional class were II in 4, III in 24 and IV in 10. Fifteen patients (group 1) received triple valve replacement at their first operation. Twenty three patients (group 2) received one or more operations before tricuspid valve replacement (TVR). Seven patients received tricuspid valve annuloplasty at first operation and received TVR later. Result: Six patients died at hospital after operation $(15.8\%)$ and all these patients were in group 2. All patients in group I survived and were discharged. Three patients $(9.4\%)$ died during follow up periods. Most of the survivors had improved functional class (I in 22, II in 8, III in 1, IV in 1). During follow up period, there were 4 valve related complications. The 10-year survival rate was $68.8\%$ and survival rate for free from valve related event at 10 years was $85.5\%$. Conclusion: After triple valve replacement, most patients showed improvement of symptoms. And during follow up period, valve related complications and survival were acceptable. Therefore, if indicated, triple valve replacement is recommended before the patients' conditions get worse.

• Advances in pediatric surgery
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• v.1 no.2
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• pp.140-148
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• 1995

To study the clinical profiles and outcome of surgery in infants with esophageal atresia, we reviewed 96 esophageal atresia cases who were treated from April, 1978 to June, 1995. There were 51 male and 45 female infants, a ratio of 1.1:1. The low birth weight(<2500g) patients were 32%. Clinical findings at the time of diagnosis included drooling in 57%, choking in 50%, cyanosis in 38%, respiratory distress in 27% and swallowing difficulty in 20%. Gross classification included 6 cases of type A esophageal atresia(6%), 79 cases of type C(82%), 3 cases of type E (3%) and 8 cases of type F(8%). Associated anomalies occurred in 34 infants(35%). Among them, cardiac anomalies were most common(60%). A primary repair of the defect was carried out in 76 patients with type A or C. A staged operation comprising a repair or gastric tube interposition after gastrostomy was performed in 8 patients. In all 3 infants with H-type, a division of fistula was performed. Esophageal resection and anastomosis was done in 8 infants with esophageal stenosis. In one infant, a gastrostomy was performed and he expired before staged operation. Anastomotic complications included leakage in 16 cases(17%), stricture in 37 cases(39%) and recurrent tracheoesopohageal fistula in 3 cases(3%). The mortality rate was 14% and the leading cause of death was pneumonia. The overall survival rate was 86%, and according to Waterston criteria, the survival rates were 93%, 85% and 58% in class A, Band C, respectively. 75 patients were followed up with median follow up 6.4 years. Among them, 93% were uneventful and 7% had frequent pneumonia.

• Journal of Chest Surgery
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• v.35 no.12
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• pp.871-875
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• 2002

Despite early aggressive treatment, post myocardial infarction(MI) ventricular septal defect(VSD) revealed high surgical mortality. We reviewed the 10-year experiences of surgically treated post-MI VSD in Yonsei University. Material and Method: From Jan. 1991 to May 2001, 17 patients underwent surgical repair of post-MI VSD. Ages ranged between 47 and 77 years(mean age＝63.2$\pm$9.1). There were 10 males and 7 females. VSD was located at anterior in 16 patients and at posterior in one. IABP was inserted preoperatively in 12 patients due to cardiogenic shock. Mean interval from MI to occurrence of VSD was 5.6 days. Among patients undergoing early surgical correction(n＝13), mean interval from occurrence of VSD to operation was 2.5 days. In 11 patients, concomitant CABG was performed during repair of VSD. Result: Four patients died within 30 days after the operation(30 day mortality＝23.5%). Among 12 patients with preoperative cardiogenic shock, 4 patients died within 30 days(30-day mortality＝33.3%). During mean follow up period of 52 months, one patient died of unknown cause and 10-year survival of discharged patients was 66.7%. All follow-up patients were in NYHA functional class I or II when their last OPD visit. Conclusion: In the treatment of post-MI VSD, aggressive medical treatment with early surgical correction seems to be very important in terms early and long-term survival of patients.