Purpose: This post-marketing surveillance (PMS) study was conducted to monitor the usage of axitinib (Inlyta) in clinical practice of Korean patients with advanced renal cell carcinoma (RCC) with disease progression during or after a prior systemic therapy in real world. Materials and Methods: In this multicenter, observational study, patients indicated for oral axitinib 5 mg twice daily as second-line therapy for advanced RCC were followed up under routine clinical practices, and their safety and effectiveness outcomes were collected. Results: Between 2012 and 2021, 125 patients were enrolled, and data from 111 patients were analyzed. Median age was 65 years (range, 30 to 84 years), 81% was male, and 110 (99%) had clear cell RCC. The median daily dose of axitinib was 10 mg (range, 4.36 to 15.95 mg) with a median administration period of 5.6 months (range, 15 to 750 days). Eighty-three percentage of patients experienced any grade of adverse events, 71% of which were related to study treatment, including diarrhea (36%), hypertension (21%), stomatitis (17%), decreased appetite (14%), palmar-plantar erythrodysesthesia syndrome (12%), and asthenia (11%). Most adverse events were generally well tolerated and manageable, with 13% of grade ≥ 3. Axitinib dose reduction was required in 20% of the adverse events and discontinuation in 8%. Median progression-free survival was 12.4 months (95% confidence interval [CI], 9.6 to 18.9). Objective responses were observed in 30% of patients (95% CI, 21 to 39) with 4% of complete response and 26% of partial response. Conclusion No new safety signal was found in the present PMS study of Korean RCC patients. Axitinib showed consistent outcomes in terms of effectiveness and safety confirming that the drug is a valid option for second-line therapy in patients with advanced RCC in a real-world setting.

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.

Purpose: To compare image quality in selective intracoronary contrast-injected computed tomography angiography (SelectiveCTA) with that in conventional intravenous contrast-injected CTA (IV-CTA). Materials and Methods: Six pigs (35 to 40 kg) underwent both IV-CTA using an intravenous injection (60 mL) and Selective-CTA using an intracoronary injection (20 mL) through a guide-wire during/after percutaneous coronary intervention. Images of the common coronary artery were acquired. Scans were performed using a combined machine comprising an invasive coronary angiography suite and a 320-channel multi-slice CT scanner. Quantitative image quality parameters of CT attenuation, image noise, signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), mean lumen diameter (MLD), and mean lumen area (MLA) were measured and compared. Qualitative analysis was performed using intraclass correlation coefficient (ICC), which was calculated for analysis of interobserver agreement. Results: Quantitative image quality, determined by assessing the uniformity of CT attenuation (399.06 vs. 330.21, p<0.001), image noise (24.93 vs. 18.43, p<0.001), SNR (16.43 vs. 18.52, p=0.005), and CNR (11.56 vs. 13.46, p=0.002), differed significantly between IV-CTA and Selective-CTA. MLD and MLA showed no significant difference overall (2.38 vs. 2.44, p=0.068, 4.72 vs. 4.95, p=0.078).The density of contrast agent was significantly lower for selective-CTA (13.13 mg/mL) than for IV-CTA (400 mg/mL). Agreement between observers was acceptable (ICC=0.79±0.08). Conclusion Our feasibility study in swine showed that compared to IV-CTA, Selective-CTA provides better image quality and requires less iodine contrast medium.

In cryptogenic stroke patients, early detection of new-onset atrial fibrillation (AF) and recurrent stroke is required to prevent poor clinical outcomes. Therefore, we investigated the predictors of new-onset AF and recurrent stroke in cryptogenic stroke patients without previously diagnosed AF. In total, 390 patients who were diagnosed with stroke and non-sustained atrial tachycardia (NSAT) on 24-hour Holter monitoring were followed up to assess new-onset AF and recurrent stroke. The 5-year event-free survival as well as the predictors of recurrent stroke or new-onset AF were investigated. Based on receiver operating characteristic analysis, frequent premature atrial contractions (PACs) were defined as PACs >44 beats/day. The median follow-up period was 35 months. The composite event rate was 11.5%. In Kaplan-Meier analysis, the 5-year cumulative incidence of composite events was higher in cryptogenic stroke patients with frequent PACs than in those without frequent PACs. Multivariate analysis revealed that current smoking, increased left atrial volume index, and frequent PACs were poor prognostic predictors of composite event, and frequent PACs were an independent poor prognostic factor of new-onset AF in cryptogenic stroke patients. Therefore, frequent PACs might be associated with poor clinical outcomes (new-onset AF and recurrent stroke) in cryptogenic stroke patients with concomitant NSAT.

A 57-year-old woman scheduled for cochlear implant removal exhibited preoperative electrocardiographic findings of early repolarization (ER). Four episodes of transient ST segment elevations during surgery raised suspicion for vasospastic angina (VA). In the post-anesthetic care unit, the patient complained of chest discomfort and received sublingual nitroglycerin with uncertain effect. The patient refused to proceed with postoperative invasive coronary angiography, resulting in inconclusive diagnosis. Intraoperative circumstances limit the diagnosis of VA, which emphasizes the need for further testing to confirm the diagnosis. When VA is suspected in patients with underlying ER, it is reasonable to consider invasive examination to establish the diagnosis and prevent recurrence of VA. If ST changes are observed during surgery in patients with preoperative ER, careful monitoring is recommended. Due to general anesthesia, the absence of patient symptoms limits the definitive diagnosis of those with suspected VA. Therefore, additional postoperative surveillance is recommended.
Anesthesia, General ; Cochlear Implants ; Coronary Angiography ; Diagnosis ; Electrocardiography ; Female ; Head ; Humans ; Middle Aged ; Neck ; Nitroglycerin ; Recurrence ; Thorax

BACKGROUND: Left atrial (LA) remodeling develops as a result of longstanding pressure overload. However, determinants and clinical outcome of excessive remodeling, so called giant left atrium (GLA), are not clear. METHODS: Clinical characteristics of patients with GLA (antero-posterior diameter higher than 65 mm), including echo-Doppler parameters, and follow-up clinical outcomes from a tertiary referral hospital were investigated. RESULTS: Among 68519 consecutive primary patients who underwent echocardiography over a period of 10 years, data from 163 GLA cases (0.24%) were analyzed. Main causes were significant rheumatic mitral stenosis (n = 58, 36%); other causes comprised significant rheumatic mitral regurgitation (MR; n = 10, 6%), mitral valve (MV) prolapse or congenital mitral valvular disease (MVD) (n = 20, 12%), and functional MR (n = 25, 15%). However, mild rheumatic MV disease (n = 4, 3%) or left ventricular (LV) systolic or diastolic dysfunction without significant MR (n = 46, 28%) were also causes of GLA. During median follow-up of 22 months, 42 cases (26%) underwent composite events. MV surgery was related to lower rate of composite events. In multivariate analysis, MV surgery, elevated pulmonary arterial systolic pressure, and increased LA volume index were independent predictors of future events (p < 0.05) regardless of underlying diseases or history of MV surgery. CONCLUSION: Although rheumatic MVD with atrial fibrillation is the main contributor to GLA, longstanding atrial fibrillation with LV dysfunction but without MVD also could be related to GLA. Even in GLA state, accurate measurement of LA volume is crucial for risk stratification for future events, regardless of underlying disease.
Atrial Fibrillation ; Blood Pressure ; Echocardiography ; Follow-Up Studies ; Heart Atria* ; Humans ; Mitral Valve ; Mitral Valve Insufficiency ; Mitral Valve Stenosis ; Multivariate Analysis ; Prognosis* ; Prolapse ; Tertiary Care Centers

BACKGROUND AND OBJECTIVES: Prognostic value of additional carotid Doppler evaluations to carotid intima-media thickness (IMT) and plaque has not been completely evaluated. SUBJECTS AND METHODS: A total of 1119 patients with risk factors for, but without, overt coronary artery disease (CAD), who underwent both carotid ultrasound and Doppler examination were included in the present study. Parameters of interest included peak systolic and end-diastolic velocities, resistive indices of the carotid arteries, IMT, and plaque measurements. The primary end-point was all-cause cerebro-cardiovascular events (CVEs) including acute myocardial infarction, coronary revascularization therapy, heart failure admission, stroke, and cardiovascular death. Model 1 covariates comprised age and sex; Model 2 also included hypertension, diabetes and smoking; Model 3 also had use of aspirin and statin; and Model 4 also included IMT and plaque. RESULTS: The mean follow-up duration was 1386+/-461 days and the mean age of the study population was 60+/-12 years. Amongst 1119 participants, 43% were women, 57% had a history of hypertension, and 23% had diabetes. During follow-up, 6.6% of patients experienced CVEs. Among carotid Doppler parameters, average common carotid artery end-diastolic velocity was the independent predictor for future CVEs after adjustments for all models variables (HR 0.95 per cm/s, 95% confident interval 0.91-0.99, p=0.034 in Model 4) and significantly increased the predictive value of Model 4 (global chi2=59.0 vs. 62.8, p=0.029). CONCLUSION: Carotid Doppler measurements in addition to IMT and plaque evaluation are independently associated with future CVEs in asymptomatic patients at risk for CAD.
Aspirin ; Carotid Arteries ; Carotid Artery, Common ; Carotid Intima-Media Thickness ; Coronary Artery Disease ; Female ; Follow-Up Studies ; Heart Failure ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Hypertension ; Myocardial Infarction ; Risk Factors ; Smoke ; Smoking ; Stroke ; Ultrasonography

BACKGROUND AND OBJECTIVES: We sought to determine whether an elevated homocysteine (Hcy) level is associated with a worse prognosis in Korean patients with coronary artery disease (CAD). SUBJECTS AND METHODS: A total of 5839 patients (60.4% male, mean age 61.3±11.2 years) with CAD were enrolled from 2000 to 2010 at Gangnam Severance Hospital. CAD was diagnosed by invasive coronary angiography. Laboratory values including Hcy level were obtained on the day of coronary angiography and analyses were performed shortly after sampling. Patients were divided into two groups according to their Hcy levels. Baseline risk factors, coronary angiographic findings, length of follow-up, and composite endpoints including cardiac death (CD) and non-fatal myocardial infarction (NFMI) were recorded. 1:1 propensity score matched analysis was also performed. RESULTS: Over a mean follow-up period of 4.4±2.5 years, there were 132 composite endpoints (75 CD and 57 NFMI) with an event rate of 2.3%. Mean Hcy level was 9.9±4.3 µmol/L (normal Hcy 7.9±1.5 µmol/L and elevated Hcy 13.9±5.1 µmol/L). Kaplan-Meier survival analysis showed an association of elevated Hcy level with worse prognosis (p<0.0001). In addition, a multivariate Cox regression analysis showed an association of elevated Hcy level with worse prognosis for both the entire cohort (hazard ratio [HR] 2.077, 95% confidence interval [CI] 1.467-2.941, p<0.0001) and the propensity score matched cohort (HR 1.982, 95% CI 1.305-3.009, p=0.001). CONCLUSION: Elevated Hcy level is associated with worse outcomes in Korean patients with CAD.
Cohort Studies ; Coronary Angiography ; Coronary Artery Disease* ; Coronary Vessels* ; Death ; Follow-Up Studies ; Homocysteine* ; Humans ; Male ; Myocardial Infarction ; Prognosis ; Propensity Score* ; Risk Factors

PURPOSE: Enterovirus (EV) infection in children can manifest various diseases from asymptomatic infection to nonspecific febrile illness, hand-foot-mouth disease, and aseptic meningitis. This study was aimed to investigate epidemiology and clinical significance of various genotypes of EV infections in pediatric inpatient. METHODS: We collected the stool samples from the admitted pediatric patients in Inha University Hospital from March 2014 to March 2015. EV detection and genotype identification were performed by real-time RT-PCR and semi-nested RT-PCR. Phylogenetic trees were constructed by neighbor joining method. RESULTS: A total of 400 samples were collected during study period and 112 patients (28%) were diagnosed with EV infections. The mean age of EV positive patients was 2.66 years (0.1-14) and sex ratio was 1.73:1. Genetic sequences of EVs were identified; coxsackievirus B5 (17, 15.2%), coxsackievirus A16 (13, 11.6%), enterovirus 71 (10, 8.9%), and coxsackievirus A2 (9, 8.0%). Nonspecific febrile illness (96, 86%) was the most common clinical manifestation and the duration of fever was 0-11 days (mean 3.1 days). Rash (44, 39%) and meningitis (43, 38%) were followed. Patients who were attending daycare center or had siblings accounted for 82.1%. Phylogenetic relationship tree revealed 6 distinct genogroups among 56 types of EVs. CONCLUSIONS: This study is the report of epidemiology, serotype distribution and clinical manifestations of children with EV infection in Incheon. This data will be helpful for further study about the epidemiology of EV infection in Korea.
Asymptomatic Infections ; Child ; Enterovirus* ; Epidemiology* ; Exanthema ; Fever ; Genotype ; Humans ; Incheon* ; Inpatients* ; Korea ; Meningitis ; Meningitis, Aseptic ; Sex Ratio ; Siblings ; Trees

PURPOSE: Left ventricular (LV) filling pressure affects atrial fibrillation (AF) recurrence. We investigated the relationship between diastolic dysfunction and AF recurrence after cardioversion, and whether LV filling pressure was predictive of AF recurrence. MATERIALS AND METHODS: Sixty-six patients (mean 58+/-12 years) with newly diagnosed persistent AF were retrospectively enrolled. We excluded patients with left atrial (LA) diameters larger than 50 mm, thereby isolating the effect of LV filling pressure. We evaluated the differences between the patients with (group 1) and without AF recurrence (group 2). RESULTS: Group 1 showed increased LA volume index (LAVI) and E/e' compared to group 2 (p<0.05). During a mean follow-up period of 25+/-19 months, AF recurrence after cardioversion was 60.6% (40/66). The area under the receiver operating characteristics curve of E/e' for AF recurrence was 0.780 [95% confidence interval (CI): 0.657-0.903], and the optimal cut-off value of the E/e' was 9.15 with 75.0% of sensitivity and 73.1% of specificity. A Kaplan-Meier survival curve showed that the cumulative recurrence-free survival rate was significantly lower in patients with higher LV filling pressure (E/e'>9.15) compared with patients with lower LV filling pressure (E/e'< or =9.15) (log rank p=0.008). Cox regression analysis revealed that E/e' [hazards ratio (HR): 1.100, 95% CI: 1.017-1.190] and LAVI (HR: 1.042, 95% CI: 1.002-1.084) were independent predictors for AF recurrence after cardioversion. CONCLUSION: LV filling pressure predicts the risk of AF recurrence in persistent AF patients after cardioversion.
Aged ; Atrial Fibrillation/*physiopathology ; Electric Countershock ; Female ; Follow-Up Studies ; Heart Atria/pathology/physiopathology ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Proportional Hazards Models ; ROC Curve ; Recurrence ; Regression Analysis ; Retrospective Studies ; Sensitivity and Specificity ; Survival Rate ; Ventricular Dysfunction, Left/*physiopathology