Background and Objectives: Several real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15–49 mL/min). Methods: XARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints. Results: XARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30–49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15–29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m 2 . The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA 2 DS 2 -VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m 2 per year. Conclusions XARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.

Background and Objectives: Several real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15–49 mL/min). Methods: XARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints. Results: XARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30–49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15–29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m 2 . The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA 2 DS 2 -VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m 2 per year. Conclusions XARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.

Background and Objectives: Several real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15–49 mL/min). Methods: XARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints. Results: XARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30–49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15–29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m 2 . The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA 2 DS 2 -VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m 2 per year. Conclusions XARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.

Background and Objectives: Several real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15–49 mL/min). Methods: XARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints. Results: XARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30–49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15–29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m 2 . The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA 2 DS 2 -VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m 2 per year. Conclusions XARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.

Background: Although rhythm control could be the best for symptomatic atrial fibrillation (AF), some patients fail to achieve sinus rhythm (SR). This study aimed to identify clinical risk factors of failed electrical cardioversion (ECV). Methods: A total of 248 patients who received ECV for persistent AF or atrial flutter (AFL) were retrospectivelyreviewed. Patients were divided into three groups: Group 1 maintained SR for > 1 year, group 2 maintained SR ≤ 1 yearafter ECV, and group 3 failed ECV. SR maintenance was assessed using regular electrocardiography or Holter monitoring. Results: Patients were divided into group 1 (73, 29%), group 2 (146, 59%), and group 3 (29, 12%). The mean ageof patients was 60 ± 10 years, and 197 (79%) were male. Age, sex, and baseline characteristics were similar amonggroups. However, increased cardiac size, digoxin use, heart failure (HF), and decreased left ventricular ejection frac‑ tion (LVEF) were more common in group 3. Univariate analysis of clinical risk factors for failed ECV was increasedcardiac size [hazard ratio (HR) 2.14 (95% confidence interval [CI], 1.06–4.34, p = 0.030)], digoxin use [HR 2.66 (95% CI, 1.15–6.14), p = 0.027], HF [HR 2.60 (95% CI, 1.32–5.09), p = 0.005], LVEF < 40% [HR 3.45 (95% CI, 1.00–11.85), p = 0.038], and decreased LVEF [HR 2.49 (95% CI, 1.18–5.25), p = 0.012]. Among them, HF showed clinical significance only by multivariate analysis [HR 3.01 (95% CI, 1.13–7.99), p = 0.027]. Conclusions Increased cardiac size, digoxin use, HF, LVEF < 40%, and decreased LVEF were related to failed ECV for persistent AF or AFL. Among these, HF was the most important risk factor. Further multi-center studies including greater number of participants are planned.

Background: Non-vitamin K antagonist oral anticoagulants (NOACs) are effective in preventing thromboembolisms and reduce the risk of bleeding compared with warfarin. There are few reports on the outcomes of on-label reduced-dose NOACs. The aim of this study was to assess the safety and efficacy of on-label reduced-dose edoxaban in patients with atrial fibrillation (AF). Methods: This study is a multi-center, prospective, non-interventional study to evaluate the safety and efficacy of on-label reduced-dose edoxaban in patients with AF. We evaluated outcomes of major bleeding, stroke or systemic embolism, all-cause death, and composite clinical outcomes. Results: A total of 2,448 patients (mean age 75.0 ± 8.3 years, 801 [32.7%] males) was included in the present study. The mean CHA 2 DS 2 -VASc score was 3.7 ± 1.5. Major bleeding events occurred at a rate of 1.34%/yr. The event rate of strokes and systemic embolisms was 1.13%/ yr. The overall net clinical outcomes occurred at a rate of 3.19%/yr. There were no significant differences according to the number of dose reduction criteria, renal dysfunction, or body weight. Higher HAS-BLED score and higher combination of CHA 2 DS 2 -VASc and HAS-BLED score was associated with an increased risk of composite clinical outcomes compared to the lower score groups. Conclusions This study was the largest prospective real-world study to investigate the safety and efficacy of on-label low-dose edoxaban in an Asian population. Reduced-dose edoxaban can be used safely in patients with severe renal dysfunction or extremely low body weight. Our observation suggests that physicians should consider bleeding risk even in a low-dose regimen.

No abstract available.
Anti-Bacterial Agents/therapeutic use ; Cardiac Tamponade/etiology ; Drainage ; Empyema, Pleural/diagnosis/*etiology/microbiology/therapy ; Heart Diseases/diagnosis/*etiology/microbiology/therapy ; Humans ; Kidney Failure, Chronic/*therapy ; Male ; Methicillin-Resistant Staphylococcus aureus/isolation & purification ; Middle Aged ; Pericardial Effusion/etiology ; Pericardial Window Techniques ; Pericardiocentesis ; Peritoneal Dialysis, Continuous Ambulatory/*adverse effects ; Peritonitis/diagnosis/drug therapy/*etiology/microbiology ; Pleural Effusion/etiology ; Staphylococcal Infections/diagnosis/drug therapy/*etiology/microbiology ; Tomography, X-Ray Computed ; Treatment Outcome

BACKGROUND: Various treatment modalities for hypertrophic scars and keloids have been used. However, there is no consensus as to what the optimum approach should be. Most common treatments are corticosteroid intralesional injection (ILI) and cryotherapy as well as combination of these two modalities. To this date, however, there are no prospectively comparative, scar-split studies between steroid ILI monotherapy and combination of steroid ILI and cryotherapy. OBJECTIVE: The purpose of this article is to investigate and compare the efficacy of steroid ILI monotherapy and the combination of steroid ILI and cryotherapy. METHODS: Eighteen women who had thyroid operation scars were recruited. Patients received steroid ILI with cryotherapy on the right half, and steroid ILI monotherapy on the left half of the scar. Patients were treated for four sessions with three weeks of intervals. Subjects were evaluated on their scar status with the modified Vancouver scar scale (MVSS) and scar redness by using colorimeter at baseline and every visit day. RESULTS: After four treatment sessions, MVSS was significantly improved on both sides of scar. Significant improvement was observed after one treatment session on the right half, and after two treatment sessions on the left half. There was no significant difference between left and right side after four sessions of treatment. The scar redness of both sides of scar showed no significant differences between the baseline and at the end of the study. CONCLUSION: Both corticosteroid ILI with cryotherapy and corticosteroid ILI monotherapy are effective treatment modalities for hypertrophic scars. However, the results of the present study suggest that a combination therapy might lead to more rapid improvements.
Cicatrix ; Cicatrix, Hypertrophic ; Consensus ; Cryotherapy ; Female ; Humans ; Injections, Intralesional ; Keloid ; Thyroid Gland

Although the prognosis of patients with differentiated thyroid carcinoma (DTC) is generally encouraging, a diagnostic dilemma is posed when an increasing level of serum thyroglobulin (Tg) is noted, without detection of a recurrent tumor using conventional imaging tools such as the iodine-131 whole-body scanning (the [131I] scan) or neck ultrasonography (US). The objective of the present study was to evaluate the diagnostic value of [124I]-PET/CT and [18F]-FDG-PET/CT in terms of accurate detection of both iodine- and non-iodine-avid recurrence, compared with that of conventional imaging such as the [131I] scan or neck ultrasonography (US). Between July 2009 and June 2010, we prospectively studied 19 DTC patients with elevated thyroglobulin levels but who do not show pathological lesions when conventional imaging modalities are used. All involved patients had undergone total thyroidectomy and radioiodine (RI) treatment, and who had been followed-up for a mean of 13 months (range, 6-21 months) after the last RI session. Combined [18F]-FDG-PET/CT and [124I]-PET/CT data were evaluated for detecting recurrent DTC lesions in study patients and compared with those of other radiological and/or cytological investigations. Nine of 19 patients (47.4%) showed pathological [18F]-FDG (5/19, 26.3%) or [124I]-PET (4/19, 21.1%) uptake, and were classed as true-positives. Among such patients, disease management was modified in six (66.7%) and disease was restaged in seven (77.8%). In particular, the use of the described imaging combination optimized planning of surgical resection to deal with locoregional recurrence in 21.1% (4/19) of patients, who were shown to be disease-free during follow-up after surgery. Our results indicate that combination of [18F]-FDG-PET/CT and [124I]-PET/CT affords a valuable diagnostic method that can be used to make therapeutic decisions in patients with DTC who are tumor-free on conventional imaging studies but who have high Tg levels.
Adult ; Aged ; Aged, 80 and over ; Carcinoma/metabolism/*radionuclide imaging/surgery ; Female ; Fluorodeoxyglucose F18/chemistry/diagnostic use ; Follow-Up Studies ; Humans ; Iodine Radioisotopes/chemistry/diagnostic use ; Male ; Middle Aged ; Neck/ultrasonography ; Positron-Emission Tomography and Computed Tomography ; Prospective Studies ; Radiopharmaceuticals/chemistry/*diagnostic use ; Recurrence ; Thyroglobulin/blood ; Thyroid Neoplasms/metabolism/*radionuclide imaging/surgery ; Thyroidectomy ; Whole Body Imaging

BACKGROUND: The N-terminal fragment of pro Brain Natriuretic Peptide (NT-pro BNP) is a neuro-hormone synthesized in the cardiac ventricles in response to increased wall tension. The purpose of this study was to assess the correlation between the NT-pro BNP levels and the New York Heart Association function class (NYHA Fc) of dyspnea and echocardiographic findings for the patients who visited our cardiology departments. METHODS: From October, 2002 to April, 2003, serum NT-pro BNP levels were measured in 348 patients who visited the Samsung Medical Center and the Jong Koo Lee Heart Clinic. RESULTS: The NT-pro BNP levels were increased with the progression of NYHA Fc of dyspnea (p< 0.001 by ANOVA), the increase in the systolic left ventricular internal dimension (p< 0.05), and the decrease in the ejection fraction (p< 0.01). For the NYHA Fc I patients, the NT-pro BNP levels were positively correlated with age (p< 0.001) and left atrial size (p< 0.001). For the patients with ischemic heart disease, the NT-pro BNP levels were also positively correlated with the NYHA Fc (p< 0.001 by ANOVA). The NT-pro BNP levels were increased with the increase in the systolic (p< 0.001) and diastolic pressure (p=0.017), the left ventricular internal dimension as well as the decrease in the ejection fraction (p< 0.001). The area under the receiver operating characteristic (ROC) curve for the NT-pro BNP levels was 0.994 (95% confidence interval, 0.979-0.999), and the most reliable cut-off level for the NT-pro BNP was 293.6 pg/mL. CONCLUSION: The NT-pro BNP levels were positively correlated with the NYHA Fc of dyspnea and the systolic dysfunction for the patients who visited our cardiology departments. A 300 pg/mL value for the NT-pro BNP cut-off point appears to be a sensitive level to differentiate dyspnea originating from an ailing heart or not for the patients who visited our cardiology departments.
Dyspnea/physiopathology ; Female ; Heart Failure, Congestive/*blood/*physiopathology ; Humans ; Male ; Middle Aged ; Nerve Tissue Proteins/*blood ; Peptide Fragments/*blood ; Prospective Studies ; *Severity of Illness Index ; Stroke Volume/physiology ; Systole/physiology ; Ventricular Dysfunction, Left/physiopathology