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 and Objectives: Atrial fibrillation (AF), the most common atrial arrhythmia (AA), is an increasing healthcare burden in Korea. The objective of this sub-analysis of the Cryo Global Registry was to evaluate long-term efficacy, symptom burden, quality of life (QoL), and healthcare utilization outcomes and factors associated with AA recurrence in Korean patients treated with cryoballoon ablation (CBA). Methods: Patients were treated and followed up according to local standard-of-care in 3 Korean hospitals. Kaplan-Meier estimates were used in analyzing (1) efficacy defined as freedom from ≥30 second recurrence of AA at 24 months, (2) healthcare utilization, and (3) predictors of 24-month AA recurrence. Patient-reported QoL (using European Quality of Life-5 Dimensions-3 Levels) and predefined AF-related symptoms were assessed at baseline and 24-month follow-up. Results: Efficacy was 71.9% in paroxysmal AF (PAF) and 49.3% in persistent AF (PsAF) patients (p<0.01). A larger left atrial diameter (LAD), an increased time from AF diagnosis to CBA, and PsAF were independent predictors of AA recurrence. The percentage of patients with no AF symptoms significantly increased from baseline (24.5%) to 24-month (89.5%)follow-up (p<0.01). Improvement in QoL from baseline to 24 months was not statistically different between AF cohorts. PAF patients experienced greater freedom from repeat ablations (93.9% vs. 81.4%) and cardiovascular hospitalizations (91.3% vs. 72.5%, p<0.001 for both). Conclusions In alignment with global outcomes, CBA is an effective treatment for AF in the Korean population, with patients possessing a large LAD and not receiving ablation soon after diagnosis being the most at risk for AA recurrence.

Background and Objectives: Atrial fibrillation (AF), the most common atrial arrhythmia (AA), is an increasing healthcare burden in Korea. The objective of this sub-analysis of the Cryo Global Registry was to evaluate long-term efficacy, symptom burden, quality of life (QoL), and healthcare utilization outcomes and factors associated with AA recurrence in Korean patients treated with cryoballoon ablation (CBA). Methods: Patients were treated and followed up according to local standard-of-care in 3 Korean hospitals. Kaplan-Meier estimates were used in analyzing (1) efficacy defined as freedom from ≥30 second recurrence of AA at 24 months, (2) healthcare utilization, and (3) predictors of 24-month AA recurrence. Patient-reported QoL (using European Quality of Life-5 Dimensions-3 Levels) and predefined AF-related symptoms were assessed at baseline and 24-month follow-up. Results: Efficacy was 71.9% in paroxysmal AF (PAF) and 49.3% in persistent AF (PsAF) patients (p<0.01). A larger left atrial diameter (LAD), an increased time from AF diagnosis to CBA, and PsAF were independent predictors of AA recurrence. The percentage of patients with no AF symptoms significantly increased from baseline (24.5%) to 24-month (89.5%)follow-up (p<0.01). Improvement in QoL from baseline to 24 months was not statistically different between AF cohorts. PAF patients experienced greater freedom from repeat ablations (93.9% vs. 81.4%) and cardiovascular hospitalizations (91.3% vs. 72.5%, p<0.001 for both). Conclusions In alignment with global outcomes, CBA is an effective treatment for AF in the Korean population, with patients possessing a large LAD and not receiving ablation soon after diagnosis being the most at risk for AA recurrence.

Background and Objectives: Atrial fibrillation (AF), the most common atrial arrhythmia (AA), is an increasing healthcare burden in Korea. The objective of this sub-analysis of the Cryo Global Registry was to evaluate long-term efficacy, symptom burden, quality of life (QoL), and healthcare utilization outcomes and factors associated with AA recurrence in Korean patients treated with cryoballoon ablation (CBA). Methods: Patients were treated and followed up according to local standard-of-care in 3 Korean hospitals. Kaplan-Meier estimates were used in analyzing (1) efficacy defined as freedom from ≥30 second recurrence of AA at 24 months, (2) healthcare utilization, and (3) predictors of 24-month AA recurrence. Patient-reported QoL (using European Quality of Life-5 Dimensions-3 Levels) and predefined AF-related symptoms were assessed at baseline and 24-month follow-up. Results: Efficacy was 71.9% in paroxysmal AF (PAF) and 49.3% in persistent AF (PsAF) patients (p<0.01). A larger left atrial diameter (LAD), an increased time from AF diagnosis to CBA, and PsAF were independent predictors of AA recurrence. The percentage of patients with no AF symptoms significantly increased from baseline (24.5%) to 24-month (89.5%)follow-up (p<0.01). Improvement in QoL from baseline to 24 months was not statistically different between AF cohorts. PAF patients experienced greater freedom from repeat ablations (93.9% vs. 81.4%) and cardiovascular hospitalizations (91.3% vs. 72.5%, p<0.001 for both). Conclusions In alignment with global outcomes, CBA is an effective treatment for AF in the Korean population, with patients possessing a large LAD and not receiving ablation soon after diagnosis being the most at risk for AA recurrence.

Background and Objectives: Atrial fibrillation (AF), the most common atrial arrhythmia (AA), is an increasing healthcare burden in Korea. The objective of this sub-analysis of the Cryo Global Registry was to evaluate long-term efficacy, symptom burden, quality of life (QoL), and healthcare utilization outcomes and factors associated with AA recurrence in Korean patients treated with cryoballoon ablation (CBA). Methods: Patients were treated and followed up according to local standard-of-care in 3 Korean hospitals. Kaplan-Meier estimates were used in analyzing (1) efficacy defined as freedom from ≥30 second recurrence of AA at 24 months, (2) healthcare utilization, and (3) predictors of 24-month AA recurrence. Patient-reported QoL (using European Quality of Life-5 Dimensions-3 Levels) and predefined AF-related symptoms were assessed at baseline and 24-month follow-up. Results: Efficacy was 71.9% in paroxysmal AF (PAF) and 49.3% in persistent AF (PsAF) patients (p<0.01). A larger left atrial diameter (LAD), an increased time from AF diagnosis to CBA, and PsAF were independent predictors of AA recurrence. The percentage of patients with no AF symptoms significantly increased from baseline (24.5%) to 24-month (89.5%)follow-up (p<0.01). Improvement in QoL from baseline to 24 months was not statistically different between AF cohorts. PAF patients experienced greater freedom from repeat ablations (93.9% vs. 81.4%) and cardiovascular hospitalizations (91.3% vs. 72.5%, p<0.001 for both). Conclusions In alignment with global outcomes, CBA is an effective treatment for AF in the Korean population, with patients possessing a large LAD and not receiving ablation soon after diagnosis being the most at risk for AA recurrence.

Background and Objectives: Although a single-lead electrocardiogram (ECG) patch may provide advantages for detecting arrhythmias in outpatient settings owing to user convenience, its comparative effectiveness for real-time telemonitoring in inpatient settings remains unclear. We aimed to compare a novel telemonitoring system using a single-lead ECG patch with a conventional telemonitoring system in an inpatient setting. Methods: This was a single-center, prospective cohort study. Patients admitted to the cardiology unit for arrhythmia treatment who required a wireless ECG telemonitoring system were enrolled. A single-lead ECG patch and conventional telemetry were applied simultaneously in hospitalized patients for over 24 hours for real-time telemonitoring. The basic ECG parameters, arrhythmia episodes, and signal loss or noise were compared between the 2 systems. Results: Eighty participants (mean age 62±10 years, 76.3% male) were enrolled. The three most common indications for ECG telemonitoring were atrial fibrillation (66.3%), sick sinus syndrome (12.5%), and atrioventricular block (10.0%). The intra-class correlation coefficients for detecting the number of total beats, atrial and ventricular premature complexes, maximal, average, and minimal heart rates, and pauses were all over 0.9 with p values for reliability <0.001. Compared to a conventional system, a novel system demonstrated significantly lower signal noise (median 0.3% [0.1–1.6%] vs. 2.4% [1.4–3.7%], p<0.001) and fewer episodes of signal loss (median 22 [2–53] vs. 64 [22–112] episodes, p=0.002). Conclusions The novel telemonitoring system using a single-lead ECG patch offers performance comparable to that of a conventional system while significantly reducing signal loss and noise.

Background and Objectives: Previous studies have reported an association between impaired renal function and poor outcomes after radiofrequency catheter ablation in patients with atrial fibrillation (AF). However, outcomes of cryoballoon ablation (CBA) in patients with renal insufficiency are not fully elucidated. This study aimed to compare outcomes of CBA in AF patients with chronic kidney disease (CKD) versus those without CKD and to assess changes in renal function over 12 months following CBA. Methods: A total of 839 patients (65.1% with non-paroxysmal AF [PAF]) who underwent de novo CBA were prospectively enrolled. We divided patients into two groups based on creatinine clearance rate (CCr) and performed intracardiac echocardiography (ICE)-guided contrast agent-free CBA. Results: In comparison with patients without CKD (CCr >50, n=722), those with CKD (CCr ≤50, n=117) were older and predominantly female, had a lower body mass index, and showed a higher prevalence of heart failure and hypertension. Mean CHA 2 DS 2 -VAS score was significantly higher in CKD group than in non-CKD group. Procedure-related complications were not significantly different between two groups. During a mean follow-up period of 25.4±11.9 months, clinical recurrence occurred in 182 patients (21.7%) and not significantly different between two groups. In multivariate analysis, non-PAF and left atrial size were independent predictors of AF recurrence. CCr levels significantly improved over 12 months after CBA in CKD group. Conclusions ICE-guided contrast-agent-free CBA showed comparable long-term clinical outcomes without increasing procedure-related complications and improvement of renal function over 12 months following CBA in AF patients with CKD.