Background and Objectives: Cryoballoon catheter ablation for the treatment of patients with symptomatic atrial fibrillation (AF) has been adopted globally, but there are limited multicenter reports of 12-month outcomes in the Korean patient population. This analysis evaluated the clinical performance and safety of cryoballoon ablation (CBA) according to standard-of-care practices in Korea. Methods: This evaluation of Korean patients with AF was conducted within the larger Cryo Global Registry, which is a prospective, multicenter, post-market registry. Freedom from a ≥30-second recurrence of atrial arrhythmias (after a 90-day blanking period until 12 months) and procedural safety were examined in subjects treated with CBA at 3 Korean centers. Results: Overall, 299 patients with AF (60±11 years old, 24.7% female, 50.5% paroxysmal AF) underwent CBA using the Arctic Front Advance cryoballoon. Of those, 298 were followed-up for at least 12 months. Mean procedure-, left atrial dwell- and fluoroscopy time was 76±21 minutes, 56±23 minutes, and 27±23 minutes, respectively. Freedom from AF recurrence at 12 months was 83.9% (95% confidence interval [CI], 76.9–88.9%) in the paroxysmal and 61.6% (95% CI, 53.1–69.0%) in the persistent AF cohort. Rhythm monitoring was performed on average 4.7±1.4 times during the follow-up period. Serious device- or procedure-related adverse events occurred in 2 patients (0.7%). The 12-month Kaplan-Meier estimate of freedom from repeat ablation and cardiovascular-related hospitalization was 93.8% (95% CI, 90.4–96.1%) and 89.7% (95% CI, 85.6–92.7%), respectively. Conclusions CBA is an efficient, effective, and safe procedure for the treatment of AF patients when used according to real-world practices in Korea.Trial Registration: ClinicalTrials.gov Identifier: NCT02752737

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.