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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., Trial Registration: ClinicalTrials.gov Identifier: NCT02752737., Competing Interests: Dr. Jada M Selma, Fred J Kueffer, Dr. Kelly A van Bragt, and Valentine Obidigbo are employees of Medtronic. The remaining authors have no conflicts of interest pertaining to this manuscript to declare., (Copyright © 2024. The Korean Society of Cardiology.)

Background: Limited information is available on the safety and efficacy of cryoballoon ablation (CBA) in elderly patients with atrial fibrillation (AF). Moreover, global utilization of CBA in this population (≥ 80 years old) has not been reported. This study's objectives were to determine the use, efficacy, and safety of CBA to treat octogenarians suffering from AF., Methods: In this sub-analysis of the Cryo Global Registry, 12-month outcomes of treating AF via CBA in octogenarians were compared to patients < 80 years old. Efficacy was evaluated as time to a ≥ 30 s atrial arrhythmia (AA) recurrence. Healthcare utilization was determined via repeat ablations and hospitalizations. Improvement upon disease burden was evaluated through patient reporting of symptoms and the EQ-5D-3L quality of life (QoL) survey., Results: The octogenarian cohort (n = 101) had a higher prevalence of females (51.5% vs 35.7%) and CHA 2 DS 2 -VASc scores (4.2 ± 1.3 vs 2.0 ± 1.5) compared to the control cohort (n = 1573, both p < 0.01). Even when adjusting for baseline characteristics and antiarrhythmic drug usage, freedom from AA recurrence at 12 months (80.6% vs 78.9%, HR adj :0.97 [95% CI:0.59-1.58], p = 0.90) was comparable between octogenarians and control, respectively. Similar serious adverse event rates were observed between octogenarians (5.0%) and control (3.2%, p = 0.38). The groups did not differ in healthcare utilization nor reduction of AF-related symptoms from baseline to follow-up, but both experienced an improvement in QoL at 12 months., Conclusions: Despite more age-related comorbidities, CBA is a safe and effective treatment for AF in octogenarians, with efficacy and adverse events rates akin to ablations performed in younger patients., Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT02752737., (© 2023. The Author(s).)

Background: Cryoballoon ablation is a well-established anatomical approach for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Although widely adopted, regional variations in standards of care have not been well characterized., Methods: Patients with AF were enrolled in the Cryo Global Registry (NCT02752737) from May 2016 to Sept 2021 at 128 sites in 37 countries and treated with cryoballoon ablation according to local clinical practice. Baseline patient and procedural characteristics were summarized for 8 regions (Central Asia & Russia, East Asia, Europe, Middle East, North America, South Africa, South America, and Southeast Asia). Serious procedure-related adverse events (SAEs) were evaluated in a subset of patients with ≥ 7 days of follow-up., Results: A total of 3,680 patients undergoing initial PVI for AF were included. Cryoballoon ablation was commonly performed in patients with paroxysmal AF. Mean age ranged from 47 ± 12 years in the Middle East to 64 ± 11 years in East Asia. Mean procedure time was ≤ 95 min in all regions. Average freeze duration ranged from 153 ± 41 s in Southeast Asia to 230 ± 29 s in Central Asia & Russia. Acute procedural success was ≥ 94.7% in all geographies. In 3,126 subjects with ≥ 7 days of follow-up, 122 procedure-related SAEs were reported in 111 patients (3.6%) and remained low in all regions. One procedure-related death was reported during data collection., Conclusions: Despite regional variations in patient selection and procedural characteristics, PVI using cryoballoon ablation was performed with high acute success and short procedural times around the world., Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT02752737., (© 2023. The Author(s).)

Background: Pulmonary vein isolation (PVI) with cryoballoon catheter ablation (CBA) is a well-established and widely adopted method for the treatment of patients with atrial fibrillation (AF) to prevent recurrences of AF. CBA adoption in South Africa (SA) and outcome data in SA patients are limited., Objectives: To evaluate real-world usage, safety and effectiveness of CBA in SA., Methods: In this sub-analysis of the Cryo Global Registry, 81 participants with paroxysmal AF (PAF) and persistent AF (PsAF) were enrolled between 2017 and 2021 across two private SA hospitals. Baseline characteristics, procedural characteristics, 12-month safety, effectiveness (atrial arrhythmia recurrence), healthcare utilisation (repeat ablation and all-cause hospitalisation), quality of life (QoL; measured by EQ-5D-3L) and predefined symptoms were reported on., Results: Participants in the SA cohort were a mean (standard deviation) of 60 (12) years old, 19 (23.5%) were female, and 48 (59.3%) presented with PAF. The overall presence of baseline comorbidities in the SA cohort was relatively low compared with the entire Cryo Global Registry cohort. The acute PVI success rate was high (98.8%). Two serious procedure-related adverse events occurred in 2 (2.5%) participants in the SA cohort. Freedom from arrhythmia recurrence was 97.4% (95% confidence interval (CI) 83.2 - 99.6%) in PAF and 78.4% (95% CI 58.1 - 89.7%) in persistent AF (p=0.035). Kaplan-Meier estimates for freedom from repeat ablations and all-cause hospitalisations were 97.0% (95% CI 88.4 - 99.2%) and 98.5% (95% CI 90.0 - 99.8%), respectively. Participants reported significant improvement in EQ-5D-3L index score and symptoms from baseline (0.90 (0.11)) - 12 months (0.97 (0.07), p<0.001)., Conclusion: CBA standard-of-care procedures in SA resulted in a high clinical freedom from arrhythmia recurrence, with a low risk of safety events within 12 months post ablation. In addition, participants experienced an improvement in QoL and high freedom from healthcare utilisation at 12 months. The obtained results will be important for guiding clinical decisions around CBA in SA.