Cryoballoon ablation for atrial fibrillation in South Africa: One-year outcome from the Cryo Global Registry

Abstract

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.