Cryoballoon versus radiofrequency catheter ablation: insights from Norwegian randomized study of persistent atrial fibrillation (NO-PERSAF study)

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Helse Vest, Norway (LBS) Background Pulmonary vein isolation (PVI) is still regarded as a cornerstone for treatment of persistent atrial fibrillation (AF). Both radiofrequency ablation (RFA) and cryoballoon ablation (CBA) are frequently employed to achieve PVI. Purpose This randomized study aimed to evaluate the effectiveness of PVI performed with CBA in comparison with RFA in patients with persistent AF. Methods A total of 101 patients with symptomatic persistent AF were enrolled and randomized (1:1) to CBA or RFA groups and followed up for 12 months. The primary endpoint was any documented recurrent atrial tachyarrhythmia (ATA) lasting longer than 30 s following a 3-month blanking period. Secondary endpoints were procedure-related complications, procedure and ablation duration, and fluoroscopy time. The ATA-free survival curves were estimated by Kaplan–Meier method and analyzed by log-rank test. Results According to intention-to-treat analysis, freedom from ATA was achieved in 36 out of 52 patients in the CBA group and 30 out of 49 patients in the RFA group (69.2% vs. 61.2%, P=0.393). No difference of AF recurrence was found between the two groups (27.5% in CBA vs. 38.0% in RFA, P=0.258), and less atrial flutter recurrence was documented in the CBA group compared with the RFA group (3.9% vs. 18.0%, P=0.020). The procedure and ablation duration were significantly shorter in the CBA group (160±31 vs. 197±38 minutes, P