Abstract
BackgroundEffective treatment of paroxysmal atrial fibrillation (AF) is essential for reducing the risk of stroke and heart failure. Cryoballoon (CB) ablation has been developed as an alternative to the use of radiofrequency (RF) energy for electrical isolation of the pulmonary veins. Herein, we provide long-term data regarding the efficacy of CB ablation in comparison to RF.MethodsFreezeAF was a randomised non-inferiority study comparing CB ablation with RF ablation for the treatment of patients with drug-refractory paroxysmal AF. Procedural success for the long-term follow-up (30 months) was defined as freedom from AF with an absence of persistent complications.ResultsOf the 315 patients that were randomised and received catheter ablation, 292 (92.7%) completed the 30-month follow-up (147 in the RF group and 145 in the CB group). The baseline characteristics of the RF and CB groups were similar. Single-procedure success was achieved by 40% of patients in the RF group and 42% of the CB group (p < 0.001 for non-inferiority). When including re-do procedures in the analysis, the multiple procedure success rate was 72% in the RF group and 76% in the CB group.ConclusionThe data provide long-term evidence that CB ablation is non-inferior to RF ablation, with high proportions of patients reporting freedom from AF 30 months after the index procedure.Trial registrationClinicalTrials.gov Identifier: NCT00774566; first registered October 16, 2008; first patient included October 20, 2008.
Highlights
Effective treatment of paroxysmal atrial fibrillation (AF) is essential for reducing the risk of stroke and heart failure
FreezeAF is a prospective randomised controlled trial designed to assess whether pulmonary vein isolation (PVI) with the Arctic Front Cardiac CryoAblation Catheter System (Medtronic, Inc., Minneapolis, MN) is non-inferior to that achieved using standard RF ablation [19]
The baseline characteristics of the RF group (N = 147) and the CB group (N = 145) did not differ significantly, a common ostium was slightly more prevalent in the RF group compared to CB (23.8% vs. 13.8%; p = 0.04)
Summary
Effective treatment of paroxysmal atrial fibrillation (AF) is essential for reducing the risk of stroke and heart failure. A number of studies have compared RF with CB ablation for the treatment of paroxysmal AF, and have found similar procedural success rates [6, 11,12,13,14,15]. There are few studies that are both randomised and involve an appropriate number of patients with a sufficiently long follow-up period for providing a robust comparison of the efficacy of the two ablation methods. One such study is FreezeAF, which demonstrated non-inferiority of CB to RF at both 6 and 12 months post-procedure [16]. Non-inferiority was observed in the FIRE AND ICE trial, where 1-year Kaplan–Meier estimates for clinical failure after 12 months were reported to be 34.6% and 35.9% for CB and RF, respectively (p < 0.0001 for non-inferiority) [8, 17]. In the Cryo Versus RF trial, procedural success was reported to be higher for CB ablation compared to RF, with single-procedure success rates at 12 months being 76% and 47%, respectively (p < 0.001) [18]
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