Cryoballoon vs. open irrigated radiofrequency ablation for paroxysmal atrial fibrillation: long-term FreezeAF outcomes

Armin Luik, Kevin Kunzmann, Patrick Hörmann, Kerstin Schmidt, Andrea Radzewitz, Peter Bramlage, Thomas Schenk, Gerhard Schymik, Matthias Merkel, Meinhard Kieser, Claus Schmitt, Armin Luik, Kevin Kunzmann, Patrick Hörmann, Kerstin Schmidt, Andrea Radzewitz, Peter Bramlage, Thomas Schenk, Gerhard Schymik, Matthias Merkel, Meinhard Kieser, Claus Schmitt

Abstract

Background: Effective 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.

Methods: FreezeAF 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.

Results: Of 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.

Conclusion: The 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 registration: ClinicalTrials.gov Identifier: NCT00774566 ; first registered October 16, 2008; first patient included October 20, 2008.

Keywords: Atrial fibrillation; Catheter ablation; Cryoablation; Cryoballoon; Pulmonary vein isolation; Radiofrequency.

Figures

Fig. 1
Fig. 1
Patient flow, including planned sample size recalculation. *The initial sample size calculation resulted in 244 patients, which was readjusted in March 2011 after a pre-specified blinded sample size recalculation [16, 33]. Patients withdrawing consent prior to treatment were unaware of the assignment and were excluded from the population. Patients that refused a follow-up were contacted by phone to verify that they were alive, though no heart rhythm was obtained. RF, radiofrequency; CB, cryoballoon
Fig. 2
Fig. 2
Freedom from AF, without persistent complications (ITT analysis, single procedure success). RF: N = 147; CB: N = 145. P-values are for non-inferiority
Fig. 3
Fig. 3
Freedom from AF, without persistent complications (ITT analysis, multiple procedure success). Thirty-month analysis includes 6 CB patients who underwent RF as a re-do procedure. No RF patients had a CB re-do procedure. P-values are for non-inferiority

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