Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial

Abstract

Aims: The primary safety and efficacy endpoints of the randomized FIRE AND ICE trial have recently demonstrated non-inferiority of cryoballoon vs. radiofrequency current (RFC) catheter ablation in patients with drug-refractory symptomatic paroxysmal atrial fibrillation (AF). The aim of the current study was to assess outcome parameters that are important for the daily clinical management of patients using key secondary analyses. Specifically, reinterventions, rehospitalizations, and quality-of-life were examined in this randomized trial of cryoballoon vs. RFC catheter ablation.

Methods and results: Patients (374 subjects in the cryoballoon group and 376 subjects in the RFC group) were evaluated in the modified intention-to-treat cohort. After the index ablation, log-rank testing over 1000 days of follow-up demonstrated that there were statistically significant differences in favour of cryoballoon ablation with respect to repeat ablations (11.8% cryoballoon vs. 17.6% RFC; P = 0.03), direct-current cardioversions (3.2% cryoballoon vs. 6.4% RFC; P = 0.04), all-cause rehospitalizations (32.6% cryoballoon vs. 41.5% RFC; P = 0.01), and cardiovascular rehospitalizations (23.8% cryoballoon vs. 35.9% RFC; P < 0.01). There were no statistical differences between groups in the quality-of-life surveys (both mental and physical) as measured by the Short Form-12 health survey and the EuroQol five-dimension questionnaire. There was an improvement in both mental and physical quality-of-life in all patients that began at 6 months after the index ablation and was maintained throughout the 30 months of follow-up.

Conclusion: Patients treated with cryoballoon as opposed to RFC ablation had significantly fewer repeat ablations, direct-current cardioversions, all-cause rehospitalizations, and cardiovascular rehospitalizations during follow-up. Both patient groups improved in quality-of-life scores after AF ablation.

Clinical trial registration: ClinicalTrials.gov identifier: NCT01490814.

Keywords: Atrial fibrillation; Catheter ablation; Cryoballoon; Follow-up; Radiofrequency; Rehospitalization.

© The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Figure 1

Repeat ablations. (A) Number of repeat ablations by days since the index ablation. (B) Kaplan–Meier event-free survival curves.

Figure 2

All-cause rehospitalizations (A) and cardiovascular rehospitalizations (B). Both panels show the number of rehospitalizations by days since the index ablation in the upper panel and Kaplan–Meier event-free survival curves in the lower panel.

Figure 3

Direct-current cardioversion. (A) Number of direct-current cardioversions by days since the index ablation. (B) Kaplan–Meier event-free survival curves.

Figure 4

Cox proportional-hazards regression model. (A) Subgroup analyses of cardiovascular rehospitalization. (B) Kaplan–Meier event-free survival curves by history of direct-current cardioversion subgroups.

Figure 5

Graphs of quality-of-life (Short Form-12 physical and mental) scores. (A) Subject mental performance from baseline throughout 30 months of follow-up. (B) Physical performance of subjects throughout 30 months of follow-up. (C) The mean Short Form-12 score reported across both mental and physical scores through the 30 months of follow-up.