title: Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov identifier: NCT01490814.
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg, Lohmühlenstr. 5, 20099 Hamburg, Germany k.kuck@asklepios.com.
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Kuck
authors.affiliation: Cardioangiologisches Centrum Bethanien, Frankfurt, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Fürnkranz
authors.affiliation: Cardioangiologisches Centrum Bethanien, Frankfurt, Germany.
authors.forename: K R Julian
authors.initials: KR
authors.lastname: Chun
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg, Lohmühlenstr. 5, 20099 Hamburg, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Metzner
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg, Lohmühlenstr. 5, 20099 Hamburg, Germany.
authors.forename: Feifan
authors.initials: F
authors.lastname: Ouyang
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg, Lohmühlenstr. 5, 20099 Hamburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Schlüter
authors.affiliation: Isala Klinieken, Zwolle, The Netherlands.
authors.forename: Arif
authors.initials: A
authors.lastname: Elvan
authors.affiliation: Medtronic, Inc., Minneapolis, MN, USA.
authors.forename: Hae W
authors.initials: HW
authors.lastname: Lim
authors.affiliation: Medtronic, Inc., Minneapolis, MN, USA.
authors.forename: Fred J
authors.initials: FJ
authors.lastname: Kueffer
authors.affiliation: Herz-Zentrum, Bad Krozingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Arentz
authors.affiliation: Clinique Pasteur, Toulouse, France.
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Albenque
authors.affiliation: Centro Cardiologico Monzino, University of Milan, Milan, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Tondo
authors.affiliation: Universitätsspital Basel, Basel, Switzerland.
authors.forename: Michael
authors.initials: M
authors.lastname: Kühne
authors.affiliation: Universitätsspital Basel, Basel, Switzerland.
authors.forename: Christian
authors.initials: C
authors.lastname: Sticherling
authors.affiliation: Hospital Clinic, University of Barcelona, Barcelona, Spain.
authors.forename: Josep
authors.initials: J
authors.lastname: Brugada
mesh_terms: D001281:Atrial Fibrillation; D017115:Catheter Ablation; D003452:Cryosurgery; D006801:Humans; D011667:Pulmonary Veins; D011788:Quality of Life; D012008:Recurrence; D016896:Treatment Outcome
keywords: Atrial fibrillation; Catheter ablation; Cryoballoon; Follow-up; Radiofrequency; Rehospitalization