TY  - JOUR
A1  - Kuck, Karl-Heinz
A1  - Fürnkranz, Alexander
A1  - Chun, Kyoung-Ryul Julian
A1  - Metzner, Andreas
A1  - Ouyang, Feifan
A1  - Schlüter, Michael
A1  - Elvan, Arif
A1  - Lim, Hae W.
A1  - Kueffer, Fred J.
A1  - Arentz, Thomas
A1  - Albenque, Jean-Paul
A1  - Tondo, Claudio
A1  - Kühne, Michael
A1  - Sticherling, Christian
A1  - Brugada, Josep
T1  - Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation : reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial
T2  - Implementation science
N2  - 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.
KW  - Atrial fibrillation
KW  - Catheter ablation
KW  - Cryoballoon
KW  - Rehospitalization
KW  - Radiofrequency
KW  - Follow-up
Y1  - 2016
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/46338
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-463382
SN  - 1748-5908
N1  - This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
VL  - 37
IS  - 38
SP  - 2858
EP  - 2865
PB  - BioMed Central
CY  - London
ER  -