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

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 s...

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Autores principales: Kuck, Karl-Heinz, Fürnkranz, Alexander, Chun, K.R. Julian, Metzner, Andreas, Ouyang, Feifan, Schlüter, Michael, Elvan, Arif, Lim, Hae W., Kueffer, Fred J., Arentz, Thomas, Albenque, Jean-Paul, Tondo, Claudio, Kühne, Michael, Sticherling, Christian, Brugada, Josep
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070448/
https://www.ncbi.nlm.nih.gov/pubmed/27381589
http://dx.doi.org/10.1093/eurheartj/ehw285
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author Kuck, Karl-Heinz
Fürnkranz, Alexander
Chun, K.R. Julian
Metzner, Andreas
Ouyang, Feifan
Schlüter, Michael
Elvan, Arif
Lim, Hae W.
Kueffer, Fred J.
Arentz, Thomas
Albenque, Jean-Paul
Tondo, Claudio
Kühne, Michael
Sticherling, Christian
Brugada, Josep
author_facet Kuck, Karl-Heinz
Fürnkranz, Alexander
Chun, K.R. Julian
Metzner, Andreas
Ouyang, Feifan
Schlüter, Michael
Elvan, Arif
Lim, Hae W.
Kueffer, Fred J.
Arentz, Thomas
Albenque, Jean-Paul
Tondo, Claudio
Kühne, Michael
Sticherling, Christian
Brugada, Josep
author_sort Kuck, Karl-Heinz
collection PubMed
description 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.
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spelling pubmed-50704482016-10-20 Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial Kuck, Karl-Heinz Fürnkranz, Alexander Chun, K.R. Julian Metzner, Andreas Ouyang, Feifan Schlüter, Michael Elvan, Arif Lim, Hae W. Kueffer, Fred J. Arentz, Thomas Albenque, Jean-Paul Tondo, Claudio Kühne, Michael Sticherling, Christian Brugada, Josep Eur Heart J Fasttrack Clinical 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. Oxford University Press 2016-10-07 2016-07-05 /pmc/articles/PMC5070448/ /pubmed/27381589 http://dx.doi.org/10.1093/eurheartj/ehw285 Text en © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology. http://creativecommons.org/licenses/by-nc/4.0/ 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
spellingShingle Fasttrack Clinical
Kuck, Karl-Heinz
Fürnkranz, Alexander
Chun, K.R. Julian
Metzner, Andreas
Ouyang, Feifan
Schlüter, Michael
Elvan, Arif
Lim, Hae W.
Kueffer, Fred J.
Arentz, Thomas
Albenque, Jean-Paul
Tondo, Claudio
Kühne, Michael
Sticherling, Christian
Brugada, Josep
Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial
title Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial
title_full Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial
title_fullStr Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial
title_full_unstemmed Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial
title_short Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial
title_sort cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the fire and ice trial
topic Fasttrack Clinical
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070448/
https://www.ncbi.nlm.nih.gov/pubmed/27381589
http://dx.doi.org/10.1093/eurheartj/ehw285
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