Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation

Reintervention, rehospitalization, and quality-of-life outcomes in the FIRE and ICE trial

Karl Heinz Kuck, Alexander Fürnkranz, K. R Julian Chun, Andreas Metzner, Feifan Ouyang, Michael Schlüter, Arif Elvan, Hae W. Lim, Fred J. Kueffer, Thomas Arentz, Jean Paul Albenque, Claudio Tondo, Michael Kühne, Christian Sticherling, Josep Brugada

Research output: Contribution to journalArticle

96 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)2858-2865
Number of pages8
JournalEuropean Heart Journal
Volume37
Issue number38
DOIs
Publication statusPublished - 2016

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Atrial Fibrillation
Quality of Life
Electric Countershock
Catheter Ablation
Nucleic Acid Repetitive Sequences
Health Surveys
Safety
Pharmaceutical Preparations
Surveys and Questionnaires

Keywords

  • Atrial fibrillation
  • Catheter ablation
  • Cryoballoon
  • Follow-up
  • Radiofrequency
  • Rehospitalization

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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.

In: European Heart Journal, Vol. 37, No. 38, 2016, p. 2858-2865.

Research output: Contribution to journalArticle

Kuck, KH, Fürnkranz, A, Chun, KRJ, Metzner, A, Ouyang, F, Schlüter, M, Elvan, A, Lim, HW, Kueffer, FJ, Arentz, T, Albenque, JP, Tondo, C, Kühne, M, Sticherling, C & Brugada, J 2016, 'Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: Reintervention, rehospitalization, and quality-of-life outcomes in the FIRE and ICE trial', European Heart Journal, vol. 37, no. 38, pp. 2858-2865. https://doi.org/10.1093/eurheartj/ehw285
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. In: European Heart Journal. 2016 ; Vol. 37, No. 38. pp. 2858-2865.
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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.",
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T2 - Reintervention, rehospitalization, and quality-of-life outcomes in the FIRE and ICE trial

AU - Kuck, Karl Heinz

AU - Fürnkranz, Alexander

AU - Chun, K. R Julian

AU - Metzner, Andreas

AU - Ouyang, Feifan

AU - Schlüter, Michael

AU - Elvan, Arif

AU - Lim, Hae W.

AU - Kueffer, Fred J.

AU - Arentz, Thomas

AU - Albenque, Jean Paul

AU - Tondo, Claudio

AU - Kühne, Michael

AU - Sticherling, Christian

AU - Brugada, Josep

PY - 2016

Y1 - 2016

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.

AB - 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.

KW - Atrial fibrillation

KW - Catheter ablation

KW - Cryoballoon

KW - Follow-up

KW - Radiofrequency

KW - Rehospitalization

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