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Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation
Open accessAbstract
BACKGROUND: Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation. Radiofrequency ablation is the most common method, and cryoballoon ablation is the second most frequently used technology. METHODS: We conducted a multicenter, randomized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation. The primary efficacy end point in a time-to-event analysis was the first documented clinical failure (recurrence of atrial fibrillation, occurrence of atrial flutter or atrial tachycardia, use of antiarrhythmic drugs, or repeat ablation) following a 90-day period after the index ablation. The noninferiority margin was prespecified as a hazard ratio of 1.43. The primary safety end point was a composite of death, cerebrovascular events, or serious treatment-related adverse events. RESULTS: A total of 762 patients underwent randomization (378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation). The mean duration of follow-up was 1.5 years. The primary efficacy end point occurred in 138 patients in the cryoballoon group and in 143 in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 34.6% and 35.9%, respectively; hazard ratio, 0.96; 95% confidence interval [CI], 0.76 to 1.22; P<0.001 for noninferiority). The primary safety end point occurred in 40 patients in the cryoballoon group and in 51 patients in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 10.2% and 12.8%, respectively; hazard ratio, 0.78; 95% CI, 0.52 to 1.18; P=0.24). CONCLUSIONS: In this randomized trial, cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation, and there was no significant difference between the two methods with regard to overall safety. (Funded by Medtronic; FIRE AND ICE ClinicalTrials.gov number, NCT01490814.).
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“achievable by point-by-point radiofrequency ablation, linear lesions encircling the pulmonary veins, or cryoballoon ablation, with similar outcomes.[732][733][734]”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [734]
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“It also seems even less common after cryoballoon ablation, 734”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [734]
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Arai, H., Mizukami, A., Hanyu, Y., Kawakami, T., Shimizu, Y., Hiroki, J., Yoshioka, K., Otani, H., Kuroda, S., Iwatsuka, R., et al. (2020) · Journal of Arrhythmia · doi:10.1002/joa3.12378 · Cited by 7
Verlato, R., Pieragnoli, P., Iacopino, S., Rauhe, W., Molon, G., Stabile, G., Rebellato, L., Allocca, G., Arena, G., Rovaris, G., et al. (2020) · Pacing and Clinical Electrophysiology · doi:10.1111/pace.13975 · Cited by 7
Self-citationDevelopment of adaptive resistance to electric pulsed field treatment in CHO cell line in vitro
Polajžer, T., & Damijan Miklavčič, A. (2020) · Scientific Reports · doi:10.1038/s41598-020-66879-w · Cited by 7
Extreme Obesity Is Associated With Low Success Rate Of Atrial Fibrillation Catheter Ablation
Lakkireddy, D. (2020) · Journal of Atrial Fibrillation · doi:10.4022/jafib.2242 · Cited by 7
Kiełbasa, G., & Jastrzębski, M. (2020) · Advances in Interventional Cardiology · doi:10.5114/aic.2020.101760 · Cited by 7
Blockhaus, C., Waibler, H., Gülker, J.-E., Bufe, A., Seyfarth, M., Koektuerk, B., & Shin, D. (2021) · Reviews in Cardiovascular Medicine · doi:10.31083/j.rcm2203114 · Cited by 7
Choi, J., Park, S., Park, K., Kim, J. S., & On, Y. K. (2022) · PLoS ONE · doi:10.1371/journal.pone.0265482 · Cited by 7
Miyazaki, S., Kajiyama, T., Watanabe, T., Hada, M., Yamao, K., Nakamura, H., Hachiya, H., Tada, H., Hirao, K., & Iesaka, Y. (2018) · International Journal of Cardiology · doi:10.1016/j.ijcard.2018.03.134 · Cited by 7
Keçe, F., Riva, M., Naruse, Y., Dehnavi, R. A., Wijnmaalen, A. P., Schalij, M. J., Zeppenfeld, K., & Trines, S. A. I. P. (2019) · Journal of Cardiovascular Electrophysiology · doi:10.1111/jce.13913 · Cited by 7
Filipovic, K., Steven, D., Sultan, A., van den Bruck, J., Wörmann, J., Scheurlen, C., Dittrich, S., & Lüker, J. (2022) · International Journal of Arrhythmia · doi:10.1186/s42444-022-00080-0 · Cited by 6
Chaumont, C., McDonnell, E., Bovéda, S., Savouré, A., Rollin, A., Combes, S., Hamoud, R. A., Mandel, F., Zeriouh, S., Eltchaninoff, H., et al. (2024) · Archives of cardiovascular diseases · doi:10.1016/j.acvd.2024.01.005 · Cited by 6
Cappato, R., Lévy, S., Providencia, R. A., Ali, H., Av, A., Barra, S., Creta, A., Farkowski, M. M., Heeger, C.-H. H., Kanagaratnam, P., et al. (2025) · Journal of Cardiovascular Electrophysiology · doi:10.1111/jce.16561 · Cited by 6
Ghoshouni, H., Shamloo, A. S., Mirjalili, S. R., Soltani, F., Bakhshandeh, H., Hindricks, G., & Dagres, N. (2025) · Heart Rhythm · doi:10.1016/j.hrthm.2025.04.050 · Cited by 6
Atrial Fibrillation Recurrence After Catheter Ablation: The Puzzle We Have and the Pieces We Need
Vlachakis, P. K., Apostolos, A., Theofilis, P., Karakasis, P., Koniari, I. C., Kordalis, A., Leventopoulos, G., Drakopoulou, M., Leontsinis, I., Tousoulis, D. M., et al. (2025) · Pacing and Clinical Electrophysiology · doi:10.1111/pace.15221 · Cited by 7
Kallergis, E. M., & SIMANTIRAKIS, E. N. (2025) · Arrhythmia & Electrophysiology Review · doi:10.15420/aer.2025.20 · Cited by 6
Reißmann, B., Schlüter, M., Santoro, F., Maurer, T., Heeger, C.-H. H., Lemeš, C., Fink, T., Riedl, J., Rillig, A., Mathew, S., et al. (2017) · Circulation Journal · doi:10.1253/circj.cj-17-0956 · Cited by 6
Self-citationA Chronicle of Hybrid Atrial Fibrillation Ablation Therapy: From Cox Maze to Convergent
Kaba, R. A., Ahmed, O., Behr, E. R., & Momin, A. (2022) · Arrhythmia & Electrophysiology Review · doi:10.15420/aer.2022.05 · Cited by 6
Zhou, X., Xue, H., Chen, Q., Lv, Z., Mao, W., & Wang, X. (2022) · Reviews in Cardiovascular Medicine · doi:10.31083/j.rcm2312397 · Cited by 6
Jeong, J. H., Lee, H., Choi, Y. Y., Kim, Y. G., Choi, J., Kim, Y., Lim, H. E., Oh, I., Cha, M., Lee, S., et al. (2023) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2023.1303635 · Cited by 6
Chen, Z., Zhang, R., Zhang, X., & Xu, W. (2024) · BMC Cardiovascular Disorders · doi:10.1186/s12872-024-03784-4 · Cited by 6
Schiavone, M., Fassini, G. M., Moltrasio, M., Majocchi, B., Tundo, F., Casati, F., & Tondo, C. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13051259 · Cited by 6
Self-citationRisk and Protective Factors of Recurrence after Catheter Ablation for Atrial Fibrillation
Guo, X., & Li, J. (2024) · Reviews in Cardiovascular Medicine · doi:10.31083/j.rcm2503081 · Cited by 6
Teumer, Y., Hilgarth, F., Katov, L., Melnic, R., Rottbauer, W., Bothner, C., & Weinmann, K. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13082262 · Cited by 6
Chinese Guidelines for the Diagnosis and Management of Atrial Fibrillation
Chinese Society of Cardiology, C. M. A., & Heart Rhythm Committee of Chinese Society of Biomedical Engineering (2024) · Cardiology Discovery · doi:10.1097/cd9.0000000000000123 · Cited by 7
Lü, J., Zhang, N., Yang, F., Gao, Y., Ren, Y., & Ma, D. (2024) · Medicine · doi:10.1097/md.0000000000038435 · Cited by 6
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Self-citationSultan, A., Kreutzer, S., Wörmann, J., Lüker, J., Ackmann, J., Schipper, J., van den Bruck, J., Filipovic, K., Scheurlen, C., Rosenberger, K. D., et al. (2025) · EP Europace · doi:10.1093/europace/euaf066 · Cited by 6
Gunawardene, M., Hartmann, J., Dickow, J., Wahedi, R., Harloff, T., Jezuit, J., Tigges, E. P., Jularic, M., Dinov, B., Geßler, N., et al. (2025) · IJC Heart & Vasculature · doi:10.1016/j.ijcha.2025.101674 · Cited by 6
Metadata
- Authors
- Kuck, K.-H., Brugada, J., Fürnkranz, A., Metzner, A., Ouyang, F., Chun, K. R. J., Elvan, A., Arentz, T., Bestehorn, K., Pocock, S. J., Albenque, J.-P., & Tondo, C.
- Affiliations
- University of Milan (IT)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-06-09
- Volume
- 374
- Issue
- 23
- Pages
- 2235-2245
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2333001326
- Cited by
- 1,950
- References
- 22
- Citations by year
- 2026: 127 · 2025: 182 · 2024: 184 · 2023: 194 · 2022: 201 · 2021: 218 · 2020: 223 · 2019: 196 · 2018: 176 · 2017: 179 · 2016: 67
- FWCI
- 169.93
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Arrhythmias and Treatments
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
- Keywords
- paroxysmal atrial fibrillation, cryoballoon ablation, radiofrequency ablation, pulmonary vein isolation, catheter ablation, non-inferiority, drug-refractory atrial fibrillation, atrial flutter, atrial tachycardia, antiarrhythmic drug use, repeat ablation, treatment-related adverse events, mortality, cerebrovascular events
- MeSH terms
- Aged, Atrial Fibrillation, Cryosurgery, Female, Follow-Up Studies, Humans, Male, Middle Aged, Postoperative Complications, Recurrence, Reoperation, Single-Blind Method, Catheter Ablation, Disease-Free Survival, Kaplan-Meier Estimate
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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