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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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Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins.
Haïssaguerre, M., Jaïs, P., Shah, D. C., Takahashi, A., Hocini, M., Quiniou, G., Garrigue, S., Mouroux, A. L., Métayer, P. L., & Clémenty, J. (1998) · New England Journal of Medicine · doi:10.1056/nejm199809033391003 · Cited by 8,040
Approaches to catheter ablation for persistent atrial fibrillation
Verma, A., Jiang, C.-Y., Betts, T. R., Chen, J., Deisenhofer, I., Mantovan, R., Macle, L., Morillo, C. A., Haverkamp, W., Weerasooriya, R., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1408288 · Cited by 2,339
Self-citationCalkins, H. G., Kück, K., Cappato, R., Brugada, J., Camm, A. J., Chen, S., Crijns, H. J. G. M., Damiano, R. J., Davies, D. W., Dimarco, J., et al. (2012) · Journal of Interventional Cardiac Electrophysiology · doi:10.1007/s10840-012-9672-7 · Cited by 1,685
Self-citationCalkins, H., Kuck, K. H., Cappato, R., Brugada, J., Camm, A. J., Chen, S.-A., Crijns, H. J. G., Damiano, R. J., Davies, D. W., DiMarco, J., et al. (2012) · Heart Rhythm · doi:10.1016/j.hrthm.2011.12.016 · Cited by 1,456
Self-citationWilber, D. J., Pappone, C., Neuzil, P., De Paola, A., Marchlinski, F., Natale, A., Macle, L., Daoud, E. G., Calkins, H., Hall, B., et al. (2010) · JAMA · doi:10.1001/jama.2009.2029 · Cited by 1,170
Cryoballoon Ablation of Pulmonary Veins for Paroxysmal Atrial Fibrillation
Packer, D. L., Kowal, R. C., Wheelan, K. R., Irwin, J. M., Champagne, J., Guerra, P. G., Dubuc, M., Reddy, V. Y., Nelson, L., Holcomb, R. G., et al. (2013) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2012.11.064 · Cited by 919
Paroxysmal AF Catheter Ablation With a Contact Force Sensing Catheter
Natale, A., Reddy, V. Y., Monir, G., Wilber, D. J., Lindsay, B. D., McElderry, H. T., Kantipudi, C., MANSOUR, M. C., Melby, D. P., Packer, D. L., et al. (2014) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2014.04.072 · Cited by 476
Kautzner, J., Neužil, P., Lambert, H., Peichl, P., Petrů, J., Cihak, R. J., Skoda, J., Wichterle, D., Wißner, E., Yulzari, A., et al. (2015) · EP Europace · doi:10.1093/europace/euv057 · Cited by 374
Luik, A., Radzewitz, A., Kieser, M., Walter, M., Bramlage, P., Hörmann, P., Schmidt, K., Horn, N., Brinkmeier-Theofanopoulou, M., Kunzmann, K., et al. (2015) · Circulation · doi:10.1161/circulationaha.115.016871 · Cited by 275
Kuck, K.-H., Hoffmann, B. A., Ernst, S., Wegscheider, K., Treszl, A., Metzner, A., Eckardt, L., Lewalter, T., Breithardt, G., & Willems, S. (2016) · Circulation Arrhythmia and Electrophysiology · doi:10.1161/circep.115.003337 · Cited by 261
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Hindricks, G., Potpara, T., Dagres, N., Arbelo, E., Bax, J. J., Blomström‐Lundqvist, C., Boriani, G., Castella, M., Dan, G.-A., Dilaveris, P., et al. (2020) · European Heart Journal · doi:10.1093/eurheartj/ehaa612 · Cited by 10,550
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Kirchhof, P. F., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., Castellà, M., Diener, H., Heidbüchel, H., Hendriks, J., et al. (2016) · EP Europace · doi:10.1093/europace/euw295 · Cited by 6,438
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Kirchhof, P., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., Castella, M., Diener, H.-C., Heidbuchel, H., Hendriks, J., et al. (2016) · European Heart Journal · doi:10.1093/eurheartj/ehw210 · Cited by 6,418
Calkins, H. G., Hindricks, G., Cappato, R., Kim, Y., Saad, E., Aguinaga, L., Akar, J. G., Badhwar, V., Brugada, J., Camm, A. J., et al. (2017) · Heart Rhythm · doi:10.1016/j.hrthm.2017.05.012 · Cited by 2,794
Self-citation2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Kirchhof, P., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., Castella, M., Diener, H.-C., Heidbuchel, H., Hendriks, J., et al. (2016) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezw313 · Cited by 1,403
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
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