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Radiofrequency Ablation vs Antiarrhythmic Drugs as First-line Treatment of Symptomatic Atrial Fibrillation: A Randomized Trial
Abstract
CONTEXT: Treatment with antiarrhythmic drugs and anticoagulation is considered first-line therapy in patients with symptomatic atrial fibrillation (AF). Pulmonary vein isolation (PVI) with radiofrequency ablation may cure AF, obviating the need for antiarrhythmic drugs and anticoagulation. OBJECTIVE: To determine whether PVI is feasible as first-line therapy for treating patients with symptomatic AF. DESIGN, SETTING, AND PARTICIPANTS: A multicenter prospective randomized study conducted from December 31, 2001, to July 1, 2002, of 70 patients aged 18 to 75 years who experienced monthly symptomatic AF episodes for at least 3 months and had not been treated with antiarrhythmic drugs. INTERVENTION: Patients were randomized to receive either PVI using radiofrequency ablation (n=33) or antiarrhythmic drug treatment (n=37), with a 1-year follow-up. MAIN OUTCOME MEASURES: Recurrence of AF, hospitalization, and quality of life assessment. RESULTS: Two patients in the antiarrhythmic drug treatment group and 1 patient in the PVI group were lost to follow-up. At the end of 1-year follow-up, 22 (63%) of 35 patients who received antiarrhythmic drugs had at least 1 recurrence of symptomatic AF compared with 4 (13%) of 32 patients who received PVI (P<.001). Hospitalization during 1-year follow-up occurred in 19 (54%) of 35 patients in the antiarrhythmic drug group compared with 3 (9%) of 32 in the PVI group (P<.001). In the antiarrhythmic drug group, the mean (SD) number of AF episodes decreased from 12 (7) to 6 (4), after initiating therapy (P = .01). At 6-month follow-up, the improvement in quality of life of patients in the PVI group was significantly better than the improvement in the antiarrhythmic drug group in 5 subclasses of the Short-Form 36 health survey. There were no thromboembolic events in either group. Asymptomatic mild or moderate pulmonary vein stenosis was documented in 2 (6%) of 32 patients in the PVI group. CONCLUSION: Pulmonary vein isolation appears to be a feasible first-line approach for treating patients with symptomatic AF. Larger studies are needed to confirm its safety and efficacy.
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“Fewer data are available reporting the effectiveness and safety of catheter ablation in patients with persistent or long-standing persistent AF, but all point to lower recurrence rates after catheter ablation compared to antiarrhythmic drug therapy with or without cardioversion.185,717,[723][724][725][726]1039”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [723]
In the citing paper
“Fewer data are available reporting the effectiveness and safety of catheter ablation in patients with persistent or long-standing persistent AF, but all point to lower recurrence rates after catheter ablation compared to antiarrhythmic drug therapy with or without cardioversion.185,717,[723][724][725][726]1039”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [723]
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“RFA has been successfully used in the management of AF [87].”
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“It is becoming increasingly effective in eliminating the arrhythmia [1, 2] and has been shown to improve quality of life when compared to pharmacologic rhythm management [3, 4].”
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“We, therefore, chose a sample size of 80 patients (40 per arm) to be consistent with the sample sizes of other published comparative AF ablation pilot studies.(12,13) Only subjects undergoing ablation with both CFAE and PVI procedures completed were included for analysis.”
ResultPokushalov, E. A., Romanov, A. B., Melis, M. D., Николаевич, А. С., Викторовна, Б. В., Losik, D., Байрамова, С. А., Karaskov, A. M., Mittal, S., & Steinberg, J. S. (2013) · Circulation Arrhythmia and Electrophysiology · doi:10.1161/circep.113.000495 · Cited by 55
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Catheter ablation of atrial fibrillation in the young: insights from the German Ablation Registry
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“This may be due to different inclusion criteria and rather reflect real-world experience than trial data from selected high-volume centers [13, 14].”
BackgroundResultRadiofrequency Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation
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“, 2010) with a better rhythm control efficacy as compared to anti-arrhythmic drugs (Wazni et al., 2005).”
BackgroundLeft Atrial Diverticula in Patients Referred for Radiofrequency Ablation of Atrial Fibrillation
Peng, L., Yu, J., Yang, Z., Wu, D., Xu, J.-J., Chu, Z., Li, X., Chen, D., Luo, Y., Shao, H., et al. (2012) · Circulation Arrhythmia and Electrophysiology · doi:10.1161/circep.111.965665 · Cited by 47
“Main Findings The main findings of this study were that (1) LAD were common entities, with a prevalence of 36.”
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“Third, it is unfortunate that persistent AF subgroups are often not published for mixed persistent/paroxysmal trials [27, 28], so these data were not be included in this meta-analysis.”
BackgroundUnderstanding Atrial Fibrillation: The Signal Processing Contribution, Part II
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Atrial Fibrillation in Congestive Heart Failure
Seiler, J., & Stevenson, W. G. (2009) · Cardiology in Review · doi:10.1097/crd.0b013e3181c21cff · Cited by 44
“Two small randomized trials of 70 and 112 patients found that catheter ablation of AF was superior to treatment with antiarrhythmic drugs in the maintenance of sinus rhythm, improvement of exercise capacity and quality of life.(117,118) However, these high success rates reported from patients with predominantly no or…”
BackgroundChen, S., Pürerfellner, H., Ouyang, F. O., Kiuchi, M. G., Meyer, C. G., Martinek, M., Futyma, P., Zhu, L., Schratter, A., Wang, J., et al. (2021) · EP Europace · doi:10.1093/europace/euab185 · Cited by 45
Martinek, M., Nesser, H., Aichinger, J., Boehm, G., & Pürerfellner, H. (2007) · Journal of Interventional Cardiac Electrophysiology · doi:10.1007/s10840-006-9067-8 · Cited by 44
“With radiofrequency ablation finding its way to probably become a first-line therapy in AF at least for selected patients, ablation strategies have to meet a few crucial points [18].”
BackgroundGerstenfeld, E. P., Callans, D. J., Dixit, S., Lin, D., Cooper, J. M., Russo, A. M., Verdino, R. J., Weiner, M., Zado, E. S., & Marchlinski, F. E. (2006) · Journal of Cardiovascular Electrophysiology · doi:10.1111/j.1540-8167.2006.00662.x · Cited by 44
JCS / JHRS 2020 Guideline on Pharmacotherapy of Cardiac Arrhythmias
Ono, K., Iwasaki, Y., Akao, M., Ikeda, T., Ishii, K., Inden, Y., Kusano, K., Kobayashi, Y., Koretsune, Y., Sasano, T., et al. (2022) · Journal of Arrhythmia · doi:10.1002/joa3.12714 · Cited by 41
Sciarra, L., Rebecchi, M., Ruvo, E. D., Luca, L. D., Zuccaro, L. M., Fagagnini, A., Corò, L., Allocca, G., Lioy, E., Delise, P., et al. (2010) · EP Europace · doi:10.1093/europace/euq327 · Cited by 42
New Technologies in Atrial Fibrillation Ablation
Burkhardt, J. D., & Natale, A. (2009) · Circulation · doi:10.1161/circulationaha.109.858233 · Cited by 43
Kim, Y. G., Shim, J., Choi, J., & Kim, Y. (2016) · PLoS ONE · doi:10.1371/journal.pone.0163755 · Cited by 43
The burden of proof: The current state of atrial fibrillation prevention and treatment trials
Zakeri, R., Wagoner, D. R. V., Calkins, H. G., Wong, T., Ross, H., Heist, E. K., Meyer, T. E., Kowey, P. R., Mentz, R. J., Cleland, J. G. F., et al. (2017) · Heart Rhythm · doi:10.1016/j.hrthm.2017.01.032 · Cited by 42
Five‐Year Change in the Renal Function After Catheter Ablation of Atrial Fibrillation
Park, J., Yang, P., Bae, H., Yang, S., Yu, H. T., Kim, T., Uhm, J., Joung, B., Lee, M., & Pak, H. (2019) · Journal of the American Heart Association · doi:10.1161/jaha.119.013204 · Cited by 43
Yang, P., Sung, J., Jang, E., Yu, H. T., Kim, T., Uhm, J., Kim, J., Pak, H., Lee, M., & Joung, B. (2020) · Journal of the American Heart Association · doi:10.1161/jaha.119.015740 · Cited by 43
Quality of Life and Health Care Utilization in the CIRCA-DOSE Study
Andrade, J. G., Macle, L., Verma, A., Deyell, M. W., Champagne, J., Dubuc, M., Leong‐Sit, P., NOVAK, P. G., Roux, J.-F., Sapp, J. L., et al. (2020) · JACC. Clinical electrophysiology · doi:10.1016/j.jacep.2020.04.017 · Cited by 43
Namdar, M., Chierchia, G., Westra, S. W., Sorgente, A., Meir, M. L., Bayrak, F., Rao, J. Y., Ricciardi, D., de Asmundis, C., Sarkozy, A., et al. (2011) · EP Europace · doi:10.1093/europace/eur299 · Cited by 42
“Recently gathered evidence, including the STOP-AF trial, where patients were treated by CBA, adds substantially to hitherto available analyses.(25,34) Our favourable results as compared to the STOP-AF study, however, might be due to the highly experienced operators, the single-centre nature of the study and the younge…”
Gimelli, A., Liga, R., Agostini, D., Bengel, F. M., Ernst, S., Hyafil, F., Saraste, A., Scholte, A. J. H. A., Verberne, H. J., Verschure, D. O., et al. (2021) · European Heart Journal - Cardiovascular Imaging · doi:10.1093/ehjci/jeab007 · Cited by 42
“(PVI) represents the cornerstone technique for treating patients with AF resistant to standard pharmacological therapies.(48) However, the success rate of the first AF ablation remains only 60% at 1 year.”
MethodQuality of life in older people with atrial fibrillation
Lane, D. A., & Lip, G. Y. H. (2008) · Journal of Interventional Cardiac Electrophysiology · doi:10.1007/s10840-008-9318-y · Cited by 42
“Direct comparison of ‘traditional’ rhythm control (with anti-arrhythmic drugs) and these ‘newer’ rhythm-control interventions has demonstrated significant improvement in QoL in patients undergoing radiofrequency ablation of the pulmonary vein [22, 23] compared to those receiving antiarrhythmic pharmacological therapy.”
ResultBulková, V., Fiala, M., Havránek, Š., Šimek, J., Škňouřil, L., Januška, J., Špinar, J., & Wichterle, D. (2014) · Journal of the American Heart Association · doi:10.1161/jaha.114.000881 · Cited by 42
López, M. Á., Font, E. R., & Alberola, A. G. (2005) · Revista Española de Cardiología · doi:10.1016/s0300-8932(05)74075-6 · Cited by 42
Pappone, C., Ciconte, G., Vicedomini, G., Mangual, J. O., Li, W., Conti, M. A., Giannelli, L., Lipartiti, F., McSpadden, L. C., Ryu, K., et al. (2018) · Circulation Arrhythmia and Electrophysiology · doi:10.1161/circep.117.005904 · Cited by 42
Aytemir, K., Oto, A., Canpolat, U., Sunman, H., Yorgun, H., ŞAHINER, L., & Kaya, E. B. (2013) · Journal of Interventional Cardiac Electrophysiology · doi:10.1007/s10840-013-9834-2 · Cited by 41
Catheter ablation for paroxysmal and persistent atrial fibrillation
Chen, H. S., Wen, J., Wu, S., & Liu, J. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007101.pub2 · Cited by 42
CAABL-AF (California Study of Ablation for Atrial Fibrillation)
Srivatsa, U. N., Danielsen, B. H., Amsterdam, E. A., Pezeshkian, N. G., Yang, Y., Nordsieck, E. J., Fan, D., Chiamvimonvat, N., & White, R. H. R. (2018) · Circulation Arrhythmia and Electrophysiology · doi:10.1161/circep.117.005739 · Cited by 42
Singh‐Moon, R. P., Marboe, C. C., & Hendon, C. P. (2015) · Biomedical Optics Express · doi:10.1364/boe.6.002494 · Cited by 41
Efficacy of Cryoballoon Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation
Guhl, E., Siddoway, D., ADELSTEIN, E. C., Voigt, A., Saba, S., & Jain, S. K. (2016) · Journal of Cardiovascular Electrophysiology · doi:10.1111/jce.12924 · Cited by 39
Gómez-Barea, M., García-Sánchez, T., & Ivorra, A. (2022) · Scientific Reports · doi:10.1038/s41598-022-20212-9 · Cited by 40
“Enthalpy is related to temperature by the following expression48,49: (1) ∇ · (σ∇�) = 0”
Pontoppidan, J., Nielsen, J. C., Poulsen, S. H., & HANSEN, P. S. (2009) · Pacing and Clinical Electrophysiology · doi:10.1111/j.1540-8159.2009.02357.x · Cited by 40
Ito, Y., Yamasaki, H., Naruse, Y., Yoshida, K., Kaneshiro, T., Murakoshi, N., Igarashi, M., Kuroki, K., Machino, T., Xu, D., et al. (2013) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2012.12.020 · Cited by 40
Catheter ablation for atrial fibrillation: Should it be first-line therapy?
Wharton, J. M. (2007) · American Heart Journal · doi:10.1016/j.ahj.2007.01.017 · Cited by 40
Aljuaid, M., Marashly, Q., Danaf, J. A., Tawhari, I. H., Barakat, M. M., Barakat, R., Zobell, B., Cho, W., Chelu, M. G., & Marrouche, N. F. (2020) · Clinical Medicine Insights Cardiology · doi:10.1177/1179546820901508 · Cited by 40
Metadata
- Authors
- Wazni, O. M., Marrouche, N. F., Martin, D. O., Verma, A., Bhargava, M., Saliba, W., Bash, D., Schweikert, R., Brachmann, J., Gunther, J., Gutleben, K., Pisano, E., Potenza, D., Fanelli, R., Raviele, A., Themistoclakis, S., Rossillo, A., Bonso, A., & Natale, A.
- Affiliations
- Cleveland Clinic (US)
- Corresponding author
- Natale, Andrea
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2005-06-01
- Volume
- 293
- Issue
- 21
- Pages
- 2634
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2154269490
- Cited by
- 1,121
- References
- 39
- Citations by year
- 2026: 18 · 2025: 31 · 2024: 38 · 2023: 29 · 2022: 61 · 2021: 52 · 2020: 45 · 2019: 36 · 2018: 53 · 2017: 40 · 2016: 44 · 2015: 52 · 2014: 69 · 2013: 75 · 2012: 78
- FWCI
- 43.53
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- 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
- atrial fibrillation, radiofrequency ablation, pulmonary vein isolation, antiarrhythmic drugs, first-line therapy, atrial fibrillation recurrence, hospitalization, quality of life, pulmonary vein stenosis, anticoagulation, thromboembolic events, Short Form 36 Health Survey, randomized trial comparison, cost-effectiveness, patient satisfaction
- MeSH terms
- Anti-Arrhythmia Agents, Atrial Fibrillation, Humans, Middle Aged, Pilot Projects, Prospective Studies, Pulmonary Veins, Quality of Life, Survival Analysis, Treatment Outcome, Catheter Ablation
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