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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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Evaluating the Cost-effectiveness of Catheter Ablation of Atrial Fibrillation
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“CA by elimination of arrhythmogenic foci has been proven as an effective method for restoring sinus rhythm and appears to be superior to anti-arrhythmic agent therapy [3, 4].”
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“Atrial fibrosis is also a major determinant for the success of rhythm control strategies in AF, including catheter ablation, one of the most efficacious methods of treating patients with AF [8].”
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“37%) in 67 patients at 1 year.(70) At 15-month follow-up, 27 of 55 patients with AF (49%) with isolation of each individual pulmonary vein and 37 of 55 patients with AF (67%) with isolation of large areas around both ipsilateral pulmonary veins had no AF or atrial flutter after a single radiofrequency ablation.”
BackgroundLong-Standing Persistent Atrial Fibrillation
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“Some preliminary studies suggest that ablation may become a first-line treatment in such patients (7).”
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“(1) The average MCL post-PV isolation was 135 ± 24 ms with approximately 45 ± 17% of the LA surface area consisting of areas of CFAE (i.”
BackgroundDefining endpoints in clinical trials on atrial fibrillation
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“Based on the results of clinical studies evaluating different PVI techniques, several conclusions can be drawn: (1) empirical isolation of all PVs is necessary to eliminate the majority of AF triggers and improve arrhythmia-free survival; (2) PVI should be verified with a circular mapping catheter; (3) a wide antral P…”
Uremic Toxins and Atrial Fibrillation: Mechanisms and Therapeutic Implications
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Efficacy of pulmonary vein isolation with a novel hot balloon ablation catheter
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“Catheter ablation for the treatment of symptomatic atrial fibrillation (AF) has gained increasing acceptance as effective therapy [1, 2], with improvement in quality of life when compared to pharmacologic rhythm management [3, 4].”
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Catheter Ablation of Atrial Fibrillation
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Site Localization and Characterization of Pain During Radiofrequency Ablation of the Pulmonary Veins
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“Ganglionated plexi were abundant in both atria and were identified on (1) the superior surface of the right atrium, (2) the superior surface of the left atrium, (3) the posterior surface of the right atrium, (4) the posterior medial surface of the left atrium, and (5) the inferior and lateral aspects of the posterior…”
Catheter ablation of atrial fibrillation in the elderly: does the benefit outweigh the risk?
Kennedy, R. T., & Oral, H. (2013) · Expert Review of Cardiovascular Therapy · doi:10.1586/erc.13.2 · Cited by 19
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InfluentialAtrial Fibrillation: Goals of Therapy and Management Strategies to Achieve the Goals
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“Exclusion criteria were defined as the following: (1) advanced structural heart disease, including moderate-tosevere valvular stenosis or insufficiency; (2) previous myocardial infarction; (3) congenital heart disease; (4) left ventricular ejection fraction <50%; (5) coronary artery bypass graft surgery within 3 month…”
BackgroundCurative ablation for atrial fibrillation: A systematic review
Gjesdal, K., Vist, G. E., Einar Bugge, B., Rossvoll, O., Johansen, M., Norderhaug, I. N., & Ohm, O. (2008) · Scandinavian Cardiovascular Journal · doi:10.1080/14017430701798838 · Cited by 19
“(7) studied 70 patients, 67 with paroxysmal and three with persistent AF.”
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Population-Based Evaluation of Major Adverse Events After Catheter Ablation for Atrial Fibrillation
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“As improvements in CA technology and operator experience broaden patient selection criteria for the procedure (1), the assessment of periprocedural AEs at the population level over time is essential.”
BackgroundRhythm versus rate control for atrial fibrillation in heart failure with preserved ejection fraction
Al‐Sadawi, M., Aleem, S., Aslam, F., Jacobs, R., Stevens, G., Almasry, I. O., Singh, A., Fan, R., & Rashba, E. J. (2022) · Heart Rhythm O2 · doi:10.1016/j.hroo.2022.06.009 · Cited by 18
Evolving Role of Catheter Ablation for Atrial Fibrillation: Early and Effective Rhythm Control
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Fluoroless catheter ablation of atrial fibrillation: a step-by-step workflow
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Ablation as First-line Therapy for Atrial Fibrillation
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“In recent years, transvenous pulmonary vein isolation has become the first choice for patients with highly symptomatic atrial fibrillation refractory to antiarrhythmic drugs [3].”
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Gender and AF: Differences and Disparities
Pothineni, N. V. K., & Vallurupalli, S. (2018) · US Cardiology Review · doi:10.15420/usc.2017:39:1 · Cited by 22
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“The superiority of CA over antiarrhythmic treatment in patients with symptomatic AF has been already demonstrated[22-25].”
BackgroundZhang, J., Xia, S., Du, X., Jiang, C., Lai, Y., Wang, Y., Jia, Z., He, L., Tang, R., Dong, J., et al. (2021) · BMC Cardiovascular Disorders · doi:10.1186/s12872-021-02139-7 · Cited by 19
Silent Cerebral Thromboembolism with Left Atrial Ablation: A Lurking Danger
Asirvatham, S. J., & Friedman, P. A. (2006) · Journal of Cardiovascular Electrophysiology · doi:10.1111/j.1540-8167.2005.00337.x · Cited by 18
Lesion-forming technologies for catheter ablation of atrial fibrillation
Cesario, D. A., Mahajan, A., & Shivkumar, K. (2006) · Heart Rhythm · doi:10.1016/j.hrthm.2006.12.025 · Cited by 18
Cost-effectiveness of catheter ablation for atrial fibrillation
Khaykin, Y. (2006) · Current Opinion in Cardiology · doi:10.1097/hco.0b013e32801129d7 · Cited by 19
Vassilikos, V. P., Pagourelias, E. D., Laroche, C., Blomström‐Lundqvist, C., Kautzner, J., Maggioni, A. P., Tavazzi, L., Dagres, N., Brugada, J., Stuehlinger, M., et al. (2020) · EP Europace · doi:10.1093/europace/euaa236 · Cited by 19
What clinical trials of ablation for atrial fibrillation tell us – and what they do not
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Blomström‐Lundqvist, C., & Wettervik, V. S. (2021) · EP Europace · doi:10.1093/europace/euab318 · Cited by 17
REVIEW: New Approaches to Atrial Fibrillation Management: Treat the Patient, not the ECG
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Santangeli, P., Biase, L. D., Pelargonio, G., Russo, A. D., Casella, M., Sánchez, J., Horton, R., Gallinghouse, G. J., & Natale, A. (2011) · Journal of Interventional Cardiac Electrophysiology · doi:10.1007/s10840-011-9562-4 · Cited by 17
“Antiarrhythmic Drugs as First-Line Treatment of Symptomatic Atrial Fibrillation trial, 70 patients with monthly symptomatic episodes of AF for at least 3 months (96% paroxysmal AF) were randomly assigned to PVAI or antiarrhythmic drug therapy [7].”
BackgroundMethodResultInfluentialMaenosono, R., Oketani, N., Ishida, S., Iriki, Y., Ichiki, H., Okui, H., Ninomiya, Y., Hamasaki, S., Namino, F., Matsushita, M., et al. (2012) · Journal of Cardiology · doi:10.1016/j.jjcc.2012.02.009 · Cited by 18
In-Hospital Management of Atrial Fibrillation: The CHADS2 Score Predicts Increased Cost
Kotowycz, M. A., Filion, K. B., Joza, J. E., Dube, D., Reynolds, M. R., Pilote, L., Eisenberg, M. J., & Essebag, V. (2011) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2011.01.002 · Cited by 17
“There is also growing evidence that catheter ablation therapy may be superior to antiarrhythmic medication in controlling AF,(9-13) and some data suggest that ablation may reduce hospitalizations and may be reasonably cost effective when compared with medical therapy.(14-16) Given that hospitalizations play such an im…”
BackgroundYalçın, M. U., Gürses, K. M., Koçyiğit, D., Kesikli, S. A., Dural, M., Evranos, B., Yorgun, H., ŞAHINER, L., Kaya, E. B., Oto, M. A., et al. (2015) · Journal of Cardiovascular Electrophysiology · doi:10.1111/jce.12665 · Cited by 17
Atrial Fibrillation in the Elderly: A Review
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Agasthi, P., Lee, J. Z., Amin, M., Al‐Saffar, F., Goel, V., Tseng, A. S., Almader‐Douglas, D., Killu, A. M., Deshmukh, A. J., Munoz, F. D., et al. (2019) · Journal of Arrhythmia · doi:10.1002/joa3.12146 · Cited by 16
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Kim, Y. G., Shim, J., Oh, S., Lee, K., Choi, J., & Kim, Y. (2019) · Scientific Reports · doi:10.1038/s41598-019-43566-z · Cited by 16
Adverse Clinical Events during Long-Term Follow-Up After Catheter Ablation of Atrial Fibrillation
Arai, M., Okumura, Y., Nagashima, K., Watanabe, I., Watanabe, R., Wakamatsu, Y., Otsuka, N., Yagyu, S., Kurokawa, S., Ohkubo, K., et al. (2019) · International Heart Journal · doi:10.1536/ihj.18-517 · Cited by 16
Actualización detallada de las guías de la ESC para el manejo de la fibrilación auricular de 2012
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“The RAAFT study reported that catheter ablation as a first-line therapy for symptomatic AF was associated with less AF recurrence, an improved quality of life, and lower hospitalization rate in normal LVEF patients [16].”
BackgroundChoo, W. K., Farwell, D. J., & Harris, S. J. (2011) · Archives of cardiovascular diseases · doi:10.1016/j.acvd.2011.05.003 · Cited by 16
Catheter Ablation for “Lone” Atrial Fibrillation: Efficacy and Predictors of Recurrence
Buiatti, A., Kaess, B. M., Reents, T., Semmler, V., TELISHVESKA, M., Bourier, F. J., Kornmayer, M., Kottmaier, M., Hessling, G., & Deisenhofer, I. (2016) · Journal of Cardiovascular Electrophysiology · doi:10.1111/jce.12936 · Cited by 16
Catheter ablation of atrial fibrillation
Santangeli, P., Biase, L. D., BURKHARDT, D. J., Horton, R., Sánchez, J., Bai, R., Pump, A., Perez, M. V., Wang, P. J., Natale, A., et al. (2011) · Journal of Cardiovascular Medicine · doi:10.2459/jcm.0b013e32834f2371 · Cited by 16
Atrial Fibrillation and Deterioration in Cognitive Function
Chinta, V., Askandar, S., Nanda, A. S., Sharma, A., Abader, P., Kabra, R., & Khouzam, R. N. (2018) · Current Problems in Cardiology · doi:10.1016/j.cpcardiol.2018.07.001 · Cited by 16
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Cost-effectiveness of atrial fibrillation catheter ablation
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A 1 Per 1,000 Mortality Rate After Catheter Ablation of Atrial Fibrillation
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Hunter, T. D., Palli, S. R., & Rizzo, J. A. (2016) · Journal of Medical Economics · doi:10.1080/13696998.2016.1187153 · Cited by 16
Role of Intracardiac echocardiography in Atrial Fibrillation Ablation.
Russo, A. D., Russo, E., Fassini, G., Casella, M., Innocenti, E., Zucchetti, M., Cefalu, C., Solimene, F., Mottola, G., Colombo, D., et al. (2013) · Europe PMC (PubMed Central) · doi:10.4022/jafib.786 · Cited by 16
“ICE has proved to be helpful in the setting of electrophysiological (EP) procedures and in particular for AF catheter-based ablation allowing: (1) a correct identification of the endocardial structures (assessment of pulmonary veins anatomy, ostium size, and normal blood flow via 2-D anatomical imaging and Doppler mea…”
Elsayed, M., Abdelfattah, O., Sayed, A., Prasad, R. M., Barakat, A. F., Elgendy, I. Y., Andrade, J. G., Bunch, T. J., Thosani, A. J., Saliba, W. I., et al. (2021) · Journal of Cardiovascular Electrophysiology · doi:10.1111/jce.15308 · Cited by 15
“Our network meta‐analysis aimed to compare cryoablation versus RFA versus AAD as first‐choice therapies in the treatment of AF.”
BackgroundInfluentialContact‐Force Recovery Can Predict Cardiac Perforation during Radiofrequency Ablation
Nazeri, A., Ganapathy, A. V., Massumi, A., Massumi, M., Constantine, G., RAZ, S., & Razavi, M. (2014) · Pacing and Clinical Electrophysiology · doi:10.1111/pace.12409 · Cited by 15
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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