Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation.

BACKGROUND There are limited data comparing radiofrequency catheter ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation. METHODS We randomly assigned 294 patients with paroxysmal atrial fibrillation and no history of antiarrhythmic drug use to an initial treatment strategy of either radiofrequency catheter ablation (146 patients) or therapy with class IC or class III antiarrhythmic agents (148 patients). Follow-up included 7-day Holter-monitor recording at 3, 6, 12, 18, and 24 months. Primary end points were the cumulative and per-visit burden of atrial fibrillation (i.e., percentage of time in atrial fibrillation on Holter-monitor recordings). Analyses were performed on an intention-to-treat basis. RESULTS There was no significant difference between the ablation and drug-therapy groups in the cumulative burden of atrial fibrillation (90th percentile of arrhythmia burden, 13% and 19%, respectively; P=0.10) or the burden at 3, 6, 12, or 18 months. At 24 months, the burden of atrial fibrillation was significantly lower in the ablation group than in the drug-therapy group (90th percentile, 9% vs. 18%; P=0.007), and more patients in the ablation group were free from any atrial fibrillation (85% vs. 71%, P=0.004) and from symptomatic atrial fibrillation (93% vs. 84%, P=0.01). One death in the ablation group was due to a procedure-related stroke; there were three cases of cardiac tamponade in the ablation group. In the drug-therapy group, 54 patients (36%) underwent supplementary ablation. CONCLUSIONS In comparing radiofrequency ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation, we found no significant difference between the treatment groups in the cumulative burden of atrial fibrillation over a period of 2 years. (Funded by the Danish Heart Foundation and others; MANTRA-PAF ClinicalTrials.gov number, NCT00133211.).

[1]  Hugh Calkins,et al.  Complications arising from catheter ablation of atrial fibrillation: temporal trends and predictors. , 2011, Heart rhythm.

[2]  H. Tanner,et al.  Catheter ablation of atrial fibrillation as first-line therapy--a single-centre experience. , 2011, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[3]  Silvia G Priori,et al.  2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. , 2011, Circulation.

[4]  Kenneth A Ellenbogen,et al.  2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (updating the 2006 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. , 2011, Circulation.

[5]  A. Verma,et al.  Canadian Cardiovascular Society atrial fibrillation guidelines 2010: rate and rhythm management. , 2011, The Canadian journal of cardiology.

[6]  Ulrich Schotten,et al.  Electropathological Substrate of Long-Standing Persistent Atrial Fibrillation in Patients With Structural Heart Disease: Longitudinal Dissociation , 2010, Circulation. Arrhythmia and electrophysiology.

[7]  Ulrich Schotten,et al.  Electropathological Substrate of Longstanding Persistent Atrial Fibrillation in Patients With Structural Heart Disease: Epicardial Breakthrough , 2010, Circulation.

[8]  Jeroen J. Bax,et al.  Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). , 2010, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[9]  D. Lin,et al.  Efficacy and Risk of Atrial Fibrillation Ablation Before 45 Years of Age , 2010, Circulation. Arrhythmia and electrophysiology.

[10]  E. Kholmovski,et al.  Evaluation of the left atrial substrate in patients with lone atrial fibrillation using delayed-enhanced MRI: implications for disease progression and response to catheter ablation. , 2010, Heart rhythm.

[11]  D. Tamborero,et al.  Circumferential pulmonary vein ablation: does use of a circular mapping catheter improve results? A prospective randomized study. , 2010, Heart rhythm.

[12]  Gerhard Hindricks,et al.  Performance of a New Leadless Implantable Cardiac Monitor in Detecting and Quantifying Atrial Fibrillation Results of the XPECT Trial , 2010, Circulation. Arrhythmia and electrophysiology.

[13]  Burr Hall,et al.  Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. , 2010, JAMA.

[14]  V. Santinelli,et al.  Pulmonary vein isolation after circumferential pulmonary vein ablation: comparison between Lasso and three-dimensional electroanatomical assessment of complete electrical disconnection. , 2009, Heart rhythm.

[15]  Stephan Willems,et al.  Early and comprehensive management of atrial fibrillation: executive summary of the proceedings from the 2nd AFNET-EHRA consensus conference 'research perspectives in AF'. , 2009, European heart journal.

[16]  G. Hindricks,et al.  Complications of Atrial Fibrillation Ablation in a High‐Volume Center in 1,000 Procedures: Still Cause for Concern? , 2009, Journal of cardiovascular electrophysiology.

[17]  Matthew R. Reynolds,et al.  Treatment of Atrial Fibrillation With Antiarrhythmic Drugs or Radiofrequency Ablation: Two Systematic Literature Reviews and Meta-Analyses , 2009, Circulation. Arrhythmia and electrophysiology.

[18]  J. Hartikainen,et al.  The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial: clinical rationale, study design, and implementation. , 2009, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[19]  Joshua J. E. Blauer,et al.  Detection and Quantification of Left Atrial Structural Remodeling With Delayed-Enhancement Magnetic Resonance Imaging in Patients With Atrial Fibrillation , 2009, Circulation.

[20]  A. Capucci,et al.  Presence and Duration of Atrial Fibrillation Detected by Continuous Monitoring: Crucial Implications for the Risk of Thromboembolic Events , 2009, Journal of cardiovascular electrophysiology.

[21]  F. Sacher,et al.  Catheter Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation: The A4 Study , 2008, Circulation.

[22]  Bertil Olsson,et al.  Outcome parameters for trials in atrial fibrillation: executive summary. , 2007, European heart journal.

[23]  V. Santinelli,et al.  A randomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation: the APAF Study. , 2006, Journal of the American College of Cardiology.

[24]  Antonio De Simone,et al.  Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study). , 2006, European heart journal.

[25]  G. Hindricks,et al.  Value of Different Follow‐Up Strategies to Assess the Efficacy of Circumferential Pulmonary Vein Ablation for the Curative Treatment of Atrial Fibrillation , 2005, Journal of cardiovascular electrophysiology.

[26]  Mandeep Bhargava,et al.  Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. , 2005, JAMA.