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Updated: Nov 30, 2025
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation
Jason G Andrade1, George A Wells1, Marc W Deyell1
1From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.
Background:
Guidelines recommend a trial of one or more antiarrhythmic drugs before catheter ablation is considered in patients with atrial fibrillation. However, first-line ablation may be more effective in maintaining sinus rhythm.
Methods:
We randomly assigned 303 patients with symptomatic, paroxysmal, untreated atrial fibrillation to undergo catheter ablation with a cryothermy balloon or to receive antiarrhythmic drug therapy for initial rhythm control. All the patients received an implantable cardiac monitoring device to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was the first documented recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 and 365 days after catheter ablation or the initiation of an antiarrhythmic drug. The secondary end points included freedom from symptomatic arrhythmia, the atrial fibrillation burden, and quality of life.
Results:
At 1 year, a recurrence of atrial tachyarrhythmia had occurred in 66 of 154 patients (42.9%) assigned to undergo ablation and in 101 of 149 patients (67.8%) assigned to receive antiarrhythmic drugs (hazard ratio, 0.48; 95% confidence interval [CI], 0.35 to 0.66; P<0.001). Symptomatic atrial tachyarrhythmia had recurred in 11.0% of the patients who underwent ablation and in 26.2% of those who received antiarrhythmic drugs (hazard ratio, 0.39; 95% CI, 0.22 to 0.68). The median percentage of time in atrial fibrillation was 0% (interquartile range, 0 to 0.08) with ablation and 0.13% (interquartile range, 0 to 1.60) with antiarrhythmic drugs. Serious adverse events occurred in 5 patients (3.2%) who underwent ablation and in 6 patients (4.0%) who received antiarrhythmic drugs.
Conclusions:
Among patients receiving initial treatment for symptomatic, paroxysmal atrial fibrillation, there was a significantly lower rate of atrial fibrillation recurrence with catheter cryoballoon ablation than with antiarrhythmic drug therapy, as assessed by continuous cardiac rhythm monitoring. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).
Insights
First-line catheter cryoballoon ablation significantly reduces atrial fibrillation recurrence compared to antiarrhythmic drugs in patients with symptomatic paroxysmal atrial fibrillation. This approach offers a more effective strategy for maintaining sinus rhythm over 12 months.
Area of Science:
- Cardiology
- Electrophysiology
- Medical Devices
Background:
- Current guidelines suggest antiarrhythmic drugs before considering catheter ablation for atrial fibrillation.
- However, the efficacy of first-line catheter ablation in maintaining sinus rhythm remains an area of investigation.
Purpose of the Study:
- To compare the effectiveness of initial catheter cryoballoon ablation versus antiarrhythmic drug therapy for rhythm control in patients with symptomatic paroxysmal atrial fibrillation.
- To assess the rates of atrial tachyarrhythmia recurrence and other clinical outcomes over a 12-month follow-up period.
Main Methods:
- A randomized trial involving 303 patients with untreated, symptomatic, paroxysmal atrial fibrillation.
- Patients were assigned to either catheter cryoballoon ablation or antiarrhythmic drug therapy.
- Continuous cardiac rhythm monitoring via implantable devices was used to detect atrial tachyarrhythmias.
Main Results:
- At 1 year, atrial tachyarrhythmia recurrence occurred in 42.9% of the ablation group versus 67.8% of the drug therapy group (HR, 0.48; P<0.001).
- Symptomatic recurrence was significantly lower with ablation (11.0%) compared to drugs (26.2%) (HR, 0.39).
- Serious adverse events were comparable between the two groups.
Conclusions:
- Catheter cryoballoon ablation is more effective than antiarrhythmic drug therapy in reducing atrial fibrillation recurrence in the initial treatment of symptomatic paroxysmal atrial fibrillation.
- Continuous cardiac rhythm monitoring revealed a significantly lower recurrence rate with ablation.
- First-line ablation demonstrates a superior strategy for maintaining sinus rhythm.
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