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Progression of Atrial Fibrillation after Cryoablation or Drug Therapy
Jason G Andrade1, Marc W Deyell1, Laurent Macle1
1From 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, Montreal (J.G.A., L.M., J.C.-T.), the University of Ottawa Heart Institute, Ottawa (G.A.W.), McGill University Health Centre, Montreal (V.E., A.V.), Université Laval, Quebec (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), University of Western Ontario, London (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's 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 (S.W.) - all in Canada; and Marienhospital Osnabrück, Niedersachsen, Germany (S.K.).
Insights
Initial cryoballoon ablation for atrial fibrillation significantly reduced persistent episodes and recurrent atrial tachyarrhythmia compared to antiarrhythmic drugs over three years. This rhythm-control therapy offers a superior alternative for managing paroxysmal atrial fibrillation.
Area of Science:
- Cardiology
- Electrophysiology
- Medical Devices
Background:
- Atrial fibrillation (AF) is a progressive disorder with risks of thromboembolism and heart failure.
- Persistent AF is associated with worse outcomes.
- Catheter ablation may alter AF progression.
Purpose of the Study:
- To compare the 3-year outcomes of initial cryoballoon ablation versus antiarrhythmic drugs for paroxysmal atrial fibrillation.
- To evaluate the incidence of persistent AF, recurrent atrial tachyarrhythmia, AF burden, and safety.
Main Methods:
- 303 patients with paroxysmal AF were randomized to cryoballoon ablation or antiarrhythmic drug therapy.
- Implantable loop recorders monitored daily rhythm.
- Follow-up included assessments of persistent AF, atrial tachyarrhythmia recurrence, AF burden, quality of life, healthcare utilization, and safety.
Main Results:
- Fewer patients in the ablation group developed persistent AF (1.9% vs 7.4%).
- Recurrent atrial tachyarrhythmia was less frequent with ablation (56.5% vs 77.2%).
- Median AF burden was significantly lower with ablation; fewer hospitalizations and serious adverse events were observed.
Conclusions:
- Initial cryoballoon ablation for paroxysmal AF led to a lower incidence of persistent AF and recurrent atrial tachyarrhythmia over 3 years compared to antiarrhythmic drugs.
- Catheter ablation represents a more effective initial rhythm-control strategy.
- The EARLY-AF trial demonstrates the benefits of early ablation in managing AF.
Background:
Atrial fibrillation is a chronic, progressive disorder, and persistent forms of atrial fibrillation are associated with increased risks of thromboembolism and heart failure. Catheter ablation as initial therapy may modify the pathogenic mechanism of atrial fibrillation and alter progression to persistent atrial fibrillation.
Methods:
We report the 3-year follow-up of patients with paroxysmal, untreated atrial fibrillation who were enrolled in a trial in which they had been randomly assigned to undergo initial rhythm-control therapy with cryoballoon ablation or to receive antiarrhythmic drug therapy. All the patients had implantable loop recorders placed at the time of trial entry, and evaluation was conducted by means of downloaded daily recordings and in-person visits every 6 months. Data regarding the first episode of persistent atrial fibrillation (lasting ≥7 days or lasting 48 hours to 7 days but requiring cardioversion for termination), recurrent atrial tachyarrhythmia (defined as atrial fibrillation, flutter, or tachycardia lasting ≥30 seconds), the burden of atrial fibrillation (percentage of time in atrial fibrillation), quality-of-life metrics, health care utilization, and safety were collected.
Results:
A total of 303 patients were enrolled, with 154 patients assigned to undergo initial rhythm-control therapy with cryoballoon ablation and 149 assigned to receive antiarrhythmic drug therapy. Over 36 months of follow-up, 3 patients (1.9%) in the ablation group had an episode of persistent atrial fibrillation, as compared with 11 patients (7.4%) in the antiarrhythmic drug group (hazard ratio, 0.25; 95% confidence interval [CI], 0.09 to 0.70). Recurrent atrial tachyarrhythmia occurred in 87 patients in the ablation group (56.5%) and in 115 in the antiarrhythmic drug group (77.2%) (hazard ratio, 0.51; 95% CI, 0.38 to 0.67). The median percentage of time in atrial fibrillation was 0.00% (interquartile range, 0.00 to 0.12) in the ablation group and 0.24% (interquartile range, 0.01 to 0.94) in the antiarrhythmic drug group. At 3 years, 8 patients (5.2%) in the ablation group and 25 (16.8%) in the antiarrhythmic drug group had been hospitalized (relative risk, 0.31; 95% CI, 0.14 to 0.66). Serious adverse events occurred in 7 patients (4.5%) in the ablation group and in 15 (10.1%) in the antiarrhythmic drug group.
Conclusions:
Initial treatment of paroxysmal atrial fibrillation with catheter cryoballoon ablation was associated with a lower incidence of persistent atrial fibrillation or recurrent atrial tachyarrhythmia over 3 years of follow-up than initial use of antiarrhythmic drugs. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).
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