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Randomized Controlled Trial Multicenter Study
Stepwise ablation approach versus pulmonary vein isolation in patients with paroxysmal atrial fibrillation: Randomized controlled trial.
- Massimiliano Faustino, Carmine Pizzi, Tullio Agricola, Borejda Xhyheri, Grazia Maria Costa, Maria Elena Flacco, Lorenzo Capasso, Giancarlo Cicolini, Enrico Di Girolamo, Luigi Leonzio, and Lamberto Manzoli.
- Cardiology Department, Private Hospital "L. Pierangeli," Pescara, Italy; Electrophysiology Operating Unit, Cardiovascular Department, "Spirito Santo" Hospital, ASL Pescara, Pescara, Italy.
- Heart Rhythm. 2015 Sep 1; 12 (9): 1907-15.
BackgroundPulmonary vein isolation (PVI) is a central procedure for the treatment of paroxysmal atrial fibrillation (PAF). However, in patients with PAF and structural atrial disease, PVI may fail and cause progressive atrial remodeling, often leading to persistent/permanent atrial fibrillation.ObjectiveWe performed a prospective, single-blind, 2-center randomized controlled trial to compare the efficacy of PVI alone with that of PVI plus stepwise ablation in achieving sinus rhythm and nonatrial arrhythmia inducibility in patients with PAF refractory to antiarrhythmic therapy.MethodsPatients were randomized to perform a first catheter ablation procedure either through PVI alone or through PVI plus substrate modification in stepwise ablation. Data were recorded at 3, 6, and 12 months after both ablation procedures. Patients who experienced atrial fibrillation/atrial tachycardia (AF/AT) recurrence were encouraged to undergo repeat ablation using the technique of the first ablation procedure.ResultsA total of 150 patients were enrolled (mean age 62.8 ± 8.7 years; 92 (61.3%) men; 104 (69.3%) hypertensive; AF mean duration 10.7 months), with 75 patients in each group. After 12 months of the first procedure, patients who were converted to sinus rhythm using stepwise ablation showed a significantly lower rate of AF/AT recurrence (26.7%) than did those who were treated using PVI alone (46.7%; P < .001). Similar results were observed in the 52 patients who underwent a second catheter ablation procedure. After adjusting for several potential confounders, the hazard ratio of 12-month AF/AT recurrence after the first ablation procedure was 0.53 (95% confidence interval 0.30-0.91) for those treated using stepwise ablation.ConclusionIn addition to PVI, stepwise ablation achieving sinus rhythm and nonatrial arrhythmia inducibility has relevantly improved the clinical outcome of the PAF control strategy.Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
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