Amiodarone after surgical ablation for atrial fibrillation: Is it really necessary? A prospective randomized controlled trial.

Objective: Prophylactic antiarrhythmic drug (AAD) treatment is a well-established practice after catheter ablation for atrial fibrillation (AF), but it is controversial after surgical ablation. This prospective randomized controlled trial examined whether amiodarone after surgical ablation reduced atrial arrhythmia recurrence within the first 3 months after surgery.

Methods: Ninety patients were randomized to receive (n = 45) or not receive (n = 45) amiodarone after surgical ablation. Rhythm status was ascertained via clinical follow-up and 72-hour continuous monitoring at 6 and 12 weeks, using Heart Rhythm Society guidelines. Primary outcome was defined as atrial arrhythmia recurrence, cardioversion, ablation, or crossover from no-amiodarone to amiodarone as a result of atrial arrhythmia during follow-up. An intention-to-treat approach was used.

Results: The 2 study groups were similar in traditional predictors for failure, including left atrium size (5.0 vs 5.1 cm, P = .734), median AF duration (23 vs 20 months, P = .513), and long-standing persistent AF (44% vs 33%, P = .280). The primary outcome occurred in 52% of the no-amiodarone group (23 of 44) and 19% of the amiodarone group (8 of 43; P = .001). Cumulative freedom from primary outcome was greater in the amiodarone group (81.4% vs 47.7%, P < .001). Amiodarone was discontinued in 18 patients randomized to amiodarone for side effects, bradycardia, or noncompliance.

Conclusions: Prophylactic amiodarone reduced early atrial arrhythmia recurrence. These results are consistent with catheter AF ablation findings and should inform recommendations for prophylactic class I/III AAD after surgical AF ablation, regardless of discharge rhythm status. As previously recommended, monitoring for side effects and amiodarone discontinuation by 3 months, for patients in sinus rhythm, is warranted.

Clinical Trial Registration: NCT01416935.