Prophylactic pulmonary vein isolation during isthmus ablation for atrial flutter: the PReVENT AF Study I.

Background: Although catheter ablation of isthmus-dependent atrial flutter (AFL) is successful at eliminating the target arrhythmia, many patients subsequently experience new-onset atrial fibrillation (AF).

Objective: The aim of this study was to determine whether AF can be prevented by prophylactic pulmonary vein ablation in patients with AFL.

Methods: A prospective, single-blind, randomized clinical trial in patients whose sole arrhythmia was AFL without AF was conducted. Patients were randomized to cavotricuspid isthmus ablation alone or with concomitant pulmonary vein isolation. All patients received an implantable cardiac monitor.

Results: Fifty patients completed the trial, and patients were well matched. Isthmus ablation was successful in all patients; pulmonary vein isolation was successful in 25 (100%) randomized patients. Procedure (P < .0001) and fluoroscopy (P < .0001) times were longer in the combined ablation group. More patients in the isthmus ablation-only group experienced new-onset AF during follow-up (52% vs. 12%; P = .003). The 1-year AF burden also favored the combined ablation group compared with the isthmus ablation-only group (8.3% vs. 4.0%; P = .034). In the isthmus ablation-only group, 8 (32%) patients subsequently underwent another ablation for AF. The performance of pulmonary vein isolation and male sex were independent predictors of freedom from AF.

Conclusion: In the PREVENT-AF Study I randomized clinical trial of patients in whom only typical AFL had been observed clinically, the addition of pulmonary vein isolation to cavotricuspid isthmus ablation resulted in a marked reduction of new-onset AF during clinical follow-up as assessed with a continuous implantable cardiac monitor.