Prophylactic pulmonary vein isolation during isthmus ablation for atrial flutter: Three‐year outcomes of the PREVENT AF I study

Abstract Introduction The PREVENT AF I study demonstrated that prophylactic pulmonary vein isolation (PVI) in patients with pure typical atrial flutter (AFL) resulted in substantial reduction of new‐onset atrial fibrillation (AF) during 1‐year follow‐up as assessed by continuous implantable cardiac monitor (ICM). The objective of this study was to assess 3‐year outcomes. Methods and results Fifty patients with documented AFL were randomized to either cavotricuspid isthmus (CTI) ablation alone (n = 25) or CTI with concomitant PVI (n = 25). The primary endpoint of the study was the occurrence of any atrial tachyarrhythmia with the monthly burden exceeding 0.5% on the ICM. At the end of 3 years, freedom from any atrial tachyarrhythmia was 48% (95% confidence interval [CI]: 32–72%) in the CTI plus PVI group as compared to 20% (95% CI: 9–44%) in the CTI‐only group (P = 0.01). Freedom from redo procedures was also higher: 92% (95% CI: 82–100%) versus 68% (95% CI: 52–89%), respectively (P = 0.027). The 3‐year AF burden favored the combined ablation group: 6.2% versus 16.8% (P = 0.03). In the CTI‐only group, 12 (48%) patients were hospitalized compared to 4 (16%) in the PVI + CTI group (P = 0.03). Two patients in the CTI‐only group developed stroke with no serious adverse events in the PVI + CTI group. Conclusion Prophylactic PVI in patients with only typical AFL resulted in a significant reduction of new‐onset AF and burden during long‐term follow‐up as assessed by ICM, with consequent reduction in hospitalizations and need to perform repeat ablation for AF.