Abstract

Introduction: Atrial fibrillation increases the risk of stroke 5-fold. The efficacy of endocardial catheter ablation (CA) for drug - refractory persistent and longstanding persistent AF (PsAF) is limited and has led to the development of minimally invasive hybrid epicardial/endocardial ablation technique (hybrid Convergent) to achieve a comprehensive lesion set with durable transmural lesions. The CONVERGE IDE randomized controlled trial prospectively evaluated the effectiveness of Convergent ablation compared to CA for the treatment of PsAF. Methods: PsAF patients, >18 to <80 years with left atrial sizes up to 6 cm, no limit on the duration of PsAF, refractory/intolerant to class I/III anti-arrhythmic drugs (AADs) were randomized 2:1 to Convergent vs CA at 27 sites (US, UK). Freedom from atrial arrhythmia (AF/AFL/AT) through 12-mo was assessed using 24-hr Holter at 6-mo and 12-mo and ECGs at 3-mo or unscheduled visits. An analysis of freedom from atrial arrhythmia stratified by AAD use was performed. Results: One hundred fifty-three patients (102 Convergent, 51 CA) with similar baseline characteristics were treated. Body mass index (mean 33.7, range 19.1- 50.1) and years since PsAF diagnosis (mean 4.4 years, range 0.5 - 26.0 years) were high; 42.5% (65/153) patients had longstanding persistent AF. In the Convergent arm, 4 major adverse events (3.9%, 4/102) were reported through the first 7 days and additional 4 events (3.9%) from days 8 - 30. The safety rates were lower than the performance goal of 12%. Rates of freedom from atrial arrythmia stratified by AAD use are included in Table1. Irrespective of the criteria, the hybrid Convergent procedure demonstrated significantly higher treatment success compared to CA (RR 1.28 - 1.67, p<0.05). Conclusion: The hybrid Convergent procedure combining epicardial and endocardial ablation is safe and has superior effectiveness as compared to the endocardial catheter ablation for the treatment of PsAF, irrespective of AAD use.

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