Sequential Hybrid Ablation versus Surgical CryoMaze Alone for Treatment of Atrial Fibrillation: Results of Multicentre Randomised Controlled Trial
Abstract
BACKGROUND AND AIMS: Data on the hybrid atrial fibrillation (AF) treatment are lacking in patients with structural heart disease undergoing concomitant CryoMaze procedures. The aim was to assess whether the timely pre-emptive catheter ablation would achieve higher freedom from AF or atrial tachycardia (AT) and be associated with better clinical outcomes than surgical ablation alone.
METHODS: The trial investigated patients with non-paroxysmal AF undergoing coronary artery bypass grafting and/or valve repair/replacement with mandatory concomitant CryoMaze procedure who were randomly assigned to undergo either radiofrequency catheter ablation (Hybrid Group) or no further treatment (Surgery Group). The primary efficacy endpoint was the first recurrence of AF/AT without class I or III antiarrhythmic drugs as assessed by implantable cardiac monitors.
The primary clinical endpoint was a composite of hospitalisation for arrhythmia recurrence, worsening of heart failure, cardioembolic event, or major bleeding. RESULTS: We analysed 113 and 116 patients in the Hybrid and Surgery Groups, respectively, with a median follow-up of 715 (IQR: 528-1072) days.
The primary efficacy endpoint was significantly reduced in the Hybrid Group (41.1% vs 67.4%, hazard ratio (HR)=0.38, 95% confidence interval (CI): 0.26-0.57, P<0.001) as well as the primary clinical endpoint (19.9% vs 40.1%, HR=0.51, 95% CI: 0.29-0.86, P=0.012). The trial groups did not differ in all-cause mortality (10.6% vs 8.6%, HR=1.17, 95%CI: 0.51-2.71, P=0.71).
The major complications of catheter ablation were infrequent (1.9%). CONCLUSIONS: Pre-emptively performed catheter ablation after the CryoMaze procedure was safe and associated with higher freedom from AF/AT and improved clinical outcomes.