Key result
Sequential hybrid ablation cuts AF/AT recurrence ~62% vs. surgical CryoMaze alone in non-paroxysmal AF.
Why the study?
Data on hybrid AF treatment were lacking in patients with structural heart disease undergoing concomitant CryoMaze procedures, leaving it uncertain whether timely pre-emptive catheter ablation improves arrhythmia freedom and clinical outcomes over surgical ablation alone.
Does pre-emptive staged radiofrequency catheter ablation following concomitant surgical CryoMaze reduce AF/AT recurrence and improve clinical outcomes compared to surgical CryoMaze alone in patients with non-paroxysmal atrial fibrillation undergoing cardiac surgery?
RCT (n=229)
Open-label
1:1 covariate-adaptive randomization post-operatively within 7 days after surgery, stratified by type of surgery (open/closed-heart) and CHA2DS2-VASc score
Yes
Does pre-emptive staged radiofrequency catheter ablation following concomitant surgical CryoMaze reduce AF/AT recurrence and improve clinical outcomes compared to surgical CryoMaze alone in patients with non-paroxysmal atrial fibrillation undergoing cardiac surgery?
In patients with non-paroxysmal AF undergoing cardiac surgery with concomitant CryoMaze, pre-emptive staged catheter ablation at 3 months is safe and substantially reduces both AF/AT recurrence (by 62%) and clinical hospitalizations for arrhythmia or heart failure (by 49%) compared to surgical ablation alone.
Answers are grounded in this paper and cite their sources.
Supports staged hybrid ablation after CryoMaze in non-paroxysmal AF surgery patients; extends prior observational data with first RCT evidence.
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 AND RESULTS: 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 (HG)] 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 hospitalization for arrhythmia recurrence, worsening of heart failure, cardioembolic event, or major bleeding. 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 HG [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%). CONCLUSION: Pre-emptively performed catheter ablation after the CryoMaze procedure was safe and associated with higher freedom from AF/AT and improved clinical outcomes.
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Bulava et al. (2024) conducted an RCT in Symptomatic non-paroxysmal atrial fibrillation in patients with structural heart disease undergoing cardiac surgery with concomitant CryoMaze (n=229). Sequential hybrid ablation (concomitant surgical CryoMaze followed by staged radiofrequency catheter ablation at 90 days) vs. Surgical CryoMaze procedure alone without subsequent catheter ablation was evaluated on First recurrence of AF/AT lasting >6 min without Class I or III antiarrhythmic drugs during the post-blanking follow-up period, assessed by implantable cardiac monitors (HR 0.38, 95% CI 0.26-0.57, p=<0.001). Sequential hybrid ablation reduced AF/AT recurrence compared to surgical CryoMaze alone in non-paroxysmal AF patients undergoing cardiac surgery.
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