Comparison of cardiac surgery with left atrial surgical ablation vs. cardiac surgery without atrial ablation in patients with coronary and/or valvular heart disease plus atrial fibrillation: final results of the PRAGUE-12 randomized multicentre study
Abstrakt
Aims Surgical ablation procedure can restore sinus rhythm (SR) in patients with atrial fibrillation (AF) undergoing cardiac surgery. However, it is not known whether it has any impact on long-term clinical outcomes.
Methods and results This multicentre study randomized 224 patients with AF scheduled for valve and/or coronary surgery: group A (left atrial surgical ablation, n = 117) vs. group B (no ablation, n = 107). The primary efficacy outcome was the SR presence (without any AF episode) during a 24 h electrocardiogram (ECG) after 1 year.
The primary safety outcome was the combined endpoint of death/myocardial infarction/stroke/renal failure at 30 days. A Holter-ECG after 1 year revealed SR in 60.2 of group A patients vs. 35.5 in group B (P = 0.002).
The combined safety endpoint at 30 days occurred in 10.3 (group A) vs. 14.7 (group B, P = 0.411). All-cause 1-year mortality was 16.2 (A) vs. 17.4 (B, P = 0.800).
Stroke occurred in 2.7 (A) vs. 4.3 (B) patients (P = 0.319). No difference (A vs.
B) in SR was found among patients with paroxysmal (61.9 vs. 58.3) or persistent (72 vs. 50) AF, but ablation significantly increased SR prevalence in patients with longstanding persistent AF (53.2 vs. 13.9, P < 0.001). Conclusion Surgical ablation improves the likelihood of SR presence post-operatively without increasing peri-operative complications.
However, the higher prevalence of SR did not translate to improved clinical outcomes at 1 year. Further follow-ups (e.g. 5-year) are warranted to show any potential clinical benefit which might occur later.