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

Eur Heart J. 2012 Nov;33(21):2644-52. doi: 10.1093/eurheartj/ehs290. Epub 2012 Aug 28.

Abstract

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anticoagulants / therapeutic use
  • Atrial Fibrillation / complications
  • Atrial Fibrillation / surgery*
  • Catheter Ablation / methods*
  • Coronary Disease / complications
  • Coronary Disease / surgery*
  • Electrocardiography
  • Female
  • Heart Valve Diseases / complications
  • Heart Valve Diseases / surgery*
  • Humans
  • Male
  • Operative Time
  • Postoperative Care / methods
  • Postoperative Complications / etiology
  • Prospective Studies
  • Recurrence
  • Treatment Outcome

Substances

  • Anticoagulants