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PRAGUE-12: Surgical ablation found safe, effective for AF patients undergoing cardiac surgery
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MUNICH — Left atrial surgical ablation improved the likelihood of the presence of sinus rhythm at 1 year, without increasing perioperative complications, in patients with atrial fibrillation referred for cardiac surgery.
According to final results from the randomized, multicenter PRAGUE-12 study, Holter electrocardiogram monitoring 1 year after cardiac surgery revealed sinus rhythm without any AF episodes in 60.2% of patients who had surgical ablation vs. 35.5% of patients who did not (P=.002). This was the primary efficacy outcome of the study.
However, the higher prevalence of sinus rhythm with cardiac surgery and ablation did not translate to improved clinical outcomes at 1 year, Petr Widimsky, MD, from the cardiocenter of Charles University, Prague, said at the European Society of Cardiology Congress.
The combined safety endpoint (death/MI/stroke or transient ischemic attack/new-onset renal failure requiring hemodialysis) at 30 days was positive in 10.3% of patients who had surgical ablation vs. 14.7% of patients who did not (P=.411). Researchers found no change in left ventricular ejection fraction or left atrial diameter between the two groups. All-cause mortality at 1 year was 16.2% in patients who had surgical ablation vs. 17.4% of patients who did not (P=.8). Stroke was reported more in patients who underwent cardiac surgery alone (4.3% vs. 2.7%; P=.319). Researchers reported a slight trend toward more hospitalization for HF during 1 year among patients who underwent cardiac surgery alone (26.1% vs. 23.4%; P=.68). Major bleeding was similar in both groups (ablation, 9.9% vs. no ablation, 9.8%; P=.654).
Surgical ablation prolonged total surgical time by 20 minutes (220 minutes vs. 200 minutes).
At a press conference, Widimsky said: “Surgical ablation improves the likelihood of sinus rhythm presence up to 1 year postoperatively, without perioperative complications and no impact on 1-year clinical outcomes.”
When patients were divided into subgroups based on AF type at randomization, there was no difference between the ablation and no ablation groups in the presence of sinus rhythm at 1 year among paroxysmal (ablation, 61.9% vs. no ablation, 58.3%) or persistent AF (72% vs. 50%) patients. There was a significant increase in sinus rhythm restoration rate among patients with permanent AF treated by cardiac surgery and surgical ablation at 1 year (53.2% vs. 13.9%; P<.001). The number of true responders, defined as the percentage of patients who had AF at time of surgery and sinus rhythm at 1 year, was 56% in the ablation group and 17% in the no ablation group (P=.000029).
“The most significant rhythm benefit was in patients with longstanding, persistent AF. There was no benefit seen in [patients with] paroxysmal AF,” Widimsky said at the press conference.
The PRAGUE-12 study included 224 patients with AF scheduled for valve and/or CABG who were randomly assigned to left surgical ablation (n=117) or no ablation (n=107). The study is designed to follow patients out to 5 years. – by Katie Kalvaitis
For more information:
Widimsky P. Hot line III: Late breaking trials on arrhythmias and CAD. Presented at: the European Society of Cardiology Congress; Aug. 25-29, 2012; Munich.
Budera P. Eur Heart J. 2012;doi:10.1093/eurheartj/ehs290.
Disclosure: Dr. Widimsky reports no relevant financial disclosures.