Patients with atrial fibrillation treated with radioablation had outcomes similar to those of healthy people in the general population and superior to those of peers who chose drug treatment, according to a nonrandomized study reported in the July 16th issue of the Journal of the American College of Cardiology.

"Pulmonary vein ablation improves mortality, morbidity, and quality of life as compared with medical therapy. Our findings pave the way for randomized trials to test a wider application of ablation therapy for atrial fibrillation," said Carlo Pappone, MD, PhD, lead author of the study.

Italian researchers enrolled 1,171 patients to one specialty center for treatment of their symptomatic atrial fibrillation. Based on personal preferences and the advice of an electrophysiologist, 589 patients chose a pulmonary vein ablation technique developed at the center, whereas 582 patients chose treatment with antiarrhythmic medications. The two groups of patients were generally similar, although patients in the ablation group tended to have a longer duration of symptomatic arrhythmia, to have tried more medical treatments, and to have been hospitalized more frequently than those who chose medical therapy.

The ablation procedure involved 3-dimensional mapping of the left atrium and pulmonary vein, after which a catheter was threaded into the area where the pulmonary vein joins the atrium. Radio frequency energy pulses from the catheter tip produced circular scars that were intended to interrupt abnormal electrical pacing activity.

After a median follow-up of 2.5 years (range, 5 months to 4 years) survival was higher for the ablation group than for the medical group and post-ablation survival was not different from that expected for healthy peers of the same gender and age. The ablation group had less than half the death rate of the medical group (38 deaths [6 percent] in the ablation group compared with 83 deaths [14 percent] in the medical group) and less than one third the risk for recurrent atrial fibrillation. The quality of life of patients who underwent ablation was similar to that of the general population and better than that of the medically treated group.

The authors emphasized that the study findings must be confirmed by randomized trials in order to rule out unrecognized factors that might have affected the results. The researchers also noted that many patients in both groups had no cardiovascular disease, so longer follow-up data will be needed to get a full picture of long-term outcomes.

"This kind of treatment of atrial fibrillation allows patients undergoing ablation to become drug-free in a relatively short time, greatly enhancing their quality of life. By contrast, long-term medical treatment bears remarkable proarrhythmia risks, let alone extremely high costs," Pappone said.

In an editorial, Kenneth A. Ellenbogen, MD, and Mark A. Wood, MD, called the study provocative and the results striking: "The study in this issue of the Journal raises a crucially important question. If we can nonpharmacologically maintain sinus rhythm in a high percentage of patients with atrial fibrillation safely, survival may be better than with either heart rate control or antiarrhythmic drugs."

"This is a landmark study. It opens the question about who should receive catheter ablation of atrial fibrillation and how it may be a curative procedure in many patients, leaving them with a better quality of life and even survival. The remaining issues are to confirm these findings in a prospective trial and to consider a variety of technical issues," Ellenbogen said.

The editorial noted that, to date, follow-up studies of patients undergoing ablation with the "Pappone approach" (the technique used in the study) indicate that no patient has developed pulmonary vein stenosis, one of the most feared complications of ablative approaches to atrial fibrillation. The editorial authors called for randomized trials of atrial fibrillation treatments that include ablation procedures in order to help physicians decide how to fit ablation among alternative treatment options.