BOSTON — Catheter ablation plus amiodarone therapy was substantially better than amiodarone treatment alone for preventing recurrent atrial fibrillation during 1 year of follow-up in a randomized, controlled study with 146 patients.
“This is the first illustration in a randomized study that patients with chronic atrial fibrillation can be kept in sinus rhythm,” Dr. Carlo Pappone said at an international symposium on atrial fibrillation sponsored by Massachusetts General Hospital.
The study enrolled patients with chronic atrial fibrillation for more than 6 months. Their average age was 56, and about 23% of patients had structural heart disease, most commonly nonischemic cardiomyopathy. Their average left ventricular ejection fraction was 55%, and the average duration of atrial fibrillation was more than 4 years. All patients had failed prior therapy with an average of two antiarrhythmic drugs.
A total of 69 patients were randomized to circumferential pulmonary vein ablation (PVA) using radiofrequency followed by daily treatment with amiodarone for 3 months, and 77 patients were randominzed to amiodarone only.
Patients were then followed in a blinded manner by daily, transtelephonic monitoring. During 1 year of follow-up, 75% of patients treated with PVA remained free of episodes of atrial fibrillation, compared with 4% of the control group, said Dr. Pappone, director of the division of arrhythmology at San Raffaele Hospital in Milan.
Dr. Pappone's group at San Raffaele used catheter ablation to treat more than 9,000 patients starting in the 1990s. The rate of major complications was 0.4%, with no deaths. But the outcomes varied from center to center, Dr. Pappone said at the conference, also sponsored by the Academy of Health Care Education.
