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 kept be in sinus rhythm,” Dr. Carlo Pappone said at an international symposium on atrial fibrillation sponsored by Massachusetts General Hospital.
The investigation enrolled participants with more than a 6-month history of chronic atrial fibrillation.
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 participants in the study had failed prior treatment with an average of two antiarrhythmic medications.
Patients were randomized, with 69 treated by circumferential pulmonary vein ablation (PVA) using radiofrequency followed by daily treatment with amiodarone for 3 months. The 77 control patients were treated with amiodarone only.
Patients were then followed in a blinded manner by daily, transtelephonic monitoring. During 12 months of follow-up, 75% of the patients treated with pulmonary vein ablation remained free of new episodes of atrial fibrillation, compared with 4% who were free of atrial arrhythmias in the control group, said Dr. Pappone, director of the division of arrhythmology at San Raffaele Hospital in Milan.
Dr. Pappone also reported his group's total, updated safety experience using catheter ablation to treat atrial fibrillation. From the 1990s through June 2005, his group at San Raffaele had used catheter ablation to treat more than 9,000 patients. The rate of major complications in treated patients was about 0.4%, a rate that included no deaths. However, Dr. Pappone acknowledged that the outcome of catheter ablation varied from center to center.
“There is no doubt that safety and efficacy are strongly operator dependent,” Dr. Pappone said at the conference, which was also sponsored by the Academy of Health Care Education.
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