Heart rhythm · 2013
The CURE-AF trial: a prospective, multicenter trial of irrigated radiofrequency ablation for the treatment of persistent atrial fibrillation during concomitant cardiac surgery.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Damiano Ralph J, Badhwar Vinay, Acker Michael A, Veeragandham Ramesh S, Kress David C, Robertson Jason O, Sundt Thoralf M
Аннотация
BACKGROUND: Ablation technology has been introduced to replace the surgical incisions of the Cox-Maze procedure in order to simplify the operation. However, the efficacy of these ablation devices has not been prospectively evaluated.
OBJECTIVE: The purpose of this study was to examine the efficacy and safety of irrigated unipolar and bipolar radiofrequency ablation for the treatment of persistent and long-standing persistent atrial fibrillation (AF) during concomitant cardiac surgical procedures.
METHODS: Between May 2007 and July 2011, 150 consecutive patients were enrolled at 15 U.S. centers. Patients were followed for 6 to 9 months, at which time a 24-hour Holter recording and echocardiogram were obtained. Recurrent AF was defined as any atrial tachyarrhythmia (ATA) lasting over 30 seconds on the Holter monitor. The safety end-point was the percent of patients who suffered a major adverse event within 30 days of surgery. All patients underwent a biatrial Cox-Maze lesion set.
RESULTS: Operative mortality was 4%, and there were 4 (3%) 30-day major adverse events. Overall freedom from ATAs was 66%, with 53% of patients free from ATAs and also off antiarrhythmic drugs at 6 to 9 months. Increased left atrial diameter, shorter total ablation time, and an increasing number of concomitant procedures were associated with recurrent AF (P <.05).
CONCLUSION: Irrigated radiofrequency ablation for treatment of AF during cardiac surgery was associated with a low complication rate. No device-related complications occurred. The Cox-Maze lesion set was effective at restoring sinus rhythm and had higher success rates in patients with smaller left atrial diameters and longer ablation times.
OBJECTIVE: The purpose of this study was to examine the efficacy and safety of irrigated unipolar and bipolar radiofrequency ablation for the treatment of persistent and long-standing persistent atrial fibrillation (AF) during concomitant cardiac surgical procedures.
METHODS: Between May 2007 and July 2011, 150 consecutive patients were enrolled at 15 U.S. centers. Patients were followed for 6 to 9 months, at which time a 24-hour Holter recording and echocardiogram were obtained. Recurrent AF was defined as any atrial tachyarrhythmia (ATA) lasting over 30 seconds on the Holter monitor. The safety end-point was the percent of patients who suffered a major adverse event within 30 days of surgery. All patients underwent a biatrial Cox-Maze lesion set.
RESULTS: Operative mortality was 4%, and there were 4 (3%) 30-day major adverse events. Overall freedom from ATAs was 66%, with 53% of patients free from ATAs and also off antiarrhythmic drugs at 6 to 9 months. Increased left atrial diameter, shorter total ablation time, and an increasing number of concomitant procedures were associated with recurrent AF (P <.05).
CONCLUSION: Irrigated radiofrequency ablation for treatment of AF during cardiac surgery was associated with a low complication rate. No device-related complications occurred. The Cox-Maze lesion set was effective at restoring sinus rhythm and had higher success rates in patients with smaller left atrial diameters and longer ablation times.