Abstract 12144: Impact of Different Catheter Ablation Strategies on Procedure Outcome in Coexistent Atrial Flutter and Fibrillation: Results From a Single-Blinded Randomized Study (APPROVAL)
Introduction: This study aimed to compare the impact of different ablation strategies on AF recurrence and quality of life (QoL) in coexistent atrial fibrillation (AF) and flutter (AFL).
Method: Eighty-six consecutively enrolled patients with documented AF and AFL were blinded and randomized to group 1: AF±AFL ablation (n=54) or Group 2: AFL ablation only (n=32). AF-recurrence was evaluated with event-recording and 7-day Holters at 3, 6, 9 and 12 months follow-up. QoL was assessed at baseline and 12-month follow-up using 4 self-administered questionnaires; Medical Outcome Study Short Form (SF-36), Hospital Anxiety and Depression Score (HAD), Beck Depression Inventory (BDI) and State-Trait Anxiety Inventory (STAI).
Result: Of the 54 (63%) patients in group 1, 43 had AF+AFL ablation and 11 had AF ablation. All patients in group 2 had only AFL ablation. At 16±4 months follow-up, 37 (69%) in group 1 and 9 (28%) in group 2 were arrhythmia-free (p <0.001). In group 1, scores on almost all QoL subscales showed significant improvement at follow-up, whereas group 2 patients derived relatively minor benefit (Table). STAI scores did not show any significant association with ablation outcome.
Conclusion: In patients with coexistent AF and AFL, lower recurrence and better QoL is associated with AF ± AFL ablation than with lone AFL ablation. This is the first study showing that in patients blinded to the procedure, QoL is not impacted by a placebo effect.
- © 2011 by American Heart Association, Inc.