Results From a Single-Blinded Randomized Study (APPROVAL) Comparing The Impact of Different Ablation Strategies on Long Term Procedure Outcome in Coexistent Atrial Fibrillation and Flutter
Background—This study examined the impact of different ablation strategies on AF recurrence and quality of life (QoL) in coexistent atrial fibrillation (AF) and flutter (AFL).
Methods and Results—Three-hundred sixty enrolled patients with documented AF and AFL were blinded and randomized to group 1: AF±AFL ablation (n=182) or Group 2: AFL ablation only (n=178). AF-recurrence was evaluated with event-recording and 7-day Holter at 3, 6, 9 and 12 months follow-up. QoL was assessed at baseline and 12-month follow-up using 4 questionnaires; Medical Outcome Study Short Form, Hospital Anxiety and Depression Score, Beck Depression Inventory and State-Trait Anxiety Inventory. Of the 182 patients in group 1, 58 (63±8 years, 78% male, 59±8% LVEF) had AF+AFL ablation and 124 (61±11 years, 72% male, 59±7% LVEF) had AF ablation only. In group 2 (62±9 years, 76% male, 58±10% LVEF) only flutter was ablated by achieving bidirectional isthmus conduction block. Baseline characteristics were not different across groups. At 21±9 months follow-up, 125 (69%) in group 1 and 34 (19%) in group 2 were arrhythmia-free (p <0.001). In group 1, scores on most QoL subscales showed significant improvement at follow-up, whereas group 2 patients derived relatively minor benefit.
Conclusions—In coexistent AF and AFL, lower recurrence rate and better QoL is associated with AF ablation only or AF +AFL ablation, than with lone AFL ablation. Furthermore, QoL directly correlates with freedom from arrhythmia as shown in this study for the first time, in patients blinded to the procedure.
Clinical Trial Registration Information—http://clinicaltrial.gov/. Unique Identifier: NCT01439386.
- Received February 5, 2013.
- Revision received March 26, 2013.
- Accepted March 29, 2013.