Abstract 2441: A Controlled Randomized Trial of Biatrial Ablation for Curing Long-lasting Permanent Atrial Fibrillation (The Decomplex Trial)
Background: patients with long-lasting permanent atrial fibrillation (AF) are often destined to remain in AF life-long. In this cohort outcomes of ablation techniques are disappointing, with 20 –74% success rate and 30 –50% repeat procedure. The adjunctive clinical benefit of targeting multiple right and left atrial (LA) sites beyond the pulmonary vein (PV)-LA junction with the aim of achieving acute AF termination has not been prospectively evaluated in a randomized study.
Methods and results: 60 patients with permanent atrial fibrillation of more than 1 year duration, with early recurrence after electrical cardioversion and medical therapy with one or more antiarrhythmic agents were enrolled (mean age 59±10, mean AF duration 60 months, mean LA dimension 44±7 mm, left ventricular EF >40% in all) and randomized to standard circumferential PV ablation (CPVA, control group, N=30) or an extended CPVA schema targeting also inferior LA, atrial septum, LA appendage, coronary sinus and right atrium (test group, N=30). In the test group the procedural endpoint was sinus rhythm (SR) restoration by radiofrequency energy; at each step average cycle length was measured and ablation was stopped if patient gained SR. In the control group the standard CPVA technique was applied. All patient transmitted daily transtelephonic ECG strips whereas at 3, 6 and 12 months an echocardiogram and a 48 hour Holter was obtained. Antiarrhythmic drug therapy was continued for 3 months after ablation in both group (blanking period in which patients were allowed to undergo electrical cardioversion). AF terminated in 5% and 55% of control and test subjects; mean procedure duration was 66 and 88 minutes in the 2 groups; No significant complications occurred in both groups. After a mean follow-up of 4 months, 67% of control patients were sinus as compared with 83% in the test group (p<0.05). 2 and 2 patient undergoing a repeat procedure for recurrent AF for AF (N=2) and AT (N=2). Acute AF termination was the strongest endpoint of SR maitainance (p<0.01)
Conclusion: Preliminary data show that a modified CPVA ablation strategy in patients with permanent AF is associated with acute AF termination in 55% of patients and achieves medium term restoration and maintenance of sinus rhythm in 83% of patients.