A wide interlesion distance strategy (≤6 mm) failed to meet noninferiority compared to a standard ≤4 mm strategy for acute pulmonary vein isolation success (56.7% vs 68.7%; P=0.664 for noninferiority).
RCT (n=94)
Single-blind
randomized
Yes
Does a wide interlesion distance strategy (≤6 mm) achieve non-inferior acute pulmonary vein isolation success compared to a standard strategy (≤4 mm) in patients with paroxysmal atrial fibrillation?
A wider interlesion distance of 6 mm during radiofrequency ablation for atrial fibrillation is inferior to a standard 4 mm distance for achieving acute pulmonary vein isolation, despite improving procedural efficiency.
Effect estimate: absolute difference -11.9% (95% CI -25.7 to 1.8)
Absolute Event Rate: 56.7% vs 68.7%
p-value: p=0.664 for non-inferiority
Background: Achieving pulmonary vein isolation (PVI) through contiguous lesions is important for durable PVI treatment of atrial fibrillation (AF). We hypothesized that the flexible-tip TactiFlex catheter, with its enhanced stability, would allow for successful acute PVI even with an extended interlesion distance (ILD) of 6 mm. Methods and Results: The WILD (Wide ILD) PVI trial was a prospective, multicenter, single-blind randomized non-inferiority trial. A total of 94 patients with paroxysmal AF were enrolled and randomly allocated to either a wide ILD group (≤6 mm, n=52) or a standard ILD group (≤4 mm, n=42). The primary endpoint was acute PVI success, defined as first pass isolation without early reconnection. The non-inferiority margin was set at −10.0%. The 6-mm group did not meet the criteria for non-inferiority compared to the 4-mm group (56.7% vs. 68.7%; absolute difference: −11.9% 95% confidence interval: −25.7 to 1.8%; P for non-inferiority=0.664). Conversely, the 6-mm strategy significantly reduced the total number of RF applications (47±10 vs. 73±17, P=0.001) and total ablation time (528±119 s vs. 825±233 s, P<0.001) compared to the 4-mm group. Conclusions: The 6-mm ILD strategy was inferior to the standard 4-mm strategy for acute PVI success. Despite significant gains in procedural efficiency, maintaining an ILD ≤4 mm is recommended to ensure high acute procedural success when using the TactiFlex catheter.
Oyama et al. (Tue,) conducted a rct in Paroxysmal atrial fibrillation (n=94). Wide interlesion distance (≤6 mm) strategy vs. Standard interlesion distance (≤4 mm) strategy was evaluated on Acute PVI success, defined as first pass isolation without early reconnection (absolute difference -11.9%, 95% CI -25.7 to 1.8, p=0.664 for non-inferiority). A wide interlesion distance strategy (≤6 mm) failed to meet noninferiority compared to a standard ≤4 mm strategy for acute pulmonary vein isolation success (56.7% vs 68.7%; P=0.664 for noninferiority).