Key result
6-mm interlesion distance fails non-inferiority vs. standard 4 mm for acute PVI success.
Why the study?
It was hypothesized that the flexible-tip TactiFlex catheter would allow for successful acute pulmonary vein isolation even with an extended interlesion distance of 6 mm.
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?
RCT (n=94)
Single-blind
Stratified permuted block randomization
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.
6-mm interlesion distance is not noninferior for acute PVI success; reinforces ≤4-mm spacing as standard in paroxysmal AF ablation.
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.
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Oyama et al. (2026) conducted an RCT in Paroxysmal Atrial Fibrillation (n=94). Wide interlesion distance (ILD) strategy (≤6 mm) vs. Standard ILD strategy (≤4 mm) was evaluated on Acute pulmonary vein isolation (PVI) success (first pass isolation without early reconnection) (Absolute difference -11.9%, 95% CI -25.7 to 1.8%, p=0.664 for non-inferiority). The 6-mm interlesion distance strategy failed to meet non-inferiority for acute pulmonary vein isolation success compared to the standard 4-mm strategy (56.7% vs. 68.7%, absolute difference -11.9%).
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