Circulation reports · 2026
Clinical Impact of Interlesion Distance on Acute Pulmonary Vein Isolation Success in Patients With Paroxysmal Atrial Fibrillation.
Клиническое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Oyama Keika, Naruse Yoshihisa, Arakawa Yuki, Kobayashi Shuhei, Nakamura Hironori, Ishizue Naruya, Kishihara Jun, Fukaya Hidehira, Nagao Tomoaki, Hosoya Natsuko, Sawasaki Kohei, Muto Masahiro, Kawahito Michitomo, Tokonami Yuki, Ito Kazuki, Kaneko Yutaro, Narumi Taro, Sano Makoto, Maekawa Yuichiro
Аннотация
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.
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.