Background:

So far, no head-to-head comparison of endoscopic laserballoon-guided to contact-force radio frequency (RF)-based pulmonary vein isolation (PV) was performed in a prospective, randomized, multicenter study.

Objectives:

To assess safety and efficacy of laserballoon-guided versus contact-force radio frequency (RF)-based PVI.

Methods:

A multi-center study (1:1) to compare acute and 12-months clinical outcomes of patients with paroxysmal AF (PAF) undergoing ablation using the laserballoon catheter or a Contact Force Sensing Irrigated RF (CF RF) ablation catheter. At 3, 6 and 12 months post ablation 72 hours Holter ECGs were performed.

Results:

362 patients were randomized to CF RF- (n=179) and to laserballoon-guided PVI (n=183). PVI was achieved in 99.4% PVs in the CF RF and in 96.5% in the laserballoon group (p=0.064) with no difference in procedure time. Fluoroscopy time was significantly shorter, dose area product significantly lower in the CF RF group. In the CF RF group 100/179 (61%) patients had all scheduled Holter ECG visits and 97/183 (53%) patients in the laserballoon arm with a total of 50 (27%) and 52 (27%) patients lost to follow-up. After 12 months a total of 106/129 (82.2%) and 110/131 (84%) patients were in stable SR in the CF RF arm and in the laserballoon arm (p=0.699). 11 (6.1%) and 15 (8.2%) major complications occurred in the CF RF and in the laserballoon group.

Conclusions:

Application of both technologies results in high and comparable rates of acute PVI and in comparable efficacy in prevention of AF recurrences.