Rapid pulmonary vein isolation utilizing the third-generation laserballoon - The PhoeniX registry

Area of Science:

• Cardiology
• Medical Devices
• Electrophysiology

Background:

• Balloon-based ablation systems are established for pulmonary vein isolation (PVI), demonstrating safety and efficacy.
• Previous laser balloon generations (LB2) showed promise but were limited by long procedural durations.
• The third-generation laser balloon (LB3) system was developed to automate and expedite PVI procedures.

Purpose of the Study:

• To evaluate the safety, efficacy, and procedural characteristics of the third-generation laser balloon (LB3) system for PVI.
• To compare the performance of LB3 against the second-generation laser balloon (LB2).

Main Methods:

• A prospective study enrolled 15 consecutive patients undergoing PVI with the LB3 system.
• Procedural data was compared retrospectively with 15 patients treated with the LB2 system.
• Key metrics included procedure time, left atrial dwelling time, total laser time, and adverse events.

Main Results:

• All 59 pulmonary veins (PVs) were successfully isolated in the LB3 group (100%).
• LB3 significantly reduced median procedure time (77 min vs. 91 min, p < 0.001) and left atrial dwelling time (45 min vs. 72 min, p < 0.0001) compared to LB2.
• Total laser time was also significantly decreased with LB3 (1077 sec vs. 1920 sec, p < 0.00001).
• A pure single-shot PVI was achieved in 31% of PVs with LB3.
• Major adverse events were similar between LB2 and LB3 groups (6.7% each).

Conclusions:

• The third-generation laser balloon (LB3) is a safe and effective system for pulmonary vein isolation.
• LB3 demonstrates significant improvements in procedural efficiency, reducing procedure time, left atrial dwelling time, and total laser time compared to LB2.
• The LB3 system represents a promising advancement for rapid and efficient PVI procedures.