Background:
Pulsed field ablation (PFA) allows for nonthermal electrical pulmonary veins isolation (PVI). The energy modality is characterized by high-voltage electrical pulses and their unique ability of targeting the cardiomyocytes. Initial data using a multispline catheter suggests that PVI is effective for pulmonary vein isolation (PVI) and might have the capability of overcoming continuing safety concerns associated with thermal catheter ablation of atrial fibrillation (AF). Recently, a novel CE-approved pulsed electric field generator (CENTAURI™, Galvanize Therapeutics - Electrophysiology) was introduced that enables PFA with common focal ablation catheters and mapping systems.
Aim:
The purpose of this study was to prospectively investigate the feasibility and safety of point-by-point PFA-based PVI using a commercially available, contact force sensing, solid-tip focal ablation catheter in conjunction with the novel CENTAURI System.
Methods and Results:
Consecutive patients with paroxysmal or persistent AF undergoing first-time PVI were prospectively enrolled. High-resolution three-dimensional electroanatomical reconstruction of the left atrium (LA) was obtained using a multipolar mapping catheter (PentaRayTM, Biosense Webster) and the CARTO® 3 system. Point by point ablation lesions were created by delivering energy-selectable PFA generated by the CENTAURI system through a THERMOCOOL SMARTTOUCH (Biosense Webster) ablation catheter. Energy settings were as follows: 22 Amp for the posterior PV wall, 25 Amp for the remaining part with contact force >5g. Ten (10) consecutive patients (30% female; mean age 71 ± 10 years, 40% paroxysmal AF) were included with a mean LA volume index of 39.9 ± 11.6 ml/m2. Successful PVI was achieved in 40/40 (100%) pulmonary veins (PVs) with first-pass PVI obtained in 20/20 (100%) of the right, and in 18/20 (90%) of the left PVs. Mean ablation time for the right PVs was 23.4 ± 8.3 min, and 23.8 ± 7.8 min for the left PVs. 30.9 ± 4.0 and 33.0 ± 6.14 focal PFA applications were delivered for the right and left PVs, respectively. Mean procedure, LA dwell, and fluoroscopy times were 114.7 ± 18.8 min, 95.1 ± 12.8 min, and 9.7 ± 3.4 min respectively. No complications occurred.
Conclusion:
Point-by-point PFA using a novel PFA generator was highly effective and safe. The system can easily be integrated with standard PVI workflows and systems running in an electrophysiology laboratory. Further studies are needed to evaluate the comparative, long-term effectiveness and safety of this system.