FARAPULSE PULSED FIELD ABLATION SYSTÉM FOR PULMONARY VEIN ISOLATION: REAL CLINICAL DATA

Background: Catheter ablation of atrial fibrillation using thermal energies such as radiofrequency or cryothermy is associated with indiscriminate tissue destruction. During pulsed field ablation (PFA), sub-second electric fields create microscopic pores in cell membranes – a process called electroporation. Analysis FaraPulse system PFA ablation in real clinical practise.

Methods: Ablation was performed using proprietary biphasic bipolar PFA waveform with the in two diferent configurations: basket and flower for PV isolation (in 2+2 after rotation strategy) and flower for posterior wall ablation. The index procedure was performed without general anesthesia, intravenous atropin was administered prior PFA application.

Results: In 106 patients (69 M/37 F), average age was 62,2± 11,3; BMI 28,8 ±5,0. 87 patientsundewent the procedur efor paroxysmal AF and 19 pts for persistent AF. All PVs were acutely isolated by PFA with ≤ 3 min elapsed delivery/patient, skin-to-skin procedure time of 28.4±8.4 min, and fluoroscopy time of 6,5±4,2 min. There were no significant adverse event. No phrenic nerve injury. During the mean 2,6 months follow-up, no any other adverse event. Was documented including stroke, phrenic nerve injury, PV stenosis and esophageal injury. The freedom from arrhythmia was 98.1±5.6% by repeated Holters ECGs.

Conclusions: In these first real life clinical series patients performed PFA ablation out of the clinical studies, Farapulse system of pulsed field ablation proved very high effectivity allowing facile ultra-rapid PV isolation with excellent durability and chronic safety.