Background:
Pulsed field ablation (PFA) is an emerging technology for pulmonary vein isolation (PVI) with a good safety profile. The conventional SL0 sheath workflow for transseptal access requires sheath exchange, potentially increasing procedural risk and duration.
Objectives:
To compare procedural efficacy, safety, and cost-effectiveness of direct Faradrive sheath access versus conventional SL0 sheath workflow in PFA-guided PVI.
Methods:
In this retrospective, monocentric study, 140 consecutive patients undergoing first-time PVI were evaluated: 70 patients using SL0 workflow and 70 with Faradrive sheath direct access. Primary endpoints included procedural time, fluoroscopy duration, radiation exposure, number of TSP attempts and complication rates.
Results:
Patient baseline characteristics were comparable. The Faradrive sheath workflow significantly reduced procedural duration (Faradrive: 38.7 ± 10.7 min vs. SL0: 44.7 ± 14.9 min; p=0.007) and fluoroscopy time (7.6 ± 3.7 min vs. 9.0 ± 3.7 min; p=0.034). Number of TSP attempts were comparable (1,12 +- 0,32 vs. 1,23 +-0,5, p>0.5). No air embolism occurred in the Faradrive, but one in the SL0 group. The direct Faradrive approach resulted in an estimated cost saving of €260 per patient, attributed to shorter procedural duration and elimination of sheath exchange.
Conclusion:
Direct transeptal access using the Faradrive sheath workflow in PFA-guided PVI is associated with improved procedural efficiency and lower costs compared to the traditional SL0 sheath workflow.
