Eliminating transseptal sheath exchange for pulsed field ablation procedures using a direct over-the-needle transseptal access with the Faradrive sheath.

Aims: Pulsed field ablation (PFA) for pulmonary vein isolation (PVI) combines the benefits of high procedural efficacy and safety. Transseptal puncture (TSP) to obtain left atrial (LA) access during PVI remains an important source of complications during LA procedures. For PFA procedures, TSP is generally performed using a standard transseptal sheath that is then exchanged over the wire for a dedicated PFA sheath, which might be a potential source for air embolism. We aimed to prospectively evaluate the feasibility and safety of a simplified workflow using the PFA sheath (Faradrive, Boston Scientific) directly for TSP.
Methods and Results: We prospectively enrolled 100 patients undergoing PVI using PFA at two centres. TSP was performed using the PFA sheath and a standard 98 cm transseptal needle under fluoroscopic guidance. TSP via the PFA sheath was successfully performed in all patients and no complications occurred. The median time from the first groin puncture to the completed LA access was 12 min (IQR 8-16 min).
Conclusion: An over-the-needle TSP directly with the PFA sheath proved feasible and safe in our study. This simplified workflow has the potential to reduce the risk of air embolism, to shorten procedure time, and to reduce cost.
Competing Interests: Conflict of interest: L.R.: speaker/consulting honoraria from Abbott/SJM and Medtronic and research grant for investigator-initiated research from Medtronic. T.R.: research grants for investigator-initiated research from the Swiss National Science Foundation, the Swiss Heart Foundation, sitem-insel support fund, Biotronik, Boston Scientific, and Medtronic—all for work outside the submitted study. Speaker/consulting honoraria or travel support from Abbott/SJM, Astra Zeneca, Brahms, Bayer, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Farapulse, Medtronic, Pfizer-BMS, and Roche—all for work outside the submitted study. Support for his institution’s fellowship program from Abbott/SJM, Biosense-Webster, Biotronik, Boston Scientific, and Medtronic for work outside the submitted study. A.M.: owns stock from Boston Scientific. J.S.: the spouse of J.S. is an employee and stock owner of Boston Scientific. R.K. received institutional grant support from Abbott, Biotronik, Biosense Webster, Boston Scientific, and Medtronic. He received speaking fees, travel grants, and consultancy fees from Biosense Webster. B.B. received an EHRA grant from Abbott and a Biotronik International Fellowship. He received speaking fees, travel grants, and consultancy fees from Biosense Webster. All other authors report no conflicts of interest related to this paper.
(© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)