Abstract 9803: Randomized Comparison of a Radiofrequency Wire versus a Radiofrequency Needle System for Transseptal Puncture

Abstract

Introduction: Transseptal puncture is a necessary component of many electrophysiology and structural heart procedures. A new technology utilizes a specialized introducer wire to cross the septum with radiofrequency (RF) energy, eliminating the need for a transseptal needle and wire/needle exchanges. The RF wire technique, however, has not been evaluated in a randomized trial. Methods: The Wire Instrumentation with Radiofrequency Energy to Impact Transseptal puncture (WIRE IT, NCT04645342) study was an investigator-initiated and designed trial that enrolled individuals ≥18 years of age undergoing double transseptal puncture for atrial fibrillation or left atrial flutter ablation. Participants were randomized to a transseptal approach with either a RF needle (NRG Transseptal Needle, Baylis Medical) or RF wire (Versacross RF Wire, Baylis Medical). The primary outcome was time to achieve first transseptal puncture. Timing was started at insertion of the guidewire into the short femoral vein sheath and was stopped once the transseptal sheath was positioned in the left atrium and the dilator and guidewire were removed. Secondary outcomes included second and combined transseptal puncture time, fluoroscopy time, number of equipment exchanges, and complications. Results: A total of 75 participants were enrolled between November 30, 2020 and February 2, 2022 (36 RF needle, 39 RF wire). No crossovers occurred. Randomization to the RF wire resulted in a statistically significant reduction in first transseptal time compared to the RF needle (Figure). Second and combined transseptal times and number of equipment exchanges were also reduced with the RF wire. One participant in the RF needle group experienced transient AV block due to mechanical trauma. There were no complications in the RF wire group. Conclusions: The RF wire technique resulted in faster time to transseptal puncture and fewer equipment exchanges compared to an RF needle with no difference in complications.