Comparing the Safety and Effectiveness of Dedicated Radiofrequency Transseptal Wires to Electrified Metal Guidewires

Application of electrocautery to a metal guidewire can be used to perform transseptal puncture (TSP). Dedicated radiofrequency guidewires (RF) may represent a better alternative. This study compares safety and effectiveness of electrified guidewires to a dedicated RF wire. TSP was performed on porcine hearts using an electrified 0.014” or 0.032” guidewire under various power settings compared to TSP using a dedicated RF wire with 5W power. The primary endpoint was the number of attempts required to achieve TSP. Secondary endpoints included the rate of TSP failure, TSP consistency, effect of the distance between tip of the guidewire and the tip of the dilator, and effect of RF power output level. Qualitative secondary endpoints included tissue puncture defect appearance, thermal damage to the TSP guidewire or dilator, and tissue temperature using thermal imaging. The RF wire required 1.10 ± 0.47 attempts to cross the septum. The 0.014” electrified guidewire required 2.17 ± 2.36 attempts (2.0x higher than the RF wire; p<0.01), and the 0.032” electrified guidewire required 3.90 ± 2.93 attempts (3.5x higher than the RF wire; p<0.01). Electrified guidewires had a higher rate of TSP failure, larger defects, more tissue charring, higher temperatures, and greater tissue heating. Fewer RF applications were required to achieve TSP using a dedicated RF wire compared to an electrified guidewire. Smaller defects and lower tissue temperatures were also observed using the RF wire. Electrified guidewires required greater energy delivery and were associated with equipment damage and tissue charring.