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