Purpose: Diagnostic electrophysiology catheters are single-use and their expense can act as a barrier to their use. A decapolar catheter with a re-sterilisable handle and inner core was developed, along with a disposable outer sheath. This initial experience evaluated the performance of the Khelix partially recyclable steerable decapolar electrophysiology catheter.
Methods: Sequential patients requiring a decapolar steerable catheter were included in the study. Parameters such as time to positioning from right femoral vein, fluoroscopy time and dose, pacing and sensing thresholds, and the requirement for reposition and/or support sheath were recorded. A retrospective analysis from cases using a standard disposable decapolar catheter was used to compare CS cannulation success, support sheath requirement and cost.
Results: 11 re-sterilisable catheter handles were used in 64 patients, each time with a disposable sheath, at two New Zealand centres from December 2017 to June 2018. Pre-defined safety measures were met in all patients, with no catheter-related adverse events. The catheter was successfully positioned in the coronary sinus for 59 cases (92%). Based on initial manufacturer recommendations, the inner recyclable portion of the catheter was able to be re-used successfully up to 12 times with re-sterilisation between cases.
Conclusions: This initial study of an innovative, partially reusable, steerable decapolar electrophysiology catheter demonstrates that it may be used safely and successfully. Use of such a catheter may decrease the cost required for electrophysiology studies.
Keywords: Decapolar; Incorporated stylet; Khelix; Re-sterilisable handle; Recyclable; Steerable.