Safety and performance of reprocessed 8 mm gold-tip non-irrigated RF ablation catheters in cavotricuspid isthmus ablation: a retrospective single-center study
M Funken, W Wiliams, V Knappe, A Zietzer, M M Basha, C Gestrich, G Nickenig, T BeiertAbstract
Background/Introduction
As healthcare systems face increasing economic and ecological pressures, reusing medical devices in high-volume electrophysiological procedures has gained importance. Radiofrequency (RF) ablation catheters used for cavotricuspid isthmus (CTI) ablation represent a major cost and waste source, yet evidence on the safety of resterilized catheters remains limited.
Purpose
To evaluate the clinical safety and procedural performance of resterilized 8 mm gold-tip non-irrigated RF ablation catheters in CTI ablation compared with new catheters.
Methods
We conducted a retrospective single-center study including 181 consecutive patients who underwent CTI ablation between January 2017 and May 2019. Patients were grouped according to catheter use: new (n = 67), resterilized 1–3 times (n = 77), and >3 times (n = 37; maximum 7 uses). All catheters were reprocessed by standardized ethylene-oxide resterilization. The primary endpoint was atrial flutter recurrence within 12 months, assessed by scheduled ECG follow-up or telephone contact. Secondary endpoints included total ablation time, delivered power, and catheter tip temperature.
Results
Freedom from atrial flutter recurrence at 12 months was 93.5 % for new catheters, 96.7 % for 1–3 reuses, and 96.5 % for >3 reuses (p > 0.05). Mean total ablation time was 484 ± 54 s, 551 ± 44 s, and 458 ± 44 s, respectively (p = 0.34). Mean power output was 57.5 ± 1.1 W, 58.1 ± 0.8 W, and 58.6 ± 1.1 W (p = 0.75), and mean catheter tip temperature 55.4 ± 0.9 °C, 54.8 ± 0.9 °C, and 54.3 ± 0.7 °C (p = 0.72). Additional parameters, including impedance, current, total procedure time, and time to bidirectional CTI block, showed no significant group differences.
Conclusion(s)
Ethylene-oxide resterilization of 8 mm gold-tip RF ablation catheters up to seven times does not impair safety or procedural efficacy in CTI ablation for typical atrial flutter. Implementing validated reuse protocols may provide significant economic and ecological benefits without compromising patient outcomes, supporting a sustainable approach to electrophysiological practice.