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Initial experience with a novel re-sterilisable decapolar electrophysiology catheter

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Abstract

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.

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Authors and Affiliations

  1. Cardiology Department, Waikato Hospital, Hamilton, New Zealand

    Anna L. Wilson, Kellie A. Timmins, Rosemary F. Allen, Dean Boddington, Janice Swampillai, Spencer C. Heald & Martin K. Stiles

  2. Midland Cardiovascular Services, Hamilton, New Zealand

    Anna L. Wilson, Kellie A. Timmins, Rosemary F. Allen, Paula M. Jones, Sacha L. Ware, Dean Boddington, Janice Swampillai, Spencer C. Heald & Martin K. Stiles

  3. Waikato Clinical School, University of Auckland, Auckland, New Zealand

    Janice Swampillai & Martin K. Stiles

Authors
  1. Anna L. Wilson
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  2. Kellie A. Timmins
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  3. Rosemary F. Allen
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  4. Paula M. Jones
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  5. Sacha L. Ware
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  6. Dean Boddington
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  7. Janice Swampillai
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  8. Spencer C. Heald
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  9. Martin K. Stiles
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Corresponding author

Correspondence to Anna L. Wilson.

Ethics declarations

This observational study was approved by the local Institutional Review Board (WaikatoDHB Quality and Patient Safety).

Conflict of interest

A. Wilson has received funding from CathRx to attend a conference.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The audit was approved by the local research governance body and participants were included in the study after obtaining standard informed consent for the clinical procedure.

Khelix catheter inners and sheaths were provided by CathRx Ltd. None of the authors have financial relationships with CathRx.

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Wilson, A.L., Timmins, K.A., Allen, R.F. et al. Initial experience with a novel re-sterilisable decapolar electrophysiology catheter. J Interv Card Electrophysiol 58, 177–183 (2020). https://doi.org/10.1007/s10840-019-00583-2

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  • DOI: https://doi.org/10.1007/s10840-019-00583-2

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