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Bullseye EVD: preclinical evaluation of an intra-procedural system to confirm external ventricular drainage catheter positioning

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Abstract

Purpose

External ventricular drainage (EVD) is a life-saving procedure indicated for elevated intracranial pressure. A catheter is inserted into the ventricles to drain cerebrospinal fluid and release the pressure on the brain. However, the standard freehand EVD technique results in catheter malpositioning in up to 60.1% of procedures. This proof-of-concept study aimed to evaluate the registration accuracy of a novel image-based verification system “Bullseye EVD” in a preclinical cadaveric model of catheter placement.

Methods

Experimentation was performed on both sides of 3 cadaveric heads (n = 6). After a pre-interventional CT scan, a guidewire simulating the EVD catheter was inserted as in a clinical EVD procedure. 3D structured light images (Einscan, Shining 3D, China) were acquired of an optical tracker placed over the guidewire on the surface of the scalp, along with three distinct cranial regions (scalp, face, and ear). A computer vision algorithm was employed to determine the guidewire position based on the pre-interventional CT scan and the intra-procedural optical imaging. A post-interventional CT scan was used to validate the performance of the Bullseye optical imaging system in terms of trajectory and offset errors.

Results

Optical images which combined facial features and exposed scalp within the surgical field resulted in the lowest trajectory and offset errors of 1.28° ± 0.38° and 0.33 ± 0.19 mm, respectively. Mean duration of the optical imaging procedure was 128 ± 35 s.

Conclusions

The Bullseye EVD system presents an accurate patient-specific method to verify freehand EVD positioning. Use of facial features was critical to registration accuracy. Workflow automation and development of a user interface must be considered for future clinical evaluation.

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Acknowledgements

We would like to thank Dr. Normand Robert for his assistance with the CBCT imaging throughout the duration of this study. Support for this study was provided by the William and Susanne Holland Chair for Musculoskeletal Research.

Funding

This study was funded by the William and Susanne Holland Chair in Musculoskeletal Research.

Author information

Authors and Affiliations

  1. Orthopaedic Biomechanics Laboratory, Sunnybrook Research Institute, Toronto, ON, Canada

    Adam Hopfgartner, David Burns, Michael Hardisty & Cari M. Whyne

  2. Division of Orthopaedic Surgery, University of Toronto, Toronto, ON, Canada

    David Burns, Michael Hardisty & Cari M. Whyne

  3. Institute of Biomedical Engineering, University of Toronto, Toronto, ON, Canada

    David Burns & Cari M. Whyne

  4. Division of Neurosurgery, University of Toronto, Toronto, ON, Canada

    Suganth Suppiah

  5. Department of Neurological Surgery, University of California, Davis, Sacramento, CA, USA

    Allan R. Martin

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  1. Adam Hopfgartner
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Correspondence to Cari M. Whyne.

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The authors declare that they have no conflict of interest.

Ethical approval

This study was approved by the Research Ethics Board (REB) of Sunnybrook Health Sciences Centre (#4885) which operates in compliance with the Tri-Council Policy Statement 2nd edition, ICH GCP Guidelines, Part C Division 5 of the Food and Drug Regulations, Part C Division 3 of the Food and Drug Regulations, Part 4 of the Natural Health Products Regulations, Part 3 of the Medical Devices Regulations, and the Provisions of PHIPA 2004 and its applicable regulations. The Sunnybrook Research Ethics Board is registered with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protection (OHRP). The Sunnybrook REB has determined that an Informed Consent Form is not required for this cadaveric study.

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Hopfgartner, A., Burns, D., Suppiah, S. et al. Bullseye EVD: preclinical evaluation of an intra-procedural system to confirm external ventricular drainage catheter positioning. Int J CARS 17, 1191–1199 (2022). https://doi.org/10.1007/s11548-022-02679-z

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  • DOI: https://doi.org/10.1007/s11548-022-02679-z

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