Single-use optical tracking navigation for external ventricular drain placement: Preclinical 3D-Printed and cadaveric...

Area of Science:

• Neurosurgery
• Medical Devices
• Image-Guided Therapy

Background:

• External ventricular drain (EVD) placement is a common neurosurgical procedure.
• Malposition rates for EVDs can be as high as 38%, necessitating improved placement accuracy.
• Current technical adjuncts exist, but simpler, user-friendly navigation solutions are needed.

Purpose of the Study:

• To evaluate the feasibility and accuracy of a novel single-use optical tracking navigation (OTN) system for EVD placement.
• To assess the usability of the OTN device in both 3D-printed and cadaveric head models.

Main Methods:

• The study involved neurosurgeons performing OTN-assisted EVD placements in 9 3D-printed head models and 2 cadaveric heads.
• Accuracy was primarily assessed using the Kakarla grading system.
• Additional outcomes included fluoroscopy-derived tip-to-target distance, procedure duration, and user satisfaction (Likelihood to Recommend - LTR).

Main Results:

• All 11 EVD placements achieved Kakarla grade 1, indicating successful and accurate placement.
• Mean fluoroscopy-derived tip-to-target distances were 13.3 mm (3D-printed) and 22.2 mm (cadaveric).
• The average procedure time was 12.1 minutes, with positive user satisfaction (mean LTR of 7/10).

Conclusions:

• The single-use OTN device facilitates accurate, real-time image-guided EVD placement in simulated environments.
• The device's accuracy appears independent of user experience.
• Further research, including larger cadaveric studies and clinical trials, is warranted to confirm accuracy and clinical utility.