554 Clinical Validation Trial of Rapid Sequence, Markerless, Headset-Contained Augmented Reality Stereotactic Neuronavigation System

INTRODUCTION: Digital enhancement and visualization technologies such as augmented reality (AR) are being increasingly used in surgery. Rapid, accurate patient registration with minimal device confinements enables AR systems to increase efficiency, safety, and effectiveness, especially in urgent/emergent and/or bedside scenarios. This study was designed to quantitatively evaluate an AR headset-based neuronavigation system in comparison to a standard of care reference array-based neurosurgical stereotactic navigation system in a real-world setting. METHODS: Patients were consented and enrolled after meeting the study inclusion/exclusion criteria. Preoperative CT and MRI images were rendered and used for construction of a 3D hologram model including surface-based target fiducial markers for comparison. Patients were stereotactically registered to the pre-operative imaging studies using standard techniques. Registration coordinates for the fiducial markers (control) and registration time were recorded. The AR system was then deployed to create a separate stereotactic registration to the same preoperative imaging studies. A second set of registration coordinates for the fiducial markers were acquired (experimental) using the AR system, and the time for this process was also recorded. Wilcoxon signed-rank test was performed to assess differences in registration time, linear mixed-effect model (LMM) was used to conduct equivalence testing of coordinates between the control and experimental datasets. RESULTS: The baseline validation error of the control system was 0.73 ± 0.29 mm (Standard Deviation [SD], range 0-1.0 mm). Average registration accuracy of the AR system compared to the control system was 2.16 ± 0.12 mm. LMM with equivalence testing conducted with a margin of 3 mm and 2.5 demonstrated equivalence of ground truth coordinates to the AR system (p value < 0.001 and p value < 0.003, respectively, per equivalence margin). Time to patient model registration for AR was significantly shorter with a mean of 45.98 ± 15.00 seconds compared to the control system at 228.86 ± 100.06 seconds, (p value < 0.001). CONCLUSIONS: The AR navigation system provided statistically similar registration accuracy and significantly faster patient model registration compared to a standard of care stereotactic neuronavigation system. Utilization of accurate, fast, and minimal footprint AR navigation technology may offer new opportunities to incorporate stereotaxis in low resource, bedside, and urgent/emergent settings.