High-Accuracy Augmented Reality Guidance for Intracranial Drain Placement Using a Standalone Head-Worn Navigation System: First-in-Human Results
 
High-Accuracy Augmented Reality Guidance for Intracranial Drain Placement Using a Standalone Head-Worn Navigation System: First-in-Human Results ■
 
Frederick Van Gestel, Frederick Van Gestel, Taylor Frantz, Taylor Frantz, Félix Buyck, Félix Buyck, Anthony G Gallagher, Anthony G Gallagher, Wietse Geens, Wietse Geens, Quentin Neuville, Quentin Neuville, Michael Bruneau, Michael Bruneau, Bart Jansen, Bart Jansen, Thierry Scheerlinck, Thierry Scheerlinck, Jef Vandemeulebroucke, Jef Vandemeulebroucke, Johnny Duerinck, Johnny Duerinck
 
Abstract ■

BACKGROUND AND OBJECTIVES: External ventricular drain (EVD) placement is often performed freehand, a technique subpar to accurate yet impractical image-guided methods, yielding optimal placement in only 70\%. The aim of this study was to address shortcomings in EVD placement and image guidance technologies by implementing high-accuracy augmented reality (AR) guidance.METHODS: We conducted a prospective clinical pilot study to assess feasibility, safety, and clinical performance of EVD placement using a standalone AR headset equipped with high-accuracy inside-out infrared tracking and software addressing EVD placement. Placement quality was reported using a newly defined extended modified Kakarla scale, and dichotomized into clinically relevant outcome parameters. Results were compared with a nonconcurrent freehand control group using one-sided Fisher exact tests.RESULTS: Eleven AR-guided EVD placements were performed, achieving functional placement in all cases on the first attempt, vs 7 (64\%) in the control group (P = .045); successful placement in 9 (82\%) vs 5 (45\%); optimal in 8 (73\%) vs 3 (27\%) (P = .043); suboptimal in 2 (18\%) vs 5 (45\%); and failed in 0 vs 1 (9\%). No AR-guided placements required revision, whereas the freehand group had a 36\% reintervention rate (P = .045). Procedure-related complications occurred in 2 AR-guided cases (18\%), vs 5 (45\%) freehand (all post-reintervention).CONCLUSION: This study presents the first clinical use case of EVD placement using high-accuracy AR guidance contained in a standalone head-worn navigation system. Safe and reliable outcomes using a validated pipeline were demonstrated, eliminating stick-and-poke attempts and resulting in improved quality, increased single attempt success rates, and reduced revision and complication rates. Based on these results, a multicenter randomized controlled trial will be initiated.