High-Accuracy Augmented Reality Guidance for Intracranial Drain Placement Using a Standalone Head-Worn Navigation System: First-in-Human Results.

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.