Van Gestel, FrederickFrederickVan GestelFrantz, TaylorTaylorFrantzBuyck, FelixFelixBuyckGallagher, Anthony G.Anthony G.GallagherGeens, WietseWietseGeensNeuville, QuentinQuentinNeuvilleBruneau, MichaelMichaelBruneauJansen, BartBartJansenScheerlinck, ThierryThierryScheerlinckVandemeulebroucke, JefJefVandemeulebrouckeDuerinck, JohnnyJohnnyDuerinck2025-05-222025-05-2220250148-396XWOS:001488695800032https://imec-publications.be/handle/20.500.12860/45702BACKGROUND 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.High-Accuracy Augmented Reality Guidance for Intracranial Drain Placement Using a Standalone Head-Worn Navigation System: First-in-Human ResultsJournal article10.1227/neu.0000000000003401WOS:001488695800032EXTERNAL VENTRICULAR DRAINCATHETER PLACEMENTFREEHAND INSERTIONRISKMEDLINE:40112137