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使用独立头戴式导航系统进行颅内引流管置入的高精度增强现实引导:首例人体试验结果

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

作者信息

Van Gestel Frederick, Frantz Taylor, Buyck Félix, Gallagher Anthony G, Geens Wietse, Neuville Quentin, Bruneau Michael, Jansen Bart, Scheerlinck Thierry, Vandemeulebroucke Jef, Duerinck Johnny

机构信息

Department of Neurosurgery, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels , Belgium.

Research Group Center For Neurosciences (C4N-NEUR), Vrije Universiteit Brussel (VUB), Brussels , Belgium.

出版信息

Neurosurgery. 2025 Jun 1;96(6):1217-1226. doi: 10.1227/neu.0000000000003401. Epub 2025 Mar 20.

DOI:10.1227/neu.0000000000003401
PMID:40112137
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12052230/
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.

摘要

背景与目的

脑室外引流(EVD)置管通常采用徒手操作,该技术不如精确但不实用的影像引导方法,仅有70%能实现最佳置管。本研究旨在通过实施高精度增强现实(AR)引导来解决EVD置管及影像引导技术的不足。

方法

我们进行了一项前瞻性临床试点研究,以评估使用配备高精度由内而外红外跟踪技术及用于EVD置管软件的独立AR头戴设备进行EVD置管的可行性、安全性及临床性能。使用新定义的扩展改良卡卡拉萨量表报告置管质量,并将其分为临床相关结局参数。结果与非同期徒手操作对照组使用单侧Fisher精确检验进行比较。

结果

共进行了11例AR引导下的EVD置管,所有病例首次尝试均实现功能置管,而对照组为7例(64%)(P = 0.045);成功置管9例(82%),对照组为5例(45%);最佳置管8例(73%),对照组为3例(27%)(P = 0.043);次优置管2例(18%),对照组为5例(45%);失败置管AR引导组为0例,对照组为1例(9%)。AR引导置管无一例需要修正置管,而徒手操作组再次干预率为36%(P = 0.045)AR引导的操作中有2例(18%)发生与操作相关的并发症,徒手操作组为5例(45%)(均在再次干预后)。

结论

本研究展示了在独立头戴式导航系统中使用高精度AR引导进行EVD置管的首个临床应用案例。使用经过验证流程取得了安全可靠结果消除了盲目试探性操作,提高了置管质量增加了单次尝试成功率,降低了修正置管率及并发症发生率。基于这些结果将启动一项多中心随机对照试验。

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本文引用的文献

1
External ventricular drains and risk of freehand placement: A systematic review and meta-analysis.脑室外引流管和徒手置管风险:系统评价和荟萃分析。
Clin Neurol Neurosurg. 2023 Aug;231:107852. doi: 10.1016/j.clineuro.2023.107852. Epub 2023 Jun 29.
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STTAR: Surgical Tool Tracking Using Off-the-Shelf Augmented Reality Head-Mounted Displays.STTAR:使用现成的增强现实头戴式显示器进行手术工具跟踪。
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Neuro-oncological augmented reality planning for intracranial tumor resection.
用于颅内肿瘤切除的神经肿瘤学增强现实规划
Front Neurol. 2023 Mar 14;14:1104571. doi: 10.3389/fneur.2023.1104571. eCollection 2023.
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The effect of image-guided ventricular catheter placement on shunt failure: a systematic review and meta-analysis.影像引导下脑室导管放置对分流失败的影响:系统评价和荟萃分析。
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Freehand frontal external ventricular drain (EVD) placement: Accuracy and complications.徒手额前外脑室引流(EVD)置管:准确性和并发症。
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The effect of augmented reality on the accuracy and learning curve of external ventricular drain placement.增强现实对外科脑室引流管放置准确性和学习曲线的影响。
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