Stereotactic Accuracy and Technique Utilizing the SmartFrame OR Platform with Stereotactic Navigation and Cone Beam CT Image-Guided Forward Projection.

Abstract

Introduction: Asleep deep brain stimulation (DBS) is limited by its reliance on interventional/intraoperative MRI in many cases. A frameless stereotaxy system can be used in combination with optical navigation for initial coarse alignment, followed by a navigational iCT scan to enable asleep DBS in standard operating rooms, aiming to improve accessibility and precision.

Methods: This retrospective study analyzed 32 patients (33 procedures) undergoing DBS electrode placement using the SmartFrame OR™ system (ClearPoint Neuro Inc., San Diego, CA). Radial targeting error and operative duration were assessed. Surgical workflows combined O-arm imaging (Medtronic Inc, Minneapolis, MN) and StealthStation™ S8 neuronavigation (Medtronic Inc, Minneapolis, MN, USA). Targets included the ventral intermediate nucleus (VIM), subthalamic nucleus (STN), globus pallidus internus, hippocampus, and thalamic nuclei.

Results: Median radial targeting error was 0.40 mm (range: 0-1.6 mm), with bilateral procedures showing marginally lower errors (0.35 mm vs. 0.50 mm unilateral). The VIM exhibited the highest precision (0.35 mm), while STN targeting had slightly higher error (0.53 mm). Median operative time was 189 min (140-275 min), with bilateral procedures requiring longer durations (190 vs. 155 min, p = 0.001). No major complications occurred, and no revisions were needed.

Conclusion: The ClearPoint SmartFrame OR™ system achieved submillimeter accuracy and operational efficiency comparable to MRI-guided platforms while eliminating MRI dependency. Its integration with O-arm and Stealth Navigation enhances accessibility, reduces costs, and maintains safety, positioning it as a scalable solution for asleep DBS in standard neurosurgical settings.