Objective:

To objectively compare the efficacy and safety of magnetic robotic guidewire navigation with conventional manual manipulation.

Background:

Neurovascular interventions require precise guidewire manipulation, navigation and catheterization in complex anatomies is difficult and time-consuming. Limited guidewire control can prolong procedures and increase the risk of complications. A novel approach integrating robotic steering with a magnetically deflectable guidewire has demonstrated promising preclinical feasibility. We evaluated navigation and catheterization performance using quantitative metrics in realistic anatomical models, directly comparing magnetic navigation (MN) with conventional manual navigation (CN). 

Design/Methods:

Comparative navigation and catheterization performance were evaluated between MN and CN using 3 anatomical models of increasing difficulty. Four operators varying in levels of clinical experience each performed manual and robotic-assisted procedures. Efficacy was quantified by procedure duration and guidewire tip travel distance measured using AI-based automated tracking. Safety was assessed by predefined metrics; unintended guidewire tip contact with aneurysm walls or entry into non-target branches. Outcomes were compared between both groups.

Results:

 A total of 72 procedures were analyzed across 4 operators with various levels of neurointerventional experience. In both moderate and difficult anatomies, MN required significantly less guidewire translation compared with CN (515 ± 261mm vs. 275 ± 82 mm: P<0.001). Safety outcomes also favored magnetic navigation, with a significantly lower incidence of undesirable or potentially risky guidewire maneuvers (12.9 ± 6.36 vs. 1.45 ± 0.72: P<0.05). Notably, with MN, performance metrics did not differ significantly between operators of higher and lower experience, indicating that less-experienced users achieved outcomes comparable to those with greater experience, without a negative effect on more experienced operators

Conclusions:

Magnetic robotic guidance improved precision, efficiency, and potential safety of guidewire navigation and catheterization compared with manual techniques in challenging anatomies. The technology enabled less experienced operators to achieve outcomes comparable to senior interventionalists, reducing variability in performance and enhance training efficiency.