RESUMEN
PURPOSE: To assess the potential adjunctive role of a 3D electromagnetic (EM) navigational system for use in above-knee vessels afflicted with peripheral artery disease (PAD). Peripheral artery disease can be challenging to operators encountering significant vessel tortuosity, calcium, and stenoses, which may require prolonged procedure times and excessive use of nephrotoxic iodinated contrast when performed with conventional fluoroscopy. MATERIALS AND METHODS: Following appropriate ethical oversight, five 3D-printed bench phantoms modeling tortuous calcified PAD were created based on source CTA (computed tomography angiography) data sets from real patients. Investigational software was developed based on a commercially available aortic EM navigation platform (Intraoperative Positioning System [IOPS]; Centerline Biomedical, Inc., Cleveland, Ohio), with patient-specific structural maps of vessel lumens and calcification. Using a sensorized prototype 6 French (Fr) catheter and 0.035" guidewire, 15 interventionalists traversed each phantom using the EM platform as well as 2D simulated fluoroscopy-like image guidance and the times were recorded. Participants completed a 10-item standard system usability scale (SUS) questionnaire (score 1-5, 5=strongly agree) evaluating system usability and user satisfaction. Navigation times and SUS scores were compared with a 1-tailed statistical t test. RESULTS: Participants demonstrated a statistically significant reduction in navigation times using EM guidance, performing 0.7 minutes (42 seconds) faster on average (P < .001), corresponding to a 25% average relative reduction. Participants reported sufficiently high levels of usability satisfaction, with a mean SUS score of 4.29 (P < .001), exceeding the acceptance criterion (score ≥3.5). CONCLUSION: This preclinical phantom study highlights the future potential of Centerline Biomedical's EM navigation technology as a possible adjunct to fluoroscopy for highly precise visualization and navigation of PAD-afflicted vasculature. CLINICAL IMPACT: This preclinical proof-of-concept study highlights the feasibility of EM navigation not only for branch vessel cannulation, but also for inline navigation of peripheral vessels afflicted with calcified plaques via benchtop iliofemoral phantom simulations. The navigation platform studied addresses the need for improvements in EM technology through modelling algorithms that facilitate 3D visualization of calcified plaque in any projection in real time, in addition to sensorization of both catheter and guidewire in a compact 6Fr system.