Evaluation of an Electromagnetic 3D Navigation System to Facilitate Endovascular Tasks: A Feasibility Study

Abstract 

Introduction

We describe a novel approach to arterial cannulation using the StealthStation^® Guidance System (Medtronic, USA). This uses electromagnetic technology to track the guidewire, displaying a 3D image of the vessel and guidewire.

Methods

The study was performed on a ‘bench top’ simulation model called the Cannulation Suite comprising of a silicone aortic arch model and simulated fluoroscopy. The accuracy of the StealthStation^® was assessed. 16 participants of varying experience in performing endovascular procedures (novices: 6 participants, ≤5 procedures performed; intermediate: 5 participants, 6–50 procedures performed; experts: 5 participants, >50 procedures performed) underwent a standardised training session in cannulating the left subclavian artery on the model with the conventional method (i.e. with fluoroscopy) and with the StealthStation^®. Each participant was then assessed on cannulating the left subclavian artery using the conventional method and with the StealthStation^®. Performance was video-recorded. The subjects then completed a structured questionnaire assessing the StealthStation^®.

Results

The StealthStation^® was accurate to less than 1mm [mean (SD) target registration error 0.56mm (0.91)]. Every participant was able to complete the cannulation task with a significantly lower use of fluoroscopy with the navigation system compared with the conventional method [median 0s (IQR 0–2) vs median 14s (IQR 10–19), respectively; p=<0.001]. There was no significant difference between the StealthStation^® and conventional method for: total procedure time [median 17s (IQR 9–53) vs median 21s (IQR 11–32), respectively; p=0.53]; total guidewire hits to the vessel wall [median 0 (IQR 0–1) vs median 0 (IQR 0–1), respectively; p=0.86]; catheter hits to the vessel wall [median 0.5 (IQR 0–2) vs median 0.5 (IQR 0–1), respectively; p=0.13]; and cannulation performance on the global rating scale [median score, 39/40 (IQR 28–39) vs 38/40 (IQR 33–40), respectively; p=0.40]. The intra-class correlation coefficient for agreement between video-assessors for all scores was 0.99. 88% strongly agreed that the StealthStation^® can potentially decrease exposure of the patient to contrast and radiation.

Conclusion

Arterial cannulation is feasible with the StealthStation^®.

Keywords: Catheterization, Electromagnetic, Vascular