Abstract
OBJECTIVE: Fiber Optic RealShape (FORS) is a new technology that visualises the full three dimensional (3D) shape of guidewires using an optical fibre embedded in the device. Co-registering FORS guidewires with anatomical images, such as a digital subtraction angiography (DSA), provides anatomical context for navigating these devices during endovascular procedures. The objective of this study was to demonstrate the feasibility and usability of visualising compatible conventional navigation catheters, together with the FORS guidewire, in phantom with a new 3D Hub technology and to understand potential clinical benefits. METHODS: The accuracy of localising the 3D Hub and catheter in relation to the FORS guidewire, was evaluated using a translation stage test setup and a retrospective analysis of prior clinical data. Catheter visualisation accuracy and navigation success was assessed in a phantom study where 15 interventionists navigated devices to three pre-defined targets in an abdominal aortic phantom using an Xray or computed tomography angiography (CTA) roadmap. Additionally, the interventionists were surveyed about the usability and potential benefits of the 3D Hub. RESULTS: The location of the 3D Hub and catheter along the FORS guidewire was detected correctly 96.59% of the time. During the phantom study, all 15 interventionists successfully reached the target locations 100% of the time and the error in catheter visualisation was 0.69 mm. The interventionists agreed or strongly agreed that the 3D Hub was easy to use and the greatest potential clinical benefit over FORS is in offering interventionists choice over which catheter they used. CONCLUSION: This set of studies has shown that FORS guided catheter visualisation, enabled by a 3D Hub, is accurate and easy to use in a phantom setting. Further evaluation is needed to understand the benefits and limitations of the 3D Hub technology during endovascular procedures.