Three Dimensional Visualisation of Endovascular Guidewires and Catheters Based on Laser Light instead of Fluoroscopy with Fiber Optic RealShape Technology: Preclinical Results

Objective: Fiber Optic RealShape (FORS) is a new technology platform that enables real time three dimensional (3D) visualisation of endovascular guidewires and catheters, based on the concepts of fibre optic technology instead of fluoroscopy. Anatomical context is provided by means of co-registered prior anatomical imaging, such as digital subtraction angiography or computed tomography. This preclinical study assesses the safety and feasibility of FORS technology. Methods: Six physicians performed endovascular tasks in a phantom model and a porcine model using FORS enabled floppy guidewires, Cobra-2 catheters and Berenstein catheters. Each physician performed a set of predefined tasks in both models, including setup of the FORS system, device registration, and 12 aortic and peripheral target vessel cannulation tasks. The evaluation of the FORS system was based on (i) target vessel cannulation success; (ii) safety assessment; (iii) the accuracy of the FORS based device visualisation; and (iv) user experience. Results: Successful cannulation was achieved in 72 of the 72 tasks (100%) in the phantom model and in 70 of the 72 tasks (97%) in the porcine model. No safety issues were reported. The FORS based device visualisation had a median offset at the tip of 2.2 mm (interquartile range 1.2-3.8 mm). The users judged the FORS based device visualisation to be superior to conventional fluoroscopic imaging, while not affecting the mechanical properties (torquability, pushability) of the FORS enabled guidewire and catheters. Conclusion: The combined outcomes of high cannulation success, positive user experience, adequate accuracy, and absence of safety issues demonstrate the safety and feasibility of the FORS system in a preclinical environment. FORS technology has great potential to improve device visualisation in endovascular interventions.