Endovascular navigation with Fiber Optic RealShape technology

OBJECTIVE: Fiber Optic RealShape (FORS) technology has recently been introduced as an adjunctive guidance technology that allows real-time three-dimensional visualization of dedicated endovascular devices while avoiding radiation exposure. It consists of equipment which sends pulses of light through hair-thin optical fibers that run within a dedicated hydrophilic wire and selective catheters. The purpose of the study is to report the observed benefits and limitations related to the first edition of FORS technology.

METHODS: Data was prospectively collected from the first 50 patients undergoing FORS-guided endovascular repair at a single center between February 2020 and February 2021 as part of the global multi-center FORS Learn registry. All consecutive, elective procedures, with one or more navigation tasks attempted with FORS were included. Factors related to FORS navigation task success were assessed. Time required for the catheterization of each task as well as the amount of radiation exposure (fluoroscopy time, dose area product and estimated skin dose) were collected. A per-task analysis was conducted. Endpoints included success rate in achieving a stable FORS guided catheterization, catheterization time, and radiation dose during catheterization.

RESULTS: During the study period from February 2020 to February 2021, 50 patients were treated using FORS technology. Forty-five patients were treated for aortic aneurysm, 4 for iliac artery aneurysm, and 1 for splenic artery aneurysm. Overall, 201 navigation tasks were completed for these procedures and FORS was used in 186 tasks (92.5%). No FORS-related complication was recorded and a success rate of 60.2% (n=116) was observed. Target vessel (TV) angle of ≥45°, TV stenosis, and the renal arteries as navigation tasks (compared to celiac artery or superior mesenteric artery) were associated with a lower success rate. Catheterization of a TV through a branch more frequently required a standard catheter in combination with the FORS enabled guidewire. Successful task catheterization using FORS guidance was associated with a shorter catheterization time 6 min (IQR 3-11) vs. 16 min (10-24); p<0.001) and lower radiation exposure compared to unsuccessful catheterization (Dose Area Product 4.4 vs 12.5 cGy/cm2, p<0.001).

CONCLUSION: FORS technology was successfully implemented as a new guidance technology in a complex endovascular aortic repair program and was associated with an encouraging success rate and a high potential for radiation reduction.