Single Center Experience using Fiber Optic RealShape (FORS) Technology in Patients Treated with Complex Endovascular Aneurysm Repair.

PURPOSE: Fiber Optic RealShape (FORS) is a novel technology using light instead of X-rays to visualize guidewire and catheters during endovascular procedures. A 3D-Hub allows visualization of conventional catheters when used in combination with the FORS guidewire. This study evaluates the FORS performance and radiation exposure during visceral target vessel (TV) catheterization in complex endovascular aortic repair (cEVAR).

MATERIALS AND

METHODS

Single-centre data were retrieved from the prospective FORS Learn Registry cohort study. The primary outcome was FORS technical success, defined as successful catheterization using FORS without reverting to a conventional guidewire. Secondary outcomes included catheterization and fluoroscopy time, Dose Area Product (DAP) and Air Kerma (AK), compared across technical success, technical failure and conventional catheterizations using analysis of variance (ANOVA) with post hoc testing.

RESULTS

Between December 2020 and December 2023, 96 patients underwent cEVAR. In total 319 visceral targets were catheterized, including 176 FORS attempts with a technical success rate of 63.6%. This success rate decreased in TVs with versus without ostial stenosis (21.7% vs 69.9%, P < .001) or with versus without calcification (14.3% vs 67.9%, P < .001), and increased with versus without the use of the 3D-Hub (80.6% vs 60.0%, P = .039). Type of TV, stent graft configuration or prior TV stent did not affect technical success rates. Radiation exposure was significantly lower during successful FORS catheterizations (fluoroscopy time 1.7 ± 2.1 min; DAP 3.7 ± 8.5 Gy∙cm2; AK 30.8 ± 55.9 mGy) compared to FORS technical failures (fluoroscopy time 6.5 ± 4.3 min, P < .001; DAP 8.8 ± 6.4 Gy∙cm2, P = .030; AK 126.5 ± 116.5 mGy, P < .001) and conventional catheterizations (fluoroscopy time 6.2 ± 9.2 min, P < .001; DAP 9.4 ± 20.25 Gy∙cm2, P = .003; AK 111.5 ± 151.1 mGy, P < .001). No significant differences occurred between technically failed and conventional catheterizations. Catheterization time was shortest with FORS technical success (6.5 ± 5.0 min) compared to conventional catheterizations (9.7 ± 13.5 min, P = .015), followed by technical failure (14.3 ± 6.9 min, P < .001).

CONCLUSION

Fiber Optic RealShape has an acceptable technical success rate in visceral TV catheterization during cEVAR, which has improved following the 3D-Hub implementation. Successful FORS catheterization results in reduced radiation exposure and catheterization time. When reversion to conventional catheterization is required, outcomes remain comparable to primary conventional procedures, supporting initial FORS use in all catheterizations to minimize radiation. Continued device and software development is essential to optimize FORS performance.Clinical ImpactFiber Optic RealShape (FORS) is a new technology that enables visualization of exclusive FORS-guidewires and catheters using light pulses instead of radiation. This study shows acceptable technical success rates with reduced radiation exposure compared to technically unsuccessful FORS and primary conventional catheterizations of visceral target vessels during complex endovascular aortic repair. These findings support the clinical benefit of initially attempting catheterization with FORS, as it results in reduced radiation exposure, even in case of reversion to conventional devices, without compromising patient outcomes. Additionally, the technical success rates improved significantly following the implementation of the 3D Hub.