Early Experience of Fiber Optic RealShape Technology in Endovascular Interventions for Peripheral Artery Disease: A Prospective Single-Center Study

OBJECTIVE: Interventions in peripheral artery disease (PAD) have changed significantly over the past decades. Most centers have adopted an endovascular-first strategy resulting in an increased radiation exposure, especially for the treatment team. Fiber Optic RealShape (FORS) technology uses laser light instead of fluoroscopy to visualize the specially designed guidewire and catheters. The aim of this early experience overview was to evaluate feasibility and safety of FORS-guided navigation for endovascular interventions in PAD. METHODS: This overview presents prospectively collected, single-center data of FORS-guided PAD interventions. Feasibility was evaluated through technical success in crossing stenotic lesion(s) or occlusion(s). Lesion characteristics were also recorded. Safety was assessed by scoring of intraoperative adverse events related to FORS. Secondary assessments included navigation time, and radiation exposure outcomes (cumulative air kerma [CAK], air kerma-area product [KAP], and fluoroscopy time [FT]) during crossing of the culprit lesion. RESULTS: In 22 patients (31 lesions) selected for FORS-guided PAD interventions, 22 of 31 lesions (71.0%) were successfully crossed while using FORS-enabled devices, without adverse events. Median length of the treated lesions was 48.0 mm (23.0-87.0). Sixteen lesions (51.6%) had a severe degree of stenosis and 10 lesions (32.3%) had a moderate degree of stenosis, defined according to the North American Symptomatic Carotid Endarterectomy Trial criteria. Navigation times, CAK, and FT were highest during FORS-guided interventions of most complex stenotic lesions. CONCLUSION: Fiber Optic RealShape-guided navigation and lesion crossing in PAD interventions is feasible and safe. Expansion of the FORS portfolio hypothetically in combination with other radiation-reducing technologies might enable a radiation-free interventional environment in the future.Clinical ImpactFiber Optic RealShape (FORS) represents a novel technology that enables visualization of specially designed endovascular devices by utilizing laser light instead of fluoroscopy. These devices facilitate real-time visualization with three-dimensional features to simplify endovascular navigation without the necessity of using fluoroscopy during navigation. This is the first single-center study that presents an overview of 31 peripheral arterial disease (PAD) lesions (in 22 patients) showing that using FORS guided navigation in PAD interventions is safe and feasible. Ultimately, the use of FORS in combination with other radiation reducing technologies might eventually enable a radiation-free interventional environment in the future.