Robotic-assisted carotid artery stenting with R-OneTM: Feasibility and safety assessment in patients with carotid web lesions.

Abstract

PurposeRobotic-assisted carotid artery stenting (CAS) procedures are on the rise and have demonstrated benefits compared to manual intervention. The R-OneTM robotic platform has demonstrated safety and efficacy for percutaneous coronary interventions, but its utility for procedures in the common carotid artery has not been thoroughly studied. This study aims to assess the feasibility and initial safety of the R-OneTM robotic platform for treating patients with carotid artery disease (CAD) presenting with carotid web-diaphragm lesions.MethodsThe prospective CArotid Robotic procedure Evaluation study included patients with CAD suitable for CAS. The primary endpoint was procedure technical success, defined as the absence of any unplanned manual assistance or conversion to manual CAS for procedural completion. Secondary endpoints included the absence of intra-procedural complications, primary operator radiation exposure, patient radiation exposure, procedure time, and contrast volume.ResultsA total of seven patients were enrolled (mean age: 49.57 ± 13.10 years; 5 females). Procedure technical success rate was 85.7% (6/7). The absence of intra-procedural complications rate was 100%. Mean overall procedure time was 41.71 ± 9.83 min, mean robotic procedure time was 15.86 ± 7.60 min, and mean CAS procedure time was 27.14 ± 8.71 min. The average patient radiation exposure dose was 135.50 ± 78.88 mGy. The mean overall procedure contrast volume was 68.14 ± 20.14 mL, and the mean robotic procedure contrast volume was 1.43 ± 3.78 mL.ConclusionCAS procedures using R-OneTM are feasible and safe with a good technical success rate without complications. To confirm these findings, larger multi-center trials with a diverse range of patients are necessary.