The role of robotic endovascular catheters in fenestrated stent grafting.

ABSTRACT

OBJECTIVE: Fenestrated stent grafting has allowed the treatment of complex thoraco-abdominal aneurysm disease via a totally endovascular approach, but the procedure can be technically challenging and time consuming. We investigated whether this procedure may be enhanced by remotely steerable robotic endovascular catheters. METHODS: A four-vessel fenestrated stent graft partially deployed within a computed tomography (CT)-reconstructed pulsatile thoraco-abdominal aneurysm silicon model was used. Fifteen operators were recruited to participate in the study and divided into three groups, based on their endovascular experience group A (n = 4, 100-200 endovascular procedures, group B (n = 5, 200-300), and group C (n = 6, >300). All operators were asked to cannulate the renal and visceral vessels under fluoroscopic guidance, using conventional and robotic techniques. Quantitative (catheterization times and wire/catheter tip movements) and qualitative metrics (procedure-specific-rating scale [IC3ST]), which grades operators on catheter use, instrumentation, successful cannulation/catheterization, and overall performance were compared. RESULTS: Median procedure time for cannulation of all four vessels was reduced using the robotic system (2.87 min, interquartile range [IQR; 2.20-3.90] versus 17.24 min [11.90-19.80]; P < .001) for each individual operator, regardless of the level of endovascular experience. The total number of wire/catheter movements taken to complete the task was also significantly reduced (38, IQR [29-57] versus 454 [283-687]; P < .001). There were significant differences in time and movement for cannulation of each individual vessel in the phantom. Robotic catheter operator radiation exposure was negligible as the robotic workstation is remote and away from the radiation source. Overall performance scores significantly improved using the robotic system, despite minimal operator exposure to this technology (IC3ST score 29/35, IQR [22.8-30.7] versus 19/35 [13-24.3]; P = .002). Each group of operators demonstrated an improvement in performance with robotic cannulation. For group A, median IC3ST score was 28/35, IQR (22-33) versus 15/35 (11-20); P = .04; for group B, 30/35 (27-31) versus 19/35 (18-24); P = .07; and for group C, 28.8/35 (28.5-29) versus 22/35 (16-24); P = .06. For groups B and C, these differences did not reach statistical significance. CONCLUSION: Robotic catheterization of target vessels during this procedure is feasible and minimizes radiation exposure for the operator. Steerable robotic catheters with intuitive control may overcome some of the limitations of standard catheter technology, enhance target vessel cannulation, reduce instrumentation, and improve overall performance scores.