Feasibility and Safety of Remote Endovascular Catheter Navigation in a Porcine Model

Purpose: To evaluate the feasibility and safety of a redesigned remotely operated vascular catheter versus manual catheter manipulation in a porcine model. Methods: Following femoral artery puncture and wire insertion, 4 pigs had either a robotically steered catheter (3 animals) or standard manual catheter manipulation to cannulate the contralateral iliac artery, bilateral renal arteries, and the superior mesenteric artery. After harvesting, the vessels were evaluated histologically by an independent laboratory using hematoxylin and eosin staining. Each cannulated artery was assessed for disruption of the intimal surface, intimal thrombus, damage to the tunica muscularis (dissection), mural hemorrhage, and inflammation by a pathologist who was blinded to the technique utilized for cannulation. Results: No histological evidence of intimal thrombus, disruption, inflammation, or hemorrhage was demonstrated in any vessel section from the robotic cases. In the SMA, 1 of 61 sections from the robotic cases demonstrated mild focal dissection, while 1 of 9 slices from the manual control showed intimal thrombus. Of 129 slices from the renal arteries catheterized by the robotic system, 4 sections demonstrated mild focal dissection, while 2 of 23 sections from the manual control showed grade 1 intimal thrombus. In the iliofemoral arteries, 3 of 91 sections showed mild focal dissection in the robotic cases; in the manual control, 1 of 9 slices demonstrated extensive dissection and another showed mild intimal thrombus. Conclusion:The robotically operated catheter was at least as safe as manual manipulation. More extensive injury was actually observed with the manual technique. This newly designed robotic catheter has the potential to offer many advantages in terms of flexibility and range of motion. J Endovasc Ther. 2011;18:243-249