Performance Assessment of a Radiofrequency Powered Guidewire for Crossing Peripheral Arterial Occlusions Based on Lesion Morphology

Abstract

Endovascular wires and devices for peripheral arterial disease therapy have evolved greatly, yet failure rates of these procedures remain high. Information on lesion composition may inform device selection to improve the success rates of these procedures. This paper, presents an approach for informed guidewire selection. The objective of this study is to quantitatively assess the performance of a radiofrequency powered guidewire in the crossing of various morphology types of peripheral chronic total occlusions. Samples taken from amputated patient limbs are characterized by magnetic resonance imaging. Using a customized catheter test station, the performance of a radiofrequency powered guidewire in puncturing these lesions is compared to a conventional guidewire, and to itself when not powered. The analysis includes quantitative and statistical comparisons of the puncture forces experienced by the different guidewires in “hard” vs. “soft” lesions as well as qualitative assessment of deflections, buckling and puncture success of the wires. Results indicate that the use of radiofrequency ablation significantly reduces the required puncture force, reduced events of buckling and deflection, and resulted in a significantly higher puncture success rate.