Helical stents have been developed to treat peripheral arterial disease (PAD) in the superficial femoral artery (SFA), with the premise that their particular geometry could promote swirling flow in the blood. The aim of this work is to provide evidence on the existence of this swirling flow by quantifying its signatures. This study consists of in vitro and in vivo parts. For the in vitro part, 3 helical stent models of different helicity degrees and 1 straight model were fabricated, and the flow was assessed at the inlet and outlet of each model. For the in vivo part, only 1 patient, treated with the helical stent, was eligible to participate in the study. The stent implanted in the SFA of the patient was evaluated in 2 leg postures (straight and flexed), and flow was assessed in 12 locations along the SFA. The in vivo study was approved by an ethical board (NL80130.091.21) in the Netherlands. High-frame-rate ultrasound was used to acquire data from the regions of interest (ROIs), using microbubbles as contrast agents. After processing the data via a correlation-based algorithm (echo particle image velocimetry or echoPIV), the velocity vector field within each ROI was extracted and analyzed for parameters such as vector complexity and velocity profile skewedness. The results show that in the outlet of the helical stents, when compared with the inlet, the flow vector field is more complex and the velocity profile is more skewed. For the in vivo case, the outcomes demonstrate more complexity and higher variability in the sign of skewedness inside the stent when compared with the flow in the proximal to the stent. Helical stents make the vector field of the flow more complex and the velocity profile more skewed, both of which are signatures of swirling flow. Further studies are needed to evaluate whether these features can benefit patients in terms of patency rates. This study demonstrates that helical stent models alter the blood flow when compared with straight stent models. Particularly, the flow grows more complex and its velocity profile becomes more skewed, both of which hint at the existence of swirling flow inside the helical stent. These observations, alongside with population-based studies that are currently being carriet out, may provide the evidence that helical stents have some advantages over straight stents for the patients.
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