Safety and Efficiency of a Novel Argus Optical Coherence Tomography: A Preclinical Experiment

Abstract

Aims: This study investigated the application of the domestic Argus Insight-100 optical coherence tomography (OCT) system in porcine arteries and to evaluate the efficiency and safety of Insight-100°CT immediately after implantation and at 4-week follow-up. Subjects and Methods: Eight porcine arteries were implanted with HELIOS drug-eluting stents. Scans were performed with Insight-100 and C7-XR OCT immediately after implantation and at 4-week follow-up, respectively, to obtain lumen images and measured data. Statistical Analysis Used: SPSS v22 software was used for statistical analysis. Results: Both the Insight-100 and C7-XR scans were successfully performed during the implantation and follow-up. Parameters at 4-week postoperatively showed no significant difference between these two groups. No differences were observed in the reference vessel minimal lumen diameters between Insight-100 and C7-XR in the same frame (2.59 ± 0.18 mm vs. 2.60 ± 0.23 mm, respectively, P = 0.91 and 2.83 ± 0.27 mm vs. 2.98 ± 0.27 mm, respectively, P = 0.19). Moreover, the values of mean lumen diameter in the stent segment are comparable between Insight-100 and C7-XR (2.91 ± 0.11 mm vs. 2.97 ± 0.16 mm, P = 0.50). At 4-week follow-up, the mean lumen diameter of Insight-100 was 2.54 ± 0.28 mm, while that of C7-XR was 2.55 ± 0.32 mm, without difference between two groups (P = 0.92). Conclusions: The Argus OCT system appears to be safe during implantation and follow-up. The efficacy and measurement accuracy of Argus OCT is equivalent to that of the C7-XR.