A post-market, multi-vessel evaluation of the imaging of peripheral arteries for diagnostic purposeS comparing optical Coherence tomogrApy and iNtravascular ultrasound imaging (SCAN)

Edward Pavillard, Luke Sewall, Edward Pavillard, Luke Sewall

Abstract

Background: Intravascular imaging plays an important part in diagnosis of vascular conditions and providing insight for treatment strategy. Two main imaging modalities are intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The objective of this study was to prove non-inferiority of OCT imaging to IVUS images in matched segments of peripheral vessels in patients with suspected peripheral vascular disease.

Methods: The SCAN study was a prospective, non-inferiority clinical study of matched IVUS and OCT images collected along defined segments of peripheral vessels from twelve subjects (mean age 68 ± 10.3 years; 10 men) displaying symptoms of vascular disease. Luminal diameters were measured by both imaging systems at the distal, middle, and proximal points of the defined segments. Three blinded interventional radiologists evaluated the quality of both imaging modalities in identifying layered structures (3-point grading), plaque (5-point grading), calcification (5-point grading), stent structure (3-point grading), and artifacts (3-point grading) from 240 randomly ordered images. Mean grading scores and luminal diameters were calculated and analyzed with Student's t-Test and Mann-Whitney-Wilcoxon testing. Intrareader reproducibility was calculated by intraclass correlation (ICC) analysis.

Results: The mean scoring of plaque, calcification, and vascular stent struts by the three readers was significant better in terms of image quality for OCT than IVUS (p < 0.001, p = 0.001, p = 0.004, respectively). The mean scores of vessel wall component visibility and artifacts generated by the two imaging systems were not significantly different (p = 0.19, p = 0.07, respectively). Mean vessel luminal diameter and area at three specific locations within the vessels were not significantly different between the two imaging modalities. No patient injury, adverse effect or device malfunction were noted during the study.

Conclusions: Imaging by OCT provides the physician with better visualization of some vessel and plaque chacteristics, but both IVUS and OCT imaging are safe and effective methods of examining peripheral vessels in order to perform diagnostic assessment of peripheral vessels and provide information necessary for the treatment strategy of peripheral artery disease.

Trial registration: NCT03480685 registered on 29 March 2018.

Keywords: Diagnosis; IVUS; Intravascular imaging; OCT; Plaque; Treatment strategy.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Morphologies and characteristics of peripheral vessels noted with either IVUS or OCT imaging. a Layered structures of the vessel wall shown with OCT (left) and IVUS (right) imaging. IEL – internal elastic lamina; EEL – external elastic lamina. b Plaque (stars) present in the vessel wall denoted by IVUS imaging. c Plaque (stars) present in the vessel wall presented by OCT imaging. d Calcium present in the vessel imaged by IVUS (arrows). e Calcium as imaged by OCT (arrows). f Vascular stent struts noted with IVUS (arrows). g OCT imaging of vascular stent struts (arrows)
Fig. 2
Fig. 2
Example of distal, middle, and proximal image sampling points for (a) IVUS and (b) OCT imaging catheters
Fig. 3
Fig. 3
Matched images of the nonlayered structures at the same location in a peripheral artery from IVUS imaging (a) and OCT imaging (b). The IVUS image was displayed as number 228 in the series of images provided to the readers and the OCT image was displayed as number 14

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