title: Reproducibility of coronary optical coherence tomography for lumen and length measurements in humans (The CLI-VAR [Centro per la Lotta contro l'Infarto-VARiability] study).
abstract: Frequency-domain optical coherence tomography (FD-OCT) is becoming a useful diagnostic tool for coronary imaging for quantitative coronary analysis. Second-generation FD-OCT produces detailed coronary lumen images. However, the reproducibility of coronary measurements using FD-OCT in humans has not been thoroughly explored. Our goal was to determine the intraobserver, interobserver, and interpullback reproducibility of the in vivo FD-OCT measurements of the lumen area and/or lesion length. Twenty-five patients undergoing coronary angioplasty were included. In all subjects, FD-OCT pullbacks (20 mm/s) were acquired twice from the same coronary segment different from the target lesion, at an interval of 5 minutes, with no other intervention. A total of 9,396 cross-sectional lumen area frames and the relative coronary lesion length of each pullback were analyzed off-line with dedicated software by 2 independent expert readers (A and B). We compared the lumen area and length measurements as follows: pullback 1, read by reader A twice at an interval of 7 days (intraobserver analysis); pullback 1, independently read by readers A and B (interobserver comparison); and pullback 1 versus pullback 2, read by reader A (interpullback comparison). The per-segment and per-frame analyses showed very high and significant correlation coefficients for the interobserver, intraobserver, and interpullback comparisons for the lumen area and lesion length (R ≥0.95 and p <0.001 in all cases). Accordingly, the Bland-Altman estimates of bias showed nonsignificant differences in the interobserver, intraobserver, and interpullback comparisons at all levels, with average biases never >0.150 mm(2) for the lumen area or 0.200 mm for the lesion length. In conclusion, coronary imaging using FD-OCT showed excellent reproducibility, with low intraobserver, interobserver, and interpullback variability for both lumen area and lesion length measurements in humans. Thus, FD-OCT can be proposed for precise analysis in the catheterization laboratory to guide decision making and in clinical trials focusing on imaging end points.
authors: Centro per la Lotta contro l'Infarto Foundation, Rome, Italy.
authors: Silvio
authors: S
authors: Fedele
authors: Giuseppe
authors: G
authors: Biondi-Zoccai
authors: Piotr
authors: P
authors: Kwiatkowski
authors: Luca
authors: L
authors: Di Vito
authors: Michele
authors: M
authors: Occhipinti
authors: Alberto
authors: A
authors: Cremonesi
authors: Mario
authors: M
authors: Albertucci
authors: Laura
authors: L
authors: Materia
authors: Giulia
authors: G
authors: Paoletti
authors: Francesco
authors: F
authors: Prati
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D003287:Contrast Media; D017023:Coronary Angiography; D003327:Coronary Disease / Q000473:pathology*; D003331:Coronary Vessels / Q000473:pathology*; D005260:Female; D006801:Humans; D007090:Image Interpretation, Computer-Assisted; D007558:Italy; D008297:Male; D011446:Prospective Studies; D015203:Reproducibility of Results; D012984:Software; D041623:Tomography, Optical Coherence / Q000379:methods*; D014283:Triiodobenzoic Acids
chemical_list: D003287:Contrast Media; D014283:Triiodobenzoic Acids; C044834:iodixanol