Antonsen Lisbeth, Thayssen Per, Junker Anders, Veien Karsten Tange, Hansen Henrik Steen, Hansen Knud Nørregaard, Hougaard Mikkel, Jensen Lisette Okkels
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Cardiovasc Revasc Med. 2015 Dec;16(8):469-77. doi: 10.1016/j.carrev.2015.08.010. Epub 2015 Sep 10.
Frequency-domain optical coherence tomography (FD-OCT) is a high-resolution imaging tool (~10-15 μm), which enables near-histological in-vivo images of the coronary vessel wall. The use of the technique is increasing, both for research- and clinical purposes. This study sought to investigate the intra- and interobserver reliability, as well as the intra-catheter reproducibility of quantitative FD-OCT-assessment of morphometric stent parameters and qualitative FD-OCT-evaluation of strut coverage in 10 randomly selected 6-month follow-up Nobori® biolimus-eluting stents (N-BESs).
Ten N-BESs (213 cross sectional areas (CSAs) and 1897 struts) imaged with OCT 6 months post-implantation were randomly selected and analyzed by 2 experienced analysts, and the same 10 N-BESs were analyzed by one of the analysts 3 months later. Further, 2 consecutive pullbacks randomly performed in another 10 N-BESs (219 CSAs and 1860 struts) were independently assessed by one of the analysts.
The intraobserver variability with regard to relative difference of mean luminal area and mean stent area at the CSA-level was very low: 0.1%±1.4% and 0.5%±3.2%. Interobserver variability also proved to be low: -2.1%±3.3% and 2.1%±4.6%, and moreover, very restricted intra-catheter variation was observed: 0.02%±6.8% and -0.18%±5.2%. The intraobserver-, interobserver- and intra-catheter reliability for the qualitative evaluation of strut coverage was found to be: kappa (κ)=0.91 (95% confidence interval (CI): 0.88-0.93, p<0.01), κ=0.88 (95% CI: 0.85-0.91, p<0.01), and κ=0.73 (95% CI: 0.68-0.78, p<0.01), respectively.
FD-OCT is a reproducible and reliable imaging tool for quantitative evaluation of stented coronary segments, and for qualitative assessment of strut coverage.
频域光学相干断层扫描（FD-OCT）是一种高分辨率成像工具（分辨率约为10 - 15μm），能够获取冠状动脉血管壁近乎组织学的体内图像。该技术在研究和临床领域的应用日益广泛。本研究旨在调查10个随机选取的植入6个月后的Nobori®生物可吸收涂层雷帕霉素洗脱支架（N-BES）中，观察者内和观察者间对形态学支架参数进行定量FD-OCT评估以及对支架小梁覆盖率进行定性FD-OCT评估的可靠性，以及导管内的可重复性。
随机选取10个植入后6个月用OCT成像的N-BES（213个横截面面积（CSA）和1897个支架小梁），由2名经验丰富的分析人员进行分析，其中1名分析人员在3个月后对同样的10个N-BES再次进行分析。此外，另一名分析人员对另外10个N-BES（219个CSA和1860个支架小梁）中随机进行的2次连续回撤进行独立评估。
在CSA水平上，观察者内关于平均管腔面积和平均支架面积相对差异的变异性非常低：分别为0.1%±1.4%和0.5%±3.2%。观察者间变异性也较低：分别为 - 2.1%±3.3%和2.1%±4.6%，而且，观察到导管内变异非常有限：分别为0.02%±6.8%和 - 0.18%±5.2%。支架小梁覆盖率定性评估的观察者内、观察者间和导管内可靠性分别为：kappa（κ）=0.91（95%置信区间（CI）：0.88 - 0.93，p<0.01），κ=0.88（95%CI：0.85 - 0.91，p<0.01），以及κ=0.73（95%CI：0.68 - 0.78，p<0.01）。
FD-OCT是一种用于定量评估冠状动脉支架植入段以及定性评估支架小梁覆盖率的可重复且可靠的成像工具。
