The Heart Center of IN, Indianapolis, Indiana, USA.
Catheter Cardiovasc Interv. 2011 Aug 1;78(2):202-10. doi: 10.1002/ccd.22842. Epub 2011 Mar 16.
The objective of this human pilot study was to determine the safety and the level of agreement between a novel nonimaging 2.7 Fr. catheter-based system (LumenRECON, LR) that uses electrical conductance for measurement of lumen cross-sectional area (CSA) with intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA). Based on previous animal studies, we hypothesized the level of agreement between LR and IVUS to be 13%.
Accurate and reproducible vessel sizing is essential for optimal percutaneous coronary intervention (PCI).
A total of 12 patients were studied to evaluate the safety, accuracy, and reproducibility of the system in comparison with IVUS and QCA. The CSA of coronary arteries was determined by IVUS, QCA, and LR in the distal, proximal, and center of a lesion during standard PCI.
A Bland-Altman plot of the LR versus IVUS and QCA show a nonsignificant mean difference between the two measurements of 0.04 and 0.07 mm in diameter, respectively. The root mean square error of LR versus IVUS and QCA was 14.3 and 25.8% of the mean IVUS or QCA diameter, respectively. The mean of the difference between two LR duplicate measurements was nearly zero (0.03 mm) and the repeatability coefficient was within 8.7% of the mean of the two measurements. There were no procedural complications nor were any device-related MACE reported within 30 days of the procedure.
This proof of concept pilot study establishes the safety and accuracy of the conductance technology for a pivotal trial of coronary sizing.
本项人体初步研究旨在确定一种新型非影像化 2.7Fr 导管基系统（LumenRECON，LR）的安全性和一致性，该系统使用电导测量血管内腔横截面积（CSA），并将其与血管内超声（IVUS）和定量冠状动脉造影（QCA）进行对比。基于先前的动物研究，我们假设 LR 与 IVUS 的一致性水平为 13%。
准确且可重复的血管测量对于优化经皮冠状动脉介入治疗（PCI）至关重要。
本研究共纳入 12 例患者，旨在评估该系统与 IVUS 和 QCA 对比的安全性、准确性和可重复性。在标准 PCI 期间，于病变的远端、近端和中心处，通过 IVUS、QCA 和 LR 分别确定冠状动脉的 CSA。
LR 与 IVUS 和 QCA 的 Bland-Altman 图显示，两种测量方法之间的平均直径差异无统计学意义，分别为 0.04 和 0.07mm。LR 与 IVUS 和 QCA 的均方根误差分别为 IVUS 或 QCA 平均直径的 14.3%和 25.8%。LR 两次重复测量之间差值的平均值接近零（0.03mm），重复性系数在两次测量平均值的 8.7%以内。该研究过程中无操作相关并发症，也未报告任何与器械相关的 30 天内主要不良心血管事件。
本概念验证初步研究确立了电导技术用于关键冠状动脉尺寸测量的安全性和准确性。
