Abstract
As investigations into nonsurgical treatment for atherosclerosis expand, the measurement of plaque regression and progression has become an important end point to evaluate. Measurements of three-dimensional (3D) plaque volume are more reliable and sensitive to change than are traditional estimates of stenosis severity or cross-sectional area. 3D ultrasound (3D US) imaging may allow monitoring of plaque volume changes but has not been used routinely due to the cumbersome motorized units required to drive transducers. We investigated the variability, reliability, and the least amount of change detectable by 1D plaque measures, as well as 2D and 3D measures of plaque morphometry, that can be applied in a clinical environment.
3D US imaging was obtained in 10 patients with carotid stenosis. The lumen and outer wall boundaries were outlined in serial cross-sectional images 1 mm apart. Three observers manually segmented vessel wall volumes (VWVs), and the segmentation was repeated again 4 weeks later. This allowed measurement of interobserver and intraobserver variability of 6 pairs of observations. We measured Bland-Altman statistics, intraclass correlation coefficients, coefficient of variability, and the minimum detectable plaque change for each morphometric measure.
The mean VWV of carotid lesions in the study was 1276.8 mm(3) (range, 620.6-1956.3 mm(3)). Bland-Altman plots demonstrated low interobserver and intraobserver variability. The interobserver variability of volume measurements as a function of mean volume was 14.8% and interobserver variability was 8.9%. Reliability was 87% as quantified by the interclass correlation and was 95% by the intraclass correlation. The least detectable change in VWV was 12.9% for interobserver variability and 4.5% for intraobserver variability for the three observers.
Carotid plaque diameter measurements from B-mode images have high variability. Plaque burden, as estimated by VWV, can be measured reliably with a 3D US technique using a clinical scanner. The volumetric change, with 95% confidence, that must be observed to establish that a plaque has undergone growth or regression is ∼12.9% for different observers and 4.5% for the same observer performing the follow-up study.