New three-dimensional volumetric ultrasound probe for accurate quantification of atherosclerotic plaque volume

Abstract

Abstract Background Atherosclerosis burden is directly related with the development of clinical cardiovascular events. Recent ESC guidelines endorse carotid and/or femoral plaque burden assessment as a complement for conventional cardiovascular risk evaluation. Compared with previous 3D probes, new 3D-matrix transducers for vascular ultrasound imaging are designed to improve functionality and image quality for an accurate study of atherosclerosis burden. Purpose We aimed to validate a commercially available 3D-matrix transducer for plaque volume measurement in early disease stages (small plaques) when accurate plaque detection and quantification is challenging, and intermediate-advanced (medium-large size) plaques in carotid and femoral arteries. Methods We performed an ex vivo study using carotid and femoral arterial specimens from a pig model of early atherosclerosis in which actual 3D vascular ultrasound (3DVUS) volume measurements obtained using the new 3D-matrix transducer (XL14–3) were correlated against gold-standard histological measurements. Moreover, we performed a clinical experiment in a subset of intermediate-high risk patients from the “Athero-Brain: Head to Heart (H2H)” study with patent carotid and femoral atherosclerosis for comparing plaque volume evaluated by the new XL14–3 3D-matrix transducer, based on “electronic” 3D-sweep technology, with that measured by previously validated VL13–5 “mechanical” 3D-sweep transducer that uses a mechanically steered linear-array. Results In the ex vivo setting, we evaluated 11 atherosclerotic plaques (6 carotid and 5 femoral plaques, mean plaque volume 16.5±22.5 mm3 ranging in size from 1 to 56 mm3), finding a strong correlation between 3DVUS measures and the histological gold-standard with an intraclass correlation coefficient (ICC) of 0.994 (95% CI [0.976; 0.998]). In the clinical setting, we measured 25 plaques (14 carotid and 11 femoral plaques; mean plaque volume 273.4±216.5 mm3 ranging in size from 10 to 859 mm3) from 8 patients (mean age 75±5 years old, 45% men) finding again a strong correlation between 3DVUS electronic-based and mechanical-based volume measurements (ICC=0.996 95% CI [0.991; 0.998]). Correlation and Bland-Altman plots for the measurements of both experiments are displayed in the figure and showed good agreement (Slope close to 1 in the Passing Bablock analysis) with small or lower than clinically relevant differences between measurements. Conclusions 3DVUS using new matrix technology accurately measures plaque volumes of early (small-size) to intermediate-advanced plaques located in superficial arteries like carotid and femoral arteries. Figure 1 Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Institute of Health Carlos III Institute through an Integrated Excellence Project Grant