Percutaneous intravascular ultrasound imaging: validation of a real-time synthetic aperture array catheter

This study was designed to validate the dimensional accuracy and ability to characterize atherosclerotic vessel morphology of a new percutaneously passed ultrasound catheter. The 5.5F catheter used for this study has a synthetic aperture array transducer providing a radial field of view perpendicular to the catheter and can be passed over a standard 0.014-in guide wire. Initial in vitro studies were performed to assess accuracy of dimensional and morphologic information. In vitro images of fixed human vessels demonstrated good boundary definition, and dimensional measurements were closely correlated with histological samples (luminal area, r = .97; maximal lumen diameter, r = .95; maximal wall thickness, r = .83). Morphological subtypes were also closely correlated, with increasing severity of histological atherosclerosis characterized by predictable changes in the ultrasound images. Subsequently, the catheter was passed percutaneously in 28 patients to obtain images of coronary (n = 20) and pelvic (n = 12) vessels. Ultrasound images were compared with simultaneous digital angiograms. Correlation between ultrasonic and angiographic estimations of vessel diameters was good (r = .92). We conclude that intravascular ultrasound imaging will be useful for dimensional and morphological characterization of vascular disease, for the study of regression or progression of atherosclerosis, and, potentially, for guidance of therapeutic interventions such as atherectomy and angioplasty.