An in vitro study was performed to evaluate the accuracy of intravascular ultrasound imaging compared with roentgenography for determining the cross-sectional area of a lumen; and to determine if the functional significance of an irregular stenosis is predicted more accurately by intravascular ultrasound than roentgenography. Varying degrees of stenosis were made in 17 rubber tubings by adjusting a plastic constrictor. The cross-sectional areas at the normal and the stenotic segments were determined by intravascular ultrasound, roentgenography, and then measured directly from an acrylamide gel cast of the lumen. To evaluate the functional significance of a stenosis, the pressure drop across the stenosis was measured using a fluid pumping circuit. The actual pressure drop was then compared with the predicted pressure drop derived from hydrodynamic equations using cross-sectional areas obtained by intravascular ultrasound or roentgenography. There was an excellent correlation between the cross-sectional areas at the tightest stenosis measured by intravascular ultrasound compared with the area from the acrylamide cast (7.2 +/- 2.6 v 6.6 +/- 2.4 mm 2, mean +/- SD, r = .93). Measurements of cross-sectional area from the roentgenograms (10.9 +/- 3.9 mm 2) also provided a relatively good correlation with those from the acrylamide casts (r = .84); however, the roentgenograms consistently overestimated the cross-sectional area of the stenosis. The mean values of the actual pressure drop and the predicted pressure drop by intravascular ultrasound and roentgenograms were 15.7 +/- 13.5, 11.3 +/- 11.9, and 4.3 +/- 4.5 mmHg, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Background

Intravascular ultrasound imaging was performed in 27 patients after coronary balloon angioplasty to quantify the lumen and atheroma cross-sectional areas.

Methods and results

A 20-MHz ultrasound catheter was inserted through a 1.6-mm plastic introducer sheath across the dilated area to obtain real-time images at 30 times/sec. The ultrasound images distinguished the lumen from atheroma, calcification, and the muscular media. The presence of dissection between the media and the atheroma was well visualized. These observations of tissue characterization were compared with an in vitro study of 20 human atherosclerotic artery segments that correlated the ultrasound images to histological preparations. The results indicate that high-quality intravascular ultrasound images under controlled in vitro conditions can provide accurate microanatomic information about the histological characteristics of atherosclerotic plaques. Similar quality cross-sectional ultrasound images were also obtained in human coronary arteries in vivo. Quantitative analysis of the ultrasound images from the clinical studies revealed that the mean cross-sectional lumen area after balloon angioplasty was 5.0 +/- 2.0 mm2. The mean residual atheroma area at the level of the prior dilatation was 8.7 +/- 3.4 mm2, which corresponded to 63% of the available arterial cross-sectional area. At the segments of the coronary artery that appeared angiographically normal, the ultrasound images demonstrated the presence of atheroma involving 4.7 +/- 3.2 mm2, which was a mean of 35 +/- 23% of the available area bounded by the media.

Conclusions

Intravascular ultrasound appears to be more sensitive than angiography for demonstrating the presence and extent of atherosclerosis and arterial calcification. Intracoronary imaging after balloon angioplasty reveals that a significant amount of atheroma is still present, which may partly explain why the incidence of restenosis is high after percutaneous transluminal coronary angioplasty.

A prototype ultrasound imaging catheter was evaluated in vitro using 17 human atherosclerotic artery segments before and after balloon dilatation angioplasty. The catheter was 1.2 mm in diameter and incorporated a single 20-MHz ultrasound transducer to obtain cross-sectional images of the arterial lumen. In 15 of the 17 (88%) arteries, high quality images were obtained, which demonstrated clear demarcation between the lumen and the endothelium, the atheroma plaque, the muscular media, and the adventitia. Qualitative characteristics of plaque disruption, dissection, and residual flaps were readily visible. In addition, quantitative information about cross-sectional lumen area was obtained before and after balloon dilatation. The mean cross-sectional lumen area increased from 8.7 to 15.1 mm2 (p less than 0.01) following balloon dilatation. The lumen area measured from the ultrasound images following dilatation correlated closely with the area measured from histologic sections (r = 0.88). The results from this study indicate that a small-diameter ultrasound imaging catheter can be developed that will provide high-resolution qualitative and quantitative information during peripheral and coronary angioplasty.

A prototype intravascular ultrasound imaging catheter with a 20 MHz transducer was used to obtain 59 cross-sectional images in 14 segments of human atherosclerotic arteries. Three distinct components of the arterial wall were visualized on the ultrasound images: a highly reflective intima, an echolucent media, and a moderately reflective adventitia. Images were obtained at 1 mm increments in vitro and were compared with histologic sections at the same levels. Measurements of the arterial layers showed a close correlation between ultrasound images and histologic sections for the thickness of the intimal plaque (r = 0.91), the media (r = 0.83), and the total wall thickness (r = 0.85). The ultrasound images overestimated the mean intimal and total wall thickness by 0.3 mm and 0.7 mm compared to measurements in histologic sections (p less than 0.001). Intravascular imaging with high-frequency ultrasound is an accurate method for measuring microanatomic arterial dimensions and the extent of atheromatous involvement of the arterial wall. This method could represent an important adjunct to traditional angiographic techniques for assessing the severity of atherosclerosis.

Because conventional imaging methods are inadequate for evaluating human coronary arteries in vivo, an intravascular ultrasonic imaging catheter was developed that allows the arterial wall to be studied in cross-section from within the artery. The catheter incorporates a mechanically rotating 20-MHz transducer, which is designed so that the ringdown occurs within the catheter and imaging is permitted up to the catheter's surface. The device rotates at 1800-rpm within a plastic sleeve and provides real-time cross-sectional images at 30 frames/sec. Preliminary experimental and clinical studies indicate that the intravascular ultrasonic imaging catheter could play a valuable role in providing preoperative information concerning arterial wall thickness and tissue characteristics, in distinguishing normal from diseased arterial wall structures during therapeutic intervention, and in assessing the results of intervention.