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PURPOSE:To improve the patency rate for angioplasty in chronic occlusion of the superficial femoral artery by deploying stents after angioplasty. MATERIALS AND METHODS:Angioplasty and stent placement were performed in 61 arteries in 48 male patients. The mean occlusion length was 13.5 cm and the mean stent length was 30 cm. Patency rates were analyzed at 6 months and at 1, 2, 3, and 4 years. The predictors of restenosis were analyzed by univariate and multiple logistic regression. RESULTS:Patency rates were 87% at 6 months, consisting of 74% primary, 6% primary assisted, and 7% secondary; 79% at 1 year, consisting of 47% primary, 19% primary assisted, and 13% secondary; 72% at 2 years, consisting of 36% primary, 26% primary assisted, and 10% secondary; 70% at 3 years, consisting of 26% primary, 22% primary assisted, and 22% secondary; and 63% at 4 years, consisting of 25% primary, 0% primary assisted, and 38% secondary. There was a 15% morbidity rate and one mortality as a result of retroperitoneal bleeding. Better patency rates were noted at all time intervals in diabetic limbs, 7-mm-diameter versus 10-mm-diameter stents, shorter obstructions and shorter stents, nonsmokers, in limbs in which urokinase was not necessary after stent deployment, and in limbs with an International Society of Cardiovascular Surgery (ISCVS) classification under 3. Patency rates were not affected by age, race, number of trifurcation vessels patent, experience in performing the procedures, and procedures requiring less time. By multivariate logistic analysis, the independent predictors of patency at 6 months were postprocedure ankle/brachial index (ABI) and shorter stent length; at 1 year, preprocedure ABI, shorter stent length, and the presence of diabetes; at 2 years, preprocedure ABI and the presence of diabetes; and at 3 years, the preprocedure ABI. CONCLUSIONS:The techniques used to reestablish antegrade flow in these superficial femoral arteries yielded a high success rate. In addition, the use of angioplasty with stents may improve patency rates over angioplasty without stents.

BackgroundIntravascular ultrasound (IVUS) images vary in intensity because of the angle of the transducer relative to the plaque. The purpose of this study was to determine the angle dependence of ultrasound backscatter when the IVUS transducer is aligned coaxially in atherosclerotic arteries and to examine its feasibility in tissue characterization of human atherosclerotic tissue.Methods and resultsThirty-nine noncalcified regions of interest (ROI, 0.4 to 0. 6 mm in diameter) within cross sections of formalin-fixed human iliac arterial plaque were imaged with a 3.9F, 25-MHz IVUS catheter in saline at room temperature. The catheter was moved coaxially from 8 to 16 positions and spanned 50 to 122 degrees relative to the ROI and the lumen center. Echo intensity for each ROI was defined as the videointensity relative to a standard reflector. The angle dependence of echo intensity was defined as the slope of the regression line between the angle of incidence and echo intensity. Each ROI was histologically classified into 4 groups: fibro-acellular (fibrous cap, n=7), fibro-cellular (n=9), fibro-fatty (n=13), or fatty tissue (n=10). The echo intensity of the majority (72%) of plaque components in IVUS images are significantly affected by the angle of incidence of the transducer. The angle dependence of fibro-acellular samples was significantly greater than that of the other 3 groups (4.69 +/- 3.29 x 10(-3) x echo intensity/degree vs 1.06 +/- 1.10 in fibro-cellular area, 2.09 +/- 1.75 in fibro-fatty area, and 2.16 +/- 1.92 in fatty area, P

OBJECTIVES:Intravascular ultrasound imaging (IVUS) is limited by the size of the imaging catheter. To facilitate imaging before and during interventions, a 30-MHz ultrasonic imaging device was developed that is the same dimension as a 0.018-inch guide wire. The purpose of this study was to evaluate the clinical feasibility of this device. METHODS AND RESULTS:The imaging core was tested in 8 patients with the use of a monorail guiding sheath that was advanced through a 7F catheter. In addition, after coronary interventions, the standard guide wire was removed, the imaging core was placed inside a compatible balloon, and imaging was performed. In 4 patients, imaging was also performed with a standard 3.2F IVUS catheter. The lumen-plaque interface and the media-plaque interface were clearly visualized in all patients. There was no detectable loss in image quality between the new imaging device and the larger IVUS catheter, and measurements of lumen cross-sectional area were not statistically different. CONCLUSIONS:Improvements in manufacturing technology have permitted the development of a mechanically rotating ultrasound imaging core 0.018 inches in diameter. It is compatible with current balloon catheters without degradation of image quality.

To examine the accuracy of intravascular ultrasound (IVUS) in assessing the biophysical properties of atherosclerotic plaque, 33 human iliac arteries were imaged with a 25 MHz IVUS transducer and classified into four groups on the basis of IVUS appearance: minimally diseased arterial wall, bright echogenic plaque with acoustic shadowing, bright echogenic plaque without shadowing, and hypoechogenic plaque (so-called "soft echoes"). The hardness of each plaque was assessed with an ultrasensitive compression ergonometer. The radial static stress-strain relations fit well (r > 0.98) to exponential curves, providing a compression stiffness constant (K) defined as the coefficient of the exponential power. K for bright echogenic plaque with shadowing was significantly greater than that of the other tissues. However, K among minimally diseased entire arterial wall, hypoechogenic plaque, and bright echogenic plaque without shadowing was not significantly different, but these tissues are not physically soft compared with adipose tissue. Therefore, tissue characterization by IVUS distinguishes calcified from noncalcified plaque and accurately predicts its biomechanical hardness. However, soft echoes, although less firm than calcium, do not necessarily correspond to soft tissue.

ObjectivesOne potential complication of stenting is "stent jail" due to placement of a stent across a side branch, which may impede additional interventions. Another form of stent entrapment may occur if the guidewire is accidentally withdrawn and then unknowingly passes through a stent loop during reentry with subsequent high pressure expansion. The purpose of this study was to evaluate this form of stent entrapment in vitro by intravascular ultrasound (IVUS).MethodsA guidewire was passed through the end or middle diamonds of Palmaz-Schatz and Palmaz stents or the middle of Gianturco-Roubin stents. A 3.5 mm balloon was inflated over the guidewire through the various side holes of the stents.ResultsIVUS images presented three distinct patterns depending on the type of stent and position of balloon entry: 1) external compression and loss of wall continuity in the Palmaz-Schatz and Palmaz stents, 2) displacement of the side diamond across the lumen, and 3) external compression of the Gianturco-Roubin stent. The first and second patterns but not the third one were associated with impairment of lumen access.ConclusionsBased upon this in vitro verification, IVUS imaging can be used to identify the presence of stent entrapment in vivo.

The purpose of the study was to compare four intravascular ultrasound (IVUS) machines in vitro for their image representation of coronary arterial walls. There has been considerable variability among reported studies on the accuracy of morphometric measurements of coronary arteries by IVUS. This variability may be caused in part by the difference in the IVUS system used. A total of 24 formalin-fixed coronary arteries were imaged in saline at 37 degrees with four different IVUS systems. The images were interpreted independently and compared with histology. Each system had benefits and limitations: System 1 overestimated the lumen area and had difficulty in identifying the media; System 2 underestimated the media area, but had a lower positive bias for lumen area; System 3 overestimated the lumen area but more clearly identified tissue characteristics such as internal elastic membrane and the echolucent media zone which improved the likelihood of observing a three-layer appearance; and System 4 showed less distinct separation of the arterial components and had poor correlations with histology for media measurements. The ability to make accurate morphometric measurements from IVUS images depends on the clarity of the separation of plaque and media. Among the four systems studied, there is significant variability in the appearance of the ultrasound images and the accuracy of morphometric measurements. These system differences should be considered when comparing IVUS studies performed by different groups.

Different intravascular ultrasound (IVUS) systems vary in their image presentation. The purpose of this study was to compare four IVUS systems in vitro to determine the accuracy of tissue characterization of atherosclerotic plaque compared with histology. Ninety-eight plaque segments from 23 formalin-fixed human iliac arteries were imaged in saline at room temperature with four different IVUS systems. To assess the accuracy of IVUS in describing plaque, three types of analysis were performed: (1) the ability to identify the presence and extent of lumen or plaque boundary; (2) sensitivity, specificity, and interobserver variability of IVUS in qualitatively identifying plaque components compared with histology; and (3) quantification of calcification. The synthetic aperture device had a lower sensitivity in identifying lumen and plaque boundaries (87%, 38% respectively) compared with other machines (96%-100%, 95%-100%). All three mechanically rotating systems had fair to good sensitivities for identifying calcification (57%-73%) or lipid filled areas (50%-83%). The sensitivity of discriminating fibrous tissue from fatty areas was low (39%-52%). The synthetic aperture system had a significantly lower sensitivity for identifying all three tissue types (4%-21%). There was significant interobserver variability (kappa value = 0.47-0.68) as well as machine to machine variability (kappa value = 0.52) for tissue characterization. Calcified areas were underestimated by System 1 (p < .05) and System 4 (p < .01) because of weaker echo reflections or poor image quality. There are significant differences in image representation among these four IVUS systems in the diagnosis of tissue components of complex atherosclerotic plaque. These variabilities should be considered when interpreting studies performed with different machines.

The purpose of the study was to compare four intravascular ultrasound (IVUS) machines in vitro for their image representation of coronary arterial walls. There has been considerable variability among reported studies on the accuracy of morphometric measurements of coronary arteries by IVUS. This variability may be caused in part by the difference in the IVUS system used. A total of 24 formalin-fixed coronary arteries were imaged in saline at 37 degrees with four different IVUS systems. The images were interpreted independently and compared with histology. Each system had benefits and limitations: System 1 overestimated the lumen area and had difficulty in identifying the media; System 2 underestimated the media area, but had a lower positive bias for lumen area; System 3 overestimated the lumen area but more clearly identified tissue characteristics such as internal elastic membrane and the echolucent media zone which improved the likelihood of observing a three-layer appearance; and System 4 showed less distinct separation of the arterial components and had poor correlations with histology for media measurements. The ability to make accurate morphometric measurements from IVUS images depends on the clarity of the separation of plaque and media. Among the four systems studied, there is significant variability in the appearance of the ultrasound images and the accuracy of morphometric measurements. These system differences should be considered when comparing IVUS studies performed by different groups.

Different intravascular ultrasound (IVUS) systems vary in their image presentation. The purpose of this study was to compare four IVUS systems in vitro to determine the accuracy of tissue characterization of atherosclerotic plaque compared with histology. Ninety-eight plaque segments from 23 formalin-fixed human iliac arteries were imaged in saline at room temperature with four different IVUS systems. To assess the accuracy of IVUS in describing plaque, three types of analysis were performed: (1) the ability to identify the presence and extent of lumen or plaque boundary; (2) sensitivity, specificity, and interobserver variability of IVUS in qualitatively identifying plaque components compared with histology; and (3) quantification of calcification. The synthetic aperture device had a lower sensitivity in identifying lumen and plaque boundaries (87%, 38% respectively) compared with other machines (96%-100%, 95%-100%). All three mechanically rotating systems had fair to good sensitivities for identifying calcification (57%-73%) or lipid filled areas (50%-83%). The sensitivity of discriminating fibrous tissue from fatty areas was low (39%-52%). The synthetic aperture system had a significantly lower sensitivity for identifying all three tissue types (4%-21%). There was significant interobserver variability (kappa value = 0.47-0.68) as well as machine to machine variability (kappa value = 0.52) for tissue characterization. Calcified areas were underestimated by System 1 (p < .05) and System 4 (p < .01) because of weaker echo reflections or poor image quality. There are significant differences in image representation among these four IVUS systems in the diagnosis of tissue components of complex atherosclerotic plaque. These variabilities should be considered when interpreting studies performed with different machines.

The purpose of this investigation was to compare the accuracy of intravascular ultrasound (IVUS) and electron-beam computed tomography (EBCT) in quantitating human atherosclerotic plaque and calcium. In experiment 1, 12 human atherosclerotic arterial segments were obtained at autopsy and imaged by using IVUS and EBCT. The plaque from each arterial segment was dissected and a volume measurement of the dissected plaque was obtained by water displacement. The plaque from each arterial segment was ashed at 700 degrees F, and the weight of the remaining ashes was used as an estimate of the calcium mass. In experiment II, 11 calcified arterial segments were obtained at autopsy and imaged by using IVUS at one site along the artery. A corresponding histologic cross section stained with Masson's trichrome was prepared. In experiment I, the mean plaque volume measured by water displacement was 165.3 +/- 118.4 microliters. The mean plaque volume calculated by IVUS was 166.1 +/- 114.4 microliters and correlated closely with that by water displacement (r = 0.98, p < 0.0001). The mean calcium mass measured by ashing was 19.4 +/- 15.8 mg. The mean calculated calcium mass by EBCT was 19.9 mg and correlated closely with that by ashing (r=0.98, p

Intravascular ultrasound imaging was performed in vitro on six histologically normal and 104 minimally diseased arteries in patients aged 13 to 83 years. This study tested the hypothesis that normal coronary arteries produce a three-layer image that corresponds to the histologic layers of intima, media, and adventitia. The results showed a very good correlation between area of the echolucent ultrasound layer with the media and the inner echogenic layer with intimal area. In addition, a three-layer appearance was consistently seen when the internal elastic membrane was present with or without intimal hyperplasia. If the internal elastic membrane was absent, a three-layer appearance was still seen if the collagen content of the media was low. However, a two-layer appearance was observed when there was absence of the internal elastic membrane as well as a high collagen content of the media.