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PurposeThe mechanisms of brain metastasis are incompletely understood. Circulating tumor cells travel to the right heart and through the pulmonary circulation, where they may become lung metastases, and can circulate further to the left heart and brain. In patients who develop brain metastases without lung involvement, we hypothesized that cancer cells may travel directly from the right atrium to left atrium via a patent foramen ovale (PFO), akin to paradoxical embolism. If the prevalence of PFO is greater in these individuals compared to the general population (20-30%), PFO may play a role in brain metastasis, and prophylactic closure may provide benefit. Accordingly, we investigated the prevalence of PFO in patients with brain metastases without prior lung involvement.MethodsWe prospectively identified patients with brain metastases from a non-lung primary cancer with no preceding or concurrent lung involvement. Nine eligible participants underwent a transcranial Doppler study with intravenous agitated saline to assess for PFO.ResultsAmong nine participants, primary cancers were breast (n = 6), upper gastrointestinal (n = 2), and thyroid (n = 1). A positive bubble study was identified in 2/9 (22.2%) participants: one female with breast cancer and one male with duodenal adenocarcinoma. No participants developed lung metastases on subsequent chest imaging.ConclusionIn this prospective pilot study, we found a similar prevalence of PFO in patients who developed brain metastases without preceding lung involvement compared to estimates for the general population. Through a larger study is needed, the development of brain metastases in these individuals may primarily reflect tumor-specific biological factors diecting metastasis organotropism.

UnlabelledThe mycophenolate mofetil (MMF) trial involved 650 heart transplant patients from 28 centers who received MMF or azathioprine (AZA), both in combination with cyclosporine and corticosteroids. Baseline and 1-year intravascular ultrasound (IVUS) were performed in 196 patients (102 MMF and 94 AZA) with no differences between groups in IVUS results analyzed by morphometric analysis (average of 10 evenly spaced sites, without matching sites between studies). Baseline to first-year IVUS data can also be analyzed by site-to-site analysis (matching sites between studies), which has been reported to be more clinically relevant. Therefore, we used site-to-site analysis to reanalyze the multicenter MMF IVUS data.ResultsIVUS images were reviewed and interpretable in 190 patients (99 MMF and 91 AZA) from the multicenter randomized trial. The AZA group compared to the MMF group had a larger number of patients with first-year maximal intimal thickness (MIT)>or=0.3 mm (43% vs. 23%, p=0.005), a greater decrease in the mean lumen area (p=0.02) and a decrease in the mean vessel area (the area actually increased in the MMF group, p=0.03).ConclusionMMF-treated heart transplant patients compared to AZA-treated patients, both concurrently on cyclosporine and corticosteroids, in this study have significantly less progression of first-year intimal thickening.

ObjectivesThe purpose of this study was to assess whether the newer stent delivery systems provide a stented lumen cross-sectional area (CSA) that is equal to the delivery balloon nominal dimensions.BackgroundFirst generation stents were often not adequately expanded with their delivery system and frequently required higher pressure or a larger balloon after deployment. Newer stents were designed to optimize expansion with noncompliant, high-pressure balloons provided as the delivery systems.MethodsIntravascular ultrasound (IVUS) was used to evaluate 38 stents in 32 patients after deployment at 14 to 16 atm with their delivery balloon system. Minimum stent lumen CSA and stent minimum lumen diameter (MLD) were measured by IVUS imaging. The manufacturer's expected stent diameter was defined as the balloon diameter measured by the company at the maximum pressure used. The manufacturer's expected stent area was calculated based on the manufacturer's expected stent diameter.ResultsThe MLD (2.5 +/- 0.5 mm) and minimum stent CSA (6.0 +/- 1.7 mm(2)) by IVUS were significantly smaller than the manufacturer's expected stent diameter (3.5 +/- 0.4 mm) and area (9.5 +/- 1.9 mm(2)) (p < 0.0001, respectively). The mean MLD by IVUS was 72 +/- 8% of the expected stent diameter, and the mean minimum stent CSA by IVUS was 62 +/- 10% of the expected stent area.ConclusionsDespite moderately high-pressure inflations, the mean minimum stent CSA actually achieved was, on average, only 62% of the manufacturer's expected stent area. To optimize stent deployment, these IVUS observations should be considered during coronary artery stenting.

The success rate of percutaneous transluminal coronary angioplasty for chronic total arterial occlusions is still unsatisfactory. Inability to cross the lesion with a guidewire is a major cause of failure. Optical coherent reflectometry (OCR) is a new method of using laser light to measure the depth of tissue from the end of an optic fiber. This study tests whether an OCR prototype guidewire provides a guidance system that might be useful to assist reopening chronic total arterial occlusions. An OCR fiber optic within a 0.014" hypotube was developed using the interference pattern of two reflected light beams (wave length 1,300 nm). To determine if OCR can distinguish different tissue types, plaques of human lower extremity arterial segments were visually divided into three types (calcified, white, or yellow). The slope of the initial reflectance of the OCR curve was calculated and compared between the three groups. In six other arteries, the OCR wire was advanced longitudinally through occluded human artery segments in vitro. Guidewire position was determined by OCR and compared to the position of the guidewire tip observed simultaneously by intravascular ultrasound (IVUS) imaging. In 16 arterial surface segments, calcified plaques had a significantly steeper slope than white or yellow plaques (-227.2 +/- 82.2; -81.5 +/- 12.9; -103.6 +/- 19.6 dB/mm; P < 0.01). For the determination of the guidewire position, IVUS and OCR corresponded correctly in 82% of 28 measurements. Sensitivity and specificity of OCR for detection of plaque versus the media/adventitia boundary were 79% and 89%, respectively (P < 0.001). OCR can distinguish calcified from noncalcified plaque and may distinguish plaque from the media/adventitia boundary. This technology may be useful as a means to help navigate a guidewire safely through an occluded artery.

HypothesisPatency after primary percutaneous transluminal angioplasty (PTA) and stenting of superficial femoral artery (SFA) occlusions is better than historical experience with PTA alone.DesignConsecutive case series of primary PTA with stenting, and follow-up with duplex imaging every 6 months (mean +/- SD follow-up, 32 +/- 15 months).SettingVeterans Affairs medical center.Patients and methodsPatients were 57 previously untreated men with 71 limbs having chronic atherosclerotic SFA occlusion with suprageniculate reconstitution and patent tibial runoff. Critical ischemia (Society for Vascular Surgery [SVS] category, 4-6) was present in 7 (10%), the remainder had intermittent claudication only (SVS, 1-3).InterventionsGuidewire recanalization followed by PTA, Wallstent deployment, and adjunctive thrombolysis as necessary; 19 limbs (27%) required thrombolysis to manage periprocedural thrombosis.Main outcome measuresCumulative patency, limb salvage, and complications.ResultsLength (mean +/- SD) of occlusion was 14.4 +/- 9.9 cm. Length of stented artery was 24.3 +/- 11.1 cm. Ankle brachial index increased from 0.59 +/- 0.14 to 0.86 +/- 0.16 (P

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.

ObjectivesThe purpose of this study was to evaluate two different techniques of stent placement in bifurcation lesions.BackgroundAlthough stent placement with dedicated techniques has been suggested to be a useful therapeutic modality for bifurcation lesions, limited information is available if stent placement on the side branch and on the parent branch provides any advantage over a simpler strategy of stenting the parent vessel and balloon angioplasty of the side branch.MethodsBetween March 1993 and April 1999, we treated a total of 92 patients with bifurcation lesions with two strategies: stenting both vessels (group B, n = 53) or stenting the parent vessel and balloon angioplasty of the side branch (group P, n = 39). Paired angiograms were analyzed by quantitative angiography, and clinical follow-up was obtained.ResultsStent placement on both branches resulted in a lower residual stenosis (7.4 +/- 10.9% vs. 23.4% +/- 18.7%, p < 0.001) in the side branch. Acute procedural success was similar in the two groups (group B: 87% vs. Group P: 92%). In-hospital major adverse cardiac events (MACE) occurred only in group B (13% vs. 0%, p < 0.05). At the six-month follow-up, the angiographic restenosis rate (group B: 62% vs. Group P: 48%) and the target lesion revascularization rate (38% vs. 36%, respectively) were similar in the two groups. There was no difference in the incidence of six-month total MACE (51% vs. 38%).ConclusionsFor the treatment of true bifurcation lesions, a complex strategy of stenting both vessels provided no advantage in terms of procedural success and late outcome versus a simpler strategy of stenting only the parent vessel.

The use of intravascular ultrasound catheters to produce images of lumen and plaque cross-sectional areas has had a profound effect on the practice of interventional cardiology. This imaging modality provides, for the first time, a low-power microscopic view of vascular anatomy within a living patient. This article will review some of the advantages of intravascular ultrasound imaging compared with angiography when used for diagnostic or interventional therapeutic procedures.

BackgroundIntravascular ultrasound (IVUS) is a sensitive method for assessing allograft vasculopathy in heart transplant recipients, but it is not known whether this instrumentation traumatizes the transplanted arteries and affects progression of arteriopathy.Methods and resultsYearly coronary angiograms were obtained in 86 patients who underwent heart transplantation between January 1991 and May 1995. Patients were divided into 3 groups: (1) no IVUS performed after transplantation (group 1, n = 47); (2) IVUS of the left anterior descending artery (LAD) performed only at year 1 (group 2, n = 13); and (3) IVUS of the LAD performed at both baseline (within 2 months after transplantation) and year 1 after transplantation (group 3, n = 26). Coronary angiography measurements of lumen diameter were performed at 5 segments along the length of the LAD and left circumflex artery (LCX) from baseline through the second-year studies except in group 2, which did not receive a baseline angiogram; IVUS measurements were obtained at 10 cross sections from each artery. At baseline, there was no significant difference in vessel diameter for either the LAD or the LCX artery between the IVUS (group 3) and no IVUS (group 1) groups. Within each group, the lumen of both the LAD and LCX narrowed from baseline to year 1 (group 1: 3.3 +/- 0.6 mm to 2.8 +/- 0.5 mm in LAD, P =.001; 3. 3 +/- 0.6 mm to 3.0 +/- 0.5 mm in LCX, P =.006; group 3: 3.5 +/- 0.7 mm to 3.1 +/- 0.6 mm in LAD, P =.01; 3.1 +/- 0.6 mm to 2.8 +/- 0.5 mm in LCX, P = 0.07), but there were no significant differences between the instrumented artery (LAD) and control artery (LCX) or further changes observed at year 2. There were also no significant differences in the percent reductions at year 1 and year 2 between arteries or between groups. By IVUS, from baseline to year 1 in group 3, the plaque cross-sectional area (CSA) increased (1.6 +/- 1. 9 to 2.3 +/- 1.7 mm(2), P

Although intravascular ultrasound (IVUS) is used for evaluation of plaque volume and lumen size as well as detection of vessel wall structures after catheter-based interventions, differentiation between the lumen and plaque structures can be difficult. This study attempted to evaluate the efficacy of negative contrast IVUS imaging for assessment of vessel wall morphology after coronary interventions. IVUS studies were performed in 67 lesions in 66 patients before and after coronary interventions. After the baseline ultrasound imaging run, warm 5% glucose solution was injected manually through the guiding catheter into the coronary artery to washout blood from the lumen to avoid speckled reflections from red blood cells (negative contrast). Quantitative measurements were obtained and plaque morphology was assessed for the presence and extent of medial dissections and intimal flaps. There was no difference in each quantitative parameter between baseline images and negative contrast images. The vessel wall boundary was clearly delineated from the lumen, which was defined as effective negative contrast in 51 of 67 lesions (76%). The baseline images revealed plaque dissection in 9 lesions (18%) and an intimal flap in 13 lesions (25%). In addition, 4 dissections (8%) and 16 intimal flaps (31%) were visualized during the infusion of negative contrast. Additional treatment was performed in 4 lesions (8%) based on the images with negative contrast. Negative contrast IVUS was more sensitive in demonstrating a plaque fracture than were baseline images. This method is useful for enhancing the diagnostic capability of IVUS imaging and may influence the decision-making process during interventional procedures.

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.

ObjectivesThis study was performed to determine predictors of in-stent restenosis from a high volume, single-center practice.BackgroundIntracoronary stents have been shown to reduce the restenosis rate as compared with balloon angioplasty, but in-stent restenosis continues to be an important clinical problem.MethodsBetween April 1993 and March 1997, 1,706 patients with 2,343 lesions were treated with a variety of intracoronary stents. The majority of stents were placed with high pressure balloon inflations and intravascular ultrasound (IVUS) guidance. Angiographic follow-up was obtained in 1,173 patients with 1,633 lesions (70%). Clinical, angiographic and IVUS variables were prospectively recorded and analyzed by univariate and multivariate models for the ability to predict the occurrence of in-stent restenosis defined as a diameter stenosis > or =50%.ResultsIn-stent restenosis was angiographically documented in 282 patients with 409 lesions (25%). The restenosis group had a significantly longer total stent length, smaller reference lumen diameter, smaller final minimal lumen diameter (MLD) by angiography and smaller stent lumen cross-sectional area (CSA) by IVUS. In lesions where IVUS guidance was used, the restenosis rate was 24% as compared with 29% if IVUS was not used (p < 0.05). By multivariate logistic regression analysis, longer total stent length, smaller reference lumen diameter and smaller final MLD were strong predictors of in-stent restenosis. In lesions with IVUS guidance, IVUS stent lumen CSA was a better independent predictor than the angiographic measurements.ConclusionsAchieving an optimal stent lumen CSA by using IVUS guidance during the procedure and minimizing the total stent length may reduce in-stent restenosis.

Outside the United States, Palmaz-Schatz coronary stents are implanted by hand-crimping the stent to a high pressure balloon without the use of a protective sheath. This lowers the delivery profile, increases the ease of deployment, and ensures that the postdilatation balloon is centered on the stent. To assess this bare stenting technique, 209 patients were retrospectively analyzed: 92 patients (107 lesions) with the sheath protected stent delivery system (SDS) and 117 patients (150 lesions) with the bare stent approach. The number of balloons used per lesion in the bare stent group was significantly less than in the SDS group (1.9 +/- 0.6 vs. 3.8 +/- 1.2, P < 0.0001). In addition, the procedure time in the bare stent group was significantly shorter than in the SDS group (106 +/- 55 vs. 134 +/- 60 min, P = 0.001). There was no difference in frequency of adverse events or stent displacement during the procedure. The bare stenting technique decreases the procedure time, reduces the number of balloons used, and is as safe as the SDS approach.

BackgroundIntravascular ultrasound (IVUS) provides more precise information than angiography about vascular dimensions. This information is used by some centers to optimize intracoronary stent implantation. There are no direct comparisons of the effects on restenosis of optimal IVUS-guided versus angiography-directed high-pressure stenting.Methods and resultsLesions of patients who had a 6-month angiographic follow-up study were eligible for matching. From 445 consecutive lesions treated by Palmaz-Schatz (P-S) stenting guided by IVUS (IVUS group) in Milan, 173 lesions were individually matched with 173 of 476 consecutive lesions treated by P-S stenting directed by angiography (Angio group) in Hamburg. Lesions were selected by a computerized program according to baseline clinical, angiographic, and procedural variables. Immediate and 6-month angiographic results were retrospectively compared, distinguishing an "early phase" from a "late phase." This distinction was based on the more aggressive dilation strategy with larger balloons and more demanding IVUS criteria for optimal stent expansion used in Milan in the early phase. In both phases, a larger minimum lumen diameter (MLD) immediately after stenting and after 6 months was achieved in the IVUS group than in the Angio group. In the early phase, the dichotomous restenosis rate was lower in the IVUS group than in the Angio group (9.2% versus 22.3%; P=.04). In the late phase, there was no difference in restenosis between the groups (22.7% versus 23.7%; P=1.0).ConclusionsIn matched lesions treated with high-pressure stenting, IVUS guidance achieved a larger MLD than angiographic guidance. However, in the IVUS group, the restenosis rate was lower only in the early phase, when balloons larger than currently used were selected to maximize the stent lumen area.

Late coronary aneurysm formation was observed following treatment by directional coronary atherectomy. Intravascular ultrasound disclosed that the mechanism involved was plaque rupture. The cause of coronary aneurysm may be multifactorial after coronary interventions. Intravascular ultrasound imaging is useful for understanding the pathologic mechanism of coronary aneurysm production.

This case documents the finding of a spontaneous plaque rupture with thrombus formation in the left main coronary artery of a patient who presented with an infarction of the circumflex artery. This serendipitous observation supports the hypothesis that spontaneous plaque ruptures occur sporadically and do not necessarily lead to occlusion.

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 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.

ObjectivesThe purpose of this study was to test the hypothesis that in occlusions of the superficial femoral artery, removal of atherosclerotic plaque would result in a higher long-term patency rate compared to balloon dilatation alone. A secondary hypothesis was that long term patency would be proportional to the amount of plaque removed.MethodsA randomized controlled study of patients with occluded superficial femoral arteries was performed comparing balloon dilatation alone versus a 2.7 mm or a larger (4.0 mm or 4.7 mm) transcutaneous extraction catheter (TEC) atherectomy device followed by balloon dilatation. The effect of these devices on plaque area was assessed directly by intravascular ultrasound imaging.ResultsThe mean occlusion length was 19.4 cm +/- 11.7 cm. The mean lumen area increased from 4.7 mm2 to 15.1 mm2, primarily due to balloon dilatation, but the mean atheroma area of 19.8 mm2 did not change with either size of TEC device. Although the initial procedure success rate was high (79%), the 6 month patency was only 45%. There was no difference in 6 month patency between the 3 groups.ConclusionsThe data indicate that the TEC atherectomy devices do not remove a significant amount of atherosclerotic plaque in occluded superficial femoral arteries. The 6 month patency is no different with these atherectomy devices than with balloon dilatation alone. The larger (4.0 mm or 4.7 mm) TEC device does not remove any more tissue than the smaller (2.7 mm) device. The use of intravascular ultrasound to quantitate the effects of this atherectomy device provides important insights into the mechanism of action and lack of efficacy of the TEC atherectomy catheter.

Coronary calcium as detected by electron beam computed tomography always signifies at least some atherosclerosis, appears to be correlated with coronary risk factors, cardiac history, and overall angiographic severity of disease, but is inconsistently related to degree of atherosclerotic lesion stenosis in a given artery. Increasing evidence, however, suggests an association between coronary artery calcium, atherosclerosis, and coronary risk. But atherosclerosis is a very common condition, its prevalence increasing with age. No fully validated method for determining the quantity of coronary calcium is available, and we do not know whether the amount of calcium is a consistently accurate reflection of the amount of atherosclerosis or whether the amount of atherosclerosis reflects the degree of risk. Furthermore, the prognostic significance of coronary calcium in any given atherosclerotic lesion is not yet established. What is clear from cohort studies, however, is that at least three quarters of asymptomatic individuals, at least half of whom would have "positive" coronary calcium electron beam computed tomographic scans, will live for at least 10 years without cardiac problems of any kind. Investigation is needed to determine whether medical intervention may impact the clinical outcome of the rest of those identified with a positive scan but destined to suffer future clinical events. Despite lack of validation, this test has widespread appeal, both to the public as a means of being able to find out the condition of their coronary arteries "without injections or dye" and to hospitals and private medical groups who view this both as an innovation in cardiovascular diagnosis and as a potentially profitable diagnostic procedure.(ABSTRACT TRUNCATED AT 250 WORDS)

The rate of restenosis after directional coronary atherectomy (DCA) is higher than expected. To elucidate why, the current study used intravascular ultrasound (IVUS) imaging to investigate the mechanism of DCA. An in vitro validation study was performed to determine the accuracy of the measurement of plaque removal by IVUS. DCA was performed in eight human atherosclerotic artery segments. The volume of removed plaque was measured by water displacement and was compared with the volume calculated from IVUS images. A clinical study of DCA was performed in 32 lesions. IVUS was performed in 28 lesions after successful DCA. Measurements of lumen dimensions from digital angiograms before and after DCA were compared with observations of lumen and plaque size from the cross-sectional IVUS images. In the in vitro study, the mean plaque volume removed by DCA was 19.9 +/- 8.5 microliters. The calculated estimate of removed plaque volume by IVUS was 18.6 +/- 7.9 microliters and correlated closely with the volume by water displacement (r = 0.92). The calculated volume of plaque removed from histologic sections was 14.3 +/- 6.0 microliters and was linearly correlated with plaque volume by water displacement (r = 0.81). In the clinical study, the angiographic mean minimum lumen diameter increased from 1.0 +/- 0.4 to 2.7 +/- 0.5 mm and the percentage stenosis decreased from 70% to 19% (p < 0.0001). The IVUS images before and after DCA showed that the lumen DCA improved from 2.9 +/- 1.5 to 7.0 +/- 1.5 mm2 (p < 0.0001). In addition the vessel cross-sectional area (CSA) increased from 17.1 +/- 5.9 to 18.7 +/- 5.5 mm2. The atheroma CSA was reduced from 14.2 +/- 5.0 to 11.7 +/- 4.8 mm2. This combined effect of reduction in atheroma CSA and stretching of the outer vessel diameter resulted in an improvement in percentage plaque area stenosis from 83% +/- 7% to 61% +/- 9%. It is concluded that despite a successful angiographic appearance, DCA removed an average of 2.5 mm2 from the atheroma, which corresponds to only 18% of the atheroma CSA. The total lumen CSA increased 4.1 mm2; 61% of the new lumen was created by cutting and removal of plaque, whereas 39% of the new lumen was made by stretching the external wall of the artery. Despite an excellent angiographic result, IVUS imaging reveals that after DCA a significant amount of residual atheroma remains. As in balloon dilatation, a stretching effect is a significant component of DCA.

BackgroundThe placement of stents in coronary arteries has been shown to reduce restenosis in comparison to balloon angioplasty. However, clinical use of intracoronary stents is impeded by the risk of subacute stent thrombosis and complications associated with the anticoagulant regimen. To reduce these complications, the hypothesis that systemic anticoagulation is not necessary when adequate stent expansion is achieved was prospectively evaluated on a consecutive series of patients who received intracoronary stents.Methods and resultsFrom March 1993 to January 1994, 359 patients underwent Palmaz-Schatz coronary stent insertion. After an initial successful angiographic result with < 20% stenosis by visual estimation had been achieved, intravascular ultrasound imaging was performed. Further balloon dilatation of the stent was guided by observation of the intravascular ultrasound images. All patients with adequate stent expansion confirmed by ultrasound were treated only with antiplatelet therapy (either ticlopidine for 1 month with short-term aspirin for 5 days or only aspirin) after the procedure. Clinical success (procedure success without early postprocedural events) at 2 months was achieved in 338 patients (94%). With an inflation pressure of 14.9 +/- 3.0 atm and a balloon-to-vessel ratio of 1.17 +/- 0.19, optimal stent expansion was achieved in 321 of the 334 patients (96%) who underwent intravascular ultrasound evaluation, with these patients receiving only antiplatelet therapy after the procedure. Despite the absence of anticoagulation, there were only two acute stent thromboses (0.6%) and one subacute stent thrombosis (0.3%) at 2-month clinical follow-up. Follow-up angiography at 3 to 6 months documented two additional occlusions (0.6%) at the stent site. At 6-month clinical follow-up, angiographically documented stent occlusion had occurred in 5 patients (1.6%). At 6-month clinical follow-up, there was a 5.7% incidence of myocardial infarction, a 6.4% rate of coronary bypass surgery, and a 1.9% incidence of death. Emergency intervention (emergency angioplasty or bailout stent) for a stent thrombosis event was performed in 3 patients (0.8%). The overall event rate was relatively high because of intraprocedural complications that occurred in 16 patients (4.5%). Intraprocedural complications, however, decreased to 1% when angiographically appropriately sized balloons were used for final stent dilations. There was one ischemic vascular complication that occurred at the time of the procedure and one ischemic vascular complication that occurred at the time of angiographic follow-up. By 6 months, repeat angioplasty for symptomatic restenosis was performed in 47 patients (13.1%).ConclusionsThe Palmaz-Schatz stent can be safely inserted in coronary arteries without subsequent anticoagulation provided that stent expansion is adequate and there are no other flow-limiting lesions present. The use of high-pressure final balloon dilatations and confirmation of adequate stent expansion by intravascular ultrasound provide assurance that anticoagulation therapy can be safely omitted. This technique significantly reduces hospital time and vascular complications and has a low stent thrombosis rate.

ObjectivesThis study attempted to determine why there is a discrepancy between angiographic and intravascular ultrasound measurements after coronary balloon angioplasty.BackgroundPrevious studies have shown a poor correlation between angiographic and intravascular ultrasound measurements after percutaneous coronary balloon angioplasty.MethodsAfter successful balloon angioplasty, 91 lesions in 84 patients were studied by intravascular ultrasound. Plaque morphology on intravascular ultrasound was classified as demonstrating a superficial injury if there was either no fracture or only a small tear that did not extend to the media versus a deep injury defined as the presence of a plaque fracture that reached the media. Measurements of minimal lumen diameter were compared between angiography and intravascular ultrasound.ResultsOn ultrasound imaging, a superficial injury pattern was observed in 44 lesions, whereas a deep injury was seen in 47 lesions. There were no statistical differences at baseline in patient or lesion characteristics. In the superficial injury group there was a significant correlation between angiography and intravascular ultrasound for minimal lumen diameter (r = 0.67) and lumen cross-sectional area (r = 0.69). In the deep injury group there was a poor correlation for minimal lumen diameter (r = 0.05) and lumen cross-sectional area (r = 0.28). After balloon angioplasty, the angiographic appearance showed a normal contour in 34%, the presence of dissection in 38% or a hazy appearance in 23%. On ultrasound imaging after angioplasty, the superficial injury group comprised 65% of lesions with a normal angiographic appearance and 67% of lesions with a hazy appearance, whereas 77% of lesions with an angiographic diagnosis of dissection were in the deep injury group by ultrasound (p = 0.0005).ConclusionsThese observations suggest that the discrepancies between angiographic and ultrasound measurements are due to differences in plaque morphology created by balloon dilation. Superficial injuries demonstrate similar results by angiography or ultrasound, whereas a deep injury to the plaque produces a difference in measurements between angiography and ultrasound. When angiography reveals a dissection, there is a high probability that intravascular ultrasound will demonstrate a plaque fracture extending to the media.