Performance standards and edge detection with computerized quantitative coronary arteriography. The Lovastatin Restenosis Trial Group.

Quantitative coronary angiography (QCA) has become an important tool for evaluating coronary angiograms. Many methodologic factors, such as the choice of frame to analyze, the selection of the "normal," segment and the method of edge detection used may affect the results of QCA. The sequential steps in performing QCA, including a comparison of visual and automated edge-detection methodologies, were evaluated using 12 precision-drilled phantoms and 20 patient films. Normal diameter, minimal lumen diameter, and diameter stenosis were measured. In the phantom studies, the measurements from both visual and automated systems correlated well with the true measurements of the phantoms and between systems (all r values >0.92). To study the difference between methodologies on QCA results as influenced by the choice of frame and normal segment analyzed, the patient films were analyzed independently in 3 separate rounds of interpretation. In round 1, each system's operator individually chose frames and normal segments for analysis. In round 2, both systems analyzed the same preselected frames, but independently chose normal segments. In round 3, both systems analyzed the same preselected normal segments and frames. The intersystem correlations between visual and automatic systems for rounds 1, 2, and 3 were: normal diameter, r = 0.25, r = 0.37, and r = 0.75, respectively; minimal lumen diameter, r = 0.79, r = 0.86, and r = 0.85, respectively; and diameter stenosis, r = 0.65, r = 0.73, and r = 0.87, respectively. The manual edge-detection and automated edge-detection systems used in this study are reasonably accurate and consistent on phantom studies. In patient studies, the nonautomated processes (choice of frame and normal segment for analysis) produced significant differences in the QCA results, thus illustrating that operator-dependent factors other than edge detection are very important in QCA.

Lesion-directed administration of alteplase with intracoronary heparin in patients with unstable angina and coronary thrombus undergoing angioplasty.

Percutaneous coronary revascularization in patients with unstable angina and coronary thrombus carries a high complication rate. A new strategy to reduce thrombus burden before revascularization was tested in a multicenter prospective trial. Patients with unstable angina and coronary thrombus (n = 45) received alteplase through an infusion catheter at the proximal aspect of the target lesion and concomitant intracoronary heparin via a standard guiding catheter. Angiography was performed before and alter lesion-directed therapy and post-intervention. Systemic fibrinogen depletion and thrombin activation were not observed, while fibrinolysis was evident for > or = 4 hr after treatment. Target lesion stenosis did not change significantly after lesion-directed therapy, but thrombus score was reduced, particularly among patients who had large thrombi (mean 2.2 vs. 1.6, P = 0.02). Revascularization was successful in 89% of patients. Median final stenosis was 30% and mean final thrombus score was 0.4. Complications included recurrent ischemia (11%), MI (7%), abrupt closure (7%), severe bleeding (4%), and repeat emergency angioplasty (2%). Patients with overt thrombus appeared to derive the most angiographic benefit from lesion-directed alteplase plus intracoronary heparin. Later revascularization was highly successful. This strategy may be a useful adjunct to percutaneous revascularization for patients with unstable angina and frank intracoronary thrombus.

Comparisons of angiographic core laboratory analyses of phantom and clinical images: interlaboratory variability.

Centralized, quantitative coronary analysis (QCA) has become the standard for determining change in coronary anatomy in clinical investigations. QCA systems and laboratory methods, however, vary among core facilities, and analysis variability among angiographic core laboratories (ACL) has not be studied. We evaluated QCA accuracy and variability among active ACL, using differing QCA systems by comparing analyses of phantom and clinical cinefilm images. Automated, unedited analyses were performed on images of 11 plexiglass phantom lumens (0.67-5.05 mm) acquired under varying radiographic conditions. Analysis differences from actual luminal diameters ranged widely (+0.42 - (-)0.45 mm) among ACL. Measurement of diameters < 1.0 mm were overestimated and diameters > 3.0 mm were underestimated. Measurements of midrange diameters (> 1.0 mm and < 3.0 mm) were most comparable among ACL (93% within +/- 0.2 mm). Clinical image analysis was performed using differing QCA systems and laboratory methodology on 11 randomly selected study films. Comparative analyses revealed significant variability between laboratories in the assessment of minimal lumen diameter (0.22 +/- 0.38 mm P < 0.05). These data describe analysis variability among ACL and demonstrate a need for establishing ACL performance standards.

Relation between coronary artery stenosis assessed by visual, caliper, and computer methods and exercise capacity in patients with single-vessel coronary artery disease. The Veterans Affairs ACME Investigators.

BACKGROUND: Practitioners often assume a close relation between angiographic coronary artery stenosis and patient functional capacity. To test this unproven hypothesis, we analyzed the relation between coronary artery stenosis measured by different methods and maximal treadmill exercise tolerance in patients with single-vessel disease before and after intervention by percutaneous transluminal coronary angioplasty (PTCA). METHODS AND RESULTS: Coronary angiography and maximal exercise testing off anti-ischemic medication were performed before random assignment of 227 patients with single-vessel coronary artery disease to PTCA or drug therapy. Six months later, angiography and exercise testing were repeated with patients assigned to PTCA off anti-ischemic therapy so that the altered coronary stenosis was the only consistent variable. Patients assigned to drug therapy were exercised on drug therapy. Coronary stenosis was assessed visually by the local investigator and quantitatively by blinded caliper and computer methods in central laboratories. Variabilities of caliper and computer measurements were established in a subset read twice. Visually estimated stenosis > or = 90% at baseline was associated with shorter exercise duration (7.9 versus 9.2 minutes, P < .04). Similar segregation at baseline was not observed with caliper or computer methods. Regardless of the method of measurement used, correlation between changes of lesion severity and exercise duration from baseline to follow-up was poor. Patients were angiographically classified as "better," "unchanged," or "worse" if follow-up stenosis was below, within, or above 2 SD of mean technical variability from baseline (+/- 18.8%, caliper, +/- 14.6%, computer). Exercise duration for PTCA patients improved among those with better lesions (+2.4 minutes, n = 50, P = .001) but also among those with unchanged lesions (+1.9 minutes, n = 41, P < or = .001). Unchanged medically treated patients improved less (+0.5 minutes, n = 86, P = .04). Results were similar when patients were angiographically classified by minimum lumen diameter. CONCLUSIONS: Handheld calipers and quantitative coronary angiography are equivalent techniques for making anatomic measurements. Neither method identified patients having reduced exercise capacity at baseline as well as visual estimation. The relation between changes of coronary stenosis and exercise duration is highly variable, at least in part because of the insensitivity of angiographic methods for detecting small but potentially important changes. Minimal anatomic improvement 6 months after PTCA does not preclude a good functional outcome. Contrary to common belief, angiographic stenosis does not correlate well with functional capacity, even in patients with single-vessel disease.

Characterization of pulsed-dye laser-mediated vasodilatation in a rabbit femoral artery model of vasoconstriction.

Vasoconstriction is a clinical problem associated with invasive vascular procedures, microvascular reconstruction and subarachnoid hemorrhage. We sought to characterize the ability of pulsed-dye laser irradiation to reverse and prevent vasoconstriction in an anesthetized rabbit model of surgically and pharmacologically induced vasoconstriction. Five groups of experiments were performed to study the effect of pulsed-dye laser irradiation delivered through a 320 microns core ball-tip fiber into the femoral artery. The studies demonstrated that pulsed-dye irradiation can reproducibly cause vascular dilatation. The zone of vasodilatation propagated equally proximal and distal to the site of irradiation within the vessel. When saline was infused into the vessel to replace flowing blood during delivery of laser irradiation, no significant vasodilatation occurred. After laser irradiation reversed surgical and pharmacologic vasoconstriction, the vessel was resistant to further pharmacologic vasoconstriction. This resistance to pharmacologic vasoconstriction did not occur if the vessel was pharmacologically predilated before delivery of laser irradiation. Pathologic analysis of the vessels revealed endothelial damage and mild to moderate medial necrosis, most significant at the site of energy delivery. These studies provide characterization of pulsed-dye laser-mediated vasodilatation in an in vivo model. Delivery of pulsed-dye laser energy has potential clinical application and warrants further investigation.

Accuracy of individual and panel visual interpretations of coronary arteriograms: implications for clinical decisions.

The visual interpretation of coronary arteriograms by individuals has been shown to be variable and inaccurate. To determine whether observer accuracy improves with experience or with use of the mean values obtained from a panel of observers, the visual readings of percent diameter stenosis and "normal" reference segment diameter were compared with the quantitative analyses of 13 randomly chosen coronary stenoses. Visual interpretation was also performed on cineangiograms of seven phantom stenoses ranging in severity from 17% to 83%. Repeated quantitative arteriography demonstrated good intraobserver variability for minimal stenosis diameter (r = 0.91, SD = 0.23 mm) and percent diameter stenosis (r = 0.93, SD = 6.4%). When the mean of the repeated quantitative analyses was used as the standard, visual interpretations of percent diameter stenosis were found to have considerable inaccuracy (r = 0.78, SD = 14.5%). Phantom percent diameter stenosis data were better correlated (r = 0.85), but accuracy remained poor (SD = 17.8%). Fifty percent narrowings were read over a range from 30% to 95%. Substantial inaccuracies were also found for observer assessment of normal reference segment diameter (r = 0.75, SD = 0.75 mm). Observer accuracy of percent stenosis did not correlate with prior angiographic experience but was progressively improved by taking the mean value of the interpretations of three and five experienced angiographers (r = 0.88, 0.89; SD = 11.3%, 8.3%, respectively). These findings suggest that arteriographic interpretations accurate enough for interventional decisions can only be obtained using quantitative arteriography or the mean value of data from a large panel of angiographers.

Quantitative assessment of global and regional left ventricular function with low-contrast dose digital subtraction ventriculography.

Few studies have compared the use of low-contrast dose digital subtraction ventriculography with conventional ventriculography for quantitative assessment of both global and regional left ventricular function. Accordingly, 34 patients underwent conventional ventriculography using 36 ml of ionic contrast material and digital ventriculography (mask-mode) using 10 ml of contrast diluted in 10 ml of saline and injected over two seconds. Data from two patients were excluded because of ectopy during cineventriculography and from one because of ectopy during both studies. End-diastolic and end-systolic volumes were calculated from both studies by an area-length method and used to calculate ejection fractions. Regional wall motion was quantitated by the centerline method. Results of linear regression analysis demonstrated high correlations for all parameters (end-diastolic volume, r = 0.85; end-systolic volume, r = 0.93; ejection fraction, r = 0.92; quantitative regional wall motion, r = 0.90). Thus, low-contrast dose digital subtraction ventriculography provides an accurate assessment of both global and regional ventricular function and minimizes the required dose and inherent risks of contrast media.

Validation in dogs of a rapid digital angiographic technique to measure relative coronary blood flow during routine cardiac catheterization.

Assessment of the functional significance of anatomically defined coronary stenoses has been hampered by the lack of clinically applicable techniques of measuring coronary blood flow or flow ratios. A digital angiographic technique is reported that allows rapid analysis of relative regional coronary blood flow during routine cardiac catheterization. This technique was validated in dogs by comparing digital flow ratio estimates with electromagnetic-flow (EMF) ratio measurements. Fourteen open-chest dogs had EMF probes placed on the proximal left anterior descending artery before selective coronary angiography. Electrocardiographically gated images were acquired directly by a digital radiographic system during both baseline blood flow and either contrast or papaverine-induced hyperemia. Dual-parameter functional images were generated using color and intensity coding to represent contrast arrival time and contrast density, respectively. For analysis, myocardial areas of interest were created over the distal perfusion bed of the left anterior descending coronary artery. Mean contrast density/appearance time (CD/AT) values were computer calculated as the mean density divided by the mean arrival time for each. Coronary flow reserve was determined as the ratio of the CD/AT value for a hyperemic image divided by the CD/AT value for the corresponding baseline image. CD/AT ratios correlated well (r = 0.92) with actual EMF ratios (CD/AT Ratio = 0.90 EMF Ratio +0.12, n = 48 ratios). Reproducibility was +/- 13%. Interobserver (r = 0.99) and intraobserver (r = 0.98) variability was excellent. Thus, rapid, accurate and reproducible estimates of relative regional coronary blood flow are possible using digital radiography.