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Biomedical subjects

M B Leon

Publications and source records attributed to M B Leon.

At least 109 records · Page 6Linked to original sources
PubMed1999

Intravascular ultrasound assessment of the presence of vascular remodeling in diseased human saphenous vein bypass grafts.

Remodeling occurs in diseased human coronary arteries; however, reports of remodeling in diseased autologous saphenous vein bypass graft (SVG) stenoses are inconsistent. Preintervention intravascular ultrasound and quantitative coronary angiography were used to study 104 SVG stenoses in 93 consecutive patients. Lesion site and proximal and distal reference segment measurements included vein graft, external elastic membrane, lumen, wall (vein graft minus lumen), and plaque (external elastic membrane minus lumen) areas. Three indexes of remodeling were assessed: (1) lesion site SVG (or external elastic membrane) area was compared with the average reference segment, (2) SVG area was correlated with the wall area and external elastic membrane area was correlated with the plaque area, and (3) the impact of excess plaque accumulation (at the stenosis compared with the reference segment) on lumen compromise was calculated. Overall, the ratio of lesion/reference vein graft area was 1.07 +/- 0.25; however, 23 lesions were classified as negative remodeling (ratio <0.9), 37 as intermediate remodeling (ratio between 0.9 and 1.1), and 44 as positive remodeling (ratio >1.1). Reference segment vein graft area correlated with wall area (r = 0.906, p <0.0001), and external elastic membrane area correlated with plaque area (r = 0.703, p <0.0001). Similarly, lesion site vein graft area correlated with wall area (r = 0.978, p <0.0001), and external elastic membrane area correlated with plaque area (r = 0.961, p <0.0001). The regression line relating delta lumen area to delta wall area was y = -0.22 x - 6.2 (r = 0.451, p <0.0001) and the regression line relating delta lumen to delta plaque area was y = -0.47 x - 4.5 (r = 0.572, p <0.0001). (A slope of 0 would indicate perfect positive remodeling and a slope of 1.0 no positive remodeling.) Diseased SVGs undergo positive and negative remodeling similar to native coronary arteries.

Adult↗
PubMed1999

Quantitative angiographic analysis of stent restenosis in the Scripps Coronary Radiation to Inhibit Intimal Proliferation Post Stenting (SCRIPPS) Trial.

To identify luminal dimension changes occurring within the stent alone and within the stent + margin segment, we reviewed the quantitative angiographic results obtained from the Scripps Coronary Radiation to Inhibit Proliferation Post Stenting (SCRIPPS) trial, a prospective randomized trial assessing the effect of iridium-192 (Ir-192) on the prevention of stent restenosis. Fifty-five patients were randomly assigned to receive Ir-192 or placebo sources after successful intervention. Procedural and 6-month follow-up cineangiograms were quantitatively reviewed in 52 patients to identify changes within the stent and the stent + margin segment. The percent diameter stenosis was lower within the stent than within the stent + margin segment after the procedure (6 +/- 22% vs 21+/- 15%, p <0.0001) and at follow-up (28 +/- 29% vs 42 +/- 21%, p <0.0001). As a result, a lower restenosis rate was found within the stent than within the stent + margin (25% vs 37%, p <0.0001); isolated stent margin restenosis occurred in 11.5% of lesions. Treatment with Ir-192 reduced restenosis within the stent (8% vs 39%; p = 0.010) and within the stent + margin segment (17% vs 54%; p = 0.010); the reduction in restenosis at the margin only (8.3% vs 14.3%, p = 0.503) was not significant. The lowest relative risk for restenosis resulting from Ir-192 occurred within the stent (0.21; 95% confidence interval [CI] 0.05 to 0.86) compared with the stent + margin segment (0.31; 95% CI 0.12 to 0.81) or the stent margin (0.58; 95% CI 0.12 to 2.91). In the SCRIPPS trial, 32% of restenosis occurred at the stent margins. Treatment with Ir-192 reduced restenosis primarily within the stent rather than the margin. Whether extending the treatment length to fully include the stent margins will further reduce restenosis requires further study.

Brachytherapy↗
PubMed1999

Long-term follow-up after percutaneous transluminal coronary angioplasty was not performed based on intravascular ultrasound findings: importance of lumen dimensions.

BACKGROUND: Angiography is limited in determining the anatomic severity of coronary artery stenoses. Clinical decision-making in patients with symptoms and intermediate lesions remains challenging. METHODS AND RESULTS: The current analysis included 300 patients (357 intermediate native artery lesions) in whom intervention was deferred based on intravascular ultrasound (IVUS) findings. Standard clinical, angiographic, and IVUS parameters were collected. Patients were followed for >1 year. Events occurred in 24 patients (8%). They included 2 cardiac deaths, 4 myocardial infarctions, and 18 target-lesion revascularizations (TLR; 12 percutaneous transluminal coronary angiographies and 6 coronary artery bypass grafts; only 3 TLRs occurred within 6 months after the IVUS study). All significant univariate clinical, angiographic, and IVUS parameters (P<0.05) were tested in multivariate models. These included diabetes mellitus, IVUS lesion lumen area, maximum lumen diameter, minimum lumen diameter, plaque area, plaque burden, and area stenosis (AS). No angiographic measurement was significant at P<0.05. The only independent predictors of an event (death, myocardial infarction, or TLR) were IVUS minimum lumen area and AS. The only independent predictors of TLR were diabetes mellitus, IVUS minimum lumen area, and AS. In 248 lesions with a minimum lumen area >/=4.0 mm(2), the event rate was only 4.4% and the TLR rate 2.8%. CONCLUSIONS: Long-term follow-up after IVUS-guided deferred interventions in patients with de novo intermediate native artery lesions showed a low event rate. In patients with a minimum lumen area >/=4.0 mm(2), the event rate was especially low. IVUS imaging is an acceptable alternative to physiological assessment in these patients.

Angioplasty, Balloon, Coronary↗
PubMed1999

Preintervention arterial remodeling as an independent predictor of target-lesion revascularization after nonstent coronary intervention: an analysis of 777 lesions with intravascular ultrasound imaging.

BACKGROUND: Pathological and intravascular ultrasound (IVUS) studies have documented arterial remodeling during atherogenesis. However, the impact of this remodeling process on the long-term outcome after percutaneous intervention is unknown. METHODS AND RESULTS: We used preintervention IVUS to define positive and negative/intermediate remodeling in a total of 777 lesions in 715 patients treated with nonstent techniques. Positive remodeling (lesion external elastic membrane area greater than average reference) was present in 313 lesions; intermediate/negative remodeling (lesion external elastic membrane area less than or equal to reference) was present in the other 464. Baseline clinical and angiographic characteristics were similar, except for a slightly higher percentage of insulin-dependent diabetic patients (10.2% versus 6.1%; P=0.054) in the negative/intermediate-remodeling group. Angiographic success and in-hospital and short-term complications were comparable in the 2 groups. There was no significant correlation between remodeling (as a continuous variable) and final lumen area (r=0.06) or final lesion plaque burden (r=0.17). At 18+/-13 months of clinical follow-up, both groups had similar rates of death and Q-wave myocardial infarction: 3.4% and 2.5% for the negative/intermediate-remodeling group versus 2.7% and 2.7% for the positive-remodeling group. However, the target-lesion revascularization (TLR) rate was 20.2% for the negative/intermediate-remodeling group versus 31.2% for the positive-remodeling group (P=0.007), and remodeling, as a continuous variable, was strongly correlated with probability of TLR (P=0.0001). By multivariable logistic regression analysis, diabetes (OR=2.3), left anterior descending artery location (OR=1.8), and remodeling (OR=5.9) were independent predictors of TLR. CONCLUSIONS: Positive lesion-site remodeling is associated with a higher long-term TLR after a nonstent interventional procedure. Thus, long-term clinical outcome appears to be determined in part by preintervention lesion characteristics.

Aged↗
PubMed1999

Comparative analysis of early and late angiographic outcomes using two quantitative algorithms in the Balloon versus Optimal Atherectomy Trial (BOAT).

Although substantial intersystem variability has been shown among several commercially available quantitative angiographic (QA) analysis algorithms, no previous study has compared the angiographic findings using 2 different QA systems performed at the same central angiographic laboratory. The purpose of this study was to compare the early and late QA results obtained with the CMS (MEDIS) and ARTREK (ImageComm) QA systems in the Balloon versus Optimal Atherectomy Trial. Directional atherectomy (n = 496) or balloon angioplasty (n = 490) was performed in 986 patients; late QA follow-up was available in 767 patients (77.7%). QA analysis was performed by 2 independent observers using the CMS and ARTREK systems. Correlation between the 2 QA systems for baseline measurements was good (Pearson's R = 0.78), although the CMS system resulted in larger baseline reference diameter (RD) (3.22 +/- 0.45 vs 3.07 +/- 0.40 mm; p <0.0001) and baseline minimal lumen diameters (MLD) (1.05 +/- 0.35 vs 0.92 +/- 0.32; mm p <0.0001) than the ARTREK system. The final and follow-up RD (+0.17 and +0.11 mm, respectively) were also larger using the CMS system. In contrast, the final and follow-up measurements of MLD and percent diameter stenosis were not significantly different using the 2 QA systems. The QA system did not affect the ability to detect a difference in restenosis rates (>50% follow-up diameter stenosis) between the 2 treatment groups (CMS, directional atherectomy [31.8%]; balloon angioplasty [40.5%]; p = 0.013 and ARTREK, directional atherectomy [33.9%], balloon angioplasty [41.3%]; p = 0.036). Only lesion irregularity contributed to the difference in baseline measurements of MLD and percent diameter stenosis. We conclude that important differences in measurements of RD, baseline MLD, and percent diameter stenosis were noted using the CMS and ARTREK systems. Both systems, however, were able to detect a treatment benefit associated with directional atherectomy in BOAT. The comparability of other angiographic systems will require similar evaluation in other studies.

Algorithms↗
PubMed1999

Intravascular ultrasound assessment of the relation between early and late changes in arterial area and neointimal hyperplasia after percutaneous transluminal coronary angioplasty and directional coronary atherectomy.

Previous serial intravascular ultrasound (IVUS) analysis after percutaneous transluminal coronary angioplasty or directional coronary atherectomy showed (1) early (within 1 month) increase in arterial area, (2) late (1- to 6-month) decrease in arterial area, and (3) an increase in plaque area from immediately to 6 months after intervention. To further understand these findings, we used serial IVUS to study the relations between changes in arterial and plaque area during the follow-up period after coronary intervention. Serial IVUS was performed before intervention and immediately, 24 hours, 1 month, and 6 months after percutaneous transluminal coronary angioplasty (n = 35) or directional coronary atherectomy (n = 26) in 57 patients. Arterial, lumen, and plaque areas were measured at the lesion site with the smallest preintervention and follow-up lumen areas at all time points. The increase in plaque area in the first month after intervention was accompanied by an equal or greater increase in arterial area (r = 0.670, p <0.0001). There was a decrease in arterial area from 1 to 6 months after intervention, which correlated inversely with both the increase in plaque area (r = 0.434, p <0.0001) or arterial area (r = 0.515, p <0.0001) during the first month after intervention and directly with the 1- to 6-month increase in plaque area (r = 0.460, p <0.0001). Comparison of the late (1 to 6 months) and early (within 1 month) delta arterial versus delta plaque area regression lines suggested that the late decrease in arterial area was superimposed on the relation between delta arterial area and delta plaque area. These relations were especially strong in restenotic (vs nonrestenotic) lesions. The early increase and late decrease in stenosis arterial area and neointimal hyperplasia appear to be interrelated, especially in restenotic stenoses.

Angioplasty, Balloon, Coronary↗
PubMed1999

Serial volumetric intravascular ultrasound assessment of arterial remodeling in left main coronary artery disease.

Serial volumetric intravascular ultrasound (IVUS) was used to study de novo, nontreated left main coronary arteries (LMCAs) in 31 patients. Using an automated contour detection algorithm, analysis of 7.2 +/- 2.5 mm long segments included arterial, lumen, and plaque volumes and plaque burden (plaque/arterial volumes). During follow-up (7.7 +/- 2.4 months), the percent change in lumen volume correlated with the percent change in arterial volume (r = 0.897, p <0.0001), but not with the percent change in plaque volume (r = 0.066, p = 0.7263). Percent changes in arterial volume correlated with percent changes in plaque + media volume (r = 0.448, p = 0.0115), indicating arterial remodeling. However, there was a spectrum of responses ranging from inadequate remodeling (decrease in lumen volume despite no increase or a decrease in plaque volume: i.e., arterial shrinkage) to overcompensation (an increase in lumen volume despite an increase in plaque volume). Serial volumetric IVUS (1) confirms the existence of both positive and negative remodeling in LMCA, and (2) shows that in moderate LMCA disease, luminal changes resulted primarily from positive versus negative remodeling, not plaque progression and/or regression.

Aged↗
PubMed1999

Tissue proliferation within and surrounding Palmaz-Schatz stents is dependent on the aggressiveness of stent implantation technique.

In-stent restenosis is entirely due to intimal hyperplasia. Histologic studies have indicated that intimal hyperplasia is related to the arterial injury induced during stent implantation. We used intravascular ultrasound (IVUS) imaging to study whether tissue proliferation inside and surrounding stents is related to the aggressiveness of the implantation technique. After intervention and follow-up (mean 5.6 +/- 3.7 months), serial IVUS imaging was performed in 102 native artery stented stenoses in 91 patients. Measurements at 5 predetermined segments within each stented lesion included external elastic membrane, stent, and lumen cross-sectional areas (CSAs). Calculations included mean plaque CSA growth outside of the stent (external elastic membrane-stent) and mean neointimal hyperplasia CSA and thickness within the stent (stent-lumen). Stenoses were categorized depending on the aggressiveness of stent placement (group 1, adjunct percutaneous transluminal coronary angioplasty pressure < 16 atm and/or balloon/artery ratio < 1.1; group 2, adjunct percutaneous transluminal coronary angioplasty pressure > or = 16 atm and balloon/artery ratio > or = 1.1). An aggressiveness score was calculated as balloon/artery ratio x inflation pressure. Mean intimal hyperplasia CSA (2.9 +/- 1.5 vs 2.2 +/- 1.6 mm2, p = 0.028), mean intimal hyperplasia thickness (0.34 +/- 0.19 vs 0.25 +/- 0.19 mm, p = 0.012), and mean peristent tissue growth CSA (2.5 +/- 1.0 vs 1.1 +/- 1.4 mm2, p = 0.003) were significantly greater in group 2 stenoses. In addition, intimal hyperplasia CSA and thickness correlated significantly with balloon/artery ratio x inflation pressures: r = 0.305, p = 0.002 and r = 0.329, p = 0.0007, respectively, as did peristent tissue proliferation CSA (r = 0.466, p = 0.001). Tissue proliferation inside and surrounding stents may be related to aggressiveness of the stent implantation technique.

Angioplasty, Balloon, Coronary↗
PubMed1999

Immediate results and late clinical outcomes after new CrossFlex coronary stent implantation.

This study evaluates the safety and efficacy of the new CrossFlex stent in the treatment of native coronary artery disease. The CrossFlex stent is a flexible, balloon-expandable new device with an excellent flexibility, radial strength, conformability, and radio-opacity. Little data are available concerning the clinical and angiographic outcomes of this device. The CrossFlex stent was implanted in 209 consecutive patients with 226 lesions. Follow-up angiography was performed at 6 months, and clinical evaluation was undertaken at regular intervals after stent implantation. Procedural success was achieved in all lesions without in-hospital complications. Angiographic follow-up data were available in 153 of the 187 eligible lesions (follow-up rate, 82%), and the overall angiographic restenosis rate was 16.3%. Minimal lumen diameter immediately after stent placement was the only predictor of angiographic restenosis. Clinical follow-up was obtained in all patients at 10.5 +/- 5.2 months. There were 4 deaths (1 cardiac in origin, the others noncardiac in origin), and 1 nonfatal myocardial infarction (nonstented artery) during follow-up. Target lesion revascularization was required in 15 patients (7%), and the overall event-free survival rate (death, myocardial infarction, and repeat revascularization) was 87% at the end of the follow-up period. The CrossFlex stent is a safe and effective device with a high procedural success rate, and a favorable late clinical outcome for treatment of native coronary artery disease. Further randomized trials are needed to compare the CrossFlex stent with standard slotted-tube stents.

Aged↗
PubMed1999

Intravascular ultrasound predictors of target lesion revascularization after stenting of protected left main coronary artery stenoses.

We evaluated the predictors of late clinical outcomes after stenting of protected left main coronary artery (LMCA) stenoses. Intravascular ultrasound (IVUS) guided stenting of protected LMCA stenoses was performed in 87 consecutive patients between January 1994 and December 1996. Results were evaluated using conventional (clinical, angiographic, and IVUS) methodology. Late (12 month) clinical follow-up information was obtained in all patients. Initial procedural success was achieved in 86 patients (99%). There was 1 in-hospital death (in the 1 patient with a procedural failure). There were no other in-hospital complications, including Q-wave myocardial infarction, emergency bypass surgery, or repeat coronary angioplasty. The overall target lesion revascularization (TLR) rate was 13%. Using multivariate logistic regression analysis, the only independent predictor of TLR was the postintervention lumen area by IVUS. A final lumen area > or =7.0 mm2 was obtained in 74 patients (86%); the TLR rate for these patients was 7%. This was compared with patients with a final lumen area <7.0 mm2 in whom the TLR rate was 50% (p = 0.0011). Stenting of protected LMCA stenoses is safe and effective with acceptable long-term clinical outcomes. The most important factor determining long-term success was the postintervention lumen area by IVUS.

Aged↗
PubMed1999

Effects of dopamine and aminophylline on contrast-induced acute renal failure after coronary angioplasty in patients with preexisting renal insufficiency.

In phase 1 of this study, 60 patients undergoing coronary angioplasty were randomized to receive saline, dopamine, or aminophylline; the overall incidence of contrast-induced renal failure was 38%, without difference among the 3 groups. In phase 2 of this study, 72 patients with established contrast-induced renal failure were randomized to receive saline or dopamine; dopamine had a deleterious effect on the severity of renal failure, prolonging the course.

Acute Kidney Injury↗
PubMed1999

Percutaneous transmyocardial laser revascularization: an overview.

Transmyocardial revascularization (TMR) is a novel strategy designed to improve anginal symptoms and enhance myocardial perfusion by applying laser energy directly into the ischemic myocardium. Preliminary surgical experiences using TMR have indicated a significant reduction in angina severity, improved quality of life, and some evidence of improved myocardial perfusion in refractory coronary ischemic syndromes. Possible mechanisms to explain the clinical benefit include stimulated angiogenesis, local myocardial denervation, or both. The goal of catheter-based TMR is to create nontransmural endomyocardial channels smaller in size but comparable in tissue effect to the surgical TMR procedure. At present, most percutaneous TMR experiences seem very promising, although derived from nonrandomized registries with a relatively small number of patients. More rigorous assessments of objective and subjective endpoints derived from ongoing larger randomized clinical trials are needed to render definitive conclusion about the validity of this therapeutic strategy in patients with refractory coronary ischemic syndromes. Cathet. Cardiovasc. Intervent. 47:354-359, 1999.

Angina Pectoris↗
PubMed1999

A large coronary artery saphenous vein bypass graft aneurysm with a fistula: case report and review of the literature.

We describe a patient who developed a large aneurysm of saphenous vein graft to the right coronary artery with a fistulous communication to the right atrium. The presence of a fistulous communication of a saphenous vein graft aneurysm after coronary bypass surgery to one of the heart chambers is extremely rare. The diagnosis was made by coronary angiography and confirmed by CT and MRI. At surgery the aneurysm was ligated and excised. The fistula to the right atrium was closed. Repeat coronary artery bypass surgery with aortic valve replacement was performed at the same time without complications. Cathet. Cardiovasc. Intervent. 48:214-216, 1999.

Coronary Aneurysm↗
PubMed1999

Evaluation of the acute and chronic safety of the biosense injection catheter system in porcine hearts.

Direct myocardial injection of therapeutic agents has been explored as a new method for myocardial revascularization. The integration of a 3D electromechanical mapping catheter with a retractable injection needle should allow for intramyocardial injection to identified sites, obviating the need for open heart surgery. This study assessed the procedural safety and performance characteristics of a novel guided catheter-based transendocardial injection system. The electromagnetic guidance system was coupled with a retrievable 27G needle for left ventricular endocardial injection. Using this system, we injected, transendocardially, methylene-blue (MB) dye tracer at a volume of 0.1 or 0.2 ml per injection in eight normal pigs. Animals were sacrificed acutely, at 1, 3, and 7 days (two animal in each time). Three animals served as controls. The injections were followed by coronary angiography and echocardiogram to assess possible ventricular or coronary perforation and wall motion abnormalities. CK-MB levels were measured up to 24 hr following the procedure. The animals were sacrificed at the assigned time for gross and histopathology evaluation. A total of 101 injections were made in all regions of the heart except the apex and the mitral valve. No animal died as a result of the mapping or injection procedures. Vital signs did not change relative to baseline after the mapping and injection procedures. CK-MB values did not increase over time and there was no evidence of sustained arrhythmia or hemodynamic compromise. There was no evidence of left ventricular or coronary perforation, global or regional wall motion abnormalities, or hemopericardium. On histologic evaluation, the estimated volume of tissue staining was greater than the volume of the injected MB dye due to dispersion of the injectate in the interstitial and intracellular fluid compartments. It is concluded that using this magnetic guidance catheter-based navigational system, it is feasible and safe to perform the transendocardial injection procedure. Thus, if it is determined that direct intramyocardial injection of drugs is a valid therapeutic strategy, this approach offers a clear advantage over surgically based transepicardial injection procedures. Cathet. Cardiovasc. Intervent. 48:447-453, 1999.

Animals↗