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Biomedical subjects

M B Leon

Publications and source records attributed to M B Leon.

At least 253 records · Page 14Linked to original sources
PubMed1994

Long-term angiographic and clinical outcome after implantation of a balloon-expandable stent in the native coronary circulation. Palmaz-Schatz Stent Study Group.

OBJECTIVES: The purpose of this study was to examine the long-term clinical and angiographic outcome after coronary stent implantation. BACKGROUND: Previous reports have shown a discordance between the excellent initial angiographic results and subsequent adverse clinical events after coronary artery stenting. METHODS: Single Palmaz-Schatz stents were electively implanted in the native coronary arteries of 300 consecutive patients. Angiograms were obtained at baseline, after balloon angioplasty, after stent implantation and at 6 months after implantation. Films were analyzed by a panel of angiographers utilizing an automated edge detection program. Clinical events, including death, myocardial infarction, coronary bypass surgery and repeat angioplasty, were recorded for 1 year. RESULTS: Although there were no acute in laboratory vessel closures, stent thrombosis occurred in 14 patients (4.7%) at a mean +/- SD of 5 +/- 3 days after implantation. Two hundred fifty-eight (90%) of 286 eligible patients had follow-up angiography at 6.1 +/- 2.2 months after stent implantation. Minimal lumen diameter increased from 0.80 +/- 0.39 mm at baseline to 1.65 +/- 0.51 mm after angioplasty and further increased to 2.55 +/- 0.49 mm after stent placement (p = 0.0001). At follow-up there was a 0.85-mm late loss in lumen diameter, with a final minimal lumen diameter at 6 months of 1.70 +/- 0.71 mm. Restenosis, defined as > or = 50% diameter stenosis at follow-up, occurred in 14% of patients with previously untreated lesions and in 39% of patients with previous angioplasty (p < 0.001). Clinical events after 1 year for the entire group of 300 patients included death in 0.7%, myocardial infarction in 3.7%, bypass grafting in 8% and repeat angioplasty in 13%. Freedom from any adverse clinical event was 80% for all treated patients and 87% for those with previously untreated lesions. CONCLUSIONS: Elective use of this balloon-expandable stent in the native coronary circulation is associated with a low restenosis rate by quantitative angiography in previously untreated lesions and a favorable clinical outcome with an excellent event-free survival rate at 1 year.

Angioplasty, Balloon, Coronary↗
PubMed1994

Limitations of angiography for analyzing coronary atherosclerosis progression or regression.

PURPOSE: To analyze the utility and limitations of serial coronary angiography for determining atherosclerosis progression and regression. DATA SOURCES: A MEDLINE search of the English-language literature (1966 to January 1994) using the keywords atherosclerosis regression, atherosclerosis progression, lipid reduction therapy, and coronary angiography. STUDY SELECTION: Selected articles on the effects of cholesterol reduction and lifestyle modification on angiographic coronary artery disease, on the animal models of atherosclerosis progression and regression, and on the limitations of coronary angiography. DATA EXTRACTION: Independent extraction by two authors. RESULTS: Although several studies have reported that the rate of atherosclerosis progression, defined by serial coronary angiography, can be reduced and that luminal diameter can be improved somewhat by aggressive lipid modification, the reported changes are small (0.3 mm or 10% change) and have required a prolonged study duration (range, 1 to 10 years). More importantly, angiography simply does not measure atherosclerosis and cannot assess lesion composition. Angiography also underestimates the extent of atherosclerosis, especially in angiographically normal segments. In addition, difficulties with data acquisition, such as substantial variabilities in serial measurements of percent diameter stenosis and minimal luminal diameters, require large sample sizes to show statistically significant regression, even with computerized quantification. CONCLUSIONS: Given its current limitations, serial coronary angiography is not a satisfactory means of detecting atherosclerosis progression or regression.

Anticholesteremic Agents↗
PubMed1994

A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators.

BACKGROUND: Coronary-stent placement is a new technique in which a balloon-expandable, stainless-steel, slotted tube is implanted at the site of a coronary stenosis. The purpose of this study was to compare the effects of stent placement and standard balloon angioplasty on angiographically detected restenosis and clinical outcomes. METHODS: We randomly assigned 410 patients with symptomatic coronary disease to elective placement of a Palmaz-Schatz stent or to standard balloon angioplasty. Coronary angiography was performed at base line, immediately after the procedure, and six months later. RESULTS: The patients who underwent stenting had a higher rate of procedural success than those who underwent standard balloon angioplasty (96.1 percent vs. 89.6 percent, P = 0.011), a larger immediate increase in the diameter of the lumen (1.72 +/- 0.46 vs. 1.23 +/- 0.48 mm, P < 0.001), and a larger luminal diameter immediately after the procedure (2.49 +/- 0.43 vs. 1.99 +/- 0.47 mm, P < 0.001). At six months, the patients with stented lesions continued to have a larger luminal diameter (1.74 +/- 0.60 vs. 1.56 +/- 0.65 mm, P = 0.007) and a lower rate of restenosis (31.6 percent vs. 42.1 percent, P = 0.046) than those treated with balloon angioplasty. There were no coronary events (death; myocardial infarction; coronary-artery bypass surgery; vessel closure, including stent thrombosis; or repeated angioplasty) in 80.5 percent of the patients in the stent group and 76.2 percent of those in the angioplasty group (P = 0.16). Revascularization of the original target lesion because of recurrent myocardial ischemia was performed less frequently in the stent group than in the angioplasty group (10.2 percent vs. 15.4 percent, P = 0.06). CONCLUSIONS: In selected patients, placement of an intracoronary stent, as compared with balloon angioplasty, results in an improved rate of procedural success, a lower rate of angiographically detected restenosis, a similar rate of clinical events after six months, and a less frequent need for revascularization of the original coronary lesion.

Angioplasty, Balloon, Coronary↗
PubMed1994

Potential role of human cytomegalovirus and p53 interaction in coronary restenosis.

A subset of patients who have undergone coronary angioplasty develop restenosis, a vessel renarrowing characterized by excessive proliferation of smooth muscle cells (SMCs). Of 60 human restenosis lesions examined, 23 (38 percent) were found to have accumulated high amounts of the tumor suppressor protein p53, and this correlated with the presence of human cytomegalovirus (HCMV) in the lesions. SMCs grown from the lesions expressed HCMV protein IE84 and high amounts of p53. HCMV infection of cultured SMCs enhanced p53 accumulation, which correlated temporally with IE84 expression. IE84 also bound to p53 and abolished its ability to transcriptionally activate a reporter gene. Thus, HCMV, and IE84-mediated inhibition of p53 function, may contribute to the development of restenosis.

Adolescent↗
PubMed1994

Impact of preintervention intravascular ultrasound imaging on transcatheter treatment strategies in coronary artery disease.

Preintervention intravascular ultrasound (IVUS) imaging was performed in 313 target lesions in 301 patients. Revascularization strategy intended before imaging was compared with the treatment actually performed; there was a change in therapy in 124 lesions (40%) in 121 patients (40%). This included: (1) assessment of lesion severity leading to revascularization when none had been planned (n = 20, 6%), (2) avoiding surgery or catheter-based revascularization that had originally been planned (n = 21, 7%), and (3) assessment of lesion composition leading to a change in revascularization strategy (n = 20, 6%) or for selecting the revascularization strategy (n = 63, 20%). Nine of these 121 patients were referred for coronary artery bypass graft surgery. IVUS minimal lumen diameter correlated well with angiography (r = 0.83); however, a disagreement was the reason for deciding to perform or not to perform revascularization in 41 lesions (13%). IVUS assessment of target lesion calcification, eccentricity and unusual morphology were the reasons for changing or selecting specific devices: (1) concentric and eccentric lesions with significant superficial calcium were treated with rotational atherectomy, excimer laser angioplasty or surgery; (2) eccentric lesions that did not contain significant superficial calcium were treated with directional atherectomy; (3) dissections and true aneurysms were treated with stent placement even if calcified; (4) thrombus-containing lesions in vein grafts were treated with thrombolytic therapy or extraction atherectomy, or both; and (5) fibrotic vein graft lesions were treated with balloon angioplasty or stent placement.

Adult↗
PubMed1994

A dual-purpose angioplasty-drug infusion catheter for the treatment of intragraft thrombus.

An investigational angioplasty-drug infusion catheter (Transport, CardioVascular Dynamics, Irvine, CA) was used to treat a saphenous vein graft stenosis associated with a thrombus. The catheter was successfully used both to infuse urokinase at the site of angioplasty and to perform effective angioplasty, demonstrating the feasibility and utility of a dual-purpose angioplasty catheter capable of angioplasty and/or local drug infusion with the same catheter.

Angioplasty, Balloon, Coronary↗
PubMed1994

Clinical significance of distal embolization after transluminal extraction atherectomy in diffusely diseased saphenous vein grafts.

Standard balloon angioplasty of degenerated saphenous vein graft lesions may be complicated by distal embolization, particularly in the presence of intragraft thrombus. Transluminal extraction atherectomy may be useful in this setting because of its ability to remove particulate debris. This study was designed to identify the incidence and prognostic significance of distal embolization after transluminal extraction atherectomy in high-risk saphenous vein graft lesions. To address these issues the clinical course of 65 consecutive patients (86 high-risk saphenous vein graft lesions) was reviewed after extraction atherectomy. Distal embolization occurred in 11 (12.8%) of 86 high-risk lesions. The majority (63.6%) of these episodes occurred after adjunct balloon dilatation following uncomplicated use of the extraction atherectomy catheter. Correlates of distal embolization included patient age and the presence of intragraft thrombus. Major in-hospital complications developed more often in patients with distal embolization (46% vs 2% in those without distal embolization, p < 0.001), resulting in a reduced procedural success rate in this group (55% vs 91%, p = 0.01). We conclude that the risk of distal embolization after saphenous vein graft angioplasty, although potentially reduced, is not eliminated with transluminal extraction atherectomy, particularly in lesions with superimposed thrombus.

Aged↗
PubMed1994

Rotational atherectomy multicenter registry: acute results, complications and 6-month angiographic follow-up in 709 patients.

OBJECTIVES: The purpose of this study was to describe data collected for an industry-sponsored multicenter registry of rotational atherectomy. BACKGROUND: Several new devices are in use or under development for coronary atherectomy. The clinical role for each is in part defined by descriptive registry data. METHODS: We describe results in 709 consecutive patients undergoing 743 procedures representing 874 lesions. The majority of lesions were in the left anterior descending coronary artery. Lesion morphology was described as eccentric (61.1%), calcified (32%), tortuous (26.6%) and long (24.9%), with previous intervention in 32.7%. RESULTS: Overall procedural success rate, including lesions treated with rotational atherectomy alone and with balloon angioplasty was 94.7% and did not vary between lesion type, location, characteristics or severity. Previously treated lesions had a significantly higher success rate (97.4%, p = 0.04) than new lesions. Major complications, including death 0.8% (95% confidence interval [CI] 0.3% to 1.7%), Q wave myocardial infarction 0.9% (95% CI 0.4% to 1.9%) and emergent coronary artery bypass surgery 1.7% (95% CI 0.9% to 3.0%), were similar to other reported devices and were associated with length and number of lesions treated. Non-Q wave myocardial infarction occurred in 3.8% of patients and was significantly associated with female gender and history of previous myocardial infarction. Abrupt occlusion occurred in 3.1% of patients and was significantly associated with bifurcated lesions and the use of adjunctive therapy. Angiographic evidence of dissection was seen in 10.5% (95% CI 8.3% to 12.7%) of patients and was significantly associated with more complex lesions, such as eccentric, long, calcified and American College of Cardiology/American Heart Association type C lesions. Overall restenosis rate was 37.7%, determined with 6-month angiography, representing 64% of treated lesions. Higher restenosis rates were associated only with poorer initial treatment outcome, diabetes and lower follow-up angiographic rate per reporting center. CONCLUSIONS: Rotational atherectomy appears to be a safe method of treatment with a high success rate in a broad spectrum of lesion types, with restenosis rates similar to other techniques. Further conclusions will require randomized trials.

Aged↗
PubMed1994

Coronary perforation after excimer laser coronary angioplasty: the Excimer Laser Coronary Angioplasty Registry experience.

OBJECTIVES: This study assessed the frequency of perforation with excimer coronary angioplasty. BACKGROUND: Coronary artery perforation after conventional percutaneous transluminal coronary angioplasty is extremely rare. Because laser coronary angioplasty involves actual tissue ablation, it has an increased potential for perforation. METHODS: All patients in the Excimer Laser Coronary Angioplasty Registry were included in this prospective study. Those who had a perforation related to the procedure were compared with those who did not have this complication. RESULTS: Of 2,759 consecutive patients in the Excimer Laser Coronary Angioplasty Registry, 36 (1.3%) had perforation. In these patients, the left anterior descending coronary artery was the most frequently treated vessel (53%). There were no differences in fiber sizes between patients with and those without perforation. Among the patients with perforation, 36.1% required coronary artery bypass surgery, 16.7% experienced an infarction and 5.6% had a fatal outcome. Among the patients without perforation, the rates were 3.1%, 3.8% and 0.6%, respectively. However, 41.7% of the patients with documented coronary artery perforation did not need coronary artery bypass surgery or experience myocardial infarction or death. No angiographic characteristics distinguished lesions with from those without perforation. The frequency of coronary artery perforation declined over time with increasing operator experience, from 1.6% in the first 1,888 patients to only 0.4% in the last 1,000 patients (p = 0.002). CONCLUSIONS: With increasing operator experience, the rate of perforation with excimer laser coronary angioplasty has decreased. When perforation occurs, subsequent event rates increase.

Angioplasty, Balloon, Coronary↗
PubMed1994

Functional properties of a prototype rheolytic catheter for percutaneous thrombectomy. In vitro investigations.

RATIONALE AND OBJECTIVES: The performance of a rheolytic catheter designed to provide rapid fragmentation and evacuation of debris was evaluated. Specifically, fragmentation and evacuation efficiency was investigated in vitro. METHODS: Fragmentation, aspiration, and recanalization of large thrombotic occlusions (8-cm length, 6-mm inner diameter) composed of clot (n = 11) or collagen gels (n = 20) of different stiffness were performed with different jet pressures at rates optimized by visual observation and were recorded on videotape for subsequent analysis. The size and number of the resulting particles in the evacuated fluid and those remaining in the artificial vessel were determined using filtration and laser light scattering techniques. The rate of fragmentation, mean particulate size, and efficiency of evacuation were evaluated as a function of operating parameters and "clot stiffness." RESULTS: Complete fragmentation of fresh thrombus occurred at 11,000 psi by direct action of the 6 radially disposed jets, which created a trapping vortex from which most of the particles (80%) were evacuated by suction. At lower pressure (5,500 psi), fragmentation efficiency was unchanged for fresh thrombus and softer 5% gels. Ninety-five percent of the thrombus was fragmented in very small particles with a mean diameter of 0.8 +/- 0.4 micron, while 5% of the mass of the fragmented thrombus was in particles > 40 microns. At 11,000 psi, the maximal rate of advancement associated with complete material fragmentation decreased with stiffness. For very stiff gels or heavily cross-linked old thrombus, complete fragmentation and removal of material was not achieved. CONCLUSION: The high-pressure rheolytic catheter rapidly fragmented and evacuated large thrombi much larger than the catheter diameter--features with potential for treating large thrombi, such as acute pulmonary emboli or deep vein thrombi. However, this rapid forceful disruption may damage vessel walls and invariably creates a broad range of particulate sizes, which makes evacuation of almost all of the particulate material imperative to minimize clinically relevant distal embolization.

Catheterization↗
PubMed1994

Relation of clinical presentation, stenosis morphology, and operator technique to the procedural results of rotational atherectomy and rotational atherectomy-facilitated angioplasty.

BACKGROUND: Rotational atherectomy using the Rotablator has recently become available to treat coronary stenoses. This study was performed to determine the relation of patient characteristics, stenosis morphology, and operator technique to procedural outcome to gain insight into which patients might be best treated with this device. METHODS AND RESULTS: Four hundred stenoses from 316 patients randomly selected from the initial Rotablator experience at three major referral institutions were analyzed. Angiographic data were assessed at a central angiographic laboratory using standardized morphological criteria and caliper measurement. Patients were somewhat more elderly than most percutaneous transluminal coronary angioplasty (PTCA)-treated groups (mean age, 64 +/- 11 years), 74% were men, and the lesions treated were often complex (modified American College of Cardiology/American Heart Association lesion type A, 24%; B1, 40%; B2, 30%; and C, 6%). Elective adjunctive PTCA was used for 82% of stenoses treated. Procedural success was achieved in 89.8% of stenoses (93.5% if results with creatine kinase two to three times normal are not counted as failures), and major ischemic complications (death, 0.3%; non-Q-wave myocardial infarction, 5.7%; Q-wave myocardial infarction, 2.2%; or emergency bypass surgery, 0.9%) occurred in 8.9% of patients. Complications were due to epicardial coronary obstruction in 3.8% of patients and to delayed coronary runoff ("slow reflow") in 5.1% of patients. Procedural failure was correlated independently with outflow obstruction (success rate, 64%; odds ratio for failure, 5.4; multivariate P = .002), lesion irregularity (76%; odds ratio, 3.3; P = .003), stenosis bend > or = 60 degrees (73%; odds ratio, 3.7; P = .03), and female sex (84%; odds ratio, 2.4; P = .03). Ischemic complications were correlated independently with lesion length (> or = 50% narrowing) > or = 4 mm (complication rate, 12%; odds ratio, 3.6; multivariate P = .005), right coronary artery stenosis (13%; odds ratio, 2.4; P = .02), stenosis bend > or = 60 degrees (27%; odds ratio, 6.1; P = .03), and female sex (13%; odds ratio, 3.0; P = .04). Slow reflow was correlated with total burring duration (odds ratio, 1.005/s; multivariate P = .001), right coronary artery stenosis (incidence, 17%; odds ratio, 4.5; P = .009), and to a lesser extent with recent myocardial infarction in the treated territory (44%; odds ratio, 4.3; P = .08). CONCLUSIONS: The procedural outcome of rotational atherectomy is highly correlated with stenosis morphology and location and sex of the patient. After stratification for these parameters, overall outcome with the Rotablator appears to be similar to that with balloon angioplasty and other competing techniques. Short-term outcome with specific subsets of patients may be superior with the Rotablator (calcified stenoses), but this technique might best be avoided in some patients (those with irregular or possibly thrombus-containing stenoses, highly angulated stenoses, and possible right coronary artery stenoses or those associated with impaired distal runoff caused by a recent myocardial infarction or manifest by a fixed thallium defect).

Aged↗
PubMed1994

Vascular stent deployment in vein bypass grafts: observations in an animal model.

BACKGROUND: An important cause of vein graft failure is anastomotic stenosis caused by myointimal hyperplasia. Intravascular stents may allow balloon dilation of these hyperplastic lesions, thereby increasing secondary graft patency. METHODS: To evaluate intravascular stent deployment in vein grafts, we implanted 26 stents across the anastomotic sites of reversed vein grafts in 13 sheep. Stent deployment was evaluated immediately and at 3, 8, and 24 weeks by arteriography, light microscopy, and scanning electron microscopy. In a second animal cohort, stent-arterial wall contact after deployment was evaluated with intravascular ultrasonography (IVUS). Stents were imaged with IVUS after partial (n = 5) and complete (n = 5) expansion in 10 sheep carotid arteries. RESULTS: Stents were deployed across vascular anastomoses without immediate thrombosis. Partial neointimal coverage occurred after 3 and 8 weeks, with complete coverage by 24 weeks. Complications included distal migration (n = 3), arteriographic stenosis (n = 2), and late graft occlusion (n = 2). Incomplete stent-vessel wall contact at deployment was observed in the stents with complications. IVUS accurately showed stent expansion and the degree of stent-vessel wall contact. CONCLUSIONS: Stents can be deployed in vein grafts with the expectation of neointimal coverage and maintenance of graft patency. IVUS may prove important in guiding optimal stent deployment by providing an assessment of stent-vessel wall contact.

Anastomosis, Surgical↗
PubMed1994

Primary coronary angioplasty in patients with acute myocardial infarction.

In some patients with acute myocardial infarction, thrombolytic therapy may be limited by its failure to reperfuse the occluded artery, by recurrent ischemia (despite initially successful reperfusion), and by major hemorrhagic complications. Primary coronary angioplasty may circumvent these limitations. This article reviews the results of primary angioplasty reported in patients with myocardial infarction and makes recommendations for its use. The review includes pertinent articles found in the English language literature from July 1987 to July 1993 on MEDLINE. Nonrandomized series of primary angioplasty in acute myocardial infarction have demonstrated high procedural success rates (86% to 99%) and infrequent recurrent ischemia (4%). Two randomized trials comparing primary angioplasty and thrombolytic therapy have shown that primary angioplasty results in lower mortality, less recurrent ischemia, shorter length of hospital stay, and improved left ventricular function. Two other randomized studies have shown little benefit from primary angioplasty on myocardial salvage, recurrent ischemia, or ventricular function. One major limitation of primary angioplasty is that it requires 24-hour availability of a catheterization laboratory and experienced surgical personnel. Primary angioplasty may be the preferred approach in patients with extensive myocardial infarction who have immediate (< 120 min) access to a cardiac catheterization laboratory with experienced personnel. Patients having 1) contraindications to thrombolytic therapy, 2) cardiogenic shock, 3) prior coronary bypass surgery, or 4) "stuttering" onset of pain may also benefit from primary angioplasty. Poor candidates for this procedure are those with a small myocardial infarction, those in whom undue delays in access to a cardiac catheterization facility would be expected, or those with complex coronary anatomy, including left main coronary artery disease.

Angioplasty, Balloon, Coronary↗
PubMed1993

Fate of lesion-related side branches after coronary artery stenting.

OBJECTIVES: The aim of this study was to assess the immediate and long-term patency of lesion-associated side branches after coronary artery stenting. BACKGROUND: The possible adverse effects related to implantation of coronary stents are not completely known. An important potential complication of stenting is side branch occlusion due to mechanical obstruction or thrombosis. METHODS: Serial coronary angiography was performed in 153 patients (167 lesions) at baseline, after conventional balloon angioplasty, immediately after Palmaz-Schatz stent placement and at 6 months. The patency of side branches, where present, was analyzed at each of these points. RESULTS: Of 167 lesions stented, 57 stent placements spanned 66 side branches with a diameter > or = 1 mm. Twenty-seven (41%) of these side branches had > or = 50% ostial stenosis before standard balloon angioplasty. Six side branches became occluded after standard balloon angioplasty and remained occluded after stenting. Of the 60 side branches patent after conventional angioplasty, 57 (95%) remained patent immediately after stenting. All three side branches that became occluded after stenting had > or = 50% ostial stenosis at baseline. All 60 side branches, including the 3 initially occluded after stenting, were patent at 6-month follow-up. CONCLUSIONS: These findings demonstrate that 1) acute side branch occlusion due to coronary stenting occurs infrequently; 2) when side branch occlusion occurs, it is associated with intrinsic ostial disease; and 3) the patency of side branch ostia is well maintained at long-term follow-up.

Adult↗