Transluminal intracoronary reperfusion catheter: a device to maintain coronary perfusion between failed coronary angioplasty and emergency coronary bypass surgery.

The reperfusion catheter is a 4.3F catheter with 30 holes over its distal 10 cm. It is used to maintain coronary blood flow in patients awaiting emergency coronary bypass surgery after failed coronary angioplasty. The insertion of the reperfusion catheter was attempted in 20 patients (14 with total occlusion and 6 with severe residual stenosis judged to be in jeopardy of reclosure before operation). The reperfusion catheter was successfully placed across the obstruction in 18 patients (90%). After successful insertion of the reperfusion catheter, 16 patients had good anterograde flow (Thrombolysis in Myocardial Infaction [TIMI] trial grade II or III); angiographic improvement was associated with significant lessening of ST segment elevation as well as a decrease in chest pain in most patients. Two patients had poor or absent anterograde flow (TIMI grade O or I) because of extensive preexisting intracoronary thrombosis; one died from refractory ventricular fibrillation. In each of the remaining patients emergency coronary bypass surgery was performed with no deaths or significant cardiac complications. The reperfusion catheter is a safe and effective method to reestablish and maintain coronary blood flow before coronary bypass surgery after failed coronary angioplasty. Because there is the potential risk of serious complications, particularly thrombus formation within this catheter, the reperfusion catheter should be used cautiously and the patient should undergo immediate bypass surgery.

Primary peripheral arterial stenoses and restenoses excised by transluminal atherectomy: a histopathologic study.

Atherectomy is a new therapeutic intervention for the treatment of peripheral arterial disease, and permits the controlled excision and retrieval of portions of stenosing lesions. The gross and light microscopic features of 218 peripheral arterial stenoses resected from 100 patients by atherectomy were studied. One hundred seventy of these lesions were primary stenoses and 48 were restenoses subsequent to prior angioplasty or atherectomy. Microscopically, primary stenoses were composed of atherosclerotic plaque (150 lesions), fibrous intimal thickening (15 lesions) or thrombus alone (5 lesions). Atherosclerotic plaques had a variable morphology and, in one-third of cases, were accompanied by abundant surface thrombus that probably added to the severity of stenosis. Most patients with fibrous intimal thickening or thrombus alone had typical atherosclerotic plaque removed elsewhere from within the same artery. Intimal hyperplasia, with or without underlying residual plaque, was found at 36 sites of restenosis, the remaining 12 consisting of plaque only. Intimal hyperplasia had a distinctive histologic appearance and was due to smooth muscle cell proliferation within a loosely fibrous stroma. Superimposed thrombus may have contributed to arterial narrowing in 25% of hyperplastic and 8% of atherosclerotic restenoses (p = 0.41). Pathologic examination of tissues recovered by peripheral atherectomy is an important adjunct that may provide insight into the efficacy of vascular interventions and the phenomenon of postintervention restenosis.

Prognostic value of the simplified Selvester QRS score in patients with coronary artery disease.

The relation of the simplified Selvester QRS scoring system for the estimation of myocardial infarct size to survival was studied in 1,915 nonsurgically treated patients with documented coronary artery disease. Electrocardiograms (ECGs) were scored according to a simplified 29 point QRS scoring system. Using Cox model analyses, QRS scores were found to provide strong prognostic information by themselves (p less than 0.0001). Higher QRS scores were associated with lower survival rates. Patients with a score of 0 had a 1 year survival rate of 95% and a 5 year survival rate of 88%; patients with a score of 10 or more had survival rates of 81 and 52%, respectively, at the same intervals. Directly compared with the presence or absence of Q waves on the ECG, QRS scores provided greater prognostic information (p less than 0.001). When compared with 13 individual factors previously shown to provide the greatest independent prognostic information, the QRS score was the third most powerful individual prognostic factor. It did not contribute independent prognostic information in combination with the whole group, but did provide independent information in combination with the six most predictive factors. Its prognostic information overlapped mostly with clinical factors related to heart failure, and combined best with clinical factors related to the severity of ongoing myocardial ischemia. Because it is inexpensive and simple and maximizes the prognostic information from the ECG, the simplified Selvester QRS scoring system can be a useful clinical descriptor for practitioners and clinical investigators.

Restenosis after directional coronary atherectomy.

OBJECTIVES: This study evaluates the incidence of restenosis after successful directional coronary atherectomy and identifies risk factors for restenosis. BACKGROUND: Directional coronary atherectomy has been shown to be a safe and effective treatment of obstructive coronary artery disease; however, information regarding restenosis is limited. METHODS: Between October 1986 and December 1989, 289 patients with 332 lesions were successfully treated with directional coronary atherectomy and followed up prospectively. Clinical follow-up information was available for 98% and angiographic follow-up information was obtained for 82% at approximately 6 months, or earlier if symptoms recurred. Angiograms were quantitatively analyzed. Restenosis was defined as greater than 50% stenosis at the site of intervention. RESULTS: Seventy-four percent of patients were either asymptomatic or clinically improved after the procedure. Thirty-two percent were subsequently treated by coronary artery bypass surgery (14%), percutaneous transluminal coronary angioplasty (4%) or repeat atherectomy (13%). Angiographic evidence of restenosis was observed in 42%. The restenosis rate in native coronary arteries was 31% for primary lesions and 28% and 49%, respectively, for lesions treated with one or two previous angioplasty procedures. The restenosis rate for saphenous vein grafts was 53% for primary lesions and 58% and 82%, respectively, for lesions treated with one or two previous angioplasty procedures. The median interval to angiographically documented restenosis was 133 days. A higher restenosis rate was associated with a saphenous vein graft, hypertension, a longer lesion (greater than or equal to 10 mm), a smaller vessel diameter (less than 3 mm), a noncalcified lesion and use of a smaller (6F) device. CONCLUSIONS: Restenosis remains a limitation of directional coronary atherectomy. A subset of patients with larger vessels, shorter lesions or lesions treated with a larger (7F) device may have a more favorable outcome.

Effect of lesion characteristics on outcome of directional coronary atherectomy.

Directional coronary atherectomy, a new transluminal procedure for treatment of obstructive lesions in coronary arteries by excision and removal of tissue, was performed on 447 lesions in 382 procedures. Successful outcome, defined as a reduction of stenosis by greater than or equal to 20% with a less than 50% residual stenosis, was achieved in 89.5% of lesions and mean stenosis was reduced from 75.9 +/- 13.3% to 14.5 +/- 22.1% (p less than 0.001). Complications included vessel occlusion during the procedure, 2.4%; vessel occlusion after the procedure, 1.3%; new lesion, 0.5%; nonobstructive guiding catheter-induced dissection, 0.3%; perforation, 0.8%; distal embolization, 2.1%; Q wave myocardial infarction, 0.8% and non-Q wave myocardial infarction, 4.2%. Twelve patients (3.1%) required coronary artery bypass surgery for these complications. The atherectomy success rate was greater than 80% and the combined atherectomy and angioplasty success rate was greater than 90% for complex morphologic features such as eccentric lesions, lengthy lesions, lesions with abnormal contour, angulated lesions, ostial lesions and lesions with branch involvement. In the presence of calcific deposition, atherectomy success rate was 52% for primary lesions and 83% for restenosed lesions. Among angiographically complex lesions, calcium was the predictor for failed atherectomy (p less than 0.0001). In summary, directional coronary atherectomy is safe and effective for treatment of obstructive lesions in coronary arteries in selected cases. In particular, it achieves a high success rate in lesions with complex morphologic characteristics, such as eccentricity, abnormal contour and ostial involvement.

Abrupt vessel closure after directional coronary atherectomy. The U.S. Directional Atherectomy Investigator Group.

From October 1, 1986 to December 31, 1989 directional coronary atherectomy was performed during 1,020 procedures (1,140 lesions) at 14 clinical centers. Abrupt vessel closure, defined as a total coronary occlusion or subtotal occlusion associated with clinical evidence of myocardial ischemia, occurred in 43 procedures (4.2%). It developed in the catheterization laboratory in 34 patients, but was delayed 1 to 96 h after directional atherectomy in 9 patients. By univariate analysis the incidence of abrupt closure was higher in directional atherectomy of de novo lesions (p less than 0.001), lesions in the right coronary artery (p = 0.001) and diffuse lesions (p = 0.04). The incidence of abrupt closure tended to be lower in directional atherectomy of saphenous vein grafts as opposed to native coronary arteries (1.6% vs. 4.4%; p = 0.08). Clinical findings during abrupt closure included severe angina in 26 patients, myocardial infarction in 17 patients, hypotension in 5 patients and death in 2 patients. Balloon angioplasty was attempted in 32 patients after abrupt vessel closure. In 16 patients balloon angioplasty resulted in initial resolution of the closure episode, although 1 patient died 96 h after the procedure. Fifteen of 16 patients without initial improvement after balloon angioplasty underwent coronary bypass operation; 9 additional patients with abrupt closure were referred directly for bypass operation. It is concluded that abrupt vessel closure develops relatively infrequently after directional coronary atherectomy. In the absence of severe coronary dissection, abrupt closure after directional atherectomy may be effectively managed with balloon angioplasty in some cases, although coronary bypass operation is often required.

Survival and cardiac event rates in the first year after emergency coronary angioplasty for acute myocardial infarction.

One year survival and event-free survival rates were analyzed in 342 patients with acute myocardial infarction who were consecutively enrolled in a treatment protocol of early intravenous thrombolytic therapy followed by emergency coronary angioplasty. Ninety-four percent of the patients achieved successful reperfusion, including 4% with failed angioplasty whose perfusion was maintained by means of a reperfusion catheter before emergency bypass surgery. The procedural mortality rate was 1.2% and the total in-hospital mortality rate was 11%. Ninety-two percent of surviving nonsurgical patients who underwent repeat cardiac catheterization were discharged from the hospital with an open infarct-related artery. The related cumulative 1 year survival rate for all patients managed with this treatment strategy was 87%, and the cardiac event-free survival rate was 84%. The 1 year survival for hospital survivors was 98% and the infarct-free survival rate was 94%. Multivariable analysis identified the following factors as independent predictors of subsequent cardiovascular death: cardiogenic shock, greater age, lower ejection fraction, female gender and a closed infarct-related vessel on the initial coronary angiogram. Among patients with cardiogenic shock, despite a 42% in-hospital mortality rate, only 4% died during the first year after hospital discharge. Similarly, the in-hospital and 1 year postdischarge mortality rates were 19 and 4%, respectively, for patients with an initial ejection fraction less than 40, and 25 and 3%, respectively, for patients greater than 65 years. An aggressive treatment strategy including early thrombolytic therapy, emergency cardiac catheterization, coronary angioplasty and, when necessary, bypass surgery resulted in a high rate of infarct vessel patency.(ABSTRACT TRUNCATED AT 250 WORDS)

Late restenosis after emergent coronary angioplasty for acute myocardial infarction: comparison with elective coronary angioplasty.

The late restenosis rate after emergent percutaneous transluminal coronary angioplasty for acute myocardial infarction was assessed by performing outpatient follow-up cardiac catheterization in 79 (87%) of 91 consecutive patients who had been discharged from the hospital with a successful coronary angioplasty. The majority of patients (90%) received high dose intravenous thrombolytic therapy with streptokinase in addition to angioplasty. Similar follow-up data were obtained in 206 (90%) of 228 consecutive patients who had successful elective angioplasty during the same period. The interval from angioplasty to follow-up was 28 +/- 9 weeks for the myocardial infarction group and 30 +/- 11 weeks for the elective group. Baseline clinical variables were similar for both the myocardial infarction and elective groups except for a higher percentage of men in the infarction group (81 versus 63%, p = 0.001). The number of coronary lesions undergoing angioplasty and the incidence of intimal dissection were similar, but multivessel angioplasty was more common in the elective group (13 versus 4%, p = 0.02). The rate of in-hospital reocclusion was higher in the patients receiving angioplasty for myocardial infarction (13 versus 2%, p = 0.0001). At the time of late follow-up after hospital discharge, the patients with myocardial infarction were more often asymptomatic (79 versus 55%, p = 0.0001), and the rate of angiographic coronary restenosis was lower for the infarction group both overall (19 versus 35%, p = 0.006) and when multivessel angioplasty patients were excluded (19 versus 33%, p = 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

Effects of adjunctive balloon angioplasty after intravascular ultrasound-guided optimal directional coronary atherectomy: the result of Adjunctive Balloon Angioplasty After Coronary Atherectomy Study (ABACAS).

OBJECTIVES: This study was conducted to evaluate: 1) the effect of adjunctive percutaneous transluminal coronary angioplasty (PTCA) after directional coronary atherectomy (DCA) compared with stand-alone DCA, and 2) the outcome of intravascular ultrasound (IVUS)-guided aggressive DCA. BACKGROUND: It has been shown that optimal angiographic results after coronary interventions are associated with a lower incidence ofrestenosis. Adjunctive PTCA after DCA improves the acute angiographic outcome; however, long-term benefits of adjunctive PTCA have not been established. METHODS: Out of 225 patients who underwent IVUS-guided DCA, angiographically optimal debulking was achieved in 214 patients, then theywere randomized to either no further treatment or to added PTCA. RESULTS: Postprocedural quantitative angiographic analysis demonstrated an improved minimum luminal diameter (2.88 +/- 0.48 vs. 2.6 +/- 0.51 mm; p = 0.006) and a less residual stenosis (10.8% vs.15%; p = 0.009) in the adjunctive PTCA group. Quantitative ultrasound analysis showed a larger minimum luminal diameter (3.26 +/- 0.48 vs. 3.04 +/- 0.5 mm; p < 0.001) and lower residual plaque mass in the adjunctive PTCA group (42.6% vs. 45.6%; p < 0.001). Despite the improved acute findings in the adjunctive PTCA group, six-month angiographic and clinical results were not different. The restenosis rate (adjunctive PTCA 23.6%, DCA alone 19.6%; p = ns) and target lesion revascularization rate (20.6% vs. 15.2%; p = ns) did not differ between the groups. CONCLUSIONS: With IVUS guidance, aggressive DCA can safely achieve optimal angiographic results with low residual plaque mass, and this was associated with a low restenosis rate. Although adjunctive PTCA after optimal DCA improved the acute quantitative coronary angiography and quantitative coronary ultrasonography outcomes, its benefit was not maintained at six months.

Remodeling after directional coronary atherectomy (with and without adjunct percutaneous transluminal coronary angioplasty): a serial angiographic and intravascular ultrasound analysis from the Optimal Atherectomy Restenosis Study.

OBJECTIVES: The intravascular ultrasound (IVUS) substudy of OARS (Optimal Atherectomy Restenosis Study) was designed to assess the mechanisms of restenosis after directional coronary atherectomy (DCA). BACKGROUND: Recent serial IVUS studies have indicated that late lumen loss after interventional procedures was determined primarily by the direction and magnitude of arterial remodeling, not by cellular proliferation. METHODS: Complete quantitative coronary angiography (QCA) and IVUS were obtained in 104 patients before and after intervention and during follow-up. All studies were performed after administration of 200 microg of intracoronary nitroglycerin. Angiographic measurements included minimum lumen diameter (MLD), interpolated reference diameter and diameter stenosis (DS). Intravascular ultrasound measurements included lesion and reference external elastic membrane (EEM), lumen and plaque+media cross-sectional area (CSA). The axial location of the lesion site was at the smallest follow-up lumen CSA; the reference segment was the most normal-looking cross section within 10 mm proximal to the lesion but distal to any major side branch. Results are reported as mean +/- one standard deviation. RESULTS: The QCA reference decreased from 3.51 +/- 0.46 mm to 3.22 +/- 0.44 mm; the MLD decreased from 3.22 +/- 0.47 mm to 2.03 +/- 0.72 mm; and the DS increased from 8 +/- 10% to 38 +/- 20%. On IVUS, the decrease in lumen CSA (from 8.8 +/- 2.5 mm2 to 5.5 +/- 4.0 mm2) was associated with a significant decrease in EEM (from 19.7 +/- 5.6 mm2 to 16.9 +/- 6.2 mm2); there was no significant increase in P+M (from 10.9 +/- 4.2 mm2 to 11.3 +/- 3.9 mm2). A change in lumen correlated with a change in EEM (r = 0.790, p < 0.0001), not with a change in P+M (r = 0.133, p = 0.2258). A decrease in reference EEM (from 19.1 +/- 7.7 mm2 to 17.6 +/- 8.0 mm2) also correlated with a decrease in lesion EEM (r = 0.665, p < 0.0001). Results in restenotic lesions were similar. CONCLUSION: Restenosis after optimal DCA is caused primarily by a decrease in EEM CSA that extends into contiguous reference segments.

Replication in restenotic atherectomy tissue.

Previously, we demonstrated that replication in restenotic coronary atherectomy specimens was an infrequent and modest event. In general, this data was interpreted with caution, as immunocytochemistry for the proliferating cell nuclear antigen (PCNA) was used to subjectively assess proliferation and most of the tissue specimens were resected more than 3 months after the initial interventional procedure. The purpose of the present study was to use a more sensitive method of detecting replication, in situ hybridization for histone 3 (H3) mRNA, to determine the replication profile of human directional atherectomy specimens. Restenotic directional coronary atherectomy specimens from lesions that had undergone an interventional procedure within the preceding 3 months were studied. In addition, larger atherectomy specimens from peripheral arterial lesions were assessed to ensure that pockets of replication were not being overlooked in the smaller coronary specimens. We found evidence for replication in tissue resected from 2/17 coronary and 9/12 peripheral artery restenotic lesions. In contrast, 3/11 specimens resected from primary lesions of peripheral arteries also expressed H3 mRNA. We estimated that the maximum percentage of cells that were replicating in restenotic coronary, restenotic peripheral and primary peripheral artery tissue slides to be <0.5, < or =1.2 and <0.01%, respectively. Replication was found in tissue specimens resected both early and late after a previous interventional procedure. For specimens with >15 replicating cells per slide we found high levels of focal replication. Therefore, cell replication, as assessed by the expression of H3 mRNA, was infrequent in restenotic coronary artery specimens, whereas peripheral restenotic lesions had more frequent and higher levels of replication regardless of the interval from the previous interventional procedure. For all specimens the percentage of cells that were replicating was low, however focal areas with relatively high replication indices were presented. Although replication was more abundant in restenotic lesions it does not appear to be a dominant event in the pathophysiology of restenosis.

Recovery of systolic and diastolic left ventricular function after a 60-second coronary arterial occlusion during percutaneous transluminal coronary angioplasty for angina pectoris.

Recovery of global and regional systolic and global diastolic left ventricular (LV) function was examined after 60 seconds of coronary arterial occlusion in 9 men without myocardial infarction undergoing elective percutaneous transluminal coronary angioplasty. Hemodynamic and electrocardiographic recordings and a simultaneous digital subtraction LV angiogram in the 30 degree right anterior oblique view were performed before coronary occlusion, after 60 seconds of the first 2 occlusions and at 20, 40, 60 and 90 seconds of reperfusion. Diastolic pressure-volume relations paired the digital volumes to corresponding high-fidelity analog pressures. Similar and significant depression of global ejection fraction, percent radial shortening in the jeopardized region, maximal positive dP/dt and significant elevation of LV end-diastolic pressure and ST segments occurred with each 60-second coronary occlusion. All of these variables except LV end-diastolic pressure returned to control levels within 40 seconds of reperfusion. Significant elevation of the diastolic pressure-volume relation occurred with each coronary occlusion and progressively diminished to control values with 60 seconds of reperfusion. No statistically significant difference in any measurement occurred between the 2 occlusions and reperfusions at any point. This study shows that similar and significant depression and time course of recovery of global and regional systolic and global diastolic LV function accompanied each 60-second coronary occlusion with recovery of systolic function preceding recovery of diastolic function.

Evaluation of methods of measurement and estimation of left ventricular function after acute myocardial infarction.

Using multiple gated cardiac blood pool imaging and single-plane ventriculography from cardiac catheterization, 2 independent measures of left ventricular (LV) ejection fraction (EF) were determined in each of 21 patients. Patients were seen 2 to 6 weeks after their first acute myocardial infarction and were free of electrocardiographic evidence of conduction abnormalities and left or right ventricular hypertrophy. Differences between the 2 measures of LVEF were examined and then compared with the extent of myocardial necrosis estimated from the standard 12-lead electrocardiogram using the complete 54-criteria/32-point Selvester QRS scoring system. Regression analysis yielded an r value of 0.81 (SEE = 8.05) for the overall relation between the 2 measures of LVEF. Correlation coefficients of -0.70, -0.66 and -0.72 were obtained for the relations of radionuclide LVEF, catheterization LVEF and the mean of these 2 determinations, respectively, compared with QRS score. A QRS score 4 or less achieved 100% specificity and that of 8 or less 100% sensitivity for predicting an LVEF greater than 40%. Thus, the Selvester QRS scoring system may be of value in identifying patients with or without markedly impaired LVEF. This risk stratification may be important in reaching optimal postinfarction therapeutic decisions.

Directional coronary atherectomy of saphenous vein graft narrowings: multicenter investigational experience.

Directional coronary atherectomy (DCA) of saphenous vein graft lesions was performed at 21 centers between June 1988 and September 1990, which represents the multicenter investigational experience. A total of 318 procedures were performed and 363 vein graft lesions were treated. Angiographic success with DCA was achieved in 86% of lesions and clinical success was achieved in 85% (269 of 318) of patients. Major complications occurred in 2.5% of patients, with Q wave myocardial infarction (MI) in 1.3%, death in 0.9%, and urgent bypass surgery in 0.9%. Other complications included non-Q wave MI in 4.4%, distal embolization in 7.2%, coronary occlusion in 1.9%, and vessel perforation in 0.6%. Although there was a trend toward lower success rates with ostial vein graft lesions (82% vs 88% for other graft sites) and with diffuse (length > 20 mm) graft lesions (75% vs 87% for shorter lesions), the differences were not significant. Baseline clinical and angiographic factors did not identify predictors of lower success or more frequent complications in the study group. Overall restenosis rate in the 149 patients with angiographic restudy was 57%. The restenosis rate was significantly lower with primary vein graft lesions (38%) compared with a 75% restenosis rate for grafts with prior restenosis, p < 0.001. This initial multicenter investigational experience indicates that directional coronary atherectomy is a safe and effective therapy for selected saphenous vein graft disease. Although the overall restenosis rate is relatively high, the restenosis rate following DCA of primary vein graft lesions is significantly lower than for vein grafts having had prior intervention.(ABSTRACT TRUNCATED AT 250 WORDS)

A comprehensive estimation of acute myocardial infarct size using enzymatic, electrocardiographic and mechanical methods.

This prospective study compares the estimated size of acute myocardial infarction (AMI) by cumulative serum creatine kinase isoenzyme MB (CK-MB), Selvester QRS score, and 2-dimensional (2-D) echocardiographic dyssynergy of the left ventricle in 63 consecutive patients with their first anterior (n = 31) or inferior AMI (n = 32). The correlations among these parameters were good for patients with anterior AMI (r = 0.74 to 0.78, standard error of the estimate = 29 to 33%) but only fair for those with inferior AMI (r = 0.35 to 0.47, standard error of the estimate = 38 to 73%). Based on previous autopsy studies, estimates of CK-MB and QRS score were then converted to percent of infarcted left ventricle. Linear regression analyses between mean percent AMI size by cumulative CK-MB plus QRS score vs the number of dyssynergic segments by 2-D echocardiography were used to develop a comprehensive formula for estimating AMI size by a combination of all 3 techniques. Thus, a formula is proposed that may optimally estimate AMI size derived from leakage of cytosolic enzymes, changes in the sequence of myocardial depolarization, and irregularities of left ventricular contraction.

Directional atherectomy of coronary and saphenous vein graft ostial stenoses.

Directional coronary atherectomy (DCA) has been proposed as an alternative to balloon dilatation for treating coronary ostial stenoses, but the long-term efficacy of this procedure has not been well studied. To determine the procedural success and long-term efficacy of DCA for ostial stenoses, clinical data from 1 large registry database and from 2 single centers were retrospectively reviewed. Patients included in the study underwent DCA of aortocoronary (left main or right coronary artery), non-aortocoronary (left anterior descending or circumflex), or vein graft ostial stenoses. In 158 patients undergoing DCA of 160 lesions (30 left main or right coronary, 73 left anterior descending or circumflex, and 57 vein graft stenoses), overall procedural success, defined as < 50% residual stenosis without death, Q-wave myocardial infarction, or need for urgent bypass graft surgery, was 87%. The major complication rate was 0.6%. There were no deaths or Q-wave infarctions; only 1 patient required urgent bypass surgery. Other complications included non-Q-wave myocardial infarction (9%), arterial dissection (9%), abrupt closure (4%), and distal coronary embolization (4%). Angiographic follow-up was available for 65% of the 138 eligible patients. The overall 6-month angiographic restenosis rate, defined as > 50% diameter stenosis at the site of DCA, was 48% (de novo lesions 40% and restenotic lesions 61%). Restenosis rates for de novo and restenotic lesions were: aortocoronary (33%/50%), native coronary (38%/35%), and vein graft (47%/93%), respectively. We conclude that DCA of ostial stenoses is an effective revascularization strategy associated with a high procedural success rate and a low incidence of major complications.(ABSTRACT TRUNCATED AT 250 WORDS)

Repeat percutaneous transluminal coronary angioplasty and predictors of recurrent restenosis.

One hundred seventeen consecutive patients undergoing repeat percutaneous transluminal coronary angioplasty (PTCA) were studied to assess procedural success and recurrent restenosis rates. Clinical, anatomic and procedural variables were examined as predictors of recurrent restenosis using stepwise logistic regression analysis. Primary success was achieved in 114 patients (97.5%). One patient (0.8%) died after acute occlusion. No other in-hospital complications were encountered. After a mean follow-up interval of 218 +/- 160 days, 72 of 114 successfully dilated patients (63%) remained angina free. There were no late deaths. Three patients (2.6%) experienced a late myocardial infarction. Follow-up arteriography was performed in 100 patients (88%), of whom 32% had recurrent restenosis (greater than 50% luminal diameter narrowing). On univariate analysis, the presence of 3 clinical variables at repeat PTCA was associated with significantly higher recurrent restenosis rates compared with their absence, that is, unstable angina (48 vs 20%, p = 0.003), diabetes (61 vs 26%, p = 0.003) and hypertension (46 vs 18%, p = 0.003). Patients with recurrent restenosis had a shorter interval between first and second PTCA compared with those who remained patent (136 +/- 116 vs 214 +/- 163 days, p = 0.018). Multivariate analysis confirmed unstable angina, diabetes and hypertension as independent predictors of recurrent restenosis. Repeat PTCA may be performed for restenosis with a high likelihood of success and low incidence of complications. The rate of recurrent restenosis is similar to that reported for initial angioplasty. Patients with unstable angina, diabetes and hypertension appear to be at higher risk for recurrent restenosis.

Prediction of early recurrent myocardial ischemia and coronary reocclusion after successful thrombolysis: a qualitative and quantitative angiographic study.

To determine the association of qualitative and quantitative measurements of the myocardial infarct-related coronary narrowing with subsequent recurrent ischemia/reocclusion after successful thrombolysis, 47 patients treated with high-dose (150 mg) tissue plasminogen activator over 6 to 8 hours were studied in the setting of acute myocardial infarction. No patient underwent emergent coronary angioplasty. All patients had Thrombolysis in Myocardial Infarction (TIMI) grade 2 flow or higher at the baseline (90-minute) angiogram; 31 patients had a protocol 24-hour catheterization as well. Eighteen patients had recurrent ischemia/reocclusion whereas 29 had an uneventful hospital course. There was no significant difference in baseline clinical characteristics between the 2 groups. Twenty-five (86%) of those with an uneventful course had TIMI grade 3 flow at baseline angiogram compared with 56% of patients with recurrent events. No significant difference in angiographic morphologic characteristics was found between the 2 groups at baseline catheterization. At 24 hours, however, none of the patients who subsequently had recurrent events had a concentric narrowing, while 13 (58%) of them had a complex morphology. In contrast, quantitative parameters of minimal lumen diameter, percent area stenosis and percent diameter stenosis at baseline and 24 hours were not significantly different between those who did and did not have recurrent ischemia/reocclusion. These findings suggest that the degree and quality of coronary flow at baseline catheterization are more important determinants of sustained patency and event-free hospitalization than are quantitative dimensions or coronary morphology. In addition, narrowings that fail to become concentric within the first 24 hours are more likely to be associated with subsequent ischemia or reocclusion during the early periinfarct period.

Influence of vessel selection on the observed restenosis rate after endoluminal stenting or directional atherectomy.

In comparing the restenosis rates among different interventions, 1 potential confounder might be the differences in the vessels treated, as dictated by the technical limitations of particular devices. The purpose of this study was to use current "acute gain-late loss" analysis to examine what influence vessel selection has on the restenosis rates seen after coronary stenting or directional atherectomy. The minimal luminal diameter of native coronary lesions was measured before and immediately after intervention in 102 single Palmaz-Schatz stents and 347 atherectomies, 367 (82%) of which had repeat angiographic measurement 6 months after intervention. Atherectomy-treated lesions had a higher proportion of left anterior descending to right coronary arteries (68 vs 24%) compared with stents (31 vs 54%), p < 0.001. Although subsequent restenosis rates were similar for stenting (25%) and atherectomy (30%, p = 0.42), left anterior descending versus right coronary lesions had a significantly higher restenosis rate for the overall group (35 vs 18%, p = 0.009), for stents (44 vs 13%, p = 0.008) and for atherectomy (35 vs 22%, p = 0.10), respectively. Multivariable analysis demonstrated that postprocedure luminal diameter (p = 0.03, p = 0.009) and coronary location (the proportion of left anterior descending vessels treated, p = 0.002, p < 0.001), but not device type (stent vs atherectomy), were strong independent determinants of restenosis according to both binary (> 50% diameter stenosis) and continuous (late percent stenosis) definitions.(ABSTRACT TRUNCATED AT 250 WORDS)

Results of directional coronary atherectomy during multicenter preapproval testing. The US Directional Coronary Atherectomy Investigator Group.

Between 1988 and 1990, clinical testing was performed at 12 US institutions using the Simpson Coronary AtheroCath under an Investigational Device Exemption. Data on 1,069 lesions (873 patients) were analyzed and presented to the Food and Drug Administration (FDA) advisory panel in the summer of 1990, forming the basis for approval of this device in September 1990. Analysis of these preapproval data shows a primary success rate of 85% (defined as tissue removal, > or = 20% reduction in stenosis, < 50% residual stenosis after directional atherectomy, and no major complication), with somewhat higher primary success in prior restenosis and noncalcified lesions. Including the use of conventional angioplasty performed after atherectomy, the overall success rate was 92%. One or more major complications occurred in 4.9% of procedures, and included death (0.5%), nonfatal Q-wave myocardial infarction (0.9%), and emergency bypass surgery (4.0%). These complications were more frequent in right coronary, de novo, and diffuse (> 20-mm length) lesions. Six-month angiography results were available in 384 (77%) of 498 lesions eligible for follow-up when the registry closed and showed a restenosis rate (late stenosis > 50%) of 42%. The restenosis rate in both native vessels (30 vs 46%) and bypass grafts (31 vs 68%) was lower in primary (de novo) lesions compared with lesions that had developed restenosis after a prior intervention. Despite the use of prototype atherectomy catheters and still evolving procedural technique, this preapproval experience provided an important initial indication of the situations in which directional coronary atherectomy was most useful and helped set clear standards for performance of this procedure following FDA approval.