Long-term vessel response to a self-expanding coronary stent: a serial volumetric intravascular ultrasound analysis from the ASSURE Trial.A Stent vs. Stent Ultrasound Remodeling Evaluation.

OBJECTIVES: We sought to investigate the in vivo mechanical properties of a new self-expanding coronary stent (RADIUS) and, particularly, the subsequent vessel response over time. BACKGROUND: Preclinical studies have suggested that self-expanding stents may produce less vessel wall injury at initial deployment, leading to larger follow-up lumens than with balloon-expandable stents. However, the influence of the chronic stimulus from self-expanding stents on the vessel wall remains unknown. METHODS: Sixty-two patients were randomly assigned to either the RADIUS self-expanding stent group (n = 32) or the Palmaz-Schatz balloon-expandable stent group (n = 30). Intravascular ultrasound was performed after stent deployment and at six-month follow-up. RESULTS: At follow-up, the RADIUS stents had increased 23.6% in overall volume, while the Palmaz-Schatz stents had remained unchanged. Due to the greater mean neointimal area (3.0 +/- 1.7 mm2 vs. 1.9 +/- 1.2 mm2, p = 0.02) in the RADIUS group, no significant difference in net late lumen loss was observed between the two groups. On the other hand, analysis at the peristent margins demonstrated that mean late loss was significantly smaller in the RADIUS group than it was in the Palmaz-Schatz group (0.1 +/- 2.1 mm2 vs. 1.9 +/- 2.4 mm2, p = 0.02). CONCLUSIONS: Serial volumetric IVUS revealed that the RADIUS stents continued to enlarge during the follow-up period. In this stent implantation protocol, this expansion was accompanied by a greater amount of neointima than the Palmaz-Schatz stents, resulting in similar late lumen loss in both configurations. In the peristent margins, however, late lumen loss was minimized with the RADIUS stents.

Directional coronary atherectomy (DCA): a report from the New Approaches to Coronary Intervention (NACI) registry.

Directional coronary atherectomy (DCA) with the Simpson coronary atherocath seeks to debulk rather than simply displace obstructive tissue and is a means of enlarging the stenotic coronary lumen. This report from the New Approaches to Coronary Intervention (NACI) registry describes the experience of 1,196 patients who underwent DCA as the sole treatment for either native vessel or vein graft lesions. Device success (post-DCA residual stenosis <50% and > or =20% improvement) was achieved in 87.8%, with a lesion success rate (postprocedural residual stenosis <50% and > or =20% improvement) of 94.0%. The mean resultant stenosis after all interventions (by core laboratory) was 19%. Significant in-hospital complications occurred in 2.8% of patients with DCA attempts, including death 0.6%, Q-wave myocardial infarction (MI) 1.5%, and emergent coronary artery bypass graft surgery (CABG) 2.8%. At 1-year follow-up, cumulative mortality was 3.6%, with repeat revascularization in 28% (repeat percutaneous transluminal coronary angioplasty, 20.1%; CABG, 10.6%). This reflected percutaneous or surgical revascularization of the original lesion (target lesion revascularization) in 22.6% of patients. Subgroup analysis showed a lower lesion success rate and an increased complication rate for unplanned use, vein graft treatment, and treatment of a de novo (vs a restenotic) lesion. Multivariate analysis shows that diabetes mellitus, unstable angina, treatment of a restenotic lesion, and greater residual stenosis after the initial procedure were independent predictors of the composite endpoint of death/Q-wave MI/target lesion revascularization by 1-year follow-up. Among these generally favorable acute and 1-year results, the NACI directional atherectomy data confirm the "bigger is better" hypothesis: that lesions with a lower residual stenosis after a successful procedure had significantly fewer target lesion revascularizations between 30 days and 1 year, with no increase in major adverse events.

Predictors of acute and long-term outcome with transluminal extraction atherectomy: the New Approaches to Coronary Intervention (NACI) registry.

The New Approaches to Coronary Intervention (NACI) registry was established to define the role of new coronary devices in overcoming the limitations of balloon angioplasty. The purpose of the present study was to evaluate the acute and long-term efficacy of the transluminal extraction catheter (TEC) device utilizing data from the NACI registry and identify clinical and anatomic patient subsets who may benefit from this device. From 1990-1994, >4,300 patients from 39 clinical sites enrolled consecutive patients treated with one of the 7 new devices to the NACI registry. The study population consists of 331 patients (385 lesions) treated with planned TEC as the sole new device. Of these patients, 243 (292 lesions) were treated for saphenous vein graft (SVG) disease and 88 (93 lesions) for native disease. Patients undergoing SVG treatment were older and more likely to be male. They had lower ventricular function, more unstable angina, and a higher incidence of congestive heart failure. Multivessel disease was more prevalent in the SVG cohort, as was evidence of thrombus before treatment. Although device success was achieved in 50% of SVG lesions and 41% of native lesions, lesion success was achieved in 90% and 78%, respectively, after adjunctive balloon angioplasty, and procedure success rates were 86% and 79%, respectively. The in-hospital major complication (death/Q-wave myocardial infarction/emergency coronary artery bypass graft [CABG] surgery) rate was higher in the SVG cohort (6.2% vs 2.3%), mainly due to higher mortality rate (5.3% vs 1.1%). Multivariate analysis showed that SVG was not an independent predictor for either an in-hospital major complication or clinical failure. The risk factors for major in-hospital complications were history of congestive heart failure (odds ratio = 3.17) and thrombus (odds ratio = 3.36). For clinical failure the risk factors were diabetes (odds ratio = 1.88), thrombus (odds ratio = 2.08), and calcium (odds ratio = 3.09). One-year rates of death, Q-wave myocardial infarction, or any repeat revascularization were 51% in the SVG cohort and 41% in the native cohort. Following adjustment, patients treated for SVG disease did not have a higher risk when compared with those treated for native disease. The factors significantly associated with this composite event at 1 year are male (relative risk = 1.41), patients with history of congestive heart failure (relative risk = 1.56), and total occlusions (relative risk = 1.52). This study shows that for both SVG and native cohorts, device success rates were low with TEC alone, but acceptable lesion success rates were achieved when adjunctive PTCA was used. In-hospital as well as 1-year major complications were higher in the SVG cohort. However, after adjusting for other risk factors, SVG attempt was not significantly associated with either in-hospital or 1-year events.

Reduced distal embolization with transluminal extraction atherectomy compared to balloon angioplasty for saphenous vein graft disease.

Extraction atherectomy utilizes suction aspiration as an attempt to limit distal emboli during atherectomy. We sought to test the hypothesis that extraction atherectomy produces less distal embolization than balloon angioplasty when treating saphenous vein grafts. Among 163 consecutive, nonrandomized patients, 103 patients underwent transluminal extraction catheter (TEC) atherectomy with or without adjunctive balloon angioplasty, and 60 patients had conventional balloon angioplasty. Both groups showed comparably high procedural success rates (TEC 90.3%, angioplasty 83.3%, P = NS). TEC cases had a significantly lower incidence of angiographic distal embolization, compared with angioplasty (3.9% vs. 16.7%, P = 0.005). In cases with angiographic evidence of thrombus in the grafts, TEC maintained a significantly lower incidence of distal embolization than angioplasty (5.6% vs. 31.8%, P = 0.004). There were no statistical differences between the two groups regarding the incidence of other procedure-related complications, including death, myocardial infarction, or emergency coronary artery bypass grafting. TEC atherectomy appears to have a significantly lower incidence of distal embolization than balloon angioplasty when treating saphenous vein grafts, particularly in the presence of angiographically apparent thrombus.

Salvage atherectomy: using retrieved tissue to determine the etiology of acute closure.

Directional coronary atherectomy was successfully performed in the mid-left anterior descending artery at the site of failed balloon angioplasty. We presumed that intracoronary thrombus had resulted in acute vessel closure following balloon angioplasty, due to the angiographic appearance of the lesion and the clinical situation. However, examination of the extracted specimen from the atherectomy device revealed predominantly atheromatous tissue with minimal thrombus.

Comparison of percutaneous transluminal coronary angioplasty outcome and hospital costs for low-volume and high-volume operators.

Whether higher operator case volume is associated with improved percutaneous transluminal coronary angioplasty (PTCA) clinical and cost outcomes is the subject of this study. Hospital volume-related improvement in clinical outcomes has been shown for coronary artery bypass grafting (CABG) and PTCA. Physician case volume-related differences in clinical outcomes have not been clearly demonstrated, and differences in hospital costs have not been examined. For clinical and cost outcomes, risk-adjusted analysis of differences in PTCA outcomes has not been reported. In addition, controversy exists about the appropriate annual case volume considered adequate to maintain skills and achieve optimal clinical outcomes in performing PTCA procedures. We studied 2,350 PTCAs performed between March 1, 1991, and February 28, 1994. Physicians were divided into 2 volume groups: high (>50 cases/year) and low (<50 cases/year). The rate of emergency CABG after PTCA was 2.1% for high- and 3.9% for low-volume operators (p = 0.009). Hospital morbidity associated with PTCA was lower in high-than in low-volume operators (6.46% vs 10.73%, p <0.001). The risk-adjusted ratios for emergency CABG and morbidity were 2.05 (p = 0.005) and 1.79 (p <0.001), respectively. The length of stay averaged 4.07 +/- 4.54 days for high- and 4.49 +/- 4.33 days for low-volume operators (p = 0.003). Hospital costs averaged $7,977 +/-$7,269 for high- and $8,278 +/- $6,289 for low-volume operators (p = 0.065). The risk adjusted ratio was 1.091 (p = 0.004) for length of stay and 1.050 (p = 0.029) for cost. Thus, PTCA performed by high-volume operators is significantly less likely to require emergency CABG and is also significantly associated with lower hospital morbidity, shorter hospital length of stay, and lower hospital costs.

Clinical aspects of preconditioning and implications for the cardiac surgeon.

Ischemic preconditioning is one of the most powerful means to reduce myocardial ischemic cell death in the experimental laboratory. Data are now emerging suggesting that ischemic preconditioning also can occur in the human heart. Studies performed on human myocardial biopsies, angioplasty studies, clinical studies assessing acute tolerance to angina, and some studies evaluating the effect of angina prior to myocardial infarction, lend support to the concept that the human heart can be preconditioned. The ultimate objective is to develop preconditioning-mimetic agents that can be administered prophylactically prior to the time of cardiopulmonary bypass surgery or administered to hearts that have been harvested for transplant in order to better preserve the ischemically jeopardized myocyte.

Transluminal extraction catheter for the treatment of diseased saphenous vein grafts: a multicenter experience.

To evaluate the efficacy, safety, and long-term results of atherectomy using the Transluminal Extraction catheter (TEC), patients with diseased saphenous vein grafts were enrolled in a prospective nonrandomized trial. Patients were followed to hospital discharge for acute complications and underwent routine 6-mo reevaluation with repeat cardiac catheterization to assess restenosis. Atherectomy was performed on 650 graft lesions in 538 consecutive patients (male 81%; mean age 66 yr; range 37-81). Mean graft age was 8.3 yr; (range 0.3-20) with 85% of grafts > 3 yr of age. Complex lesion morphology included thrombus (28%), ulceration (13%), and eccentricity (50%). Lesion success was achieved in 606 lesions (93%) with clinical success in 479 patients (89%). Lesion success was achieved in 90% of thrombus containing lesions, 97% of ulcerated lesions, and 97% of grafts > 3 yr. Complications included nonfatal myocardial infarction in 4 (0.7%) of patients, emergency bypass surgery in 2 (0.41%), and in-hospital death in 17 patients (3.2%). Angiographic follow-up at 6 mo was obtained from 268 lesions in 227 patients. The overall lesion angiographic restenosis rate was 60%. TEC atherectomy can be performed in patients with diseased saphenous vein grafts with high primary success and low complication rates. It is suitable for use in aged grafts, particularly in the presence of thrombus and ulcerations, and may be superior to balloon angioplasty alone in this group of patients.

Previous angina alters in-hospital outcome in TIMI 4. A clinical correlate to preconditioning?

BACKGROUND: Ischemic preconditioning has been shown to reduce myocardial infarct size in experimental models, but its role in patients remains unclear. Angina before myocardial infarction reflects brief episodes of ischemia and may be a marker of preconditioning. As part of the Thrombolysis in Myocardial Infarction (TIMI) 4 study, we performed an analysis on the effect of a history of previous angina on in-hospital outcomes for patients with acute myocardial infarction. METHODS AND RESULTS: Patients eligible for thrombolytic therapy were enrolled into the study. Data were collected from case report forms regarding previous history of angina, in-hospital outcome and 6-week follow-up. Two hundred eighteen patients had a history of previous angina at any time before acute myocardial infarction, and 198 patients did not have previous angina. Patients with any previous history of angina were less likely than with those without angina to experience in-hospital death (3% versus 8%) (P = .03), severe congestive heart failure (CHF) or shock (1% versus 7%, P = .006), or the combined end point of in-hospital death, severe CHF, or shock (4% versus 12%, P = .004). Moreover, patients with any history of angina were more likely to have a smaller creatine kinase (CK)-determined infarct size (119 versus 154 CK integrated units; P = .01) and were less likely to have Q waves on their ECG (57% versus 69%; P = .01). In the subset of patients who experienced angina within the 48 hours before infarction (compared with those who did not), there was a trend toward less likely in-hospital death (3% versus 6%; P = .09), a lower incidence of severe CHF or shock (1% versus 6% P = .008), a lower combined end point of death, CHF, or shock (3% versus 10%; P = .006), smaller infarct size assessed by CK (115 versus 151 CK units; P = .03), and a trend toward fewer Q-wave infarcts. However, patients with a history of previous angina did have a trend toward more recurrent ischemic pain. Of importance is that the beneficial in-hospital effects of previous angina were not dependent on angiographically visible coronary collaterals. CONCLUSIONS: Previous angina confers a beneficial effect on in-hospital outcome after acute myocardial infarction. The reasons for this benefit are uncertain, but one potential mechanism for this observation may be ischemic preconditioning.

Late direct angioplasty in patients with myocardial infarction and fluctuating chest pain.

Myocardial infarctions may be associated with reduced but persistent blood flow to the infarct zone. We developed clinical criteria to select patients likely to have persistent perfusion to the infarct zone in the setting of acute myocardial infarction. Twenty-four consecutive patients with fluctuating pain and/or ST segment elevation who presented within 24 hours of the onset of infarction were studied with coronary angiography followed by direct percutaneous transluminal coronary angioplasty. Sixty-seven percent of patients had residual flow to the infarct territory. Eighteen patients had repeat angiography on day 9.4 +/- 4.1, and all arteries were patent (21% +/- 12% stenosis). Ejection fraction had risen from 50.0% +/- 15% to 54.0% +/- 14% (p less than 0.05). At follow-up (9.1 +/- 4.6 months), one patient died of noncardiac causes, and five redeveloped angina and underwent repeat procedures. Patients with fluctuating symptoms and/or ST segments are likely to have residual flow to the infarct zone, and late angioplasty may improve ventricular function in this group.

The effect of balloon angioplasty on vasa vasorum blood flow in canine coronary arteries.

To assess the effects of balloon dilatation on vasa vasorum flow, we performed percutaneous transluminal coronary angioplasty on the circumflex arteries of 12 dogs. Left anterior descending and circumflex coronary vasa vasorum flows were measured with radioactive microspheres at baseline, during, and 10 minutes after a 3-minute, 8 atm balloon inflation. With inflation, vasa vasorum flow at the balloon dilatation site profoundly decreased (from 0.25 +/- 0.08 to 0.03 +/- 0.01 ml/min/gm). The flow returned to normal within 10 minutes after deflation. This effect was not mediated by hemodynamic deterioration during coronary occlusion and did not occur in the contralateral coronary artery. Endomyocardial flow in the distribution of the dilated artery decreased markedly during balloon inflation (from 1.14 +/- 1.9 to 0.08 +/- 0.04 ml/min/gm), which confirmed coronary occlusion. We conclude that a prolonged decrease in vasa vasorum flow is not produced by experimental balloon angioplasty, which makes it unlikely that a sustained vasa vasorum flow reduction plays a role in the maintenance of patency or the induction of restenosis.

Usefulness of esophageal pill electrode atrial pacing with quantitative two-dimensional echocardiography for diagnosing coronary artery disease.

Noninvasive diagnosis of coronary artery disease (CAD) is difficult in patients who are unable to exercise. In this study esophageal pill electrode atrial pacing was used as a myocardial stress not requiring exercise, and changes in ejection fraction and pressure volume ratio during pacing with 2-dimensional echocardiography were quantitatively analyzed. All patients had completed a Bruce protocol treadmill exercise test and had undergone coronary arteriography. Of 26 patients, 22 were successfully paced (85%). Comparable rate-pressure products were obtained for treadmill exercise (23,500 +/- 5,900 mm Hg/min) and pacing (24,100 +/- 4,400 mm Hg/min; difference not significant). Of the 22 patients completing the study 8 had normal coronary arteries (group I) and 14 had CAD (group II). The change in ejection fraction with pacing in group I patients was not significant (3 +/- 8%). In group II ejection fraction decreased with pacing (-8 +/- 13%; p = 0.025). The pressure/volume ratio increased in group I with pacing (3.8 +/- 1.8 mm Hg/min/m2; p = 0.05) and was unchanged in group II (0.3 +/- 1.8 mm Hg/min/m2; difference not significant). Using an ejection fraction decrease with pacing or a failure to increase pressure/volume ratio with pacing as criterion for the presence of CAD, similar predictive accuracies were obtained when compared to treadmill exercise testing. Esophageal pill electrode atrial pacing with quantitative 2-dimensional echocardiography may be a useful noninvasive, nonexercise method to detect CAD.

Precordial ST elevation with acute conus branch occlusion.

A 70-year-old man developed anterior precordial ST elevation during coronary angiography in the presence of a normal left coronary artery. Injection of a proximally totally occluded right coronary artery caused occlusion of the conus branch. The electrocardiographic findings are shown, and the pathogenesis is discussed.

Chest trauma and subvalvular left ventricular aneurysms.

Two patients were discovered to have pulsatile saccular lesions at the base of the left ventricle and mitral regurgitation following blunt trauma to the chest. These aneurysms resembled annular subvalvular aneurysms which have previously been reported as congenital defects in African blacks and as acquired lesions following endocarditis or mitral valve replacement. The first patient had two aneurysms, while the second had an aneurysm in continuity with a traumatic ventricular septal defect. These aneurysms were detected by echocardiography and magnetic resonance imaging and should be sought in patients who develop valvar regurgitation following chest trauma.

Early experience with esophageal pill electrode atrial pacing in the diagnosis of coronary artery disease--a trend toward improved specificity compared to treadmill exercise.

Esophageal pill electrode pacing, treadmill exercise and coronary angiography were performed in 23 patients with chest pain. Atrial pacing produced fewer false positive studies resulting in higher specificity compared to treadmill exercise. Some possible explanations of the improved specificity are the better quality tracings obtained with atrial pacing and the increased control of the heart rate and blood pressure response during atrial pacing as opposed to treadmill exercise. This preliminary study suggests that esophageal pill electrode atrial pacing tachycardia studies may be a reasonable alternative to treadmill exercise testing in the noninvasive diagnosis of coronary artery disease.