Effect of the distal-balloon protection system on microembolization during carotid stenting.

BACKGROUND: The distal-balloon protection system is being evaluated for its efficacy in preventing embolic neurological events during carotid stenting (CAS). We sought to determine the effect of this system on the frequency of Doppler-detected microembolic signals (MES) during CAS. METHODS AND RESULTS: Using transcranial Doppler, we compared the frequency of MES during CAS in 2 groups: 39 patients without distal protection and 37 who used the distal-balloon protection system (GuardWire). There were no significant differences in the clinical or angiographic characteristics between the 2 groups. Three phases with increased MES counts were identified during unprotected CAS; these were stent deployment, predilation, and postdilation (75+/-57, 32+/-36, and 27+/-25 METS, respectively). The distal-balloon protection significantly reduced the frequency of MES during CAS (MES counts: 164+/-108 in the control versus 68+/-83 in the protection group; P=0.002), particularly during these 3 phases. MES in the protection group were detected predominantly during sheath placement, guidewire manipulation, and distal-balloon deflation. CONCLUSION: Three phases with increased MES counts were identified during unprotected CAS (eg, stent deployment, predilation, and postdilation). The distal-balloon protection system significantly reduced the frequency of MES during CAS, particularly during these 3 phases.

Immediate and late clinical outcomes of carotid artery stenting in patients with symptomatic and asymptomatic carotid artery stenosis: a 5-year prospective analysis.

BACKGROUND: Carotid stenting is a less invasive percutaneous procedure than carotid endarterectomy for the treatment of carotid stenosis. Reports suggest that it can be performed with periprocedural complication rates similar to those of carotid endarterectomy. The purpose of this study was to determine short- and long-term outcomes in the largest prospective cohort of carotid stenting patients. METHODS AND RESULTS: This study followed 528 consecutive patients (604 hemispheres/arteries) undergoing carotid stenting. There was a 0.6% (n=3) fatal stroke rate and 1% (n=5) nonstroke death rate at 30 days. The major stroke rate was 1% (n=6), and the minor stroke rate was 4.8% (n=29). The overall 30-day stroke and death rate was 7.4% (n=43). Over the 5-year study period, the 30-day minor stroke rate improved from 7.1% (n=7) for the first year to 3.1% (n=5) for the fifth year (P:<0.05 for trend). The best predictor of 30-day stroke and death was age >/=80 years. After the 30-day period, the incidence of fatal and nonfatal stroke was 3.2% (n=31). On Kaplan-Meier analysis, the 3-year freedom from ipsilateral or fatal stroke was 92+/-1%. CONCLUSIONS: Experience from a single group of operators demonstrates that carotid stenting can be performed with an acceptable 30-day complication rate. Late follow-up also demonstrates a low rate of fatal and nonfatal stroke. These results suggest that carotid stenting may be comparable to carotid endarterectomy, and it underscores the clinical equipoise and premise for the National Institute of Health-supported, randomized Carotid Revascularization Endarterectomy Versus Stent Trial comparing carotid stenting with carotid endarterectomy.

Effectiveness of clopidogrel and aspirin versus ticlopidine and aspirin in preventing stent thrombosis after coronary stent implantation.

BACKGROUND: Ticlopidine has been shown to reduce the incidence of stent thrombosis compared with warfarin, but it may cause serious hematological side effects. Clopidogrel, a new thienopyridine derivative, may be a safe alternative to ticlopidine. The aim of this study was to compare the safety and efficacy of clopidogrel and aspirin with those of ticlopidine and aspirin in patients undergoing coronary stent implantation. METHODS AND RESULTS: The population of this study consisted of 2 groups: patients who underwent coronary stenting and were treated with ticlopidine and aspirin (TA group, n=1406), and patients who underwent coronary stenting followed by treatment with clopidogrel and aspirin (CA group, n=283). At 1-month follow-up, there was no difference in stent thrombosis (1.5% versus 1.4%, P=1.0) or major adverse cardiac events (3.1% versus 2.4%, P=0. 85) between the TA and CA groups, respectively. The probability of any side effect (neutropenia, diarrhea, rash) was significantly higher in the TA group (10.6% versus 5.3%, P=0.006; relative risk, 0. 53; CI, 0.32 to 0.86). CONCLUSIONS: These data suggest that clopidogrel may be an effective pharmacological regimen after coronary stent implantation. Furthermore, the simpler dosing regimen, the absence of neutropenia, and the lower frequency of other side effects make it a safe alternative to ticlopidine.

Effect of short pulsed nonablative infrared laser irradiation on vascular cells in vitro and neointimal hyperplasia in a rabbit balloon injury model.

BACKGROUND: Neointimal hyperplasia after PTCA is an important component of restenosis. METHODS AND RESULTS: Cultures of rabbit endothelial cells and smooth muscle cells (SMCs) were irradiated with different doses of nonablative infrared (1064-nm) radiation. Normalized viability index detected with nondestructive Alamar Blue assay and direct cell count were studied. Our experiments demonstrated dose-dependent cytostatic or cytotoxic effects of laser irradiation. We also evaluated the long-term effect of endoluminal nonablative infrared laser irradiation on neointimal hyperplasia in a rabbit balloon injury model. PTCA of both iliac arteries of 23 New Zealand White rabbits was performed. One iliac artery was subjected to intra-arterial subablative infrared irradiation via a diffuse tip fiber. The contralateral vessel served as control. The diet was supplemented with 0.25% cholesterol and 2% peanut oil for 10 days before and 60 days after PTCA. Morphometry after 60 days showed that intimal areas were 0.76+/-0.18 and 1.85+/-0.30 mm(2) in the laser and control arteries, respectively (P=2.2x10(-11)). CONCLUSIONS: We conclude that nonablative infrared laser inhibited neointimal hyperplasia after PTCA in cholesterol-fed rabbits for up to 60 days.

Randomized comparison of GR-II stent and Palmaz-Schatz stent for elective treatment of coronary stenoses.

BACKGROUND: This prospective multicenter randomized clinical trial was designed to evaluate the long-term angiographic and clinical outcomes of elective treatment with the GR-II stent compared with the Palmaz-Schatz (PS) stent in patients with coronary stenoses. METHODS AND RESULTS: Seven hundred fifty-five patients with myocardial ischemia and de novo native coronary stenoses in 3- to 4-mm vessels were randomly assigned to the PS (375 patients) or the GR-II stent (380 patients). The primary end point was 12-month target lesion revascularization (TLR)-free survival. Angiography was performed at baseline and at follow-up in the first 300 consecutive patients to assess the frequency of angiographic restenosis. Procedure success was 98.5% for the GR-II stent and 99.4% for the PS stent (P:=0.19). At 30 days, patients assigned to the GR-II stent had a higher stent thrombosis rate (3.9% versus 0.3% for PS stent, P:<0.001) and TLR rate (3.9% versus 0.5% for PS stent, P:<0.001). The GR-II group had a higher follow-up restenosis frequency (47.3% versus 20.6% for the PS group, P:<0.001) and a lower 12-month TLR-free survival rate (71.7% versus 83.9% for the PS group, P:<0. 001). Multivariate logistic regression analysis identified a smaller final stent minimal lumen diameter (odds ratio [OR] 2.49, 95% CI 1. 56 to 3.98; P:<0.001), diabetes mellitus (OR 2.14, 95% CI 1.42 to 3. 22; P:<0.001), and use of the GR-II stent (OR 1.78, 95% CI 1.20 to 2. 64; P:<0.01) as independent determinants of 12-month TLR. CONCLUSIONS: On the basis of these long-term follow-up data, we conclude that use of the GR-II stent should be limited to the acute treatment of abrupt or threatened closure after failed conventional balloon angioplasty procedures.

Vascular pathology of balloon-expandable flexible coil stents in humans.

The morphologic changes in atherosclerotic coronary arteries and saphenous vein bypass grafts after placement of a balloon-expandable flexible coil stent (Cook) are described. In each case, the vessels were patent despite morphologic evidence of injury and dissection in the vessel wall. The stented region was reendothelialized and the tissue overlying the stent wires consisted primarily of smooth muscle cells. There was minimal inflammatory reaction to the stent wires. These findings suggest that the balloon-expandable flexible coil stent can effectively maintain vessel patency even in the setting of postangioplasty lumen disruption. In addition, the vessels tolerate the metal prosthesis with little evidence of tissue inflammatory reaction.

The QRS scoring system for estimating myocardial infarct size: clinical, angiographic and prognostic correlations.

The relation between a QRS score derived from the routine electrocardiogram and left ventricular function was investigated in 181 patients after myocardial infarction. Patients with left ventricular hypertrophy and conduction defects were excluded. The QRS score correlated closely with the severity of wall motion abnormalities and left ventricular ejection fraction. The more severe the dyssynergy, the higher the QRS score (hypokinesia = 3.0; akinesia = 5.4; dyskinesia = 9.1). The left ventricular ejection fraction (percent) = 66 - (3.3 x QRS score) (correlation coefficient [r] = -0.81, probability [p] less than 0.001). With use of this regression equation, the QRS score predicted angiographic left ventricular ejection fraction to within 12% of the angiographic ejection fraction in 29 of 30 additional patients studied prospectively. The QRS score was also related to clinical functional class. The worse the clinical manifestation of left ventricular dysfunction, the higher the QRS score (Killip class I = 3.5; class II = 6.5; class III = 7.1). A QRS score greater than or equal to 7 had a specificity of 97% and a sensitivity of 59% for predicting an ejection fraction of less than 45%. Patients with a QRS score of 7 or greater had severe wall motion abnormalities, higher peak serum creatine kinase levels, higher prevalence of multivessel coronary disease, poor clinical functional class and an unfavorable outcome. The QRS score provides an inexpensive, clinically useful estimate of left ventricular function after myocardial infarction and can identify patients at high risk.

Coronary aneurysms after stent placement: a suggestion of altered vessel wall healing in the presence of anti-inflammatory agents.

Coronary aneurysms are rare after conventional angioplasty and have not been reported after coronary stenting. Coronary artery stent sites were examined by follow-up angiography at a median of 4 months in 29 patients who received the Cook stent (Gianturco-Roubin) for acute coronary closure. Nineteen patients were treated with glucocorticoids administered intravenously or orally, or both, with or without colchicine and results were compared with those in 10 patients who were treated with neither agent. Standard therapy for all patients included routine administration of aspirin and heparin before and warfarin sodium (Coumadin) and aspirin after stent placement. Most patients also received dipyridamole and lovastatin during the follow-up period. Compliance with medications was confirmed by telephone conversation with each patient. Six (32%) of the 19 stented arteries showed evidence of coronary artery aneurysm, defined as expansion of the lumen outside the margins of the stent. None of the patients in the control group (who did not receive steroids or colchicine) developed aneurysm. This pattern of altered vascular healing in stented coronary segments appears to be due to the addition of multiple anti-inflammatory drugs rather than to stent presence alone. This observation demonstrates the possibility of medical impairment of normal vascular remodeling after acute injury and stent placement, which may be of benefit in designing future trials on restenosis.

A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty.

OBJECTIVES: A new percutaneous collagen hemostasis device was compared with conventional compression techniques after diagnostic catheterization and angioplasty. BACKGROUND: Peripheral vascular complications after diagnostic catheterization or more complex interventional procedures, as well as the discomfort of manual compression and prolonged bed rest, represent significant morbidity for invasive cardiac procedures. METHODS: A prospective, multicenter, randomized trial was designed to compare the hemostasis time in minutes and the incidence of vascular complications in patients receiving a vascular hemostasis device with those undergoing conventional compression techniques. RESULTS: After diagnostic catheterization, hemostasis time was significantly less with the vascular hemostasis device than with conventional manual compression (4.1 +/- 2.8 min [n = 90 patients] vs. 17.6 +/- 9.2 min [n = 75], p < 0.0001). This difference was greater in patients undergoing angioplasty and was unrelated to the anticoagulation status (4.3 +/- 3.7 min [n = 71 not receiving heparin], 7.6 +/- 11.6 min [n = 85 receiving heparin], 33.6 +/- 24.2 min [n = 134 control patients not receiving heparin], p < 0.0001 vs. control patients). The time from the start of the procedure to ambulation was slightly less after diagnostic catheterization in patients treated with the device (13.3 +/- 12.1 h vs. 19.2 +/- 17.8 h, p < 0.05). It was also less in patients who underwent angioplasty when the device was used after discontinuation of anticoagulation (23.0 +/- 11.1 h, without heparin), as compared with control compression techniques (32.7 +/- 18.8 h, p < 0.0001). Time to ambulation was even shorter (16.1 +/- 11.1 h, p < 0.0001) in patients in whom the device was placed immediately after angioplasty while they were still fully anticoagulated with a prolonged activated clotting time (336 +/- 85 s). There were no major complications (surgery or transfusion) after diagnostic catheterization and a low incidence of major complications in patients who underwent angioplasty (0.7% in control patients, 1.4% with the device without heparin, 1.2% with the device and heparin, p = NS). After angioplasty, there was a trend toward fewer hematomas when the device was used in the absence of heparin (4.2% vs. 9.7% in control patients, p = 0.14). CONCLUSIONS: A new vascular hemostasis device can significantly reduce the puncture site hemostasis time and the time to ambulation without significantly increasing the risk of peripheral vascular complications. The role of this technology in reducing complications, length of hospital stay and cost remains to be determined.

Effect of nifedipine on recurrent stenosis after percutaneous transluminal coronary angioplasty.

This double-blind, randomized study evaluated the effect of nifedipine on restenosis after coronary angioplasty. Two hundred forty-one patients with dilation of 271 coronary sites were randomized at the time of hospital discharge to receive nifedipine, 10 mg (123 patients), or placebo (118 patients) four times daily for 6 months. No patient was known to have coronary artery spasm. The mean duration of therapy was 4.4 +/- 2 (mean +/- SD) months for nifedipine and 4.3 +/- 2 months for placebo. A restudy angiogram was available in 100 patients (81%) in the nifedipine group and 98 patients (83%) in the placebo group. A recurrent coronary stenosis was noted in 28% of patients in the nifedipine group and in 29.5% of those in the placebo group (p = NS). The mean diameter stenosis was 36.4 +/- 23% for the nifedipine group and 36.7 +/- 23% for the placebo group (p = NS). By pill count, 78% of patients receiving nifedipine and 82% of those receiving placebo complied with the study drug regimen. Coronary stenosis recurred in 33% of patients in the placebo group and in 29% of patients in the nifedipine group who complied with the regimen and had angiograms (p = NS). In conclusion, the study did not demonstrate a significant beneficial effect of nifedipine on the incidence of recurrent stenosis after successful percutaneous transluminal coronary angioplasty.

Effects of nifedipine on arterial oxygenation at rest and during exercise in patients with stable angina.

The effects of nifedipine on arterial oxygenation and hemodynamics were studied at rest and during bicycle exercise in 12 men (mean age 55 years, range 41 to 67) with stable exertional angina. The study was conducted double-blind on 2 days, 1 week apart, using a placebo-controlled crossover design. On each day, measurements at rest were made before and 20 minutes after 20 mg sublingual nifedipine or placebo and were followed by measurements made during exercise. Compared with placebo, nifedipine reduced mean arterial pressure, systemic vascular resistance and pulmonary vascular resistance, and increased heart rate and cardiac output at rest and during exercise. It did not alter mean pulmonary artery or pulmonary artery wedge pressures at rest, but decreased them during exercise. Nifedipine decreased arterial oxygen tension (PaO2) from 96 +/- 10 to 90 +/- 13 mm Hg (p less than 0.05) at rest and from 99 +/- 11 to 92 +/- 12 mm Hg (p less than 0.005) at submaximal exercise (33 +/- 21 W), but did not alter it (100 +/- 12 versus 100 +/- 16 mm Hg, p = NS) at maximal exercise (68 +/- 30 W). The reduction in PaO2 was not due to alveolar hypoventilation, because nifedipine did not alter arterial carbon dioxide tension, or to changes in mixed venous oxygen tension, which nifedipine increased at rest (39 +/- 2 versus 43 +/- 3 mm Hg, p less than 0.001) and during submaximal exercise (31 +/- 4 versus 33 +/- 4 mm Hg, p less than 0.03) and maximal exercise (27 +/- 3 versus 31 +/- 3 mm Hg, p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

Nonsurgical closure of femoral pseudoaneurysms complicating cardiac catheterization and percutaneous transluminal coronary angioplasty.

OBJECTIVES: This study was performed to describe the initial experience and follow-up of ultrasound-guided compression of pseudoaneurysms in patients receiving systemic anticoagulant or antiplatelet therapy, or both, after recent cardiac catheterization or percutaneous transluminal coronary angioplasty. BACKGROUND: Femoral artery pseudoaneurysm formation after an interventional procedure is becoming more common as larger caliber catheters and prolonged anticoagulant and antiplatelet therapy are being used. Traditional treatment of this complication has been surgical repair. This study describes a new method of closing femoral pseudoaneurysms by using external compression guided by Doppler color flow imaging. METHODS: Fifteen patients, 3 undergoing cardiac catheterization and 12 undergoing coronary angioplasty, developed an expansile groin mass at the vascular access site diagnosed as a femoral artery pseudoaneurysm by Doppler ultrasound. Seven of the patients had undergone coronary stenting and were receiving postprocedural anticoagulant therapy. These patients underwent progressive graded mechanical (C-clamp) external compression guided by ultrasound. The mechanical compression was titrated to obliterate the vascular tracts to these aneurysms and maintain adequate flow in the femoral artery. RESULTS: After an average compression time of 30 min (range 10 to 120), these tracts remained closed. Follow-up ultrasound examination at 24 h or later confirmed continued closure in all. CONCLUSIONS: This study suggests that nonsurgical closure of femoral pseudoaneurysms is feasible. This technique may be valuable in managing vascular access-related complications after diagnostic and interventional procedures, even in patients requiring prolonged anticoagulant therapy.

In-hospital cardiac mortality after acute closure after coronary angioplasty: analysis of risk factors from 8,207 procedures.

Cardiac death consequent to acute vessel closure after coronary angioplasty occurred in 13 of 294 closures from 8,207 consecutive procedures performed at two centers since 1981 (0.16% cardiac mortality rate). To determine the predictors of cardiac death after acute coronary closure, 50 clinical, angiographic and procedural variables were analyzed by an observer unaware of the clinical outcome for each of the 13 patients who died and also 100 patients randomly chosen, in whom vessel closure after angioplasty did not result in death during hospitalization. Univariate analysis found female gender (p less than 0.0001), collateral channels from the vessel dilated (p less than 0.0001), use of balloon counterpulsation (p less than 0.0002), pre- and postprocedural hypotension (p = 0.0003 and p = 0.003, respectively), jeopardy score greater than or equal to 2.5 (p = 0.003), left ventricular hypertrophy (p = 0.013), hypertension (p = 0.02), diabetes (p = 0.02) and multivessel disease (p = 0.03) to be predictive of death. Multivariate analysis found collateral vessels, female gender and multivessel disease to be independent predictors of death. Thus, cardiac death after elective coronary angioplasty is very rare in experienced centers and occurs most often in women with a large amount of potentially ischemic myocardium. Hypotension often precedes the fatal closure event. Close attention to the amount of potentially ischemic myocardium and to the fluid volume status of these patients would seem to be especially warranted.

Incomplete redistribution in delayed thallium-201 single photon emission computed tomographic (SPECT) images: an overestimation of myocardial scarring.

To determine if incomplete redistribution at 4 h in exercise tomographic thallium-201 studies is always due to a myocardial scar, 141 patients were evaluated before and after a total of 160 successful percutaneous transluminal coronary angioplasty procedures. Thallium studies were analyzed using polar "bull's-eye" maps. For both immediate and delayed images, abnormalities were quantified as a thallium score by calculating a standard deviation-weighted sum of pixels greater than 2.5 SD below gender-matched normal limits. One hundred forty-four of 160 studies indicated abnormalities before angioplasty. Of these 144, incomplete redistribution occurred in 111 (77%): 16 (14%) in patients with and 95 (86%) in patients without prior Q wave myocardial infarction. After angioplasty, improvement in delayed image score occurred in 8 (50%) of 16 patients with prior infarction and 72 (76%) of 95 patients without prior infarction (p less than 0.05). After angioplasty, delayed images were normal in 1 (6%) of 16 patients with prior infarction and 32 (34%) of the 95 without (p less than 0.05). Before angioplasty, delayed image scores were positively correlated with scores in the immediate postexercise images in patients with (r = 0.84) and those without (r = 0.69) prior infarction. To determine if additional delayed images could help differentiate scar from ischemia, an 8 to 24 h delayed image was obtained in each of 40 other patients with incomplete redistribution at 4 h. Of 28 patients without prior infarction, 15 had no redistribution, and 13 had further redistribution at 8 to 24 h.

Repeat coronary angioplasty: correlates of a second restenosis.

To identify the correlates of a second restenosis after repeat percutaneous coronary angioplasty, the records of 384 patients with single vessel disease who underwent repeat angioplasty for restenosis complicating a first elective angioplasty were examined. A second restenosis occurred in 47 (31%) of 151 patients having angiographic follow-up. Univariate correlates of a second restenosis were an interval between the first and second angioplasty less than 5 months (41 versus 20% of patients had restenosis, p less than 0.01), male gender (35 versus 12%, p less than 0.05), lesions length greater than or equal to 15 mm before the second angioplasty (62 versus 28%, p less than 0.05), diameter stenosis greater than 90% before the second angioplasty (67 versus 29%, p less than 0.05), final gradient greater than 20 mm Hg after the second angioplasty (52 versus 28%, p less than 0.05) and an additional site requiring dilation at the time of the second angioplasty (50 versus 29%, p = 0.10). Multivariate predictors of a second restenosis were an interval of less than 5 months between the first and the second angioplasty (p = 0.001), male gender (p = 0.001), lesion length greater than or equal to 15 mm before the second angioplasty (p = 0.001) and the need to have an additional site dilated at the time of the second angioplasty (p = 0.002). Patients at increased risk of restenosis after the second angioplasty can be identified and may serve as a useful population for intervention studies.

Prognostic importance of lower extremity arterial disease in patients undergoing coronary revascularization in the Bypass Angioplasty Revascularization Investigation (BARI).

OBJECTIVES: The purpose of this study was to evaluate the prevalence and prognostic importance of lower extremity arterial disease (LEAD) in patients with multivessel coronary artery disease. BACKGROUND: The presence of clinically evident LEAD increases the risk of death in patients with known coronary artery disease. Because studies have lacked noninvasive measures of subclinical LEAD, the true prognostic importance of lower extremity atherosclerosis in this population has probably been underestimated. METHODS: Ankle blood pressures were measured in 405 consecutive patients with angiographically documented multivessel coronary disease from seven Bypass Angioplasty Revascularization Investigation (BARI) sites and a parallel study site within 3 years of enrollment. Lower extremity arterial disease was defined as an ankle/arm systolic blood pressure ratio of 0.90 or less. RESULTS: Among patients studied, 69 (17%) had LEAD. These patients were more likely to be current smokers, treated for diabetes, older and present with unstable angina compared with patients without LEAD. Among patients who underwent coronary arterial bypass grafting, major complications occurred in 2.8% of those without LEAD compared with 20.7% of those with LEAD (p = 0.002). Five-year mortality rates were similar for symptomatic LEAD (14%) and asymptomatic LEAD (14%). Patients without LEAD had a 3% mortality. After adjusting for baseline differences, the relative risk of death was 4.9 times greater for patients with LEAD compared with those without (95% confidence interval [CI]: 1.8, 13.4, p < 0.01). CONCLUSIONS: Patients with LEAD have a significantly higher risk of death than patients without LEAD, regardless of the presence of symptoms. An abnormal ankle/arm index is a strong predictor of mortality and can be used to further stratify risk among patients with multivessel coronary artery disease.

Noninvasive assessment of acute effects of nifedipine on rest and exercise hemodynamics and cardiac function in patients with aortic regurgitation.

The acute effects of nifedipine (20 mg sublingually) on hemodynamics and cardiac function were studied at rest and during supine bicycle exercise in 20 patients with aortic regurgitation. At rest, heart rate increased by 13%, systemic vascular resistance decreased by 34% and regurgitant index decreased by 17%. The change in systemic vascular resistance was related to its initial rest level (r = 0.82, p less than 0.001) and to the changes in forward cardiac output (r = 0.58, p less than 0.01) and regurgitant index (r = 0.60, p less than 0.01). Left ventricular end-diastolic and end-systolic volumes, stroke volume and ejection fraction were unchanged, whereas right ventricular ejection fraction increased. During exercise, nifedipine administration further increased heart rate by 8% and decreased systemic vascular resistance by 19%. Both forward stroke volume and forward cardiac output increased, but total left ventricular stroke volume was unchanged, resulting in a significant decrease in regurgitant index. Although left ventricular end-diastolic volume was slightly decreased, end-systolic volume did not increase; thus, ejection fraction was higher than that during control exercise (p less than 0.01). Right ventricular ejection fraction increased further. In aortic regurgitation, the acute administration of nifedipine improved cardiac performance and reduced regurgitation at rest and during exercise as a result of afterload reduction and increased heart rate. Whether these beneficial effects will occur during long-term therapy requires further investigation.

Hemodynamic and metabolic basis of impaired exercise tolerance in patients with severe left ventricular dysfunction.

Hemodynamic and metabolic changes were measured at rest and during exercise in 23 patients with chronic heart failure and in 6 control subjects. Exercise was limited by leg fatigue in both groups and capacity was 40% lower in the patients with failure. At rest, comparing patients with control subjects, heart rate and right atrial and pulmonary wedge pressure were higher; cardiac output, stroke volume and work indexes and ejection fraction were lower; mean arterial and right atrial pressure and systemic resistance were similar. During all phases of exercise in patients with heart failure, pulmonary wedge pressure and systemic vascular resistance were higher and pulmonary vascular resistance remained markedly elevated compared with values in control subjects. Cardiac output was lower in the patients with failure, but appeared to have the same physiologic distribution in both groups during exercise. Although arterial-femoral venous oxygen content difference was higher in patients with heart failure, this increase did not compensate for the reduced blood flow. Even though the maximal oxygen consumption was significantly reduced, femoral venous lactate and pH values were higher than values in control subjects, but femoral venous pH was similar in both groups at their respective levels of maximal exercise. Ejection fraction was lower in those with heart failure at rest and did not increase with exercise. Ventilation in relation to oxygen consumption was higher in patients with failure than in control subjects.(ABSTRACT TRUNCATED AT 250 WORDS)

Multicenter investigation of coronary stenting to treat acute or threatened closure after percutaneous transluminal coronary angioplasty: clinical and angiographic outcomes.

OBJECTIVES: This study reports on the initial experience with the Gianturco-Roubin flexible coronary stent. The immediate and 6-month efficacy of the device and the incidence of the complications of death, myocardial infarction, emergency coronary artery bypass surgery and recurrent ischemic events are presented. BACKGROUND: Abrupt or threatened vessel closure after coronary angioplasty is associated with increased risk of myocardial infarction, emergency coronary artery bypass graft surgery and in-hospital death. When dissection or prolapse of dilated plaque into the lumen is unresponsive to additional or prolonged balloon catheter inflation, coronary stenting offers a nonsurgical mechanical means to rapidly restore stable vessel geometry and adequate coronary blood flow. METHODS: From September 1988 through June 1991, 518 patients underwent attempted coronary stenting with the 20-mm long Gianturco-Roubin coronary stent for acute or threatened vessel closure after angioplasty. In 494 patients, one or more stents were deployed. Thirty-two percent of patients received stents for acute closure and 69% for threatened closure. RESULTS: Successful deployment was achieved in 95.4% of patients. Overall, stenting resulted in an immediate angiographic improvement in the diameter stenosis from 63 +/- 25% before stenting to 15 +/- 14% after stenting. Emergency coronary artery bypass graft surgery was required in 4.3% (21 of 493 patients). The incidence of in-hospital myocardial infarction (Q wave and non-Q wave) was 5.5% (27 of 493 patients). At 6 months, myocardial infarction was infrequent, occurring in 1.6% (8 of 493 patients). The incidence of in-hospital death was 2.2% (11 of 493 patients). Late death occurred in 7 patients (1.4%) and 34 patients (6.9%) required later bypass graft surgery. Complications included blood loss, primarily from the arterial access site, and subacute thrombosis of the stented vessel in 43 patients (8.7%). CONCLUSIONS: The early multicenter experience suggests that this stent is a useful adjunct to coronary angioplasty to prevent or minimize complications associated with flow-limiting coronary artery dissections previously correctable only by surgery. Although this study was not randomized, it demonstrated a high technical success rate and encouraging results with respect to the low incidence of emergency coronary artery bypass graft surgery and myocardial infarction.

Multicenter study of percutaneous transluminal angioplasty for right coronary artery ostial stenosis.

Over a 5 year period at three centers, 53 patients underwent percutaneous transluminal angioplasty of a right coronary artery ostial stenosis. The procedure was successful in 42 patients (79%) and unsuccessful in 11, of whom 5 (9.4%) required emergency coronary artery bypass grafting because of abrupt closure. The right coronary ostial lesion had distinctive technical requirements to achieve success, including high pressure balloon inflation (10 +/- 4 atm) and the need for unconventional right coronary guide catheters. Technical factors that account for increased difficulty in these patients include: problems with guide catheter impaction and ostial trauma; inability to inflate the balloon with adequate guide catheter support; and need for increased intracoronary manipulation. The stenoses were quite discrete (4 +/- 5 mm) and calcified in the majority (40) of the 53 patients. Long-term follow-up (mean 12.5 months, range 4 to 60) of these patients demonstrated clinical recurrence of angina in 20 patients (48%) and angiographically proved restenosis in 16 (38%). Repeat coronary angioplasty was successful in three of six patients for relief of symptoms for over 6 months. In conclusion, angioplasty of the right coronary ostial lesion compared with nonostial dilation leads to a suboptimal early success rate; an apparent high risk of emergency bypass surgery; and a high restenosis rate. Careful assessment of the patient with this lesion and improved technology appear to be warranted.