The StarClose Vascular Closure System: interventional results from the CLIP study.

BACKGROUND: The StarClose Vascular Closure System is a femoral access site closure technology that uses a flexible nitinol clip to complete a circumferential, extravascular arteriotomy close. The Clip CLosure In Percutaneous Procedures study was initiated to study the safety and efficacy of the StarClose device in subjects undergoing diagnostic and interventional catheterization procedures. METHODS: A total of 17 U.S. sites enrolled 596 subjects, with 483 subjects randomized at a 2:1 ratio to receive StarClose or standard compression of the arteriotomy after the percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. RESULTS: The results of the diagnostic StarClose cohort have been reported separately. Results for the interventional arm revealed major vascular complications occurring in 1.1% of StarClose subjects (2/184) and 1.1% in manual compression subjects (1/91; P = 1.00). No infections were seen in either cohort. Minor complications in the StarClose interventional group occurred at a rate of 4.3% (8/184) and with compression at 9.9% (9/91; P = 0.107). Pseudoaneurysm or arteriovenous fistula was not seen with StarClose. With StarClose, procedural success was 100% (136/136) for the diagnostic group and 98.9% (181/183) in the interventional group. Device success for the treatment group was 86.8%. In the interventional cohort, 87.3% (158/181) of StarClose subjects reported a pain scale of 0-3 compared with 93.3% (84/90) in the compression group, which was not statistically different. CONCLUSIONS: The clinical results of this study demonstrate that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures. StarClose significantly reduced time to hemostasis, ambulation, and dischargeability when compared with compression.

The safety and efficacy of the StarClose Vascular Closure System: the ultrasound substudy of the CLIP study.

BACKGROUND: The StarClose Vascular Closure System (Abbott Vascular, Redwood City, CA) features a nitinol clip that is designed to achieve closure of the femoral arteriotomy access site. The CLIP Study was performed to assess the safety and efficacy of StarClose when compared with standard manual compression following 5-6 French diagnostic or interventional percutaneous procedures. A substudy of this trial was designed to assess the utility of duplex ultrasonography to assess patency of the femoral artery and to determine access site complications (pseudoaneurysm, arteriovenous fistula, hematoma, deep vein thrombosis) in a multicenter prospective trial. This is the report of the duplex ultrasound (DUS) substudy of the CLIP trial. METHODS: A total of 17 U.S. sites enrolled 596 subjects with 483 subjects randomized at a 2:1 ratio to receive StarClose or manual compression of the arteriotomy after a percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. A substudy of the CLIP interventional arm evaluated DUS images of the closure site at five study sites, targeting 100 subjects at day 30 following hemostasis. The DUS protocol was devised and implemented by an independent vascular ultrasound core laboratory with extensive experience in vascular device trials. DUS inguinal region from 6 cm proximal to 6 cm distal to the arteriotomy puncture was performed. A qualitative examination was performed to determine the presence of iatrogenic vascular injuries: hematoma, pseudoaneurysm (PSA), arteriovenous fistula (AVF), and arterial/venous thrombosis or stenosis using 2-dimensional gray scale, color, and focused Doppler images. RESULTS: DUS of 96 subjects randomized to StarClose (n = 71) and compression (n = 25) were performed and evaluated. There was no evidence of hematoma, PSA, or AVF observed in the StarClose group. No StarClose subjects in the substudy had a PSA or AVF. All patients in the substudy demonstrated patency of the access site artery and vein without thrombosis or stenosis. Finally, in the entire study cohort, no clinically-driven DUS studies demonstrated iatrogenic vascular injury or vessel thrombosis in the StarClose treated patients. CONCLUSION: DUS, a safe and reliable method for determining the safety and efficacy of access site closure devices, is a reliable, safe, inexpensive and accurate method of assessing vascular access site complications in multicenter trials. In this substudy of the CLIP study, DUS found no statistical difference in access site complications between the StarClose and manual compression groups. Both groups maintained vessel patency without stenosis, thrombosis, hematoma, pseudoaneurysm, or AV fistula.

Final results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) study.

BACKGROUND: Intravascular ultrasound (IVUS) can assess stent geometry more accurately than angiography. Several studies have demonstrated that the degree of stent expansion as measured by IVUS directly correlated to clinical outcome. However, it is unclear if routine ultrasound guidance of stent implantation improves clinical outcome as compared with angiographic guidance alone. METHODS AND RESULTS: The CRUISE (Can Routine Ultrasound Influence Stent Expansion) study, a multicenter study IVUS substudy of the Stent Anti-thrombotic Regimen Study, was designed to assess the impact of IVUS on stent deployment in the high-pressure era. Nine centers were prospectively assigned to stent deployment with the use of ultrasound guidance and 7 centers to angiographic guidance alone with documentary (blinded) IVUS at the conclusion of the procedure. A total of 525 patients were enrolled with completed quantitative coronary angiography, quantitative coronary ultrasound, and clinical events adjudicated at 9 months for 499 patients. The IVUS-guided group had a larger minimal lumen diameter (2.9+/-0.4 versus 2.7+/-0. 5 mm, P<0.001) by quantitative coronary angiography and a larger minimal stent area (7.78+/-1.72 versus 7.06+/-2.13 mm(2), P<0.001) by quantitative coronary ultrasound. Target vessel revascularization, defined as clinically driven repeat interventional or surgical therapy of the index vessel at 9 month-follow-up, occurred significantly less frequently in the IVUS-guided group (8.5% versus 15.3%, P<0.05; relative reduction of 44%). CONCLUSIONS: These data suggest that ultrasound guidance of stent implantation may result in more effective stent expansion compared with angiographic guidance alone.

Directional coronary atherectomy: optimal atherectomy trials and new combined strategies with coronary stents.

Directional coronary atherectomy (DCA) has evolved from its early use as a tool for minimal plaque debulking to its current use of more aggressive lumen enlargement. The trend toward improved lumen results and reduced restenosis following DCA compared to percutaneous transluminal coronary angioplasty (PTCA) in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT) was confirmed as a significant improvement in the subsequent Balloon versus Optimal Atherectomy Trial (BOAT). BOAT showed that acute lumen results and late angiographic restenosis could be significantly improved by DCA over PTCA, without any increase in procedural complications or late cardiac events. The role of DCA in conjunction with coronary stents is currently being defined as studies suggest that residual plaque burden after stenting is predictive of late restenosis. The Atherectomy before Multilink Stent Improves Lumen Gain and Clinical Outcomes Study (AMIGO) will help determine whether plaque debulking prior to stenting can reduce restenosis.

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.

'Optimal' directional coronary atherectomy: final results of the Optimal Atherectomy Restenosis Study (OARS).

BACKGROUND: Previous clinical trials of directional coronary atherectomy (DCA) have failed to show significant improvement in early or late outcomes compared with balloon angioplasty (PTCA). The present study tested the hypothesis that more aggressive "optimal" atherectomy could be performed safely to produce larger initial lumen diameters and a lower late restenosis rate. METHODS AND RESULTS: The present study was a prospective multicenter registry of consecutive patients undergoing optimal DCA of de novo or restenotic lesions in 3.0- to 4.5-mm native coronary arteries. Optimal DCA was defined as using a 7F atherectomy device and adjunctive PTCA if necessary to achieve a < 15% residual stenosis. Six-month angiographic and 1-year clinical follow-up was planned in all patients. A total of 199 patients with 213 lesions met eligibility criteria for enrollment. Short-term procedural success was achieved in 97.5%, with a major complication rate (death, emergency bypass surgery, or Q-wave myocardial infarction [MI]) of 2.5%. There were no early deaths. Non-Q-wave MI (CK-MB > 3 times normal) occurred in 14% of patients. Mean reference vessel diameter was 3.28 mm. Mean diameter stenosis was reduced from 63.5% to a final stenosis of 7%. Late 1-year clinical follow-up revealed one cardiac death and a target lesion revascularization rate of 17.8%. The angiographic restenosis rate at 6 months was 28.9%, with the major predictor of restenosis being a smaller postprocedure lumen diameter. CONCLUSIONS: Optimal DCA produced a low residual percent diameter stenosis and a lower restenosis rate than seen in previous trials without an increase in early or late major adverse events.

Balloon angioplasty of the internal mammary artery trunk for early postoperative ischemia: a case report.

In this case report kinking of the internal mammary artery graft with possible superimposed spasm is described. Angiographic diagnosis was made 72 hrs following coronary artery bypass surgery and the lesion was successfully dilated with balloon angioplasty.

Safety and efficacy of intravenous diltiazem in atrial fibrillation or atrial flutter.

This study examines the efficacy of various doses of intravenous diltiazem to control the ventricular response during atrial fibrillation or atrial flutter. Control of the ventricular response of patients with atrial fibrillation and a rapid ventricular response can provide patients with relief of symptoms and improve hemodynamics. Eighty-four consecutive patients with atrial fibrillation or atrial flutter, or both, received an intravenous bolus dose of diltiazem followed by a continuous infusion of diltiazem at 5, 10, and 15 mg/hour. The mean ventricular response and blood pressure were monitored. Overall, 94% of patients (79 of 84) responded to the bolus dose with a > 20% reduction in heart rate from baseline, a conversion to sinus rhythm, or a heart rate < 100 beats/min. Seventy-eight patients received the continuous infusion. After 10 hours of infusion, 47% of patients (confidence interval [CI]: 36%, 59%) had maintained response with the 5 mg/hour infusion, 68% (CI: 57%, 79%) maintained response after the infusion was titrated to 10 mg/hour, and 76% (CI: 66%, 85%) after titration from the 5 and 10 mg/hour infusion to the 15 mg/hour dose. For the 3 diltiazem infusions studied, mean (+/- SD) heart rate was reduced from a baseline value of 144 +/- 14 beats/min to 98 +/- 19, 107 +/- 25, 107 +/- 22, 101 +/- 22, 91 +/- 17, and 88 +/- 18 beats/min at infusion times 0, 1, 2, 4, 8, and 10 hours, respectively. By the end of the infusion, 18% of patients (14 of 78) had conversion to sinus rhythm.(ABSTRACT TRUNCATED AT 250 WORDS)

Mobile cardiac catheterization registry: report of the first 1,001 patients.

The purpose of this study was to evaluate prospectively the efficacy and safety of mobile cardiac catheterization. Mobile cardiac catheterization was introduced into clinical practice in 1989, but there has been no systematic study of its performance and safety. A registry was established in 1989 to monitor outcomes with mobile cardiac catheterization and is reported here. Patients were screened for eligibility for mobile cardiac catheterization using the joint AHA/ACC criteria for outpatient angiography. Eligible patients underwent mobile catheterization at eight hospitals within 120 miles of the base tertiary center. Helicopter evacuation services were available at each mobile site. The indications, findings, dispositions, and complications of mobile cardiac catheterization were recorded by means of a checklist, telephone follow-up and chart review. A total of 1,001 consecutive patients were entered into the registry in the first 20 months of operation, including 436 females and 565 males aged 22 to 84 years. Angina (Canadian Classes II-IV) was the most frequent primary indication for catheterization (46.4%), followed by atypical chest pain (36.9%), or a positive exercise stress test (25.6%). Infrequent indications for catheterization included a history of myocardial infarction (5.6%), congestive heart failure (7.1%), arrhythmias (4.1%), and valvular heart disease (0.7%). Catheterization was accomplished in 99.9% of patients. Angiographically normal studies were observed in 22.8%, and mild (< or = 50%) coronary artery disease in 13.6% of patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Mobile cardiac catheterization: comparison with outpatient and inpatient catheterization at tertiary facilities.

The study group included 1,553 consecutive patients from areas serviced by our mobile catheterization laboratories: 719 procedures were performed in the mobile unit at their local hospitals, 277 were performed at a tertiary hospital with less than a 24 hr hospital stay, and 557 were performed at a tertiary hospital as inpatients. The indications for mobile catheterization were predominantly atypical chest pain, angina pectoris, or positive treadmill stress test, whereas patients with less than 24 hr hospitalization at the tertiary center had their catheterization performed for additional reasons. The majority of the inpatient indications were for recent myocardial infarction or unstable angina. Using the American College of Cardiology/American Heart Association (ACC/AHA) criteria for outpatient catheterization, the mobile catheterizations were performed safely with a complication rate of only 0.7% compared to a complication rate of 3.1% for inpatients demonstrating that a low risk group of patients can be prospectively identified and catheterized safely in the mobile setting. An extremely high risk group of patients with ongoing unstable angina and recent myocardial infarction was also identified which should undergo catheterization only at a tertiary center.

A comparison of directional atherectomy with coronary angioplasty in patients with coronary artery disease. The CAVEAT Study Group.

BACKGROUND: Directional coronary atherectomy is a new technique of coronary revascularization by which atherosclerotic plaque is excised and retrieved from target lesions. With respect to the rate of restenosis and clinical outcomes, it is not known how this procedure compares with balloon angioplasty, which relies on dilation of the plaque and vessel wall. We compared the rate of restenosis after angioplasty with that after atherectomy. METHODS: At 35 sites in the United States and Europe, 1012 patients were randomly assigned to either atherectomy (512 patients) or angioplasty (500 patients). The patients underwent coronary angiography at base line and again after six months; the paired angiograms were quantitatively assessed at one laboratory by investigators unaware of the treatment assignments. RESULTS: Stenosis was reduced to 50 percent or less more often with atherectomy than with angioplasty (89 percent vs. 80 percent; P < 0.001), and there was a greater immediate increase in vessel caliber (1.05 vs. 0.86 mm, P < 0.001). This was accompanied by a higher rate of early complications (11 percent vs. 5 percent, P < 0.001) and higher in-hospital costs ($11,904 vs $10,637; P = 0.006). At six months, the rate of restenosis was 50 percent for atherectomy and 57 percent for angioplasty (P = 0.06). However, the probability of death or myocardial infarction within six months was higher in the atherectomy group (8.6 percent vs. 4.6 percent, P = 0.007). CONCLUSIONS: Removing coronary artery plaque with atherectomy led to a larger luminal diameter and a small reduction in angiographic restenosis, the latter being confined largely to the proximal left anterior descending coronary artery. However, atherectomy led to a higher rate of early complications, increased cost, and no apparent clinical benefit after six months of follow-up.

Lesion-specific technique considerations in directional coronary atherectomy.

Directional coronary atherectomy (DCA) has expanded over the past several years to include treatment of a wide variety of complex coronary lesions in difficult vessel locations. Ulcerated, eccentric, and hazy lesions; ostial, mid, distal, and bifurcation lesions; saphenous vein graft lesions; tandem and long lesions; and "rescue" of failed angioplasty lesions are all potentially well-suited for DCA. This paper describes a lesion-specific strategy for DCA and outlines equipment selection and techniques helpful for performing DCA in a broad range of cases.

Preservation of regional myocardial function during coronary angioplasty with an autoperfusion balloon catheter: a case report.

Echocardiographic assessment of regional myocardial function was performed during standard balloon coronary angioplasty followed by autoperfusion balloon angioplasty of a proximal left anterior descending artery stenosis. Septal and apical akinesis occurred within 60 seconds of standard balloon inflation, but regional function was well preserved during prolonged autoperfusion balloon inflation.

Hemorrhoidal ligation. A review of efficacy.

Two hundred forty-one patients undergoing hemorrhoidal rubber band ligation over a five-year period were reviewed to focus on complications. Three patients (1.2 percent) were hospitalized. Two, on oral anticoagulants, recovered from bleeding complications. One patient developed a band-related abscess that resolved with drainage. Twenty patients (8.3 percent) reported pain associated with the procedure. Three patients went on to subsequent surgical hemorrhoidectomy. There were no deaths in the series. This report agrees with previously published series highlighting the efficacy and cost containment of hemorrhoidal ligation. Continued reliance on this approach to hemorrhoidal disease is justified.

Myocardial protection during coronary angioplasty with an autoperfusion balloon catheter in humans.

An autoperfusion balloon catheter was developed to allow passive myocardial perfusion during inflation through a central lumen and multiple side holes in the shaft proximal and distal to the balloon. We report its safety and efficacy in 11 patients undergoing elective angioplasty to a single coronary lesion. Each lesion was dilated three times with the autoperfusion inflation bracketed between two inflations by standard angioplasty catheters. Chest pain score, 12-lead electrocardiogram, heart rate, and mean aortic pressure were recorded before each inflation and at 1-minute intervals after inflation. Inflation duration during autoperfusion angioplasty (513 +/- 303 seconds) was longer than for the pre- (107 +/- 55 seconds, p = 0.0004) and post- (139 +/- 71 seconds, p = 0.0006) standard dilatations. The maximum ST-segment elevation and depression in any lead during autoperfusion angioplasty (0.3 +/- 0.5 and 0.6 +/- 0.8 mm) was significantly less than for the pre- (2.4 +/- 1.7 mm, p = 0.002 and 2.2 +/- 1.3 mm, p = 0.0004) or post- (1.9 +/- 1.3 mm, p = 0.002 and 1.6 +/- 1.3 mm, p = 0.018) standard dilatations at the same point in time. Maximal chest pain score during autoperfusion (3.2 +/- 3.5) was lower than for the pre- (6.1 +/- 2.1, p = 0.003) but not the post- (5.2 +/- 3.1, p = 0.07) standard angioplasty. All 11 patients underwent successful, uncomplicated procedures. We conclude that this autoperfusion catheter significantly reduces ischemic symptoms and signs during coronary angioplasty, allowing prolonged periods of balloon inflation.

The ventilatory threshold: quantitative analysis of reproducibility and relation to arterial lactate concentration in normal subjects and in patients with chronic congestive heart failure.

The present study evaluates optimal ventilatory criteria and exercise protocols for determining the ventilatory threshold, and assesses the day-to-day reproducibility of the ventilatory threshold and its relation to peak oxygen uptake VO2 and blood lactate concentration in normal subjects and patients with stable chronic congestive heart failure (CHF). Eighteen normal subjects and 18 patients underwent rapid (1-minute stage) and gradual (3-minute stage) bicycle exercise tests on consecutive days. The ventilatory threshold was determined from computer-generated printouts of expired gas variables measured breath by breath. Interobserver variability of ventilatory threshold was small in both normal (0.66 +/- 0.85 ml/min/kg) and CHF patients (0.50 +/- 0.46 ml/min/kg). Variability in the normal subjects was lower for the rapid exercise protocol (0.66 +/- 0.85 ml/min/kg) than the gradual protocol (1.72 +/- 1.63 ml/min/kg) (p less than 0.05), but both protocols produced similar results in the CHF group. Day-to-day reproducibility of ventilatory threshold was high (r = 0.91, standard error of the estimate 1.74 ml/min/kg) and was similar to that of peak VO2 (r = 0.95, standard error of the estimate 3.31 ml/min/kg). The use of co-plotted ventilatory equivalents for oxygen and carbon dioxide yielded ventilatory threshold values comparable to values obtained by using multiple parameters (r = 0.94, p less than 0.0001). Although the ventilatory threshold did not predict a precise lactate level for individual subjects, the lactate increment at the ventilatory threshold occurred within a narrow range in both normal subjects and patients with CHF; the increase was 7.5 +/- 4.5 mg/dl and 7.7 +/- 4.1 mg/dl, respectively, indicating a relation to initial increases in blood lactate.

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)

The risk for systemic embolization associated with percutaneous balloon valvuloplasty in adults. A prospective comprehensive evaluation.

STUDY OBJECTIVE: To prospectively investigate the evidence for embolic phenomena associated with percutaneous mitral and aortic valvuloplasty. DESIGN: Prospective, consecutive case series before and after balloon valvuloplasty. SETTING: Referral center hospital and cardiac catheterization laboratory. PATIENTS: Consecutive sample of 32 patients having balloon valvuloplasty for critical symptomatic stenosis of the mitral or aortic valve. Twenty-six patients had aortic stenosis; 6 had mitral stenosis. INTERVENTION: Computed tomography of the head, funduscopy, and electrocardiography were done in all patients before and after valvuloplasty. Cardiac isoenzymes were measured serially in 19 patients. MEASUREMENTS AND MAIN RESULTS: Previous cerebral infarction was seen in nine patients, with three showing a new abnormality after aortic valvuloplasty. In one of these patients a funduscopic hemorrhage was detected by photography. Total creatinine kinase and MB fraction were elevated in 1 of 19 patients. Serial electrocardiograms were unchanged in all patients. CONCLUSIONS: The incidence of cerebral neurologic events and myocardial injury are acceptably low after balloon valvuloplasty of calcific aortic and mitral stenosis. Both episodes of symptomatic cerebral infarction occurred in patients with apparent bicuspid aortic valvular stenosis, suggesting that calcific bicuspid aortic stenosis may be associated with more neurologic events after aortic valvuloplasty.

Coronary perfusion during acute myocardial infarction with a combined therapy of coronary angioplasty and high-dose intravenous streptokinase.

Two hundred and sixteen patients with acute myocardial infarction were treated with immediate infusion of high-dose (1.5 million units) intravenous streptokinase followed by emergency coronary angioplasty. The infarct lesion was crossed and dilated in 99% and persistent coronary perfusion after the procedure was achieved in 90% (including 3% with significant residual stenosis). Total in-hospital mortality was 12%. Multivariable analysis showed a higher hospital mortality with cardiogenic shock (41% vs 5% without shock), older age, lower left ventricular ejection fraction, and female sex. Final patency of the infarct-related vessel was determined by follow-up in-hospital cardiac catheterization. Coronary reocclusion occurred in 11% (symptomatic in 7%, treated with emergency angioplasty or bypass surgery; silent in 4%, treated medically). Of the surviving patients with successful initial establishment of infarct vessel patency, 94% were discharged from the hospital with an open infarct artery or a bypass graft to the infarct vessel. There was significant improvement in both ejection fraction (44% to 49%; p less than .0001) and regional wall motion in the infarct zone (-3.0 SD to -2.4 SD; p less than .0001) among patients with persistent coronary perfusion and insignificant residual stenosis at the time of the follow-up cardiac catheterization. Thus, a treatment strategy for acute myocardial infarction that includes immediate administration of streptokinase followed by emergency coronary angioplasty, and coronary bypass surgery when necessary, results in a high rate of early and sustained patency of the infarct-related vessel.