Point-of-care measured platelet inhibition correlates with a reduced risk of an adverse cardiac event after percutaneous coronary intervention: results of the GOLD (AU-Assessing Ultegra) multicenter study.

BACKGROUND: The optimal level of platelet inhibition with a glycoprotein (GP) IIb/IIIa antagonist necessary to minimize thrombotic complications in patients undergoing a percutaneous coronary intervention (PCI) is currently unknown. METHODS AND RESULTS: Five hundred patients undergoing a PCI with the planned use of a GP IIb/IIIa inhibitor had platelet inhibition measured at 10 minutes, 1 hour, 8 hours, and 24 hours after the initiation of therapy with the Ultegra Rapid Platelet Function Assay (Accumetrics). Major adverse cardiac events (MACES: composite of death, myocardial infarction, and urgent target vessel revascularization) were prospectively monitored, and the incidence correlated with the measured level of platelet function inhibition at all time points. One quarter of all patients did not achieve >/=95% inhibition 10 minutes after the bolus and experienced a significantly higher incidence of MACEs (14.4% versus 6.4%, P=0.006). Patients whose platelet function was <70% inhibited at 8 hours after the start of therapy had a MACE rate of 25% versus 8.1% for those >/=70% inhibited (P=0.009). By multivariate analysis, platelet function inhibition >/=95% at 10 minutes after the start of therapy was associated with a significant decrease in the incidence of a MACE (odds ratio 0.46, 95% CI 0.22 to 0.96, P=0.04). CONCLUSIONS: Substantial variability in the level of platelet function inhibition is achieved with GP IIb/IIIa antagonist therapy among patients undergoing PCI. The level of platelet function inhibition as measured by a point-of-care assay is an independent predictor for the risk of MACEs after PCI.

Manifestations of coronary atherosclerosis in young trauma victims--an autopsy study.

OBJECTIVES: The aim of this study was to look at the prevalence of coronary atherosclerosis, its severity and site of involvement in patients < 35 years old who died from noncardiac trauma. BACKGROUND: Autopsies performed on casualties of the Korean War revealed coronary artery involvement in 77.3% of the hearts studied, and data after the Vietnam War noted the presence of atherosclerosis in 45% of casualties with severe disease in 5%, suggesting a decline in the prevalence of coronary atherosclerosis in young men. METHODS: One hundred eleven victims of noncardiac trauma (86.4% white with a mean age of 26 +/- 6 years) underwent pathologic examination of their coronary arteries to estimate the presence and severity of coronary atherosclerosis grossly, microscopically and through computerized planimetry. Identified segments of the coronary arteries were sectioned at 3-mm intervals, stained with special stains and after microscopic examination transferred to videotape and digitized to allow estimation of the percent compromise in the lumen area by atherosclerotic plaque. RESULTS: Signs of coronary atherosclerosis were seen in 78.3% of the total study group, with > 50% narrowing in 20.7% and > 75% narrowing in 9%. No demographic or anatomic features separated the groups with less or more severe involvement of their coronary arteries. Proximal involvement was more common except in the right coronary artery, which was as frequently involved distally. CONCLUSIONS: The overall prevalence of coronary atherosclerosis in a young, predominantly male study group was comparable with that noted after the Korean War. Left main or significant two- and three-vessel involvement was noted in 20% of the group studied and emphasizes the need for aggressive risk factor modification in this group.

Early ambulation after 5 French diagnostic cardiac catheterization: results of a multicenter trial.

Because earlier ambulation and discharge after cardiac catheterization may result in the increased utilization of outpatient facilities, a prospective five center clinical pilot trial assessing the safety and outcome of early ambulation after routine left heart catheterization was performed in 287 patients. Catheterization routines at each clinical center were unchanged throughout the study. After the diagnostic catheterization using 5 French (F), preformed, large lumen catheters and arterial puncture compression (mean 15 min, range 5 to 52), 260 patients were ambulated by a physician at a mean time of 2.6 h (range 1.8 to 3.1) after catheterization. Follow-up examination or a phone call 24 to 72 h later was performed to assess late results. The mean age of the patients was 58 years (range 25 to 91); 166 (58%) were men. Left ventricular ejection fraction was 54 +/- 15%. One hundred twenty-seven patients (44%) received intravenous heparin (1,500 to 5,000 U as an intravenous bolus) and 136 (47%) received aspirin. Major complications included transient ischemic attack (one patient) and ventricular tachycardia requiring cardioversion during ventriculography (two patients). A small hematoma (less than 5.0 cm) after ambulation occurred early (from compression to standing) in 14 patients (5%; 9 received heparin, 8 were taking aspirin) and later (after standing to 72 h) in 9 patients (3%; 2 receiving heparin, 2 taking aspirin). Five patients with a hematoma had studies with a 6F sheath. No patient required surgical intervention for early or late hematoma. Only three patients (1%) needed a 7F or 8F catheter because of suboptimal 5F coronary angiography.(ABSTRACT TRUNCATED AT 250 WORDS)

Influence of insurance type on the use of procedures, medications and hospital outcome in patients with unstable angina: results from the GUARANTEE Registry. Global Unstable Angina Registry and Treatment Evaluation.

OBJECTIVES: The purpose of this study was to investigate whether or not there is an association between managed care insurance and the delivery and outcome of care in patients presenting with unstable angina. BACKGROUND: The proportion of U.S. patients with managed care health insurance is increasing. This may be associated with recent improvements in the control of health care costs. It is unknown whether or not there is a difference in process of care in angina patients presenting with managed care versus fee-for-service health insurance. METHODS: We compared baseline characteristics, process and outcome of care in 636 patients with managed care insurance (MC) and 1,404 patients with fee-for-service (FFS) insurance who presented with unstable angina to 35 hospitals participating in the global Unstable Angina Registry and Treatment Evaluation (GUARANTEE) Registry. RESULTS: Although, there was little difference in baseline characteristics and hospital treatments between cohorts, MC patients were more likely to be discharged on guideline-recommended medications (aspirin and beta-adrenergic blocking agents). In addition, FFS patients were more likely to undergo cardiac catheterization (odds ratio = 1.25 95% confidence interval = 1.1 to 1.5), but not revascularization during the hospitalization. There was no difference in hospital mortality (0.9% versus 1.2% in MC versus FFS; p = 0.60). CONCLUSIONS: In patients admitted with suspected unstable angina, MC patients are less likely to undergo coronary angiography, but are more likely to be discharged on indicated medications.

Peripheral vascular complications in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I).

OBJECTIVES: In-hospital peripheral vascular complications of balloon angioplasty were compared with those of directional atherectomy in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I) to identify patients at risk and evaluate costs and outcomes. BACKGROUND: The incidence, costs and outcomes of peripheral vascular complications after coronary intervention have not been fully characterized as a function of randomly assigned therapy. METHODS: At 35 sites in the United States and Europe, 1,012 patients were randomized. Peripheral vascular complications were defined as the composite of pulse loss, pseudoaneurysm, hematoma > 4 cm in diameter or groin hemorrhage necessitating blood transfusion. Logistic models were derived to 1) predict these complications from baseline and procedural characteristics, 2) test the relevance of randomization assignment, and 3) assess their impact on hospital costs and long-term outcomes. RESULTS: Sixty-seven patients (6.6%) developed peripheral vascular complications, of whom 15 (22.4%) required a blood transfusion, 14 (20.9%) underwent vascular surgery, and 2 (3.0%) died. Both in-hospital deaths occurred in patients with peripheral vascular complications. There was no difference in composite peripheral vascular complication rates among patients randomized to angioplasty or atherectomy. Greater age, female gender, postprocedural heparin and intraaortic balloon counterpulsation were predictive of increased risk. In a representative 60% subset, mean hospital costs increased from $9,583 in patients without to $18,350 in those with peripheral vascular complications (p = 0.0001). The unadjusted mortality rate at 1 year was 7.5% for patients with peripheral vascular complications compared with 1.1% for all others (p = 0.0001). These complications identified patients at greater risk of death, myocardial infarction or repeat revascularization at 30 days and 1 year. The atherectomy group had a trend toward more frequent deaths and myocardial infarction. CONCLUSIONS: Directional atherectomy and balloon angioplasty had similar in-hospital peripheral vascular complication rates. Female gender, greater age, postprocedural heparin and intraaortic balloon counterpulsation were predictive of higher risk. The twofold increase in cost and sevenfold increase in long-term deaths highlight the need to prevent these periprocedural events and monitor patients closely.

Increased risk of non-Q wave myocardial infarction after directional atherectomy is platelet dependent: evidence from the EPIC trial. Evaluation of c7E3 for the Prevention of Ischemic Complications.

OBJECTIVES: We sought to determine the effects of platelet glycoprotein IIb/IIIa receptor blockade on adverse outcomes, especially non-Q wave myocardial infarction, in patients undergoing directional atherectomy in the Evaluation of c7E3 for the Prevention of Ischemic Complications (EPIC) trial. BACKGROUND: Randomized trials comparing directional atherectomy with percutaneous transluminal coronary angioplasty (PTCA) have demonstrated modest benefits favoring atherectomy but at a cost of increased acute ischemic complications, notably non-Q wave myocardial infarction. The mechanism for this excess risk is unknown. METHODS: Of 2,038 high risk patients undergoing coronary intervention in the EPIC trial, directional atherectomy was performed in 197 (10%). Patients randomly received the chimeric glycoprotein IIb/IIIa antibody 7E3 (c7E3), as a bolus or a bolus and 12-h infusion or placebo. Study end points included death, myocardial infarction, repeat intervention or bypass surgery. RESULTS: Patients undergoing directional atherectomy had a lower baseline risk for acute complications but had a higher incidence of any myocardial infarction (10.7% vs. 6.3%, p = 0.021) and non-Q wave myocardial infarction (9.6% vs. 4.9%, p = 0.006). Bolus and infusion of c7E3 reduced non-Q wave myocardial infarctions by 71% after atherectomy (15.4% for placebo vs. 4.5% for bolus and infusion, p = 0.046). Non-Q wave myocardial infarction rates after PTCA were not affected by c7E3, although Q wave myocardial infarctions were reduced from 2.6% to 0.8% (p = 0.017). CONCLUSIONS: The EPIC trial confirmed the increased risk of non-Q wave myocardial infarction with directional atherectomy use compared with PTCA. A bolus and 12-h infusion of the glycoprotein IIb/IIIa receptor inhibitor c7E3 abolished this excess risk. Directional atherectomy-related non-Q wave myocardial infarction appears to be platelet aggregation dependent.

Outcome and profile of ventricular septal rupture with cardiogenic shock after myocardial infarction: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded Coronaries in cardiogenic shocK?

OBJECTIVES: We wished to assess the profile and outcomes of patients with ventricular septal rupture (VSR) in the setting of cardiogenic shock (CS) complicating acute myocardial infarction (MI). BACKGROUND: Cardiogenic shock is often seen with VSR complicating acute MI. Despite surgical therapy, mortality in such patients is high. METHODS: We analyzed 939 patients enrolled in the SHOCK Trial Registry of CS in acute infarction, comparing 55 patients whose shock was associated with VSR with 884 patients who had predominant left ventricular failure. RESULTS: Rupture occurred a median 16 h after infarction. Patients with VSR tended to be older (p = 0.053), were more often female (p = 0.002) and less often had previous infarction (p < 0.001), diabetes mellitus (p = 0.015) or smoking history (p = 0.033). They also underwent right-heart catheterization, intra-aortic balloon pumping and bypass surgery significantly more often. Although patients with rupture had less severe coronary disease, their in-hospital mortality was higher (87% vs. 61%, p < 0.001). Surgical repair was performed in 31 patients with rupture (21 had concomitant bypass surgery); 6 (19%) survived. Of the 24 patients managed medically, only 1 survived. CONCLUSIONS: There is a high in-hospital mortality rate when CS develops as a result of VSR. Ventricular septal rupture may occur early after infarction, and women and the elderly may be more susceptible. Although the prognosis is poor, surgery remains the best therapeutic option in this setting.

Modifiable risk factors for vascular access site complications in the IMPACT II Trial of angioplasty with versus without eptifibatide. Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis.

OBJECTIVES: This study was designed to identify potential predictors of vascular access site (VAS) complications in the large-scale Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT) II trial, which studied angioplasty with versus without a new glycoprotein (GP) IIb/IIIa receptor inhibitor (eptifibatide). BACKGROUND: GP IIb/IIIa receptor inhibition during coronary interventions has been associated with excess VAS complications. If other predictors of VAS complications could be identified, they might be manipulated to reduce complications. METHODS: A total of 4,010 patients undergoing percutaneous transluminal coronary revascularization (PTCR) were randomized into one of three bolus/20- to 24-h infusion arms: placebo bolus/placebo infusion; 135-microg/kg body weight eptifibatide bolus/0.5-microg/kg per min eptifibatide infusion; or 135-microg/kg eptifibatide bolus/0.75-microg/kg per min eptifibatide infusion. Heparin during the procedure was weight adjusted and stopped 4 h before sheaths were removed. Logistic regression modeling was used to identify independent predictors of VAS complications. RESULTS: VAS complications were more common in patients treated with eptifibatide (9.9% vs. 5.9% placebo-treated patients, p < 0.001). Multivariate analysis identified eptifibatide therapy (p < 0.0001), advanced age (p = 0.0001), longer time to sheath removal (p = 0.0002), stent placement (with intense post-stent anticoagulation) (p = 0.0004), female gender (p = 0.0006), PTCR within 24 h of thrombolytic therapy (p = 0.002), larger heparin doses during PTCR (p = 0.009), major coronary dissection (p = 0.03) and placement of a venous sheath (p = 0.04) as independent predictors of VAS complications. CONCLUSIONS: VAS complications may be reduced by early sheath removal, by avoiding placement of venous sheaths and by limiting heparin dosing to avoid excessive activated clotting times. Early sheath removal during inhibition of platelet aggregation by eptifibatide is feasible.

Impact of the Duett sealing device on quality of life and hospitalization costs for coronary diagnostic and interventional procedures: Results from the Study of Economic and Quality of Life substudy of the SEAL trial.

BACKGROUND: The Simple and Effective Arterial Closure (SEAL) trial examined the safety and effectiveness of the Duett vascular sealing device (Vascular Solutions, Minneapolis, Minn) versus manual compression after diagnostic and interventional coronary procedures. We compared quality of life and initial hospitalization costs among patients treated with the Duett device versus manual compression. METHODS: Functional status was assessed with the Duke Activity Status Index (DASI) at 7 and 30 days after intervention. General health status was assessed with the Short Form (SF-36) at 30 days after intervention. Hospitalization costs were derived from the UB92 formulation of the hospital bill. RESULTS: There was a strong trend toward higher functional status in patients receiving treatment with the Duett device at 7 days both before (P =.04) and after (P =.08) adjustment for significant covariates. This difference was significant in the diagnostic group but not in the interventional group. No significant differences in quality of life between the Duett device and manual compression at 30 days were found. There was no significant difference in total hospitalization costs between treatment arms (P =.91). For interventional patients, mean total in-hospital costs were $10,167 in the Duett group and $10,225 in the manual compression group (P =.82). For diagnostic patients, mean hospitalization costs were $7784 and $7996 for the Duett device and manual compression groups, respectively (P =.72). Trends toward reduced recovery/observation room costs with the Duett device (P =.06) were found; this difference was significant in the diagnostic group ($198 vs $279, P =.02). CONCLUSIONS: The Duett sealing device was associated with significantly higher functional status at 7 days after the procedure in addition to shortened time to hemostasis and ambulation, with no associated increase in cost.

Publications concerning costs of various cardiovascular procedures and drugs.

The following is a compendium of economic articles considered to be the most important and informative in the field of mechanical and pharmacologic treatment of coronary artery disease. This reference list was compiled from the literature and the MEDLINE database and includes citations before 1996.

Economic and angiographic factors in determining optimal catheter size in performing outpatient left-sided heart and coronary angiography.

A prospective randomized trial was performed in 300 patients to establish the optimal catheter size (5.2, 6, or 7Fr) in performing outpatient left heart and coronary arteriography. A secondary randomization was performed between an attending physician and cardiovascular fellow to determine if the experience level of the operator was an important factor when using smaller French-sized catheters. The primary end point of the trial was total resource utilization of the patient's hospitalization. Hospital cost was calculated with cost accounting methodology using a "bottom-up" approach, and physician "cost" was determined with the Resource-Based Relative Value Scale. Angiographic quality was graded with qualitative and quantitative methods. Procedures were faster and time to hemostasis shorter with smaller catheters. The more experienced operators performed faster procedures and used less fluoroscopy. In the cardiac catheterization laboratory, health-care personnel cost was higher with the 6Fr catheters and when the attending physician was the primary operator. Postprocedure care was slightly less expensive with the smaller catheters. Overall, there was no difference in total cost between the catheter sizes and primary operators. Angiographic quality was similar between the catheter sizes. Smaller catheters used in performing outpatient left-sided heart and coronary arteriography are not associated with cost savings but do not compromise angiographic quality.

Costs of coronary restenosis (Lovastatin Restenosis Trial).

Within the Lovastatin Restenosis Trial, restenosis has been clearly shown to increase resource utilization and costs. While it is not possible to generalize these results to other patient populations, it is clear that successful efforts to decrease restenosis will certainly improve efficacy while decreasing follow-up costs and increasing the cost-effectiveness of intervention in the coronaries.

Cost and therapeutic modification of intracoronary ultrasound-assisted coronary angioplasty.

Intracoronary ultrasound is used to define plaque morphology and quantitative characteristics before and after coronary angioplasty. The cost of the technique was defined in 87 patients who underwent elective, noncomplex procedures: group A was composed of 37 patients without intracoronary ultrasound, who served as a control group; group B comprised 23 patients who had only postcoronary angioplasty ultrasound; and group C was 27 patients who had pre-and postangioplasty ultrasound. Economic analysis was done for the hospital ("bottom-up" methodology of equipment, supplies, support personnel, post-PTCA room) and physician costs (using resource-based relative value scale). The cost in the cardiac catheterization laboratory was: group A = $3,679 +/- $688; group B = $4,650 +/- $457; and group C = $5,301 +/- $835, p < 0.0001. The postprocedure cost for all groups was similar. The total cost was: group A = $5,326 +/- $1,135; group B = $6,815 +/- $1,276; and group C = $7,240 +/- $1,494, p < 0.0001. Intracoronary ultrasound modified the coronary angioplasty procedure in 36% of patients. Precoronary angioplasty intracoronary ultrasound defined the luminal diameter, precluding the use of additional balloons, and thus decreased the cost approximately $650. Use of ultrasound after the procedure increases the cost approximately $200 as a result of performing additional interventions. For intracoronary ultrasound to be economically viable, the change in angioplasty technique will need to be accompanied by improved clinical outcome.

Usefulness of coronary angioplasty in asymptomatic patients.

Of 6,545 patients who had elective coronary angioplasty procedures performed over a 7.5-year period from June 1980 through December 1987, 114 (1.7%) never had symptoms of myocardial ischemia. Exercise-induced silent myocardial ischemia was documented before angioplasty in 94% of these asymptomatic patients. Angioplasty was successful in 87%, whereas emergency coronary artery bypass grafting was required in 4%, and a further 2% had myocardial infarctions after the procedures. The remaining 7% had unsuccessful angioplasty procedures but experienced no in-hospital cardiac events. The follow-up period after hospital discharge averaged 43 +/- 20 months (range 5 to 93). There were no deaths. In the group of 99 patients with initially successful angioplasty procedures the follow-up interval ranged from 5 to 92 months. During that period, 7 patients underwent coronary bypass surgery, 4 patients had myocardial infarction and 30 patients had repeat angioplasty procedures for restenosis. The cumulative probability of event-free survival over 5 years for the group with successful angioplasty was: 100% freedom from death, 95% freedom from myocardial infarction, 87% freedom from myocardial infarction or coronary bypass surgery and 61% freedom from myocardial infarction, coronary bypass surgery or repeat angioplasty. Thus, coronary angioplasty performed in 114 asymptomatic patients, most with exercise-induced silent myocardial ischemia, achieved very good primary success and was accompanied by low cardiac event rates and no deaths over several years of patient follow-up.

Relation of coronary artery size to one-year clinical events after new device angioplasty of native coronary arteries (a New Approach to Coronary Intervention [NACI] Registry Report).

The influence of vessel size on clinical and angiographic outcomes after new device angioplasty has not been well documented. We reviewed clinical and angiographic outcomes of 2,044 patients undergoing new device angioplasty of native vessels enrolled in the New Approaches to Coronary Interventions (NACI) Registry. Quantitative angiography was performed using standard methods. Patients were divided into 3 groups according to reference vessel diameter (RVD) (<2.75, 2.75 to 3.25, and >3.25 mm). Patients with the smallest vessels had a higher incidence of diabetes (26% vs. 16%, p<0.01), multivessel disease (50% vs. 45%, p<0.01), left anterior descending coronary artery disease (61% vs. 39% p<0.01), and in general, more severe baseline lesion characteristics than patients with larger (>3.25 mm) vessels. Absolute baseline and final minimal lumen diameter (MLD) was also smaller in patients with RVD <2.75 mm despite similar final percent diameter stenosis. Although in-hospital events were similar, patients who underwent interventions in vessels <2.75 mm had an increased incidence of death (p<0.01), surgical revascularization (p<0.05), and target lesion revascularization (TLR) (p<0.01) at 1 year. Multivariate analysis by vessel size showed a stepwise increase in the risk of TLR by 1 year in patients with the smaller RVD (p = 0.0001) and the combined end point of 1 year death/Q wave-myocardial infarction/TLR (p = 0.02). Thus, despite similar early clinical events among patients undergoing new device angioplasty, patients who underwent treatment of smaller vessels had a significantly increased risk of major adverse clinical events and particularly TLR by 1 year after new device angioplasty of native coronary arteries.

Economic implications of the prophylactic use of intraaortic balloon counterpulsation in the setting of acute myocardial infarction. The Randomized IABP Study Group. Intraaortic Balloon Pump.

Intraaortic balloon counterpulsation (IABP) has been shown to improve coronary artery patency and reduce the rates of recurrent myocardial ischemia and its sequelae in selected patients when used within 24 hours of acute myocardial infarction. The economic implications of prophylactic IABP use are unknown. We obtained hospital bills for 102 patients enrolled in the Randomized IABP Trial (56%) and converted charges to costs using each hospital's Medicare cost report. In-hospital costs for patients who had 48 hours of IABP were compared with those of patients who did not. The costs of angiographic and clinical complications were determined. Small differences in clinical and angiographic characteristics existed between patients in the economic substudy and the overall population, but overall angiographic and clinical outcomes were comparable. Costs for patients who had IABP versus control patients were similar: mean $22,357 +/- $14,369 versus $19,211 +/- $8,414, median (25th and 75th percentiles) $17,903 ($15,787, $22,147) versus $17,913 ($15,144, $21,433), p = 0.45. Hospital costs were higher with the development of recurrent ischemia: mean $23,125 +/- $7,690 versus $20,416 +/- $12,449, median $21,069 ($17,896, $26,885) versus $17,492 ($14,892, $20,998) p = 0.02. Patients who had an adverse clinical event (death, stroke, reinfarction, and emergency revascularization) also had higher hospital costs: mean $25,598 +/- $10,024 versus $19,790 +/- $12,045, median $21,877 ($18,380, $28,049) versus $17,364 ($14,773, $20,779), p = 0.002. The prophylactic use of IABP in patients at high risk of infarct artery reocclusion within 24 hours of acute myocardial infarction provides sustained clinical benefit without substantially increasing hospital costs.

Clinical pharmacology of higher dose eptifibatide in percutaneous coronary intervention (the PRIDE study).

This study describes the dose-exploration phase of the PRIDE trial, an investigation of the clinical pharmacology of higher dose eptifibatide in patients who underwent elective percutaneous coronary intervention (PCI). Outcomes of treatment with the platelet glycoprotein IIb/IIIa inhibitors were dependent upon proper dosing selection. In this multicenter, placebo-controlled clinical study, 127 patients were randomized 1:1:2:2 into 1 of the following treatment groups: placebo; eptifibatide as a 135 microg/kg bolus followed by a 0.75 microg/kg/min infusion; eptifibatide as a 180 microg/kg bolus with a 2.0 microg/kg/min infusion; or eptifibatide as a 250 microg/kg bolus with a 3.0 microg/kg/min infusion. Light transmission aggregometry was used to determine platelet aggregation in response to 20 microM adenosine diphosphate, and platelet receptor occupancy was also determined. Eptifibatide exhibited linear pharmacokinetics over the dose range studied. Inhibition of platelet aggregation was greater in samples collected in sodium citrate compared with those collected in D-phenylalanyl-L-prolyl-L-arginine chloromethyl ketone. The 180/2.0 dosing regimen achieved 90% inhibition of platelet aggregation immediately (5 minutes) and at steady state (8 to 24 hours). At 1 hour, mean inhibition of platelet aggregation was 80%. Eptifibatide exhibited dose-dependent pharmacodynamics that were dependent upon choice of anticoagulant. A 180 microg/kg bolus followed by a 2.0 microg/kg/min infusion at steady state achieved >80% inhibition of platelet aggregation. With the single-bolus regimen, however, there was an early loss of the inhibition of platelet aggregation before steady state was reached. Additional dose-exploration studies may further optimize eptifibatide dosing.

Comparison of slow oscillating versus fast balloon inflation strategies for coronary angioplasty.

Previous studies suggest that slow and/or oscillating balloon inflation during coronary angioplasty may decrease the incidence of coronary dissection and improve clinical outcomes. To compare the effect of slow oscillating versus conventional fast inflation techniques on the incidence of severe coronary dissection during angioplasty, 622 patients were randomized to slow oscillating inflation versus fast inflation. Angiographic outcomes of the procedures and in-hospital clinical events were recorded. The primary end point of severe (type C, D, E, F) dissection occurred in 7.7% of patients undergoing slow oscillation and 6.6% of patients undergoing fast inflation (p = 0.87). Major complications (death, urgent coronary artery bypass graft surgery, stroke, abrupt closure, or Q-wave myocardial infarction) occurred in 4.7% of patients undergoing slow oscillation and 3.5% of patients undergoing fast inflation (p = 0.45). The 2 inflation strategies did not differ in the pressure at which the balloon achieved full expansion, angiographic success rate, residual stenosis, and incidence of all minor and/or major complications. We conclude that there is no benefit of slow oscillating inflation over routine fast inflation in angioplasty. Slow oscillating inflation did not dilate lesions at lower pressures, decrease the incidence of dissection or severe dissection, or reduce the incidence of adverse clinical outcomes.

Noncardiogenic pulmonary edema complicating massive verapamil overdose.

Noncardiogenic pulmonary edema has not been (to our knowledge) previously reported associated with a verapamil overdose. We describe a 27-year-old woman who developed this complication after an overdose of 15, 120-mg verapamil tablets (total of 1,800 mg). This report illustrates the possibility of serious pulmonary embarrassment in the course of a verapamil overdose and the need to avoid excessive crystalloid administration during the hypotensive period.

Surgical complications from hemostatic puncture closure devices.

BACKGROUND: For securing immediate hemostasis following percutaneous arterial catheterization, the Food and Drug Administration has approved three hemostatic puncture closure devices. We reviewed our institutional experience with one device (Angio-Seal). METHODS: A retrospective, single-center, nonrandomized observational study was made of all vascular complications following femoral cardiac catheterization. RESULTS: An immediate mechanical failure of the device was experienced in 34 (8%) patients. Surgical repair was required in 1.6% (7 of 425) of patients following Angio-Seal versus 0.3% (5 of 1662) following routine manual compression (P = 0.004). In 5 patients, the device caused either complete occlusion or stenosis of the femoral artery. The polymer anchor embolized in 1 patient and was retrieved with a balloon catheter at surgery. CONCLUSION: During the first year of utilization of a percutaneous hemostatic closure device following cardiac catheterization, we observed a marked increase in arterial occlusive complications requiring surgical repair. Surgeons must be familiar with the design of these devices to achieve precise repair of surgical complications.