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James C Blankenship

Publications and source records attributed to James C Blankenship.

At least 19 recordsLinked to original sources
PubMed2007

Thrombus predicts ischemic complications during percutaneous coronary intervention in saphenous vein grafts: results from TARGET (do Tirofiban and ReoPro give similar efficacy trial?).

BACKGROUND: Saphenous vein graft (SVG) percutaneous coronary intervention (PCI) carries a high risk of ischemic complications. However, there are scant recent data to identify which SVG lesions carry particularly high risk in recent years. We studied demographic and angiographic factors associated with ischemic complications after SVG PCI without distal protection in the TARGET (do tirofiban and reopro give similar efficacy trial?) study. METHODS: TARGET was a multicenter double-dummy, double-blinded study randomizing 4,809 PCI patients to tirofiban or abciximab. Of these, 254 patients underwent PCI involving an SVG lesion. The primary endpoint of this analysis was major adverse cardiac events (MACEs) at 30 days, including death, nonfatal myocardial infarction (MI), and urgent target vessel revascularization. RESULTS: No demographic characteristic was associated with 30-day MACE. Lesion length > 20 mm (odds ratio [OR] = 2.7, P = 0.03), thrombus (OR = 3.9, P = 0.003), eccentricity (P = 0.001), thrombolysis in myocardial infarction flow < 3 post-procedure (OR = 5.6, P = 0.037), and >1 target lesion (OR = 2.5, P = 0.035) were univariate variables associated with 30-day MACE. Multivariate analysis associated only thrombus (OR = 3.8, P = 0.015) with 30-day MACE. No difference in outcomes was noted between patients receiving abciximab and tirofiban. SVG patients had lesser angiographic success (95.6% vs. 98%, P = 0.04) and increased 30-day Q-wave MI (2.5% vs. 0.9%, P = 0.039) compared with non-SVG patients, but a similar incidence of death (0% vs. 0.4%), non-Q-MI (5.9% vs. 4.5%), and target vessel revascularization (0.5% vs. 1%). CONCLUSION: In the era of routine stenting and GpIIb/IIIa inhibitors, thrombus is the angiographic characteristic most closely associated with adverse outcomes of SVG PCI.

Abciximab↗
PubMed2006

Ethical considerations in CT angiography.

The rapid development and clinical deployment of CT angiography raises several important issues, including assurance of professional competence and technical quality, self-referral, the relative role of radiologists and cardiologists, appropriateness and proper indications, the detection and disposition of unexpected or incidental findings and the concern for the rapidly increasing costs of health care and imaging. These questions are properly addressed within the framework of medical ethics, including principles of beneficence, autonomy and justice.

Advertising↗
PubMed2006

Angiographic adverse events, creatine kinase-MB elevation, and ischemic end points complicating percutaneous coronary intervention (a REPLACE-2 substudy).

Several angiographic adverse events during coronary balloon angioplasty have been associated with increased creatine kinase-MB (CK-MB) enzymes and adverse clinical outcomes. The significance of angiographic adverse events in the stent era has not been widely studied. We analyzed 10 types of angiographic adverse events that were reported in the 6,010-patient Second Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2) trial to determine their relation to CK-MB elevation and clinical ischemic end points after percutaneous coronary intervention (PCI). Angiographic adverse events occurred in 9.1% of REPLACE-2 patients. Most (8 of 10) types of angiographic adverse events were associated with an increased risk of increased CK-MB (p <0.001 for each), and 47% of all patients with an angiographic adverse event developed increased CK-MB. Logistic regression analysis showed that the strongest predictor of death, myocardial infarction, or revascularization at 6 months was the occurrence of an angiographic adverse event during PCI (odds ratio 1.9, 95% confidence interval 1.6 to 2.4, p <0.001). Side branch closure, abrupt closure, any decreased flow during the procedure, angiographic distal embolization, and perforation or tamponade were individual predictors of the occurrence of the combined clinical ischemic end point at 6-month follow-up (p <0.005 for each). In conclusion, most angiographic adverse events during PCI are associated with increased CK-MB and are powerful predictors of adverse clinical events within 6 months.

Angioplasty, Balloon, Coronary↗
PubMed2006

Infection control guidelines for the cardiac catheterization laboratory: society guidelines revisited.

In the early years of diagnostic cardiac catheterization, strict sterile precautions were required for cutdown procedures. Thirteen years ago, when the original guidelines were written, the brachial arteriotomy was still frequently utilized, femoral closure devices were uncommon, "implantables," such as intracoronary stents and PFO/ASD closure devices, were in their infancy, and percutaneous valve replacement was not a consideration. In 2005, the cardiac catheterization laboratory is a complex interventional suite with percutaneous access routine and device implantation standard. Despite frequent device implantation, strict sterile precautions are often not observed. Reasons for this include a decline in brachial artery cutdown, limited postprocedure follow-up with few reported infections, limited use of hats and masks in televised cases, and lack of current guidelines. Proper sterile technique has the potential to decrease the patient infection rate. Hand washing remains the most important procedure for preventing infections. Caps, masks, gowns, and gloves help to protect the patient by maintaining a sterile field. Protection of personnel may be accomplished by proper gowning, gloving, and eye wear, disposal of contaminated equipment, and prevention and care of puncture wounds and lacerations. With the potential for acquired disease from blood-borne pathogens, the need for protective measures is as essential in the cardiac catheterization laboratory as is the standard Universal Precautions, which are applied throughout the hospital. All personnel should strongly consider vaccination for hepatitis B. Maintenance of the cardiac catheterization laboratory environment includes appropriate cleaning, limitation of traffic, and adequate ventilation. In an SCAI survey, members recommended an update on guidelines for infection control in the cardiac catheterization laboratory. The following revision of the original 1992 guidelines is written specifically to address the increased utilization of the catheterization laboratory as an interventional suite with device implantation. In this update, infection protection is divided into sections on the patient, the laboratory personnel, and the laboratory environment. Additionally, specific CDC recommendation sections highlight recommendations from other published guidelines.

Antibiotic Prophylaxis↗
PubMed2006

Ad hoc percutaneous coronary interventions in patients with stable coronary artery disease--a study of prevalence, safety, and variation in use from the American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR).

OBJECTIVE: To utilize the American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR) to monitor the performance and safety of ad hoc PCIs. BACKGROUND: The performance of ad hoc PCI remains controversial. Patients' preference, cost, and vascular access issues favor an ad hoc strategy. Adequate time for thoughtful decision-making, scheduling complexity, informed consent, and physician reimbursement favor PCI on a subsequent day. METHODS: We analyzed results in 68,528 patients with stable angina entered in the ACC-NCDR from 2001-2003. Ad hoc PCI was evaluated in many clinical and nonclinical subgroups. A multivariable analysis was performed to determine whether ad hoc PCI had an independent relationship with complications or procedure success. RESULTS: Overall, 60.6% of patients underwent ad hoc PCI. There was no difference in ad hoc PCI mortality, renal failure, or vascular complications from staged PCI. A lower percentage of patients at high vs. low risk and with vs. without renal failure underwent ad hoc PCIs (58.6% vs.63.0% and 50.7% vs. 60.9% respectively). There was wide variation in the performance of ad hoc PCIs according to payer (70.2-60.3%), hospital PCI volume (67-50.2%), hospital owner (89.7-59.6%), and geographic area (75.5-47.4%). Ad hoc PCI per se was not independently related to PCI success or complications. CONCLUSIONS: PCI success was related to patient/lesion related factors and not to the performance of ad hoc PCIs per se. Although ad hoc PCI can be performed in more patients than at present, this strategy will never be possible in all patients at all times.

Aged↗
PubMed2005

Snare retrieval of the distal tip of a fractured rotational atherectomy guidewire: roping the steer by its horns.

Numerous methods have been described for retrieving fractured guidewires from the coronary circulation. We report a case of a fractured rotational atherectomy guidewire retained within a coronary artery. The standard technique of snaring the proximal end of the retained fragment was impossible because its radiolucency rendered it invisible. The snare was passed beyond the retained fragment and retracted to capture the distal tip. When snaring a foreign body, identifying the most accessible part is critical to the success of the procedure.

Aged↗
PubMed2005

Coronary artery stenting in patients with severe left ventricular dysfunction.

PURPOSE: To assess the outcome of stenting in patients with severe left ventricular dysfunction, 149 consecutive patients undergoing coronary stenting with an ejection fraction less than or equal to 40% (mean 35 +/- 10%) were analyzed. Angiographic and clinical success were achieved in all patients. At follow-up of at least 6 months (mean: 24 months), 130 patients (89%) were alive and 124 (85%) were less symptomatic than before percutaneous coronary intervention (PCI). We conclude that PCI can be performed safely in patients with depressed left ventricular ejection fraction and is associated with improved symptoms at long-term follow-up.

Aged↗
PubMed2004

Evaluation of routine functional testing after percutaneous coronary intervention.

Following percutaneous coronary intervention, 348 patients were randomized to either routine or selective functional testing strategies. For the primary end point of maximal exercise endurance on a treadmill at 9 months, achievement was similar in the routine and selective groups. For the secondary end points measuring functional status and quality of life, scores were also similar. There was little difference in the rates of invasive cardiac procedures for the 2 groups at 9 months.

Angioplasty, Balloon, Coronary↗
PubMed2004

Angiographic adverse events during percutaneous coronary intervention fail to predict creatine kinase-MB elevation.

We attempted to determine if aggressive detection of angiographic adverse events during coronary intervention could predict subsequent creatine kinase (CK)-MB elevations. During coronary intervention, both fluoroscopy and cine angiography were used to detect angiographic adverse events. At least one angiographic adverse event occurred in 133/251 (53%) of procedures. CK-MB elevation occurred in 24% of procedures. Slow flow during the procedure (P=0.002) and chest discomfort at the end of the procedure (P=0.007) were the strongest predictors of CK-MB elevation. Among procedures with no angiographic adverse events, CK-MB elevation occurred in 15/121 (12%), accounting for 25% of CK-MB elevations. We conclude that CK-MB elevation occurs after angiographically uncomplicated coronary interventions even when angiographic adverse events are aggressively detected. Routine monitoring of cardiac enzymes is necessary to detect all patients who will experience myocardial injury after coronary intervention.

Aged↗
PubMed2004

SCAI statement on ad hoc versus the separate performance of diagnostic cardiac catheterization and coronary intervention.

Coronary intervention may be combined with diagnostic cardiac catheterization or performed separately. In the early years of angioplasty, performing these procedures separately was standard practice. Gradually, ad hoc intervention (performing diagnostic angiography and coronary intervention within the same session) has become more common, largely because of its convenience for patients and efficiency for physicians. However, the safety and potential cost savings of this approach remain uncertain. Criteria for the appropriate use of ad hoc intervention have not been established. Ad hoc intervention is reasonable for many, but not appropriate for all patients and should not be considered standard therapy. This document updates an earlier review of this topic and provides suggestions for the use of ad hoc intervention as a routine strategy.

Angioplasty, Balloon, Coronary↗
PubMed2004

Triple antiplatelet therapy does not increase femoral access bleeding with vascular closure devices.

BACKGROUND: The use of arteriotomy closure devices (CDs) to achieve hemostasis after femoral artery access in percutaneous coronary intervention is steadily increasing. However, the safety information with these devices in the era of triple antiplatelet therapy is limited. METHODS: We reviewed prospectively collected data from the Do Tirofiban and ReoPro Give Similar Efficacy Outcomes Trial (TARGET), where all patients received aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibitor therapy. At the treating physician's discretion, manual compression (MC) or a vascular hemostasis device was selected following femoral angiography. Patients receiving MC were to have sheaths removed 2 to 6 hours postprocedure when the activated clotting time was < or = 175 seconds. RESULTS: Of 4809 patients, 4736 had femoral access, and 985 of these had a CD (Perclose 47%, Angio-Seal 43%, VasoSeal 5%, and other 5%). The MC and CD groups were similar regarding most demographic characteristics, including age, systolic blood pressure, and weight, but those with MC were more often female, diabetic, and had history of peripheral vascular disease. Patients with a CD had a lower ischemic event rate suggesting they were a lower risk cohort overall. There were no differences in major bleeding at the access site (0.4% vs 0.5%, P =.588), minor bleeding at the access site (1.9% vs. 3.1%, P =.142) or transfusions (0.8% vs 1.0%, P =.513) between the MC and CD groups, respectively. CONCLUSIONS: In contemporary percutaneous coronary intervention practice, with appropriate patient selection, a CD can be safely utilized despite aggressive polypharmacy for procedural anticoagulation.

Angioplasty, Balloon, Coronary↗
PubMed2004

Ethics in interventional cardiology: combining coronary intervention with diagnostic catheterization.

As coronary intervention procedures have become more common, their performance at the time of diagnostic coronary arteriography has become more routine. Combined arteriography and coronary intervention may be slightly less costly and, for some patients, more dangerous than staged intervention. Combined intervention is appropriate in selected patients if they are well informed and it can be done safely; however, a combined strategy should not be applied to all patients.

Cardiac Catheterization↗
PubMed2004

Temporal spectrum of ischemic complications with percutaneous coronary intervention: the ESPRIT experience.

We determined the timing of ischemic complications within 30 days after percutaneous coronary intervention (PCI) in patients enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial. Complications (death, myocardial infarction [MI], target vessel revascularization) occurred in 178 of 2064 patients (8.6%) within 30 days. More than 85% of complications occurred within the 24 hours following randomization, with the greatest risk hazard at 12-18 hours. Unexpectedly, 31% of patients who ultimately met criteria for an endpoint MI within 24 hours of PCI had completely normal CK-MB concentrations at the first 6-hour measurement. There was no rebound increase in events after cessation of eptifibatide. Treatment benefit persisted to 30 days. Post-procedural MI is often not detected until greater than or equal to 12 hours after PCI. Treatment with a glycoprotein IIb/IIIa inhibitor is the only modifiable parameter that reduces the risk for early ischemic complications.

Aged↗
PubMed2003

Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial.

CONTEXT: Although low levels of high-density lipoprotein cholesterol (HDL-C) increase risk for coronary disease, no data exist regarding potential benefits of administration of HDL-C or an HDL mimetic. ApoA-I Milano is a variant of apolipoprotein A-I identified in individuals in rural Italy who exhibit very low levels of HDL. Infusion of recombinant ApoA-I Milano-phospholipid complexes produces rapid regression of atherosclerosis in animal models. OBJECTIVE: We assessed the effect of intravenous recombinant ApoA-I Milano/phospholipid complexes (ETC-216) on atheroma burden in patients with acute coronary syndromes (ACS). DESIGN: The study was a double-blind, randomized, placebo-controlled multicenter pilot trial comparing the effect of ETC-216 or placebo on coronary atheroma burden measured by intravascular ultrasound (IVUS). SETTING: Ten community and tertiary care hospitals in the United States. PATIENTS: Between November 2001 and March 2003, 123 patients aged 38 to 82 years consented, 57 were randomly assigned, and 47 completed the protocol. INTERVENTIONS: In a ratio of 1:2:2, patients received 5 weekly infusions of placebo or ETC-216 at 15 mg/kg or 45 mg/kg. Intravascular ultrasound was performed within 2 weeks following ACS and repeated after 5 weekly treatments. MAIN OUTCOME MEASURES: The primary efficacy parameter was the change in percent atheroma volume (follow-up minus baseline) in the combined ETC-216 cohort. Prespecified secondary efficacy measures included the change in total atheroma volume and average maximal atheroma thickness. RESULTS: The mean (SD) percent atheroma volume decreased by -1.06% (3.17%) in the combined ETC-216 group (median, -0.81%; 95% confidence interval [CI], -1.53% to -0.34%; P =.02 compared with baseline). In the placebo group, mean (SD) percent atheroma volume increased by 0.14% (3.09%; median, 0.03%; 95% CI, -1.11% to 1.43%; P =.97 compared with baseline). The absolute reduction in atheroma volume in the combined treatment groups was -14.1 mm3 or a 4.2% decrease from baseline (P<.001). CONCLUSIONS: A recombinant ApoA-I Milano/phospholipid complex (ETC-216) administered intravenously for 5 doses at weekly intervals produced significant regression of coronary atherosclerosis as measured by IVUS. Although promising, these results require confirmation in larger clinical trials with morbidity and mortality end points.

Adult↗
PubMed2003

Angiographic variables predict increased risk for adverse ischemic events after coronary stenting with glycoprotein IIb/IIIa inhibition: results from the TARGET trial.

OBJECTIVES: We sought to assess whether pre-procedural angiographic characteristics are associated with adverse clinical outcomes after coronary stenting with glycoprotein IIb/IIIa inhibition. BACKGROUND: Ischemic complications after balloon angioplasty are associated with pre- and post-procedural angiographic variables. However, in the current era of stenting with IIb/IIIa inhibition, it is unknown whether angiographic features assessed before intervention confer an increased risk of adverse procedural and subsequent clinical outcomes. METHODS: In the Do Tirofiban and ReoPro Give Similar Efficacy Outcomes? Trial (TARGET), 4,809 patients undergoing planned stenting were randomized to tirofiban or abciximab. Baseline demographic, clinical, and angiographic variables were obtained. Clinical end points were recorded at 30 days and six months. The relationship between angiographic variables and adverse clinical outcomes was assessed. RESULTS: Patients with the combination of thrombus, lesion eccentricity, and lesion length >20 mm had a 21.4% composite incidence of death, myocardial infarction, or urgent target vessel revascularization (TVR) at 30 days, compared with 4.2% in those patients without these high-risk features (hazard ratio [HR] 3.24, p < 0.001). After adjustment, the risk was independently associated with thrombus (HR 1.40, p = 0.034), eccentricity (HR 1.67, p < 0.001), and lesion length >20 mm (HR 1.89, p < 0.001). The risk of six-month TVR was independently associated with left anterior descending coronary artery lesions (HR 1.46, p < 0.001), restenotic lesions at baseline (HR 1.58, p = 0.006), and lesion length (HR 1.19, p = 0.03). CONCLUSIONS: Patients with thrombus, eccentric lesions, or lesion length >20 mm are at high risk for ischemic outcomes after coronary stenting, despite IIb/IIIa inhibition. Further research into novel anti-thrombotic therapies or procedural strategies is necessary for these patients.

Abciximab↗
PubMed2002

Effect of abciximab on angiographic complications during percutaneous coronary stenting in the Evaluation of Platelet IIb/IIIa Inhibition in Stenting Trial (EPISTENT).

In the Evaluation of Platelet IIb/IIIa Inhibition in Stenting Trial (EPISTENT), abciximab reduced ischemic complications of stent implantation at 30 days and 6 months. The responsible mechanisms remain unclear. We sought to determine if abciximab decreases ischemic complications by decreasing the incidence of angiographic complications during coronary stenting. In EPISTENT, patients were randomized to stenting with abciximab (abciximab group), stenting with placebo (placebo group), or balloon angioplasty with abciximab. Angiographic complications (including major or minor dissection, distal embolization, thrombus postprocedure, side branch or other vessel occlusion, residual stenosis >50%, transient coronary occlusion, and Thrombolysis In Myocardial Infarction final flow <3) were recorded prospectively. Creatine kinase (CK)-MB enzyme levels after intervention were measured at 6-hour intervals. We analyzed angiographic complications and CK-MB elevations in the abciximab group (n = 784) and the placebo group (n = 803). Angiographic complications were 29% less frequent in the abciximab group compared with the placebo group (17.0% vs 23.8%; p = 0.001). In patients with angiographic complications, there was a nonsignificant reduction in the incidence of CK-MB elevation >3 times normal with abciximab therapy (19.7% vs 24.5% in placebo group; p = 0.314). Abciximab (compared with placebo) significantly reduced the incidence of CK-MB elevation >3 times normal in those without any angiographic complications (6.5% vs 10.7%; p = 0.007). In summary, abciximab (compared with placebo) significantly reduced angiographic complications during coronary stenting. Abciximab also prevented CK-MB elevations in patients without angiographic complications.

Abciximab↗