Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
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Catheter Cardiovasc Interv · Nov 2006
Randomized Controlled Trial Multicenter StudyThe safety and efficacy of the StarClose Vascular Closure System: the ultrasound substudy of the CLIP study.
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. ⋯ 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.
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Catheter Cardiovasc Interv · Jan 2006
Randomized Controlled Trial Comparative StudyRandomized comparison of operator radiation exposure during coronary angiography and intervention by radial or femoral approach.
Controversial data have been published on the amount of radiation exposure during radial coronary procedures. We hypothesized that in the current era, high-volume operators with optimal technique would not be exposed to higher radiation doses during radial procedures. A total of 297 patients undergoing cardiac catheterization (195 elective diagnostic coronary angiograms and 102 elective coronary interventions) were prospectively assigned in a random fashion to the radial access (RA) or femoral access (FA). ⋯ This study demonstrates that the radial approach is burdened with a 100% increase in operator radiation exposure during diagnostic coronary catheterization procedures and a 50% increase during coronary interventions, provided that no special devices for radiation protection are used. Measurements of radiation dose, such as fluoroscopy time and dose-area product, substantially underestimate the disproportionate rise in radiation exposure. Special precautions are warranted to improve radiation protection during invasive coronary procedures via the radial approach.
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Catheter Cardiovasc Interv · Jul 2005
Randomized Controlled TrialBrief repetitive balloon occlusions enhance reperfusion during percutaneous coronary intervention for acute myocardial infarction: a pilot study.
The objective of this study was to determine whether acutely ischemic myocardium may be conditioned during percutaneous coronary intervention for acute myocardial infarction. Ischemic preconditioning is a powerful cardioprotective mechanism that limits infarct size in animal investigations and ischemic sequelae during percutaneous coronary intervention in man. However, the conditioning stimulus in all these studies has been applied prior to the defining episode of ischemia. ⋯ Distal coronary velocimetry indicated significant improvement in coronary flow velocity reserve in the conditioning group at the protocol conclusion (conditioning, 1.8 +/- 0.2; control, 1.4 +/- 0.1; P < 0.008). Brief periods of occlusion and reperfusion during percutaneous intervention for acute myocardial infarction mitigate the extent of ischemic injury and improve distal myocardial perfusion. Such ischemic conditioning represents a potentially useful adjunct to strategies for enhancing reperfusion during acute myocardial infarction.
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Catheter Cardiovasc Interv · Oct 2004
Randomized Controlled Trial Comparative Study Clinical TrialPatient tolerance and resource utilization associated with an arterial closure versus an external compression device after percutaneous coronary intervention.
We assessed patient tolerance and resource utilization of using the AngioSeal closure device versus assisted manual compression using the Femostop device after percutaneous coronary intervention (PCI). Patients undergoing PCI with clean arterial access and no procedural hematoma were randomized to receive the AngioSeal or Femostop device to achieve femoral arterial hemostasis. Times from procedure end to removal from angiography table, hemostasis, ambulation, and hospital discharge were recorded. ⋯ There were no differences in ultrasound-determined vascular complications (two each). Femoral access site closure using the AngioSeal device resulted in a small delay in leaving the angiography suite and a higher disposable cost compared to using the Femostop device. However, patients receiving the AngioSeal were able to ambulate sooner and reported less pain, which may justify the increased costs involved.
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Catheter Cardiovasc Interv · Nov 2002
Randomized Controlled Trial Comparative Study Clinical TrialProspective randomized study of N-acetylcysteine, fenoldopam, and saline for prevention of radiocontrast-induced nephropathy.
The objective of this study was to compare the efficacy of N-acetylcysteine (NAC), fenoldopam, and saline in preventing radiocontrast-induced nephropathy (RCIN) in high-risk patients undergoing cardiovascular procedures. We prospectively enrolled 123 patients who were scheduled for cardiovascular procedures and had a baseline creatinine > 1.6 mg/dl or creatinine clearance of < 60 ml/min. Patients were randomly assigned to receive either saline (0.45% normal saline at 1 cc/kg) for 12 hr before and 12 hr after the procedure, or fenoldopam (0.1 microg/kg/min) plus saline for 4 hr prior and 4 hr after the procedure, or NAC orally (600 mg) plus saline every 12 hr for 24 hr prior and 24 hr after the procedure. ⋯ Of the 20 patients who developed RCIN, 2 required dialysis. Serum creatinine decreased after 48 hr (vs. baseline) in 38% patients in the NAC group, 18% in the fenoldopam group, and 15% in the saline group. In patients with chronic renal insufficiency, NAC or fenoldopam offered no additional benefit over hydration with saline in preventing RCIN.