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The Efficacy and Safety of Angio-Seal Percutaneous Femoral Artery Closure Device after Diagnostic and Therapeutic Cardiac Catheterizations

2016-04-26 / Categories:Arterial, hemostasis,
  
Also, patients need prolonged bed rest, which results in discomfort, longer hospital stay and additional costs. Reported vascular complication occurs in 0.8% to 1.8% of diagnostic cardiac catheterizations and 1.5% to 9% of percutaneous coronary intervention (PCI) cases when performed via transfemoral access, and 20% to 40% of these patients who experience such complications require surgical repair.1-5 Since the introduction of vascular closure devices, the efficacy and safety of these devices have been evaluated.6-8 A re cent meta-analysis of 30 randomized trials showed that there is only marginal evidence that arterial puncture closing devices are effective and they may increase the risk of hematoma and pseudoaneurysm.9 The frequent use of antiplatelet and anticoagulant agents in PCI cases usually has higher rate of vascular complications. Therefore, we sought to compare the efficacy and safety of the Angio-Seal Vascular Closure Device (St. Jude Medical, St Paul, MN) in patients undergoing diagnostic and therapeutic cardiac catheterizations in this referred medical center.

MATERIALS AND METHODS

The study was conducted at the cardiac catheterization laboratory, National Cheng Kung University Hospital, in southern Taiwan. Patients in our institution undergoing diagnostic cardiac catheterization or PCI using the femoral artery approach were included in the study. Patients were not eligible for a percutaneous femoral artery closure device if they had peripheral arterial occluded disease, presence of ST-segmental elevation myocardial infarction, presence of hematoma before sheath removal, or suspicion of profunda femoris puncture. Finally, a total of 102 diagnostic catheterization and PCI procedures between January 2007 and May 2007 were retrospectively enrolled. There were 45 patients (44%) experiencing PCI procedures and the others received only diagnostic cardiac catheterizations.

Cardiac catheterization and PCI procedures

Diagnostic cardiac catheterization and PCI procedures were performed via the percutaneous femoral approach using 7 French introducers and guide catheters. Our cardiovascular fellows performed the arterial puncture. If patients just received diagnostic procedures, we did not give heparin during the procedure. If patients received elective PCI procedures, we routinely gave 10000 U heparin into the coronary artery through the guiding catheter to maintain an activated clotting time (ACT) between 250 and 300 seconds. Blood samples for ACT measurements were obtained at the end of the procedure. Patients receiving intracoronary stents would receive aspirin 100-300 mg/day and clopidogrel 300 mg as a loading dose followed by 75 mg/day if there were no contraindications.