Prospektive Untersuchung zum Wert des arteriellen Verschlusssystems (Starclose®) beim antegraden Gefäßzugang an der Femoralarterie

We analyzed in a prospective study at 100 patients with peripheral arterial occlusive disease (PAOD) undergoing antegrade puncture due to a therapeutic intervention or an antegrade diagnostic angiography in standby for intervention, safety and efficiency of clip-based closure system StarClose ® for hemostasis after arterial puncture . One patient was excluded due to retrograde puncture, so that 99 patients (59 men, 40 women, mean age 72.5 years (42 -100 years) were evaluated. The sheath size was between 5 French (F) (1.67 mm) and 8 F (2.7 mm) In 73 patients 5F, in 17 patients 6F, in 4 7F and in 5 8F. In 73 cases was percutaneous transluminal angioplasty, in 15 cases stent implantation, and in 10 cases aspiration thrombectomy by use of Urokinaselyse performed. The technical success rate, defined as successful applying of the clip and achieving initial hemostasis was 100%. In two cases there were mechanical problems in the applying of the clip, the procedure was finally successful. In all patients was after applying of the clip the oozing time recorded, which was an average of 4.2 min ± 3. According to the preference of the interventionalists, manual compression was performed and a compression bandage was applied. We observed two major complications (defined as complications requiring change in treatment or hospital stay-related): In an patient with dementia and considerable restlessness after a few hours a bleeding was occurred, for the patient's safety, a pressure bandage is applied, and he was taken for monitoring into the intensive care unit. The second major complication occurred as a oozing in an obese patient, on the second postinterventional day and was successfully treated by a pressure bandage for 12 hours. A further intervention was required and no permanent damage remained. Minor complications, we observed at 4 minor bleeding, and 2 small (<5 cm) hematomas. In a subgroup analysis of of lysis patients which were treated with 100,000 IU urokinase initially and 30000-50000 IU urokinase / h for at least 4 hours, and additionally received heparin and aspirin, were showed no specific abnormalities. Despite the tendency of larger arteriotomy (6-8 F) and the medication, the mean bleeding time is only 2.4 minutes, Major complications didn’t occur in this group. In a multiple regression were the patient's age and low platelet count the independent risk marker for a prolonged bleeding time. The application of antiplatelet drugs, sex, PTT, Quick, body mass index (BMI) and the sheath size were not independent risk marker. In summary the analyzed vascular closure system can be used after antegrade puncture with a high technical success rate and low complication rate. Low platelet counts and great age are a risk marker for a longer bleeding time. Serious post-puncture complications were not observed, although two of the six cases of bleeding formally had to be considered as major complications.