One hundred patients undergoing routine diagnostic or interventional catheterization were randomly assigned to receive either percutaneously applied collagen (group A; n = 50) or conventional pressure dressing (group B; n = 50) for sealing of the femoral artery. Clinical variables were comparable in both groups. The heparin dose was 100 IU/kg in 30 patients and 200 IU/kg in 20 patients of either group. The average compression time was 4.3 min in group A and 42.3 min in group B (p < .001). Bleeding was not observed in group A but was observed in 6/50 patients in group B. The time to ambulation was 6.4 hr (range, 4-12 hr) in group A and 21.6 hr (range, 10-48 hr) in group B (p < .001). Hematomas with a diameter of > 6 cm developed in 4/50 patients in group A and in 11/50 patients in group B (p < .05). Blood-transfusions or surgical interventions were not required and there was no loss of ankle pulses in either group. In conclusion, percutaneously applied collagen reduced compression time and duration of bedrest after diagnostic catheterization and PTCA. Despite earlier ambulation, the incidence of bleeding was lower with collagen than with conventional pressure dressing.
Percutaneously introduced absorbable purified bovine collagen was used to plug the hole at the site of femoral arterial puncture in 50 patients (42 men, 8 women; median age 58 [22-75] after percutaneous coronary angiography (n = 32; heparin dosage 100 IU/kg) or transluminal coronary balloon dilatation (n = 18; heparin dosage 200 U/kg). Local bleeding ceased after compression of 4 min in 48 of the 50 patients. A pressure bandage was needed additionally in the other two. Bed-rest lasted for 1-24 (median 19) hours. A haematoma of more than 6 cm diameter developed in five patients, but required neither transfusion nor surgical intervention. 39 of the 50 patients were re-examined after a median of 39 days: all of them had had a small pain-free swelling for 2-6 weeks over the puncture site. One patient developed a deep-vein thrombosis one week after the procedure, in another fever occurred after the same period, lasting for two days. These early findings are encouraging. The method may significantly shorten the time of arterial compression and bed-rest, as well as reduce the risk of a large haematoma after arterial punctures.
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