A NEW HEMOSTATIC PUNCTURE CLOSURE DEVICE FOR THE IMMEDIATE SEALING OFARTERIAL PUNCTURE SITES

After angiography, 6 to 24 hours of bedrest is indicated to assure tha t adequate hemostasis of the femoral artery has been achieved. Recentl y, a new hemostatic puncture closure device (HPCD) has been developed, which consists of a resorbable polymer anchor, a resorbable suture, a small collagen plug and an 8Fr delivery device. The device is deliver ed into the femoral artery through the introducer sheath, the anchor i s secured against the intraluminal artery wall. and the collagen plug is deployed on the arterial wall. The prototype of the HPCD was used i n 20 patients administered heparin. After insertion of the HPCD, hemos tasis was achieved in 1.2 +/- 2.1 minutes: in 2 patients a light press ure dressing was applied for 4 hours to stop oozing. No late bleeding occurred. In 1 patient the positioning suture broke, requiring the app lication of a pressure bandage. Patients were uneventfully mobilized a fter 6.7 +/- 3.5 hours. In all patients serial duplex scanning of the femoral artery was performed before and after 1, 7, 30 and 90 days aft er HPCD placement. In 5 patients a small subcutaneous hematoma close t o the site of introduction could be detected by ultrasound 1 day after catheterization. All but 1 patient had normalization of the flow patt erns in the femoral artery. It is concluded that (1) the HPCD is an ef fective device to achieve immediate hemostasis after arterial catheter ization despite antithrombotic therapy, (2) early mobilization was une ventful, (3) duplex ultrasound studies demonstrated only transient cha nges in the punctured femoral artery, and (4) further investigations a re needed to establish the efficacy and safety of the device.