901-21 Percutaneous Vascular Surgery: Suture Mediated Percutaneous Closure of Femoral Artery Access Site Following Coronary Intervention

A new device (prostarTm, Perclose, Inc.) was developed to close femoral artery access sites percutaneously following coronary interventions in fully anticoagulated patients. The catheter deploys four needles with two pairs of sutures around the hole of femoral artery access sites. The sutures are then tied to close the arteriotomy site mechanically to achieve immediate hemostasis. As a pilot phase, the device was tested in six centers. The device was used immediately following coronary intervention in 91 access sites. Despite an average ACT at the time of the procedure of >300 seconds, immediate complete hemostasis was achieved in 82 sites (90%). The devices were not appropriately positioned in 8 cases and procedures were aborted followed by reinsertion of a sheath or manual compression. Two patients (2.2%) required surgical repair of the femoral artery; one with device mechanical failure and one with bleeding from the initial puncture site in the posterior wall despite successful closure of the sheath site in the front wall. There were no AV fistulae or pseudoaneurysms requiring surgery and no infection, distal embolism or need for blood transfusion. In conclusion, this pilot study suggests that this suture mediated closure device appears to provide safe and effective hemostasis at the femoral access site in fully anticoagulated patients following coronary interventions.