Final report of the European multi-center registry using the Duett vascular sealing device.

Duett, a novel vascular sealing device, was first clinically used in July 1997. A European multi-center registry was established to evaluate the safety and procedural success of the Duett sealing device in a broad range of patients undergoing diagnostic or interventional endovascular procedures. At 25 European sites 1587 patients were enrolled. All patients (> or = 18 years) must have given informed consent for the use of the sealing device after a diagnostic and/or interventional endovascular procedure performed via a femoral arterial approach. Standard length (< or = 10 cm) 5 to 9 F introducer sheaths had to be used. An ACT of < or = 400 s, and any approved GP IIb/IIIa platelet receptor antagonist was permitted. Successful deployment could be achieved in 96.2% (1526/1587 patients) with complete hemostasis within 2 to 5 minutes in over 95% of the patients. The complication-free rate was 96.4%. Arterial occlusions were rare (4 patients) and successfully treated with surgical repair in 1 and with thrombolysis in 3 patients. Pseudoaneurysms occurred in 34 patients, the majority (30/34) were successfully treated with ultrasound-guided compression or resolved spontaneously. The total rate of major complications was 2.6% (41/1587). The final results of the European registry demonstrate that the Duett sealing device can be used with a high procedural success following diagnostic and interventional endovascular procedures. The incidence of major complications is low and comparable to all other approved vascular closure devices and manual compression. CE-mark certification was approved at the end of 1998.