Arterial Access Site Closure with a Novel Sealing Device: DuettTM

Abstract

Management of arterial access sites following percutaneous endovascular procedures is associated with patient discomfort and local complications. A new vascular sealing device, comprised of a balloon delivery catheter and a flowable procoagulant consisting of thrombin and collagen, was tested. Immediately following catheterization 200 patients (age, 66.1 +/- 11.2 years) were treated with the sealing device (Duett). Of these 200 patients, 132 underwent diagnostic catheterization, 67 underwent percutaneous transluminal coronary angioplasty, and one underwent percutaneous transluminal angioplasty. The sheath sizes included 2-5 Fr, 166-6 Fr, 25-7 Fr and 7-8 Fr. All patients undergoing diagnostic procedures received at least 5,000 U of intravenous heparin during the procedure. The Duett was used successfully in 198/200 (99%) patients immediately following completion of the endovascular procedure. In two patients a device malfunction resulted in uncomplicated crossover to manual compression. The time to hemostasis ranged from 3 to 5 minutes. All patients were walking 2 to 5 hours following the procedure unless a complication had occurred. No patient experienced leg ischemia, required surgical repair of the arterial access site, or had an infection at the site. In three patients (1.5%), a pseudoaneurysm occurred and was successfully treated with ultrasound-guided compression and three patients received a blood transfusion. No late complications were observed following hospital discharge. This novel vascular sealing device successfully achieves rapid hemostasis and allows early ambulation following percutaneous endovascular procedures with a low incidence of complications.

The use of closure devices

“…Rates of successful deployment have been quite high ranging from 93% to 100% [25][26][27][28]. When compared with manual compression, the time to hemostasis and ambulation were significantly decreased when the Duett device was employed [29,30].…”

Safety and efficacy of staple‐mediated femoral arteriotomy closure: Results from a randomized multicenter study

“…Irregardless of the potential advantages of mechanical closure, several deficiencies associated with currently approved closure devices have led to slow market acceptance, such that they are utilized in only 15–20% of catheter based femoral arterial procedures worldwide. These deficiencies include; 1) a significant learning curve, 2) requirements for bed rest following closure, 3) complication rates similar to manual closure, 4) increased incidence of certain types of complications compared to manual closure (arterial occlusion and infection), 5) impaired or delayed ability to re‐access the femoral artery, and 6) additional procedure related costs [6–28]. Furthermore, most of the currently available devices may affect the inner arterial lumen during closure.…”