Efficacy and safety of a novel vascular closure device (Glubran 2 seal) after diagnostic and interventional angiography in patients with peripheral arterial occlusive disease.

PURPOSE

To prospectively evaluate safety and efficacy of a novel vascular closure device (Glubran 2 Seal) after peripheral angiography in patients with peripheral arterial occlusive disease (PAOD).

METHODS

From December 2010 to June 2011, all consecutive patients with PAOD undergoing peripheral angiography were prospectively enrolled onto the study after percutaneous antegrade or retrograde puncture of the common femoral artery. After angiography, the Glubran 2 Seal device was used to achieve hemostasis. The following data were registered: technical success and manual compression duration, patients' discomfort (scale 0-5), operators' technical difficulty (scale 0-5), and vascular complications. The site of hemostasis was evaluated by clinical inspection and color-coded Duplex ultrasound performed 1 day and 1 month after the procedure.

RESULTS

One hundred seventy-eight patients were enrolled (112 male, mean age 70.8 years) with a total of 206 puncture sites, including 104 (50.5 %) antegrade accesses. The device was successful in 198(96.1 %) of 206 procedures, with 8 cases of manual compression lasting longer than 5 min (maximum 20 min). No major vascular complications were observed, resulting in 100 % procedural success. Minor complications occurred in seven procedures (3.4 %), including two cases of pseudoaneurysms, successfully treated by ultrasound-guided glue injection. The mean ± standard deviation score for patients' discomfort was 0.9 ± 0.7, whereas the mean score for operators' difficulty was 1.2 ± 0.9.

CONCLUSION

In patients with PAOD, the Glubran 2 Seal represents a simple, painless, and efficient vascular closure device, able to achieve hemostasis both in antegrade and retrograde accesses.