Efficacy and Long-Term Safety of StarClose™ for Hemostasis of Arterial Puncture Sites Distal to Common Femoral Artery Bifurcation After Percutaneous Coronary Interventions
- Volume 22 - Issue 11 - November, 2010
- Posted on: 10/28/10
- 0 Comments
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Three patients had died and another 3 patients refused ultrasound follow up. All patients with Doppler ultrasound demonstrated patency of the CFA, SFA and PFA, with no instance of arterial or venous thrombosis or stenosis. Soft-tissue reaction to the SC evidenced by periarterial inflammation was not observed on any examination. The SC nitinol clip, seen as a bright echogenic image superficial to the arterial lumen, could be identified in 30 (28%) patients. There was no evidence of pseudoaneurysm, arteriovenous fistula or abnormal blood flow in the CFA, SFA or PFA in any patient.
The main finding of the present study is that SC can be successfully used for arterial puncture sites located distal to the CFA bifurcation and results in adequate hemostasis without long-term adverse effects on arterial morphology and function. To our knowledge, this is the first study to report on immediate efficacy and long-term safety of any VCD for arterial punctures distal to the CFA bifurcation.