Korean J Radiol.  2005 Dec;6(4):248-255. 10.3348/kjr.2005.6.4.248.

Prospective Comparison of Collagen Plug (Angio-SealTM) and Suture-Mediated (the Closer STM) Closure Devices at Femoral Access Sites

• Park Y
• Roh HG
• Choo SW
• Lee SH
• Shin SW
• Do YS
• Byun HS
• Park KB
• Jeon P

• KMID: 1777283
• DOI: http://doi.org/10.3348/kjr.2005.6.4.248

Abstract

OBJECTIVE
Rapid and effective hemostasis at femoral puncture sites minimizes both the hospital stay and patient discomfort. Therefore, a variety of arterial closure devices have been developed to facilitate the closure of femoral arteriotomy. The objective of this prospective study was to compare the efficacy of two different closure devices; a collagen plug device (Angio-Seal) and a suture-mediated closure device (the Closer S). MATERIALS AND METHODS: From March 28, 2003 to August 31, 2004, we conducted a prospective study in which 1, 676 cases of 1, 180 patients were treated with two different types of closure device. Angio-Seal was used in 961 cases and the Closer S in 715 cases. The efficacy of the closure devices was assessed, as well as complications occurring at the puncture sites. RESULTS: Successful immediate hemostasis was achieved in 95.2% of the cases treated with Angio-Seal, and in 89.5% of the cases treated with the Closer S (p < 0.05). The rates of minor and major complications occurring between the two groups were not significantly different. In the Closer S group, we observed four major complications (0.6%), that consisted of one massive retroperitoneal hemorrhage (surgically explored) and three pseudoaneurysms. In the Angio-Seal group, we observed three major complications (0.3%) that consisted of one femoral artery occlusion, one case of infection treated with intravenous antibiotics and one pseudoaneurysm. CONCLUSION: The use of Angio-Seal was found to be more effective than that of the Closer S with regard to the immediate hemostasis of the femoral puncture sites. However, we detected no significant differences in the rate at which complications occurred.

Keyword

Closure device; Angio-Seal; The Closer S; Angiography; Femoral artery; Hemostasis; Vascular complication

MeSH Terms

Treatment Outcome
*Sutures
Prospective Studies
Postoperative Complications
Middle Aged
Male
Humans
Hemostatic Techniques/*instrumentation
Femoral Artery/*surgery
Female
*Collagen
Aged
Adult
Adolescent

Figure

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  Fig. 1 Learning Curve

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  Fig. 2 Right common femoral artery occlusion (white arrow) in a 63-year-old woman receiving Angio-Seal at one month after transarterial chemoembolization. A. Right femoral arteriography. B. Collateral circulation has already developed.

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  Fig. 3 A pseudoaneurysm (arrow) in a 57-year-old man who received the Closer S at 1 week after TACE. A. Right common femoral CT angiography. B. Right common femoral angiography. C. A pseudoaneurysm was treated by thrombin injection.

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