Prospective comparison of collagen plug (Angio-Seal) and suture-mediated (the Closer S) closure devices at femoral access sites.
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).


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.


CONCLUSIONS
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.
Park
Yulri
Y
Department of Radiology and Center for Imaging Science, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Roh
Hong Gee
HG
Choo
Sung Wook
SW
Lee
Sung Hoon
SH
Shin
Sung Wook
SW
Do
Young Soo
YS
Byun
Hong Sik
HS
Park
Kwang Bo
KB
Jeon
Pyoung
P
D000293:Adolescent; D000328:Adult; D000368:Aged; D003094:Collagen; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D013537:Sutures; D016896:Treatment Outcome
D003094:Collagen