Efficacy of femoral vascular closure devices in patients treated with anticoagulant, abciximab or thrombolytics during percutaneous endovascular procedures.
OBJECTIVE
This study assessed the outcomes of using vascular closure devices following percutaneous transfemoral endovascular procedures in the patients who were treated with heparin, abciximab or thrombolytics (urokinase or t-PA) during the procedures.


METHODS
From March 28, 2003 to August 31, 2004, we conducted a prospective and randomized study in which 1,676 cases of 1,180 patients were treated with one of the two different closure devices (the collagen plug device was Angio-Seal; the suture-mediated closure device was The Closer S) at the femoral access site after instituting percutaneous endovascular procedures. Among the 1,676 cases, 108 cases (the drug group) were treated with heparin only (n = 94), thrombolytics only (n = 10), heparin and thrombolytics (n = 3), or abciximab and thrombolytics (n = 1) during the procedures; 1,568 cases (the no-drug group) were treated without any medication. We compared the efficacy and complications between the two groups. Of the drug group, 42 cases underwent arterial closures with the collagen plug devices and 66 cases underwent arterial closures with the suture-mediated closure devices. We also compared the efficacy and complications between these two groups.


RESULTS
The immediate hemostasis rates were 92.9% (1,456/1,568) in the no-drug group and 91.7% (99/108) in the drug group. Early complications occurred in four cases of the drug group. These included two episodes of rebleeding with using the Closer S, which required manual compression for at least 10 minutes, and two episodes of minor oozing with using one Angio-Seal and one Closer S, which required two hours of additional bed rest. There was no late complication. So, the total success rates were 90.8% (1,423/1,568) in the no-drug group and 88.0% (95/108) in the drug group. These results were not significantly different between the two groups (p = 0.34). In the drug group, the difference of the successful hemostasis rate between the collagen plug devices and the suture-mediated devices was also not statistically significant (92.9% vs. 84.8%, respectively; p = 0.21).


CONCLUSIONS
Arterial closure of the femoral access site with using vascular closure devices is both safe and effective, even in the patients who received heparin, abciximab or thrombolytics.
Kim
Ha Young
HY
Department of Radiology and Center for Imaging Science, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Choo
Sung Wook
SW
Roh
Hong Gee
HG
Han
Heon
H
Kim
Sam Soo
SS
Lee
Ji Yeon
JY
Park
Yul Ri
YR
Lee
Sung Hoon
SH
Shin
Sung Wook
SW
Park
Kwang Bo
KB
Do
Young Soo
YS
Cho
Sung Ki
SK
Lee
In Ho
IH
Kim
Sung Mok
SM
Byun
Hong Sik
HS
Jeon
Pyoung
P
D000077284:Abciximab; D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use*; D000925:Anticoagulants / Q000494:pharmacology / Q000627:therapeutic use*; D003094:Collagen; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D005343:Fibrinolytic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D006487:Hemostasis / Q000187:drug effects*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D013537:Sutures
D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D005343:Fibrinolytic Agents; D007140:Immunoglobulin Fab Fragments; D003094:Collagen; D000077284:Abciximab