Safety and efficacy of staple-mediated femoral arteriotomy closure: results from a randomized multicenter study.
BACKGROUND
Mechanical closure of percutaneous femoral arteriotomies following catheter based procedures remains problematic.


METHODS
The EVS closure device is the first to utilize a staple to effect arteriotomy closure and was compared to manual compression following sheath removal in a 362 patient randomized (2:1 to device) multicenter trial. As pre-specified, one half of the patients underwent coronary intervention.


RESULTS
Time to hemostasis was significantly reduced in the EVS group for both diagnostic (3.3 +/- 2.6 vs. 19.3 +/- 5.7 minutes; p < 0.001) and interventional procedures (5.5 +/- 5.1 vs. 22.3 +/- 9.9 minutes; p < 0.0001). Time to ambulation was similarly reduced in the EVS group following diagnostic (2.4 +/- 3.3 vs. 6.0 +/- 5.2 hours; p < 0.001) and interventional procedures (3.4 +/- 4.5 vs. 7.6 +/- 7.0 hours; p < 0.001). The incidence of major complications was similar between the EVS and manual compression groups at discharge (0.4% vs. 1.7%; p = NS) and at 30 day follow-up (0.4% vs. 2.5%; p = NS).


CONCLUSIONS
Compared to manual compression, the EVS device provides a safe and effective method of femoral artery closure.
Section of Cardiology, Riverside Methodist Hosptial, Columbus, Ohio, USA. gansel@mocvc.com
Gary
G
Ansel
Stephen
S
Yakubov
Christopher
C
Neilsen
David
D
Allie
Robert
R
Stoler
Patrick
P
Hall
Peter
P
Fail
Timothy
T
Sanborn
Ronald P
RP
Caputo
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D002406:Catheterization, Peripheral; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D005500:Follow-Up Studies; D006488:Hemostasis, Surgical / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013528:Surgical Staplers; D017792:Surgical Stapling / Q000009:adverse effects; D016896:Treatment Outcome