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Catheter Cardiovasc Interv. 2006 Apr;67(4):546-53.

Safety and efficacy of staple-mediated femoral arteriotomy closure: results from a randomized multicenter study.

Author information

1
Section of Cardiology, Riverside Methodist Hosptial, Columbus, Ohio, USA. gansel@mocvc.com

Abstract

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).

CONCLUSION:

Compared to manual compression, the EVS device provides a safe and effective method of femoral artery closure.

PMID:
16538688
DOI:
10.1002/ccd.20628
[Indexed for MEDLINE]

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