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 (2:11 to device) multi center 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. (c) 2006 Wiley-Liss, Inc.