Safety and efficacy of staple‐mediated femoral arteriotomy closure: Results from a randomized multicenter study

Abstract

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

Vascular Closure Devices

“…Should most patients undergoing femoral arterial access get a VCD? For diagnostic cases, the answer may be "yes" based upon both decreased complication rates and improved time to ambulation (1,4,8,16,54). As outlined in the preceding text, however, there are numerous subgroups of diagnostic patients for whom insufficient data are available to make a clear recommendation.…”

“…This review will focus on the immediate, active hemostasis closure devices given their greater utilization over the past decade. The adoption of VCD has occurred because of a clear technological feat: VCD reliably shortens the time to hemostasis (elapsed time between sheath removal and first observed hemostasis) compared with manual compression and thus allows earlier patient ambulation (1,8,10,16,17) ( Table 2). Alternative strategies for achieving early ambulation are the use of smaller sheaths for diagnostic catheterization as well as the use of the radial artery approach.…”

“…Vascular closure device pivotal studies have generally included 250 to 600 randomized patients. Given their limited sample sizes, such studies can reliably identify those complications that occur in 3% to 5% of the highly selected subjects enrolled in the trials (1,2,8,10,22). Vascular closure device trials have not been expanded to higher-risk patient cohorts; thus, there is a lengthy list of precautions and warnings on the instructions for use for each device (Table 1).…”

“…Vascular closure devices decrease the time to ambulation, the time to discharge, and decrease complications for patients undergoing diagnostic angiographic procedures (4): How can similar benefits be shown for a broader group of patients? Two groups believed to be at high risk for VCD use have been routinely excluded from the pivotal studies leading to VCD approval: patients undergoing PCI for acute myocardial infarction (58) and patients who have documented femoral arterial disease or other peripheral vascular disease (8,20,40,47). Prior studies of PCI patients with clinically important peripheral vascular disease have suggested an enhanced relative risk of vascular complications of 40% to 89% with absolute rates of complications from 2.6% to 8.9% (7,40,59 -62) (Fig.…”

Posterior wall capture and resultant common femoral occlusion complicating StarClose access closure

“…Studies have shown that the use of VCDs, in contrast to manual compression, decreases the time to ambulation and hemostasis. [1][2][3] Unfortunately, VCD adverse events can occur with significant short-and long-term implications. [4][5][6][7][8] There are currently no prospective randomized trials to show a reduction in arterial-related events comparing standard compression therapy and VCDs.…”