Micropuncture vs. Standard Common Femoral Artery Access

Vascular access complications can occur during or after cardiac or peripheral arterial
catheterization. These complications increase patient morbidity and mortality, as well as
healthcare costs. Several strategies and devices have been employed to decrease the risk
for vascular access complications, such as fluoroscopy-guided access, ultrasound-guided
access and vascular closure devices. Randomized trial data has failed to demonstrate that
fluoroscopic guidance reduces common femoral artery access complications. While
meta-analysis data has demonstrated that vascular closure devices decrease time to arterial
hemostasis, increase patient mobilization and facilitate earlier patient discharge, they do
not reduce the incidence of vascular complications as compared to hemostasis achieved with
manual pressure. Ultrasound guidance has been shown to facilitate femoral artery access and
reduce femoral artery vascular complications. A new device, the Micropuncture Kit (Cook
Medical, Bloomington, IN) allows vascular access with a small 21gauge needle as opposed to
the standard method, which requires an 18 gauge needle. The use of the Micropuncture Kit for
the purpose of decreasing vascular access complications has not been examined in a
randomized study to date.

The present study is a 552 patient randomized controlled clinical trial that will help
determine whether femoral arterial access obtained using the Micropuncture Kit will reduce
the incidence of vascular access complications compared to the standard 18 gauge needle.

The specific aim of this proposal is to compare the rate of femoral artery access
complications using the Micropuncture Kit vs. standard femoral artery access.

It is our hypothesis that the incidence of femoral artery access complications will be lower
among patients in whom the Micropuncture Kit is used.