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Analysis of Extra-Vascular Closure Device after Transbrachial Artery Access
Aleem K.H. Mirza, Bachelor of Science, Samuel N. Steerman, Medical Doctor, Jonathan A. Higgins, Medical Doctor, Sirisha Mushti, R.A, Jean Panneton, Medical Doctor.
Eastern Virginia Medical School, Norfolk, VA, USA.

Objectives:
The brachial artery has become an invaluable route for endovascular procedures and imaging. Extra-vascular closure devices (eVCD) have been developed to obtain hemostasis after trans-femoral artery access, but other sites of access have not been analyzed. We seek to determine if eVCD are safe and effective after transbrachial access.
Methods:
A retrospective analysis of patient’s undergoing transbrachial access from November 2005 to February 2011 was performed. Hemostasis at the access site was achieved using manual compression or an eVCD as selected by the surgeon. History, operative data, and complications were recorded. Thrombotic (brachial artery thrombosis, embolism, limb ischemia) and hemorrhagic complications (bleeding, hematoma requiring intervention, and pseudoaneurysm) were compiled and categorized. Total major adverse effects (MAEs) encompassed brachial artery thrombosis, limb ischemia, additional surgery, and 30-day mortality. Minor complications were defined as bleeding not requiring surgery or transfusion, increased pain, additional compression and transient sensory nerve deficit. Analysis was performed using the student’s t-test, the Mann-Whitney test and chi-square. Relative risk was computed when applicable.
Results:
Procedures with brachial artery access were performed on 148 patients and 154 limbs. Manual compression (MC) was performed on 134 brachial arteries and 20 arteries were controlled with an extra-vascular closure device. Groups were well matched for sex (p=0.34), race (p=0.75), smoking (p=0.73), anticoagulation (p=0.71), and diagnostic vs. therapeutic procedure (p=0.61). The complications profile is shown:
MC (n=134)eVCD (n=20)p-value
Minor complications14 (10%)1 (5%)0.45
Device FailureN/A1 (5%)N/A
Thrombotic Complication6 (4%)00.43
Hemorrhagic Complication3 (2%)1 (5%)0.47
Major Adverse Events (MAE)9 (7%)1 (5%)0.77

Factors that were associated with an increased incidence of thrombosis after MC were female sex (p=0.07) and sheath size &gt6 Fr (p=0.008). Diagnostic procedures had a decreased risk of brachial artery thrombosis (p=0.04) as all 6 instances of thrombosis occurred following an interventional procedure (Relative Risk, RR:9.1). Age, race, and BMI had no effect on complications rate in either hemostatic procedure.
Conclusions:
Extra-vascular closure devices are safe for use in the brachial artery following an endovascular procedure. They may be best applied in patients that are high risk for thrombosis, such as, females, patients undergoing an interventional procedure or access with a sheath &gt6 Fr.


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