The EVS- Vascular Closure System by Angiolink

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Citation
US Cardiology 2004;2004:1(1):1-4

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Background

Every year, millions of people worldwide undergo a femoral artery catheterization. The early discharge of these patients undergoing elective diagnostic and interventional procedures, such as angiography, percutaneous transluminal coronary angioplasty (PTCA), stenting, atherectomy, and catheter ablation, hinges on the lack of bleeding complications at the access site after the procedure sheath is removed from the femoral artery. The size of the access route, coupled with routine administration of anticoagulants, creates a strong need to stop bleeding at the puncture site as quickly as possible. However, hemostasis must be achieved without producing clotting in the vessels just treated in order to prevent a potentially fatal myocardial infarction or thrombosis.

Simple compression - the use of hand pressure, clamps, and/or sandbags - is currently the standard of care for managing femoral vascular access sites following interventional cases. Under this conventional technique, anticoagulation therapy is discontinued for up to four hours prior to vascular closure in order to permit the patientÔÇÖs clotting capability to return to a normal state. Throughout this period, the introducer sheath remains in place and the patient must remain immobilized to prevent bleeding. Upon sheath removal, direct compression is applied to prevent bleeding and formation of hematomas. While the patient lies flat, a nurse or technician holds direct manual pressure on the site for 20 to 60 minutes until thrombus forms to seal the access site. This monotonous and tiresome task often relies on trained hospital personnel to administer. Use of sandbags and other adjunctive mechanical compression devices like C-clamps may reduce the need for the nurse or other skilled individual to continuously hold initial manual pressure.There is the possibility for these compression devices to slip, necessitating close monitoring of the patient during this critical time to ensure correct compression of the access site. Additionally, these devices have failed to show measurable advantages over hand pressure and may increase patient discomfort.

Once hemostasis has been achieved, the patientÔÇÖs leg must remain motionless for a minimum of six and up to 24 hours (depending on the amount of anticoagulation drug therapy used and the particular procedure) in order to avoid dislodging of the clot, which can lead to internal or external bleeding. Because this restriction to the patient can lead to great discomfort - especially those suffering with back problems - this period is anything but bed rest.1

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