Preliminary report on a new concept stent prototype designed for venous implant

Area of Science:

• Vascular Surgery
• Biomedical Engineering
• Interventional Radiology

Background:

• Chronic venous insufficiency (CVI) significantly impacts patients, often stemming from iliocaval venous obstruction.
• Current stenting procedures for CVI, while effective, predominantly use arterial stents, limiting their application in specific venous districts.
• The need for specialized venous stents is critical to overcome limitations of arterial devices.

Purpose of the Study:

• To evaluate the deliverability and safety of a novel, self-expanding nickel-titanium stent specifically designed for endovascular venous implantation.
• To compare two distinct stent designs (Stent A with proximal tapering, Stent B without) for their performance in venous environments.

Main Methods:

• Two types of braided, self-expanding nickel-titanium stents (Stent A and Stent B) were implanted in the internal jugular vein of sheep.
• Deliverability was assessed during implantation.
• Safety and stability were evaluated using completion venography and intravascular ultrasound examination.

Main Results:

• Both stents exhibited optimal deliverability during implantation.
• Stent B migrated to the right atrium, indicating a design flaw for venous stability.
• Stent A maintained its position, demonstrating excellent stability and adaptability to the vein wall without scaffolding effect.

Conclusions:

• The proximal tapering design of Stent A is crucial for preventing migration and ensuring stability in venous implants, even in challenging anatomical locations like the jugular vein.
• Stent A offers high radial force, flexibility, and precise deployment, meeting the requirements for effective venous stenting.
• Further studies are warranted to confirm the long-term efficacy and safety of Stent A in clinical settings.