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

ABSTRACT

Venous obstruction at iliocaval level in both forms, primary and secondary, is a significant cause of severe chronic venous insufficiency. A new therapeutic approach to this pathology emerged with the introduction of stenting procedures that proved effective, leading to good long-term results. However, at present, the majority of implanted stents have been designed for arterial implant and this can pose a limit in particular districts. The purpose of this preliminary acute study was to verify the deliverability and safety of a new stent specially designed for venous-vessel implant. We assess the safety and deliverability of two braided, self-expanding, nickel-titanium stents (Jotec GmbH, Hechingen, Germany) specially designed for endovascular implant in veins. The two stents, despite being based on the same concept, have a different design: stent A presents a proximal tapering shape specially designed to reduce migration, while stent B does not. Both of them are enlarged at their distal extremity and present variable radial force the length of the stent itself, the said force becoming very high in the intermediate segment. Stents were implanted in the internal jugular vein of a sheep, showing optimal deliverability. The completion venography showed the migration of stent B into the right atrium. Stent A maintained its location, confirmed by intravascular ultrasound examination. No scaffolding effect was detected and an adequate adherence and adaptability to the vein wall was obtained. In conclusions, the stent A design matches the characteristics required by vein implants. Stability is achieved even where difficult anatomical conditions apply, such as in the jugular vein. Deployment is easy and precise in a given landing zone. Radial resistive force is very high, as required in specific vein districts, but is also associated with good flexibility. Following this preliminary acute report, further studies are required.