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Sail Valve Self Expanding Valve System for Deep Veins Tested in an Animal Model

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    Boersma DVink A,  Moll FL,  de Borst G have published an article evaluating a vein valve system for deep veins.  The article was published in the Journal of Endovascular Therapy.; 2017 (Mar 1).  The title of the article is Proof-of-Concept Evaluation of the SailValve Self Expanding Deep Venous Valve System in a Porcine Model.


    Unlike valve repair or replacement in the heart, there have been no durable valve replacement or repair systems for the venous system. There is a clinical need for such techniques for patients with deep venous insufficiency. 


    Superficial veins insufficiency, unlike deep venous insufficiency, is treated with vein stripping or endovenous ablation. 


    This article deals with the DEEP VEINS. 

    The authors did their study in a porcine model at 1) Department of Vascular Surgery, University Medical Centre, Utrecht, the Netherlands; 2) Department of Surgery, Jeroen Bosch Ziekenhuis, Den Bosch, the Netherlands and 3) Department of Pathology, University Medical Centre, Utrecht, the Netherlands.


     The goal was to evaluate a new SailValve self-expanding deep venous valve concept based on a single polytetrafluoroethylene cusp floating up and down in the bloodstream like a sail, acting as a flow regulator and allowing minimal reflux to reduce thrombogenicity.


    Both iliac veins of 5 pigs were implanted with SailValve devices. The first was an acute pilot experiment to show the feasibility of accurately positioning the SailValve via a femoral access. The other 4 were followed for 2 weeks (n=2) or 4 weeks (n=2) under a chronic implantation protocol. Valve function was valuated directly using ascending and descending venography after implantation and at termination. All animals were treated with clopidogrel and calcium carbasalate.


    The authors showed that deployment was technically feasible in all 10 iliac veins, and all were patent directly after placement. Ascending venography in the follow-up animals confirmed patency of all valves after 2 or 4 weeks. 


    This animal study shows the potential of the SailValve concept with sufficient valve function after adequate positioning and no (thrombogenic) occlusions after short-term follow-up. The researchers concluded that research is essential to optimize valve material and long-term patency.


    Dr. Karamanoukian's note:  To date, prosthetic valves implanted in veins have failed due to clotting (thrombosis). Cadaver valve transplantation has failed and is complicated because it is not autologous tissue. Vein valve transplantation from the arm to the iliac veins has also failed. SO, techniques such as this show promise and have clinical valve if they have long term patency and stop deep venous insufficiency.