A long-term evaluation of a new percutaneously placed bioprosthetic, bicuspid venous valve (BVV) consisting of a square stent and small intestinal submucosa (SIS) covering was performed in 12 sheep. Of 26 BVVs placed into the jugular veins, 25 exhibited good valve function on immediate venography and 22 on venograms obtained before the sheep were killed. Gross and histologic examination results demonstrated incorporation of remodeled and endothelialized SIS BVVs into the vein wall. Slight to moderate leaflet thickening was found mostly at their bases. Percutaneously placed SIS BVV is a promising one-way, competent valve that resists venous back-pressure while allowing forward flow.
Lower extremity chronic deep venous insufficiency (CDVI) is common and remains a major health problem worldwide. Selected patients benefited from direct deep vein valve surgical repair or valve transplantation. A major limitation of this approach is that most of the patients are not candidates for these procedures due to obstructions or residual thrombus throughout the vein. The past 15 years have witnessed experimental efforts at catheter-based management of CDVI. This review describes the initial designs and experimental evolution of a mechanical and bioprosthetic venous valve that can be implanted by using a transcatheter technique. These valves consisted of single, double, or triple cusp leaflets made of synthetic or biological materials attached to a carrier or frame. All described devices for percutaneous transcatheter valve placement rely on some form of a vascular stent for valve attachment.
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