ABSTRACT
Jorge H. Ulloa, M.D
Chief Division of Vascular and Endovascular Surgery
Fundacion Santa Fe de Bogota
Bogota, Distrito Capital de Bogota, Colombia
Chronic venous insufficiency with incompetence of the deep valvular system is a disabling disease with limited treatment options. A non-operative approach remains the mainstay of treatment, including compression stockings and limb elevation. However, high ulcer recurrence rates and impaired quality of life are not uncommon. Limited surgical options are available. A promising open bioprosthetic valve implant has shown good results; however, the invasive nature of the procedure limits its usability in several patients. We present a novel endovascular valve implant technique that is a potential paradigm shift for treating deep venous insufficiency.
Methods:
This new and unique bioprosthetic transcatheter venous valve is an implant consisting of a biological and a fabric-covered self-expanding nitinol frame subassembly. The nitinol frame is symmetrical in design. The biological subassembly comprises a porcine-derived, laser-cut pericardial tissue leaflet and laser-cut pericardial tissue skirt preserved by glutaraldehyde crosslinking. The laser-cut tissue leaflet is folded on itself and sewn with polybutester monofilament suture to create a monocusp with its tissue wall. The laser-cut tissue skirt is sewn to the inflow end of the tissue leaflet monocusp to form the biological tissue subassembly. A thin laser-cut polyester (PET) fabric is sutured to the inner diameter of the nitinol frame along its entire length before the tissue subassembly is attached to the inner diameter of the fabric-covered stent with polybutester monofilament surgical suture. The nitinol frame is laser cut from nickel-titanium alloy (nitinol) tubing, heat set to final device size, electropolished, and passivated. The enVVe valve is currently manufactured in two dimensions, 9mm and 10mm.
Results:
This is an early report of the First-In-Human study performed in Colombia. Ten patients with C4b - C6 disease underwent placement of this device in the femoral vein through percutaneous access in the popliteal vein using a 13F access of this vein. This report will include early results of patency, thrombosis, and complications of this new device.
Conclusions:
Surgical management of deep valvular insufficiency has been a topic of interest and research for over five decades. Open techniques such as valvular replacement have demonstrated promising results recently. However, endovascular approaches are still uncertain. We present a novel endovascular valve implant technique, which appears to be safe and effective in the short term. This could begin a new era in treating deep valvular insufficiency.