Percutaneous Venous Valve Bioprosthesis: Initial Observations

Abstract

Chronic deep venous insufficiency remains a major health problem in the United States and worldwide. Selected patients benefit from direct deep vein valve repair or valve transplantation; however, most are not candidates for these procedures. Experience with the bovine monocusp venous valve surgically inserted into the common femoral vein (CFV) demonstrates potential benefit and good long-term patency. A venous valve placed distal to the CFV via percutaneous access has great appeal and potential for further improving venous hemodynamics, as well as reducing ambulatory venous hypertension and ulceration. Two patients were treated with a percutaneous venous valve bioprosthesis as part of a Phase I trial. The primary objective was to evaluate the safety, patency, and efficacy of the percutaneous venous valve bioprosthesis to restore competency to the deep venous system.

Percutaneous management of chronic deep venous reflux: review of experimental work and early clinical experience with bioprosthetic valve

“…[25][26][27][28][30][31][32][33] These valves consisted of single, double, or triple cusp leaflets made of synthetic or biological materials attached to a carrier or frame, usually a selfexpanding metallic stent. These artificial venous valves were tested in animals and clinically in a few patients [34][35][36] with good short-term and disappointing long-term results.…”

Elastomechanical properties of bovine veins

“…Indeed, bovine veins and valves are increasingly used as graft material (Gale et al, 2004). Venous elasticity is recognized to play a role in the development of varicose veins, and may also be linked to venous insufficiency (Clarke et al, 1989).…”

Preclinical Testing of a New Venous Valve

“…The most common practice to test the thrombotic potential is in an animal model, where eight out of ten studies reviewed failed due to in vivo thrombosis. The two most successful vein valve studies use acellular tissues: the SG-BVV was constructed from porcine small intestine submucosa (SIS), and the PVVB used gluteraldehyde-preserved bovine jugular valves (Moll, 2003), (Gale et al, 2004). The GT vein valve provides several advantages over SIS and gluteraldehyde-preserved bovine jugular valves.…”