Percutaneous deployment of a valved bovine jugular vein in the swine venous system: A potential treatment for venous insufficiency

PURPOSE: To develop a system for potential use in the treatment of chronic venous insufficiency by using percutaneous techniques. MATERIALS AND METHODS: A segment of a glutaraldehyde-fixed bovine external jugular vein with valves was trimmed and sutured to a nitinol stent, Animals were premedicated and anesthetized (n = 11), Venography of the right external jugular vein, inferior vena cava (IVC), and common iliac vein was performed. Deployment was accomplished via a sheath (12-24 F) with use of fluoroscopic guidance, Eleven bioprostheses were deployed in 11 animals. Bioprostheses were deployed in the IVC (n = 3) or right external iliac vein (n = 6), Animals were killed immediately after deployment (n = 7) at 1 week (n = 1) or at 2 weeks (n = 2), One animal was found dead in the cage. At necropsy, each bioprosthesis (n = 4) was explanted and histopatholose analysis was performed. RESULTS: Deployments of the bioprostheses were successful in nine of 11 swine. Two deployments were unsuccessful (one accidental deployment in the right renal vein, one deployment in the IVC caused rupture of the vein), Postdeployment venography (n = 9) confirmed no reflux (in the recumbent position of the swine) of the valve leaflets and patency of the vein inferior to the level of the bioprostheses. in the first group of animals (n = 5), valve leaflets were normal and competent, In the survival animal group (n = 4), the bioprostheses remained patent without evidence of thrombus formation by ascending and descending venography, Gross inspection of the explanted bioprostheses (n = 4) demonstrated grossly normal valves that fully occluded the lumen. Complications included hemarthrosis (n = 1), death (n = 1), and bioprosthesis thrombosis immediately after deployment (n = 1), Histopatholose analysis showed endothelial cells covering the luminal surfaces. The wall of the bioprostheses had granulomatous response and foreign body reaction. Bacterial contamination was noted in one bioprosthesis. CONCLUSIONS: Deployment of a glutaraldehyde-fixed bovine vein sutured to a self-expanding nitinol stent in the swine iliac vein or IVC is technically feasible, Development of a venous bioprosthesis that can be placed percutaneously may have important clinical applications as an endovascular treatment for chronic venous insufficiency when it is due to valvular incompetence.