The Chemically Treated Bovine Ureter—Clinical Performance of a Novel Biological Vascular Prosthesis

Abstract

Aim This paper describes the rationale, development and clinical performance of a novel small-diameter vascular prosthesis of non-vascular animal tissue origin. Method Durable conduits suitable for coronary and peripheral arterial reconstruction are prepared for the first time from non-vascular animal tissue. Australian bovine ureters from young steers from protected herds are processed to form strong, bloodflow-compatible and non-immunogenic biologic grafts (‘Flonova’ R, Bionova International Pty Ltd, Melbourne). Fifty-six patients lacking suitable autogenous veins received 62 prostheses (32 bypasses were implanted above knee and 30 below knee). Determination of patency and function included Doppler ultrasound, duplex scanning and angiography. Findings The primary patency rate at 1, 2 and 5 years, respectively was 67, 59 and 52% and the secondary patency for the same time frames was 88, 73 and 61%. There were no occlusions as a result of intimal hyperplasia. Dilatation of the wall was diagnosed in one prosthesis at 3.5 years, and one at 7 years, and a false aneurysm of unknown aetiology occurred in another at 3 months. There were no primary graft infections. Conclusion This evaluation shows the chemically treated bovine ureter (CTBU) is a viable medium-term alternative to the currently available artificial vascular prostheses for peripheral revascularisation.

Development of Small‐Diameter Vascular Grafts

“…36,37 Natural Biomaterials An attractive approach to vascular materials is the use of biologic tissues with a preexisting extracellular matrix (ECM), such as arteries 38 or ureters. 39 These ''scaffolds'' are derived from human or animal tissues. Natural biomaterials are composed of ECM proteins that can serve as intrinsic templates for cell attachment and growth.…”

“…An attractive approach to vascular materials is the use of biologic tissues with a preexisting extracellular matrix (ECM), such as arteries38 or ureters 39. These “scaffolds” are derived from human or animal tissues.…”

In vivo engineering of blood vessels

“…Many decellularised tissue tubes have been investigated as potential vascular grafts. Examples include human and xenogenic arteries (5), human (6) and xenogenic ureters (7) and human umbilical vein grafts (8). The majority of investigators attempted to produce stable constructs designed to maintain structural integrity with little attention paid to maintaining the ability of the graft to be remodelled.…”