Aortic and venous valve for percutaneous insertion

The purpose of this paper is to present in vitro and in vivo experimental e valuation of a new, artificial, bicuspid, aortic and venous valve. Valves w ere constructed from square stents with barbs covered by porcine small inte stine submucosa (SIS). A valve 15 mm in diameter was tested in a flow model (2.5 l/min) with pressure measurement. A 100-ml rubber bag attached to a s ide arm of the flow model simulated heart ejection fraction. In acute (n=6) and short-term (n=3) experiments conducted in four swine and four dogs, va lves ranging from 16 - 28mm in diameter were placed into the ascending aort a through 10 F sheaths; three were placed subcoronary and six in a supracor onary position. Function and stability of the valves were studied with pres sure measurements and aortograms. Three short term animals were sacrificed for gross and histologic evaluation at one, two and four weeks respectively . In an acute experiment, venous valves with four barbs were placed into th e IVC through an 8 F guiding catheter in three dogs. For longer-term testin g, valves were placed into the IVCs and iliac veins of three young swine. T he animals were followed up after two weeks with venograms, then were sacri ficed for gross and histologic evaluation.