A stentless trileaflet valve from a sheet of decellularized porcine small intestinal submucosa.

Purpose: The purpose of this study was to investigate the function of a trileaflet pulmonary valve constructed from a sheet of porcine small intestinal submucosa.

Description: In four sheep, the native pulmonary valve and a segment of the pulmonary trunk was excised and replaced with a trileaflet valve constructed from decellularized porcine small intestinal submucosa. The valve construct was created from a sheet of the xenograft material by a method of involuting flaps of tissue inside a cylinder of itself. The function of the valve was assessed by echocardiography, catheter pullback across the valve, and observation of an excised valve in a flow simulator.

Evaluation: The valve constructs exhibited low gradients and symmetrical leaflet movement with good mobility when tested under physiologic conditions in an acute sheep model.

Conclusions: This method offers a means to create a functional trileaflet valve replacement from a sheet of tissue.