Design and performance characteristics of the Pericarbon Stentless valve.

The Pericarbon Stentless valve (PS) in an unstented bioprosthesis made of glutaraldehyde tanned bovine pericardium. Its design concept and chemical fixation process are based on those developed for the stented Pericarbon valve, which has been in clinical use for eight years. The two-sheet design and the special suture pattern with which the two pieces of pericardium are attached aim at avoiding stress concentration during function. The resulting cylindrical structure is a relatively low-profile valve conduit, which can be further trimmed by the implanting surgeon to the individual patient's specific anatomical requirements. The main advantage of the stentless concept is optimum hemodynamic characteristics, inherent in the high external/internal diameter ratio. The unique design and material selection of the PS valve offer the following advantages: Free-hand insertion similar to that with homograft aortic valves. Absence of any fabric cover or reinforcement providing a maximum effective orifice area and reduced risk of infection. Wide range of available sizes from 15 mm to 29 mm. Special methods have been developed for laboratory testing of the PS. These, and the in vitro results are presented in detail, with particular emphasis on the hydrodynamic performances under different flow conditions. Clinical implantation of the Pericarbon Stentless valve has already been started, and early results in the aortic position show good hemodynamic function and a low rate of complications.