Background and aim of the study: A new bioprosthesis has been developed that is: (i) constructed from glutaraldehyde-treated autologous pericardium due to its lack of antigenicity and low cost; (ii) easily constructed in the operating room; (iii) stentless but easy to implant by using a temporary stent that is removed once its function is no longer necessary; and (iv) implanted with a single proximal suture and three commissural stitches.
Methods: This prosthesis was implanted in the subcoronary aortic position of six sheep. The mean prosthesis size was 19.7 +/- 3.5 mm, and manufacturing time 16 +/- 3 min. Cardiopulmonary bypass and cross-clamp times were 142.5 +/- 26.7 min and 100.2 +/- 28.8 min, respectively. Three sheep were euthanized at three, seven, or 27 days, and the remainder at five months postoperatively.
Results: In all cases the valve was competent and the single commissural stitches were well-anchored. The pericardium was pliable in all cases, but one animal had obvious endocarditis (at 27 days). Small calcific nodules were found at the commissures in valves explanted at five months. Histology showed an intact collagen and elastin structure, and neointimal growth was seen covering the basal quarter of the leaflets and commissures.
Conclusion: This new bioprosthesis might offer a particularly attractive alternative for the young patient population of the developing world. The simplicity of construction, low cost, and absence of any need for anticoagulation makes this prosthesis close to the ideal aortic valve substitute.