Truly stentless molded autologous pericardial aortic valve prosthesis with single point attached commissures in a sheep model☆

Abstract

Aortic valve cusp extension and free-hand aortic valve replacement with autologous pericardium has been described. The long-term results were shown to be comparable with commercially available aortic bioprostheses. Nevertheless the relatively demanding surgical technique could not find wide acceptance. We developed a new design of a molded aortic valve, fashioned from autologous pericardium, treated briefly with glutaraldehyde, and simplified the implantation technique using single point attached commissures (SPAC). Molded autologous valve prostheses were implanted in the subcoronary aortic position in 10 sheep with the commissures connected to the aortic wall at three single commissural points (SPAC). The prosthesis mean size was 21.6+/-1.3 mm and the construction time (excluding 10 min glutaraldehyde treatment) was 6.2+/-1.2 min. Cardiopulmonary bypass and cross-clamp time was 111.1+/-12.4 min and 75.0+/-16.3 min, respectively. Six sheep were euthanized after 201.2+/-10.3 days (6 months) and four sheep were euthanized after 330.8+/-6.5 days (11 months) postoperatively. In all sheep, the valve was immediately competent. At sacrifice, SPAC has proven to be well anchored to the aortic wall and the pericardial valve to be pliable in all cases. The maximum transvalvular gradient after cardiopulmonary bypass and at sacrifice was 3.7+/-2.2 mmHg and 10.6+/-5.2 mmHg, respectively. This new truly stentless molded autologous aortic valve with simplified implantation technique (SPAC) makes a reliable implantation in a standard timeframe possible. The simplicity of construction, low cost and absent need for anticoagulation of this molded autologous aortic bioprosthesis offers an attractive alternative and not only for patients in the developing world.