A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model

Abstract

Background: Despite improved anticalcification technology, bioprosthetic heart valves still cannot be used in younger patients because of progressive structural valve degeneration. A novel advanced tissue preservation technology was developed that uses stable functional group capping and preservation by glycerolization. Valves incorporating this novel technology can be stored in a dry condition and do not require rinsing before use. The aim of the study was to assess the effects of this new technology in terms of valve function and durability in a chronic sheep model of orthotopic implantation.

Methods: Forty-five juvenile sheep were randomized and either a Perimount mitral valve (6900P, control group) or the same valve design incorporating the novel tissue preservation technology (test group) was implanted in the mitral position. All valves were 25 mm. A transthoracic echocardiography was performed at 1 week and at 8 months postoperatively. The animals were then killed, an autopsy was performed, and the valves were examined radiographically (soft tissue radiograph), histologically (hematoxylin and eosin and Von Kossa staining), and chemically (calcium content). Exclusion criteria for analysis included surgical or procedural death, bacterial endocarditis or other diseases leading to premature death.

Results: Thirty-one animals (14 controls and 17 test animals) remained in perfect condition during the 8-month follow-up period. Echocardiography at 1 week showed normal valve function in both groups. At 8 months, cardiac output increased significantly to the same extent in both groups (vs baseline; P < .01). The mean transvalvular pressure gradient also increased but significantly more in the control group compared with the test group (P = .03). Flow turbulence across the prosthesis was increased in the control valves compared with the test valves. The test valves had significantly less calcium content than the controls (1.9 ± 0.3 vs 6.8 ± 1.6 μg/mg; P = .002). This was confirmed by radiographic analysis and histology.

Conclusions: This study demonstrates that the novel tissue preservation technology, when applied to the Perimount mitral valve, significantly improves hemodynamic and anticalcification properties compared with the standard Perimount, a valve currently considered the standard of care.