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Novel Tissue Technology Platform Improves Durability and Valve Function over Current Standard Bovine Pericardial Valves.
Bart Meuris, Erik Verbeken, Willem Flameng.
KU Leuven, Leuven, Belgium.

OBJECTIVE: Use of bioprosthetic heart valves is limited in younger patients because of early progressive structural valve deterioration. To address this problem, a novel tissue technology platform was developed using stable functional group capping and preservation by glycerolization. The aim of this study was to evaluate the hemodynamic performance and durability of pericardial valves using this novel platform in a chronic ovine model.
METHODS: Forty-five juvenile sheep were prospectively randomized to receive a bovine pericardial mitral valve replacement (Carpentier-Edwards PERIMOUNT, model 6900P; Edwards Lifesciences, Irvine, CA) with (TEST) or without (CONTROL) the novel tissue technology platform. All valves were size 25mm. Transthoracic echocardiography was performed at 1 week and 8 months postoperatively. All animals were sacrificed at 8 months. Perimount valves were analyzed radiographically, histologically, and chemically for calcium content. Animals that died during the operation, or that developed serious infections leading to early death, were excluded from analysis.
RESULTS: Thirty-one animals (TEST, n = 17; and, CONTROL, n = 14) survived to 8 months. At 1 week, transthoracic echocardiography demonstrated normal valve function in both groups. At 8 months, cardiac output was significantly increased to the same extent in both groups. The mean pressure gradient was significantly lower in the TEST compared to the CONTROL, 4.0 vs. 5.6 mm Hg (p = 0.04). Leaflet mobility was greater in the TEST compared to the CONTROL, with greater turbulence observed in the CONTROL. Compared to the CONTROL, calcium content measured was significantly reduced in the TEST (2.0 ± 0.3 vs. 6.8 ± 1.6 μgm/mg, p = 0.002), supported by Faxitron analysis and histology. Histology also demonstrated less leaflet pannus formation in the TEST group.
CONCLUSIONS: The results from this prospective, randomized chronic ovine study demonstrated significantly improved hemodynamic performance, leaflet mobility, and reduced calcium content with a trend toward reduced pannus formation, after mitral valve replacement with bovine pericardial valves using a novel tissue technology platform.

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