The Heart Valve Society

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Longterm Evaluation of a Novel Autologous Tissue Heart Valve
Yoshiaki Takewa, Yasuhide Nakayama, Hirohito Sumikura, Kei Iizuka, Daichi Akiyama, Eisuke Tatsumi.
National Cerebral and Cardiovascular Center, Osaka, Japan.

OBJECTIVE: We are developing a novel autologous tissue heart valve (Biovalve) with a unique in-body tissue engineering. This enables us to use for multi-purpose valve replacement and to select tailor-made therapy for each patient keeping better biocompatibility. In this study, we made 3 types of heart valves with this method and tested their feasibility and long-term availability in large animal experiments.
METHODS: We created many kinds and sizes of molds for Biovalves using plastic rods with 3D printer easily and quickly considering the recipient character. In this study, we selected 3 types (a conventional type, a full-root type and a valve with a metalic stent for transcatheter implantation) and embedded them in the subcutaneous spaces of adult goats for 1-2 months. After extracting the molds with the tissue and removing the plastic rods only, Biovalve with tri-leaflets similar to those of the native valves were constituted from completely autologous connective tissues and fibroblasts. Five cases of conventional Biovalves were implanted in the aorta under cardiopulmonary bypass, 15 cases of fullroot type were implanted in the apico-aortic bypass or the pulmonary artery, and 25 cases of stent-valve type were implanted with transcatheter technique into in situ the aortic and pulmonary valves (17 and 8, respectively).
RESULTS: In each type, Biovalves were successfully implanted and showed smooth movement of the leaflets with a little regurgitation in angiogram, and the maximum duration reached to 16 months in fullroot type and 21 months in stent valve type. Histological examination of the Biovalves showed the autologous cells covering the laminar surface of the valve leaflets as the endothelium and also getting into the body and constructing special tissues similar to native leaflets .
CONCLUSIONS: The Biovalves have a potential to be used for multiple valve replacements and satisfy the higher requirements of the systemic and pulmonary circulation constructing functional and biocompatible autologous tissues similar to native ones.


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