Original articleAdult cardiacTen Years of Clinical Results With a Tissue-Engineered Pulmonary Valve
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Material and Methods
The scaffold used for seeding was a commercially available cryopreserved pulmonary allograft (Cryolife Inc, Kennesaw, GA). The valves were decellularized and sterilized according to a proprietary process in the AutoTissue laboratories (AutoTissue GmbH, Berlin, Germany) to yield a scaffold exclusively composed of collagen and elastin [9]. The scaffolds were seeded with AVEC respecting the standards of good manufacturing practice. Sterility was proven during each single production step as well as
Valve Assembly: Endothelial Cell Harvesting and Culture
From the first 7 patients a piece of cephalic vein was harvested, and from the remaining 4 a piece of the greater saphenous vein was prepared. Preparation of the saphenous vein allowed the decrease of cell culture time to a total of 2 weeks. In one patient, the autologous serum was not sufficient to grow endothelial cells in vitro. For this patient pooled donor serum was used.
After the second passage a mean number of 5.4 × 106 ± 2.9 × 106 endothelial cells were available, which was considered
Comment
Although mechanical and biological valve prostheses are widely used, both have limitations in younger patients. Hammermeister and colleagues [15] showed, in 394 patients undergoing isolate aortic valve replacement, that the number of reoperations was significantly higher with bioprosthetic valves than with mechanical valves at 15 years follow-up (29 ± 5% vs 10 ± 3%, p = 0.004).
In a recent study, Ruel and colleagues [16] showed in patients under 60 years, after aortic valve replacement (n =
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