Innovative Sutureless Fabrication Strategy for Tissue-Engineered Pediatric Heart Valves Using an Evolutive Support System.

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Current pediatric heart valve protheses lack growth potential, leading to repeated surgeries and long-term complications. Tissue-engineered heart valves (TEHVs), composed of living tissue, offer the ability to remodel and may accommodate somatic growth. This study introduces a sutureless fabrication strategy for TEHV designed to eliminate suture-related weak points and preserve valve geometry during in vitro maturation through a novel evolutive support system. This system was used to form and maintain the geometry of a fibrin-based valve scaffold embedded with human adipose-derived stromal cells during in vitro culture by mechanically constraining tissue contraction in all directions except thickness. Dimensional analysis confirmed geometry preservation throughout 28 days of perfusion bioreactor culture. At the end of the culture period, the matured valve was released from the evolution support system, after which the valve contracted to stable dimensions of approximately 16 mm in diameter, 23 mm in height, and 400 µm in thickness, corresponding to reductions of 26%, 43%, and 84% in diameter, height, and thickness, respectively, relative to the initial molded geometry. These ratios provide critical design guidance for pediatric target dimensions. Cell viability exceeded 90% upon molding, and cell density increased nearly 100-fold during culture. Histology revealed progressive c

Evidence level

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

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