In Vitro Proof of Concept of a First-Generation Growth-Accommodating Heart Valved Conduit for Pediatric Use.
In Vitro Proof of Concept of a First-Generation Growth-Accommodating Heart Valved Conduit for Pediatric Use.
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DOI：
10.1002/mabi.202300011
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发表时间：
2023-07
影响因子：
4.6
通讯作者：
中科院分区：
文献类型：
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目前可用的心脏瓣膜假体没有增长潜力，需要患有心脏瓣膜疾病的儿童忍受具有复合风险的多次瓣膜置换手术。这项研究证明了一种生物稳定的聚合物三叶带瓣管道的概念，该管道设计用于外科植入，随后通过经导管球囊扩张进行扩张，以适应儿科患者的成长，并推迟或避免重复的心内直视手术。阀门管道是通过使用聚二甲基硅氧烷基聚氨酯通过浸塑成型形成的，聚二甲基硅氧烷是一种生物相容性材料，在机械载荷下能够永久拉伸。阀门叶的设计具有更大的结合面积，以在扩大的直径下保持阀门的能力。对4条直径22 mm的带瓣管道进行了体外流体力学测试，球囊扩张到新的永久性直径23.26±0.38 mm，然后再次进行测试。进一步扩张时，两个带瓣管道发生叶撕裂，而两个存活的装置最终直径为24.38±0.19 mm。每次成功扩张后，瓣膜管道的有效瓣口面积增加，跨瓣压差减小，同时保持较低的返流。这些结果证明了聚合物球囊可膨胀装置的概念、可行性和进一步的发展，以替代儿童瓣膜并避免再次手术。我们报告了一种生物稳定的聚合物带瓣管道的概念的体外验证，该管道旨在通过经导管球囊扩张来适应生长。最初将四个装置的直径从22毫米扩大到23.26毫米。两个装置进一步扩张到24.38毫米，而剩下的两个装置继续撕裂小叶。存活的瓣膜显示瓣口面积增大，跨瓣压差减小。
Currently available heart valve prostheses have no growth potential, requiring children with heart valve diseases to endure multiple valve replacement surgeries with compounding risks. This study demonstrates the in vitro proof of concept of a biostable polymeric trileaflet valved conduit designed for surgical implantation and subsequent expansion via transcatheter balloon dilation to accommodate the growth of pediatric patients and delay or avoid repeated open-heart surgeries. The valved conduit is formed via dip molding using a polydimethylsiloxane-based polyurethane, a biocompatible material shown here to be capable of permanent stretching under mechanical loading. The valve leaflets are designed with an increased coaptation area to preserve valve competence at expanded diameters. Four 22 mm diameter valved conduits are tested in vitro for hydrodynamics, balloon dilated to new permanent diameters of 23.26 ± 0.38 mm, and then tested again. Upon further dilation, two valved conduits sustain leaflet tears, while the two surviving devices reach final diameters of 24.38 ± 0.19 mm. After each successful dilation, the valved conduits show increased effective orifice areas and decreased transvalvular pressure differentials while maintaining low regurgitation. These results demonstrate concept feasibility and motivate further development of a polymeric balloon-expandable device to replace valves in children and avoid reoperations. We report the in vitro proof of concept of a biostable polymeric valved conduit, designed to accommodate growth via transcatheter balloon dilation. Four devices are initially expanded from 22 to 23.26 mm in diameter. Two devices are further dilated to 24.38 mm, while the remaining two sustain leaflet tears. The surviving devices demonstrate increased orifice areas and decreased transvalvular gradients.
影响因子：
4.9
作者：
Christian, Abigail J.;Alferiev, Ivan S.;Connolly, Jeanne M.;Ischiropoulos, Harry;Levy, Robert J.
通讯作者：
Levy, Robert J.