Visions of TAVR Future: Development and Optimization of a Second Generation Novel Polymeric TAVR.
Visions of TAVR Future: Development and Optimization of a Second Generation Novel Polymeric TAVR.
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TAVR 未来的愿景：第二代新型聚合物 TAVR 的开发和优化。
DOI：
10.1115/1.4054149
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发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Bluestein,Danny
中科院分区：
文献类型：
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作者：
Kovarovic,Brandon;Helbock,Ryan;Baylous,Kyle;Rotman,OrenM;Slepian,MarvinJ;Bluestein,Danny
基于组织的经导管主动脉瓣（AV）置换（TAVR）器械已成为治疗主动脉瓣狭窄的突破性方法。然而，随着TAVR扩展到年轻和低风险患者，长期耐久性和血栓形成问题仍然存在。聚合物瓣膜技术的最新进展有助于设计更耐用的瓣膜，体内不良反应最小。我们介绍我们的第二代聚合物经导管主动脉瓣（TAV）器械，其设计和优化旨在解决这些问题。我们介绍了器械的优化过程，其中器械展开和功能的每个方面都针对性能进行了优化，包括聚合物技术的独特考虑，以减少聚合物材料的体积，从而降低压握输送轮廓。对支架框架进行了优化，以产生更大的径向力和更少的材料体积，确保稳健的展开和锚定。优化了瓣叶形状以及不同的瓣叶厚度，以降低弯曲循环应力和瓣膜的流体动力学。我们的第一代聚合物器械已经证明，其流体动力学性能符合并超过ISO标准和患者特定体外情况下的组织器械。瓣膜已达到900 × 106次加速耐久性试验循环，相当于患者使用20年以上。优化框架和技术导致了第二代聚合物TAV设计-目前正在进行体外流体动力学测试和体内动物试验。随着TAVR应用的迅速扩大，我们严格的生物工程优化方法和先进的聚合物技术有助于建立聚合物TAV技术，作为现有组织型TAV技术面临的挑战的可行替代方案。
Tissue-based transcatheter aortic valve (AV) replacement (TAVR) devices have been a breakthrough approach for treating aortic valve stenosis. However, with the expansion of TAVR to younger and lower risk patients, issues of long-term durability and thrombosis persist. Recent advances in polymeric valve technology facilitate designing more durable valves with minimal in vivo adverse reactions. We introduce our second-generation polymeric transcatheter aortic valve (TAV) device, designed and optimized to address these issues. We present the optimization process of the device, wherein each aspect of device deployment and functionality was optimized for performance, including unique considerations of polymeric technologies for reducing the volume of the polymer material for lower crimped delivery profiles. The stent frame was optimized to generate larger radial forces with lower material volumes, securing robust deployment and anchoring. The leaflet shape, combined with varying leaflets thickness, was optimized for reducing the flexural cyclic stresses and the valve's hydrodynamics. Our first-generation polymeric device already demonstrated that its hydrodynamic performance meets and exceeds tissue devices for both ISO standard and patient-specific in vitro scenarios. The valve already reached 900 × 106cycles of accelerated durability testing, equivalent to over 20 years in a patient. The optimization framework and technology led to the second generation of polymeric TAV design- currently undergoing in vitro hydrodynamic testing and following in vivo animal trials. As TAVR use is rapidly expanding, our rigorous bio-engineering optimization methodology and advanced polymer technology serve to establish polymeric TAV technology as a viable alternative to the challenges facing existing tissue-based TAV technology.