Department of Cardiovascular Surgery -, Villa Torri Hospital, GVM Care&Research, Bologna, Italy.
Department of Cardiac Surgery, Tours University Hospital, Tours, France.
Expert Rev Med Devices. 2021 Mar;18(3):239-244. doi: 10.1080/17434440.2021.1886921. Epub 2021 Feb 27.
The Inspiris Resilia tissue valve was recently introduced into clinical practice. This review summarizes the pre-clinical and clinical studies leading to this new bioprosthesis.
The novel Resilia tissue was tested extensively in a large animal model. The clinical use of the tissue started in 2011 with the European Feasibility study, followed by a North-American multi-center study. Since 2017, the Inspiris Resilia valve has been in full commercial use. Further prospective evaluations and registries are ongoing.
The Inspiris Resilia valve was clinically introduced after pre-clinical tests revealed superiority compared to contemporary therapy such as the Perimount valve. Prospective long-term follow-up studies on Resilia are ongoing since 2011 and reveal no major complications. Full 5-year data show no signs of early degeneration, but longer follow-up is certainly still needed. Several prospective registries are actively monitoring the outcome with the Inspiris Resilia valve now. The novel tissue, designed to mitigate calcification and increase durability, together with the expandable stent, facilitating potential future valve-in-valve (ViV) procedures, are the cutting-edge aspects. Clinical use in younger patients is currently ongoing: their follow-up and outcome will determine the added value of this valve.
Inspiris Resilia 组织瓣膜最近已应用于临床实践。本综述总结了促成这种新型生物瓣膜的临床前和临床研究。
新型 Resilia 组织在大型动物模型中进行了广泛的测试。该组织于 2011 年开始在欧洲可行性研究中使用，随后在北美进行了多中心研究。自 2017 年以来，Inspiris Resilia 瓣膜已全面商业化使用。进一步的前瞻性评估和注册研究仍在进行中。
Inspiris Resilia 瓣膜在临床应用前，经过临床前测试，显示出优于同期疗法（如 Perimount 瓣膜）的优越性。自 2011 年以来，对 Resilia 的前瞻性长期随访研究一直在进行，没有发现重大并发症。完整的 5 年数据显示没有早期退化的迹象，但仍需要更长时间的随访。目前有几个前瞻性登记处正在积极监测 Inspiris Resilia 瓣膜的结果。这种新型组织旨在减轻钙化并提高耐久性，同时可扩张的支架也为未来的瓣膜内瓣（ViV）手术提供了可能性，这些都是该瓣膜的先进之处。目前正在对年轻患者进行临床应用：他们的随访和结果将决定该瓣膜的附加价值。
