2025年度经导管主动脉瓣置换术治疗单纯主动脉瓣反流的器械研发进展

Progress of Device Research and Development for Transcatheter Aortic Valve Replacement to Treat Pure Aortic Regurgitation by 2025

摘要: 单纯主动脉瓣反流(pure aortic regurgitation, PAR)已经成为了经导管主动脉瓣置换术(TAVR)适用范围扩大的主要限制因素，原因在于它具有特殊的解剖学特征，即主动脉环扩张并且没有钙化锚定位置。传统的TAVR装置不能满足治疗PAR的需求，主要是因为锚定稳定性差以及瓣周漏(PVL)发生率高。近几年来，在针对PAR的病理生理特征研制出专门的TAVR设备方面取得了重要的进展，通过改进了锚定系统、密封结构和血流动力学性能来提高装置的安全性和适用性。无论是国产还是进口的定制装置，在管理PAR方面都具有很好的临床疗效。本文对2025年研发进展、技术突破以及核心PAR专用TAVR装置的临床证据进行了系统性的总结，并对未来的发展趋势以及未解决的临床问题进行了进一步地阐述，为PAR-TAVR标准化诊断与治疗及器械革新提供理论参考和实证依据。

Abstract: Pure aortic regurgitation (PAR) has emerged as a major constraint on the expanded application of transcatheter aortic valve replacement (TAVR), owing to its unique anatomical characteristics of an enlarged aortic annulus and the absence of calcified anchoring sites. Conventional TAVR devices are ill-suited for PAR treatment, primarily due to poor anchoring stability and a high incidence of paravalvular leakage (PVL). In recent years, significant progress has been made in the development of dedicated TAVR devices tailored to the pathophysiological features of PAR, with enhanced anchoring systems, sealing structures and haemodynamic performance to improve the safety and applicability of the devices. Both domestic and imported customised devices have demonstrated favourable clinical efficacy in the management of PAR. This paper systematically summarises the research and development advances, technological breakthroughs and clinical evidence for core PAR-specific TAVR devices in 2025, and further elaborates on future development trends and unresolved clinical issues, aiming to provide theoretical references and empirical evidence for the standardised diagnosis and treatment of PAR-TAVR as well as instrumental innovation.