Clinical and Interventional Cardiology Department, IRCCS Policlinico San Donato, Milan, Italy.
Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
JACC Cardiovasc Interv. 2023 Aug 28;16(16):1974-1985. doi: 10.1016/j.jcin.2023.07.026.
Transcatheter aortic valve replacement (TAVR) in patients with pure severe native aortic valve regurgitation (NAVR) has been associated with suboptimal results. The available evidence concerns mostly outdated transcatheter heart valves (THVs).
The aim of this study was to investigate the performance of new-generation THVs in patients treated for pure severe NAVR.
The PANTHEON (Performance of Currently Available Transcatheter Aortic Valve Platforms in Inoperable Patients With Pure Aortic Regurgitation of a Native Valve) study retrospectively included patients who underwent TAVR with currently available devices (both self-expanding [SE] and balloon expandable [BE]) for severe NAVR. Technical and device success rates as well as a composite of all-cause mortality and heart failure rehospitalization at 1 year were evaluated. The rate and clinical consequences of acute transcatheter valve embolization or migration (TVEM) were also considered.
A total of 201 patients were included. Overall technical and device success rates were 83.6% and 76.1%, respectively, and did not differ between SE and BE devices. These figures were due mostly to TVEM occurrence (14.6% vs 16.1%; P = 0.47) and residual moderate or greater aortic regurgitation (9.2% vs 10.1%; P = 0.87). Patients who experienced TVEM compared with those without TVEM had a significantly higher incidence of the composite endpoint at 1 year (25.7% vs 15.8%; P = 0.05).
Despite improved THV platforms and techniques, TAVR for pure severe NAVR remains a challenging procedure, with significant risk for TVEM. SE and BE platforms demonstrated comparable performance in this setting. (Performance of Currently Available Transcatheter Aortic Valve Platforms in Inoperable Patients With Pure Aortic Regurgitation of a Native Valve [PANTHEON]; NCT05319171).
经导管主动脉瓣置换术（TAVR）治疗单纯严重原发性主动脉瓣反流（NAVR）患者的效果并不理想。现有证据主要涉及过时的经导管心脏瓣膜（THV）。
本研究旨在探讨新一代 THV 在单纯严重 NAVR 患者中的应用效果。
回顾性纳入接受目前可用器械（自膨式和球囊扩张式）治疗严重 NAVR 的患者，进行 PANTHEON（目前可用经导管主动脉瓣平台在不可手术的单纯原发性主动脉瓣反流患者中的性能）研究。评估技术和器械成功率以及 1 年时全因死亡率和心力衰竭再入院的复合终点，还考虑了急性经导管瓣膜栓塞或迁移（TVEM）的发生率和临床后果。
共纳入 201 例患者。总体技术和器械成功率分别为 83.6%和 76.1%，自膨式和球囊扩张式器械之间无差异。这些数字主要归因于 TVEM 的发生（14.6% vs. 16.1%；P=0.47）和残余中度或以上主动脉瓣反流（9.2% vs. 10.1%；P=0.87）。与未发生 TVEM 的患者相比，发生 TVEM 的患者在 1 年时复合终点的发生率显著更高（25.7% vs. 15.8%；P=0.05）。
尽管 THV 平台和技术有所改进，但 TAVR 治疗单纯严重 NAVR 仍然是一项具有挑战性的操作，TVEM 风险较大。在这种情况下，自膨式和球囊扩张式器械具有相似的性能。（目前可用经导管主动脉瓣平台在不可手术的单纯原发性主动脉瓣反流患者中的性能（PANTHEON）；NCT05319171）。
