Poletti Enrico, Amat-Santos Ignacio, Criscione Enrico, Popolo Rubbio Antonio, García-Gómez Mario, Orzalkiewicz Mateusz, Pan Manuel, Sisinni Antonio, Squillace Mattia, Del Blanco Bruno García, Bruno Francesco, Panoulas Vasileios, Pracon Radoslaw, De Backer Ole, Taramasso Maurizio, Costa Giuliano, Barbanti Marco, Van Mieghem Nicolas M, Regazzoli Damiano, Mangieri Antonio, Scotti Andrea, Latib Azeem, Saia Francesco, Bedogni Francesco, Testa Luca
Clinical and Interventional Cardiology Department, I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Milan, Italy.
Instituto de Ciencias del Corazón (ICICOR), Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
Cardiovasc Revasc Med. 2025 May;74:28-33. doi: 10.1016/j.carrev.2024.08.007. Epub 2024 Aug 22.
The off-label utilization of transcatheter heart valve (THV) devices for the treatment of inoperable or high-surgical risk patients with pure native aortic valve regurgitation (NAVR) has demonstrated suboptimal outcomes, both with self- and balloon-expandable (BE) devices. The aim of this study is to compare the use of different BE scaffolds in treating pure NAVR.
Consecutive patients with pure severe NAVR who were deemed to be at high-risk and were treated with last-generation BE-THVs among seventeen Centers in Europe and US. Technical and device success rates were the primary objectives.
Between February 2018 and July 2023, among 144 patients, 41 (28 %) received a MyVal device and 103 (72 %) were treated with a Sapien THV. Patients treated with a MyVal THV had an extra-large annulus more frequently compared to the Sapien group (49%vs.20 %, p < 0.001). Technical and device success rates were 90 % and 81 %, respectively, p > 0.1. The rate of THV migration/embolization (MyVal 4.9%vs. Sapien 11 %, p = 0.4) and second valve needed (4.9%vs.7.8 %, p = 0.7) were numerically lower in the MyVal group, whereas the rate of at least moderate paravalvular leak (15%vs.7.8 %, p = 0.2) and permanent pacemaker implantation (25%vs.18 %, p = 0.16) were numerically higher in the Myval group.
Off-label use of BE devices for pure NAVR represents a potential alternative in high-risk patients in the absence of dedicated devices. However, BE in NAVR is associated with suboptimal outcomes. The availability of larger THV sizes may introduce transcatheter aortic valve replacement as an effective treatment for patients traditionally deemed unsuitable.
NON-STANDARD ABBREVIATIONS AND ACRONYMS: AR = aortic regurgitation, BE = balloon-expandable, NAVR = native aortic valve regurgitation, PM = pacemaker, TAVR = transcatheter aortic valve replacement, THV = transcatheter heart valve, TVEM = transcatheter valve embolization and migration, VARC-3 = Valve Academic Research Consortium 3.
经导管心脏瓣膜（THV）装置用于治疗无法手术或手术风险高的单纯原发性主动脉瓣反流（NAVR）患者的标签外使用，无论是自膨胀式还是球囊扩张式（BE）装置，其结果都不尽人意。本研究的目的是比较不同BE支架在治疗单纯NAVR中的应用。
在欧洲和美国的17个中心，对连续的被认为是高风险的单纯严重NAVR患者使用新一代BE-THV进行治疗。技术成功率和装置成功率是主要目标。
在2018年2月至2023年7月期间，144例患者中，41例（28%）接受了MyVal装置治疗，103例（72%）接受了Sapien THV治疗。与Sapien组相比，接受MyVal THV治疗的患者超大瓣环更为常见（49%对20%，p<0.001）。技术成功率和装置成功率分别为90%和81%，p>0.1。MyVal组的THV迁移/栓塞率（MyVal为4.9%对Sapien为11%，p=0.4）和需要再次植入瓣膜的比例（4.9%对7.8%，p=0.7）在数值上较低，而MyVal组至少中度瓣周漏的发生率（15%对7.8%，p=0.2）和永久性起搏器植入率（25%对18%，p=0.16）在数值上较高。
在没有专用装置的情况下，BE装置用于单纯NAVR的标签外使用对高风险患者来说是一种潜在的替代方法。然而，BE用于NAVR与不理想的结果相关。更大尺寸THV的可用性可能会使经导管主动脉瓣置换成为传统上被认为不适合的患者的有效治疗方法。
AR = 主动脉反流，BE = 球囊扩张式，NAVR = 原发性主动脉瓣反流，PM = 起搏器，TAVR = 经导管主动脉瓣置换，THV = 经导管心脏瓣膜，TVEM = 经导管瓣膜栓塞和迁移，VARC-3 = 瓣膜学术研究联盟3
