Jain Akash, Jose John, Montorfano Matteo, Nissen Henrik, Martin Pedro, Seth Ashok, Stambuk Kresimir, Sengottuvelu Gunasekaran, Abdurashid Mussayev, García-Gómez Mario, Fernandez-Cordón Clara, Rodriguez Marcelo, Jorgensen Mathias D, Campo Alberto, Serrador Ana, Vallinas-Hernandez Silvia, Carrasco-Moraleja Manuel, San Román Alberto, Amat-Santos Ignacio J
Cardiology Department, University Clinic Hospital of Valladolid, Valladolid, Spain.
Christian Medical College, Vellore, India.
EuroIntervention. 2025 Jul 7;21(13):e758-e765. doi: 10.4244/EIJ-D-24-01112.
The Myval series is the first commercially available balloon-expandable transcatheter aortic valve implantation (TAVI) system designed as an alternative to the SAPIEN series. The LANDMARK trial recently demonstrated its non-inferiority compared to contemporary systems. However, the long-term durability of the Myval series remains unknown.
We aimed to evaluate the 4-year durability of the Myval series using Valve Academic Research Consortium (VARC)-3-defined endpoints.
We carried out a multicentre ambispective study of patients with severe aortic stenosis who underwent TAVI with the Myval series between December 2017 and April 2020. Baseline characteristics were prospectively recorded in a dedicated database. Clinical and echocardiographic follow-up was performed at 4 years. Outcomes included haemodynamic valve deterioration (HVD), bioprosthetic valve failure (BVF), and patient-prosthesis mismatch (PPM) as defined by the VARC-3 criteria, assessed at a central echocardiography laboratory.
A total of 366 patients from 9 institutions were included, all of whom completed 4-year follow-up or were followed up until death. The 4-year survival rate was 81.8%, with residual ≥moderate aortic regurgitation observed in 9.2% of patients. BVF criterion 1 (symptomatic valve failure) occurred in 3.3%, while no cases of BVF criteria 2 or 3 were reported. Stage 2 HVD was observed in 9.7% of patients and stage 3 HVD in 0.7% at 4 years. Moderate and severe PPM were identified in 3.6% and 2.1% of patients at 1 year, respectively.
In a real-world cohort, 4-year outcomes with the balloon-expandable Myval series demonstrated acceptable valve durability, low haemodynamic deterioration, and comparable performance to contemporary TAVI systems.
Myval系列是首个可商业化获得的球囊扩张式经导管主动脉瓣植入术（TAVI）系统，被设计作为SAPIEN系列的替代产品。LANDMARK试验最近证明了其与当代系统相比的非劣效性。然而，Myval系列的长期耐用性仍然未知。
我们旨在使用瓣膜学术研究联盟（VARC）-3定义的终点来评估Myval系列的4年耐用性。
我们对2017年12月至2020年4月期间使用Myval系列进行TAVI的重度主动脉瓣狭窄患者进行了一项多中心双向研究。基线特征前瞻性记录在一个专用数据库中。在4年时进行临床和超声心动图随访。结局包括血流动力学瓣膜恶化（HVD）、生物瓣膜失效（BVF）和患者-假体不匹配（PPM），由VARC-3标准定义，在一个中央超声心动图实验室进行评估。
来自9个机构的366例患者被纳入，所有患者均完成了4年随访或随访至死亡。4年生存率为81.8%，9.2%的患者观察到残余≥中度主动脉瓣反流。BVF标准1（有症状的瓣膜失效）发生在3.3%，而未报告BVF标准2或3的病例。4年时，9.7%的患者观察到2期HVD，0.7%的患者观察到3期HVD。1年时，分别有3.6%和2.1%的患者被确定为中度和重度PPM。
在一个真实世界队列中，球囊扩张式Myval系列的4年结局显示出可接受的瓣膜耐用性、低血流动力学恶化以及与当代TAVI系统相当的性能。
