Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich Heine University, Medical Faculty, Moorenstr. 5, 40225, Düsseldorf, Germany.
CARID (Cardiovascular Research Institute Düsseldorf), Moorenstr. 5, 40225, Düsseldorf, Germany.
Clin Res Cardiol. 2022 Dec;111(12):1358-1366. doi: 10.1007/s00392-022-02052-9. Epub 2022 Jun 29.
Transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) stenosis has become more frequent in the last years. This may pose challenges for long-time valve durability. Therefore, we aimed to evaluate the prevalence of bioprosthetic valve dysfunction (BVD) with the newest-generation devices in BAV stenosis up to one-year follow-up (FU).
The primary endpoint was defined as the prevalence of BVD during the first procedural year according to Valve Academic Research Consortium (VARC)-3 criteria. Secondary endpoints were defined as failure in device success and clinical endpoints according to VARC-3.
A total of 107 patients were included. Of these, 34 subjects (31.8%) met the criteria for BVD during a mean FU of 263 ± 180 days, of which 20.2% were already documented after thirty days. Device success after one year was lower in the + BVD cohort (57.6% vs. 98.7%, p < 0.0001*). The rates of structural valve deterioration were 6.5%, non-structural valve deterioration (NSVD) 17.8%, subclinical leaflet thickening 10.3%, and endocarditis 0.9%. NSVD was foremost triggered by patient prosthesis mismatch in balloon-expandable valves. Hemodynamic valve deterioration stage 1 and 2 was confirmed in 16.8% of + BVD patients, while stage 1 and 3 bioprosthetic valve failure occurred in 1.9%. There was no impact of BVD on mortality.
There is critical evidence of early BVD after TAVI in BAV during one-year FU in one-third of patients, also lowering device success. The most frequently observed bioprosthetic valve dysfunction was NSVD due to patient prosthesis mismatch following TAVI with a balloon-expandable valve.
近年来，经导管主动脉瓣植入术（TAVI）在二叶式主动脉瓣（BAV）狭窄中的应用越来越频繁。这可能对长期瓣膜耐久性构成挑战。因此，我们旨在评估在最新一代器械治疗 BAV 狭窄的患者中，在一年随访（FU）期间生物瓣功能障碍（BVD）的发生率。
主要终点定义为根据 Valve Academic Research Consortium（VARC）-3 标准，在第一个程序年内 BVD 的发生率。次要终点定义为根据 VARC-3 定义的器械成功和临床终点的失败。
共纳入 107 例患者。其中，34 例（31.8%）在平均 263±180 天的 FU 期间符合 BVD 标准，其中 20.2%在 30 天后已被记录。在一年时，BVD 阳性组的器械成功率较低（57.6% vs. 98.7%，p<0.0001*）。结构性瓣膜恶化的发生率为 6.5%，非结构性瓣膜恶化（NSVD）为 17.8%，亚临床瓣叶增厚为 10.3%，心内膜炎为 0.9%。NSVD 主要由球囊扩张瓣的患者-假体不匹配触发。在 16.8%的 BVD 阳性患者中证实存在血流动力学瓣膜恶化 1 期和 2 期，而 1.9%的患者出现 1 期和 3 期生物瓣故障。BVD 对死亡率无影响。
在 1 年 FU 期间，三分之一的患者在 BAV 中接受 TAVI 后存在早期 BVD，这也降低了器械成功率。最常观察到的生物瓣功能障碍是 NSVD，这是由于 TAVI 后球囊扩张瓣的患者-假体不匹配导致。
