Verena Veulemans, Jacqueline Heermann, Rik Adrichem, Salome Hecht, Philipp C Seppelt, Thijmen W Hokken, Rutger-Jan Nuis, Mohamed Abdel-Wahab, Nicolas M van Mieghem, David Leistner, Marc M Vorpahl, Tobias Zeus
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In this retrospective multicenter study, we aimed to assess for bioprosthetic valve dysfunction (BVD) during three-year follow-up (FU) and potential differences between self-expandable (SEV) and balloon-expandable valves (BEV) under real-world conditions.</p><p><strong>Methods: </strong>Endpoints were defined according to VARC-3 criteria, including VARC composite endpoints during three-year FU.</p><p><strong>Results: </strong>A total of 1233 patients with tricuspid aortic valve stenosis, who underwent TAVR with contemporary transcatheter heart valve (THV) devices from three different tertiary care centers were included. One-fifth of the study population showed BVD at three-year FU (BVD[-]: n = 957;77.6%; BVD[+]: n = 276;22.4%). Non-structural valve deterioration (NSVD) was the most represented category (8.5%) followed by structural valve deterioration (SVD, 5.3%). BVD was more common in association with BEV as compared with SEV (60.9% vs 39.1%; p < 0.001) owing to higher rates of SVD (13.5% vs 9.5%; p = 0.028) and NSVD (17.9% vs. 13.8%; p = 0.048). Subclinical leaflet thrombosis was only documented in BEV (1.7%, p < 0.001). At three years, all-cause mortality was higher in BVD+ patients (BVD[-] vs. BVD[+]: 13.2% vs. 22.5%; HR: 1.99; 95%-CI: 1.39-2.85; p < 0.001*) but did not differ between THV platform.</p><p><strong>Conclusion: </strong>BVD after TAVR is common and associated with higher all-cause mortality. 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BVD was more common in association with BEV as compared with SEV (60.9% vs 39.1%; p < 0.001) owing to higher rates of SVD (13.5% vs 9.5%; p = 0.028) and NSVD (17.9% vs. 13.8%; p = 0.048). Subclinical leaflet thrombosis was only documented in BEV (1.7%, p < 0.001). At three years, all-cause mortality was higher in BVD+ patients (BVD[-] vs. BVD[+]: 13.2% vs. 22.5%; HR: 1.99; 95%-CI: 1.39-2.85; p < 0.001*) but did not differ between THV platform.</p><p><strong>Conclusion: </strong>BVD after TAVR is common and associated with higher all-cause mortality. 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引用次数: 0
摘要
目的：经导管主动脉瓣置换术（TAVR）在年轻患者和手术风险较低的患者中显著增加。在这项回顾性的多中心研究中，我们旨在评估三年随访（FU）期间生物假体瓣膜功能障碍（BVD），以及在现实条件下自膨胀瓣膜（SEV）和球囊膨胀瓣膜（BEV）的潜在差异。方法：根据VARC-3标准定义终点，包括3年FU期间的VARC复合终点。结果：共有1233例三尖瓣主动脉瓣狭窄患者接受了TAVR，并使用了当代经导管心脏瓣膜（THV）装置，来自三个不同的三级保健中心。五分之一的研究人群在3年FU时出现BVD (BVD[-]: n = 957;77.6%；BVD[+]: n = 276;22.4%)。非结构性瓣膜恶化（NSVD）是最具代表性的类别（8.5%），其次是结构性瓣膜恶化（SVD, 5.3%）。与SEV相比，BVD与BEV的关联更为常见(60.9% vs 39.1%；结论：TAVR后BVD很常见，且与较高的全因死亡率相关。尽管与球囊膨胀瓣膜相关的BVD占优势，但THV平台之间的死亡率仍然相似。临床试验注册：NCT01805739。
Evidence of bioprosthetic valve dysfunction during three-year follow-up following TAVR.
Objective: Transcatheter aortic valve replacement (TAVR) has increased significantly in younger patients and patients at lower surgical risk. In this retrospective multicenter study, we aimed to assess for bioprosthetic valve dysfunction (BVD) during three-year follow-up (FU) and potential differences between self-expandable (SEV) and balloon-expandable valves (BEV) under real-world conditions.
Methods: Endpoints were defined according to VARC-3 criteria, including VARC composite endpoints during three-year FU.
Results: A total of 1233 patients with tricuspid aortic valve stenosis, who underwent TAVR with contemporary transcatheter heart valve (THV) devices from three different tertiary care centers were included. One-fifth of the study population showed BVD at three-year FU (BVD[-]: n = 957;77.6%; BVD[+]: n = 276;22.4%). Non-structural valve deterioration (NSVD) was the most represented category (8.5%) followed by structural valve deterioration (SVD, 5.3%). BVD was more common in association with BEV as compared with SEV (60.9% vs 39.1%; p < 0.001) owing to higher rates of SVD (13.5% vs 9.5%; p = 0.028) and NSVD (17.9% vs. 13.8%; p = 0.048). Subclinical leaflet thrombosis was only documented in BEV (1.7%, p < 0.001). At three years, all-cause mortality was higher in BVD+ patients (BVD[-] vs. BVD[+]: 13.2% vs. 22.5%; HR: 1.99; 95%-CI: 1.39-2.85; p < 0.001*) but did not differ between THV platform.
Conclusion: BVD after TAVR is common and associated with higher all-cause mortality. Despite a preponderance of BVD in association with balloon-expandable valves, mortality rates remain similar between THV platforms.
期刊介绍：
Clinical Research in Cardiology is an international journal for clinical cardiovascular research. It provides a forum for original and review articles as well as critical perspective articles. Articles are only accepted if they meet stringent scientific standards and have undergone peer review. The journal regularly receives articles from the field of clinical cardiology, angiology, as well as heart and vascular surgery.
As the official journal of the German Cardiac Society, it gives a current and competent survey on the diagnosis and therapy of heart and vascular diseases.
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