Rouen University Hospital, Department of Cardiology, FHU REMOD-VHF, Rouen, France.
EuroIntervention. 2018 Jun 8;14(3):e264-e271. doi: 10.4244/EIJ-D-18-00015.
Durability of transcatheter aortic bioprosthetic valves remains a major issue. Standardised definitions of deterioration and failure of bioprosthetic valves have recently been proposed. The aim of this study was to assess structural transcatheter valve deterioration (SVD) and bioprosthetic valve failure (BVF) using these new definitions.
All TAVI patients implanted up to September 2012 with a minimal theoretical five-year follow-up were included. Systematic clinical and echocardiographic follow-up was performed annually. New standardised definitions were used to assess durability of transcatheter aortic bioprosthetic valves. From 2002 to 2012, 378 patients were included. Mean age and logistic EuroSCORE were 83.3±6.8 years and 22.8±13.1%. Thirty-day mortality was 13.2%. Nine patients had SVD including two severe forms and two patients had definite late BVF. The incidence of SVD and BVF at eight years was 3.2% (95% CI: 1.45-6.11) and 0.58% (95% CI: 0.15-2.75), respectively.
Even though limited by the poor survival of the very high-risk/compassionate early population, our data do not demonstrate any alarm concerning transcatheter aortic valve durability. Careful prospective assessment in younger and lower-risk patients and comparison with surgical bioprosthetic valves are required for further assessment of the long-term durability of transcatheter valves.
经导管主动脉生物瓣的耐久性仍然是一个主要问题。最近提出了生物瓣恶化和失效的标准化定义。本研究的目的是使用这些新定义评估经导管瓣膜结构恶化(SVD)和生物瓣失效(BVF)。
纳入了截至 2012 年 9 月植入的所有具有最小理论五年随访期的 TAVI 患者。每年进行系统的临床和超声心动图随访。使用新的标准化定义来评估经导管主动脉生物瓣的耐久性。2002 年至 2012 年期间,共纳入 378 例患者。平均年龄和逻辑 EuroSCORE 分别为 83.3±6.8 岁和 22.8±13.1%。30 天死亡率为 13.2%。9 例患者出现 SVD,其中包括 2 例严重形式和 2 例明确的晚期 BVF。8 年时 SVD 和 BVF 的发生率分别为 3.2%(95%CI:1.45-6.11)和 0.58%(95%CI:0.15-2.75)。
尽管受到高危/同情性早期人群生存不良的限制,但我们的数据并未显示出任何关于经导管主动脉瓣耐久性的警报。需要对年轻和低危患者进行仔细的前瞻性评估,并与外科生物瓣进行比较,以进一步评估经导管瓣膜的长期耐久性。