AIMS In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Data on long-term TAV performance are still limited. We sought to evaluate the clinical and haemodynamic outcomes of the CoreValve self-expandable valve up to 8-year follow-up (FU). METHODS AND RESULTS Nine hundred and ninety inoperable or high-risk patients were treated with the CoreValve TAV in eight Italian Centres from June 2007 to December 2011. The median FU was 4.4 years (interquartile range 1.4-6.7 years). Longest FU reached 11 years. A total of 728 died within 8-year FU (78.3% mortality from Kaplan-Meier curve analysis). A significant functional improvement was observed in the majority of patients and maintained over time, with 79.3% of surviving patients still classified New York Heart Association class ≤ II at 8 years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (9 ± 4 mmHg at discharge, 9 ± 5 mmHg at 8 years, P = 0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU ≥5 years in paired analysis (P = 0.164). Structural valve deterioration (SVD) and late bioprosthetic valve failure (BVF) were defined according to a modification of the 2017 EAPCI/ESC/EACTS criteria. In cumulative incidence functions at 8 years, moderate and severe SVD were 3.0% [95% confidence interval (CI) 2.1-4.3%] and 1.6% (95% CI 0.6-3.9%), respectively, while late BVF was 2.5% (95% CI 1.2-5%). CONCLUSION While TAVs are questioned about long-term performance and durability, the results of the present research provide reassuring 8-year evidence on the CoreValve first-generation self-expandable bioprosthesis.

中文翻译：

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使用自膨胀生物假体进行经导管主动脉瓣置换术的长期临床结果和性能

目的 在过去十年中，经导管主动脉瓣 (TAV) 置换术确定了严重症状性主动脉瓣狭窄患者治疗的范式转变。关于 TAV 长期表现的数据仍然有限。我们试图评估 CoreValve 自膨式瓣膜长达 8 年随访 (FU) 的临床和血液动力学结果。方法和结果 2007 年 6 月至 2011 年 12 月，意大利 8 个中心的 990 名不能手术或高危患者接受 CoreValve TAV 治疗。中位 FU 为 4.4 年（四分位距为 1.4-6.7 年）。最长的FU达到11年。在 8 年 FU 内共有 728 人死亡（Kaplan-Meier 曲线分析的死亡率为 78.3%）。在大多数患者中观察到显着的功能改善并随着时间的推移得以维持，其中 79 人。3% 的存活患者在 8 年时仍将纽约心脏协会分类为≤ II 级。超声心动图数据显示平均跨人工主动脉梯度基本保持不变（出院时为 9 ± 4 mmHg，8 年时为 9 ± 5 mmHg，P = 0.495）。FU 期间 0/1 级瓣周漏的发生率是一致的，配对分析中从术后到 FU ≥5 年没有显着变化（P = 0.164）。结构性瓣膜退化 (SVD) 和晚期生物瓣膜失效 (BVF) 是根据 2017 年 EAPCI/ESC/EACTS 标准的修订版定义的。在 8 年的累积发病率函数中，中度和重度 SVD 分别为 3.0% [95% 置信区间 (CI) 2.1-4.3%] 和 1.6% (95% CI 0.6-3.9%)，而晚期 BVF 为 2.5% ( 95% 置信区间 1.2-5%）。