Department of Cardiology, Medical School of Athens University, Hippokration Hospital, Athens, Greece.
Department of Cardiology, Onassis Heart Center, Athens, Greece.
Am J Cardiol. 2021 May 15;147:80-87. doi: 10.1016/j.amjcard.2021.02.006. Epub 2021 Feb 20.
Transcatheter aortic valve implantation (TAVI) is an established method for treating patients with aortic valve stenosis. We sought to determine the long-term clinical outcomes and performance of a self-expanding bioprosthesis beyond 5 years. Consecutive patients scheduled for TAVI were included in the analysis. Primary end points were all-cause and cardiovascular mortality, structural valve deterioration (SVD) and bioprosthetic valve failure (BVF), based on the VARC-2 criteria and consensus statement by ESC/EAPCI. The study prospectively evaluated 273 patients (80.61 ± 7.00 years old, 47% females) who underwent TAVI with CoreValve/Evolut-R (Medtronic Inc.). The median follow-up duration was 5 years (interquartile range: 2.9 to 6; longest: 8 years). At 1, 5, and 8 years, estimated survival rates were 89.0%, 61.1%, and 56.0%, respectively, while cardiovascular mortality was 8% at the end of follow-up. Regarding valve performance, 5% of patients had early BVF and 1% had late BVF. Concerning SVD, 16 patients (6% of the total population) had moderate SVD (91% had an increase in mean gradient), with no severe SVD cases. Five patients with SVD died during follow-up. Actual analysis of the 8-year cumulative incidence of function of moderate SVD was 5.9% (2.5% to 16.2%). At multivariate analysis, the factor that emerged as an independent predictor for future SVD, was smaller bioprosthetic valve size (HR 0.58, 95% CI 0.41 to 0.82, p = 0.002). Long-term evaluation beyond 5 years after TAVI with a self-expanding bioprosthesis demonstrated low rates of cardiovascular mortality and structural valve deterioration. Valve size was an independent predictor for SVD.
经导管主动脉瓣植入术(TAVI)是治疗主动脉瓣狭窄患者的一种成熟方法。我们旨在确定自膨式生物瓣在 5 年以上的长期临床结局和性能。连续接受 TAVI 的患者被纳入分析。主要终点是根据 VARC-2 标准和 ESC/EAPCI 共识声明,全因和心血管死亡率、结构性瓣膜退化(SVD)和生物瓣故障(BVF)。该研究前瞻性评估了 273 名(80.61 ± 7.00 岁,47%为女性)接受 CoreValve/Evolut-R(美敦力公司)TAVI 的患者。中位随访时间为 5 年(四分位距:2.9 至 6;最长:8 年)。在 1、5 和 8 年时,估计生存率分别为 89.0%、61.1%和 56.0%,而在随访结束时心血管死亡率为 8%。关于瓣膜性能,5%的患者发生早期 BVF,1%的患者发生晚期 BVF。关于 SVD,16 名患者(占总人数的 6%)有中度 SVD(91%的平均梯度增加),没有严重 SVD 病例。5 名 SVD 患者在随访期间死亡。对 SVD 中度功能的 8 年累积发生率的实际分析为 5.9%(2.5%至 16.2%)。多变量分析显示,生物瓣尺寸较小是未来发生 SVD 的独立预测因素(HR 0.58,95%CI 0.41 至 0.82,p = 0.002)。TAVI 后 5 年以上的长期评估显示,心血管死亡率和结构性瓣膜退化的发生率较低。瓣膜尺寸是 SVD 的独立预测因素。
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