Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
Am Heart J. 2021 Jul;237:25-33. doi: 10.1016/j.ahj.2021.03.006. Epub 2021 Mar 10.
Previous studies from the Low Risk TAVR (LRT) trial demonstrated that transcatheter aortic valve replacement (TAVR) is safe and feasible in low-risk patients, with excellent 30-day and 1-year outcomes. The objective of this study was to report clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration (SVD) 2 years after TAVR.
The LRT trial was the first Food and Drug Administration-approved Investigational Device Exemption trial in the United States to evaluate the safety and feasibility of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis (AS). Valve hemodynamics and SVD by echo were recorded 30 days, 1 year, and 2 years post-TAVR.
The LRT trial enrolled 200 low-risk patients to receive TAVR. Their mean age was 73.6 years and 61.5% were men. At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%. The disabling stroke rate was 1.1%, permanent pacemaker implantation rate was 8.6%, and 4 patients (2.2%) presented with endocarditis (2 between years 1 and 2). Of the 14% of TAVR subjects who had evidence of HALT at 30 days, there was no impact on valve hemodynamics, endocarditis or stroke at 2 years.
TAVR for low-risk patients with symptomatic severe tricuspid AS is safe at 2 years. The presence of HALT at 30 days did not impact the early hemodynamic improvements nor the durability of the valve structure.
来自低危经导管主动脉瓣置换术（LRT）试验的先前研究表明，经导管主动脉瓣置换术（TAVR）在低危患者中是安全且可行的，具有出色的 30 天和 1 年结果。本研究的目的是报告临床结果以及 30 天低衰减瓣叶增厚（HALT）对 TAVR 后 2 年结构性瓣膜恶化（SVD）的影响。
LRT 试验是美国第一个获得食品和药物管理局批准的研究性器械豁免试验，旨在评估 TAVR 在有症状的严重三尖瓣主动脉瓣狭窄（AS）的低危患者中的安全性和可行性。在 TAVR 后 30 天、1 年和 2 年记录瓣膜血流动力学和超声心动图 SVD。
LRT 试验纳入了 200 名低危患者接受 TAVR。他们的平均年龄为 73.6 岁，61.5%为男性。2 年随访时，死亡率为 4.2%；心血管死亡率为 1.6%。致残性卒中率为 1.1%，永久性起搏器植入率为 8.6%，有 4 名患者（2.2%）发生感染性心内膜炎（2 例发生在 1 年至 2 年期间）。在 30 天时 HALT 证据的 14%的 TAVR 患者中，2 年时瓣膜血流动力学、心内膜炎或卒中没有受到影响。
对于有症状的严重三尖瓣 AS 的低危患者，TAVR 在 2 年内是安全的。30 天时存在 HALT 并不影响早期血流动力学改善或瓣膜结构的耐久性。
