Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
J Am Coll Cardiol. 2019 Feb 12;73(5):546-553. doi: 10.1016/j.jacc.2018.10.083.
Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and intermediate or high surgical risk.
The aim of this study was to compare the durability of transcatheter and surgical bioprosthetic aortic valves using standardized criteria.
In the NOTION (Nordic Aortic Valve Intervention) trial, all-comer patients with severe aortic stenosis and lower surgical risk for mortality were randomized 1:1 to TAVR (n = 139) or SAVR (n = 135). Moderate/severe structural valve deterioration (SVD) was defined as a mean gradient ≥20 mm Hg, an increase in mean gradient ≥10 mm Hg from 3 months post-procedure, or more than mild intraprosthetic aortic regurgitation (AR) either new or worsening from 3 months post-procedure. Nonstructural valve deterioration (NSVD) was defined as moderate/severe patient-prosthesis mismatch at 3 months or moderate/severe paravalvular leakage. Bioprosthetic valve failure (BVF) was defined as: valve-related death, aortic valve reintervention, or severe hemodynamic SVD.
At 6 years, the rates of all-cause mortality were similar for TAVR (42.5%) and SAVR (37.7%) patients (p = 0.58). The rate of SVD was higher for SAVR than TAVR (24.0% vs. 4.8%; p < 0.001), whereas there were no differences in NSVD (57.8% vs. 54.0%; p = 0.52) or endocarditis (5.9% vs. 5.8%; p = 0.95). BVF rates were similar after SAVR and TAVR through 6 years (6.7% vs. 7.5%; p = 0.89).
In the NOTION trial through 6 years, SVD was significantly greater for SAVR than TAVR, whereas BVF was low and similar for both groups. Longer-term follow-up of randomized clinical trials will be necessary to confirm these findings. (Nordic Aortic Valve Intervention Trial; NCT01057173).
经导管主动脉瓣置换术（TAVR）是严重主动脉瓣狭窄和中高危手术风险患者替代外科主动脉瓣置换术（SAVR）的一种选择。
本研究旨在使用标准化标准比较经导管和外科生物瓣主动脉瓣的耐久性。
在 NOTION（北欧主动脉瓣介入）试验中，所有适合接受严重主动脉瓣狭窄和死亡率较低的外科手术风险的患者均按 1:1 随机分为 TAVR（n=139）或 SAVR（n=135）组。中度/重度结构性瓣叶恶化（SVD）定义为平均梯度≥20mmHg，术后 3 个月时平均梯度增加≥10mmHg，或术后 3 个月时新出现或恶化的中度/重度瓣内主动脉瓣反流（AR）。非结构性瓣叶恶化（NSVD）定义为术后 3 个月时中度/重度患者-瓣叶不匹配或中度/重度瓣周漏。生物瓣叶失效（BVF）定义为：瓣膜相关死亡、主动脉瓣再介入或严重血流动力学 SVD。
6 年时，TAVR（42.5%）和 SAVR（37.7%）患者的全因死亡率相似（p=0.58）。SAVR 的 SVD 发生率高于 TAVR（24.0%比 4.8%；p<0.001），而 NSVD（57.8%比 54.0%；p=0.52）或心内膜炎（5.9%比 5.8%；p=0.95）无差异。SAVR 和 TAVR 组 6 年时 BVF 发生率相似（6.7%比 7.5%；p=0.89）。
NOTION 试验 6 年时，SAVR 的 SVD 明显高于 TAVR，而 BVF 发生率低且两组相似。需要对随机临床试验进行更长期的随访，以确认这些发现。（北欧主动脉瓣介入试验；NCT01057173）。
