Division of Medical Imaging, Health Management Center, Cheng Hsin General Hospital, Taipei, Taiwan, ROC.
Faculty of Medicine, National Defense Medical Center, Taipei, Taiwan, ROC.
J Chin Med Assoc. 2019 Nov;82(11):827-834. doi: 10.1097/JCMA.0000000000000187.
Data on whether different transcatheter aortic valve replacement (TAVR) devices and delivery approaches can achieve equally favorable outcomes when performed by a single heart team are scarce. We sought to compare the performance and short-term outcomes of three different TAVR devices-self-expanding Medtronic CoreValve (MCV), mechanically expanded Lotus valve, and balloon-expandable Edwards SAPIEN XT (SXT)-for the treatment of severe aortic stenosis (AS) in a single large-volume center in Taiwan.
We retrospectively reviewed consecutive patients who underwent TAVR for the treatment of severe AS. Clinical outcomes were reported following Valve Academic Research Consortium 2 (VARC-2) criteria. The composite primary endpoint was combined all-cause mortality, myocardial infarction (MI), or disabling stroke within 180 days.
A total of 231 patients (MCV n=112, Lotus n=18, and SXT n=101) were included. The device and procedural success rates were similar among all three TAVR devices. At 30 days, there was no significant difference in all-cause mortality, cardiovascular mortality, periprocedural MI, stroke, major vascular complications, life-threatening bleeding, acute kidney injury (AKI, stage 2/3), or VARC-2 composite early safety endpoints. There was no difference among groups in the rate of primary endpoint within 180 days. Lack of procedural success, presence of acute coronary occlusion during TAVR, and presence of AKI (stage 3) after TAVR were independent predictors of adverse outcomes.
TAVR using MCV, Lotus, or SXT was associated with similar 30- and 180-day clinical outcomes. The presence of periprocedural complications was one of the main determinants of short-term adverse outcomes.
关于单个心脏团队进行不同经导管主动脉瓣置换(TAVR)装置和输送方法是否可以实现同样有利的结果的数据很少。我们旨在比较三种不同的 TAVR 装置-自扩张美敦力 CoreValve(MCV)、机械扩张 Lotus 瓣膜和球囊扩张 Edwards SAPIEN XT(SXT)-在台湾的一个大型中心治疗严重主动脉瓣狭窄(AS)的性能和短期结果。
我们回顾性地审查了接受 TAVR 治疗严重 AS 的连续患者。临床结果按照 Valve Academic Research Consortium 2(VARC-2)标准报告。复合主要终点是 180 天内全因死亡率、心肌梗死(MI)或致残性中风的组合。
共纳入 231 例患者(MCV n=112,Lotus n=18,SXT n=101)。所有三种 TAVR 装置的器械和程序成功率相似。在 30 天内,三种 TAVR 装置在全因死亡率、心血管死亡率、围手术期 MI、中风、大血管并发症、威胁生命的出血、急性肾损伤(AKI,第 2/3 期)或 VARC-2 复合早期安全性终点方面无显著差异。在 180 天内主要终点的发生率在各组之间没有差异。手术成功率不足、TAVR 期间存在急性冠状动脉闭塞以及 TAVR 后存在 AKI(第 3 期)是不良结局的独立预测因素。
使用 MCV、Lotus 或 SXT 的 TAVR 与类似的 30 天和 180 天临床结果相关。围手术期并发症的存在是短期不良结局的主要决定因素之一。