Barker Colin M, Reardon Michael J
Houston Methodist DeBakey Heart and Vascular Center, Houston Methodist Hospital, Houston, Texas, USA.
Houston Methodist DeBakey Heart and Vascular Center, Houston Methodist Hospital, Houston, Texas, USA.
Can J Cardiol. 2017 Sep;33(9):1124-1128. doi: 10.1016/j.cjca.2017.06.013. Epub 2017 Jun 27.
Transcatheter aortic valve replacement (TAVR) was initially envisioned as a less invasive option for patients with severe symptomatic aortic stenosis who either were not candidates or were very high-risk candidates for surgical aortic valve replacement (SAVR). Based on data from the original Placement of Aortic Transcatheter Valve (PARTNER) trials as well as the CoreValve Pivotal trials, TAVR is now approved and accepted in the treatment of severe symptomatic aortic stenosis in extreme-risk and high-risk patient populations. Thus far, the randomized controlled trial data for TAVR have been noninferior or even superior to both medical therapy and SAVR. Recently, the US Food and Drug Administration expanded the indications for 2 balloon-expandable devices, and CE Mark status was awarded to a self-expanding device for use in patients at intermediate risk. Given all the data, the logical next step is to study low-risk patient groups. Anecdotal and nonrandomized data have been conflicting when comparing TAVR to SAVR in low-risk patients. Two low-risk randomized trials have started in the United States, and ultimately these trials will determine the feasibility of TAVR as an acceptable alternative to SAVR in low-risk patients with severe aortic stenosis.
经导管主动脉瓣置换术（TAVR）最初被设想为一种侵入性较小的选择，适用于患有严重症状性主动脉瓣狭窄且不适合或极有可能进行外科主动脉瓣置换术（SAVR）的患者。根据最初的主动脉经导管瓣膜植入（PARTNER）试验以及CoreValve关键试验的数据，TAVR目前已被批准并用于治疗极高风险和高风险患者群体中的严重症状性主动脉瓣狭窄。到目前为止，TAVR的随机对照试验数据不劣于甚至优于药物治疗和SAVR。最近，美国食品药品监督管理局扩大了两种球囊扩张式器械的适应症，一种自膨胀式器械也获得了欧洲合格认证（CE标志），可用于中度风险患者。鉴于所有这些数据，接下来合乎逻辑的步骤是研究低风险患者群体。在低风险患者中比较TAVR和SAVR时，轶事性和非随机数据一直存在矛盾。美国已经启动了两项针对低风险患者的随机试验，最终这些试验将确定TAVR作为严重主动脉瓣狭窄低风险患者可接受的SAVR替代方案的可行性。
