Boskovski Marko T, Nguyen Tom C, McCabe James M, Kaneko Tsuyoshi
Division of Cardiac Surgery, Brigham and Women's Hospital, Boston, Massachusetts.
Department of Cardiothoracic and Vascular Surgery, University of Texas at Houston.
JAMA Surg. 2020 Jan 1;155(1):69-77. doi: 10.1001/jamasurg.2019.4449.
Medically treated symptomatic severe aortic stenosis has poor outcomes, and in the past 6 decades, it has successfully been treated with surgical aortic valve replacement (SAVR). However, one-third of patients with indications for SAVR are not offered surgery because of the high risk of complications. Transcatheter aortic valve replacement (TAVR), initially developed as a less invasive treatment for inoperable patients, has successfully been used in healthier patient cohorts. In 2017, TAVR became the most common approach for aortic valve replacement in the United States.
During the past decade, the Placement of Aortic Transcatheter Valve (PARTNER) trials (for balloon-expandable valves) and the CoreValve trials (for self-expandable valves) investigated the performance of TAVR in progressively lower-risk patient cohorts. The initial trials demonstrated TAVR to be superior (PARTNER B) and noninferior (CoreValve Extreme Risk) to optimal medical therapy in inoperable patients. Subsequent trials showed both balloon-expandable and self-expandable valves to have good results in high-risk, medium-risk, and low-risk surgical patients when compared with SAVR. However, owing to the fundamentally different nature of the procedure, some complications have been more prevalent with TAVR, most notably moderate or severe paravalvular leak, conduction abnormalities necessitating permanent pacemaker placement, and vascular complications. When present, these complications have been associated with worse outcomes.
The results of the groundbreaking TAVR trials from the past decade have led to a revolution in the treatment of aortic stenosis. There are now 3 US Food and Drug Administration-approved TAVR devices, and with the encouraging results from the latest low-risk trials, TAVR is likely going to become the dominant treatment for symptomatic severe aortic stenosis. New devices on the horizon are looking to improve the complication rates of TAVR, and ongoing trials are looking to further expand the indications of TAVR and answer 1 of the main remaining questions, ie, long-term durability of percutaneously placed devices.
药物治疗有症状的重度主动脉瓣狭窄预后较差，在过去60年中，外科主动脉瓣置换术（SAVR）已成功用于治疗该疾病。然而，由于并发症风险高，三分之一有SAVR指征的患者未接受手术。经导管主动脉瓣置换术（TAVR）最初是作为一种侵入性较小的治疗方法用于无法手术的患者，现已成功应用于健康状况较好的患者群体。2017年，TAVR成为美国最常用的主动脉瓣置换方法。
在过去十年中，主动脉经导管瓣膜置入（PARTNER）试验（针对球囊扩张瓣膜）和CoreValve试验（针对自膨胀瓣膜）研究了TAVR在风险逐渐降低的患者群体中的表现。最初的试验表明，在无法手术的患者中，TAVR优于最佳药物治疗（PARTNER B试验）且不劣于最佳药物治疗（CoreValve极端风险试验）。随后的试验表明，与SAVR相比，球囊扩张瓣膜和自膨胀瓣膜在高风险、中风险和低风险外科手术患者中均取得了良好效果。然而，由于该手术本质上存在差异，一些并发症在TAVR中更为常见，最显著的是中度或重度瓣周漏、需要植入永久起搏器的传导异常以及血管并发症。出现这些并发症时，预后较差。
过去十年具有开创性的TAVR试验结果引发了主动脉瓣狭窄治疗的革命。目前有3种经美国食品药品监督管理局批准的TAVR设备，鉴于最新低风险试验的鼓舞人心的结果，TAVR可能会成为有症状的重度主动脉瓣狭窄的主要治疗方法。即将出现的新设备有望改善TAVR的并发症发生率，正在进行的试验则希望进一步扩大TAVR的适应证，并解答剩余的主要问题之一，即经皮置入设备的长期耐用性。
