Praz Fabien, Siontis George C M, Verma Subodh, Windecker Stephan, Jüni Peter
aDepartment of Cardiology, Bern University Hospital, Bern, Switzerland bDivision of Cardiac Surgery cApplied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Curr Opin Cardiol. 2017 Mar;32(2):117-122. doi: 10.1097/HCO.0000000000000379.
The goal of this review is to summarize the current evidence supporting the use of transcatheter aortic valve implantation (TAVI) in high and intermediate-risk patients. The focus is on the five randomized controlled trials comparing TAVI with surgical aortic valve replacement (SAVR) published to date, as well as two recent meta-analyses.
TAVI has profoundly transformed the treatment of elderly patients presenting with symptomatic severe aortic stenosis. In experienced hands, the procedure has become well tolerated and the results more predictable. So far, two trials using two different devices [Placement of Aortic Transcatheter Valve (PARTNER) 1A and US CoreValve High Risk] have shown that TAVI is able to compete in terms of mortality with SAVR in high-risk patients. These findings have been extended to the intermediate-risk population in two recently published randomized controlled trials [PARTNER 2 and Nordic Aortic Valve Intervention (NOTION)]. The two meta-analyses suggested improved survival in both high and intermediate-risk patients during the first 2 years following the intervention. The survival benefit was only found in patients treated via the transfemoral access, and appeared more pronounced in women.
Individual randomized trials enrolling high and intermediate-risk patients have established the noninferiority of TAVI in comparison with SAVR, whereas subsequent meta-analyses suggest superiority of transfemoral TAVI in terms of a sustained survival benefit 2 years after valve implantation irrespective of the surgical risk category. The benefit of TAVI appears more pronounced in women than in men.
本综述的目的是总结目前支持在高风险和中风险患者中使用经导管主动脉瓣植入术(TAVI)的证据。重点是迄今为止发表的五项比较TAVI与外科主动脉瓣置换术(SAVR)的随机对照试验,以及两项近期的荟萃分析。
TAVI已深刻改变了有症状的严重主动脉瓣狭窄老年患者的治疗方式。在经验丰富的医生手中,该手术已变得耐受性良好,结果也更可预测。到目前为止,两项使用不同器械的试验[主动脉经导管瓣膜置入术(PARTNER)1A和美国CoreValve高风险试验]表明,在高风险患者中,TAVI在死亡率方面能够与SAVR相竞争。这些发现已在最近发表的两项随机对照试验[PARTNER 2和北欧主动脉瓣干预(NOTION)试验]中扩展到中风险人群。两项荟萃分析表明,在干预后的头两年,高风险和中风险患者的生存率均有所提高。生存获益仅在经股动脉途径治疗的患者中发现,且在女性中更为明显。
纳入高风险和中风险患者的个体随机试验已证实TAVI与SAVR相比具有非劣效性,而随后的荟萃分析表明,无论手术风险类别如何,经股动脉TAVI在瓣膜植入后2年具有持续生存获益方面具有优越性。TAVI的获益在女性中似乎比男性更明显。