Chiam Paul T L, Ruiz Carlos E
Department of Cardiac and Vascular Interventional Services, Lenox Hill Heart and Vascular Institute, New York, New York 10021, USA.
JACC Cardiovasc Interv. 2008 Aug;1(4):341-50. doi: 10.1016/j.jcin.2008.03.018.
Aortic valve stenosis is increasing in frequency as the population ages. Surgical aortic valve replacement is the gold standard for symptomatic patients with severe aortic valve stenosis. However, in a subset of high-risk patients, the surgical option is excluded due to severe comorbidities. Recently, an alternative to surgical aortic valve replacement--percutaneous aortic valve replacement (PAVR)--has emerged. Since the first PAVR in a human in 2002, the percutaneous heart valves (PHVs) have already undergone several modifications from first generation devices. Currently, there are 2 PHVs in clinical application, a balloon-expandable and a self-expandable PHV, with several others achieving first-in-man application. With the extremely rapid technological advancements, PAVR is probably here to stay. The next steps required would be to formulate goals to assess results and outcomes of PAVR, and plan trials to test their clinical applicability. This article discusses how best to assess results and outcomes, which may require a paradigm shift in mindset. Apart from the randomized controlled trial, some of the more novel concepts in trial design, which may be more suitable in this area, are also explored.
随着人口老龄化，主动脉瓣狭窄的发病率不断上升。对于有症状的重度主动脉瓣狭窄患者，外科主动脉瓣置换术是金标准。然而，在一部分高危患者中，由于严重的合并症，手术选择被排除。最近，出现了一种替代外科主动脉瓣置换术的方法——经皮主动脉瓣置换术（PAVR）。自2002年首例人体PAVR以来，经皮心脏瓣膜（PHV）已经从第一代装置经历了多次改进。目前，有2种PHV在临床应用，一种是球囊扩张式，一种是自膨胀式PHV，还有其他几种已应用于人体首例。随着技术的飞速发展，PAVR可能会持续存在。接下来需要采取的步骤是制定评估PAVR结果和疗效的目标，并规划试验以测试其临床适用性。本文讨论了如何最好地评估结果和疗效，这可能需要思维模式的转变。除了随机对照试验，还探讨了一些在试验设计中更新颖的概念，这些概念可能更适用于该领域。
