Gooley R, Cameron J D, Meredith I T
MonashHeart, Monash Health, Melbourne, Vic., Australia; Monash Cardiovascular Research Centre, Monash University, Melbourne, Vic., Australia.
MonashHeart, Monash Health, Melbourne, Vic., Australia; Monash Cardiovascular Research Centre, Monash University, Melbourne, Vic., Australia.
Heart Lung Circ. 2015 Dec;24(12):1149-61. doi: 10.1016/j.hlc.2015.07.017. Epub 2015 Aug 8.
Since the first transcatheter aortic valve implantation (TAVI) was performed by Alain Cribier and colleagues in 2002 [1], the technology has garnered global support with more than 200,000 devices implanted. The rapid adoption of this technology has been driven by the need for a less invasive treatment modality in a cohort of patients often denied conventional surgical valve replacement due to an unacceptably high perioperative risk, whether real or perceived [2]. This, together with evidence that the technology confers morbidity and mortality advantages compared to medical therapy [3,4] and at least equivalent outcomes to surgical valve replacement [5,6] in select cohorts, has seen clinical approval in more than 50 countries. The last 13 years has seen an evolution of practises and equipment affecting almost every aspect of the TAVI procedure from pre-procedural assessment to device design and post-procedural care. The almost exponential rate of change has both benefits and risks. Benefits, in that impactful changes are translated into clinical practice very rapidly, but risks, in that meaningful comparative research studies potentially lag behind and can be outmoded by the time they are published. This instability may in turn delay regulatory review and approval processes that are based on such studies. The aim of this review is to provide an overview of the evolution of TAVI, its current clinical position and likely future directions.
自2002年阿兰·克里比埃及其同事首次进行经导管主动脉瓣植入术（TAVI）以来[1]，这项技术已获得全球支持，植入设备超过20万台。对于一组因围手术期风险过高（无论实际风险还是感知风险）而常被拒绝接受传统外科瓣膜置换术的患者而言，对侵入性较小的治疗方式的需求推动了这项技术的迅速应用[2]。此外，有证据表明，与药物治疗相比，该技术具有降低发病率和死亡率的优势[3,4]，并且在特定队列中与外科瓣膜置换术的疗效至少相当[5,6]，因此该技术已在50多个国家获得临床批准。在过去的13年里，从术前评估到设备设计以及术后护理，TAVI手术几乎每个方面的操作和设备都在不断发展。这种几乎呈指数级的变化速度既有好处也有风险。好处在于有影响力的变革能非常迅速地转化为临床实践，但风险在于有意义的比较研究可能会滞后，而且在发表时可能已经过时。这种不稳定性反过来可能会延迟基于此类研究的监管审查和批准程序。本综述的目的是概述TAVI的发展历程、其当前的临床地位以及可能的未来发展方向。
