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经导管主动脉瓣置换术的极限挑战:高容量中心的影响、过度自信还是其他因素?

Pushing the Limits in Transcatheter Aortic Valve Replacement: High-Volume Center's Effect, Overconfidence, or Something Else?

机构信息

Department of Cardiac Surgery, Centre Cardiologique du Nord de Saint-Denis, Paris, France.

Department of Cardiothoracic Surgery, Golden Jubilee National Hospital, Glasgow, United Kingdom; University of Glasgow, College of Medical, Veterinary and Life Sciences, Institute of Cardiovascular and Medical Sciences, Glasgow, United Kingdom.

出版信息

JACC Cardiovasc Interv. 2016 Nov 14;9(21):2186-2188. doi: 10.1016/j.jcin.2016.08.014. Epub 2016 Oct 12.

Abstract

The recent literature on transcatheter aortic valve replacement (TAVR) is shedding new light on the perspective to extend this procedure to other lower risk-category of patients, leading in fact to a potential erosion of the current guidelines. Notwithstanding the warnings provided in the literature regarding the risk of severely impairing complications, unclear survival advantage, and cost-inefficiency, many observational studies, especially performed in high-volume centers, support a general drive toward the recruitment of intermediate-low risk patients in the expectation of clinical advantages versus standard surgical replacement. It appears that, in combination with the development of more refined technologies, medical groups with matured experience and centers able to successfully manage patients with different profiles have been progressively "selected" and emerged pushing further the limits of the procedure itself. On the surgeon side, involved in the surgical assistance of TAVR procedures or in the standby-coverage in case of major complications, the expansion of indications and the interventionists' overconfidence have relevant implications. Considerations on the actual long-term effectiveness of the procedure on younger lower-risk patients in terms of actual hemodynamic durability and inability to deal with functional and morphological aspects of annular calcifications should be made. Also, it seems that other technologies enabling annulus decalcification, such as sutureless valve, have been totally overlooked and trials sponsored by industrial leaders in the market have taken the lead. Such a rapid expansion of TAVR indications should be better understood considering that in the surgical field valve bioprostheses needed to undergo a much longer validation period and the appearance of data on their 20 years follow-up after implantation was required before the application in younger patients.

摘要

经导管主动脉瓣置换术(TAVR)的最新文献为将该手术扩展到其他低风险类别的患者提供了新的视角,这实际上可能会侵蚀当前的指南。尽管文献中就严重并发症风险、生存优势不明确和成本效益不佳提出了警告,但许多观察性研究,尤其是在高容量中心进行的研究,支持将中低危风险患者纳入一般人群,以期望获得优于标准手术置换的临床优势。似乎,随着更精细技术的发展,经验成熟的医疗团队和能够成功管理不同类型患者的中心已经逐渐被“选择”出来,进一步推动了手术本身的极限。对于参与 TAVR 手术协助或在发生重大并发症时进行待命覆盖的外科医生来说,适应证的扩大和介入医生的过度自信都具有重要的意义。应该考虑到年轻低危患者的实际长期手术效果,包括实际血流动力学耐久性和处理瓣环钙化功能和形态方面的能力。此外,似乎还有其他能够进行瓣环去钙化的技术,如无缝线瓣膜,但完全被忽视了,市场上的工业领导者赞助的试验已经领先。考虑到在手术领域,瓣膜生物假体需要经过更长的验证期,并且在将其应用于年轻患者之前,需要在植入后 20 年的随访中获得数据,TAVR 适应证的这种快速扩展应该得到更好的理解。

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