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经导管主动脉瓣置入术中瓣中瓣治疗或栓塞的决定因素和结局:美国 PARTNER 试验(主动脉瓣经导管置换试验 Edwards SAPIEN 经导管心脏瓣膜)中多种瓣膜植入物的研究。

Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: a study of multiple valve implants in the U.S. PARTNER trial (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve).

机构信息

Heart Institute, Cedars-Sinai Heart Institute, Los Angeles, California 90048, USA.

出版信息

J Am Coll Cardiol. 2013 Jul 30;62(5):418-30. doi: 10.1016/j.jacc.2013.04.037. Epub 2013 May 15.

DOI:10.1016/j.jacc.2013.04.037
PMID:23684680
Abstract

OBJECTIVES

This study investigated the determinants and outcomes of acute insertion of a second transcatheter prosthetic valve (TV) within the first (TV-in-TV) or transcatheter valve embolization (TVE) after transcatheter aortic valve replacement (TAVR).

BACKGROUND

TAVR failure can occur with both TV-in-TV and TVE as a consequence of TAVR malpositioning. Only case reports and limited series pertaining to these complications have been reported to date.

METHODS

Patients undergoing TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve) randomized trial (cohorts A and B) and accompanying registries were studied. Data were dichotomized for those with and without TV-in-TV or TVE, respectively.

RESULTS

From a total of 2,554 consecutive patients, 63 (2.47%) underwent TV-in-TV and 26 (1.01%) TVE. The indication for TV-in-TV was significant aortic regurgitation in most patients, often due not only to malpositioning but also to leaflet dysfunction. Despite similar aortic valve function on follow-up echoes, TV-in-TV was an independent predictor of 1-year cardiovascular mortality (hazard ratio [HR]: 1.86, 95% confidence interval [CI]: 1.03 to 3.38, p = 0.041), with a nonsignificant trend toward greater all-cause mortality (HR: 1.43, 95% CI: 0.88 to 2.33, p = 0.15). Technical and anatomical reasons accounted for most cases of TVE. A multivariable analysis found TVE to be an independent predictor of 1-year mortality (HR: 2.68, 95% CI: 1.34 to 5.36, p = 0.0055) but not cardiovascular mortality (HR: 1.30, 95% CI: 0.48 to 3.52, p = 0.60).

CONCLUSIONS

Acute TV-in-TV and TVE are serious sequelae of TAVR, often resulting in multiple valve implants. They carry an excess of mortality and are caused by anatomic and technical factors, which may be avoidable with judicious procedural planning.

摘要

目的

本研究旨在探讨经导管主动脉瓣置换术(TAVR)后再次经导管植入第二枚人工心脏瓣膜(TV-in-TV)或经导管瓣膜栓塞(TVE)的决定因素和结局。

背景

TV-in-TV 和 TVE 均会因 TAVR 定位不当而导致 TAVR 失败。迄今为止,仅报道了一些关于这些并发症的病例报告和有限的系列研究。

方法

研究对象为 PARTNER(经导管主动脉瓣置换术试验-爱德华兹 SAPIEN 经导管心脏瓣膜放置)随机试验(队列 A 和 B)和相关登记处中接受 TAVR 的患者。数据分别按有无 TV-in-TV 或 TVE 进行了分类。

结果

在总共 2554 例连续患者中,有 63 例(2.47%)行 TV-in-TV,26 例(1.01%)行 TVE。大多数患者 TV-in-TV 的指征为严重主动脉瓣反流,其原因不仅与定位不当有关,还与瓣叶功能障碍有关。尽管随访回声显示主动脉瓣功能相似,但 TV-in-TV 是 1 年心血管死亡率的独立预测因素(风险比[HR]:1.86,95%置信区间[CI]:1.03 至 3.38,p = 0.041),全因死亡率呈显著升高趋势(HR:1.43,95%CI:0.88 至 2.33,p = 0.15)。技术和解剖原因是 TVE 的主要原因。多变量分析发现,TVE 是 1 年死亡率的独立预测因素(HR:2.68,95%CI:1.34 至 5.36,p = 0.0055),但不是心血管死亡率的独立预测因素(HR:1.30,95%CI:0.48 至 3.52,p = 0.60)。

结论

急性 TV-in-TV 和 TVE 是 TAVR 的严重后果,常导致多枚瓣膜植入。它们会导致死亡率增加,其原因是解剖和技术因素,这些因素可以通过谨慎的手术计划来避免。

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