Left Ventricular Health and TAVR Timing in Asymptomatic Severe Aortic Stenosis: Analysis From the EARLY TAVR Trial.

In this study, the authors sought to evaluate whether baseline left ventricular (LV) health altered the treatment effect of early intervention and to examine longitudinal LV health under different treatment strategies.

在这项研究中，作者试图评估基线左心室（LV）健康状况是否改变了早期干预的治疗效果，并检查在不同治疗策略下左心室健康状况的纵向变化。

Methods

At 75 centers in the United States and Canada, 901 patients underwent randomization to TAVR (n = 455) or CS (n = 446).

在美国和加拿大的75个中心，共有901名患者被随机分配接受经导管主动脉瓣置换术（TAVR，n = 455）或冠状动脉旁路移植术（CS，n = 446）。

Echocardiographic measurements were made in a core laboratory.

超声心动图测量在核心实验室进行。

The protocol defined integrated LV health as the composite of absolute LV global longitudinal strain (GLS) ≥15%, LV mass index (LVMi) <115 g/m2 (men) or <95 g/m2 (women), and left atrial volume index (LAVi) ≤34 mL/m2.

该方案将左心室整体健康定义为绝对左心室全局纵向应变（GLS）≥15%，左心室质量指数（LVMi）男性<115 g/m2或女性<95 g/m2，以及左心房体积指数（LAVi）≤34 mL/m2的综合指标。

Integrated LV health was a prespecified secondary endpoint and the protocol outlined longitudinal measurements to be made in the intention-to-treat(ITT) and valve implant populations.

综合左心室健康是一个预先指定的次要终点，方案概述了在意向治疗（ITT）人群和瓣膜植入人群中进行纵向测量的计划。

As a stratification variable for effect-modification testing, LV health was not prespecified, so those analyses are exploratory.

作为效应修饰检验的分层变量，左心室健康状况并未预先指定，因此这些分析是探索性的。

The trial's primary endpoint and 2 secondary composites were examined.

该试验的主要终点和2个次要复合终点已被检查。

Results

At randomization, in the ITT population, 27% had normal integrated LV health (64% normal LVMi, 42% normal LAVi, 88% normal GLS).

在随机化时，意向治疗人群中，27%的患者左心室整体健康状况正常（64%的患者左心室质量指数正常，42%的患者左心房容积指数正常，88%的患者全局纵向应变正常）。

Abnormal integrated LV health and each component were generally associated with higher event rates across several composite endpoints.

异常的左心室整体健康状况以及各个组成部分通常与多个复合终点的较高事件率相关。

Benefit of early TAVR, compared with CS, was consistently observed regardless of whether LV health (evaluated as an integrated measure and as individual components) was normal or not.

与CS相比，无论左心室健康状况（综合评估和单独评估各组分）是否正常，早期TAVR的益处都是一致观察到的。

In the ITT population, the CS group exhibited normal LV health less frequently at 2 years than those treated early according to the integrated LV health measure (35.9% vs 48.1%; P < 0.001) and component measures.

在ITT人群中，CS组在2年时的正常左心室健康状况的频率低于那些根据综合左心室健康评估（35.9% vs 48.1%；P < 0.001）和单独组分评估接受早期治疗的患者。

Among CS patients undergoing delayed AVR, LV health tended to decline from randomization to preprocedure (P < 0.10 for all measures except GLS), but baseline LV health did not predict timing of conversion to AVR nor severity of presentation.

在接受延迟主动脉瓣置换术（AVR）的慢性血栓栓塞（CS）患者中，从随机分组到术前，左心室（LV）健康状况倾向于下降（除GLS外的所有指标P < 0.10），但基线LV健康状况并未预测转换为AVR的时机或病情的严重程度。

Conclusions

For patients with asymptomatic severe AS, the benefit of early TAVR, compared with CS, is consistent regardless of baseline LV health according to integrated or individual measures.

对于无症状的严重主动脉瓣狭窄（AS）患者，与CS相比，早期经导管主动脉瓣置换术（TAVR）的益处是一致的，无论基线LV健康状况如何，根据综合或个体测量结果。

These exploratory findings suggest limited value for measures of LV health to guide the timing of TAVR in asymptomatic patients.

这些探索性发现表明，对于无症状患者，左心室健康指标在指导TAVR手术时机方面的价值有限。

Whether the worsening of LV health associated with CS and delayed aortic valve replacement underlies increased clinical events in that treatment arm requires further study.

左心室健康状况恶化与CS相关，并且延迟主动脉瓣置换是否导致该治疗组临床事件增加，需要进一步研究。

(Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis [EARLY TAVR]; NCT03042104).

(对无症状重度主动脉瓣狭窄患者进行TAVR与监测比较的评估 [EARLY TAVR]; NCT03042104).