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STICH 试验中基线超声心动图研究的核心实验室分析及对未来临床试验中超声心动图应用的建议。

Core lab analysis of baseline echocardiographic studies in the STICH trial and recommendation for use of echocardiography in future clinical trials.

机构信息

Echocardiography Core Laboratory, Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, USA.

出版信息

J Am Soc Echocardiogr. 2012 Mar;25(3):327-36. doi: 10.1016/j.echo.2011.12.002. Epub 2012 Jan 9.

DOI:10.1016/j.echo.2011.12.002
PMID:22227341
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3310914/
Abstract

BACKGROUND

The Surgical Treatment for Ischemic Heart Failure (STICH) randomized trial was designed to identify an optimal management strategy for patients with ischemic cardiomyopathy. Baseline echocardiographic examinations were required for all patients. The primary aim of this report is to describe the baseline STICH Echocardiography Core Laboratory data. The secondary aim is to provide recommendations regarding how echocardiography should be used in clinical practice and research on the basis of the experience gained from echocardiography in STICH.

METHODS

Between September 2002 and January 2006, 2,136 patients with ejection fractions (EFs) ≤ 35% and coronary artery disease amenable to coronary artery bypass grafting were enrolled. Echocardiography was acquired by 122 clinical enrolling sites, and measurements were performed by the Echocardiography Core Laboratory after a certification process for all clinical sites.

RESULTS

Echocardiography was available for analysis in 2,006 patients (93.9%); 1,734 (86.4%) were men, and the mean age was 60.9 ± 9.5 years. The mean left ventricular end-systolic volume index, measureable in 72.8%, was 84.0 ± 30.9 mL/m(2), and the mean EF was 28.9 ± 8.3%, with 18.5% of patients having EFs > 35%. Single-plane measurements of left ventricular and left atrial volumes were similar to their volumes by biplane measurement (r = 0.97 and r = 0.92, respectively). Mitral regurgitation severity by visual assessment was associated with a wide range of effective regurgitant orifice area, while effective regurgitant orifice area ≥ 0.2 cm(2) indicated at least moderate mitral regurgitation by visual assessment. Deceleration time of mitral inflow velocity had a weak correlation with EF (r = 0.25) but was inversely related to estimated pulmonary artery systolic pressure (r = -0.49).

CONCLUSIONS

In STICH patients with ischemic cardiomyopathy, Echocardiography Core Laboratory analysis of baseline echocardiographic findings demonstrated a wide spectrum of left ventricular shape, function, and hemodynamics, as well as the feasibility and limitations of obtaining essential echocardiographic measurements. It is critical that the use of echocardiographic parameters in clinical practice and research balance the strengths and weaknesses of the technique.

摘要

背景

《缺血性心力衰竭的外科治疗(STICH)》随机试验旨在确定一种针对缺血性心肌病患者的最佳治疗策略。所有患者都需要进行基线超声心动图检查。本报告的主要目的是描述基线 STICH 超声心动图核心实验室数据。次要目的是根据 STICH 中超声心动图的经验,就如何在临床实践和研究中使用超声心动图提供建议。

方法

2002 年 9 月至 2006 年 1 月期间,共纳入 2136 名射血分数(EF)≤35%且冠状动脉疾病适合冠状动脉旁路移植术的患者。122 个临床入组地点采集了超声心动图,所有临床地点都经过认证程序后,由超声心动图核心实验室进行测量。

结果

2006 名患者(93.9%)可进行分析;1734 名(86.4%)为男性,平均年龄为 60.9±9.5 岁。可测量的左心室收缩末期容积指数的平均值为 72.8%,为 84.0±30.9mL/m2,平均 EF 为 28.9±8.3%,18.5%的患者 EF>35%。左心室和左心房容积的单平面测量与双平面测量相似(分别为 r=0.97 和 r=0.92)。通过视觉评估的二尖瓣反流严重程度与有效反流口面积范围广泛相关,而有效反流口面积≥0.2cm2 表明通过视觉评估存在至少中度的二尖瓣反流。二尖瓣流入速度减速时间与 EF 相关性较弱(r=0.25),但与估计的肺动脉收缩压呈负相关(r=-0.49)。

结论

在缺血性心肌病的 STICH 患者中,基线超声心动图检查的超声心动图核心实验室分析显示了左心室形状、功能和血流动力学的广泛范围,以及获得基本超声心动图测量值的可行性和局限性。在临床实践和研究中使用超声心动图参数时,平衡技术的优缺点至关重要。

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