Core Laboratory Versus Center-Reported Echocardiographic Assessment of the Native and Bioprosthetic Aortic Valve

IF 1.6 4区医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Echocardiography-A Journal of Cardiovascular Ultrasound and Allied Techniques Pub Date : 2024-12-03 DOI:10.1111/echo.70047

Bart J. J. Velders, Michiel D. Vriesendorp, Neil J. Weissman, Joseph F. Sabik III, Michael J. Reardon, Francois Dagenais, Michael G. Moront, Vivek Rao, Shinichi Fukuhara, Ralf Günzinger, Wouter J. van Leeuwen, W. Morris Brown, Rolf H. H. Groenwold, Robert J. M. Klautz, Federico M. Asch

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Abstract

Background

Insights into quantitative differences between core laboratory and center-reported echocardiographic assessment of the native and bioprosthetic aortic valve are lacking. We aimed to explore clinically relevant differences between these evaluations.

Methods

Data were used from the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial for the Avalus valve. In this trial, patients with an indication for surgical aortic valve replacement (SAVR) due to aortic stenosis or regurgitation (AR) were enrolled. Serial echocardiographic examinations were performed at each center and blindly reanalyzed by an independent echocardiographic core laboratory (ECL). For the bioprosthetic valve analysis, postoperative data throughout the 5-year follow-up were pooled. Differences between the ECL and the centers in continuous parameters were quantified in mean differences and intraclass correlation coefficients (ICCs). Agreement on AR, paravalvular leak (PVL), and prosthesis-patient mismatch (PPM) classification was investigated using Cohen's kappa coefficients.

Results

The analysis on the native aortic valve was performed on 1118 echocardiograms. The relative mean difference was largest for the left ventricular outflow tract (LVOT) area, followed by stroke volume and effective orifice area (index), with center-reported values being 11%–7% higher. High ICCs of around 0.90 were observed for the parameters peak aortic jet velocity, mean pressure gradient, and the velocity-time integral across the aortic valve. Over 5000 echocardiograms were available for the bioprosthetic valve analysis. Therein, comparable results were observed. The kappa coefficient was 0.59 (95% confidence interval [CI] 0.56, 0.63) for agreement on native AR, 0.28 (95% CI 0.18, 0.37) for PVL, and 0.42 (95% CI 0.40, 0.44) for PPM.

Conclusions

There is high agreement between the ECL and clinical centers on continuous-wave Doppler-related measurements. In contrast, agreement is low for parameters that involve measurement of the LVOT diameter. These results provide important context for the interpretation of aortic valve performance in studies that lack central ECL evaluation.

Trial Registration

ClinicalTrials.gov identifier: NCT02088554

Abstract Image

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核心实验室与中心报告的超声心动图对原生和生物人工主动脉瓣的评估

核心实验室和中心报道的超声心动图评估天然主动脉瓣和生物假体主动脉瓣之间的定量差异尚缺乏深入了解。我们的目的是探讨这些评估之间的临床相关差异。方法采用心包外科主动脉瓣置换术（PERIGON）心脏瓣膜置换术的临床资料。在这项试验中，由于主动脉狭窄或反流（AR）而有手术主动脉瓣置换术（SAVR）指征的患者被纳入。在每个中心进行连续超声心动图检查，并由独立的超声心动图核心实验室（ECL）进行盲法再分析。对于生物假体瓣膜分析，我们汇总了5年随访期间的术后数据。连续参数中ECL与中心之间的差异以平均差异和类内相关系数（ICCs）来量化。使用Cohen's kappa系数对AR、瓣旁漏（PVL）和假体-患者错配（PPM）分类进行一致性研究。结果1118例患者超声心动图对主动脉瓣进行了分析。相对平均差异最大的是左心室流出道（LVOT）面积，其次是卒中容积和有效孔口面积（指数），中心报告值高出11%-7%。峰值主动脉射流速度、平均压力梯度和主动脉瓣速度-时间积分等参数的ICCs均在0.90左右。超过5000张超声心动图可用于生物瓣膜分析。其中，观察到可比较的结果。原生AR的kappa系数为0.59(95%可信区间[CI] 0.56, 0.63)， PVL的kappa系数为0.28 (95% CI 0.18, 0.37)， PPM的kappa系数为0.42 （95% CI 0.40, 0.44）。结论ECL与临床中心对连续波多普勒相关测量结果的一致性较高。相反，对于涉及LVOT直径测量的参数，一致性很低。这些结果为在缺乏中心ECL评估的研究中解释主动脉瓣性能提供了重要的背景。试验注册ClinicalTrials.gov标识符：NCT02088554

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来源期刊

Echocardiography-A Journal of Cardiovascular Ultrasound and Allied Techniques 医学-心血管系统

CiteScore

2.40

自引率

6.70%

发文量

211

审稿时长

3-6 weeks

期刊介绍： Echocardiography: A Journal of Cardiovascular Ultrasound and Allied Techniques is the official publication of the International Society of Cardiovascular Ultrasound. Widely recognized for its comprehensive peer-reviewed articles, case studies, original research, and reviews by international authors. Echocardiography keeps its readership of echocardiographers, ultrasound specialists, and cardiologists well informed of the latest developments in the field.