核心实验室与中心报告的天然及生物人工主动脉瓣超声心动图评估
Core Laboratory Versus Center-Reported Echocardiographic Assessment of the Native and Bioprosthetic Aortic Valve.
作者信息
Velders Bart J J, Vriesendorp Michiel D, Weissman Neil J, Sabik Joseph F, Reardon Michael J, Dagenais Francois, Moront Michael G, Rao Vivek, Fukuhara Shinichi, Günzinger Ralf, van Leeuwen Wouter J, Brown W Morris, Groenwold Rolf H H, Klautz Robert J M, Asch Federico M
机构信息
Cardiothoracic Surgery, Leiden University Medical Centre, Leiden, the Netherlands.
Cardiovascular Core Laboratories, MedStar Health Research Institute, and Georgetown University, Washington, District of Columbia, USA.
出版信息
Echocardiography. 2024 Dec;41(12):e70047. doi: 10.1111/echo.70047.
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.
背景
目前缺乏对核心实验室与各中心报告的天然主动脉瓣及生物瓣主动脉瓣超声心动图评估之间定量差异的深入了解。我们旨在探究这些评估之间临床相关的差异。
方法
使用来自心包外科主动脉瓣置换术（PERIGON）Avalus瓣膜关键试验的数据。在该试验中，纳入了因主动脉狭窄或反流（AR）而有外科主动脉瓣置换术（SAVR）指征的患者。各中心均进行了系列超声心动图检查，并由独立的超声心动图核心实验室（ECL）进行盲法重新分析。对于生物瓣分析，汇总了整个5年随访期的术后数据。ECL与各中心在连续参数上的差异通过平均差异和组内相关系数（ICC）进行量化。使用Cohen卡方系数研究在AR、瓣周漏（PVL）和人工瓣膜-患者不匹配（PPM）分类上的一致性。
结果
对1118份天然主动脉瓣的超声心动图进行了分析。左心室流出道（LVOT）面积的相对平均差异最大，其次是每搏输出量和有效瓣口面积（指数），各中心报告的值高11%-7%。对于主动脉峰值射流速度、平均压力阶差和主动脉瓣跨瓣速度时间积分等参数，观察到约0.90的高ICC。有超过5000份超声心动图可用于生物瓣分析。其中观察到了类似的结果。对于天然AR的一致性，卡方系数为0.59（95%置信区间[CI] 0.56, 0.63），PVL为0.28（95% CI 0.18, 0.37），PPM为0.42（95% CI 0.40, 0.44）。
结论
ECL与临床中心在连续波多普勒相关测量上高度一致。相比之下，对于涉及LVOT直径测量的参数，一致性较低。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背景。
试验注册
ClinicalTrials.gov标识符：NCT02088554。
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