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Comparative Study
. 2024 Dec;41(12):e70047.
doi: 10.1111/echo.70047.

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

Bart J J Velders  1 , Michiel D Vriesendorp  1 , Neil J Weissman  2 , Joseph F Sabik 3rd  3 , Michael J Reardon  4 , Francois Dagenais  5 , Michael G Moront  6 , Vivek Rao  7 , Shinichi Fukuhara  8 , Ralf Günzinger  9   10 , Wouter J van Leeuwen  11 , W Morris Brown  12 , Rolf H H Groenwold  13 , Robert J M Klautz  1 , Federico M Asch  2
Affiliations
Comparative Study

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

Bart J J Velders et al. Echocardiography. 2024 Dec.

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.

Keywords: bioprosthetic aortic valve; core laboratory; echocardiography; interobserver variability; native aortic valve.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Agreement between core laboratory and center‐reported assessment of native aortic regurgitation (AR).
FIGURE 2
FIGURE 2
Agreement between core laboratory and center‐reported effective orifice area index of bioprosthetic aortic valves. PPM was defined according to the Valve Academic Research Consortium 3 definition [14]. Please note that all echocardiographic assessments during follow‐up were stacked for this analysis except for the discharge echocardiograms. BMI, body mass index; EOA, effective orifice area; PPM, prosthesis‐patient mismatch.
FIGURE 3
FIGURE 3
Standardized mean differences between core laboratory and 10 largest clinical centers for hemodynamic parameters for bioprosthetic valve performance. The size of the pictograms corresponds to the number of patients implanted at the particular center. Please note that all echocardiographic assessments during follow‐up were stacked for this analysis except for the discharge echocardiograms. DVI, Doppler velocity index; EOA, effective orifice area; LVOTd, left ventricular outflow tract diameter; MPG, mean pressure gradient; Vmax, peak aortic jet velocity; VTIAV, velocity‐time integral across the aortic valve; VTILVOT, VTI across the LVOT.
FIGURE 4
FIGURE 4
Agreement between core laboratory and center‐reported assessment of hemodynamic obstruction for individual patients. The solid lines represent the mean difference between the value of the center and the ECL, and the dashed lines represent the 95% limits of agreement. Please note that all echocardiographic assessments during follow‐up were stacked for this analysis except for the discharge echocardiograms. DVI, Doppler velocity index; ECL, echocardiographic core laboratory; EOA, effective orifice area; MPG, mean pressure gradient; Vmax, peak aortic jet velocity.
See this image and copyright information in PMC

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