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. 2024 Jan 8;8(1):e1-e8.
doi: 10.1055/s-0043-1777765. eCollection 2024 Jan.

Validation of Echocardiographic Measurements in Patients with Pulmonary Embolism in the RIETE Registry

Mads Dam Lyhne  1 , Behnood Bikdeli  2   3   4 , David M Dudzinski  5 , Alfonso Muriel-García  6 , Christopher Kabrhel  7 , Teresa Sancho-Bueso  8 , Esther Pérez-David  9 , José Luis Lobo  10 , Ángel Alonso-Gómez  11 , David Jiménez  12   13 , Manuel Monreal  13   14 ; RIETE Investigators
Affiliations

Validation of Echocardiographic Measurements in Patients with Pulmonary Embolism in the RIETE Registry

Mads Dam Lyhne et al. TH Open. .

Abstract

Background In acute pulmonary embolism (PE), echocardiographic identification of right ventricular (RV) dysfunction will inform prognostication and clinical decision-making. Registro Informatizado Enfermedad TromboEmbolica (RIETE) is the world's largest registry of patients with objectively confirmed PE. The reliability of site-reported RV echocardiographic measurements is unknown. We aimed to validate site-reported key RV echocardiographic measurements in the RIETE registry. Methods Fifty-one randomly chosen patients in RIETE who had transthoracic echocardiogram (TTE) performed for acute PE were included. TTEs were de-identified and analyzed by a core laboratory of two independent observers blinded to site-reported data. To investigate reliability, intraclass correlation coefficients (ICCs) and Bland-Altman plots between the two observers, and between an average of the two observers and the RIETE site-reported data were obtained. Results Core laboratory interobserver variations were very limited with correlation coefficients >0.8 for all TTE parameters. Agreement was substantial between core laboratory observers and site-reported data for key parameters including tricuspid annular plane systolic excursion (ICC 0.728; 95% confidence interval [CI], 0.594-0.862) and pulmonary arterial systolic pressure (ICC 0.726; 95% CI, 0.601-0.852). Agreement on right-to-left ventricular diameter ratio (ICC 0.739; 95% CI, 0.443-1.000) was validated, although missing data limited the precision of the estimates. Bland-Altman plots showed differences close to zero. Conclusion We showed substantial reliability of key RV site-reported measurements in the RIETE registry. Ascertaining the validity of such data adds confidence and reliability for subsequent investigations.

Keywords: echocardiography; pulmonary circulation; reliability; right ventricular function; validity.

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Conflict of interest statement

Conflict of Interests B.B. is supported by a Career Development Award from the American Heart Association and VIVA Physicians (#938814) for the PE-EHR+ study. B.B. was also supported by the Scott Schoen and Nancy Adams IGNITE Award, and the Mary Ann Tynan Research Scientist award from the Mary Horrigan Connors Center for Women's Health and Gender Biology at Brigham and Women's Hospital, and the Heart and Vascular Center Junior Faculty Award from Brigham and Women's Hospital. B.B. reports that he is a consulting expert, on behalf of the plaintiff, for litigation related to two specific brand models of IVC filters. C.K. has no conflicts of interest related to this analysis. However, he does report receiving grant funding paid to his institution from Grifols and Diagnostica Stago, as well as consulting fees from BMS/Pfizer. D.J. has no conflicts of interest related to this analysis. However, he does report serving as a speaker for BMS/Pfizer. M.M. received unrestricted grants for research to sponsor the RIETE registry by Sanofi, Bayer, Leo, and Rovi. He also participated in advisory meeting for Sanofi and BMS/Pfizer. E.P.D. has no conflicts of interest related to this analysis.However, she has received speaker fees and participated in advisory meetings led by Pfizer/BMS. The remaining authors have no conflicts of interest to declare.

Figures

Fig. 1
Fig. 1
Illustrative examples of echocardiographic images. Representative echocardiographic images from an RIETE patient. Maximal tricuspid regurgitation gradient (TRG) is measured (asterisk in panel [ a ]) to calculate right ventricular (RV) systolic pressure. Tricuspid annular plane systolic excursion (TAPSE) is measured in M-mode recording ( b ) showing the longitudinal change of the RV. In panel ( c ), diameters of the RV in blue and the left ventricle in red are measured at the tip of the leaflets in end-diastole. RIETE, Registro Informatizado Enfermedad TromboEmbolica.
Fig. 2
Fig. 2
Variation in TAPSE and PASP measurements. Bland–Altman plots for the measurement of TAPSE showing the agreement between the two observers ( a ) and between the observers and the RIETE registry ( b ). Similarly, for the measurement of PASP with agreement between the two observers ( c ) and between observers and RIETE ( d ). For interpretation of Bland–Altman plots, bias (purple lines) should be close to zero and 95% Limits of Agreement (red lines) should be as narrow as possible. Furthermore, data points should be evenly distributed around the bias line without any trumpet-shape formation, that is, no systematic difference between the two comparators. For the plots shown here, we note that biases are close to zero, and limits of agreement are smaller between the two core laboratory observers. PASP, pulmonary arterial systolic pressure; RIETE, Registro Informatizado Enfermedad TromboEmbolica; TAPSE, tricuspid annular plane systolic excursion.
Fig. 3
Fig. 3
Variation in RV/LV measurements. Bland–Altman plots for the measurement of RV/LV ratio, the agreement between the two observers are shown in ( a ) and between observers and RIETE shown in ( b ). Bland–Altman interpretation is briefly explained in Fig. 2. For these plots, we note that biases are generally close to zero, but missing data are frequent in the RIETE regTaistry. LV, left ventricular; RIETE, Registro Informatizado Enfermedad TromboEmbolica; RV, right ventricular.
Fig. 4
Fig. 4
Validation of the RIETE registry by external, blinded core laboratory analysis. The RIETE registry is the world's largest registry on venous thromboembolism including acute pulmonary embolism. The reliability of site-reported echocardiographic measurements was investigated by two blinded, independent observers. This core laboratory analysis confirmed the reliability of site-reported RIETE data and adds confidence in past and future investigations. RIETE, Registro Informatizado Enfermedad TromboEmbolica.
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