Reliability, Agreement, and Presentation of a Reference Standard for Assessing Implanted Heart Valve Sizes by...

The implanted prosthetic heart valve (PHV) size is vital for the evaluation of suspected PHV dysfunction and in case of reoperation or valve-in-valve transcatheter approaches. The labeled size is not always known, and discrepancies exist between manufacturers' labeled sizes and true sizes. Reproducible methods for noninvasive PHV size assessment are lacking. We determined the reliability and agreement of PHV size measurements using multidetector-row computed tomography (MDCT) and provide reference values of MDCT measurements compared with manufacturer specifications. In vitro, 15 different PHV types in available sizes (total n = 63) were imaged. In vivo, available MDCT acquisitions of patients with PHVs were retrospectively gathered in 2 centers, and 230 patients with 249 PHVs were included. Inner valve area and area-derived diameter were measured in all PHVs. For mechanical PHVs, the inner diameter was also measured. Data were analyzed using the intraclass correlation coefficient and Bland-Altman plots and related to manufacturer specifications. Measurements could be obtained for all PHV types, except the Björk-Shiley (n = 7) because of severe valve-related artifacts hampering the image quality. Intrarater and interrater reliability was excellent for biological and mechanical PHVs (intraclass correlation coefficients ≥0.903). Agreement was good for all measurements with an overall maximal mean difference (95% confidence interval) of -2.61 mm(2) (-37.9 to 32.7), -0.1 mm (-1.1 to 1.0), and 0 mm (-0.4 to 0.3) for valve area, area-derived diameter, and inner diameter, respectively. MDCT reliably discriminated consecutive PHV sizes as labeled by the manufacturer because the absolute ranges for the measurements never overlapped. In conclusion, MDCT allows assessment of the implanted PHV size with excellent reliability and agreement and can discriminate between PHV sizes for contemporary prostheses. MDCT can be used to noninvasively identify the manufacturer-labeled PHV size.