[Department of Error] Department of Error

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Source: The Lancet

Original: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00315-6/fullt...

Published: 2026-02-21

The article describes a correction of an error in a 2025 publication by Terkelsen and colleagues that compared two types of transcatheter heart valves (SAPIEN 3 and Myval) used in aortic valve implantation[4]. The research team identified a data processing error that led to the misclassification of four patients as having moderate or severe transcatheter valve damage[4]. The primary objective of the original study was to compare the safety and efficacy of the two types of valves based on a composite endpoint including death, stroke, moderate or severe aortic regurgitation, and valve damage at 1-year follow-up[4]. The study included 1062 patients and used a non-inferiority statistical method with a pre-specified margin of 4.5% to 5.3% depending on the incidence of events[4]. The authors found that Myval valves were non-inferior to SAPIEN 3 valves[4]. The identified error in the classification of four patients did not affect the overall conclusions of the article[4]. In addition, the terminology regarding confidence intervals has also been corrected in the paper to correctly reflect the negative difference in risk[4].