TENDER Investigators2026-01-152026-01-152024-03-11TENDER Investigators 2024, 'Transapical Mitral Valve Replacement : 1-Year Results of the Real-World Tendyne European Experience Registry', JACC: Cardiovascular Interventions, vol. 17, no. 5, pp. 648-661. https://doi.org/10.1016/j.jcin.2023.12.0271936-8798https://hdl.handle.net/10641/7398Publisher Copyright: © 2024 The AuthorsBackground: Early studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort. Objectives: The authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry. Methods: All patients from the TENDER registry eligible for 1-year follow-up were included. The primary safety endpoint was 1-year cardiovascular mortality. Primary performance endpoint was reduction of mitral regurgitation (MR) up to 1 year. Results: Among 195 eligible patients undergoing TMVR (median age 77 years [Q1-Q3: 71-81 years], 60% men, median Society of Thoracic Surgeons Predicted Risk of Mortality 5.6% [Q1-Q3: 3.6%-8.9%], 81% in NYHA functional class III or IV, 94% with MR 3+/4+), 31% had “real-world” indications for TMVR (severe mitral annular calcification, prior mitral valve treatment, or others) outside of the instructions for use. The technical success rate was 95%. The cardiovascular mortality rate was 7% at 30 day and 17% at 1 year (all-cause mortality rates were 9% and 29%, respectively). Reintervention or surgery following discharge was 4%, while rates of heart failure hospitalization reduced from 68% in the preceding year to 25% during 1-year follow-up. Durable MR reduction to ≤1+ was achieved in 98% of patients, and at 1 year, 83% were in NYHA functional class I or II. There was no difference in survival and major adverse events between on-label use and “real-world” indications up to 1 year. Conclusions: This large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and “real-world” indications, offering a safe and efficacious treatment option for patients without alternative treatments.141814612enghttp://creativecommons.org/licenses/by-nc-nd/4.0/mitral annular calcificationmitral regurgitationmitral valvetranscatheter mitral valve replacementCardiology and Cardiovascular MedicineJournal ArticleYesyesjournal articleopen access10.1016/j.jcin.2023.12.027https://www.scopus.com/pages/publications/85186615604https://www.scopus.com/pages/publications/85186615604#tab=citedBy