Transapical Mitral Valve Replacement 1-Year Results of the Real-World Tendyne European Experience Registry

BACKGROUND 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 calci fication, 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, signi ficant clinical bene fits, 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 ef ficacious treatment option for patients without alternative treatments. (Tendyne European Experience Registry [TENDER]; NCT04898335) (J Am Coll Cardiol Intv 2024;17:648 -661) (c) 2024 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).