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Article Dans Une Revue JACC: Cardiovascular Interventions Année : 2024

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

Mirjam G Wild
  • Fonction : Auteur
Stephan Baldus
Tanja Rudolph
  • Fonction : Auteur
Thomas Modine
Fabien Praz
Hendrik Ruge
  • Fonction : Auteur
Lenard Conradi
  • Fonction : Auteur
Georg Nickenig
  • Fonction : Auteur
Miguel Piñón
  • Fonction : Auteur
Sebastian Barth
  • Fonction : Auteur
Marianna Adamo
Christophe Dubois
  • Fonction : Auteur
Philipp Lurz

Résumé

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 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. (Tendyne European Experience Registry [TENDER]; NCT04898335).
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hal-04516461 , version 1 (22-03-2024)

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Michaela M Hell, Mirjam G Wild, Stephan Baldus, Tanja Rudolph, Hendrik Treede, et al.. Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Experience Registry. JACC: Cardiovascular Interventions, 2024, 17 (5), pp.648-661. ⟨10.1016/j.jcin.2023.12.027⟩. ⟨hal-04516461⟩
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