Details

Autor(en) / Beteiligte

• Hell, Michaela M
• Wild, Mirjam G
• Baldus, Stephan
• Rudolph, Tanja
• Treede, Hendrik
• Petronio, Anna Sonia
• Modine, Thomas
• Andreas, Martin
• Coisne, Augustin
• Duncan, Alison
• Franco, Luis Nombela
• Praz, Fabien
• Ruge, Hendrik
• Conradi, Lenard
• Zierer, Andreas
• Anselmi, Amedeo
• Dumonteil, Nicolas
• Nickenig, Georg
• Piñón, Miguel
• Barth, Sebastian
• Adamo, Marianna
• Dubois, Christophe
• Torracca, Lucia
• Maisano, Francesco
• Lurz, Philipp
• von Bardeleben, Ralph Stephan
• Hausleiter, Jörg

Titel

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

Ist Teil von

• JACC. Cardiovascular interventions, 2024-03, Vol.17 (5), p.648-661

Ort / Verlag

United States: Elsevier/American College of Cardiology

Erscheinungsjahr

2024

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• Early studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort. The authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry. 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. 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. 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).