Key result
Tendyne TMVR yields ~55% 3-year survival with durable mitral regurgitation elimination through 2 years.
Why the study?
Clinical TMVR data are sparse with only two devices granted CE or FDA certification, necessitating evaluation of mid-term outcomes of Tendyne-TMVR.
Does transcatheter mitral valve replacement with the Tendyne system improve mitral regurgitation and clinical symptoms with acceptable survival in high surgical risk patients?
Cohort (n=100)
No
Does transcatheter mitral valve replacement with the Tendyne system improve mitral regurgitation and clinical symptoms with acceptable survival in high surgical risk patients?
TMVR with the Tendyne system provides effective and durable elimination of mitral regurgitation with acceptable mid-term survival and significant relief of heart failure symptoms in high surgical risk patients.
OBJECTIVES: Transcatheter mitral valve replacement (TMVR) is an emerging therapy option currently mainly used in patients at high surgical risk and a mitral valve anatomy not eligible for transcatheter edge to edge repair (TEER). Clinical TMVR data are sparse as currently only two devices were granted CE or FDA certification. This study evaluates mid-term clinical outcomes of 100 consecutive single-center Tendyne-TMVR patients. METHODS: From the institutional TMVR database, the first 100 consecutive patients undergoing implantation of the Abbott Tendyne mitral valve were identified. Baseline and procedural characteristics, clinical and echocardiography follow-up were prospectively recorded and retrospectively analyzed and reported following MVARC recommendations. according To evaluate a procedure-specific learning curve, the cohort was analyzed for 30-day mortality across four consecutive chronological groups (n=25 each). RESULTS: The study enrolled 100 high surgical risk patients (mean age 76.3 ± 7.0 years; mean STS predicted risk of mortality 7.7 ± 6.4%). Mitral valve pathologies included primary MR (62.0%), functional MR (29.0%), severe MAC (30%) and previous mitral valve intervention (19%). Technical success was 96.0% and 30-day device success was 74.0%. Kaplan-Meier estimated survival at 30-days was 90.0% (95% CI: 82.2-94.5%), 71.2% (95% CI:61.1-79.2%) at 1 year, 64.3% (95% CI: 53.4-73.4%) at 2 years and 54.8% (95% CI: 41.7-66.1%) at 3 years. Chronological analysis revealed no significant inter-group differences in 30-day survival across the four groups composed of consecutive 25 patients (p=0.522).At 2 years, echocardiography revealed durable MR reduction with 100% MR Grade ≤1+ (none/trace MR 84.4%) and significant relief of heart failure symptoms with 84.9% NYHA class I/II. CONCLUSIONS: TMVR with the Tendyne mitral valve system provided effective MR elimination in a cohort presenting with heterogenous mitral valve disease without evidence for a significant learning curve. Durable mitral valve function was confirmed up to 3 years. Mid-term mortality is associated with cardiovascular and non-cardiovascular mortality.
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Puluca et al. (2026) conducted a cohort in Mitral valve disease (high surgical risk) (n=100). Tendyne transcatheter mitral valve replacement was evaluated on 3-year overall survival (95% CI 41.7-66.1). Transcatheter mitral valve replacement with the Tendyne system resulted in a 3-year survival of 54.8% (95% CI 41.7-66.1%) and 100% MR Grade ≤1+ at 2 years.
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