Key result
Despite high procedural success, Tendyne TMVR in MAC patients is linked to only ~24% event-free survival.
Why the study?
Long-term data and dedicated analysis of ventricular remodelling following Tendyne transcatheter mitral valve replacement remained limited.
Does the presence of mitral annular calcification affect 3-year clinical outcomes in high-risk patients with severe symptomatic mitral regurgitation undergoing Tendyne-TMVR?
Cohort (n=30)
No
Does the presence of mitral annular calcification affect 3-year clinical outcomes in high-risk patients with severe symptomatic mitral regurgitation undergoing Tendyne-TMVR?
Tendyne-TMVR is effective for high-risk MR, but patients with mitral annular calcification have significantly worse 3-year event-free survival and higher reintervention rates.
MAC warrants caution in Tendyne-TMVR candidate selection; leaves open need for prospective validation in larger cohorts.
Background Transcatheter mitral valve replacement (TMVR) using the Tendyne system has emerged as a therapeutic alternative for high-risk patients with severe symptomatic mitral regurgitation (MR), particularly when surgical intervention is contraindicated. While short-term results are encouraging, long-term data and dedicated analysis of ventricular remodelling remain limited. Purpose To assess 3-year clinical outcomes and left/right ventricular remodelling after Tendyne-TMVR and compare composite outcomes in patients with and without mitral annular calcification (MAC). Methods This single-centre prospective registry included 30 consecutive high-risk patients undergoing Tendyne-TMVR between June 2020 and February 2024. Echocardiographic and clinical follow-up occurred at baseline, 30 days, 1 year, and annually. Remodelling was evaluated using echocardiographic parameters. MAC was identified via preprocedural CT. Primary outcomes included all-cause mortality, heart failure (HF) hospitalisation, and need for redo procedure. Results Mean age was 76 ± 8 years; 73% male; 77% NYHA class III/IV. Procedural success was 100% with no residual ≥moderate MR. At one year, LV end-diastolic and end-systolic volumes decreased significantly (−22 ml, p = 0.0012; −4.5 ml, p = 0.03), and RV dilatation improved (−4.8 mm, p = 0.0004). RV function increased (FAC from 38.5% to 43.8%, p = 0.0018), but LV strain remained impaired (−8.7%, p < 0.0001). At 3 years, cumulative mortality was 17%; 33% were hospitalised for HF; and 3 patients (10%) required redo due to paravalvular regurgitation—exclusively in MAC patients. MAC was present in 18 (60%) patients and associated with higher EuroSCORE II (8.5% vs. 5.6%, p = 0.01) and dyslipidaemia (94% vs. 50%, p = 0.017). Kaplan–Meier analysis showed reduced event-free survival in the MAC group (24% vs. 90% at 3 years, log-rank p = 0.029). Overall, 27% experienced the composite endpoint of death or redo. No significant differences in LV/RV function or dimension were observed at baseline between groups. Conclusion Tendyne-TMVR is a safe and effective therapy for high-risk MR patients, yielding high procedural success, positive biventricular remodelling, and symptomatic improvement over time. MAC identifies a high-risk subgroup with increased rates of death and reintervention, emphasising the need for optimised preprocedural assessment and careful selection in this population.
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Siti H. Omar (2026) conducted a cohort in Severe symptomatic mitral regurgitation (n=30). Mitral annular calcification (MAC) vs. No mitral annular calcification was evaluated on Event-free survival (composite of all-cause mortality, heart failure hospitalisation, and need for redo procedure) (p=0.029). Among high-risk patients undergoing Tendyne-TMVR, the presence of mitral annular calcification significantly reduced 3-year event-free survival compared to those without MAC (24% vs 90%, p=0.029).
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