June 6, 2026Journal of the American College of Cardiology
3-Year Outcomes of Transcatheter Mitral Valve Repair in Patients With Heart Failure
Key result
TMVr plus GDMT cuts heart failure hospitalizations ~51% versus GDMT alone at 36 months.
- HR 0.49
- 95% CI 0.37 to 0.63
- P<0.001
- NNT 3
- n=614
Why the study?
To determine if the clinical benefits of TMVr observed at 24 months persisted to 36 months, and whether control patients crossing over at 24 months derived similar benefit.
Does transcatheter mitral valve repair (TMVr) plus GDMT reduce heart failure hospitalizations and mortality in patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation symptomatic despite GDMT?
Population
614 symptomatic HF patients with moderate-to-severe or severe secondary MR despite maximally tolerated GDMT
Comparison
TMVr plus GDMT vs GDMT alone
Design
Randomized controlled trial
Follow-up
36 months
Authors
Discussion
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Member takes
Implication
Supports TMVr plus GDMT in HF with severe secondary MR; extends 2-year COAPT benefits through 36 months.
Key Points
- The aim is to evaluate the long-term benefits of transcatheter mitral valve repair in heart failure patients with moderate-to-severe mitral regurgitation.
- Randomized 614 patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation to TMVr plus GDMT versus GDMT alone.
- Primary effectiveness endpoint was all heart failure hospitalizations through 24-month follow-up, with 36 months of additional follow-up.
- Annualized heart failure hospitalization rates were 35.5% for TMVr versus 68.8% for GDMT alone (HR: 0.49; 95% CI: 0.37 to 0.63; p < 0.001).
- Mortality was 42.8% in TMVr group versus 55.5% in GDMT group (HR: 0.67; 95% CI: 0.52 to 0.85; p = 0.001).
- Patients crossing over to TMVr from GDMT alone had a reduced composite mortality or hospitalization rate (adjusted HR: 0.43; 95% CI: 0.24 to 0.78; p = 0.006).
Study Design
Type
RCT (n=614)
Structured PICO
Does transcatheter mitral valve repair (TMVr) plus GDMT reduce heart failure hospitalizations and mortality in patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation symptomatic despite GDMT?
P
Population
614 patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated GDMT, followed for 36 months.
I
Intervention
Transcatheter mitral valve repair (TMVr) plus guideline-directed medical therapy (GDMT)
C
Comparator
Guideline-directed medical therapy (GDMT) alone
O
Outcome
All heart failure hospitalizations (HFHs) through 24-month follow-up (with current analysis extending follow-up to 36 months)hard clinical
Main Result
Hazard Ratio: 0.49 (95% CI 0.37–0.63)
Absolute Event Rate: 35.5% vs 68.8%
Number Needed to Treat: 3
p-value: p=< 0.001
In patients with heart failure and severe secondary mitral regurgitation, transcatheter mitral valve repair provides durable benefits through 3 years, significantly reducing heart failure hospitalizations and mortality compared to medical therapy alone.
Cite This Study
Mack et al. (2021) conducted an RCT in Heart failure with moderate-to-severe or severe secondary mitral regurgitation (n=614). Transcatheter mitral valve repair (TMVr) plus GDMT vs. GDMT alone was evaluated on All heart failure hospitalizations (HFHs) (HR 0.49, 95% CI 0.37 to 0.63, p=< 0.001). Transcatheter mitral valve repair plus GDMT reduced the annualized rate of heart failure hospitalizations compared with GDMT alone (35.5% vs 68.8%; HR 0.49; 95% CI 0.37-0.63; p<0.001) at 36 months.