Heart failure & cardiomyopathies
Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation
Authors' conclusion
Among patients with heart failure with moderate to severe functional mitral regurgitation who received medical therapy, the addition of transcatheter mitral-valve repair led to a lower rate of first or recurrent hospitalization for heart failure or cardiovascular death and a lower rate of first or recurrent hospitalization for heart failure at 24 months and better health status at 12 months than medical therapy alone.
Study context
- Population
- Patients with HF and moderate to severe functional mitral regurgitation
- Participants
- 505 patients
- Comparison
- Device vs Control
- Devicen = 250
- Controln = 255reference
- Primary endpoint
- Three primary end points: composite of first or recurrent HF hospitalization or CV death (24 months); first or recurrent HF hospitalization (24 months); change in KCCQ-OS score (0–100, higher = better) from baseline to 12 months
- Follow-up
- 24 months; 12 months for KCCQ-OS
Methodological details30 sites in nine countries
- 30 sites in nine countries
Primary result
As reported in the abstract
Device
- HF hospitalization or CV death
- 37.0 events per 100 patient-years
- HF hospitalization
- 26.9 events per 100 patient-years
- Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) mean change
- 21.6±26.9 points
Control
- HF hospitalization or CV death
- 58.9 events per 100 patient-years
- HF hospitalization
- 46.6 events per 100 patient-years
- KCCQ-OS mean change
- 8.0±24.5 points
HF hospitalization or CV death
Device37.0 events per 100 patient-years
Control58.9 events per 100 patient-years
HF hospitalization
Device26.9 events per 100 patient-years
Control46.6 events per 100 patient-years
Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) mean change
Device21.6±26.9 points
Control8.0±24.5 points
Device vs ControlRate ratio (95% CI)P value
HF hospitalization or CV death, 24 months
0.64(0.48–0.85)
P = 0.002HF hospitalization, 24 months
0.59(0.42–0.82)
P = 0.002Device vs ControlMean difference, points (95% CI)P value
KCCQ-OS change, 12 months
10.9(6.8–15.0)
P < 0.001Safety
- Device-specific safety events
- 1.6% · 4 of 250
Original publication
Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation. N Engl J Med. Published 31 August 2024. doi:10.
Summarised from the published abstract; every number is checked against it