Valvular & structural heart disease
Transseptal Transcatheter Mitral Valve Replacement for Mitral Annular Calcification
- prospective, multicenter, single-arm study
Authors' conclusion
In carefully selected patients with symptomatic MAC-related MVD unsuitable for surgery or transcatheter repair, transseptal TMVR with the SAPIEN M3 system was associated with sustained MR reduction and meaningful improvements in symptoms and quality of life through 1 year. These findings support consideration of transseptal TMVR as a treatment pathway for selected patients with MAC-related MVD.
Study context
- Population
- Symptomatic patients with mitral annular calcification (MAC)-related mitral valve dysfunction (MVD), including ≥ moderate to severe mitral regurgitation (MR), severe mitral stenosis, or combined moderate MR with at least moderate mitral stenosis, considered unsuitable for surgery or transcatheter repairTVMR attempted, 364 screened, valve implanted in 93
- Participants
- 100 patients
- Outcome
- Nonhierarchical composite of:
- All-cause mortality
- Heart failure hospitalization (HFH)
- Follow-up
- 1 year
Main finding
As reported in the abstract
Kaplan-Meier estimate of all-cause mortality or heart failure hospitalization (HFH)
33.6%
95% CI 25.0%–44.1%
All-cause mortality
21.1%
HFH
19.4%
Observational data: associations, not effects.
Further findings
Baseline characteristics
- Mean age
- 76.1 ± 9.2 years
- Male
- 51.0%
- NYHA functional class III/IV
- 73.0%
- Mean STS Predicted Risk of Mortality score for mitral valve replacement
- 8.4% ± 4.9%
MR ≤1+ among implanted patients · 1 year
- MR ≤1+ achieved
- 98.5%
NYHA functional class, Kansas City Cardiomyopathy Questionnaire Overall Summary score, 6-minute walk distance · 1 year
- Improvements sustained through 1 year
Safety
Adverse events
- Disabling stroke
- 5.1%
- Clinically significant left ventricular outflow tract obstruction
- 4.8%
- Valve thrombosis
- 2.3%
- Hemolysis requiring transfusion or mitral valve reintervention
- 9.2%
- Mitral valve re-intervention
- 11.4%
Original publication
Summarised from the published abstract; every number is checked against it