Valvular & structural heart disease
Five-year outcomes of transcatheter mitral valve replacement in patients with severe symptomatic mitral regurgitation: results from the Tendyne Expanded Clinical Study
Authors' conclusion
The Tendyne TMVR was effective at achieving immediate and sustainable elimination of MR, which was associated with symptomatic improvement and absence of structural valve degeneration in a high-risk cohort over 5 years. These findings support TMVR with the Tendyne System as an alternative for patients with appropriate mitral valve anatomy and symptomatic secondary MR unsuitable for mitral surgery or TEER.
Study context
- Population
- Patients with severe symptomatic mitral regurgitation (MR) unsuitable for conventional mitral valve surgery or transcatheter edge-to-edge repair (TEER)enrolled between November 2014 and June 2020, 186 (97.4%) underwent transcatheter mitral valve replacement (TMVR) with Tendyne
- Participants
- 191 patients
Main finding
As reported in the abstract
MR grade ≥3+ at baseline
99.5%
MR grade ≤1+ at 5 years
95.3%
Observational data: associations, not effects.
Further findings
NYHA class I/II among patients surviving to 5 years (n = 49)
- NYHA class I/II, of patients surviving to 5 years (n = 49)
- 73.5%
Kansas City Cardiomyopathy Questionnaire overall summary score · 5 years
- Baseline
- 48.5 ± 22.5 points
- 5 years
- 67.6 ± 21.5 points
Safety
Serious adverse events through 5 years
- Life-threatening bleeding
- 11.5%
- Fatal bleeding
- 2.6%
- Renal insufficiency/failure
- 28.8%
- Endocarditis
- 7.3%
- Device thrombosis
- 5.8%
- New onset atrial fibrillation
- 13.1%
- No structural device degeneration or device embolism occurred through 5 years
Original publication
Summarised from the published abstract; every number is checked against it