Valvular & structural heart diseaseCohort study
Five-year outcomes of transcatheter mitral valve replacement in patients with severe symptomatic mitral regurgitation: results from the Tendyne Expanded Clinical Study
- prospective, single-arm, multicentre 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