Valvular & structural heart diseaseCohort study
Transapical Mitral Valve Replacement
- Registry study
- investigator-initiated
- real-world
- multicentre European registry
Authors' conclusion
This large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and "real-world" indications, offering a safe and efficacious treatment option for patients without alternative treatments.
Study context
- Population
- Patients undergoing Tendyne transapical transcatheter mitral valve replacement (TMVR) in the TENDER registry eligible for 1-year follow-up
- Participants
- 195 patients
- Outcome
- Primary safety endpoint: CV mortality; primary performance endpoint: reduction of MR
- Follow-up
- Up to 1 year
Main finding
As reported in the abstract
CV mortality at 1 year
17%
CV mortality at 30 days
7%
Durable mitral regurgitation (MR) reduction to ≤1+
98%
Observational data: associations, not effects.
Further findings
Technical success
- Technical success rate
- 95%
All-cause mortality
- 30 days
- 9%
- 1 year
- 29%
HF hospitalization
- Preceding year
- 68%
- During 1-year follow-up
- 25%
NYHA class I or II · up to 1 year
- NYHA class I or II
- 83%
Survival and major adverse events, on-label vs "real-world" indications (31%) · up to 1 year
- No difference between on-label use and "real-world" indications
Safety
Reintervention or surgery after discharge
- Reintervention or surgery following discharge
- 4%
Original publication
Summarised from the published abstract; every number is checked against it