Valvular & structural heart disease

Clinical outcomes and predictors of transapical transcatheter mitral valve replacement: the Tendyne Expanded Clinical Study

EuroInterventionPublished Prospective single-arm study

Authors' conclusion

The Tendyne TMVR system successfully eliminated MR with no intraprocedural deaths, resulting in an improvement in symptoms and quality of life.

Study context

Population
Patients with symptomatic mitral regurgitation (MR) (ineligible for conventional surgery) treated Nov 2014–Jun 2020
Participants
191 patients
Outcome
Outcomes (all-cause mortality) and predictors of short-term mortality
Follow-up
Up to 2 years

Main finding

As reported in the abstract

All-cause mortality · 30 days, 1 and 2 years

All-cause mortality at 30 days

7.9%

All-cause mortality at 1 year

30.8%

All-cause mortality at 2 years

40.5%

Observational data: associations, not effects.

Further findings

Technical success

Technical success
96.9% (185/191)
Intraprocedural deaths
0

Complete MR elimination (MR <1+) · 30 days, 1 and 2 years

Complete MR elimination at 30 days
99.3%
Complete MR elimination at 1 year
99.1%
Complete MR elimination at 2 years
96.3%

NYHA class and quality of life · up to 2 years

Consistent improvement in NYHA class and quality of life
P < 0.001

Independent predictors of early mortality

Age, OR 1.11
P = 0.003
Pulmonary hypertension, OR 3.83
P = 0.007
Institutional experience, OR 0.40
P = 0.047

Original publication

Clinical outcomes and predictors of transapical transcatheter mitral valve replacement: the Tendyne Expanded Clinical Study. EuroIntervention. Published 15 July 2024. doi:10.4244/eij-d-23-00904

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