Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial
Why the study?
Does the Cardioband system reduce annular septolateral dimension and MR grade in high-risk adults with symptomatic secondary mitral regurgitation?
Population
31 high-risk adult individuals with symptomatic secondary mitral regurgitation despite optimal medical…
Design
Cohort
Follow-up
30 days (1 month)
Authors
Discussion
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Member takes
Implication
Early Cardioband safety data in high-risk secondary MR support further study; leaves open randomized efficacy and durability assessment.
Structured PICO
Does the Cardioband system reduce annular septolateral dimension and MR grade in high-risk adults with symptomatic secondary mitral regurgitation?
P
Population
31 high-risk adult individuals with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy, mean age 71.8 ± 6.9 years, enrolled at five institutions in Europe.
I
Intervention
Cardioband system (transcatheter direct mitral valve annuloplasty adjustable device) implanted on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance.
O
Outcome
Technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days.surrogate
The Cardioband transcatheter direct mitral annuloplasty system is feasible and safe, effectively reducing mitral annular dimensions and MR severity at 30 days in high-risk patients.
Cite This Study
Maisano et al. (2015) studied this question.