Key result
The Carillon device for indirect mitral annuloplasty significantly reduced regurgitant volume by 7.1 ml/beat compared to a 3.3 ml/beat increase with medical management at 12 months in the highlighted REDUCE-FMR trial.
Why the study?
Traditional mitral annuloplasty for functional mitral regurgitation is limited by surgical risk and durability, making percutaneous strategies a welcome alternative.
Does indirect mitral annuloplasty using the Carillon device improve outcomes in patients with functional or secondary mitral regurgitation?
Does indirect mitral annuloplasty using the Carillon device improve outcomes in patients with functional or secondary mitral regurgitation?
Absolute Event Rate: 7.1% vs -3.3%
p-value: p=0.049
The Carillon device provides a percutaneous alternative for indirect mitral annuloplasty in patients with functional mitral regurgitation, demonstrating potential clinical and echocardiographic benefits.
Supports Carillon for symptomatic FMR; extends RCT evidence for indirect annuloplasty in high-risk patients.
Patients with functional, or secondary, mitral regurgitation (FMR, SMR) often face significant symptoms that lead to functional decline as well as hospitalization and even death. Traditional mitral annuloplasty is an important treatment option for patients with FMR, but surgical risk and durability are important limitations. Percutaneous strategies are therefore a welcome alternative. The Carillon device utilizes the relationship of the coronary sinus and the mitral annulus to effect an "indirect" annuloplasty. Early series' and recent randomized trials suggest echocardiographic and clinical benefit with a relatively straight-forward implantation technique and low rate of significant complications.
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Krishnaswamy et al. (2020) conducted a review in Functional mitral regurgitation (FMR). Carillon device vs. Medical management was evaluated on Regurgitant volume (Rvol) reduction at 12 months (ml/beat) [REDUCE-FMR trial data] (p=0.049). The Carillon device for indirect mitral annuloplasty significantly reduced regurgitant volume by 7.1 ml/beat compared to a 3.3 ml/beat increase with medical management at 12 months in the highlighted REDUCE-FMR trial.
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