Key result
Mitral valve repair using the ChordArt device achieved reduction to no or trace mitral regurgitation in 100% of patients (5/5) at 24 months, with no major adverse events observed.
Why the study?
The study was conducted to examine the early and midterm safety, efficacy, and durability of mitral valve repair for primary MR using the ChordArt device for chordal replacement.
Does the ChordArt device safely and effectively reduce mitral regurgitation in patients with symptomatic severe primary degenerative MR?
Observational (n=5)
Does the ChordArt device safely and effectively reduce mitral regurgitation in patients with symptomatic severe primary degenerative MR?
The ChordArt device for artificial chordal implantation safely and effectively reduces severe primary degenerative mitral regurgitation up to 2 years in a small initial cohort.
Objectives: This study examines the early and midterm safety, efficacy, and durability of mitral valve repair for primary mitral regurgitation (MR) using the ChordArt device (CoreMedic) for chordal replacement. Methods: Five patients with symptomatic severe primary degenerative MR due to isolated central posterior leaflet prolapse/flail were treated with the ChordArt device in a transseptal surgical approach and followed prospectively with periodical clinical and echocardiographic assessments for 2 years. Results: Reduction of MR immediately after the implantation of artificial chords was achieved in all patients showing no or trace MR (<1+/4+). In all patients, MR <1+ was maintained during 24 months of follow-up. No dehiscence, detachment, or dislocation of the implanted ChordArt devices was observed. Transthoracic echocardiography showed that left ventricle end diastolic diameter significantly decreased during the whole follow-up period in comparison to baseline condition, especially at discharge and 1-month follow-up. Left ventricle end systolic diameter also significantly decreased during the whole follow-up period in comparison to baseline condition. Left atrial volume significantly decreased during the follow-up period in comparison to discharge. No major adverse events, as defined per protocol, were observed during the intervention or during the follow-up period. Conclusions: The ChordArt device allows successful treatment of primary degenerative MR due to posterior mitral leaflet prolapse or flail, with a good safety profile and promising immediate clinical and echocardiographic benefits that are confirmed up to 24 months.
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Weber et al. (2021) conducted an observational in Symptomatic severe primary degenerative mitral regurgitation (n=5). ChordArt device was evaluated on Reduction of mitral regurgitation to <1+. Mitral valve repair using the ChordArt device achieved reduction to no or trace mitral regurgitation in 100% of patients (5/5) at 24 months, with no major adverse events observed.
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