Key result
AMEND transeptal annuloplasty safely reduces MR, leaving ~85% of patients with ≤grade 1 severity.
Why the study?
The AMEND implant is a novel transvenous transeptal mitral annuloplasty device aimed to reduce functional mitral regurgitation by selective anteroposterior dimensional reduction, with limited clinical outcome data available.
Does transeptal mitral annuloplasty with the AMEND system safely reduce mitral regurgitation in patients with grade 3 or 4 functional mitral regurgitation?
Cohort (n=13)
Yes
Does transeptal mitral annuloplasty with the AMEND system safely reduce mitral regurgitation in patients with grade 3 or 4 functional mitral regurgitation?
The AMEND transvenous transeptal mitral annuloplasty system demonstrated initial safety and effectively reduced functional mitral regurgitation to ≤grade 1 in the majority of patients at 6 months.
Answers are grounded in this paper and cite their sources.
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Should not yet change practice in MR; extends first-in-man evidence for AMEND annuloplasty but leaves open long-term outcomes.
Background: The AMEND implant is a semi-rigid closed D-shaped annuloplasty ring deployed through a transvenous transeptal approach. It is aimed to affect selective anteroposterior dimensional reduction, improving leaflet coaptation, and reduce mitral regurgitation (MR). We report the 6-month outcomes of the first cohort treated. Methods: Thirteen patients with the grade 3 or 4 functional MR were treated in 2 studies in Georgia and Israel, and with compassionate approvals in Portugal and France. They underwent mitral repair with the AMEND annuloplasty and were followed for 6 months. Results: There were no deaths, myocardial infarctions, strokes or cardiac surgery. There were 2 pericardial effusions, 1 acute and the second at 4 months. There was no anchor disengagement or device dehiscence over the follow-up period. There was a single patient who was readmitted with heart failure, and the iatrogenic atrial septal defect was closed. At 6 months the overall anteroposterior dimensional reduction achieved acutely was maintained, with MR reduction being stable, with 11 of 13 patients with ≤grade 1 MR. Conclusions: In this small multicenter cohort of patients, the AMEND annuloplasty procedure demonstrated promising safety, with stable and significant reduction of MR maintained over the 6-month follow-up period.
Melica et al. (2026) conducted a cohort in Grade 3 or 4 functional mitral regurgitation (n=13). AMEND annuloplasty was evaluated on ≤grade 1 mitral regurgitation. The AMEND annuloplasty procedure demonstrated promising safety and stable reduction of mitral regurgitation, with 84.6% (11 of 13) of patients having ≤grade 1 MR at 6 months.
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