Transeptal Mitral Annuloplasty With the AMEND System: 6-Month Results of First in Man Cohort.

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.