Objective

To report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing minimally invasive mitral valve repair (MI-MVr) with the new generation MEMO 4D semi-rigid annuloplasty ring (Figure 1).

Methods

MANTRA is a prospective, multi-center, international post-market study to collect real-life safety and performance data on Corcym devices (Corcym S.r.l, Saluggia, Italy).

Interim analysis of patients enrolled between July 2021 and October 2023 (enrolment is still ongoing).

Clinical and echocardiographic outcomes were collected preoperatively, at discharge and at each follow-up. KCCQ-12 questionnaires were collected preoperatively and at 30-days. Echocardiographic studies were assessed by an independent core-lab.

Results

Among the 170 subjects undergoing MVr with MEMO 4D ring, 97 underwent MI-MVr in 12 International institutions through mini-thoracotomy approach.Mitral regurgitation etiology was primary in 92.8% of the patients. Surgical approach was done by direct vision 42 (43.3%), video assisted 25 (25.8%) and fully endoscopic 30 (30.9%). The most commun ring size was of 38mm. Mortality was nil. Mean Mitral Pressure Gradient at 30 days was of 3.16±1.41mmHg and severe mitral regurgitation was of 1.4%.

Conclusions

In this prospective multicenter study, MI-MVr with MEMO 4D semi-rigid annuloplasty ring confirmed to be safe and effective, providing: