Minimally Invasive Mitral Valve Repair With New-Generation Annuloplasty Ring: Results From the International Prospective MANTRA Study.

Abstract

Objective: To report the short-term real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing minimally invasive mitral valve repair (MI-MVr) with the MEMO 4D ring (Corcym S.r.l., Saluggia, Italy).

Methods: MANTRA is an ongoing prospective study, evaluating the real-life safety and performance data on Corcym devices. Clinical and echocardiographic core lab-assessed outcomes were collected preoperatively, at discharge, and at follow-up, and Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) questionnaires were administrated preoperatively and at 30 days. This analysis focused on patients who underwent MI-MVr with the MEMO 4D semirigid annuloplasty ring.

Results: Between July 2021 and October 2023, 97 patients were enrolled in 12 institutions. The mean age at surgery was 59.1 ± 11.9 years with a mean EuroSCORE II of 1.3 ± 1.3. Primary mitral regurgitation (MR) was the most common etiology. The 30-day mortality was 0%, and only 2 reoperations were reported within 30 days (2.1%). Surgery resulted in a marked improvement in patient New York Heart Association class, associated with a clinically significant increase in KCCQ-12 summary score. End-diastolic left ventricular diameter decreased from 55.06 ± 6.86 preoperatively to 50.13 ± 6.57 mm at 30-day follow-up, and left atrial volume decreased from 130.96 ± 50.04 preoperatively to 89.32 ± 39.65 mL at 30 days. Mean mitral pressure gradient was 3.156 ± 1.415 mm Hg. MR decreased significantly, with 44.6% of patients showing less than moderate MR.

Conclusions: In this study, MI-MVr with MEMO 4D ring was confirmed to be safe and effective, providing good clinical short-term outcomes, improvement of patient quality of life, and good early hemodynamic performance with optimal reduction of MR severity and preservation of left ventricular function.