Hysi Ilir, Di Eusanio Marco, Choi Yeong-Hoon, Bonaros Nikolaos, Kempfert Joerg, Baeza Cristian, Troise Giovanni, Pacini Davide, Pollari Francesco, Santarpino Giuseppe, Argano Vincenzo, Badano Luigi, Dzemali Omer
Lens Hospital and Bois Bernard Private Hospital, France.
Ospedali Riuniti Ancona, Italy.
Innovations (Phila). 2025 May-Jun;20(3):283-289. doi: 10.1177/15569845251338807. Epub 2025 May 22.
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).
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.
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.
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.
报告MANTRA研究中使用MEMO 4D环（意大利萨卢贾的Corcym S.r.l.公司）进行微创二尖瓣修复（MI-MVr）患者的短期真实世界临床和血流动力学表现。
MANTRA是一项正在进行的前瞻性研究，评估Corcym设备的实际安全性和性能数据。术前、出院时和随访时收集临床和超声心动图核心实验室评估的结果，并在术前和30天时进行堪萨斯城心肌病问卷12（KCCQ-12）问卷调查。本分析聚焦于使用MEMO 4D半刚性瓣环成形环进行MI-MVr的患者。
2021年7月至2023年10月期间，12家机构共纳入97例患者。手术时的平均年龄为59.1±11.9岁，平均欧洲心脏手术风险评估系统（EuroSCORE）II评分为1.3±1.3。原发性二尖瓣反流（MR）是最常见的病因。30天死亡率为0%，30天内仅报告2例再次手术（2.1%）。手术使患者的纽约心脏协会分级显著改善，同时KCCQ-12总结评分在临床上有显著提高。舒张末期左心室直径从术前的55.06±6.86毫米降至30天随访时的50.13±6.57毫米，左心房容积从术前的130.96±50.04毫升降至30天时的89.32±39.65毫升。平均二尖瓣压力阶差为3.156±1.415毫米汞柱。MR显著降低，44.6%的患者显示MR程度低于中度。
在本研究中，使用MEMO 4D环进行MI-MVr被证实是安全有效的，可提供良好的短期临床结果、改善患者生活质量，并具有良好的早期血流动力学表现，能最佳程度降低MR严重程度并保留左心室功能。
