使用半刚性Memo 4D瓣环成形环进行二尖瓣修复：MANTRA研究的早期临床和超声心动图结果
Mitral valve repair with the semi-rigid Memo 4D annuloplasty ring: early clinical and echocardiographic outcomes from the MANTRA study.
作者信息
Dzemali Omer, Rodriguez Cetina Biefer Hector, Di Eusanio Marco, Fabre Olivier, Troise Giovanni, Bonaros Nikolaos, Grimaldi Francesco, Choi Yeong-Hoon, Santarpino Giuseppe, Baeza Cristian, Pollari Francesco, Marcheix Bertrand, Pacini Davide, Argano Vincenzo, Baghai Max, Bhabra Moninder, Mazzaro Enzo, Badano Luigi, Kempfert Joerg
机构信息
Clinic for Cardiac Surgery, University Hospital of Zurich, Zurich, Switzerland.
Clinic for Cardiac Surgery, City Hospital of Zurich-Triemli, Zurich, Switzerland.
出版信息
Interdiscip Cardiovasc Thorac Surg. 2024 Dec 25;40(1). doi: 10.1093/icvts/ivae208.
OBJECTIVES
Memo 4D is a semi-rigid ring with an exclusive saddle shape and progressive increased anteroposterior diameter. This preliminary analysis reports 30-day clinical and haemodynamic outcomes of the MANTRA Memo 4D sub-study.
METHODS
MANTRA is an 'umbrella' prospective, multicentre, worldwide post-market study to collect real-life safety and performance data on the Corcym devices. Clinical and echocardiographic outcomes were gathered preoperatively, at discharge and each follow-up. KCCQ-12 questionnaires were collected preoperatively and at 30 days. Echocardiographic studies were performed per a predefined protocol and assessed by an independent core laboratory.
RESULTS
In total, 166 patients (52, 31.3% female, mean age 60.7 ± 11.4 years) underwent mitral valve repair with Memo 4D in 17 international institutions between July 2021 and June 2023 (enrolment is still ongoing). Primary was the most common aetiology (157, 94.6%), of which 33 cases of Barlow's disease (19.9%); secondary mitral regurgitation was present in six cases (3.6%). Thirty-day mortality was 0.6% (1). One stroke event (0.6%), one acute kidney failure (0.6%), one myocardial infarction (0.6%) and two reoperations within 30 days were reported. Surgery marked improvement in the patient's NYHA class associated with a significant increase in KCCQ-12 summary score, from 69.1 (SD = 23.7) preoperatively to 83.9 (SD = 15.7) at 30 days. End-diastolic left ventricular diameters decreased from 55.19 (SD = 7.10) preoperatively to 52.70 (SD = 3.76) mm at 30 days, and left atrial volume decreased from 125.79 (SD = 46.33) preoperatively to 91.51 (SD = 37.20) ml at 30 days. Mitral regurgitation significantly reduced after the operation and up to 30-day follow-up.
CONCLUSIONS
Mitral valve repair with Memo 4D is associated with good clinical and haemodynamic outcomes in the early period.MANTRA ClinicalTrials.gov number NCT05002543.
目的
Memo 4D是一种具有独特鞍形和前后径逐渐增加的半刚性环。本初步分析报告了MANTRA Memo 4D子研究的30天临床和血流动力学结果。
方法
MANTRA是一项“综合”前瞻性、多中心、全球上市后研究，旨在收集Corcym器械的实际安全性和性能数据。术前、出院时及每次随访时收集临床和超声心动图结果。术前和30天时收集KCCQ - 12问卷。超声心动图研究按照预定义方案进行，并由独立的核心实验室评估。
结果
2021年7月至2023年6月期间，共有166例患者（52例，31.3%为女性，平均年龄60.7±11.4岁）在17个国际机构接受了Memo 4D二尖瓣修复术（入组仍在进行）。原发性是最常见的病因（157例，94.6%），其中33例为巴洛氏病（19.9%）；继发性二尖瓣反流6例（3.6%）。30天死亡率为0.6%（1例）。报告了1例中风事件（0.6%）、1例急性肾衰竭（0.6%）、1例心肌梗死（0.6%）以及30天内2例再次手术。手术显著改善了患者的纽约心脏协会（NYHA）心功能分级，KCCQ - 12总结评分显著提高，从术前的69.1（标准差 = 23.7）提高到30天时的83.9（标准差 = 15.7）。舒张末期左心室直径从术前的55.19（标准差 = 7.10）毫米降至30天时的52.70（标准差 = 3.76）毫米，左心房容积从术前的125.79（标准差 = 46.33）毫升降至30天时的91.51（标准差 = 37.20）毫升。术后至30天随访时二尖瓣反流显著减少。
结论
Memo 4D二尖瓣修复术在早期具有良好的临床和血流动力学结果。MANTRA临床试验注册号：NCT05002543。
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