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PhysioFlex半刚性开放瓣环成形环的早期结果:微创二尖瓣修复队列分析

Early Outcomes of the PhysioFlex Semi-Rigid Open Annuloplasty Ring: A Minimally Invasive Mitral Valve Repair Cohort Analysis.

作者信息

Dini Martina, Akansel Serdar, Wilkens Kristin, Miskinyte Emilija, Jacobs Stephan, Falk Volkmar, Kempfert Jörg, Kofler Markus

机构信息

Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum der Charité (DHZC), Augustenburger Platz 1, 13353 Berlin, Germany.

Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Charitéplatz 1, 10117 Berlin, Germany.

出版信息

J Clin Med. 2025 Jun 11;14(12):4155. doi: 10.3390/jcm14124155.

Abstract

: New generations of annuloplasty rings are designed to combine structural support with enhanced flexibility, allowing for better adaptation to the dynamic nature of the mitral annulus. This study investigated the early clinical and echocardiographic outcomes of minimally invasive mitral valve repair (MI-MVr) with a new semi-rigid open ring (PhysioFlex, annuloplasty ring, Edwards Lifesciences, Irvine, CA, USA). : A total of 150 consecutive patients who underwent MI-MVr for severe degenerative mitral regurgitation (DMR) using the PhysioFlex annuloplasty ring between June 2021 and April 2024 were included in the study. Preoperative, intraoperative, and postoperative data were collected for the entire population. A three-dimensional mitral valve reconstruction analysis was performed across the entire cohort using a semi-automated software package (4D Mitral Valve Analysis; Tomtec Imaging Systems, Munich, Germany). : The median age was 59 (50-67) years and 25.3% patients were female. The median Euroscore II and left ventricular ejection fraction were 0.72 (0.56-0.99) and 60% (55-65), respectively. The median implanted ring size was 34 mm (32-36). The entire cohort was discharged with no residual mitral regurgitation greater than mild and a median mean transmitral pressure gradient of 2.4 mmHg (2-3). The median hospitalization time was 7 days (6-11) and in-hospital mortality occurred in 1 (0.7%) patient. : MI-MVr was safely performed using the novel semi-rigid partial PhysioFlex ring in the DMR patient cohort with favorable early results. The PhysioFlex annuloplasty ring may be used as an alternative to complete rings in MI-MVr. Further research is needed to conduct comparisons with other currently available annuloplasty rings.

摘要

新一代瓣环成形环的设计旨在将结构支撑与增强的灵活性相结合,以便更好地适应二尖瓣环的动态特性。本研究调查了使用新型半刚性开放环(PhysioFlex瓣环成形环,美国加利福尼亚州尔湾市爱德华兹生命科学公司)进行微创二尖瓣修复术(MI-MVr)的早期临床和超声心动图结果。

2021年6月至2024年4月期间,共有150例连续使用PhysioFlex瓣环成形环进行严重退行性二尖瓣反流(DMR)的MI-MVr患者纳入本研究。收集了整个人群的术前、术中和术后数据。使用半自动软件包(4D二尖瓣分析;德国慕尼黑市Tomtec成像系统公司)对整个队列进行三维二尖瓣重建分析。

中位年龄为59(50 - 67)岁,25.3%的患者为女性。欧洲心脏手术风险评估系统(Euroscore)II中位数和左心室射血分数分别为0.72(0.56 - 0.99)和60%(55 - 65)。植入环的中位尺寸为34 mm(32 - 36)。整个人群出院时无大于轻度的残余二尖瓣反流,平均跨二尖瓣压力梯度中位数为2.4 mmHg(2 - 3)。中位住院时间为7天(6 - 11),1例(0.7%)患者发生院内死亡。

在DMR患者队列中,使用新型半刚性部分PhysioFlex环安全地进行了MI-MVr,早期结果良好。PhysioFlex瓣环成形环可作为MI-MVr中完整环的替代方案。需要进一步研究以与其他现有瓣环成形环进行比较。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b06e/12193793/90b2265b1f82/jcm-14-04155-g001.jpg

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