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使用科纳尔多功能封堵器经导管闭合膜周部室间隔缺损的短期结果:台湾地区经验

Short-term outcomes of transcatheter perimembranous ventricular septal defect closure using the konar-multifunctional occluder: the Taiwanese experience.

作者信息

Liao Li-Chin, Fu Yun-Ching, Lee Pi-Chang, Jan Sheng-Ling, Lin Ming-Chih, Chuang Chieh-Mao, Hung Hui-Chih

机构信息

Doctoral Program in Translational Medicine, National Chung Hsing University, Taichung, Taiwan.

Rong Hsing Translational Medicine Research Center, National Chung Hsing University, Taichung, Taiwan.

出版信息

Front Cardiovasc Med. 2025 May 27;12:1572812. doi: 10.3389/fcvm.2025.1572812. eCollection 2025.

Abstract

INTRODUCTION

Transcatheter device closure of perimembranous ventricular septal defect (PmVSD) using the Lifetech KONAR-MF ventricular septal defect occluder (MFO) presents a promising and effective alternative to surgical repair.

OBJECTIVES

This study aims to evaluate the 6-month safety and efficacy of the MFO device for PmVSD closure.

MATERIALS AND METHODS

We conducted a retrospective analysis of clinical data from patients who underwent percutaneous PmVSD closure using the MFO device at our institution between December 2021 and June 2024. Safety, procedural and 6-month outcomes were systematically assessed.

RESULTS

A total of 115 patients (52.2% male) underwent transcatheter PmVSD closure. The median age was 7.6 years [interquartile range (IQR), 4.0-27.2] and weight 25.6 kg (IQR, 14.2-62.6). Median defect size by angiography was 5.7 mm (IQR, 3.8-8.3) on the left ventricle side and 3.3 mm (IQR, 2.3-4.4) on the right ventricle side. Aortic valve prolapse (AVP) was noted in 114 patients (99.1%), with pre-procedural aortic regurgitation (AR) in 36 (31.3%). Median pulmonary artery pressure was 17 mmHg (IQR, 14-20); 48 (41.7%) had Qp/Qs >1.5. All procedures were successful; 33 (28.7%) used a retrograde approach. Median fluoroscopy time was 22 min (IQR, 15-33). Complete closure was achieved in 51.3% at 1 day, 62.6% at 1 month, 69.6% at 3 months, and 83.5% at 6 months. Transient conduction disturbances ( = 4), hypotension ( = 1), and femoral hematoma ( = 1) were observed. No cases of endocarditis, valve injury, or complete atrioventricular block occurred.

CONCLUSION

Transcatheter closure of PmVSD with the MFO demonstrated safety and efficacy during the 6-month follow-up period. Notably, the majority of defects in this cohort were small in size.

摘要

引言

使用深圳先健科技公司的KONAR-MF室间隔缺损封堵器(MFO)经导管装置闭合膜周部室间隔缺损(PmVSD)是一种有前景且有效的手术修复替代方案。

目的

本研究旨在评估MFO装置闭合PmVSD的6个月安全性和有效性。

材料与方法

我们对2021年12月至2024年6月期间在本机构接受使用MFO装置经皮闭合PmVSD的患者临床资料进行了回顾性分析。系统评估了安全性、手术过程及6个月的结果。

结果

共有115例患者(男性占52.2%)接受了经导管PmVSD闭合术。中位年龄为7.6岁[四分位间距(IQR),4.0 - 27.2],体重为25.6 kg(IQR,14.2 - 62.6)。血管造影显示左心室侧缺损中位大小为5.7 mm(IQR,3.8 - 8.3),右心室侧为3.3 mm(IQR,2.3 - 4.4)。114例患者(99.1%)存在主动脉瓣脱垂(AVP),术前有主动脉瓣反流(AR)的有36例(31.3%)。肺动脉压中位值为17 mmHg(IQR,14 - 20);48例(41.7%)患者的肺循环血流量与体循环血流量比值(Qp/Qs)>1.5。所有手术均成功;33例(28.7%)采用逆行途径。透视时间中位值为22分钟(IQR,15 - 33)。术后1天完全闭合率为51.3%,1个月时为62.6%,3个月时为69.6%,6个月时为83.5%。观察到短暂性传导障碍(=4例)、低血压(=1例)和股部血肿(=1例)。未发生心内膜炎、瓣膜损伤或完全性房室传导阻滞病例。

结论

在6个月的随访期内,使用MFO经导管闭合PmVSD显示出安全性和有效性。值得注意的是,该队列中的大多数缺损尺寸较小。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4af/12148872/1437770fd71f/fcvm-12-1572812-g001.jpg

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