Liao Li-Chin, Fu Yun-Ching, Lee Pi-Chang, Jan Sheng-Ling, Lin Ming-Chih, Chuang Chieh-Mao, Hung Hui-Chih
Doctoral Program in Translational Medicine, National Chung Hsing University, Taichung, Taiwan.
Rong Hsing Translational Medicine Research Center, National Chung Hsing University, Taichung, Taiwan.
Front Cardiovasc Med. 2025 May 27;12:1572812. doi: 10.3389/fcvm.2025.1572812. eCollection 2025.
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.
This study aims to evaluate the 6-month safety and efficacy of the MFO device for PmVSD closure.
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.
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.
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.
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。
本研究旨在评估MFO装置闭合PmVSD的6个月安全性和有效性。
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。
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。
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。