Fang Yanxing, Hou Kai, Lin Dawei, Zhou Daxin, Pan Wenzhi, Ge Junbo
Department of Cardiology, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, Shanghai Institute of Cardiovascular Diseases, 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.
Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Shanghai, 200032, China.
BMC Cardiovasc Disord. 2024 Dec 30;24(1):755. doi: 10.1186/s12872-024-04438-1.
Complete endothelialization is often not achieved within 6 months after implantation of an atrial septal defect (ASD) occluder, which may lead to microthrombus or thrombosis. This study aimed to assess the endothelialization and morphology of a novel puncturable ASD occluder (ReAces) compared with traditional occluders 1 year post-implantation using computed tomography angiography (CTA).
Fifteen patients from each group in a randomized controlled trial comparing ReAces with traditional occluders were included at the 1-year follow-up at Zhongshan Hospital, Fudan University. Baseline characteristics and procedural data were recorded. CTA was performed to assess the device morphology and degree of endothelialization. Independent samples t-test and Fisher's exact test were primarily used to compare the above data.
Each patient received a single device and had no residual shunts. There were no differences in defect size (15.3 ± 4.0 mm vs. 15.3 ± 4.7 mm, p = 1.00) or occluder size (21.2 ± 4.4 mm vs. 21.5 ± 5.3 mm, p = 0.882) between the two groups. At the 1-year follow-up CTA, the central region thickness (4.2 mm ± 0.9 mm vs. 7.8 mm ± 2.4 mm, p < 0.0001), left atrial device-occupied volume (1863.3 mm ± 404.4 mm vs. 4764.4 mm ± 2321.2 mm, p < 0.001), and device compression rates (10.1 ± 4.8% vs. 17.5 ± 5.6%, p = 0.001) were significantly lower in the experimental group. All occluders in the experimental group achieved complete endothelialization, whereas in the control group, 7 patients did not (100% vs. 53.3%, p = 0.006).
Compared with traditional occluders, ReAces presented a significantly greater complete endothelialization rate, lower central region thickness, lower left atrial device-occupied volume, and lower device compression rates at 1 year post-implantation by CTA.
Trial registry: ClinicalTrials.gov. Unique identifying number: NCT05371366. Date of registration: 04/05/2022.
房间隔缺损（ASD）封堵器植入后6个月内通常无法实现完全内皮化，这可能导致微血栓或血栓形成。本研究旨在使用计算机断层血管造影（CTA）评估一种新型可穿刺ASD封堵器（ReAces）与传统封堵器植入1年后的内皮化情况和形态。
复旦大学附属中山医院对一项比较ReAces与传统封堵器的随机对照试验中每组的15例患者进行了1年随访。记录基线特征和手术数据。进行CTA以评估装置形态和内皮化程度。主要使用独立样本t检验和Fisher精确检验比较上述数据。
每位患者接受单个装置且无残余分流。两组间缺损大小（15.3±4.0mm对15.3±4.7mm，p = 1.00）或封堵器大小（21.2±4.4mm对21.5±5.3mm，p = 0.882）无差异。在1年随访CTA时，实验组的中心区域厚度（4.2mm±0.9mm对7.8mm±2.4mm，p < 0.0001）、左心房装置占据体积（1863.3mm±404.4mm对4764.4mm±2321.2mm，p < 0.001）和装置压缩率（10.1±4.8%对17.5±5.6%，p = 0.001）显著更低。实验组所有封堵器均实现完全内皮化，而对照组有7例患者未实现（100%对53.3%，p = 0.006）。
与传统封堵器相比，ReAces在植入1年后通过CTA显示出显著更高的完全内皮化率、更低的中心区域厚度、更低的左心房装置占据体积和更低的装置压缩率。
试验注册机构：ClinicalTrials.gov。唯一识别号：NCT05371366。注册日期：2022年5月4日。
