Related Experiment Video
Updated: May 7, 2025
Echocardiographic Evaluation of Atrial Communications before Transcatheter Closure
Published on: February 8, 2022
Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of
Yanxing Fang1,2, Kai Hou3, Dawei Lin1,2
1Department 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.
Insights
The novel ReAces atrial septal defect occluder demonstrated superior endothelialization compared to traditional devices one year post-implantation. ReAces also showed reduced thickness, volume, and compression, indicating better integration and potentially lower thrombosis risk.
Area of Science:
- Cardiovascular Medicine
- Medical Devices
- Interventional Cardiology
Background:
- Incomplete endothelialization of atrial septal defect (ASD) occluders within 6 months can lead to thrombosis.
- A novel puncturable ASD occluder, ReAces, was developed to improve healing.
- Assessing endothelialization and morphology is crucial for device safety and efficacy.
Purpose of the Study:
- To compare the endothelialization and morphology of the ReAces occluder with traditional occluders.
- To evaluate device performance one year after implantation using computed tomography angiography (CTA).
- To determine if ReAces offers improved integration and reduced thrombotic risk.
Main Methods:
- A randomized controlled trial included 15 patients per group (ReAces vs. traditional occluders).
- Computed tomography angiography (CTA) was used at 1-year follow-up to assess device morphology and endothelialization.
- Statistical analysis included independent samples t-tests and Fisher's exact tests.
Main Results:
- The ReAces group showed significantly lower central region thickness, left atrial device-occupied volume, and device compression rates.
- Complete endothelialization was achieved in 100% of ReAces patients versus 53.3% in the traditional occluder group (p=0.006).
- No significant differences in defect or occluder size were observed between groups.
Conclusions:
- The ReAces occluder achieved a significantly higher rate of complete endothelialization compared to traditional occluders at 1 year.
- ReAces demonstrated superior morphological characteristics, including reduced thickness, volume, and compression.
- These findings suggest ReAces may offer improved safety and efficacy in ASD closure.
Background:
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).
Methods:
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.
Results:
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 mm2 ± 404.4 mm2 vs. 4764.4 mm2 ± 2321.2 mm2, 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).
Conclusions:
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 Registration:
Trial registry: ClinicalTrials.gov. Unique identifying number: NCT05371366. Date of registration: 04/05/2022.
