Key result
Percutaneous ASD closure without balloon sizing achieves 100% procedural success using formula-based device selection.
Why the study?
Conventional balloon sizing for percutaneous ASD closure has limitations, including potential overestimation of defect size, increased treatment costs, and prolonged procedure time, motivating evaluation of short-term outcomes without balloon sizing.
Does percutaneous transcatheter closure without balloon sizing achieve high procedural and technical success with low complication rates in patients with secundum atrial septal defect and suitable anatomy?
Observational (n=104)
Open-label
No
Does percutaneous transcatheter closure without balloon sizing achieve high procedural and technical success with low complication rates in patients with secundum atrial septal defect and suitable anatomy?
Echocardiography-guided percutaneous ASD closure without balloon sizing achieved 100% procedural success and 94.2% technical success with first-choice device sizing, offering a safe, rapid, and cost-effective alternative in patients with suitable anatomy.
Answers are grounded in this paper and cite their sources.
Supports feasibility of balloon-free percutaneous ASD closure in suitable anatomy; hypothesis-generating and requires randomized trials before wider adoption.
Background: Balloon sizing is a conventional method used to determine an appropriate device size for percutaneous closure of atrial septal defects (ASDs). However, balloon sizing has certain limitations, including potential overestimation of the actual defect size, increased treatment costs, and prolonged procedure time. Objective: To evaluate the short-term outcomes of percutaneous ASD closure without balloon sizing at Hanoi Heart Hospital. Methods: From October 2025 to June 2026, 104 patients with ASD underwent percutaneous device closure without balloon sizing at Hanoi Heart Hospital. Clinical, echocardiographic, procedural, and post-procedural follow-up data were collected and analyzed. The mean follow-up duration was 5.6 months, ranging from 3 to 10 months. Results: Procedural success was achieved in all 104 patients (100%), defined as successful deployment of the device in the appropriate position, stable device fixation on testing, and absence of compression or obstruction of adjacent anatomical structures. In 98 patients (94.2%), the device was successfully deployed using the initially selected size according to the sizing formula. The remaining 6 patients (5.8%) required adjustment of device size or balloon-assisted deployment: 2 required a larger device, 2 required a smaller device, and 2 required balloon assistance. All 6 cases were successfully completed. No vascular complications, device embolization, or pericardial effusion were observed during follow-up. Three patients (2.9%) developed arrhythmias: 2 had sinus bradycardia and 1 developed transient third-degree atrioventricular block one week after the procedure. All arrhythmias resolved completely without the need for permanent pacemaker implantation. Conclusion: Percutaneous ASD closure without balloon sizing is a safe and effective treatment option for patients with suitable anatomical characteristics, with a high procedural success rate and short procedure and fluoroscopy times. This approach may reduce the use of additional consumable materials during the procedure. However, further studies with larger sample sizes and longer follow-up are needed to evaluate mid- and long-term outcomes and to identify factors associated with technical failure.
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Nguyen et al. (2026) conducted an observational in Secundum atrial septal defect (n=104). Percutaneous ASD device closure without balloon sizing was evaluated on Procedural success (successful device deployment in appropriate position, stable fixation, and absence of adjacent structure compression). Percutaneous ASD closure without balloon sizing achieved 100% procedural success and 94.2% technical success with the initially formula-selected device size in 104 patients.
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