Key result
Echocardiography-guided percutaneous patent ductus arteriosus closure achieved a 100% procedural success rate, demonstrating non-inferiority to fluoroscopy-guided closure without compromising procedural time.
Why the study?
Many centers have explored transcatheter procedures without fluoroscopy, and this study aimed to assess the feasibility and safety of percutaneous PDA closure under echocardiography-only guidance.
Does echocardiography-only guidance maintain procedural success and safety compared to fluoroscopy guidance in children undergoing percutaneous PDA closure?
Cohort (n=60)
Non-randomized
No
Does echocardiography-only guidance maintain procedural success and safety compared to fluoroscopy guidance in children undergoing percutaneous PDA closure?
Absolute Event Rate: 100% vs 100%
Echocardiography-guided percutaneous PDA closure is feasible, safe, and non-inferior to fluoroscopy-guided closure, offering a radiation-free alternative for pediatric patients.
May enable radiation-free PDA closure; leaves open randomized confirmation before practice change.
Introduction: Since the first successful percutaneous closure under transesophageal echocardiographic (TEE) guidance, many centers explored transcatheter procedures without fluoroscopy. This single-center study is aimed to show the feasibility and safety of percutaneous patent ductus arteriosus (PDA) closure under echocardiography-only guidance during our 1-year experience. Methods: Patients with PDA were recruited for percutaneous PDA closure guided by either fluoroscopy or echocardiography-only in National Cardiovascular Center Harapan Kita (ClinicalTrials.gov Identifier: NCT05321849, clinicaltrials.gov/ct2/show/NCT05321849). Patients were evaluated clinically and radiologically using transthoracic echocardiography (TTE) at 6, 24, and 48 h after the procedure. The primary endpoint was the procedural success. Secondary endpoints were the procedural time and the rate of adverse events. Results: A total of 60 patients underwent transcatheter PDA closure, 30 patients with fluoroscopy and 30 patients with echocardiography guidance. All patients had successful PDA closure. There were only residual shunts, which were disappeared after follow-up in both groups, but one patient with a fluoroscopy-guided procedure had moderate tricuspid regurgitation with suspected thrombus in the tricuspid valve. The procedural time was not significantly different between the fluoroscopy and echocardiography groups.
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Siagian et al. (2022) conducted a cohort in Patent Ductus Arteriosus (PDA) (n=60). Echocardiography-guided percutaneous PDA closure vs. Fluoroscopy-guided percutaneous PDA closure was evaluated on Procedural success (successful device implantation without device migration and no residual shunt or central mild shunt). Echocardiography-guided percutaneous patent ductus arteriosus closure achieved a 100% procedural success rate, demonstrating non-inferiority to fluoroscopy-guided closure without compromising procedural time.
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