What is the clinical evidence from this study?

Study design: Cohort. Population: Secundum atrial septal defect (n=596). Intervention: Amplatzer septal occluder vs. Surgical closure. Primary outcome: Primary efficacy success rate (p=>0.05).

April 20, 2026Journal of the American College of Cardiology

Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults

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Key result

Transcatheter ASD closure matches surgical efficacy but is linked to ~70% fewer complications.

P>0.05
n=596

Why the study?

The clinical utility of the Amplatzer septal occluder for secundum ASD closure can only be judged against contemporaneous surgical results.

Does transcatheter closure using the Amplatzer septal occluder improve safety and clinical utility compared to surgical closure in patients with secundum atrial septal defect?

Comparison

Transcatheter closure using Amplatzer septal occluder vs surgical closure

Design

Multicenter nonrandomized concurrent cohort study

Follow-up

6 and 12 months for device group, 12 months for surgical group

Authors

ZDZhong‐Dong DuSoochow University ZHZiyad M. HijaziPediatric / Congenital Cardiology CKCharles S. KleinmanUniversity of Southern California

Discussion

Member takes

Implication

May reduce complications versus surgery for secundum ASD; leaves open comparative effectiveness pending RCTs.**[[1]](https://www.structuralheart.abbott/int/fileadmin/content/clinical-research/clinicalinsights-ous/PDFs/59438_Amplatzer_Septal_Occluder_Safety_Clinical_Insight_OUS.

Key Points

To compare the safety, efficacy, and clinical utility of transcatheter closure using the Amplatzer septal occluder against open surgical closure for secundum atrial septal defects.
Multicenter, nonrandomized concurrent study conducted across 29 pediatric cardiology centers between March 1998 and March 2000.
Enrolled 596 patients assigned by preference to either transcatheter Amplatzer septal occluder closure (N=442) or surgical closure (N=154), with clinical and echocardiographic follow-up up to 12 months.
Procedural attempt success was 95.7% for the device group versus 100% for the surgical group (p = 0.006), while secondary efficacy success was 91.6% versus 89.0%, respectively (p > 0.05).
Total complication rates were 7.2% for device closure compared to 24.0% for surgery (p < 0.001), with shorter hospital stays for device closure (1.0 ± 0.3 vs. 3.4 ± 1.2 days, p < 0.001) and 0% mortality in both arms.

Study Design

Type

Cohort (n=596)

Multicenter

Yes

Structured PICO

Does transcatheter closure using the Amplatzer septal occluder improve safety and clinical utility compared to surgical closure in patients with secundum atrial septal defect?

Population

596 patients with secundum atrial septal defect undergoing either transcatheter device closure or surgical repair, followed for up to 12 months.

Exposure

Transcatheter closure using the Amplatzer septal occluder (ASO)

Comparator

Surgical closure

Outcome

Safety, efficacy (early, primary, and secondary success rates), and clinical utility (complication rate, length of hospital stay, mortality)

Main Result

Absolute Event Rate: 98.5% vs 100%

p-value: p=>0.05

Transcatheter closure of secundum ASD using the Amplatzer septal occluder is a safe and effective alternative to surgical repair, offering similar efficacy with fewer complications and a shorter hospital stay.

Cite This Study

Du et al. (2002) conducted a cohort in Secundum atrial septal defect (n=596). Amplatzer septal occluder vs. Surgical closure was evaluated on Primary efficacy success rate (p=>0.05). Transcatheter closure of secundum ASD using the Amplatzer septal occluder had similar primary efficacy success to surgery (98.5% vs 100%, P>0.05) but lower complications (7.2% vs 24.0%, P<0.001).

synapsesocial.com/papers/69e643e3c3fdccbe27a8aa60 https://doi.org/10.1016/s0735-1097(02)01862-4

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Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Also Consider