What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial septal defect (n=36). Intervention: Poly-L-lactic acid (PLLA) occluder. Primary outcome: Composite clinical success (successful closure and absence of major complications at 60 months).

What question did this study set out to answer?

This study aimed to assess the long-term safety and efficacy of a biodegradable device for ASD closure in pediatric patients over five years.

April 24, 2026Open Access

Long-term follow-up results of percutaneous closure of atrial septal defect with a novel biodegradable poly-L-lactic acid device in pediatrics: data from a prospective, single-center trial

Key Result

The poly-L-lactic acid (PLLA) occluder achieved an 85.7% clinical success rate at 5 years for pediatric atrial septal defect closure, with no major complications but a 14.3% residual leak rate.

Key Points

This study aimed to assess the long-term safety and efficacy of a biodegradable device for ASD closure in pediatric patients over five years.
Enrolled 36 pediatric patients with significant ASD during a single-center trial.
Used a novel PLLA occluder for percutaneous closure with multiple follow-up assessments over five years.
Primary endpoint was a composite of clinical success, focusing on successful closure and complications at 60 months.
Device implantation successful in 97.2% of patients (35/36).
Closure success rate at five years was 85.7% (30/35), with complete closure at 77.1% (27/35).
Incidence of residual leaks was noted in 14.3% of patients, alongside a 14.3% complication rate including arrhythmias and other issues.

Study Design

Type

Cohort (n=36)

Blinding

Open-label

Multicenter

Structured PICO

Does percutaneous ASD closure using a biodegradable PLLA device improve clinical success and safety in pediatric patients with secundum ASD?

Population

36 pediatric patients (aged 3 to 18 years, weight ≥10 kg) with clinically significant secundum ASD (≥5 mm and ≤30 mm, left-to-right shunt Qp/Qs ≥1.5:1 or right ventricular volume overload) at a single center in China.

Intervention

Percutaneous ASD closure using a fully biodegradable poly-L-lactic acid (PLLA) device (device size 4-8 mm larger than defect).

Outcome

Composite of clinical success, defined as successful closure and absence of major complications at the 60-month follow-up.composite

The biodegradable PLLA device for pediatric ASD closure demonstrated a favorable 5-year safety profile but suboptimal long-term efficacy due to a 14.3% incidence of residual leaks, particularly in larger defects.

Limitations

Single-center study with a small sample size
Single-arm design without a randomized controlled group
Reliance on 2D and color-Doppler TTE may have underestimated ASD dimensions and residual shunts
Detailed biodegradation process of the device was not systematically evaluated

Abstract

Background The poly-L-lactic acid (PLLA) occluder is a novel, fully biodegradable device designed for percutaneous atrial septal defect (ASD) closure. First-in-human studies have demonstrated its preliminary safety and efficacy. Objective This study aimed to evaluate the 5-year safety and efficacy of the PLLA device for percutaneous ASD closure in a single-center pediatric cohort. Methods From May 2018 to August 2019, 36 patients with clinically significant ASD were enrolled and underwent percutaneous closure using the PLLA device. Follow-up assessments were conducted at discharge and at 1, 3, 6, 12, 24, 36, 48, and 60 months post-implantation. The primary endpoint was a composite of clinical success, defined as successful closure and absence of major complications at the 60-month follow-up. Results Successful device implantation was achieved in 35 of 36 patients (97.2%). All of the 35 patients completed the 5-year follow-up. The closure success rate and complete closure rate at 5 years were 85.7% (30/35) and 77.1% (27/35), respectively. Clinically significant residual leaks at 5- year visit were observed in 5 patients (14.3%). A total of 5 complications (14.3%) occurred, consisting of cardiac arrhythmia ( n = 3), moderate mitral regurgitation ( n = 1), and migraine ( n = 1). Patients with a larger baseline ASD indexed diameter (15.18 mm/m 2 ) and a smaller device-to-defect ratio (1.47) showed an increased risk of residual leaks after PLLA device implantation. Conclusion Long-term follow-up confirms a favorable safety profile for percutaneous ASD closure using the PLLA device, with a cumulative complication rate of 14.2% and no major adverse events reported over 5 years. However, the incidence of residual leaks remains noteworthy, suggesting suboptimal long-term efficacy in pediatric patients and in cases involving large defects.

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