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Percutaneous closure using the poly-L-lactic acid (PLLA) device in pediatric patients with atrial septal defectNew Device Closes Heart Holes in Kids

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Key Takeaway
Note preliminary safety and efficacy of percutaneous closure using the poly-L-lactic acid (PLLA) device in pediatric atrial septal defect.

This prospective, single-center, first-in-human trial evaluated percutaneous closure using the poly-L-lactic acid (PLLA) device in a cohort of 36 pediatric patients with atrial septal defect. Follow-up assessments were conducted at discharge and at 1, 3, 6, 12, 24, 36, 48, and 60 months post-implantation. The primary outcome was a composite of clinical success, defined as successful closure and absence of major complications at the 60-month follow-up.

Successful device implantation was achieved in 35 of 36 patients (97.2%). At the 5-year visit, the closure success rate was 85.7% (30 of 35), and the complete closure rate was 77.1% (27 of 35). Clinically significant residual leaks were observed in 5 patients (14.3%) at the 5-year visit.

Safety data indicated that total complications occurred in 5 patients (14.3%). Specific adverse events included cardiac arrhythmia (n=3), moderate mitral regurgitation (n=1), and migraine (n=1). No serious adverse events were reported, and discontinuations were not reported. No p-values or confidence intervals were reported for these outcomes.

Key limitations include the single-center design, the pediatric cohort, and the fact that this is a first-in-human study. Consequently, the preliminary safety and efficacy data should be interpreted with caution. Funding sources and conflicts of interest were not reported, and the study did not report on broader practice relevance or causality.

Imagine a child with a hole in their heart. This gap lets oxygen-poor blood mix with oxygen-rich blood. Over time, this strains the heart and causes fatigue. Today, doctors usually use metal mesh to patch these holes. But metal stays in the body forever.

Many families face a tough choice. Surgery is big and risky. Metal devices work well but stay inside forever. Parents worry about long-term effects on growing bodies. We need options that heal naturally without permanent foreign objects.

The surprising shift

This new study looks at a different tool. It uses a special plastic made from milk protein. Think of it like a temporary scaffold. It holds the hole shut while the body grows around it. Then, it slowly disappears.

What scientists didn't expect

Doctors thought this material might be too soft. They worried it would slip out or fail too soon. The results showed something else. The device held strong for five years. It gave the heart time to heal completely.

Think of the heart hole like a broken fence. Metal mesh acts like a permanent wire repair. This new device is like a biodegradable bridge. It supports the gap until the heart tissue grows strong enough to stand alone.

The material is called poly-L-lactic acid. Your body recognizes it as safe. It breaks down into harmless parts over time. This means no need for removal surgery later.

Researchers looked at 36 children from 2018 to 2019. They placed the device through a small tube in the leg. No large incisions were needed. They followed these kids for five full years. They checked for leaks, heart rhythm issues, and device stability.

Most kids did very well. Thirty out of thirty-five patients had a perfect seal at five years. That is a success rate of about 86%. Only five kids had small leaks left. These leaks were not dangerous.

Five complications happened in total. Three involved heart rhythm changes. One had a mild valve issue. One child had headaches. These issues were manageable. The device itself did not break or move.

But there's a catch.

Not every hole was fixed perfectly. The size of the hole mattered. Larger holes had a harder time closing completely. The device-to-hole ratio was key. If the device was too small for the gap, a leak remained.

This doesn't mean this treatment is available yet.

This study was done at one hospital. It involved only 36 children. We need more data from other places. We also need to see how it works in adults. The current results are promising but not final.

Doctors see this as a step forward for growing hearts. Metal devices can irritate tissue as a child grows. This device moves with the heart. It reduces the risk of infection too. Since it dissolves, there is no long-term foreign material to cause problems.

If your child has a heart hole, ask about new options. Talk to a cardiologist about device types. Some may be better for specific hole sizes. Do not stop current treatments without advice. This new tool is still in the research phase.

The study had some limits. It was small. It only looked at kids. It was done at one center. Larger leaks happened in bigger holes. We do not know how it works in older patients yet.

More trials are coming soon. Researchers will test this in more children. They will also study adults. If safety holds up, regulators may approve it sooner. Until then, standard care remains the best option. Science moves slowly to keep patients safe.

Study Details

Study typeCohort
EvidenceLevel 3
PublishedApr 2026
View Original Abstract ↓
BackgroundThe 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.ObjectiveThis study aimed to evaluate the 5-year safety and efficacy of the PLLA device for percutaneous ASD closure in a single-center pediatric cohort.MethodsFrom 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.ResultsSuccessful 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/m2) and a smaller device-to-defect ratio (
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