FDA approves adjustable pulmonary valve for children
The new valve can be enlarged as a child grows, but long-term data remain limited.
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The US Food and Drug Administration (FDA) has approved an adjustable pulmonary valve for children. The Autus valve can be enlarged after implantation using a balloon catheter, potentially reducing the need for open-heart surgery as children grow.
The valve is intended for children with congenital abnormalities of the pulmonary valve. That valve regulates blood flow from the heart to the lungs. The Autus Size-Adjustable Valve can initially have a diameter of about 13 millimetres and later be enlarged to about 22 millimetres, a size comparable to that of an adult pulmonary valve.
According to the FDA, this is the first approved heart valve specifically designed to grow with a child after implantation. The valve also uses plastic leaflets instead of animal tissue. The manufacturer is Autus Valve Technologies; approval was granted to Edwards Lifesciences.
The authorisation is based on a clinical study involving 62 children at twelve sites in the United States. Among the first 60 children assessed after six months, blood flow through the right side of the heart was within acceptable limits according to the FDA, with no more than mild leakage through the valve.
The initial results also include caveats. In three children, part of the valve frame broke, and in two children, a leaflet moved less well. According to the FDA, none of these events caused symptoms. In two children, performance declined when they began to outgrow the valve; in both cases, the valve could be enlarged with a catheter without a new open-heart operation.
That latter result is encouraging, but is based on only two experiences. The FDA says follow-up research is needed to assess the long-term risks and determine whether enlarging the valve actually leads to fewer operations. It is also not yet known how the plastic leaflets will perform over many years.
The approval therefore does not mean that children with a congenital heart defect will receive a treatment that prevents all later procedures. It means that doctors in the United States can consider a new option within the indication for which the FDA gave permission. Which treatment is appropriate depends on the heart defect, the child’s age and the medical assessment of the individual child.
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The approval, dimensions, study size and reported complications can be found in the FDA publication. The text explicitly states that the long-term performance and the effect on the number of operations have not yet been definitively established.
- confirmed The FDA approved the Autus Size-Adjustable Valve for children with congenital pulmonary valve disease. — This is stated in the FDA announcement. source
- confirmed The valve can be enlarged from about 13 to 22 millimetres. — The FDA gives both dimensions. source
- confirmed The clinical study involved 62 children at twelve sites. — The study size is stated in the FDA’s description of the authorisation. source
- confirmed In two children, the valve was enlarged without a new invasive operation. — The FDA reports this, but stresses that the experience is limited. source
- confirmed Long-term research into the risks and performance is still ongoing. — The FDA says that follow-up research is needed. source
Editor's note
The FDA approval and the initial study results have been confirmed. Experience with actually enlarging the valve remains limited and long-term research is ongoing; this report is not individual medical advice.Sources
- FDA Approves First Heart Valve Designed to Grow with Children — U.S. Food and Drug Administration
- Specialties: FDA approves first heart valve built to expand as children grow — Physician in the Loop
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