The Food and Drug Administration on Oct. 1 approved the first heart valve that doctors can widen after surgery, so a child does not need a new operation each time the valve is outgrown. The Autus Size-Adjustable Valve replaces the pulmonary valve in children with congenital heart disease, the FDA said in its announcement.
Edwards Lifesciences, based in Irvine, California, announced the approval the same day. The valve was developed by Autus Valve Technologies. Edwards received the approval.
How the Expandable Pediatric Heart Valve Works
Surgeons implant the valve at about 13 millimeters across, a size the FDA said suits toddlers and preschoolers. Later, a cardiologist threads a catheter with a small balloon into the valve and inflates it. The FDA said the valve can reach about 22 millimeters, roughly the size of an adult pulmonary valve.
The size range gives one way to measure the design. Going from 13 to 22 millimeters is a 9millimeter increase, or about 69% wider than the starting size. A fixed-size valve placed in a toddler has no such room, which is why children who receive one often need it replaced as they grow.
The valve also differs in what it is made of. The FDA said it is the first U.S.-approved valve to use polymer leaflets, the flaps that open and close, in place of animal tissue. The agency said animal tissue tends to harden and break down faster in children, which can bring repeat surgery sooner. The FDA described the approval as the first for any valve using polymeric leaflet material.
Edwards said the expansion happens through a minimally invasive transcatheter procedure and may reduce the need for repeat open-heart surgery. The valve had received the FDA’s Breakthrough Device designation before approval. It also took part in the agency’s Total Product Life Cycle Advisory Program, a voluntary pilot that started on Oct. 11, 2022, to speed patient access to devices through early and frequent contact with the agency.
Clinical Trial Results for the Autus Valve
The approval rests on a study that enrolled 62 children at 12 U.S. sites, according to the FDA. The agency said every patient had a successful procedure and no one died. It reported no clotrelated complications that needed treatment.
The FDA reported the following problems:
- Three patients had a fracture in the valve frame.
- Two patients had reduced movement of a valve leaflet.
- Two patients had valves whose performance began to decline as they outgrew them. Doctors expanded both valves without invasive surgery.
None of the five fracture and leaflet events caused symptoms, the agency said. Five events among 62 patients is about 8% of the group. The two patients whose valves were expanded are about 3%. The FDA said its experience with expansion is limited and that longer-term studies are under way to better understand the risks.
The FDA’s six-month findings cover the first 60 of the 62 patients. At that point, the agency said, blood flow through the valve was acceptable and backflow was no more than mild. Edwards reported longer figures in its release. Through 30 days, all patients were free from devicerelated complications, and no patient needed a second procedure on the Autus valve through six months.
Among patients who completed one year of follow-up, Edwards said all had a pressure difference across the valve of 40 millimeters of mercury or less, less than moderate backflow and no valve reinterventions. Edwards said patients will be followed for 10 years.
The two organizations report the numbers differently. The FDA’s announcement gives counts of patients with fractures and reduced leaflet movement. Edwards’ release states results as percentages of patients free from complications and does not repeat those counts. Edwards also did not give the number of patients in its one-year group.
What FDA and Doctors Said About the Approval
Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said the valve gives doctors “the option of far fewer trips to the operating room.” The agency’s announcement quotes Tarver as saying that deciding when to replace a child’s valve has always been difficult, because waiting too long can harm the child and acting too early can mean more surgeries. Dr. Emile Bacha, surgeon-in-chief at NewYork-Presbyterian/Columbia University Irving
Medical Center and a professor of surgery at Columbia University, took part in the trial. In the Edwards release, he said the valve gives heart teams “a new way to think about long-term care planning.” Edwards disclosed that Bacha has received travel and lodging reimbursement from the company for educational activities.
Bernard Zovighian, Edwards’ chief executive, said in the same release that the valve is a meaningful advance for children who have had limited treatment options.
Who Needs a Pediatric Pulmonary Valve
The FDA said congenital heart defects affect about 1 in 100 births in the United States. It cited Centers for Disease Control and Prevention data showing that pulmonary valve atresia and stenosis together affect around 4,200 babies in the United States each year. In atresia, the valve did not form properly. In stenosis, it is narrowed. Some children also develop a leaking valve that enlarges the right lower chamber of the heart and eventually needs replacement.
The FDA did not say how many of those children will need a replacement valve, and the study’s 62 patients are small next to that annual number. A trial of 62 equals about 1.5% of one year’s 4,200 babies. The agency’s approval was granted through its premarket approval pathway, which it uses for higher-risk devices. Existing options for these children have required multiple open-heart surgeries as they grow, the FDA said. The agency did not give an average number of operations.
Availability and Next Steps
The Edwards release confirms the approval and does not state a launch date or a price. It lists the company’s other congenital heart products as the SAPIEN 3 valve, the Alterra Adaptive Prestent and pediatric atrioseptostomy catheters. Families with a child who has congenital pulmonary valve disease can ask their pediatric cardiology team whether the child is a candidate and when hospitals will begin offering the valve. Edwards lists a media contact, Maureen Ranney, at media@edwards.com.
The 10-year follow-up Edwards described will show how the polymer leaflets and the frame behave as children grow into adulthood. The FDA said that longer-term studies are being conducted to better understand the risks.
