Surgeon highlights the historical significance of new adjustable heart valve for children
A new size-adjustable pulmonary valve approved by the U.S. Food and Drug Administration (FDA) could reduce the number of open-heart surgeries children with congenital heart disease need as they grow.
Cardiovascular Business spoke to Emile Bacha, MD, chair of the department of surgery and surgeon-in-chief at NewYork-Presbyterian Hospital/Columbia University Medical Center, to learn more. Bacha, a lead investigator in the clinical trial that supported FDA clearance of the Edwards Lifesciences Autus size-adjustable pulmonary valve, said this device addresses the longstanding challenge of valves not being able to grow with pediatric patients into adulthood.
"This is indeed an important new advance in the field of treatment of pediatric heart disease," Bacha, a past president of the American Association for Thoracic Surgery (AATS), explained. "When we replace a valve in a one-year-old they will grow, but the valve is not going to grow. As a consequence, we have to constantly reoperate on this child to upsize the valve. It's very traumatic for the kids. And those are very big surgeries that involve sternotomy. So it's not insignificant at all. Instead of having two, three, four or more surgeries, that child will have two, three or four catheterization procedures, which are much, much less invasive."
Approximately 1% of babies are born with congenital heart disease, Bacha explained. Many of these children have heart valves that are narrowed, leaky or have functional impairments due to congenital malformations.
The initial implantation of the Autus still requires open-heart surgery, he added, and then it will go on to expand as the child grows.
Earlier treatment for tetralogy of Fallot
The valve is designed specifically for the pulmonary position, one of the heart's four valves. Bacha said it may be particularly beneficial for patients with tetralogy of Fallot, a congenital heart defect that involves the pulmonary valve.
Following initial surgery to repair tetralogy of Fallot, some children eventually require pulmonary valve replacement as their hearts grow and the effects of the original defect become more significant. Historically, physicians delayed pulmonary valve replacement until patients were 10 to 13 years old, or even into adolescence or young adulthood, because Bacha said available valves could not accommodate continued growth.
With an adjustable valve, Bacha said physicians can now intervene earlier, knowing that subsequent enlargement could be performed through catheter-based procedures.
He said most patients receiving the Autus device in the clinical trial were between five and eight years old.
Addressing an unmet need in pediatric devices
Bacha said the valve also highlights a broader challenge in medical technology development where devices are often designed for adults, who represent a larger commercial market than children. Because of the small congenital heart market, vendors are less interested in putting a lot of money and resources into research and development in pediatric medical devices, even when the clinical need is substantial.
However, he said the FDA recognizes the disconnect and has found ways to help accelerate the review of these devices. In the case of the Autus valve, it was granted the agency's breakthrough device designation because it addressed an unmet medical need. Such designations speed up the regulatory review process and enable researchers and the vendor to work more closely with the FDA during the review and clinical trial process.
“The FDA has really acted quickly and decisively with this device to the benefit of the patients and the children it will serve,” Bacha said.
He described the approval as a significant advance in pediatric cardiovascular care, noting it is the first dedicated pediatric valve that grows with a patient to ever attain full FDA clearance. This has been a goal of congenital heart surgeons for decades.
It is also only the third pediatric heart valve to be cleared by the FDA. The Medtronic Melody Transcatheter Pulmonary Valve (TPV) initially received FDA approval in January 2010. It was the first transcatheter heart valve allowed for use in the United States. It later gained a full FDA premarket approval (PMA) with an expanded indication in March 2017. It is indicated to relieve right ventricular outflow tract (RVOT) conduit and surgical valve obstruction, restore valve function and delay the patient’s next surgical intervention.
The second valve to hit the market was the Medtronic Harmony transcatheter pulmonary valve (TPV), which gained FDA PMA in March 2021. This device included both the valve, RVOT conduit and anchoring at either end to secure it in a native or surgically-repaired RVOT without a valve already in place.
However, neither of these earlier valve system grew with the patient.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]