Anaya is in many ways a typical toddler. She loves finger paints and swinging – so much that her parents, Linet and Reji, put a swing in their family room. Sometimes, her big emotions evoke the familiar “terrible twos.” But in one important way, Anaya is not so typical – at two years old, she’s already made history.

In May 2023, Anaya became the first human patient to have to have a MASA polymeric pulmonary valve implanted in her heart. Cardiothoracic surgeon Katsuhide Maeda, MD, PhD, performed the procedure at Children’s Hospital of Philadelphia (CHOP), the first step in an early feasibility clinical study that hopes to make groundbreaking progress in the treatment for congenital heart defects.

The MASA valve is more durable and consistent in quality than homograft valves currently in use, which are made of human tissue and can fail quickly. Anaya’s encouraging post-surgery progress is a promising development for the clinical trial.

“Frequent cardiac surgery can influence normal physical as well as mental growth in children,” says Dr. Maeda. “Hopefully, this new conduit will last a long time, and it will avoid further frequent surgical interventions."

Life-changing news connects the family to CHOP

When Linet went for her 20-week anatomical scan in March 2021, she and Reji were devastated to hear that their unborn daughter had tetralogy of Fallot (TOF), a congenital heart defect characterized by, among other issues, a ventricular septal defect, a hole between the lower chambers of the heart, and pulmonary stenosis, a narrowing of the pulmonary valve that affects blood flow from the heart to the lungs.

Doctors at their local hospital referred the northern New Jersey couple to CHOP cardiologist Michele Cohen, DO. “From the very start, Dr. Cohen has been so helpful and given us confidence,” Linet says. “Anaya loves to see her whenever we have an appointment.”

Because her daughter’s heart defect was diagnosed prenatally, Linet gave birth in July 2021 in CHOP’s Garbose Family Special Delivery Unit (SDU) in the Richard D. Wood Jr. Center for Fetal Diagnosis and Treatment so Anaya could receive expert care immediately. Before going home, doctors inserted a temporary patent ductus arteriosus (PDA) stent to connect her aorta to her pulmonary artery to increase blood flow to the lungs. This gave her time to grow before her first heart surgery to implant the homograft valve.

First heart surgery at 10 months old

When she was 10 months old, in June 2022, Dr. Maeda performed Anaya’s first open-heart surgery to implant a homograft, or a pulmonary valve made of human tissue.

An echocardiogram in December 2022 showed that the valve had begun to fail, and a second homograft surgery was scheduled for April 2023, less than a year after the first. But in March, Dr. Maeda called Linet and Reji to ask if they wanted to enroll Anaya in a clinical trial to implant a new MASA polymeric pulmonary valve.

The MASA valve has several important benefits. It’s made of a material designed not to be rejected by the body’s immune system. And it can be manufactured with consistent quality, in different sizes to fit people of all ages. But it had never before been implanted in a human. Anaya would be the first.

A groundbreaking clinical trial offers new hope

Clinical trials depend on a series of approval processes before getting underway, which made the timing of Anaya’s surgery uncertain. Dr. Maeda believed it was safe for her to wait for the trial to be approved.

Both Linet and Reji work in the pharmaceutical industry on clinical trials, so they’re familiar with the protocols. "We have some understanding of the pros and cons,” says Reji. “Of course, it’s a different matter when it’s our own daughter.” Dr. Maeda gave them reading material to review, and after days of deliberation, they ultimately decided to participate in the trial.

The road ahead for Anaya

Anaya had the MASA valve implanted in May 2023. The surgery was a success; the clinical team expects the valve to last at least 10 years. Linet and Reji are amazed that their daughter’s rough early road has not dampened her sunny disposition or boundless toddler energy.

Anaya has had two open-heart surgeries in her first two years of life. At her last checkup Dr. Cohen was happy to hear a clear, strong heartbeat, with only a faint murmur. "I’ve been waiting to hear something like that,” says Linet. “It made me quite emotional.”

Meanwhile, the early feasibility clinical trial continues, at 10 hospitals around the U.S.

“Our expectations for medical care have been spoiled by CHOP,” says Reji with a laugh. “It takes us longer to get to Philadelphia, but once we are there, we know Anaya is in safe hands.”