The Living Allogenic Valve Program Offers an Alternative to Traditional Valve Replacement in Pediatric Patients with Severe Valvular Disease

Heart Institute (CICU) photoshoot. This shoot was done to highlight what goes on in the unit and also highlight the Doctors, RN's and RT's in the unit, the surgery team performing a procedure led by Krystal Nymberg and Dr. David Lehenbauer.

The Living Allogenic Valve Program Offers an Alternative to Traditional Valve Replacement in Pediatric Patients with Severe Valvular Disease

News and InnovationSubscribe to E-Newsletter

Living Allogenic Heart Valve vs. Traditional Valve Replacement

For nearly two years, pediatric cardiac surgeons and cardiologists within the Heart Institute at Cincinnati Children’s have been building the Living Allogenic Valve Program—one of the few programs of its kind. The program uses living allogenic valve replacement, previously known as a partial heart transplant, as an alternative to traditional valve replacement in patients with severe valvular disease.

“The problem with homografts (the most common valve replacement option in pediatrics) is they are decellularized and cryopreserved or frozen,” says Awais Ashfaq, MD, a congenital cardiac surgeon in the Division of Cardiovascular Surgery. “They can be stored for a long time, which is good for logistics and supply, but these ‘dead or frozen valves’ aren’t as good for patients because they work only in the short-term. Most kids who receive a homograft will have three to four surgeries to replace their heart valves by the time they’re 18.”

Living allogenic valve replacement requires the same surgical technique as a homograft conduit or valve replacement. However, it uses valves from donors and is kept “fresh” for reconstruction instead of homograft or frozen tissue.

The problem with homografts (the most common valve replacement option in pediatrics) is they are decellularized and cryopreserved or frozen.

Awais Ashfaq, MD

Congenital Cardiac Surgeon

Benefits and Risks of Living Valves

Unlike frozen or cryopreserved tissue, living tissue has the potential to grow with patients, reducing the need for additional surgeries to upsize conduits as patients grow. Fewer subsequent surgeries mean fewer times under anesthesia and on bypass. Additionally, living valves can remain preserved in a solution for a few days to weeks—unlike a complete heart transplant, which requires immediate use and avoiding urgent or emergent operations.

Because living valves come from a donor, they do require some immunosuppression, necessitating recurrent blood draws to monitor drug levels. Ashfaq anticipates that patients may not need as much immunosuppression in the future since valves aren’t the same as the heart muscle. Even with the immunosuppression, the benefits often outweigh the risks.

“There’s a lot of interest in this approach because the downside isn’t significant,” he says. “Yes, patients must take immunosuppression medication, but if they don’t tolerate it, the valve may not last as long, the same as if they would have gotten a homograft. If they tolerate immunosuppression, then the valves could grow with them and last a long time.”

Who is Eligible?

Living allogenic valve replacement is particularly beneficial for pediatric patients who may require multiple surgeries for replacing or upsizing valves or conduits as they grow into adulthood. This group includes, but isn’t limited to, patients with:

Truncus arteriosus and poorly functioning truncal valve
Neonatal aortic stenosis or regurgitation
Tetralogy of Fallot with pulmonary atresia
A need for right ventricle to pulmonary artery conduits

Eligible patients must not be expected to require full heart transplant, and they must be able to be placed on bypass and capable of waiting for an appropriate donor valve.

Clinic Logistics and Decision-Making

Benjamin Mantell, MD, PhD, a leader in immunosuppression management within the Living Allogenic Valve Program, guides communication with families pre-operatively, describing the recommended medications, side effects and follow-up practices, and serves as an immunosuppression management liaison for referring physicians following Living Allogenic Valve patient discharge.

Though still in its infancy, the program at Cincinnati Children’s has seen positive results. Two patients have received a living valve, one is now seven months out from surgery, and the valve is growing. The second patient is few months old and was discharged within a week in the hospital. Few additional patients with poorly functioning valves have needed emergency surgery within their first week of life with a traditional homograft with the intention that within six months to a year, when it needs replaced, they’ll receive a living valve.

“Basically, anyone younger than a teenager who has a valve issue that needs replaced, we’re considering them for a living valve,” says Ashfaq. “If the valves are growing, the kids could avoid potentially a lot of surgeries. That’s the biggest draw for us.”

The multidisciplinary team brings together congenital cardiac surgeons, cardiologists, transplant cardiologists, nurse coordinators, advanced practice providers and transplant pharmacists to review all valve cases, talk to parents and answer their questions.

Post-surgery, the patient should plan for weekly visits at the Cincinnati Children's Living Allogenic Valve Program for the first month, then transition back to the care of the primary cardiologist with continued immunosuppression management support thereafter (medication dose changes and follow-up lab schedule).

“We talk to all eligible families about living valves, put them on a list and then work with organ procuring agencies across the country to see if any valves in the right size are available,” says Ashfaq. “Another way we get the valves is through domino transplant, where we use the functioning valves from a heart that’s been removed during a full transplant. We ask families if they’re OK donating those valves. And almost always, parents say, ‘yes.’”

Setting the Standards, Sharing the Blueprint

When the Living Allogenic Valve Program started at Cincinnati Children’s, the entire concept was relatively new. As the program has developed, the team has sorted through a lot of logistics, including legal considerations, identification banking and reimbursement. In the process, they’ve drafted a blueprint for other institutions to reference.

“Many times, people are reluctant to convey all the information because everyone wants to be the first,” says Ashfaq. “But we wanted to create something that we found helpful, and we hope others use and adapt it.”

Referrals

Providers can make a referral through Epic, or by calling 513-636-4432 or Physician Priority Link at 513-636-7997 or 1-888-987-7997.

(Published November 2025)

Pediatric Subspecialty News and Innovation

Our experts are redefining pediatric care. Showcasing their impact is simple. Discover the leaders behind our programs, the innovations they're driving, and the research shaping tomorrow’s care.

View All Subspecialty News