New Implant to Help Patients Regenerate Their Own Heart Valves

When a person’s heart valve is severely damaged due to a birth defect, lifestyle factors, or aging, blood flow is disrupted. If left untreated, this can lead to life-threatening complications. Valve replacement and repair are currently the only ways to manage severe valvular heart disease, but both often require repeated surgeries that are costly, disruptive, and carry significant risks. Most replacement valves are made from animal tissue and last between 10 and 15 years before needing replacement. For pediatric patients, available solutions are extremely limited and may require multiple reinterventions. Now, researchers have developed a 3D-printed heart valve made from bioresorbable materials, designed to match an individual patient’s specific anatomy. Once implanted, the valve will gradually be absorbed by the body and replaced with new tissue, which will take over the function the device originally performed.

One of the main challenges in pediatrics is that children grow, which causes their heart valves to change size over time. As a result, children often need multiple surgeries to repair or replace their heart valves as they grow. The groundbreaking technology developed by researchers at Georgia Institute of Technology (Atlanta, GA, USA) could potentially allow patients to grow new valve tissue, eliminating the need for multiple valve replacements in the future. Although 3D-printed heart valves and bioresorbable materials have been used for implants before, this is the first time both technologies have been combined to create a single device made from a resorbable, shape-memory material. The team’s initial research involved selecting the appropriate material and testing various prototypes. The resulting heart valve is 3D-printed from a biocompatible material known as poly(glycerol dodecanedioate).

The valve has shape-memory properties, enabling it to be folded and delivered via a catheter, instead of requiring open-heart surgery. Once implanted and warmed to body temperature, the device will unfold into its original shape. The material then signals the body to create its own new tissue to replace the device, which will be completely absorbed within a few months. The team is currently evaluating the physical durability of the heart valve using both computational models and benchtop studies. Their laboratory is equipped with a heart simulation setup that mimics the physiological conditions of a real heart, including the pressure and flow conditions specific to an individual patient. An additional machine tests the valve’s mechanical durability by subjecting it to millions of heart cycles in a short period.

The researchers note that creating a material capable of performing the rigorous functions of a heart valve while encouraging the development of new tissue is an enormous challenge. Additionally, new medical devices face a long journey from the laboratory to clinical use, with several critical milestones to achieve along the way. The researchers hope that their technology will revolutionize heart valve treatment and usher in a new era of tissue-engineered devices. They also point out that pediatric implants are developed less frequently than adult ones, due to the rarity of childhood diseases and the high manufacturing costs. The team believes that combining bioresorbable materials with 3D printing could be the key to developing better devices for pediatric patients.

“This technology is very different from most existing heart valves, and we believe it represents a paradigm shift,” said researcher Lakshmi Prasad Dasi, the Rozelle Vanda Wesley Professor in BME. “We are moving away from using animal tissue devices that don’t last and aren’t sustainable, and into a new era where a heart valve can regenerate inside the patient.”