Cardiovascular diseases, particularly coronary heart disease (CHD), have become an epidemic in India. Shockingly, 9 out of every 1000 newborns are diagnosed with CHD annually. This means that 240,000 children born with CHD each year pose a significant challenge for healthcare providers and families. Additionally, it is worth noting that 20% of children diagnosed with CHDs do not survive beyond their first year of life.
In such scenarios, cardiologists’ primary form of treatment for children with coronary heart disease is a heart valve implant. Unfortunately, the traditional pulmonary valves have a fixed diameter that can’t match the size of the child’s heart over time. Hence, children must undergo risky invasive surgeries every few years to replace their implants.
However, Boston Children’s Hospital’s new invention, ‘Autus Valve’ has the potential to change it all!
Autus Valve, the prosthetic heart valve that adapts and grows with the kid’s biological growth!
(Image Credit: Boston Children’s Hospital (Boston, MA, USA)
The researchers found inspiration for developing the heart valve from a device that imitated the bi-leaflet function of a venous valve in leg veins. The valve’s two elastic flaps had the ideal shape for ensuring proper closure and one-way blood flow, even when the veins in the leg expanded.
Observing that, the researchers hypothesized that they could also adapt the same process to the heart. They studied the geometric profile of the human venous valve and used it as a model for creating a valve prototype. The prototype valve has two leaflets crafted from a polymer material that has a well-established history of being used as a leaflet for pediatric pulmonary valves.
They then implanted the replacement pulmonary valve prototypes into growing lambs in their studies. To their success, they discovered that this device could be fitted and expanded in sync with the growth of the heart anatomy. Moreover, the valve effectively upholds the regulation of blood circulation with utmost precision, all the while ensuring that there is no unnecessary stretching or any form of impairment to the construct or material of the device.
Before implantation, doctors can adjust the valve diameter to match the patient’s heart anatomy.
And following the valve implantation procedure, doctors assess the valve’s integrity and blood flow control through an echocardiogram. And, to ensure speed and precision for ECG testing in such scenarios, cardiologists use the latest health-tech innovations like Wellnest 12L ECG Machine that allow testing within a few minutes!
So, in the event that the valve becomes constricted due to a child’s rapid growth, expert catheterization specialists can employ the use of a catheter balloon to enlarge the valve. This could eliminate the need for invasive surgeries every few years, as the child will not require another replacement procedure until adulthood.
FDA-Approved Human Researches & Trials of the Autus Heart Valve
The Autus Valve was first implanted in a young patient at Nationwide Children’s Hospital in late 2021 as part of a collaborative clinical study involving Boston Children’s, Nationwide Children’s, and New York-Presbyterian/Columbia University Irving Medical Center.
“It’s exciting and incredibly motivating that we’re at the stage where we can actually see the device helping patients,” said the device’s inventor, Sophie-Charlotte Hofferberth, MD.
Currently, Boston Children’s Hospital is undertaking clinical trials that have been approved by the US FDA. These studies aim to evaluate the efficacy of the valve in children who fall within the age range of 2 to 11 years old. The initial research will be later followed by a larger clinical trial to seek FDA approval for making the device commercially available.