Designing New Parts That Can Repair Congenital Heart Defects
Having a bad day is not an option when you are a pediatric interventional cardiologist. That’s the mouthful of words you need to describe doctors like Mark Hoyer, MD. They are the people who repair heart defects, most often discovered at birth, but sometimes in unborn children or much later in life. Hoyer and his colleagues also diagnose and treat adults whose congenital (at birth) heart problems aren’t discovered until they are in their 20s and beyond.
For the past few decades, Mark Hoyer, MD has been involved in clinical trials to find new devices that can be implanted in babies, children and adults. Their purpose is to repair the endless variations of complex congenital heart abnormalities that seem to work their way into the human gene pool like an unruly band of uninvited guests.
Through research and innovation, these devices, combined with better surgical techniques, just keep getting better. So much better that an estimated one million adults in the United States are living with repaired congenital heart defects like atrial septal defect (ASD).
ASD is the short term that describes a hole in the septum—the wall that separates the heart’s two upper chambers. For the past 15 years or so, the solution for ASDs has been an implantable double-disk patch that closes the hole in a minimally invasive procedure. It’s a device with a huge impact, helping thousands of children with ASD avoid surgery altogether.
Like many medical devices, it only exists because of research and collaboration between device manufacturers, forward-thinking physicians like Hoyer, and, of course, the Riley at IU Health patients and families who sign up for clinical studies. Hoyer and his patients have been part of the clinical trials for ASD closure devices since their inception. Those trials continue as manufacturers work with physicians like Hoyer to find even better designs.
Many Riley at IU Health patients participate in clinical trials because they need out-of-the-box care to solve problems that are being seen for the first time, or because there is no good solution. It’s the advantage of choosing a pediatric research hospital, where specialists like Hoyer are actively working on the next big breakthrough.
“We explain what exists, why we think these new devices may really be better for them, what the risks are and ask them to enroll in our clinical trials,” he says. Patients who join the trials receive regular follow-up care and testing to evaluate effectiveness. When enough data is gathered through clinical studies at multiple sites across the U.S. and the devices prove to be safe and effective, the FDA eventually approves these devices for standard care.
Hoyer became interested in clinical research as a way to keep delivering state-of-the-art options for all kinds of heart defects in patients at Riley at IU Health. It’s a career marked by watershed moments as new valves, stents, plugs and other devices move from the research phase to approved standards of care offered everywhere.
Although he repairs abnormal hearts every day, he is constantly aware of the fact that it is a scary first-time experience for the families who entrust their children to care at Riley at IU Health. “We bring our A-game to work every day,” says Hoyer. “We have to. We owe it to the families who give us the privilege of taking care of their children.”