Repairing a hole in a child’s heart is easier than many parents expect. And now there’s a better way to do it, thanks to a new device just approved by the FDA. See why Atrium Health will be the first place in the Carolinas for people of all ages to get it.

News, Child Health | 6 months ago

A New Way to Fill Holes in Kids' Hearts

A hole in the heart, also known as an atrial septal defect, can lead to a lot of problems for a child. See how a new device, first available throughout the Carolinas at Atrium Health’s Levine Children’s Hospital and Sanger Heart & Vascular Institute, will give doctors a better option for closing these holes.

Hearing your child has a hole in his or her heart can be a scary experience. But kids in the Carolinas now have a better way to close up that hole – and open up possibilities for a heathier life.

Starting August 2019, Atrium Health now has access to a next-generation medical device that gives doctors an improved option for treating those holes. Atrium Health’s Levine Children’s Hospital (LCH) and Sanger Heart & Vascular Institute is the first location in North and South Carolina to offer this device to patients. 

Compared with other currently available devices, this new device can be used to repair larger-sized holes, also called atrial septal defects (ASDs), in both children and adults. It’s also known to avoid some of the complications associated with other devices. 

LCH is one of the first 20 hospitals nationwide to provide its patients with the device, the Gore® CARDIOFORM ASD Occluder.

Repairing a hole in a child’s heart is easier than many parents expect. And now there’s a better way to do it, thanks to a new device just approved by the FDA. Atrium Health will be the first place in the Carolinas for people of all ages to get it.

Nearly one in 100 children are born with a heart problem, with ASD being one of the most common, says Joseph Paolillo, MD, director of the Pediatric Cardiac Catheterization Program and Vice-Chief of Pediatric Cardiology at Sanger and LCH.

“Unfortunately, ASDs are the most common congenital heart defects that go undiagnosed until adulthood,” says Dr. Paolillo.

Children with an ASD are born with a hole in the wall between the two upper chambers of the heart. Blood passes through the hole, making the right side of the heart and lungs work harder than normal.

Over time, this additional stress can lead to an enlarged heart, an abnormal heart beats, and high blood pressure in the lungs. During adulthood, some people can have blood clots that travel through an ASD, leading to strokes.

That’s why it’s important to catch and treat an ASD as early as possible. Repairing an ASD typically occurs between four and six years of age, adds Dr. Paolillo.

Benefits of the new device

Before the GORE® CARDIOFORM ASD Occluder, cardiologists were limited by the devices they had to treat different sized holes.

According to Dr. Paolillo, there are effective options for closing small and medium-sized holes. But for treating larger holes, the currently available device – due to its material and design – sometimes rubbed against the heart wall, a problem called erosion.

The new device can close larger holes – up to about an inch and a half – while avoiding erosion because it’s made of a more flexible material. In the clinical trial, the device showed 100 percent closure success after six months in patients who had a successful implant.

The Congenital Heart Center at LCH/Sanger was one of the high enrollers nationwide for the clinical trial that led to the device’s approval by the FDA in May. Dr. Paolillo, along with his colleague, Matthew C. Schwartz, MD, led the clinical trial for SHVI.

Children can go home the next day

Like other ASD devices, implanting the GORE® CARDIOFORM ASD Occluder doesn’t require open heart surgery to repair the ASD. The new device uses a less invasive procedure that doctors have performed for decades: cardiac catherization. 

In this procedure, a cardiologist inserts a long, thin tube called a catheter into a vein in the leg that leads to the heart, explains Dr. Paolillo. Watching with the help of an x-ray and a special heart ultrasound, the doctor then guides the tube into the heart and moves the device through the catheter to repair the hole. 

The procedure takes only about 90 minutes, and the patient is usually released from the hospital the next day.

“You can get a large device into the heart through a tiny hole in the leg. Parents and families are very pleased with a procedure that’s a lot easier than what they were expecting,” says Dr. Paolillo.

All of these procedures at LCH are performed at the Ganatra Pediatric Cardiac Catheterization and Electrophysiology Suite, the most advanced cath lab for children in the region.

Advancing care in the Carolinas and beyond

Now that the device is available, we have performed over 50 procedures, and there are even more patients waiting. “It’s all possible because of the clinical trials we took part in right here in Charlotte,” says Dr. Paolillo. “We’re proud to be one of the centers bringing new medical advances to our patients.” 

Dr. Paolillo recently returned from a week in Euope, where he trained doctors in the UK, Germany and Italy on how to use the new ASD occluder implants.

To learn how to implant the new device, doctors from the Southeast have begun to visit LCH to observe the hospital’s team in action. And as one of the most experienced cardiologists in the country using the device, Dr. Paolillo was asked to travel to other sites to oversee other doctors’ first procedures.

Most recently, Dr. Paolillo traveled to Europe on his own time to train doctors in the United Kingdom, Germany and Italy on how to use the new ASD occluder implants. He is one of just three physicians in the U.S. asked to kick off the use of this new device in Europe. In the photo above, he is pictured with Dr. Guiseppe Santoro, pediatric cardiologist in Massa, Italy, and his team following the first procedure performed in Italy. 

We're proud to stand as leaders in this space, combining our advanced technologies with our clinical expertise to ensure that children - both near and far - can look forward to a future with a healthy heart.