New patch eliminates open-heart surgery to seal certain holes

WASHINGTON -- Specially trained cardiologists can soon begin repairing holes in some children's hearts without resorting to grueling open-heart surgery.

The Food and Drug Administration approved two patches last week -- CardioSeal and Amplatzer -- that can be threaded into the heart through tiny incisions in the groin to heal this birth defect.

"It's pretty remarkable to see just how this works," said Dr. Stuart Portnoy, of the FDA's cardiovascular and respiratory devices division.

They're not perfect: even this minimally invasive therapy can cause serious side effects. But Portnoy called the patches a breakthrough that could help hundreds of children a year.

"These devices are going to be very helpful," agreed Dr. Dianne Atkins of the University of Iowa, who chairs the American Heart Association's pediatric heart disease council.

They will allow some children to avoid open-heart surgery altogether -- and reduce the number of operations needed by some babies with complex heart defects, she said.

Hole between chambers

Up to 17,000 Americans are born each year with a septal defect, a hole between heart chambers that short-circuits how the heart pumps.

The heart has four chambers. The top two are the atria, the bottom two the ventricles. The septum is a wall separating the left and right sides of those chambers. Oxygen-rich blood is kept in the left chambers, oxygen-depleted blood in the right.

A hole in the septum means oxygen-rich blood mixes with oxygen-depleted blood and gets sent to the lungs a second time in a vicious cycle that makes the heart work harder.

Fabric and wire

CardioSeal is a fabric patch with tiny wire hooks to hold it in place over ventricular holes. Amplatzer is a fabric and wire mesh patch to seal atrial holes.

Using a thin tube called a catheter, cardiologists cut a small incision into a vein in the groin and thread the patch-bearing catheter up to the heart. Once the patch is hooked over the hole, the heart forms scar tissue that, within six months, should hold the patch permanently in place, Portnoy explained.

How well do they work? Amplatzer manufacturer AGA Medical Corp. compared 331 patch patients with 154 who had open-heart surgery. The patch proved equally as successful at closing holes in the atria, 98 percent. At the same time, it caused far fewer serious side effects.

The biggest risk is that the patches won't stay in place until scar tissue grows around them, Portnoy said, which means patients will need regular checkups with X-rays.