Back to Home > News > Saturday, Mar 31, 2007 Local Posted on Sat, Mar. 31, 2007 email this print ... First SC child to get mech

Blond, curly hair, blue eyes and the longest eyelashes you've ever seen. That's how Angela Greenwood describes her son, Joseph, who before he was admitted to a Charleston hospital nearly a week ago was looking forward to his sixth birthday next month.

Now lying on a hospital bed and heavily sedated, Joseph will be the first child in South Carolina to be implanted with the Berlin Heart, a device not yet approved by the Food and Drug Administration. The procedure will be performed next Wednesday, Greenwood said.

Last summer, doctors diagnosed Joseph with dilated cardiomyopathy, a rare weakening of the heart muscles. After Joseph fainted a couple of times, doctors discovered that he had an irregular heart rhythm and last August implanted him with a defibrillator. He collapsed on the family porch in Florence on March 24 and was airlifted to the Medical University of South Carolina.

"One of the first signs that things were going awry this past Saturday was that he was passed out and shocked by his defibrillator appropriately," said Dr. Jeremy Ringewald, director of heart failure and heart transplantation at MUSC.

The German company, called Berlin Heart, that makes the device resubmitted a request Thursday seeking FDA approval after an earlier application was returned with questions, said Bob Kroslowitz, manager for clinical affairs for the company. Despite its lack of approval, there are numerous requests for the device, he said.

"We receive requests now to implant on a daily basis," Kroslowitz said, adding that an implant was scheduled for Saturday in Boston. "The logistics has actually been the biggest problem both for us and the centers. We are not allowed to keep any equipment on the ground in the U.S."

At least 87 children in 28 centers in North America have received the device, and Kroslowitz says the success rate is around 80 percent. The device has been used in children outside of the United States since the late 1980s and the first implant in North America was done in 2000, he said.

Kroslowitz would not comment on the cost of the Berlin Heart, but said that several insurance companies have covered some of the costs associated with the operation.

The device helps pump blood from the atria of the heart to the lungs and body. Greenwood, who has not left her son's side since he was admitted to the hospital, said the device "is a risk."

He is on a waiting list, but may have to wait several months to receive a donor heart, doctors say. The Berlin Heart is temporary, but will likely sustain the boy's life until a heart becomes available for a transplant, Ringewald said.

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