FDA Approves Berlin Heart for Kids

Dec. 16, 2011— -- Today the U.S. Food and Drug Administration approved the Berlin Heart for pediatric patients waiting for heart transplants. The ventricular assist device is similar to the one worn by former Vice President Dick Cheney but scaled down for children and babies.

"Without that device I wouldn't have my son," said Traci Shaffer, whose 9-year-old son Lane survived 16 months on the Ohio transplant waiting list because of the Berlin Heart.

Lane was born with a defect that caused his heart to swell and eventually fail. With no donor heart on the horizon, Lane needed a Berlin Heart. But because it was still unapproved in the U.S., it was hard to get.

"The doctors said, 'This is experimental, it's not FDA-approved, and here's the thing: You might not even get it in time,'" said Shaffer, who lives in Philadelphia, Ohio.

Lane's doctors had to ask the FDA for emergency access to the Berlin Heart under a provision called compassionate use. Only after approval could they order the device from Germany, bringing the wait time up to seven days.

"The child has to be on death's door before you can even apply for it," said Shaffer, adding that Lane was given seven-to-10 days to live when they started the process. "We've seen kids that couldn't wait seven days. It's very scary."

Lane weighed 35 pounds when his Berlin Heart arrived at the Cleveland Clinic in May 2010 -- his ribs visible through pale skin as he lay curled up in the fetal position. But after the nine-hour procedure to implant the device, Lane started to improve.

"Immediately after the surgery I could see the color of his skin had changed," said Shaffer. "His feet were no longer white and cold; they were pink and warm. His cheeks were rosy. That was the moment when you say, 'This is working.'"

The FDA's decision to approve the Berlin Heart means hospitals can stock the device in a range of sizes -- from walnut-size pumps for babies to fist-size pumps for teens.

"I will sleep better knowing there's a Berlin Heart sitting here in the Cleveland Clinic," said Dr. Gerard Boyle, a pediatric cardiologist at the Cleveland Clinic. "In the middle of the night, if we have a device here we can support the patient immediately."

The Berlin Heart is a temporary fix, though. Like Lane, kids who receive it will ultimately need a heart transplant.

"For families with a child who needs a heart transplant -- and there are enough of those -- we can say, 'We'll try to get a heart, but while we wait we have a plan,'" said Boyle. "This device gives us confidence that the number of patients who die waiting will decline dramatically."

Lane used the Berlin Heart until December 2010, when his parents got the call that his new heart had been donated.

Now Lane weighs 75 pounds, loves sports and motorcycles and is "eating his family out of house and home," according to his mom. But he's not out of the woods yet. He'll have to take anti-rejection drugs for the rest of his life, and he might eventually need another heart transplant.

But Lane, the boy with the "biggest blue eyes and smile you have ever seen," is staying positive and living life to the fullest, Shaffer said.

"I couldn't wait to tell him about the FDA approval because it's something he's been praying for and wanted since day one," said Shaffer, describing her phone call to Lane when she heard the news. "He screamed in my ear and said, 'You're kidding me! No more kids have to die, mom!'"