Experimental Heart Pump Awaiting FDA Approval

Feb. 21, 2008 — -- Children facing heart failure are often given little chance of survival, because there are so few therapies for young patients until a donor heart becomes available.

Now doctors in the U.S. are hopeful that the Food and Drug Administration will soon approve an experimental pediatric heart pump made in Germany that can keep children, from infants to teens, alive while they wait for a donor heart.

Randy and Lori Wilson almost lost their two-year-old son T.J. after his heart suddenly failed.

"It happened so quick," said Randy. "You could see it go right out of him, he went absolutely limp."

T.J. had been sick all night, and the Wilsons took him to the emergency room, thinking he was dehydrated. Soon after they arrived at the Children's Hospital of Pittsburgh, T.J.'s illness became a medical emergency.

"The doctor took her stethoscope and put it on his chest, and she looked up at me and said, 'Oh my God, I don't have a heartbeat,' and everything just stopped," Lori said.

T.J.'s heart had given out. Tests showed that a virus had attacked his heart -- an extremely rare occurrence, but it caused so much damage, T.J. needed a heart transplant. Waiting for an organ can take weeks or months, and the chances of T.J.'s living until then were slim.

"T.J. was bound to a ventilator and, frankly, was in a tenuous state," said Dr. Peter Wearden, a heart specialist at the Children's Hospital of Pittsburgh.

Until recently, doctors could do very little for kids like T.J., but the experimental Berlin heart pump, made especially to fit children, provided some hope. It is being used more often in the U.S. to keep smaller hearts beating until a transplant heart is found.

"It was crucial that T.J. receive the Berlin heart," Wearden said. "In the simplest terms, the Berlin heart does the job of the heart, which is to pump the blood."

The pumping mechanism sits outside the chest, with only small tubes implanted to carry blood into and out of the heart. A heart-lung machine is very hard on a child's body and can only be used for two weeks, but the Berlin heart can be used for months. And patients using it don't need to be sedated.

The Berlin heart must complete clinical trials in the U.S. before it's FDA-approved. The heart can be made available to the sickest patients by petitioning the FDA, which is what happened in T.J.'s case.

The heart took a week to arrive, but the day after it was implanted in T.J., he made a remarkable turnaround.

"The next morning we went down and his eyes were open and he was able to talk to us," Lori said. "Two days after the Berlin heart they had him off the ventilator and he was talking out loud."

Within five days, a heart became available for T.J., but the time on the Berlin heart was crucial.

"Those five days allowed him to be off the ventilator, allowed him to be able to wean off the medications and get back in touch with us as a family again," Lori said.

T.J.'s dad goes even further, crediting the Berlin heart with saving his son's life.

"In his weakened condition they wouldn't have done the transplant without him getting stronger," Randy said.

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