What happens when a child needs a new heart and there's no heart readily available to transplant? That was the dilemma for doctors treating 5-year-old Joseph Greenwood.
Before his medical problems began, Joseph was a happy, healthy child. Then in March, he unexpectedly collapsed.
Joseph's father performed CPR while frantically dialing 911. Shortly thereafter an ambulance arrived and rushed them to a hospital near their hometown of Florence, S.C. From there, a helicopter flew them to the Medical University of South Carolina in Charleston.
Doctors determined his heart had failed and diagnosed the problem as dilated cardiomyopathy. They suspected a virus that Joseph contracted a year ago had caused his immune system to attack and destroy his heart muscle. Gradually, his heart grew bigger and weaker until it finally stopped.
- The FDA made an exception and permitted the use of the Berlin Heart pump, which is approved for use throughout Europe but not the United States, to keep 5-year-old Joseph Greenwood alive as he awaited a heart transplant.
In Charleston, doctors put Joseph on a standard heart-lung machine. But these machines are not designed to keep a patient alive for more than a few days. Adults can get ventricular assist devices, or VADs, but there are no such devices in the United States designed for children.
Special Care for Young Patient
The standard heart-lung machine poses significant risks for children, who have on occasion developed strokes while on it. They can also develop renal and liver failure. In Joseph's case, his lungs started to fail, which worried his doctor.
"Once his lungs start to suffer," Dr. T.Y. Hsia told ABC News, "the urgency really starts to rise. Because even if you get a good heart and the lungs don't work, you're still going to die."
Hsia and many other doctors believe there's a better life-support device, a German-built pump called the Berlin Heart that's made specifically to keep children alive while awaiting a heart transplant.
One child survived for more than 12 months on this device, which pumps like an actual heart with a pulse more natural to the body, while the standard heart-lung machine creates a steady flow of blood out, blood back into the body.
Although the Berlin Heart has been approved for use throughout Europe, it has yet to be cleared for use in the United States. (As a matter of course, the Food and Drug Administration does not comment on the application of any device or drug that it may be reviewing. Government officials would not tell us why there has been a delay in approving the Berlin Heart.)
But the FDA does allow the Berlin Heart to be used in extreme emergencies, for what it calls "compassionate release." It was what Joseph's doctors and family hoped for.
After three days of back-and-forth paperwork, the FDA agreed that Joseph's case warranted the treatment, and the Berlin Heart was flown from Germany to Charleston.
Within hours of his being placed on the machine, Joseph's mother, Angela Greenwood, said she saw his condition improve.
"He was able to wake up, come off his breathing tube, talk to us again, smile," she explained. "He started to act like Joseph again."
The Berlin Heart allowed Joseph to grow stronger until nine days later, when he received the heart transplant he needed.
"I believe the Berlin Heart was critical in making Joseph a healthier candidate to receive a heart transplant, therefore improving his prognosis," Hsia said.
The other doctors treating Joseph expressed no doubts -- the cutting-edge pump made a world of difference to a very sick little boy.
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