Heart Device Succeeds on Second Ariz. Baby

TUCSON, Ariz. – Two Arizona children have unexpectedly recovered from life-threatening heart failure without surgery.

Doctors at Tucson’s University Medical Center say the kids’ miraculous recovery will dramatically change the way children are treated in Tucson and perhaps worldwide.

The children, 16-month-old Tiana Lopez and 9-month-old Itxair Rodriguez, each survived several weeks with the help of a mechanical heart-assist device, the Berlin Heart.

Their recent, back-to-back recoveries – from heart damage that put them near death – have astonished their doctors, who fully expected both children to need donor hearts.

"This could be a paradigm shift," said Dr. Jack G. Copeland, head of the University of Arizona’s heart transplant team. Copeland implanted the Berlin Hearts in Tiana and Itxair and has pioneered the use of this device in children in the United States since 2000.

"We would now think first of recovery and second of transplant, and become more aggressive about using assist-device therapy for small children," he said, noting the children’s’ recoveries are "exceptional."

"Previously, we would not have even considered such a thing possible," he said.

Equally flabbergasted is Richard Smith, the engineer who supervises the use of all mechanical-heart devices, at the medical center.

"We’re as stunned as anybody about this, and I have to say we don’t fully understand it," Smith said. "But I think we’ve got a new therapy here."

But there remains one obstacle to making that happen in Tucson or anywhere else in the United States. The Berlin Heart, manufactured in Germany, has never gone through U.S.-based clinical trials required for approval for use in this country.

Every time doctors have used the device on fewer than 50 children in the United States, they have had to the Food and Drug Administration for permission, then have the device flown in from Germany, which can take up to a week. That can be too long for a dying child, Copeland said.

And the device must be returned to Germany after it is used on a child.

But now, after the most recent success stories out of UMC, the push is on to get a "humanitarian-device exemption" from the FDA for the Berlin Heart. If that happens, hospitals could buy Berlin Hearts and keep them in stock for immediate emergency use.

"We’re pounding on them," Smith said. "We want this thing on the shelf here, as soon as possible."

The earliest that could happen is by the end of the year, said officials at Berlin Heart in Germany. They are now enmeshed in the process of applying to the FDA for the humanitarian exemption, said Dr. Johannes Mueller, the company’s chief scientific officer.

"There’s a lot of paperwork involved," he said. "Will we get approval? We’re not 100 percent sure. It’s not easy to deal with the FDA. But we’re quite hopeful."

In the United States, the device has had an 80 percent success rate at rescuing heart-stricken children. But so far, roughly 90 percent have gone on to receive heart transplants. The number is likely to drop significantly if Copeland’s approach is widely accepted.

In the recent Tucson cases, Tiana spent 21 days on the device, while it pumped for her severely weakened and enlarged heart. She has returned home and is functioning as a normal toddler, her parents and doctors said.

Itxair was placed on the Berlin Heart on March 6 and lived on it for 15 days until it was removed last week. Both children had been slated for heart transplants but were taken off the waiting list when their own hearts began to regain strength.

Described as playful, happy, and eating well, Itxair was ready Wednesday to be moved out of intensive care and may be well enough to return home within a few days, Smith said.

The key to their wholly surprising recoveries was putting them on the Berlin Heart as soon as possible, rather than waiting until their hearts were all but gone, Copeland and Smith said. The timing was not as speedy for Tiana, who had to wait several days to have the device shipped here. But because the Berlin Heart was at UMC when Itxair got sick, she was implanted immediately.

"With these two kids, we did not wait until the very last minute, when they were going over the edge," Smith said. "We pulled that string first and got the Berlin Heart here."

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Information from: Arizona Daily Star, http://www.azstarnet.com