Stories of patients saved by new heart valve system

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In Boston, the lives of at least two of James Lock's patients were saved by the insertion of new valves via a catheter rather than the usual open-heart surgery. Same thing with Evan Zahn in Miami during the clinical study of the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System.

The procedure was just approved for limited use by the Food and Drug Administration in late January after the trial involving 99 recipients at children's hospitals in the aforementioned cities plus New York, Columbus and Seattle, and 68 more patients in Europe.

Earlier this month, Children's Hospital of Pittsburgh of UPMC became the first site outside the U.S. trial sites to do the procedure. It was done by pediatric interventional cardiologist Jacqueline Kreutzer on Brennan Ehrman, 24, of Mt. Lebanon.

Medtronic stresses in patient literature, however, that the procedure, whose lifetime is not yet known, is not a cure, but rather a means of delaying open-heart surgery. Mr. Ehrman was expecting to undergo his fourth open-heart surgery in a couple years.

"It was a miracle," said his mother, Diane Dunn.

So seemed the cases described by Drs. Lock, of Children's Hospital Boston, and Zahn, of Miami Children's Hospital.

In New England, a 16-year-old girl with underlying heart disease underwent a procedure on her aortic valve and the valve literally fell apart, Dr. Lock said. Her heart stopped and she could not be resuscitated.

"They put her on a heart-lung machine and drove her for two hours in an ambulance," Dr. Lock said. "When she got here it was clear she would not survive in any fashion with an open-heart procedure, so we took her in and did a replacement of the aortic valve in the cath lab. That was a year and a half ago." The girl now is a freshman in college.

"There are just four that have been done in this country," Dr. Lock said.

Another dramatic case involved an 8-year-old boy from southern New England who had swine flu, and, Dr. Lock said, was dying. "He needed a [pulmonary] valve replacement but the swine flu and the [bad] valve made it impossible to ventilate him. He was the smallest who ever survived - 40 pounds - and he's done extremely well."

Dr. Zahn points to transcatheter valve replacements he did on a 6-year-old girl in 2008 and on a 10-year-old boy about a year and a half ago.

"We got [the girl] on her birthday or the day after," he said. "They flew her here from Los Angeles, and she was looking at her fifth open-heart surgery. Now I get pictures of her skiing, doing sports, taking dance lessons. She's completely normal."

The boy, from Gainesville, Fla., had undergone seven operations involving a faulty tricuspid valve. "It's the least forgiving to work on," Dr. Zahn said. "We thought [open-heart surgery] was too high of a risk, including a heart transplant."

Instead. the doctors inserted a catheter in a neck vein and worked the Melody valve into position.

"It was remarkable," the pediatric interventionist cardiologist said. "We had a news conference the next day and he was there and he went home a day after that. ... It clearly saved his life."

Pohla Smith: or 412-263-1228.


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