Since the early 2000s, pediatric Riley patients with life-threatening heart issues have received the Berlin Heart as a bridge to a heart transplant. Thus, the device has saved thousands of children at our hospital.
"The Berlin Heart replaces the function of one or both sides," Dr. Mark Turrentine, pediatric cardiothoracic surgeon at Riley, explained. "Basically, it just replicates the function of the heart in that it has a chamber of various sizes. This is not a destination therapy device; this has to be used as a bridge to transplantation."
Dr. Turrentine said the procedure to place a Berlin Heart was not completed in the United States until 1997, and it was not until several years later that Riley Hospital for Children began using the tool on our patients with serious heart conditions. Dr. Turrentine said the use of the Berlin Heart faded away in the US following the very first procedure, until Riley began its program.
"Six years later, we were confronted with, I think it was 15- [or] 16-month-old and we couldn't support the child, was in terrible failure," Dr. Turrentine said. "So, thought maybe the Berlin Heart would be what we need. Went to the administration, told them, they said do what you need to do, which was a very nice green light. It shows the commitment of the people here to do what it takes to take care of children."
Dr. Turrentine said his team reached out to the U.S. Food and Drug Administration (FDA) and within two hours, they received approval for humanitarian use.
"So, we had the device sent over to Chicago, trucked down, and we implanted it," Dr. Turrentine said. "Then we subsequently transplanted that baby. That was the first young child done in the United States or in North America."
More children began receiving the Berlin Heart and subsequently heart transplants, leading up to Bailey Hunsberger. Hunsberger shared her journey with Indianapolis Motor Speedway Productions, who documented the whole process.
"This is from the president of Berlin Heart North America," Dr. Turrentine said. "Berlin Heart was almost insolvent. They were down to one of their last people they were trying to get interested in salvaging or buying the company. They called for a video copy of Bailey's story. They showed it to this potential person the next morning. He wrote a check for the company, saved the company. Because of that video done by the Indianapolis Motor Speedway video productions, that saved Berlin Heart. Consequently, it saved many children."
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