NEWS RELEASES
Texas Children’s implants Berlin Heart into one of the smallest babies to ever receive a ventricular assist device

HOUSTON (Sept. 29, 2005) – A 3-month-old Corpus Christi resident, Brady, is one of the smallest pediatric patients in the country to receive a Berlin Heart, a scaled-down heart pump that improves blood flow and is considered a “bridge” for patients awaiting heart transplants.

The infant underwent a five-hour surgery on Tuesday, Sept. 27, at Texas Children’s Hospital in Houston to implant the device.

Texas Children’s doctors sought approval from the Food and Drug Administration (FDA) for “emergency compassionate use” of the only heart device available for infants, which is manufactured in Germany.

“The Berlin Heart is a temporary measure,” said Dr. Charles D. Fraser Jr. , the chief of cardiovascular surgery at Texas Children''s Heart Center, who performed the surgery. “It gives new hope for this baby because the device takes over the pumping function of his heart and gives him time to gain strength and more weight as he waits for a donor heart to become available.”

Brady, who was diagnosed in utero with a failing heart at 26 weeks of gestation, was not expected to live to term. He was delivered at 34 weeks. Corpus Christi doctors said he had an enlarged left ventricle and severe aortic valve stenosis. His heart was so damaged that he was unable to feed by mouth, and has been on a feeding tube since birth.

At six weeks of age, Brady was transferred to the cardiovascular intensive care unit at Texas Children’s Heart Center. “At first, we performed a balloon dilation on the aortic valve to relieve the obstruction,” said Dr. David Nelson, director of pediatric cardiac intensive care. “Even though the procedure was successful, Brady’s heart muscle function still did not recover as we hoped.  We then listed him for a heart transplant.”

During that time, Brady’s condition was critical, as he awaited a donor heart.  It was then that Heart Center doctors began the approval process for emergency use of the Berlin Heart. 

“Today’s surgery demonstrates the critical need for smaller devices in this country that can save more infant lives,” said Fraser, who is also chief of the Division of Congenital Heart Surgery at Baylor College of Medicine. “I’m thrilled that our Heart Center was able to be a part of this milestone. We know that these types of devices will be vital to improving the lives of many babies who otherwise would have no options.”

Texas Children’s Heart Center is a self-contained pediatric heart treatment facility within Texas Children''s Hospital. Its unique design provides a single point of care including examinations, echocardiography, heart catheterization, congenital heart surgery and intensive care. This special setting enhances continuum and delivery of care. The Heart Center sees more than 12,000 patients and performs more than 750 surgeries annually.