It's called the Berlin Heart and has been in use around the world for close to 15 years, but has not been approved by the FDA for use in the United States. Texas Children's will now lead a 12-hospital, 36-month national study of the external, air-driven blood pump that can be used with even the youngest patients with failing hearts. Dr. Charles Fraser, chief of pediatric and congenital heart surgery at Texas Children's, is the principal investigator.Î¾Î¾Î¾
"This is a partial-heart assist device. It's not replacing the heart completely, so the patient's heart is left in their chest and this device sits outside their heart. It's a blood pump that's pneumatically-driven and assists either one side of the circulation or in cases where it's necessary, both sides of the circulation."Î¾Î¾Î¾Î¾Î¾Î¾
Doctors at Texas Children's have implanted seven Berlin Hearts over the past few years under FDA "compassionate use" exemptions. The device comes in different sizes and it attached to an external drive unit that allows patients to move around while awaiting transplants. Dr. Jeff Dreyer is medical director of cardiac transplantation at Texas Children's.
"We're able to not only get them to transplant, but get them to transplant in a better physiologic state or stronger than they might otherwise be. I can't emphasize that enough. It makes a tremendous difference in terms of their recovery after transplant when they go into the transplant doing well."Î¾Î¾Î¾
During the clinical trial, doctors at 10 hospitals in the US and two in Canada will collect data on patients who use the device. Again, Dr. Charles Fraser.
"To me it's reminiscent of what I witnessed in the early 90's in the development of these technologies for adults. Sadly, but it is true, sadly, children are about 10-15 years behind adults in that regard. There are a lot of reasons for that, but that's a fact. So I'm very excited about this."
The so-called bridge-to-transplant use of the Berlin Heart has been common in Europe over the past decade, but the U.S. market hasn't been large enough for the company that makes the device to seek FDA approval until now.Î¾Î¾