The Berlin Heart is a tiny heart pump that maintains blood flow in babies and small children with serious heart failure. A recent study, led by Dr. Charles D. Fraser Jr., surgeon-in-chief at Texas Children’s Hospital, demonstrated that the Berlin Heart is a more effective therapy and a potential bridge to transplant for patients with heart failure.
To date, the Berlin Heart has been used in approximately 1,000 children worldwide and is the only decive of its kind available for babies and children with severe heart failure.
About the Berlin Heart
The Berlin Heart® EXCOR Pediatric Ventricular Assist Device (VAD) is a blood pump that vibrates rhythmically to assist children who cannot pump enough blood with their own natural heart. It does not entirely replace the natural function of the heart. Instead, it works along with the patient’s heart to pump blood.
Without the assistance of the device, children awaiting a transplant become increasingly sick as their heart fails. The device improves circulation and keeps them alive until they receive a heart transplant. In some rare instances, patients recover enough to come off the device and maintain blood flow on their own.
The device, which comes in several sizes, is not totally implanted inside the body. Physicians insert cannulas, or flexible tubes, in the heart and they extend through the skin and connect to a small pump located outside the body. That pump, along with its computerized drive unit, maintains blood flow.
Before the Berlin Heart, physicians used complicated medical therapies to treat children with heart failure, hoping to keep them alive until a suitable donor heart became available. The most common method was extracorporeal membrane oxygenation (ECMO).
Because ECMO provides only short-term support when a child’s heart has failed completely, newborns and small children often die waiting for a heart transplant. About 75 small donor hearts become available each year, so having an effective bridge to transplant like the Berlin Heart can help children survive until a suitable donor heart is found.
Children on the Berlin Heart can leave the intensive care unit and go to a regular hospital room where they receive rehabilitation and better nutrition while waiting for a transplant.
Pioneering Study and FDA Approval
In 2011, the Berlin Heart was approved by the U.S. Food and Drug Administration (FDA) for use in children after a lengthy study led by Dr. Fraser. He worked in cooperation with 17 hospitals in collecting and reporting data to the FDA regarding the safety and probable benefit of the pediatric heart pump.
On July 21, 2011, Dr. Fraser led the study team as they presented the final data to an FDA circulatory support advisory panel, who unanimously recommended that the device be approved by the FDA.
During the pioneering study, whose findings were published in the New England Journal of Medicine, 48 children received the device between 2007 and 2010. Of those, 90% survived to get a heart transplant. In contrast, only 40 to 60% of children receiving conventional medical support, like ECMO, lived long enough to get a new heart.1
In sum, Dr. Fraser and his colleagues concluded that “a ventricular assist device available in several sizes for use in children as a bridge to heart transplantation was associated with a significantly higher rate of survival, as compared with ECMO.”2
Read more about the Berlin Heart study and the FDA approval for the device in the Texas Children’s newsroom.
The Berlin Heart at Texas Children’s Hospital
Texas Children’s Heart Center implanted its first Berlin Heart on Sept. 27, 2005, in one of the smallest babies to ever receive the device. Brady Burch, a Corpus Christi resident, is now 7 years old and in first grade.
Texas Children’s Hospital has one of the most comprehensive pediatric ventricular assist device programs in the world.
In the last 5 years, Texas Children’s Heart Center has implanted 27 Berlin Hearts.
Texas Children’s Heart Center is recognized across the globe as a leader in the highly specialized field of pediatric congenital heart surgery and performs nearly 800 surgical cardiac procedures each year with outcomes among the best in the nation.
Texas Children’s Heart Center can be reached at 832-82-HEART (43278).
1 Fraser CD Jr, Jaquiss RDB, Rosenthal DN, et al. “Prospective trial of a pediatric ventricular assist device.” N Engl J Med 2012; 367:532-541.