The U.S. Food and Drug Administration (FDA) has approved the Berlin Heart for pediatric patients waiting for heart transplants. The ventricular assist device is similar to the one worn by former Vice President Dick Cheney but scaled down in size for children and babies.
The FDA's decision to approve the Berlin Heart means hospitals can stock the device in a range of sizes - from walnut-size pumps for babies to fist-size pumps for teens. “I will sleep better knowing there's a Berlin Heart sitting here in the Cleveland Clinic,” said Dr. Gerard Boyle, a pediatric cardiologist at the Cleveland Clinic. “In the middle of the night, if we have a device here we can support the patient immediately.”
The Berlin Heart is a temporary fix, though. Children who receive it will ultimately need a heart transplant. “For families with a child who needs a heart transplant - and there are enough of those - we can say, 'We'll try to get a heart, but while we wait we have a plan,'” said Boyle. “This device gives us confidence that the number of patients who die waiting will decline dramatically.”
Heart failure in children is much rarer than in adults; in the United States, approximately 4,000 cases are among children aged 18 or younger, compared to about 500,000 adults. Pediatric heart failure is usually the result of a virus or a congenital heart defect.
Most children do not require a heart transplant; however, those that do may not survive until a donor heart becomes available; this problem is the result of a shortage of pediatric-sized donor hearts. According to the FDA, the average wait period for a donor heart in infants is 119 days; thus, between 12-17% of children and 23% of infants on the wait list die before they can receive a transplant.
The device attaches to the heart’s ventricles by slim tubes and rests on the chest. A small air hose at the device’s bottom hooks up to a machine, which provides the suction and pumping power needed to circulate blood throughout the body. Children of all ages – newborns to teens – can use the device, which usually helps cardiomyopathy patients.
“Like any machine, the heart is a machine that can malfunction. When it’s malfunctioning, your body still depends on blood being pumped to every cell in your body,” said Dr. Robert Stewart of the Cleveland Clinic Children’s Hospital. “So, this is really an auxiliary pump. This is a backup safety pump, and it essentially takes the blood as it is going into the pumping chamber, diverts it to here and pumps it to where it’s supposed to be going.”
The German company Berlin Heart AG was formed in 1997. Its three heart devices have been used widely across Europe for several years. Prior to approval in the U.S., doctors had to apply for “compassionate” use of the device.
“So there are many, many cases where people have gone on to the Berlin heart on a ventilator, even on life support systems and get off all of those machines, gain weight and they’re just a totally different person at the time of transplant, and this makes all the difference in the world in terms of recovery,” Stewart said. There is a risk of having a stroke while using the Berlin Heart, Stewart explained, as clots can form, but blood thinners are used to decrease this risk.
The device, named Excor, is already approved in Europe and Canada, the company said today in a statement. While adults can receive similar products sold by Framingham, Massachusetts-based HeartWare International Inc. (HTWR) and Pleasanton, California-based Thoratec Corp. (THOR), the device known as the Berlin Heart is the only one approved for children. The Berlin Heart was tested in 48 children across the U.S. starting in November 2007, the first-ever pediatric trial of a mechanical heart pump. A Food and Drug Administration advisory panel recommended approval in July.
“This is a landmark event for children suffering from terminal heart failure,” said Charles Fraser Jr., head of congenital heart surgery at Texas Children’s Hospital and professor of surgery and pediatrics at Baylor College of Medicine in Houston. “The medical community is now able to offer this lifesaving device to support desperate children who would not otherwise survive while awaiting a heart transplant.”