Four-year-old Alina Siman is being kept alive on a device that gained approval in the U.S. just two weeks ago. The Berlin Heart Group’s EXCOR, a ventricular assist device manufactured in Berlin, Germany, takes over the normal function of a heart by pumping blood directly to the pulmonary artery and into the lungs.
With FDA approval granted on December 16, the U.S. joins Europe and Canada in offering the device for children of all ages with end stage heart failure.
When a failing heart is unable to pump enough blood throughout the body to sustain normal functioning, temporary assist devices like the Berlin Heart continuously pump blood to keep patients alive while they wait for a donor heart to become available.
However, many patients stay on the waiting list so long—up to a year—that they die before transplant.
The average waiting time for children 17 and under is three months but for patients who wait longer, up to 20 percent die on the waiting list, according to the United Network for Organ Sharing (UNOS).
In 2010, about 300 children were on the waiting list for a new heart, according to UNOS and roughly the same number are expected to need a transplant in 2012.
“We were very nervous about the [Berlin] Heart because it required major surgery,” said Alina’s father Jacob Siman. “But the outcome surprised us.”
Alina had been losing weight and spent most of her time in bed. Now, she has gained weight and spends her days reading in her hospital room and even walking up and down the hallway.
Though she must remain close to the Ikus, a mobile unit which powers the Berlin Heart, she can sit on the floor and play with toys or sit near the window next to her two older sisters.
Perhaps no one understands this more than Children’s cardiologist Christopher Almond, the co-principal investigator of a clinical trial involving the Berlin Heart, which helped the device gain FDA approval.
Almond’s four-year study included 48 children, 90% of whom successfully transitioned to a new heart after using the device. And Almond says patients can live up to a year or more on the device while waiting for a new heart.
“The best part about the [Berlin] Heart is it feels like it’s reducing the risk of death,” said Almond. Daly was similarly optimistic saying, “it gives kids a new chance at life.”
Before the Berlin Heart was approved, physicians could request the device on a case-by-case basis for compassionate use but it had to be shipped in from Germany and returned directly after a patient received a new heart.
Now Children’s stocks several of the devices in three sizes for infants, children and teens.
The Berlin Heart wasn’t approved previously because there are fewer monetary incentives to develop a pediatric ventricular assist device since heart failure is a rare condition in children.
Even with FDA approval, the device isn’t without side effects, which include stroke, infection and internal bleeding. Alina experienced bleeding in her head while on the device and still has a lingering headache from the incident.
“We don’t like the risks but as time passes the risks are less prone to happen,” said Mary Siman, Alina’s mother.
Alina’s parents said all they can do now is wait.
“We’re hoping she’ll get a new heart soon” said Mr. Siman. “She wants to go back to playing, being a kid and we want to bring her home.”