A Houston-led study has found that the world's first heart pump for babies and children provides a life-saving bridge to transplantation, heralding a new era of care for pediatric heart patients.
Decades after heart pumps began extending the lives of adult cardiac patients, the study led by Texas Children's Hospital showed the miniature device known as the Berlin Heart kept 90 percent of children alive while they waited for a donor organ. Without the device, small children have little hope of surviving long once their hearts start failing.
"This shows children don't have to be second-class citizens any longer," said Dr. Charles Fraser Jr., surgeon-in-chief at Texas Children's and the study's principal investigator. "Doctors now should have confidence they can offer children the same kind of heart support adults have been getting."
Fraser said the study, published in Wednesday's New England Journal of Medicine, should get the word out about the pump's effectiveness for heart failure, which occurs when the heart can no longer pump enough blood to the body. The device was approved by the U.S. Food and Drug administration in December based on the study.
Fraser, also a professor of surgery and pediatrics at Baylor College of Medicine, estimated that 200 to 300 children a year could benefit from the device. Development of an artificial heart for children has lagged because heart failure in children is rare, but a third of pediatric patients on the waiting list for a transplant die before one becomes available.
Made in Germany
The pump, manufactured in Germany and available in sizes to fit children from newborns to teenagers, connects to the heart through a pair of tubes and is run by a laptop computer to help the heart's ventricles pump blood to the lungs and the rest of the body.
Fraser called the 90 percent survival rate "astonishing." The trial is the first to follow patients from the device's implantation at multiple hospitals to the patients' outcomes.
The study enrolled 48 children who received the device at 17 hospitals in the U.S. and Canada between 2007 and 2010. It compared the outcomes of the participants, from infancy to 16 and divided into two groups based on body size, with pediatric matches in a national registry of patients who received temporary support from a heart-lung machine, such as is used in open heart surgery.
Some risk of stroke
Ninety-two percent of the larger children, average age 9, were successfully transplanted or weaned off the Berlin Heart at 192 days. By contrast, 33 percent of the same size children on a heart-lung machine had died at 30 days.
Among the smaller children, average age 1, 88 percent were successfully transplanted or weaned off the Berlin Heart at 174 days. Twenty-five percent of the comparison group had died at 21 days.
The study did find a higher-than-anticipated rate of stroke associated with the device - 29 percent - though Fraser said the children all recovered without any neurological impairment. It also found significant amounts of bleeding and infection, both easily controlled.
Fraser said the risk findings will trigger efforts to further refine the device.
The Berlin Heart costs more than $100,000, including procedures and hospitalization. Treatment with the heart-lung machine costs the same.
The Berlin Heart was been approved in Europe since 1992. It has been implanted in roughly 1,000 children worldwide. Texas Children's first implanted the device in 2005.
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