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A small, implantable heart pump could help children await heart transplants at home rather than languishing in a hospital, according to a new study.
The pump is surgically attached to augment the heart's blood-pumping action, giving more time to find a donor heart, researchers said.
The pump worked well for seven children participating in a small-scale early trial of the device.
Six wound up getting heart transplants, and the seventh child's heart recovered on its own so a transplant was unnecessary, researchers reported today.
The new pump -- called the Jarvik 2015 ventricular assist device -- is slightly larger than an AA battery and can be implanted in children weighing as little as 18 pounds.
Kids with the pump can take part in many normal activities while they're at home awaiting a donor heart, researchers said.
By contrast, the only pump now available to support small children is as big as a large suitcase.
That pump -- the Berlin Heart -- weighs 60 to 200 pounds and is attached to the child with two tubes almost as large as garden hoses. It carries a fairly high stroke risk and requires hospitalization in most instances.
"Ventricular assist devices for adults have been improving every decade, but in pediatrics we're using technology from the 1960s,"lead researcher Dr. Christopher Almond, a professor of pediatric cardiology at Stanford University School of Medicine, said in a news release.
Such implantable heart pumps have been available to adults for more than 40 years, and tend to be safer and easier to use than external devices like the Berlin Heart, he said.
"There's a huge difference in the medical technology available to kids and adults, which is an important public health problem that that markets have struggled to fix because conditions like heart failure are rare in children,"Almond said.
If the new pump is approved, researchers estimate it could help 200 to 400 children worldwide each year.
Six children in the trial had heart failure caused by a disease called dilated cardiomyopathy, in which the heart muscle is unable to pump properly because it has become enlarged and weakened. The seventh child's heart was failing because of an electrical failure of the heart associated with the autoimmune disease lupus.
The children ranged in age from 8 months to 7 years when they received their pumps, and their weight ranged from 18 to 46 pounds. The pump can be used in kids who weigh up to 66 pounds.
The kids had the pump a median 149 days before they received a transplant or their health issue resolved itself. Median means half had the transplant longer, half for less time.
But researchers noted that complications were associated with the pump.
The child whose heart recovered suffered a blood clot stroke when their heart became strong enough to compete with the pump, researchers said. The pump was removed, and the child was still recovering and alive a year later.
A second child experienced failure of the right side of the heart and had to be transferred to a Berlin Heart pump to await transplant.
Based on these results, the National Institutes of Health has agreed to fund an expanded trial involving 22 patients at 14 medical centers in the U.S. and two in Europe. Researchers plan to recruit the first patient by year's end.
"We're excited to launch the next phase of the research,"Almond said. "We've overcome a number of challenges to get the work this far, and it's very exciting that there may be better options on the horizon for children with end-stage heart failure who require a pump that can act as a bridge to transplant."
The findings were reported May 7 in the Journal of Heart and Lung Transplantation.
More information
Texas Children's Hospital has more on the Jarvik 2015 heart pump.
SOURCE: Stanford Medicine, news release, May 7, 2024