Heart device sustains babies & children suffering from heart failure

Published date : 13 August 2012
Article date : 13 August 2012

The Berlin Heart, a pediatric ventricular assist device (VAD), was approved by FDA in December 2011, for use in children and babies.  It has been implanted in approximately 1,000 children awaiting heart transplants worldwide. Small flexible tubes are placed in the child’s failing heart, extend through the skin and connect to a pump outside the body. The pump and a computerised drive unit help maintain blood flow.

Following approval, a team of researchers from 17 institutions, led by Texas Children's Hospital and Baylor College of Medicine, set out to measure the Berlin Heart’s effectiveness and patient survival rate against other, more traditional therapies for pediatric heart failure.  They called the results, published in the New England Journal of Medicine, “unprecedented.”

Principal investigator Dr. Charles Fraser, surgeon-in-chief at Texas Children’s Hospital and professor of surgery and pediatrics at BCM, told FoxNews.com there are not a lot of suitable donors for children – usually only 70 to 80 small donor hearts become available in a given year. “Almost a third of children die on the waiting list,” Fraser said.  “But [the Berlin Heart] now allows patients to be on the list longer, and therefore have a better chance of surviving to receive a heart transplant.”

• Compared to the previous standard of therapy, known as extracorporeal membrane oxygenation (ECMO), the median survival time of infants (average age: 1 year old) was 28 days compared to five days on ECMO.  The longest survival time was 174 days on the Berlin Heart compared to 21 days on ECMO.
 
• By 174 days, 88 percent of children on the Berlin Heart had been successfully transplanted, while 12 percent had died or failed weaning.  In comparison, at 21 days, 25 percent of children on ECMO had died.
 
• Meanwhile, the median survival time of older children (average age: 9 years old) was 43 days on the Berlin Heart compared to five days on ECMO.  The longest survival time was 192 days on the Berlin Heart, compared to 28 days on ECMO.
 
• At 192 days, 92 percent of children on the Berlin Heart had been successfully transplanted or weaned off the device, while 33 percent of children on ECMO had died within 30 days.
 
In addition, children on the Berlin Heart experienced other benefits in quality of life. 
 
In the study, the researchers noted risks associated with the Berlin Heart – including major bleeding, infection, high blood pressure and a higher-than-expected rate of stroke. However, these risks generally did not appear to impede patients from receiving a transplant, they added. 
 
Source: foxnews.com, 09 August 2012
 
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