For pediatric patients in need of heart transplants, buying time until a donor heart becomes available is crucial. Median wait times in the U.S. for a child age 10 or younger to get a heart are about 2-1/2 to three months, according to the United Network of Organ Sharing.
One reason for this wait time is the rarity of donor hearts for youth in that age group. Until recently, pediatricians and pediatric nurses had few options, such as ECMO, or extracorporeal membrane oxygenation, to offer pediatric patients whose hearts werent strong enough to survive the wait for a transplant.
But a new device known as the Berlin Heart is being used to extend the length of time a child can wait for a heart while also improving their quality of life.
About 50 hospitals in the U.S. are using the Berlin Heart, a bridge-to-transplant ventricular-assist device that sits outside the body and pumps blood into the heart through implanted cannulas. Made by Berlin Heart GmbH in Germany, it is specially developed to help pediatric patients. The mechanism about the size of a computer mouse is attached to a mobile driver and computer. Its pumps and cannulas come in different sizes so it can be used in patients from a few days old to adolescents. It has been used as short a time as 23 hours to more than 374 days with a worldwide survival-to-transplant rate of more than 75%, says Bob Kroslowitz, vice president for clinical affairs at Berlin Heart Inc., a U.S. division.
After implantation, nurses provide one-on-one care and monitor patients intensely for signs of blood clots, stroke, and infection. The pumps are transparent, so nurses see the blood circulating and can check for clotting, which is a major risk. They use high-powered flashlights hourly to look for white fibrin deposits that can be the size of a pinhead, says Suzanne Courtwright, MS, CPNP, nurse practitioner in pediatric cardiothoracic surgery at Childrens Hospital at Montefiore Medical Center in New York City.
Nurses measure any deposits that appear, track the location, and watch to make sure the pieces dont turn dark brown or black or grow bigger, causing a blood clot.
At the bedside, the nurses … are the ones who are going to see them first. Its their assessment that is crucial to the [pediatric patients]survival, Courtwright says.
Not Yet FDA Approved
The Berlin Heart is used more widely in Europe than in the U.S. It has not yet been approved for general use in the U.S. by the Food and Drug Administration. So a case-by-case compassionate use appeal must be made to the FDA each time the situation arises.
Since its first use in 2000 in the U.S., the device, also called EXCOR, has been implanted in more than 260 patients in the U.S. and more than 600 worldwide, Kroslowitz says.
The company is in an FDA-approved IDE (investigational device exemption) study. We hope to file our application for [FDA] approval sometime in 2010, Kroslowitz says.
Costs for the equipment alone are substantial. Though some, if not all, costs are typically covered by insurance and Medicaid, the minimum kit for supporting one ventricle costs about $92,000, says Eileen Hughes, RN, MA, ANP, clinical director for cardiothoracic services at Mount Sinai Medical Center in New York City. Renting the small-refrigerator-sized drivers that churn the blood and send it back into the body can cost an additional $15,000 per month, and replacing a blood pump in the case of any clotting would cost another $37,000, Hughes says.
Mount Sinai has been using the Berlin Heart about five years and implants about three a year, Hughes says.
Pediatric cardiothoracic critical care nurses at Mount Sinai are trained at the center, updated on all developments, and must pass annual competency. The nurses never leave the bedside, Hughes says. Theres intensive hemodynamic monitoring that goes on. You are watching the function of every organ. If were doing it right, the lungs are perfused, the liver numbers are normal, the kidneys arent going to fail. Nurses also constantly watch for infection along the cannulas that enter the body.
Second Chance at Life
Samuel Weinstein, MD, chief of pediatric cardiothoracic surgery at the Childrens Hospital at Montefiore, has implanted two Berlin Hearts this year. Because the device can be used for long periods of time, he says its a better option for some patients than ECMO. Typically used less than a month, ECMO is a machine outside the body that works like a heart-lung bypass.
I was very happy with the way the device functioned in both patients, Weinstein says. This device allows them to get better, eat, and become interactive.
His most recent patient, 16-month-old Jeter Villacis from the Bronx, named by his dad for Yankees star Derek Jeter, used the device for seven weeks before he received a heart transplant Oct. 9. (He) was able to achieve developmental milestones that he was not able to prior to the device as well as put on significant amounts of weight, Weinstein says. To be on ECMO, you need to be sedated and on a ventilator in bed. With this device you can breathe on your own, you can get out of bed, eat, and play.
Though Jeter used the Berlin Heart for seven weeks until his transplant, some patients in other hospitals have had the device in for more than a year. We put [Berlin Hearts] in when the risk of not supporting the patient is greater than the risk of placing the device, Weinstein says.
That risk paid off for Jeter and his family a little more than a month ago. Jeter finally was able to go home Nov. 5, with a backpack full of Yankees memorabilia from the Turn 2 Foundation, established by Derek Jeter, one day after his namesakes team won its 27th World Series.