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Physicians Update

 
Summer 2010

Investigational Bridge to Transplant Improves Chances for Children with Failing Hearts

07/14/2010

Nearly 200 children are awaiting heart transplants in the United States, but due to a chronic shortage of donor organs many may die before a suitable heart becomes available. For a large number of these children, a device to keep them alive until they can receive a transplant is the only answer.

While small, portable ventricular-assist devices that can sustain adults for many months have been around for years (see related article, page 10), the only option for children with heart failure who are smaller than about 85 pounds has been extracorporeal membrane oxygenation (ECMO) — a bulky external blood pump and artificial lung to which a child must be tethered while lying sedated in an intensive-care bed. A severe drawback of ECMO, however, is that life-threatening complications such as bleeding often can occur after two or three weeks on the machine, and because of the sedation it is difficult for attending physicians to assess the child’s mental or neurological status.

“Once they are put on ECMO, the clock starts ticking and time becomes critical,” says Juan Alejos, medical director of the UCLA Pediatric Heart Transplant/Cardiomyopathy Program. “Every minute counts. If a heart cannot be found in time, often these patients will die while on the machine waiting for a transplant.”

PU-Summer10-Juan Alejos, MDNow, though, a device that has been used successfully in Europe since the early 1990s but has only recently become available in the United States greatly expands that window for these very fragile patients. Called the Berlin heart, it is a revolutionary pulsatile ventricular-assist device designed specifically for children, from infants to teenagers. It can support children with cardiomyopathy, acute myocarditis and other conditions for more than a year until a life-saving organ becomes available. It can also be used as a bridge to recovery in children whose hearts will be able to function on their own again.

UCLA is among a limited number of U.S. medical centers that are implanting the Berlin heart under terms of a Food and Drug Administration (FDA) investigational-device exemption study that was launched in 2007, and for compassionate use in extremely critical cases.

“It’s the only thing that we have right now that functions for these small children and allows them a chance to get to transplantation,” says Brian Reemtsen, M.D., chief of pediatric congenital heart surgery at Mattel Children’s Hospital UCLA.

Unlike ECMO, a child with a Berlin heart does not have to be sedated, remains off a ventilator and is awake and alert, Dr. Alejos explains. And because the device is relatively compact and mobile, he or she can be moved from the hospital bed for trips around the floor or hospital grounds.

That mobility enables “the children to essentially lead a somewhat normal existence and allows all their organs to improve, such as their kidneys and their lung function, before the transplant,” Dr. Reemtsen says.

“We try to get them to exercise a bit,” Dr. Alejos adds. “If they are able to walk, they can walk, do normal activities. They can eat. Their bodies actually can recuperate from a lot of the injuries they may have to other organs as a result of their cardiac condition. Then, when the transplant does take place, their bodies will be in much better condition to recover.”

PU-Summer10-Brian Reemtsen, MDSince its debut in Europe, the Berlin Heart has been used worldwide in more than 340 babies and children, including more than 115 in the United States on a compassionate-use basis. Patients have ranged from newborns weighing only four pounds to teenagers. The longest support time has been 420 days.

The device, which can support either or both ventricles, consists of one or two pneumatically driven blood pumps that connect via cannulas to the atrium or ventricle and major arteries. Blood flows through an inflow cannula into the blood chamber of the pump, and from there into an outflow cannula and on to the aorta or pulmonary artery. A tube connects each pump to a cart-like driver unit that generates suction and driving pressure. A laptop computer, through which parameters can be viewed and adjusted, sits atop the driver unit. The various sizes of blood pumps — from 10 ml to 60 ml — and a wide range of cannulas make it possible for the Berlin heart to be implanted in children of different sizes and ages.

Once the need is determined, implantation of the device can usually take place within 48 hours. California Children’s Services, as well as many private insurers, now covers the Berlin heart.

“This is something that has dramatically changed the landscape of what we are now able to offer these kids,” Dr. Alejos says. “It is a revolutionary device that will enable us to save many more young lives than we could in the past.”

To watch a video about the Berlin heart, go to: http://streaming.uclahealth.org/berlinheart





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