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Pediatric Cardiology: Investigational bridge to transplant provides new hope for children with failing hearts

12/01/2008

At any given time, nearly 200 children in the United States are awaiting heart transplants. Due to a growing shortage of donor organs, many of these critically ill youngsters will die before a suitable heart becomes available.

But a mechanical ventricular assist device that is currently under clinical investigation for pediatric use in the United States could save the lives of many of these children. The EXCOR Pediatric Ventricular Assist Device — known as the Berlin Heart after its German manufacturer — can support children with cardiomyopathy, acute myocarditis and other conditions for as long as 400 days as they wait for a life-saving donor organ.

The Berlin Heart is suitable for children of all ages, from newborns to teenagers. It can also be used as a bridge to recovery in children whose hearts will be able to work on their own again.

UCLA participates in FDA study

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 (IDE) study that launched in May 2007. The purpose of the study is to evaluate the safety and effectiveness of the device.

Since its debut in Europe in the early 1990s, the Berlin Heart has been used worldwide in 343 babies and children, 118 of them in the United States on a compassionate-use basis, the manufacturer reports. Patients have ranged from newborns weighing only 2 kg to teenagers. The longest support time was 420 days.

The Berlin Heart, 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.

A major step forward

The Berlin Heart represents a significant improvement over what until now has been the standard of care for youngsters with failing hearts — extracorporeal membrane oxygenation, or ECMO.

ECMO, an external blood pump and artificial lung, can support patients for no more than two to three weeks before life-threatening complications develop. The majority of children on ECMO do not survive to transplant. ECMO can be especially risky for older children who are too small for an adult ventricular assist device.

ECMO has other disadvantages. Youngsters on the device are prone to bleeding and infection, must remain sedated, and are strictly dependent on intensive care.
Children on the Berlin Heart, by contrast, remain off the ventilator, awake and alert. They are able to move about the ward or hospital grounds. This kind of mobility means that children will be in better physical condition for transplantation.

A long and successful history

As one of the world’s largest solid-organ transplant centers, UCLA has a long and successful history with assist devices that sustain life pending transplant.

UCLA team members are adept at navigating bureaucracy inherent in implanting an investigational device and guiding parents and caregivers through the implantation and transplant processes. Implantation can usually take place within 48 hours of initial contact.  California Children’s Services, as well as many private insurers, covers the Berlin Heart.

Keeping the youngest of heart transplant candidates alive

The Berlin Heart is an improvement over what until now has been the standard of care for critically ill heart patients — extracorporeal membrane oxygenation, or ECMO, which can keep the smallest of transplant candidates alive only about two to three weeks. The Berlin Heart can sustain life for as long as 400 days.

“The Berlin Heart offers new hope that we can keep these kids stable for a longer period of time until a donor organ becomes available,” says Juan C. Alejos, M.D., clinical professor of pediatric cardiology at UCLA and medical director of the UCLA Pediatric Heart Transplant/Heart Failure Service.

Another advantage of the Berlin Heart is that children implanted with the device remain alert and active. “We try to get them to exercise a bit,” Dr. Alejos says. “That way, their bodies will be in much better condition when the transplant takes place.”

Participating Physicians

Juan Carlos Alejos, M.D.
Professor, Department of Pediatrics
Medical Director, Pediatric Heart Transplant/Cardiomyopathy Program
Associate Medical Director, Pediatric Cardiothoracic Intensive Care Unit

Brian L. Reemtsen, M.D.
Assistant Professor, Division of Cardiothoracic Surgery
Chief, Congenital Heart Surgery, Mattel Children’s Hospital UCLA

Contact Information
(310) 825-5296 Appointments and referrals
(310) 825-9524 Fax
jalejos@mednet.ucla.edu

 





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