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Heart Transplantation for Pediatric Patients: Berlin Heart to the Rescue

Ventricular Assist Device, Berlin Heart approved by FDA

Until now, pediatric patients who were candidates for heart transplantation often waited in vain for a human heart. Now the Food and Drug Administration (FDA) has approved the first ventricular assist device (VAD), called the Berlin Heart, for children ages 30 days and older who are waiting for a heart transplant.

Pediatric patients now have a heart of a chance

The new Berlin Heart EXCOR® Pediatric VAD is the only cardiac assist device available in sizes appropriate for children ranging from infants to teens. The VADs were designed for the approximately 4,000 pediatric patients per year who have severe isolated left ventricular or biventricular dysfunction and who require circulatory support.

The pediatric VADs serve as a bridge—one that can last for days for up to several months--for young patients who are awaiting a donor heart. A ventricular assist device takes blood from a lower chamber (ventricle) of the heart and helps pump it to the rest of the body, simulating a healthy heart. A VAD can be used if one or both of the ventricles are not functioning properly.

Prior to approval of the EXCOR Pediatric System, the FDA advisory panel reviewed results from research involving the device in children ages 30 days to 4 years and 4 years to 16 years. The reviewers found that EXCOR provided better results when it came to survival to time of transplant when compared with the current standard of care, ECMO, or extracorporeal membrane oxygenation.

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Extracorporeal membrane oxygenation is a treatment that involves use of a pump that circulates blood through an artificial lung back into the bloodstream of the infant or child. The procedure is used to provide oxygen to the young patient so the lungs and heart can rest or heal, or while a patient is awaiting a heart transplant.

Use of ECMO is associated with additional risks to the child in addition to those already related to the heart problems, including bleeding, formation of blood clots, infection, and transfusion problems. The ECMO is not FDA approved.

According to the national principal investigator for the Berlin Heart EXCOR Pediatric VAD study, Charles D. Fraser, Jr., MD, Surgeon-in-Chief and Head of the Division of Congenital Heart Surgery at Texas Children’s Hospital and Professor of Surgery and Pediatrics, Baylor College of Medicine in Houston, Texas, “This is a landmark event for children suffering from terminal heart failure. The medical community is now able to offer this lifesaving device to support desperate children who would not otherwise survive while awaiting a heart transplant.”

According to the FDA Executive Summary on the Berlin Heart ventricular assist device, the pumps are available in five different sizes and “could provide stable circulatory support for children weighing as little as 3 kilograms for as long as 400 days.” For pediatric patients who are in need of a heart transplant, the Berlin Heart may come to the rescue, at least in the short-run.

Food and Drug Administration
Image source of a Ventricular Assist Devide: NIH