Florida boy is state's first to get new mechanical heart device
A gravely ill 9 -year-old Florida boy awaiting a heart transplant is the first in the state to receive the Berlin Heart, a mechanical heart device sized specifically for children.
University of Florida surgeons implanted the device, designed to boost his failing heart's pumping action until a donor organ becomes available, during a nearly five-hour procedure today (Sept. 29) at Shands at UF medical center. He was listed in critical condition and will remain in the Shands at UF Pediatric Intensive Care Unit until a donor heart becomes available.
"This patient has been in heart failure, on a ventilator, and his condition was deteriorating at a rate that was affecting his other organs--he was at risk for organ failure," said UF cardiac surgeon Dr. Mark Bleiweis. "Without a transplant or this kind of device, he would die. We're not sure how long he'd have to wait for an organ. Because of that uncertainty, we had to proceed."
Bleiweis said there are numerous risks associated with the procedure, including bleeding and clotting problems and infection, but the medical team felt it was the boy's only option.
"This gives us a chance to stabilize him and allow him to recover, so that he's ready for a transplant," he said.
The Berlin Heart, the size of a small orange, is also known as a ventricular assist device, or VAD. Produced in Germany, the computerized pump system is available in various sizes suitable for use in infants and small children. Most of the device extends outside the body and connects to the heart via tubes implanted in the patient's chest.
In addition to its use as a "bridge" to transplantation, the Berlin Heart is sometimes an option for patients who are not eligible for transplantation. In other cases, it allows the heart time to recover and transplantation can be avoided altogether.
The Shands patient, whose name has not been disclosed to protect his privacy in the days immediately after the surgery, had been a healthy child until he began exhibiting symptoms last month, including breathlessness and abdominal pain. On Aug. 11, University of Florida pediatric cardiologists diagnosed him with idiopathic dilated cardiomyopathy, a weakness of the heart muscle. Although the cause is uncertain, physicians suspect a viral infection.
"Cardiomyopathy usually is first treated with drugs," said Dr. F. Jay Fricker, chief of the division of pediatric cardiology at UF's College of Medicine. "If the heart continues to weaken, then heart replacement is your only option."
The boy was admitted to Shands at UF on Aug. 13, and UF physicians placed him on the heart transplant waiting list Aug. 25. The family faced an indefinite wait for a donor heart because their son has type O blood, which requires a compatible blood-type match. As the patient's condition continued to deteriorate, the medical team searched for interim solutions. Traditionally, options would include placing the patient on a ventilator, implanting an aortic balloon pump or using pediatric heart-lung bypass therapy.
"The issue is donor availability," Fricker said. "If a donor is not available and the patient is deteriorating, the options are some form of circulatory support. We think the Berlin Heart is an excellent way to transition patients until they can receive a transplant. It gives additional support to the failing heart. The results in older children and adults with similar devices have been very successful in bridging patients to transplant.
"There is a ventricular assist device used commonly in adults here, but the smallest child we've used it on has weighed about 75 pounds," he added. "An adult heart fills with about 2 to 3 ounces of blood, and the great vessels of a smaller child are not large enough to accept that much blood with each beat. That's why adult ventricular assist devices aren't usually suitable for children. The Berlin Heart can be used even in infants. It comes in different sizes in terms of how much blood it puts out with each beat."
The Berlin Heart is not yet approved by the U.S. Food and Drug Administration but the agency allowed UF and Shands officials to move forward on a one-time compassionate use basis. The UF Internal Review Board and Shands officials also had to approve the procedure.
A team from Berlin Heart Inc. flew in from Germany on Wednesday to assist.
The young patient is the 68th child in the United States and Canada, and one of only 200 internationally, to receive the Berlin Heart. Other U.S. and Canadian Berlin Heart recipients have relied on the device anywhere from one day to 234 days.
For patients and their families and care providers, this device could offer hope during the uncertain wait for a donor organ, said nurse practitioner Barbara Williams, pediatric heart and lung transplant coordinator at Shands at UF.
"Everyone involved in the care of this patient and these precious children is extremely hopeful that the Berlin Heart will provide the time he needs to make it to transplant," Williams said. "As a member of the Shands pediatric heart transplant team, this is a very exciting step for us. There is no way to predict or plan for the arrival of a donor heart, and unfortunately we have lost babies and children during the wait for an organ."
Georgiann Ellis, Shands at UF vice president for operations, said, "We're a team-together with UF, our Shands staff is dedicated to providing excellent medical care and compassionate solutions. We're passionate about doing the best we can for each of our patients, and we're grateful that the Berlin Heart became an option for this child."
Currently, 19 children in Florida and 236 nationally are on the heart transplant waiting list. For more information about organ donation, please visit www.donatelife.net