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In 2007, Boston Children’s Hospital cardiac surgeon Francis Fynn-Thompson, MD, received special permission from the United States Food and Drug Administration (FDA) to implant a Berlin Heart®—a mechanical device that temporarily takes over the heart’s pumping functions—in a 9-year-old boy on the waiting list for a donor heart. This groundbreaking procedure saved the patient’s life, and made pediatric medical history.
That same year, the FDA approved the nation’s first pediatric multi-center clinical trial of the Berlin Heart. Not only did a Boston Children’s cardiologist play a central role in designing the protocol and go on to serve as co-principal investigator; our hospital was also chosen as one of the study sites.
As the device awaited full approval, the FDA deemed us one of only 10 pediatric institutions in the U.S. entrusted to implant and maintain the Berlin Heart in patients.
Four years and nearly 50 trial patients later—90 percent of whom successfully transitioned to a transplanted heart after using the device—the Boston Children’s Heart Center team saw their vision realized: the FDA formally approved the use of the Berlin Heart in children of all ages experiencing end-stage heart failure.
Among all pediatric organ transplant candidates, children awaiting heart transplants have the highest mortality rate. By helping the Berlin Heart secure FDA approval, Boston Children’s has ensured that these patients have the option of a critical “bridge to transplant.”
Now, our cardiologists and cardiac surgeons are working to identify and refine the mechanical and ventricular assist devices (VADs) of the future.
In coordination with the New England Research Institute, Almond and Boston Children’s Heart Transplant Program Medical Director Elizabeth Blume, MD, are designing multi-center, multi-device clinical trials of new VADs.
These next-generation devices also carry great promise, as they allow for a continuous flow of blood while avoiding the risk of clots and stroke associated with previous VADs.
Boston Children’s is a global expert in the use of VADs for children whose hearts are failing as they wait for a donor organ. But because these devices require complex open-heart surgery and carry a risk of significant complications, we consider them a last resort—and one for the most gravely ill children, such as those with single ventricle defects.
Many other centers use VADs as the primary treatment plan for children with congestive heart failure and cardiomyopathy. Understanding timing of device placement is the next important milestone for this field.
At Boston Children’s, we believe that our combination of specialized training, extensive experience and innovative tools and techniques allows us to focus on medical therapy to sustain these children until they can undergo a transplant—and in some cases, makes it possible to delay transplantation or avoid it altogether.
The future of pediatrics will be forged by thinking differently, breaking paradigms and joining together in a shared vision of tackling the toughest challenges before us.”