In a first-of-its-kind surgery, a 57-year-old patient with terminal heart disease received a successful transplant of a genetically modified pig heart and is still doing well three days later. It was the only currently available option for the patient. The historic surgery was conducted by University of Maryland School of Medicine (UMSOM) faculty at the University of Maryland Medical Center (UMMC), together known as the University of Maryland Medicine.
This organ transplant demonstrated for the first time that a genetically modified animal heart can function like a human heart without immediate rejection by the body. The patient, David Bennett, a Maryland resident, is being carefully monitored to determine whether the transplant provides lifesaving benefits. He had been deemed ineligible for a conventional heart transplant at UMMC as well as at several other leading transplant centres that reviewed his medical records.
“It was either die or do this transplant. I want to live. I know it’s a shot in the dark, but it’s my last choice,” said Bennett a day before the surgery was conducted. He had been hospitalised and bedridden for the past few months.
The U.S. Food and Drug Administration granted emergency authorisation for the surgery on New Year’s Eve through its expanded access (compassionate use) provision. It is used when an experimental medical product, in this case the genetically modified pig’s heart, is the only option available for a patient faced with a serious or life-threatening medical condition.
“This was a breakthrough surgery and brings us one step closer to solving the organ shortage crisis. There are simply not enough donor human hearts available to meet the long list of potential recipients,” said Bartley P. Griffith, MD, who surgically transplanted the pig heart into the patient. Dr Griffith is the Thomas E. and Alice Marie Hales Distinguished Professor in Transplant Surgery at UMSOM. “We are proceeding cautiously, but we are also optimistic that this first-in-the-world surgery will provide an important new option for patients in the future.”
Xenotransplants were first tried in the 1980s, but were largely abandoned after the famous case of Stephanie Fae Beauclair (known as Baby Fae) at Loma Linda University in California. The infant, born with a fatal heart condition, received a baboon heart transplant and died within a month of the procedure due to the immune system’s rejection of the foreign heart. However, for many years, pig heart valves have been used successfully for replacing valves in humans.
Bennett was admitted to the hospital more than six weeks before the transplant with life-threatening arrythmia and was connected to a heart-lung bypass. In addition to not qualifying to be on the transplant list, he was also deemed ineligible for an artificial heart pump due to his arrhythmia.