First human recipient of genetically modified pig heart dies
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A man who became the first in the world to receive a genetically modified pig’s heart has died 2 months after the procedure, according to a press release.
In a statement, the University of Maryland School of Medicine and the University of Maryland Medical Center said David Bennett, aged 57 years, died March 8, just over 2 months after receiving a procedure that was hailed as a milestone for xenotransplantation. Bennett had terminal heart disease and was deemed ineligible for a conventional heart transplant. According to University of Maryland officials, Bennett’s condition began deteriorating several days ago. When it became clear he would not recover, he received palliative care.
“We are devastated by the loss of Mr. Bennett,” Bartley P. Griffith, MD, the Thomas E. and Alice Marie Hales Distinguished Professor in Transplant Surgery who surgically transplanted the pig heart, said in the release. “He proved to be a brave and noble patient who fought all the way to the end. We extend our sincerest condolences to his family. Mr. Bennett became known by millions of people around the world for his courage and steadfast will to live.”
At the time of the transplant, Griffith noted that there are not enough donor human hearts available to meet the long list of potential recipients and the team was “proceeding cautiously, but we are also optimistic.”
Complex procedure
As Healio previously reported, porcine heart transplants are not approved by the FDA; the agency authorized the surgery on Dec. 31 for compassionate use in this case, according to the medical team.
Bennett first came to the University of Maryland Medical Center as a patient in October 2021, where he was bedridden and placed on extracorporeal membrane oxygenation to remain alive. Before consenting to receive the transplant, Bennett, was fully informed of the procedure’s risks and that the procedure was experimental with unknown risks and benefits, according to the release.
After surgery, the transplanted heart performed very well for several weeks without any signs of rejection, according to the release; Bennett reportedly spent time with family and participated in physical therapy.
Xenotransplants are rare and can pose significant risks to patients as well as bioethical concerns. Pig hearts have been long been seen as possible for transplantation for the human heart due to many similarities, and pig heart valves are used for humans in many cases.
“We have gained invaluable insights learning that the genetically modified pig heart can function well within the human body while the immune system is adequately suppressed,” Muhammad M. Mohiuddin, MD, professor of surgery and scientific director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, said in the release. “We remain optimistic and plan on continuing our work in future clinical trials.”
Revivicor, a regenerative medicine company based in Blacksburg, Virginia, provided the genetically modified pig to the xenotransplantation laboratory at University of Maryland School of Medicine, according to their release. On the morning of the transplant surgery, the surgical team, led by Griffith and Mohiuddin, removed the pig’s heart and placed it in the XVIVO Heart Box perfusion device, a machine that keeps the heart preserved until surgery.
As Healio previously reported, in December 2020, the FDA approved an intentional genomic alteration process in a line of domestic pig known as GalSafe pigs (Revivicor) that was intended to eliminate alpha-gal sugar on the pigs’ cell surfaces. At the time, the FDA stated that the intentional genomic alteration may provide xenotransplant recipients with tissues and organs that lower the risk for immune rejection, as alpha-gal sugar is believed to be a cause of rejection in patients.
‘The beginning of hope’
In a statement, Bennett’s son, David Bennett Jr., said the family was “profoundly grateful” for time spent together that would not have been possible without the surgery. The family said they hoped the successes achieved will drive more advances and research.
“We hope this story can be the beginning of hope and not the end,” Bennett Jr. said in the release. “We also hope that what was learned from his surgery will benefit future patients and hopefully one day, end the organ shortage that costs so many lives each year. We are grateful for every innovative moment, every crazy dream, every sleepless night that went into this historic effort. We pray that those looking for hope will continue to fight for the future, fight for new ideas, fight for answers, fight for life.”
Perspective
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Mary Norine Walsh, MD, MACC
If successful for this patient long-term, this technique could help solve the decades-long problem of the lack of adequate donor hearts for the large number of patients listed for cardiac transplantation. The genetic modification may result in a decrease in rejection and the possibility that fewer immunosuppression medications would be needed.
Long-term success and possible rejection of the organ are major concerns. Also, the recipient was not felt to be eligible for a conventional cardiac transplant or durable mechanical support, so a concern is that he was so ill that his medical condition could adversely affect his outcome regardless of the performance of the cardiac graft.
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