Historic Pig-to-Human Heart Transplant Offers Hope Amidst Terminal Heart Disease Page 2 The Sun Bay Paper September 29, 2023 - October 5, 2023 In a groundbreaking medical procedure, surgeons at the University of Maryland Medical Center have successfully conducted only the second-ever pig-to-human heart transplant, providing a glimmer of hope to patients facing terminal heart disease. On September 20th, Dr. Bartley Griffith and his team achieved this remarkable feat by transplanting a genetically modified pig heart into Mr. Lawrence Faucette, a 58-year-old Navy veteran from Frederick, Maryland. Mr. Faucette, who had been grappling with end-stage heart disease, had exhausted all other treatment options due to pre-existing peripheral vascular disease and internal bleeding complications, rendering him ineligible for a traditional human heart transplant. The surgical triumph has breathed new life into Mr. Faucette. Two days post-surgery, he is now able to breathe independently, and his newly transplanted pig heart is functioning optimally without any assistance from mechanical devices. This remarkable achievement has rekindled hope for Faucette, who shared his feelings in a video message recorded by the hospital before the operation: "Nobody knows from this point forward. At least now I have hope and I have a chance. I will fight tooth and nail for every breath I can take." The road to successful xenotransplantation, the transplantation of animal organs into humans, has been a long and challenging one. Previous attempts at animal-to-human organ transplants had failed due to immediate rejection by the recipients' immune systems. However, scientists have revisited this avenue using pigs genetically modified to make their organs more compatible with human recipients. For this recent attempt, the Maryland researchers obtained special permission from the Food and Drug Administration (FDA) under its “compassionate use” program, typically reserved for emergency cases with no alternative options. This unique authorization followed extensive documentation submitted to the FDA, demonstrating the research team’s valuable insights from their earlier attempt in 2022. Though the reasons for the prior patient’s death remain partially unexplained, the medical team, along with Mr. Faucette, understood and accepted the risks involved in this experimental procedure. A critical difference this time is that Faucette, while facing end-stage heart failure, was not as near death as the prior patient. By Friday following the surgery, his new pig heart was functioning effectively without the need for supportive machinery, marking a significant milestone in this pioneering field. This compassionate use case offers some insights into how pig organs function in humans, although it is not a substitute for more formal testing. Karen Maschke, a research scholar at the Hastings Center specializing in ethics and policy recommendations for xenotransplant clinical trials, noted that FDA's allowance for this second case suggests that a clinical trial for pig heart transplants is not yet on the immediate horizon. The pig heart used in the transplant, provided by Blacksburg, Virginia-based Revivicor, featured ten genetic modifications, including the removal of certain pig genes and the addition of human genes to enhance compatibility with the human immune system. This monumental achievement represents a beacon of hope for individuals on the waiting list for organ transplants in the United States, where over 6,000 patients die each year due to a shortage of available organs. While xenotransplantation offers potential solutions, it also presents unique risks, such as the transmission of unknown pathogens and heightened immune responses. The FDA's compassionate use program played a pivotal role in making this historic surgery possible, enabling the transplantation of a genetically modified pig's heart to Mr. Faucette when it was the only remaining option. As Faucette and his family look ahead, the coming weeks will be crucial in determining his body's acceptance of the transplanted pig organ and any potential challenges that may arise. Ann Faucette, Lawrence's wife, expressed their hope: "We have no expectations other than hoping for more time together. That could be as simple as sitting on the front porch and having coffee together." Alfredo DiPasquale
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