One month after an experimental procedure for transplant the heart of a genetically modified pig In a patient with end-stage heart disease, doctors say the heart is working on its own and shows no signs of rejection.
In September, 58-year-old Lawrence Faucette underwent surgery, the second ever performed on a human being. Faucette’s heart disease and pre-existing conditions made him ineligible for a traditional human heart transplant.
“The doctors caring for him believe his heart function is excellent,” said the Bartley Griffithdirector of the Heart and Lung Transplant Program at the University of Maryland School of Medicine, who performed the surgery.
“We have had no evidence of infections and no evidence of rejection at this time.”
Muhammad Mohiuddin, director of the UMMC Cardiac Xenotransplant Program, said in an update shared Friday, “We are withdrawing all medications that initially supported his heart. So now his heart is doing everything on its own.”
Mohiuddin said the focus now is on ensuring Faucette has the strength to perform routine functions.
“We are working hard with our physiotherapy team, who spend a lot of time helping him regain the strength he lost during the last month of his hospital stay,” Mohiuddin said.
In a video released by UMMC, Faucette appears undergoing physical therapy, including cycling to improve leg strength. When his physical therapist, Chris Wells, reminds him to keep smiling, Faucette laughs and says, “That’s the hard part!”
When Faucette came in, “he never expected, frankly, to be able to stand up again,” Griffith said. Although Faucette is not yet standing on his own, he is able to get out of bed with minimal assistance and doctors say they are at a “crucial point.”
Griffith said it was time to plan the next stage of Faucette’s recovery and “think about where Larry will go in terms of his next location.”
Faucette is a married father of two, a native of Frederick, Maryland, and a 20-year Navy veteran who most recently worked as a laboratory technician at the National Institutes of Health.
In another moment shared by UMMC, Faucette is seen going over scans of his heart with his doctors. “That looks like a completely normal heart. And that’s definitely what we wanted,” he says.
Faucette was first admitted to UMMC on September 14 after experiencing symptoms of heart failure. While in hospital, his heart stopped twice and could only be recovered because of an automatic defibrillator in his room.
“My only real hope is to opt for the pig heart, the xenotransplantation,” Faucette told the hospital in an internal interview several days before the surgery.
“We have no expectations other than to spend more time together,” his wife, Ann Faucette, said at the time. “This could be as simple as sitting on the front porch and having coffee together.”
Xenotransplantation
Experimental xenotransplantation surgery has been given the green light under the US Food and Drug Administration’s (FDA) “compassionate use” program.
According to the FDAthe program is “a potential pathway for a patient with a serious or immediately life-threatening illness or condition to gain access to a experimental medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy option is available.”
The pig heart used came from a genetically modified pig from Revivcor, a subsidiary of United Therapeutics Corporation. The pig had 10 genes edited, including three genes “knocked out” or inactivated to eliminate alpha-gal sugar from the pig’s blood cells, which can trigger a serious reaction in the human immune system, causing organ rejection.
An additional pig gene was modified to control the growth of the pig’s heart, while six human genes were added to the pig genome to increase acceptance by the immune system. O FDA first approved gene-edited pigs for potential therapeutic use and consumption in 2020.
There are currently no clinical trials using pig organs for transplantation into living humans.
Doctors also treated Faucette with an experimental antibody treatment to further suppress the immune system and prevent rejection. He continues to be monitored for any signs of rejection or any development of swine-related viruses.
The donor pig was also closely examined for any signs of viruses or pathogens.
The hospital said Faucette fully consented to the experimental treatment and was informed of all risks. Additionally, he underwent a full psychiatric evaluation and discussed his case with a medical ethicist.
Mohiuddin and Griffith established the country’s first center for cardiac xenotransplantation research and carried out the first experimental surgery on 57-year-old David Bennett in January 2022. Bennett died two months after surgery.
Although there were no signs of rejection in the first few weeks after the transplant, an autopsy concluded that Bennett died of heart failure due to “a complex set of factors”, including Bennett’s condition before surgery.
Bennett had already been hospitalized and kept on a heart and lung bypass machine for six weeks before the transplant. However, a case study carried out by doctors published in Lancet also noted that there was evidence of swine viruses that had not previously been identified.
Source: CNN Brasil

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