A Maryland man with a terminal heart disease has become the second-ever patient to receive a genetically modified pig heart.
This week, Lawrence Faucette, 58, underwent transplant surgery after being deemed ineligible for a human heart transplant due to peripheral vascular disease, which reduces blood circulation.
The procedure, known as a xenotransplant, has only been performed once before on an ex-convict who died two months later. Both historic procedures were performed at the University of Maryland Medical Center (UMMC).
Mr Faucette, a married father-of-two and a 20-year Navy veteran, is breathing on his own, and his heart is functioning without any supportive devices after the surgery, which took place on Tuesday. Without the procedure, he was facing certain death.
‘My only real hope left is to go with the pig heart, the xenotransplant,’ Mr Faucette said a few days before surgery.
Lawrence Faucette, 58, is the second person in the world to receive a heart transplant from a genetically modified pig. He was deemed ineligible for a human heart due to peripheral vascular disease, which reduces blood circulation. Pictured before surgery with his wife Ann, Mr Faucette is now breathing on his own, and his heart is functioning without any supportive devices
The gene-edited pig used in this procedure was provided by Revivicor, a subsidiary of United Therapeutics, one of several biotech companies in the running to develop suitable pig organs for potential human transplant. On the morning of the surgery, the transplant team removed the heart and placed it in an XVIVO Heart Box, the size of a microwave, which keeps the organ preserved in a nutrient-rich oxygenated solution
‘Dr. Griffith, Dr. Mohiuddin and their entire staff have been incredible, but nobody knows from this point forward. At least now I have hope, and I have a chance.’
His wife, Ann Faucette, added: ‘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.’
Mr Faucette likely has a long road ahead. He’s at risk of his body rejecting the foreign organ, which occurs in 10 to 20 percent of transplant patients. The UMMC doctors believe this risk could be greater for xenotransplant patients.
The Food and Drug Administration (FDA) granted emergency approval for the surgery last week with what’s called its single-patient investigational new drug (IND) ‘compassionate use’ pathway.
This is used when an experimental medical product, such as a genetically modified pig heart, is the only option available to treat a serious or life-threatening condition.
‘We are once again offering a dying patient a shot at a longer life, and we are incredibly grateful to Mr Faucette for his bravery and willingness to help advance our knowledge of this field,’ Dr Bartley P Griffith, who transplanted pig hearts into both patients, said.
‘We are hoping that he will get home soon to enjoy more time with his wife and the rest of his loving family.’
The gene-edited pig used in this procedure was provided by Revivicor, a subsidiary of United Therapeutics, one of several biotech companies in the running to develop suitable pig organs for potential human transplant.
On the morning of the surgery, the transplant team removed the heart and placed it in an XVIVO Heart Box, the size of a microwave, which keeps the organ preserved in a nutrient-rich oxygenated solution.
Pigs have a gene that produces a molecule not found in humans that triggers an immediate and aggressive immune response in humans, called hyperacute rejection. Within minutes, the body attacks the foreign organ.
In Mr Faucette’s surgery, three genes were ‘knocked out’ in the donor pig. Six human genes, which are responsible for the immune system accepting the organ, were inserted into the genome. One additional gene in the pig was knocked out to prevent excessive growth of the pig heart tissue. In total, 10 unique genes were edited in the donor pig.
Xenotransplantation could provide another option for the 110,000 Americans currently waiting for an organ transplant. More than 6,000 of these patients die every year before they can get the organs they need, according to federal data.
Dr Mark Gladwin, Executive Vice President for Medical Affairs at the University of Maryland Baltimore, said: ‘This innovative program embodies the future of molecular medicine in surgery and speaks to a possible future where organs may be available to all patients.’
‘We recognize a heroic partnership with Mr Faucette and his family, as we partner to advance the field of transplantation medicine into the next era.’
‘We are once again offering a dying patient a shot at a longer life, and we are incredibly grateful to Mr Faucette for his bravery and willingness to help advance our knowledge of this field,’ Dr Bartley P Griffith, who transplanted pig hearts into both patients, said. Pictured is the transplant team who performed Mr Faucette’s operation
In both of these historic procedures, a pig heart was gathered for a terminal heart disease patient who was ineligible for a human heart transplant. Scientists inserted six human genes into the genome of the donor pig — modifications designed to make the organ more tolerable to the human immune system. They inactivated four genes, including sugar in its cells that is responsible for that hyper-fast organ rejection and a growth gene to prevent the pig’s heart, which weighs around 267g compared to the average human heart, which weighs 303g, from continuing to expand. Surgeons at the University of Maryland Medical Center removed the patient’s heart and inserted the altered pig heart
This procedure was first performed last year on David Bennett, 57. Like Mr Faucette, Mr Bennett was also ineligible for a human heart. He also did not follow his doctors’ orders, missed appointments and stopped taking drugs he was prescribed.
He was bedridden, on life support, and out of options. ‘It was either die or do this transplant,’ he said.
Though the surgery was deemed a success, Mr Bennett died two months later. However, the organ wasn’t rejected; experts claimed that the heart could have been infected with a virus.
Mike Curtis, chief executive of competing pig breeder eGenesis, told MIT Technology Review: ‘Without the virus, would Mr Bennett have lived? We don’t know, but the infection didn’t help. It likely contributed to the failure.’
The choice to perform the procedure on Bennett was deemed controversial when it was discovered that he served five years in prison for attacking Edward Shumaker while he played pool at a Maryland bar in April 1988 after he caught his then-wife Norma Jean Bennett sitting in Shumaker’s lap while the pair were talking and drinking.
Shumaker, then 22, was paralyzed after being stabbed seven times in the back, abdomen and chest. He survived for 19 years before suffering a stroke in 2005 and dying two years later at age 40.
His sister, Leslie Shumaker Downey, bemoaned the praise being heaped on a man who robbed her younger brother of a healthy life in an interview with the BBC in January.
Downey said he is ‘not a worthy recipient’ and dislikes his portrayal as a hero.
‘Morally, in my opinion, no,’ she said, when asked if he should have been the first person to benefit from the medical breakthrough.
David Bennett (left), died on March 9, 2022, two months after he received a first-of-its-kind pig heart transplant. His son, David Bennett Jr, is pictured on the right
David Bennett (pictured right with surgeon Dr. Bartley Griffith on his left) was the first patient in the world to get a heart transplant from a genetically modified pig
‘For the medical community, the advancement of it and being able to do something like that is great and it’s a great advancement but they’re putting Bennett in the storylines portraying him as being a hero and a pioneer and he’s nothing of that sort.’
‘I think the doctors who did the surgery should be getting all the praise and not Mr Bennett.’
Scientists have been toying with animal-to-human organ donation, known as xenotransplantation, for decades.
Skin grafts were carried out in the 1800s from a variety of animals to treat wounds, with frogs being the most popular.
In the 1960s, 13 patients were given chimpanzee kidneys, one of whom returned to work for almost 9 months before suddenly dying. The rest passed away within weeks.
At that time human organ transplants were not available and chronic dialysis was not yet in use.
In 1983, doctors at Loma Linda University Medical Center in California transplanted a baboon heart into a premature baby born with a fatal heart defect.
Baby Fae lived for just 21 days. The case was controversial months later when it emerged the surgeons did not try to acquire a human heart.
More recently, waiting lists for transplants from dead, or allogenic, donors is growing as life expectancy rises around the world and demand increases.
In October 2021, surgeons at NYU Langone Health in New York successfully transplanted a pig kidney into a human for the first time.
It started working as it was supposed to, filtering waste and producing urine without triggering a rejection by the recipient’s immune system.
The recipient was a brain-dead patient in New York with signs of kidney dysfunction whose family agreed to the experiment before she was taken off life support.
It’s unclear what Mr Faucette’s prognosis is, though he is currently in stable condition.