Doctors in the USA transplanted a pig's heart into a human: this is the first such transplant in history

A Maryland resident has been living with a pig's heart beating in his chest since January 7, reports USA Today.

Photo: Shutterstock

The operation, performed at the University of Maryland Medical Center, marks the first use of a gene-edited pig as an organ donor.

Dave Bennett, 57, agreed to be the first to risk experimental surgery, hoping it would give him a chance to return home to his duplex in Maryland and his beloved dog, Lucky.

“This is nothing short of a miracle,” his son David said on January 9, two days after his father's life-prolonging surgery. "This is what my father needed."

During a nine-hour operation, doctors replaced his heart with the heart of a one-year-old 108-kilogram pig, genetically modified and bred specifically for this purpose.

Bennett breathes on his own without a ventilator, although he remains on the ECMO machine, which does about half the work of pumping blood throughout his body. Doctors plan to gradually wean him off the device.

Scientists have worked for decades to figure out how to save human lives with animal organs. More than 100 people are queuing up for organ transplants suffering from dire symptoms and side effects. About 000 of them die each year, waiting in vain for someone's tragedy to provide them with a kidney, heart or lung.

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Pigs have organs similar to those of humans. If these organs could be used for transplantation, the wait would be over. People who will never be considered transplant candidates - who will never make it on these lists - can look forward to family meals, play with their children or grandchildren, and just get back to their lives.

This is the promise of so-called xenotransplantation. And the area made a big leap forward with the Bennett operation on January 7th.

“This is truly a remarkable breakthrough,” said Robert Montgomery, a transplant surgeon at New York University Langone and a heart transplant recipient himself. “I am excited about this news and the hope it brings to my family and other patients who will ultimately be saved by this breakthrough.”

In September, Montgomery pushed the work forward by becoming the first to transplant a pig's kidney into a human, but in this case and subsequent surgery in December, the human brain was declared dead. Montgomery kept the machine running for more than two days each time, showing that a person's immune system would not immediately reject a kidney from a genome-edited pig.

“The Maryland procedure takes what we did in September 2021 to the next level,” Montgomery said. “At that moment the race began.”

“We've all been doing this for a very long time, and I'm sure it should be fun to be first,” said Joseph Tector, transplant surgeon and xenotransplant researcher at the University of Miami.

A tector who specializes in kidney transplantation said he waits until he is sure he can deliver reliable, long-lasting results "so that when we do, we can help everyone."

Animal rights activists object to the use of pig organs. There would be more human organs available for transplant if health authorities accepted that everyone is an organ donor, without a system of rejection.

The Reverend Tadeusz Pacholczyk, director of education at the National Catholic Center for Bioethics in Philadelphia, said animal testing is needed to initiate new therapies in humans.

“Despite years of research, there are likely to be many more twists and turns on the road to getting our immune system to work well with implanted animal organs,” Pacholczyk said. “I suspect this is the first step on the path from yesterday’s ‘scientifically unimaginable’ to today’s ‘barely achievable’ to tomorrow’s ‘standard of care’.”

Patient experience

According to his son, Bennett, who has been relatively healthy for most of his life, began to experience severe chest pains in October.

He was admitted to the University of Maryland Medical Center with severe fatigue and shortness of breath. “He couldn't go up three steps,” said David, a physical therapist who understood the seriousness of the man's condition.

Two months of trying to save Bennett's own heart did not work. Several transplant programs have formally or informally denied him a heart transplant. He was deemed unsuitable for an artificial heart pump due to uncontrolled arrhythmias.

About 3000 Americans a year are lucky enough to get a new heart, but 20% of those on the transplant schedule die while waiting or become too sick to receive one.

Bennett was not on the list because he did not follow doctors' orders, missed appointments and stopped taking prescribed drugs. History has shown that people with such a track record do not tolerate organ transplants well.

At first, Bennett did not want to participate in the experimental operation. All his life he worked as odd jobs - repairing swimming pools, servicing cars, painting - depending on his physical strength, but two months in the hospital made any operation risky. He didn't want to die on the operating table.

According to his son, Bennett changed his mind when he realized that he would probably never be able to leave the hospital otherwise.

“He knew it was the best option for him,” David said. “He’s a fighter and he has a will to live.”

While Bennett still has a long way to go, David said he was optimistic about the future.

“My dad told both his sisters and me, ‘Don’t worry. God is holding my hand,” David said, describing his father as a man of faith, although not tied to any particular religion. “I believe there is ongoing reason for hope.”

Even if it doesn't change his outcome, the operation will allow Bennett to leave a legacy, according to David.

“Whatever happens, I want to help other people,” Bennett told his son before the operation.

David said Bennett had a pig valve implanted almost ten years ago and bacon is his favorite food, so he didn't bother much about getting a part from a pig. Perhaps after six months of showing that he can follow the doctor's instructions, he will be the best candidate for a heart transplant, and the pig's heart will only serve as a bridge.

"The last night I talked to the patient, he said, 'I really want to have a human heart,'" said Dr. Bartley Griffith, who directed the department of surgery at the University of Maryland Medical Center. “I said, 'I want you to have a human heart.' We'd go crazy if we took out that sweet (pig) heart, but it would be your choice."

According to Griffith, the hardest part about conducting such an experimental operation is talking to Bennett ahead of time.

“You’re not afraid to demonstrate to the FDA, the hospital, your boss and your partners that you’re ready because you are confident in yourself,” he said. "I think fear is about being honest with your patient."

The operation was experimental and the outcome was unknown.

"You have to tell the patient that, essentially, we're ready to go," Griffith said, adding that others have compared him to a shuttle astronaut. “But I constantly reminded people: we are in the control room.” This patient is going to the moon."

Three experiments in one

For years, researchers in Maryland and elsewhere have experimented with implanting genetically edited pig organs into baboons.

A team at the University of Maryland Medical, led by Dr.Muhammad Mohiuddin, kept the baboons alive for nine months until they died from something other than immune rejection. They felt ready to try the procedure on a human.

Dr. Muhammad Mohiuddin is in charge of the heart xenotransplant program at the University of Maryland School of Medicine.

Caring for a patient is "much easier than caring for a baboon," says Mohiuddin, head of the heart xenotransplant program at the University of Maryland School of Medicine.

The procedure required the right patient - a volunteer with no other treatment options, as well as support from the hospital system and three separate FDA approvals. The hospital and educational institution did not disclose the cost of the procedure, but took all the fees not covered by insurance.

The trial began on December 15, when Bennett agreed to review the procedure. Maryland officials struggled to file an application with the FDA on December 20, requesting a permit.

Then they had to answer many questions, including about the pig.

The pig, provided by Blacksburg, Virginia, by Revivicor, which raises pigs for transplantation, was genetically modified in 10 different locations before birth.

“A pig has 100 genes,” Griffith said on a Jan. 000 afternoon with Mohiuddin. “Muhammad wants me to believe that by changing 9 of them, we can transplant a pig’s heart into a human.” Are you kidding?"

“You did it,” Mohiuddin replied laughing.

Three genes were disabled that would otherwise cause immediate immune rejection - recognition of a pig's organ as belonging to a different species. Six human genes have been added to prevent blood clotting in the heart, improve molecular compatibility, and reduce the risk of rejection.

One last gene was turned off to prevent the pig from growing too big.

David Ayares, executive vice president of Revivicor and chief scientist, said the one-year-old pig that gave its heart to Bennett weighed about 108 kg; a standard male pig of the same age can weigh 204 kg.

Scientists have learned from baboon research that without editing this growth gene, even an organ taken from a young animal will continue to grow. In a couple of baboons, the transplanted pig hearts became too large for their breasts.

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“We've been down this path over the past decade, going from pig with one gene to pig with two, to five, to eight to 10, and we've rationalized each and made modifications along the way,” Ayares said.

For two decades, Ayares worked to create pigs suitable for human transplantation. Pigs bred to obtain kidneys for transplant may only need to turn off one gene to avoid immediate organ rejection. Pigs bred for the heart probably need 10 to function efficiently and safely, Ayares said.

Revivicor's parent company, United Therapeutics, is looking to pursue lung transplants from pigs to humans, Ayares said. These pigs are likely to require "at least as many" gene changes.

The second innovative aspect of the operation is the use of an immunosuppressive drug, which is essential for the long-term survival of the transplanted organ. The researchers used a version designed for baboons, but this was the first time a humanized version was used in humans.

The third aspect was the box in which the heart was placed after taking it from the pig. The researchers found that simply placing the heart on ice, as is done with the human heart, does not work for transplant between species. A German team has come up with a method to fill the heart with nutrients and hormones.

“In primates, hearts just didn’t work until they started using this pump,” said New York University’s Montgomery. “Nobody understands why.”

Bruno Reichart, a retired German heart transplant surgeon who has been testing pig hearts in baboons for years, said he believed a pig's heart probably works better if fluid is constantly flowing through it. But in essence, the proof is that it works.

“He who is successful is right, who is not successful is wrong. In surgery, there is no need for additional explanations, ”he said.

The FDA granted emergency clearance for the operation on New Years Eve, and it was performed on January 7 from approximately 8:30 am to 17:30 pm.

Before pig organs can be regularly used in transplant operations, all three aspects must be further tested on animals to meet FDA standards. Revivicor is building a pig farm that will meet FDA production requirements.

Ayares said he and the others are enjoying the moment.

“This is one of the most exciting things in my 20+ year xenocarre,” he said.

Ayares said that if they can provide an unlimited supply of organs, the transplant list is likely to grow by "orders of magnitude" as more people who are not on the verge of death begin to consider transplantation as an option.

“We have done so much work to this day,” Ayares said. "We are confident that this work will continue and lead to good results."

What does success look like?

Until now, no one has been able to save life with the help of a specially made animal organ. So any survival can be considered a success at all.

Montgomery said he believed the operation had already been successful.

“The critical point here is that we've taken this thing out of these endless primate operations,” he said. “Now we're going to get real data on people and really understand how it works.”

A professor at the University of Miami said he wouldn't give a pig kidney to a patient if he wasn't sure the person would live for at least a year.

“When we do this, we think we will get reasonable survival in the long run,” he said.

Reichart said he believed Bennett could live with a new heart indefinitely.

“I may be a little outdated, or maybe from another world, but I would estimate the success of the operation in at least a year,” he said. - Why shouldn’t the heart work for three years, five years? Let's see. That's part of the experience we're seeing now."

Reichart, CEO of XTransplant, which he founded to commercialize pig-to-human heart transplants, said he was concerned that Bennett was denied a transplant because he did not accept previous appointments.

“The patient has a great responsibility to other patients in the world to behave appropriately and take their medications,” Reichart said. “He got his chance first and everyone will be looking at the results.”

Surgeon Griffith said he was inspired by the efforts of many people to save Bennett and lay the groundwork for an animal-to-human transplant.

“It was nice to see people come together to save just one life,” he said. “They understand the meaning.”

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