The doctors said there was no hope. Alex Anaya was just 29, yet a weakened blood vessel had ruptured in his brain, and surgeons couldn’t save him.
Family members decided that he should be removed from a ventilator, and they gathered at Thomas Jefferson University Hospital to say goodbye. His heart would keep beating for a while on its own, but soon he would die.
Then the family was approached by a coordinator from Gift of Life, a nonprofit that arranges organ transplants in the Philadelphia region. She told them, gently, that it might be possible to restart Anaya’s heart and save someone else. But it would require the use of a new device to “perfuse” the organ with a warm solution of nutrients and oxygenated blood, allowing it to beat outside his body until it was time for the transplant.
They immediately agreed. Courtnee Porter, Anaya’s longtime girlfriend and the mother of his son, had worked as an administrator in a transplant program, and she knew that thousands of gravely ill people spend years on organ waiting lists. Five years earlier, Anaya’s father had been one of them, hoping for a new liver, but he died before one became available.
“It’s personal for us,” Porter said.
More than 50 years after the first human heart transplant, U.S. surgeons have become very good at the delicate procedure, regularly performing more than 3,000 a year. Nine out of 10 recipients survive for at least one year, and many live more than a decade with their new organs.
The problem is one of supply. More than 200 people each year die while waiting for a donor heart, and an additional 300 are removed from the waiting list because they have grown too sick to tolerate the surgery.
The device used to preserve Anaya’s heart could help, potentially increasing the number of donor hearts by up to 30%, said Richard Hasz, vice president of clinical services at Gift of Life, which serves eastern Pennsylvania, southern New Jersey, and Delaware.
Some cardiologists are reserving judgment on how well the technology works, even as the manufacturer, Andover, Mass.-based TransMedics Inc., has applied for approval from the U.S. Food and Drug Administration. In April, an FDA advisory panel voted 12 to 5 that the device’s apparent benefits outweighed any risks to the recipient, and 10 to 6 that it was effective. A decision is expected later this year. A similar device already is approved for use with donor lungs.
More on the medical evidence below, but first, the key reason for the heart shortage: The vast majority of people, even if they check that box on their driver’s licenses, will not be eligible to donate their hearts. In order for the organ to be usable, the donor has to die in the right way.
Generally, the person must be declared “brain-dead” — lacking any brain function — yet still connected to a ventilator, so the heart continues to beat up until the moment it is removed and preserved in cold storage, whisked off to the transplant center in a cooler like the ones on medical TV shows. Most people don’t die that way. And even among those who do, many have heart disease or damage of some sort, and the organ is not medically suitable for donation.
In cases such as Anaya’s, where the patient retains a small degree of brain function after a traumatic injury but there is no hope of recovery, the heart may beat for a while after the ventilator is removed. But with a dwindling supply of oxygen, the organ’s function declines, and the tissue starts to decay. Before long, it is not healthy enough to transplant.
That’s where the TransMedics device comes in. If the heart stops and the patient is declared dead within a half hour once the ventilator is removed, it is recovered from the donor’s body and connected to the device. A pump circulates oxygenated blood and nutrients through the heart at 93 degrees, near body temperature, causing it to restart. In addition to preserving the heart while it beats, for up to 12 hours in some cases, the device also allows physicians to test its function, determining whether it is suitable for transplant.
At first, the transplant coordinator did not burden Anaya’s family members with all the technical details. They needed time to grieve. He had seemed to be in perfect health when late one night, early in the COVID-19 pandemic, he started to throw up.
Porter, who was pregnant with the couple’s daughter and mother of Anaya’s son, Alexander Jr., wondered if he was infected with the coronavirus. He thought it was just food poisoning. But when he began to have trouble speaking, Porter called for an ambulance at their home in Frankford.
At Jefferson Frankford Hospital, emergency physicians discovered bleeding in his brain. There was no way of knowing when or why, but at some point a weak spot — an aneurysm — had formed in an artery, and that night it had ruptured. Ruptured brain aneurysms occur in 30,000 people a year, though they are more common in people decades older than Anaya.
He was soon taken to Jefferson’s flagship hospital in Center City, where surgeons tried removing a piece of his skull to relieve the pressure. But it was too late.
His mother, Sonia Torres, flew from Orlando to join Porter and Anaya’s sister, Jary Anaya, at his bedside.
They recalled his boundless energy. How he liked to skip rocks in a stream and chase after the dog with his son, now 12. The hours he spent in the kitchen, grating plantains to make pasteles and other treats from his Puerto Rican heritage, yet never adding a pound to his skinny 5-foot-9 frame. His commitment to his job as long-haul trucker, and how he’d drive home after a trip to spend three hours with the family before his next route, even if it meant staying up 24 hours in a row.
That spirit, they agreed, should live on in someone else.
When the advisory panel met in April to review the results for hearts that had been preserved with the TransMedics device, there were lots of questions.
Panel member John Hirshfeld, a cardiologist and professor emeritus at the University of Pennsylvania’s Perelman School of Medicine, had concerns about a substance called lactate.
He warned that lactate levels were high in some of the preserved hearts, a sign that they were not getting enough oxygen. (Sometimes called lactic acid, the same substance can build up in the muscles after strenuous exercise.)
Company scientists countered that higher-than-normal lactate was not a cause for concern so long as the level was stable. In one trial of 93 donor hearts preserved on the device, 18 were rejected by surgeons in part because lactate levels were rising. But with the remaining 75 hearts that were transplanted, results were promising, with 84% of recipients alive after one year — close to the success rate for hearts preserved the usual way.
Hirshfeld was unconvinced. He voted that the device appeared safe, but he voted “no” on the question of whether it was effective, arguing that some people on the waitlist might fare better if they held out for a healthier donor organ.
“Almost all the hearts were producing lactate” on the device, he said in an interview later. “To me, that means there’s something about the way the machine is supporting the heart that is not right. It’s alive. It’s beating. But it’s not metabolically happy.”
Others find the evidence encouraging. Among them is Yoshiya Toyoda, a Temple University Hospital transplant surgeon who was not on the FDA panel but has used the TransMedics device in a previous trial, when he was working at UPMC in Pittsburgh.
He agreed that hearts preserved with the device might not always function as well as hearts preserved the usual way, on ice. But if not for the technology, hearts such as Anaya’s would, in most cases, be discarded, he said. And the device allows such hearts to be tested while beating — not an option with the traditional cold-storage route.
“With this machine we can test the heart’s function,” he said. “So if we think heart function is good enough for transplant, we can proceed.”
Anaya’s heart was deemed healthy once it was placed on the machine. On a waitlist outside the Philadelphia area, a potential recipient was identified, based on a matching blood type and tissue type, and the organ was on its way.
What’s more, his other organs (which are easier to preserve than the heart) were found to be in good shape. All told, with his lungs, liver, kidneys, and heart, Anaya would save five lives.
Donor families are not told details about recipients, in order to protect patient privacy. But more than a year after Anaya’s heart was preserved and transplanted, officials at Gift of Life confirm that the recipient is still alive.
Torres, his mother, finds comfort in that fact.
“His heart is still beating,” she said. “It seems like he’s still alive.”