TransMedics device keeps organs alive outside the body

Gentle waves lap over the sand of the Cornish coastline in England. Surfers enjoy the last bit of sun before nightfall. A cool breeze ripples through the tall grass.

It is a picturesque scene, right in Lee Hall’s backyard. But the 27-year-old husband and father has never really been able to enjoy it.

Hall has spent much of his life in hospitals. At age 2, he was diagnosed with leukemia. At age 14, he was referred to a specialist for his heart.

“They said basically the left side of your heart has collapsed,” Hall said. “It’s not working efficiently anymore…your heart is very enlarged, like a water balloon.”

The walls of Hall’s heart were too thin, and it was failing. His heart had to work even harder to pump blood through his body. Doctors at Harefield Hospital in London implanted a mechanical pump, but these devices are not typically long-term solutions. Hall would need a new heart.

A heart in a cooler?

“The current situation in the United Kingdom is that we have only very few hearts,” said Dr. Andre Simon, director of transplantation at Harefield. “You’re only transplanted when you’re on the urgent waiting list.”

In the UK, an aging population is leading to a shortage of suitable donor hearts. In an attempt to salvage more organs, Harefield looked to an experimental device from the United States.

Waleed Hassanein began his career as a heart surgeon. As a junior resident, he went on an organ retrieval — getting a donor heart for transplantation from another hospital. Hassanein was put in charge of a cooler. That’s when he realized just how rudimentary the transportation of this vital organ could be.

“It really upset me,” Hassanein said. “That, at the time, to become a cardiac surgeon, and still to this day, you need to spend 10-12 years in training. And I looked at this and said, from a selfish standpoint, that I’m going to spend 12 years of my life learning how to protect this organ, but when it comes to heart transplantation, which is the pinnacle of cardiac surgery, the heart is just going to be thrown in this [cooler].”

A box designed like a body

Hassanein left medicine to start a company called TransMedics. The aim is to change the way organs are preserved and delivered for transplant. The traditional way is cold storage — flushing the heart with a solution that drops its core temperature, and then putting it in a cooler on ice. This method can have limitations, due to organ decay, time, and distance of retrieval.

“We’re losing a lot of organs because of that time and distance limitation,” Hassanein said. “This is why a lot of organs go unutilized. In fact, we’re only utilizing two or three out of every ten organs, every year.”

To improve that, TransMedics developed a device called the Organ Care System (OCS). The machine is designed to replicate our human functions as closely as possible, by keeping the organs alive outside the body.

Seven hospitals in the U.S. are currently participating in a clinical trial of the OCS. Unlike the cold storage in a cooler, the heart is still warm in the device; it’s beating, and is being fed by a steady stream of oxygenated blood and nutrients. All the while, the organ’s vitals are being monitored.

“In the beginning, of course it was really trailblazing trying to convince transplant surgeons that cold is not your friend,” Hassanein said. “And actually, we can change things.”

From 4 to 12 hours

The Organ Care System is still experimental in the United States, but it is already approved for use in other countries, like Australia and the UK.

In London, Harefield Hospital now uses it for all their heart transplants — including Lee Hall. Last summer, Hall received a heart transplant. Dr. Simon was his surgeon.

“I think we will see a significant change in technique and technology,” Dr. Simon said. “The last step we’ve taken is we’ve now taken hearts from donors who have died from heart arrest. We have been able to take those hearts and restart them outside the body in the system, so that’s another revolutionary step.”

With cold storage, the heart is ideally transplanted in under four hours. It has a low tolerance to the cold because it has to function immediately under transplantation. In the OCS, the time window has tripled, leading to an increase in viable donor hearts.

For Lee Hall, it’s a second chance. Less than a year after his transplant, he’s still not 100 percent, and has frequent check-ups at Harefield. But he went from being on borrowed time to making long-term plans with his son.

“It did feel weird at first to know someone has passed away and given something to me to stay alive,” Hall said, “but without that person I wouldn’t be there now, so I thank them for changing my life.”

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