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Your Healthy Family: FDA approves game changing heart transplant device

Posted at 9:31 AM, May 26, 2022
and last updated 2022-05-26 11:32:21-04

MINNEAPOLIS, MN — The list of Americans in need of a heart transplant has grown longer and longer each year, with advancements in transplantation failing to keep pace with need.

But the FDA has now approved a device that could help shift that balance, thanks to several years of important research, and patients willing to try.

Each year at M Health Fairview University of Minnesota Medical Center in Minneapolis, there are an average of 30 heart transplants.

On June 9, 2021, Bob Halfpop's number was called.

"I was on a transplant list for about a year and a half," Halfpop said. "I knew eventually it would be coming, but I just didn't know when. And then, all of a sudden, I got the call and I was kind of shocked."

What he didn't realize until after his surgery is that he had some help beating the odds, thanks to a device known simply as a "heart in a box."

"I've seen clips of it," Halfpop said. "It's phenomenal. It's actually great."

Today, he continues to be surprised. His recovery has moved faster than he had imagined. He's back to work in Belmond, Iowa, driving truck full time.

And in the time since, the device that helped give him a second chance, has received critical approval from the FDA.

The device, called the OCS Heart System, made by TransMedics, has been studied by a number of transplant centers across the country for several years now.

"It's wild; very exciting and fascinating technology," said Dr. Andrew Shaffer, a cardiothoracic surgeon at the University of Minnesota Medical School and principal investigator on one of two big trials that looked at the effectiveness of the "heart in a box."

"We're a little bit limited in the amount of time that we can preserve a heart on ice," Dr. Shaffer said. "But this technology, it actually pumps warm blood - like your body normally pumps. What it means, practically, is that an organ will function better than if it were to sit on ice for an extra half an hour or an hour."

Back in 2017, KARE 11 spoke to Dr. Ken Liao, who was director of the transplant program at the University of Minnesota Medical School, about an early trial showing how the technology offered hope in circumstances where long trips or complicated procedures made typical organ preservation unlikely.

"This has been a totally revolutionary change," Dr. Liao said.

In the years since, Dr. Shaffer says the added time has opened new possibilities.

Dr. Shaffer: "It allows us to travel further distances than where we normally fly to (to retrieve a heart). It also allows us - on the back end of things - if we have a more complicated recipient surgery to work through."

Kent Erdahl: "What does a little bit more time mean for you?"

Dr. Shaffer: "It can be life or death for the recipient."

Dr. Shaffer has since acted as principal investigator for a second trial of the device, which showed how it can also expand options for donors.

He says it now makes it possible for patients to donate their heart even if their hearts stop before life support is pulled.

"We're actually able to rapidly open the chest and put the heart on the device," he said. "It can restart the heart... resuscitate it."

Dr. Shaffer says that could mean up to a 20-30% increase in the the donor pool as the device now becomes more widely available. That would mean the world to an entire pool of potential recipients.

"To me, it means a lot," Halfpop said. "It could help out a lot of other people who need it. I know they're patiently waiting."

Though he may already be back on the road, Halfpop says his heart is with everyone whose number has yet to be called.

"I got my second chance and I'm making the best of it," he said.

The "heart in a box" is made by a company called Trans Medics, which is based in Massachusetts, but the University of Minnesota wasn't the only local connection. The Minneapolis Heart Institute Foundation also joined in the national trials that led to its approval.