Quick, name three things you last used your Igloo cooler for?
I’ll give you a second.
Maybe a party or picnic? Either way, you probably used it to carry food or drinks from one place to the next, right?
Here’s a better question: How many of you have transferred a human heart in one? Not in the creepy, black market way –in the perfectly legal, hospital to hospital kind of way?
For all of the technological advancements we see rising in our healthcare facilities every day, from da Vinci surgery machines to robots that disinfect rooms, hearts for transplantation have been transported the same way since Christiaan Banard successfully transplanted the first human heart in South Africa in 1967 with Perfadex, a potassium and cold storage solution, and an Igloo cooler.
While the cooler does what it is supposed to – lower the temperature of the heart to slow down the metabolic rate of the organ so that it can be transferred and transplanted – it comes with a slew of problems ranging from frostbite and uneven cooling to the inability to ensure an organ correctly meets the needs of the receiver in order to prevent rejection.
Altogether, these limitations mean that we still struggle to move organs beyond a four hour radius in any direction.
But not for long. University of Texas Health Science Center associate professors and Paragonix Technologies co-founders Leon Bunegin and Tom DeBrooke are working to make primitive cooler transportation of organs a thing of the past.
“Paragonix Technologies was founded in 2009 after I visited the UT Health Science Center and saw a presentation on the Sherpa Transport System delivered by its inventor Leon Bunegin,” DeBrooke told me as he, Leon, and I discussed the Sherpa over Tex-Mex at Blanco Café. “After we had the device reviewed by some of the biggest names in the field and they all said the same thing – it’s too good to be true – we decided to go for it.”
What makes the Sherpa so special?
First, the Sherpa (see top image) is the only organ transportation device to ever receive FDA approval and second, it has been approved for transportation up to eight hours, doubling the time frame in which we can transfer a heart.
“The ability to move a heart eight hours is important because it means we’ve finally successfully eliminated geography from the equation. We can now transport hearts from places like Hawaii back to the rest of the US. It really opens up a ton of new possibilities and doors,” DeBrooke said.
Imagine a situation in which a child in California needs a new heart but the only one available one is in New York. Before the Sherpa, there would be nothing doctors could do as the organ wouldn’t be able to last the flight. Now, transplant specialists not only have the time to deliver the organ, they have the time to make sure it’s done properly.
“Previously, doctors might have to face the decision on whether to use an organ that has passed the 4 hour threshold or suffered damage in transit,” DeBrooke said. “When it comes to a choice between someone dying or taking a risk, the decision is a no-brainer: You put the organ in and hope for the best. With the Sherpa, though, this scenario will never even arise.”
Like the cooler which relies on slowing down the organ’s rate of metabolism, the Sherpa reduces the temperature of the organ to between 4 – 8 degrees centigrade (39.2 – 46.4 degrees Fahrenheit). Unlike the cooler, though, the Sherpa is capable of maintaining this temperature with the added bonus that the perfusion model also pumps oxygen through it. This keeps the heart in much better shape and dramatically increases the likelihood that the organ will take upon transplantation.
“This extra time is huge. There is a common misconception that we can just take a heart out of one person and give it to another, but that just isn’t the case,” Bunegin said. “The problem is that there are 26 different antigens that have to line up for a heart to be perfectly suited for the recipient. Right now, with the current 4 hour window, we only have enough time to test for around 6 matches and if those six line up, we transplant the heart.”
While a heart with six matching antigens can still work in a recipient, it requires a much larger quantity of anti-rejection medication in order to ensure the organ takes. With the extra time, we can run more tests and determine even stronger matches before we send the organ off for transplantation.
DeBrooke said even beyond ensuring more properly matched organs, once the Sherpa Perfusion model receives its final FDA approval in the last quarter of 2014 and begins to hit the market, there could be an increase in the number of heart transplants.
“In the first year alone, (if Sherpa is widely adopted) we will be able to double the number of performed heart transplants,” DeBrooke said. “Roughly 2,300-2,500 transplants are performed each year in the U.S., so a doubling would only bring you to 5,000. That might not sound like a big number, but from a patient care perspective, it’s huge. The economic cost in the heart failure space is about $35 billion a year. So if we can begin to really increase the number of people receiving transplants, we can increase quality of life while reducing the financial burden of the sector.”
And because the Sherpa is comprised of common materials, he said the future cost of mass production might even rival the cooler.
While the oxygen perfusion version of the Sherpa is expected to receive FDA approval for eight hour storage later this year, Bunegin said that lab tests are beginning to demonstrate that organs in the Sherpa might be able to last up to 24 hours or beyond without showing signs of damage.
“If that’s true,” DeBrooke added, “Then Leon really deserves a Nobel Prize for this work. “He’s changed the game. People who would have died will now live because of the Sherpa.”
People often throw around the term “lifesaving invention,” but if there was ever an opportunity to use it, now is the time. The Sherpa, as Debrooke said, might really become a game changer.
*Featured/top image: Rendering of the Paragonix Sherpa Organ Transport System. Courtesy image.