UW Medicine is one of seven sites nationwide where doctors will test a new device that keeps organs warm and beating during transport, potentially boosting the number of usable organs for patients in need of transplants.
Dr. Jason Smith paused at the tower of plastic Igloo ice chests stacked in a corner at the UW Medicine Regional Heart Center in Seattle.
“This is how we do it now,” said the 43-year-old cardiothoracic surgeon and heart-transplant expert at the University of Washington School of Medicine.
For years, the ordinary picnic coolers have been the only way to get scarce hearts from deceased donors to waiting recipients hundreds of miles away. The organs are chilled, then hustled to an operating room within no more than four hours.
But that may be about to change, thanks to a device dubbed the “heart in a box,” which keeps the organs warm and beating during transport.
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UW is one of seven sites selected nationwide to conduct a clinical trial of the Organ Care System, or OCS Heart platform, a device manufactured by TransMedics Inc. of Andover, Mass., which Smith and other experts say could revolutionize the protocol for heart transplants.
Only about one in every three hearts donated for transplant is accepted, even as 4,200 people nationwide are waiting for the lifesaving operations, a recent Stanford University study found. Nearly 400 people in the U.S.— 94 in Washington state — died last year waiting for hearts, according the Organ Procurement and Transplantation Network (OPTN).
The OCS platform could boost the number of usable hearts by allowing the organs to remain outside the body longer, giving doctors more time to evaluate and transport them, Smith said.
“Having an alternative system that doesn’t rely on cold storage — the opportunity is huge,” he said.
UW is part of the International EXPANDHeart Pivotal trial aimed at testing the effectiveness of the OCS device in recruiting, preserving and assessing hearts that don’t meet standard criteria for donation. They may be from patients who are older or sicker than the accepted norm, Smith said.
About 75 patients are expected to be enrolled in the two-year trial from hospitals in California, North Carolina, Michigan and Minnesota, as well as the UW, according to the federal listing.
Smith said he worked for three years to get the UW included in the trial, arguing that the geography of the Pacific Northwest, with long distances between transplant centers, made it an ideal location for the tests.
The UW site is already up and running, with the OCS, a battery-powered unit about the size of a dishwasher, ready for use. It works by pumping near-body-temperature blood and preservatives into hearts recently removed from donor patients, keeping the organs functioning inside a clear chamber.
“This is the first time we’ve had a system that can monitor the heart outside the body,” he said.
So far, the longest time TransMedics officials have preserved and transported a heart is 11 hours, nearly triple the time allowed with cold storage, Smith said.
With the OCS, donor hearts easily can be retrieved from Hawaii, for instance, where there’s no transplant center and viable hearts now go to waste, Smith said. UW docs could obtain hearts from as far as Boston or Florida, he added.
The first call to use the OCS in the new trial could come at any time. On Monday, UW doctors were waiting to hear about a potential donor in Alaska, but there was still no word as of late Tuesday.
“We’re ready to go,” Smith said.
The OCS Heart system is still being tested. Results of a preliminary trial published in the journal The Lancet in April showed that the device is at least as safe and effective as the current standard of care in preserving standard donor hearts for transplant. TransMedics is awaiting FDA approval for a larger clinical trial of standard hearts.
For now, the organs will come from donors who’ve been declared brain-dead, but still have functioning hearts, Smith said. The OCS has been used successfully in Europe in a patient whose heart had stopped beating in his body. The organ was retrieved from the donor and restarted in a recipient, TransMedics officials reported.
Donation of hearts after cardiac death remains controversial in the U.S., however. The biggest hurdle is persuading transplant surgeons to use hearts that have undergone cardiac arrest, Smith said.
“Cardiac arrest does not mean the organ is not salvageable,” he said.
In addition to the expanded transport time, the OCS Heart device could allow wider use of hearts previously regarded as marginal, said Dr. Kiran Khush, a Stanford cardiologist who authored the recent paper on refusals of donor hearts.
After brain death, the body floods the heart with hormones that leave the organ “stunned,” she said. With time, many of the organs can recover, but doctors often can’t wait 12 to 24 hours to see if the function improves.
“Those hearts don’t end up being used. The hope is by keeping the heart beating and perfused on the Organ Care System, we may have more time to use marginal hearts.”
The biggest drawback for the OCS Heart device may be cost, Khush added. The cart itself is $250,000 and the disposable cartridges cost about $45,000 apiece.
Both she and Smith said the expense means that even if the device is approved for wide use, it will be reserved for the farthest-flung organs.
For the 86 people waiting for heart transplants in Washington, that’s a boon, said Kevin O’Connor, president and chief executive of LifeCenter Northwest, the region’s organ procurement organization.
“I think what it will mean for people on the waiting list is that the pool of hearts available will be larger exponentially,” he said.
That’s good news for Dr. John Gill, a 69-year-old retired internist in Wenatchee who was diagnosed in 2012 with cardiac sarcoidosis, a rare disease in which clusters of white blood cells form in the tissue of the heart.
He’s been on the regional heart-transplant list for 17 months and was eager to volunteer for the OCS trial while still remaining eligible for a standard transplant.
“I think it’s a terrific idea,” he said. “This expands my horizons to 2,000 miles. I would take anything I can get. I would love to get one of those hearts.”