By Matt Phillion
The American Society for Artificial Internal Organs recently published new data in its ASAIO Journal from a study comparing hospital costs and clinical outcomes among heart transplant patients. Specifically, the study compared patients who received heart transplants preserved with Paragonix’s SherpaPak versus the common practice of consumer coolers with ice. The study found the SherpaPak method netted an average cost reduction of $26,700 per heart transplantation, due to less time spent in the hospital and less time spent on mechanical circulatory support in the ICU.
“Transplant medicine is a really special area, not only because of medical and clinical challenges, but also logistical challenges,” says Lisa Anderson, PhD, CEO, president, and founder of Paragonix. “For a transplant to happen, you have to have access to the organ, recover it, bring it back to the patient waiting for the organ. This added logistical component has really slowed down innovation.”
She continues, “When I was first exposed to the issues in transplants, I wanted to understand them and traveled around with transplant teams. What I saw was this space needed a new solution desperately, but that solution couldn’t be more difficult or challenging to use than the current standard of care.”
That standard of care was inherently simple: a chest filled with crushed ice, housing a sterile plastic bag that contains the organ. “It’s literally that,” says Anderson. “Now you’ve got to think about all the logistical issues. You’re competing against a medium, ice, that’s readily available during travel. How do you come up with a high-tech solution that is easier to use, doesn’t take more time, and fits into the logistics process of donation and transplantation?”
The barrier to devising a new solution, Anderson says, is that transplants already involve a virtuosic level of logistics. There are so many moving pieces that any additional complexity will make adoption of a new technology even less likely.
Other attempts at improving this space have “overthought the problem,” says Anderson. “These were highly complicated, big pieces of technology that you can’t use in the middle of the night” when they’re needed quickly. To improve upon something as simple as the industry’s current standard, a replacement process would need to be intuitive, easy to use, and repeatable across the country.
The simplicity would have to carry over into onboarding, as well. The SherpaPak requires only a brief training session to get staff up and running. “There’s no room for complexity,” says Anderson.
Providing more data on the go
New technology could introduce a key component to the old process of organ transport: a platform enabling all of the stakeholders across the continuum of the process to communicate in a compliant, safe manner.
Naturally, the team members traveling with the organ need data about the organ itself, ensuring the transport medium is stable. But other stakeholders at both ends of the journey can also benefit from being tuned in.
“We aimed to give them the opportunity to have eyes on the environmental conditions of the state of the procedure, the organ—not only [for] the clinicians going out to retrieve the organ, but also the clinicians at the transplant center preparing for the procedure,” says Anderson. “We’re able to really provide deep insights into the process, all the clinical milestones.”
This includes geolocation data for the organ and team, temperature, estimated times of arrival, notifications in the event of a delay, and the opportunity for all stakeholders to communicate on a HIPAA-compliant platform. “The process several hours before surgery would otherwise require hundreds of text messages or phone calls, and this brings them onto a platform so all stakeholders are informed and have the information they need,” says Anderson.
Improved outcomes after transplant
The clinical data in the ASAIO Journal study shows that patients are experiencing better outcomes with the use of the SherpaPak. So what leads to this improved experience? “We’re all geared toward making sure patients have fewer complications after the transplant, have longer lives, and make sure that the organs provide the longest possible life-sustaining function,” says Anderson.
During Paragonix’s research, it would ask clinicians what they’d like to see in an organ preservation device, and clinicians would provide a laundry list of features in response, notes Anderson. But rather than try to address every problem on that massive list, Paragonix narrowed down the focus to getting one feature right: optimal temperature control for the organ.
“We knew one thing for sure: When we launched our product, we were going to collect as much data as possible. This is a space that involves highly complex, multifactor outcome surgeries. And transplant surgery patients are often very sick, facing variables you don’t see in other surgeries,” says Anderson. “There are donor factors, recipient factors, organ factors. We knew we had to collect as much data as possible to get to the value proposition, and it didn’t take very long to show our hypothesis was right: With better preservation, these patients needed less support and postoperative care than other methods.”
Paragonix wanted to be able to show, with clinical evidence, that the transport method greatly affected the end results of the transplant. “Early pioneers all look at something and say, ‘Does this make sense? Is it safe? Let’s start using it,’ ” says Anderson. “But they also needed to see the data.”
Healthcare organizations are considering how the SherpaPak might enable them to offer more transplants to patients. “Centers are adopting us not for specific procedures but as a standard of care. They consider how to improve outcomes, travel further safely, and impact their volume in a positive way,” says Anderson. “It enables them to help more patients on the waitlist.”
While its work started with heart transplants, Paragonix also offers a lung transportation product and is in the early phases of a liver product launch. The company is working toward kidneys in 2023 and also has pancreas transplants on its road map. “We really want to make this a solution that is broadly adopted for all five organ systems,” she says. “We’re trying to improve efficiency to contribute to providing a service to transplant centers so they can offload some of the additional activities they have to do to get the organ.”
Right now, there’s a lot of activity around the clinical teams sent out to the donation site to retrieve the organ. “It’s a very resource-intensive activity,” says Anderson. “They have to put a clinical team on a private jet [and] fly them to the location, where they’ll be for several hours and then head back. We’re trying to improve efficiencies for the transplant center as an end-to-end solution. If you have an organ requirement, let us organize the team, the supplies, the transport, and then deliver the organ to your OR at the center.”
This enables the clinicians involved to practice at the top of their license more often, explains Anderson. “Transplant clinicians don’t want to spend hours on private charter. They want to transplant the organ into their patient. If we can take the heavy lifting off their shoulders, we can contribute to their efficiency.”
All of this leads toward better accessibility for transplantable organs, Anderson explains. “We’re seeing great data from centers using our device in combination with specific surgical techniques to tap into new donor pools,” she says. “We believe that this combination of surgical techniques and our process can add an additional 30% to the number of transplants in the U.S. If our technology can help increase the utilization of organs, we can increase the total number of transplants.”
Right now, only three of 10 hearts available are used because of challenges like logistics and geography. “If we can contribute to raising that number, that’s a feather in our cap,” says Anderson.
Matt Phillion is a freelance writer covering healthcare, cybersecurity, and more. He can be reached at firstname.lastname@example.org.