The SherpaPak Cardiac Transport System looks little more than a lightweight white box on wheels, but it just might save your life. Developed by medical technology company Paragonix, the SherpaPak may well revolutionize the future of heart transplantation.
It’s not just the surgeries to extract and implant donor hearts that are tricky – the simple logistics of transporting a heart are a race against time. It is best to limit the time the organ spends outside the body to less than four hours, as donor hearts are unlikely to be viable again once they hit the six hour mark. It’s not a lot of time to harvest an organ, get it to the recipient, and perform complicated surgery. In addition, a myriad of disorders can arise that can make a donor’s heart non-viable even before it reaches its destination.
The SherpaPak aims to overcome these obstacles by extending the length of time that hearts can be in transit and by giving clinical teams full monitoring of the organ’s condition. A recent case report at Stanford University found that the heart could easily survive outside the body in the SherpaPak for five and a half hours. Medical device network met with Paragonix CEO Dr. Lisa Anderson to learn more about the development of the device and the implications for the field of transplantation.
Chloe Kent: What sets SherpaPak apart from conventional organ transplant systems?
Lisa Anderson: SherpaPak and the technology we use in this product are innovative because they drastically change the way organs are preserved. It deviates from the current standard, but it is still based on clinically proven and scientifically validated organ preservation methods.
What is really important to stress about the technology is that the clinical team, for the first time, has full control of the organ environment during the transport period, through control and precise temperature monitoring that the product provides. The environment of a donor heart placed in an igloo cooler is extremely difficult to control. You cannot monitor the condition of the donor’s heart during transport. Technology has made a process that was previously out of control or out of control now completely controllable and safe.
CK: How exactly does the technology work?
THE: From a technical standpoint, it is a precision temperature device that continuously reads, monitors and reports the donor’s heart environment. We are aiming for a very narrow temperature range between 4 Â° C and 8 Â° C. If you place the heart in ice in an igloo cooler, the temperature quickly reaches freezing point, causing injury to the donor heart. By increasing the temperature to 4 Â° C and 8 Â° C, which remains a very safe hypothermic interval, we ensure that the donor’s heart suffers less or no injury during transport.
What is also important in transporting a donor heart is that the whole organ is cooled evenly, so that the whole organ is at the same temperature. This is not possible in an igloo cooler with current methods. With our device, the donor’s heart benefits from a perfectly homogeneous cooling, as it is placed in a series of sterile boxes and managed inside the box thanks to a cannulation mechanism and the exclusive suspension mechanism.
What’s also great is that the device is Bluetooth enabled and paired with a mobile app. All information continuously collected during transport can be transmitted, not just to the user standing right next to the device – through our app we can also report this information to the hospital. Organ donation and transplantation involves a lot of travel, so it is very important for surgeons waiting for the donor’s heart at the receiving hospital to know how the heart is doing and how far it is, and what were the main stages of the samples. We are able to report all this information remotely.
CK: How can this technology help address the challenges caused by organ donor shortages?
THE: In order to make more donor organs available, you really need to be more aware of organ donation. But this technology ensures that the use of these organs is maximized.
When a surgeon serves a patient on the waiting list and examines available donor hearts, lungs or livers, there are a host of factors that are taken into account. One of them for example is time: how long do I have to bring this organ safely back to the transplant center? With optimized conservation, these decisions are made differently. You can be assured that this organ will come back safely and give the patient the desired result, which will certainly help increase the use of donor organs.
CK: Why this shortage of organ donors in the first place?
THE: The waiting list for patients in need of a donor organ has grown rapidly in recent decades. Hundreds of thousands of patients are currently waiting for an organ, but only a few will receive one. The process of donating from a donor is complicated and the medical situation almost has to be perfect for a donation to take place. The donor needs to be handled appropriately, and then the donor’s family needs to make the decision to give this gift of life from their loved one to another human being. I always say that the result of donation and transplantation is actually a miracle. Each of these cases is a masterpiece in terms of collaboration between different hospitals and clinical teams, and of course the altruism of a family of donors to provide these organs.
CK: You are currently working with the University of Nebraska on a project concerning donation after circulatory death (DCD). Can you tell me about the collaboration?
THE: It’s a very exciting collaboration. There is a method called normothermic regional perfusion where donors that could not be used for a heart transplant are now tapped. They do this by resuscitating a donor’s heart using very precise surgical and medical protocols.
Our collaboration with the University of Nebraska is so exciting because this method was previously limited to local donations. The donor’s heart is injured in circulatory death by a process called hot ischemia, which means that the heart does not receive oxygenated blood, which is why these hearts have generally not been used. Thanks to the combination of this incredible surgical technique and the perfect preservation environment provided by our product, it is now possible to expand beyond the local area. We believe this will certainly increase the donor pool over the next few years. With the announcement of this collaboration, we have received many inquiries from other hospitals that are currently implementing similar programs as they really see that DCD could provide more donor hearts to patients on the waiting list.
CK: What is the cost-benefit analysis of SherpaPak?
THE: We used our clinical data to perform a comprehensive economic analysis and the SherpaPak, just in postoperative care between transplant and discharge, saves over $ 20,000 per patient.
CK: Is SherpaPak viable under all transplant circumstances?
THE: We are truly proud to support the pediatric heart transplant community as well as adult patients. We are one of the few medical device companies to ensure that our technology is also available to the pediatric patient population. There is nothing more precious than a pediatric donor heart and it is incredibly gratifying that our products are in the hands of pediatric surgeons who use them for small children receiving heart transplants. This is something that we will continue with all other products as well.
CK: What does next year look like for Paragonix?
THE: We have an exciting year ahead of us. By the end of this year, we will be serving 45 transplant centers with our products, so we are incredibly affected by the interest and rapid adoption of this technology. We currently support one of the largest clinical databases, specifically examining heart preservation, lung preservation, and results related to our products. As we move into 2022, we will be releasing data from these global registries, showing dramatic improvements in postoperative outcomes when our products are used. Specifically, reducing what is called primary graft dysfunction, when the heart fails to maintain its function after implantation.
We are also in the middle of our commercial launch for a new product called LIVERguard. Livers are also very susceptible to cold injuries and we believe that with our product we can avoid much of the damage these organs suffered during transport. So new products, new clinical data, and we’re hoping to show those two things at some of the in-person conferences in the coming year.