The Donor Heart Guardian – Use of SherpaPak™ CTS at Hospital Clínico, Valladolid, Spain

A group of clinicians transporting a donor heart protected with the Paraognix SherpaPak Cardiac Transport System at Hospital Clínico, Valladolid, Spain

Cambridge, Massachusetts — March 17, 2020 – As the days went by, his heartbeat was slowly fading. His condition was terminal. From home to hospital and from hospital to home. Something was wrong with his heart. If he did not get a transplant soon, the doctors gave him a week to live. Time was running out, and all that was left was hope. The heart finally arrived. It came from a traffic accident involving a young couple.

One of the key parts in donor heart transportation is keeping the heart cold to minimize damage in transit and reduce cell metabolism due to the cooling. The traditional system involved placing it in a preservation solution and applying ice. It is an economical option, and one that used to work well.

However, innovative technologies have been developed and clinicians now are able to use  much more modern preservation systems in which the heart is placed in a protective solution and the temperature both inside and outside the storage container is monitored. This “improves preservation quality,” and a graph provides data continuously during the transport procedure. 

With this breakthrough in mind, the Heart Surgery Department at Hospital Clínico Universitario de Valladolid decided to go one step further. It became the first hospital outside the Community of Madrid—second only to the Puerta de Hierro Hospital and 12 de Octubre hospitals—to opt for this method. They have already successfully used it in three transplants.

“The heart’s temperature, and the possibility of it rising again, is what we worry about most, because it has a major impact on the heart’s function, that is, how it will contract once it has been implanted in the recipient,” explains Dr. Juan Bustamante, who is in charge of transplantation department. He says that if the heart is not kept in good conditions there is a risk of what is known as primary graft dysfunction, which means that it does not effectively perform in the recipient.

This, as he puts it, “is a major and serious complication” that is “significantly” reduced through the use of the innovative technology. Paragonix SherpaPak™ CTS—as it is called—is the first device to provide temperature and pressure control in a sterile environment for hearts traveling between operating rooms, which increases the likelihood of a successful transplant. “It has been designed to be easy to use in stressful scenarios.”

It is based on cold preservation techniques using a “novel” heart-suspension system that provides the physical and thermal protection that used to be lacking in the conventional ice cooler storage method. “The heart is suspended from the aorta and has no contact whatsoever with any surface. This is extremely important, because, in transit, it will be maintained at a temperature of between 5 and 7 degrees Celsius,” explains the head of the Cardiac Surgery Department at Hospital Clínico.

In his opinion, this is what makes the project innovative for the more than 6,000 heart transplants that are performed a year worldwide. Over the last five decades, heart transplant technology and transport systems have remained virtually unchanged. They have been performed with a system that controls neither temperature nor pressure.

Now, as Dr. Bustamante states that donor heart preservation can now be performed using a disposable transportation system that provides the organ with an insulating and protecting layer; two transparent polycarbonate sterile canisters that are leak-proof to make sure that no fluid gets in or out, and a cooling material to maintain temperatures within a range of four to eight degrees Celsius.

“It protects hearts from the harmful temperature zones that sometimes occur using the traditional ice cooler method because of the heart’s proximity to the ice.” He adds that the system has a temperature sensor submerged in the storage solution, making it possible to monitor the exact temperature at all times and check that it was properly protected while in transit.

How? The tool used by Hospital Clínico de Valladolid monitors temperatures in real time and reports them every 30 seconds. It also generates reports that can be downloaded to a mobile device by Bluetooth for the purpose of data management and to improve health-care quality control.

In this regard, Dr. Bustamente says the key benefits observed in most hospitals all over the world is a reduction in the rate of primary graft dysfunction, a condition that involves the need to use ECMO, an external machine to provide the patient with oxygen while allowing time for the heart to recover.

He proudly says that Hospital Clínico is the third hospital in Spain to use the device and that it constitutes a “major breakthrough” in healthcare. Currently, the profile of transplant patients is “more complex,” calling not only for surgical technique and sub-specialization, but also for an improvement in the different points involved in the entire process. One such point is preserving the organ, which effectively stops beating for four hours. This is why he underlines the need to use a cold solution applied through the coronary arteries, called cardioplegia, which stops cardiac activity and protects the heart, although it is essential to keep the heart at the right temperature too.

If any of these factors are not fulfilled, the transplant is not always successful. Sometimes the situation is irreversible and the patient dies. To reduce the mortality rate, this team at Hospital Clínico studied the options of modifying certain parts of the transplant protocol, one of which was maintaining the heart’s temperature.

After several talks with European colleagues along the way, they discovered this new method, which calls for collaboration between the nursing, anesthesiology and cardiology departments. In fact, they intend to continue making advances to improve outcomes and to treat patients more successfully. They have already started to work with the Guardian Registry, managed by the Massachusetts General Hospital in Boston and AKH Vienna (Austria), which, as he points out, will enable this center in Valladolid to build considerable expertise in the heart donation and transplantation process.

Written by E. Lera. Originally published March 17, 2020 by Diario de Valladolid. Republished with permission

Paragonix Technologies, Inc
245 First Street, 18th Floor
Cambridge, Massachusetts 02142
info@paragonixtechnologies.com