Chilling Choices - Heart Transplant Outcomes Using SherpaPak With Long Ischemic Time Versus Traditional Ice Storage With Short Ischemic Time

New, Open-Access ASAIO Journal Manuscript Compares Preservation Modalities Across Contrasting Ischemic Times

Access the available study online.

A recent clinical study published in the ASAIO Journal just last month delved into the effectiveness of the SherpaPak Cardiac Transport System under conditions involving longer ischemic times, compared to short ischemic times using traditional ice storage. With the potential to significantly reduce transplant waitlists and broaden access to life-saving donor hearts, this study shines a light on a critical step forward in the fight against organ shortages.

The Challenge of Traditional Ice Storage

For years, donor hearts have been preserved using ice storage, a method that cools the heart to slow its metabolism and reduce damage during transportation. However, ice storage has known risks. The uncontrolled temperature can lead to freezing and potentially cause damage to the heart’s tissue, leading to complications post-transplant. Some of the most significant risks include “primary graft dysfunction” (PGD) and right ventricular dysfunction (RVD), which occurs when the heart doesn’t function properly after the transplant.

Enter the SherpaPak Cardiac Transport System

The SherpaPak Cardiac Transport System (SCTS) is an advanced technology designed to preserve donor hearts in a controlled hypothermic environment, maintaining a more stable temperature range (4-8°C) and physically protecting the heart from external contact and damage. Keeping the heart at a controlled temperature aims to reduce the risks associated with ice storage and potentially extend the time a heart can safely be transported. In recent years, this has been shown to potentially influence the availability of viable donations – a critical need due to the ever-growing demand for donor hearts. There exists an untapped potential of accessible donations that could be transported over greater distances without sacrificing viability.

Key Findings from the Study

The study analyzed a subset of data from over 1,000 heart transplant patients in the GUARDIAN-Heart Registry, with a focus on two groups:

• ICE Group: Hearts transported with ischemic times of less than 3 hours.
• SCTS Group: Hearts transported with ischemic times greater than 4 hours.

Most notably, while the SCTS cohort had double the ischemic time and a significantly greater travel distance (765 miles vs. 82 miles for ICE), the clinical outcomes remained strikingly similar, and in some cases better, for the SCTS group.

• Primary Graft Dysfunction (PGD): There was no significant difference in the rates of PGD between the two groups despite the contrast in ischemic times.
• Mechanical Circulatory Support (MCS): The need for mechanical support after transplant, like ECMO or VAD, was similar in both groups.
• Inotrope scores and Right Ventricular Dysfunction (RVD): The SCTS group had significantly lower inotrope scores (which are associated with better heart function) and significantly less moderate and severe right ventricular dysfunction, which is a common post-transplant complication that can negatively impact patient care and outcomes. This was particularly notable given the longer ischemic times in the SCTS group.
• Survival and Length of Stay: There were no significant differences in 30-day survival rates or hospital length of stay between the groups.

Why It Matters

This study has important implications for heart transplantation. Traditionally, hearts transported with ischemic times over 4 hours were considered high-risk, but the data associated with the SherpaPak CTS has now shown a significant reduction in many of the complications typically associated with extended ischemia. In essence, using the SherpaPak CTS has been shown to protect donor hearts for a longer window of time, which could significantly increase the number of viable hearts available for transplant. Moreover, by increasing the number of hearts available for transplant, the SCTS can help to shorten wait times for patients in need, particularly in areas with fewer local donors.

Moving Forward

This study adds to a growing body of evidence that the SherpaPak CTS could be a game-changer for heart transplantation, particularly in expanding the donor organ pool and improving patient outcomes (links to additional clinical studies below). As heart transplantation faces increasing challenges with donor availability, the SherpaPak CTS presents an opportunity to safely extend the transportation time for donor hearts. This can help ensure more patients get the life-saving treatment they need without compromising the quality of the transplant. The SherpaPak CTS is no longer just a breakthrough—it’s a lifeline.

Additional Resources

Impact of controlled hypothermic preservation on outcomes following heart transplantation | JHLT Journal

Recipient Outcomes With Extended Criteria Donors Using Advanced Heart Preservation: An Analysis of the GUARDIAN-Heart Registry | JHLT Journal

Outcomes in Heart Transplant Recipients by Bridge to Transplant Strategy When Using the SherpaPak Cardiac Transport System | ASAIO Journal

Multicenter Registry Using Propensity Score Analysis to Compare a Novel Transport/Preservation System to Traditional Means on Postoperative Hospital Outcomes and Costs for Heart Transplant Patients | ASAIO Journal

Early Outcomes in Patients With LVAD Undergoing Heart Transplant via Use of the SherpaPak Cardiac Transport System | Circulation: Heart Failure

Disclaimer

Comparison of Paragonix SherpaPak to Ice Storage, Paragonix data on file.

GUARDIAN is a registered clinical study (NCT04141605) funded and administered by Paragonix Technologies. The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.

References

1. Farhoud et al,. Chilling Choices: Heart Transplant Outcomes Using SherpaPak With Long Ischemic Time Versus Traditional Ice Storage With Short Ischemic Time. ASAIO 2024
2. D’Alessandro et al., Impact of Controlled Hypothermic Preservation on Outcomes Following Heart Transplantation. JHLT 2024
3. Moayedifar et al., Recipient Outcomes With Extended Criteria Donors Using Advanced Heart Preservation: An Analysis of the GUARDIAN-Heart Registry. JHLT 2023

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