Paragonix SherpaPak System Helps Improve Donor Heart Longevity

New research is proving the benefits of preserving donor hearts with Paragonix Technologies’ SherpaPak Cardiac Transport System.

An expansive study compared long-term outcomes of donor hearts preserved with the Paragonix SherpaPak Cardiac Transport System, a U.S. Food and Drug Administration (FDA)-cleared and CE-marked device, to those stored on conventional ice storage over four years after transplantation.

Drawing on data from the GUARDIAN-Heart Registry, the study compared four-year mortality rates between the SherpaPak System and ice storage in U.S. adult heart transplant recipients. In a propensity-matched analysis, researchers found a 54% reduction in four-year mortality (p=0.018), and an improvement in survival at each yearly interval compared to historical ice storage.¹

• A 72% reduction in one year mortality (Ice – 23/243 (9.5%) vs SherpaPak – 2/243 (2.7%), p=0.003)¹
• A 68% reduction in two-year mortality (Ice – 32/241 (13.3%) vs SherpaPak – 9/213 (4.2%), p<0.001)¹
• A 52% reduction in three-year mortality (Ice – 39/235 (16.6%) vs SherpaPak – 13/165 (7.9%), p=0.010)¹
• A 54% reduction in four-year mortality (Ice – 39/177 (22.0%) vs SherpaPak – 9/88 (10.2%), p=0.018)¹

“These findings represent monumental progress in heart transplantation technology and research. The GUARDIAN Registry research data clearly demonstrates that patients whose donor hearts were preserved with the Paragonix SherpaPak experience a statistically significant improvement in outcomes,” Paragonix Technologies President Lisa Anderson, Ph.D., said. “At Paragonix, we remain committed to working alongside the transplant community to ensure every donor gift has the greatest chance to save and sustain life.”

Additionally, researchers discovered that hearts transported with a SherpaPak System experienced a 50% reduction in severe primary graft dysfunction (PGD) (p=0.017) and a 63% reduction in severe right ventricular dysfunction (RVD) (p=0.007). The study concluded the utilization of the SherpaPak System for organ preservation was associated with improved post-transplant outcomes, including a statistically significant survival advantage over four years.¹

The GUARDIAN-Heart Registry yielded other conclusions as well. Compared to conventional ice storage, for example, use of the SherpaPak System was linked to a lower development of cardiac allograft vasculopathy (CAV), one of the most common late-term morbidities in heart transplant. Research data found SherpaPak cohort patients experienced significantly lower rates of any CAV in years three and four, with year four exhibiting 17.7% (SherpaPak) vs. 23.6% (Ice) (p=0.047).²

In an analysis of Global Adult Extended Criteria Donors, the SherpaPak System was associated with a reduction in post-transplant clinical complications, including a 26% reduction in post-transplant mechanical circulatory support (0.043), a 31% reduction in PGD (p=0.020), and a 61% reduction in severe RVD (p<0.001).³

A study on rehospitalizations in the first year after heart transplantation found a significant increase in freedom from all-cause rehospitalization (p=0.003), including cardiovascular-related rehospitalizations (p=0.017) using the SherpaPak System in comparison to ice storage.⁴

“Our research indicates the use of moderate, controlled hypothermia not only significantly reduced the risk of Severe PGD and severe RVD, but also significantly reduced mortality through four years post-transplant,” stated Dr. David D’Alessandro, director of Heart Transplantation and Ventricular Assist Devices at Massachusetts General Hospital.

Paragonix works closely with transplant centers, organ procurement organizations, and healthcare professionals to ensure broad accessibility of its advanced organ preservation technology, including the SherpaPak System, which is used across more than 130 programs globally to preserve and protect donor hearts.

Paragonix Technologies develops, manufactures, and provides services to the organ transplant industry. A Getinge company, Paragonix Technologies provides advanced organ preservation (AOP) devices that safeguard donor organs during the journey between donor and recipient patients. Its FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with a digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution.

Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile processing and life science. Getinge employs approximately 12,000 people worldwide and its products are sold in more than 135 countries.

References
¹ D’Alessandro et al., 2025 ISHLT Presentation 2025, Data on File
² Uriel et al., 2025 ISHLT Presentation 2025, Data on File
³ Moayedifar et al., 2025 ISHLT Presentation 2025, Data on File
⁴ Khush et al. 2025 ISHLT Presentation 2025, Data on File