Landmark Study Demonstrates Significant 4-Year Survival Benefit in Heart Transplant Patients Using Paragonix SherpaPak System
Paragonix Technologies, a pioneer in advanced organ transplant preservation and organ procurement services, has announced compelling new clinical evidence demonstrating improved long-term outcomes for heart transplant recipients whose donor organs were preserved using its SherpaPak® Cardiac Transport System. The findings, unveiled at the 45th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT), mark a pivotal moment in transplant care and support the growing clinical adoption of next-generation preservation technologies.
The study, which drew on extensive data from the GUARDIAN-Heart Registry, compared post-transplant survival outcomes of U.S. adult heart transplant patients whose donor hearts were preserved with the SherpaPak System versus those stored using traditional ice-based methods. The SherpaPak is a proprietary cardiac transport system cleared by the U.S. Food and Drug Administration (FDA) and certified with the CE mark in Europe. It utilizes controlled hypothermic preservation to maintain donor heart temperature within a safe, regulated range, reducing the risks associated with ice storage.
In this large-scale, real-world analysis, researchers found a significant improvement in survival rates at each yearly interval over a four-year post-transplant period for patients whose hearts were transported using the SherpaPak. Most notably, the study revealed a 54% reduction in mortality at four years compared to conventional ice storage (p=0.018). This compelling survival advantage reinforces the clinical value of modernizing organ transport systems to reduce ischemic injury and improve transplant outcomes.
Year-by-Year Survival Benefits
In a propensity-matched analysis—an approach used to account for baseline differences and ensure a fair comparison between cohorts—the study reported striking year-over-year improvements in survival for the SherpaPak group:
- 1-Year Mortality: The SherpaPak group experienced a 72% reduction in mortality compared to the ice group (2.7% vs. 9.5%; p=0.003).
- 2-Year Mortality: A 68% reduction in mortality was observed (4.2% vs. 13.3%; p<0.001).
- 3-Year Mortality: A 52% reduction in mortality was recorded (7.9% vs. 16.6%; p=0.010).
- 4-Year Mortality: A 54% reduction in mortality was maintained (10.2% vs. 22.0%; p=0.018).
These improvements suggest that controlled hypothermic transport not only preserves organ viability in the short term but also confers durable benefits that extend years beyond the transplant procedure.
Reductions in Post-Transplant Complications
In addition to improvements in survival, the study found that the use of the SherpaPak System was associated with a substantial decrease in life-threatening post-transplant complications. Most notably:
- Severe Primary Graft Dysfunction (PGD): A 50% reduction (p=0.017) was observed in patients using the SherpaPak.
- Severe Right Ventricular Dysfunction (RVD): A 63% reduction (p=0.007) was reported.
These findings are especially important, as PGD and RVD are among the most serious early post-transplant complications and are closely tied to increased morbidity and mortality. The reduction in these complications underscores the clinical advantage of maintaining stable, controlled temperatures during organ transport—a benefit not achievable with conventional ice storage.
Lower Incidence of Cardiac Allograft Vasculopathy
Researchers also presented new data showing that the SherpaPak System was associated with a reduced incidence of cardiac allograft vasculopathy (CAV)—a progressive form of chronic rejection and one of the most common late-stage complications in heart transplant recipients.
At four years post-transplant, the rate of CAV in patients whose hearts were preserved with the SherpaPak was 17.7%, compared to 23.6% in the ice storage cohort (p=0.047). These results suggest that improved preservation techniques may have long-term immunologic and vascular benefits that extend well beyond the perioperative period.
Benefits in Extended Criteria Donor Transplants
Further analysis of transplant outcomes involving Global Adult Extended Criteria Donors—donors who fall outside of standard criteria due to age, comorbidities, or other factors—revealed that the SherpaPak also yielded notable improvements in this high-risk population. Use of the system was associated with:
- A 26% reduction in the need for post-transplant mechanical circulatory support (p=0.043).
- A 31% reduction in the incidence of PGD (p=0.020).
- A 61% reduction in severe RVD (p<0.001).
These findings are significant, as transplant centers increasingly rely on extended criteria donors to address the persistent shortage of donor organs. Improved preservation methods that can extend the viability and function of these marginal hearts are crucial to expanding the donor pool and improving recipient outcomes.
Fewer Rehospitalizations in the First Year
Another key outcome from the GUARDIAN-Heart Registry was the reduced rate of all-cause rehospitalizations in the first year following transplant. Patients who received donor hearts preserved with the SherpaPak were significantly more likely to remain free from hospital readmissions (p=0.003), including those for cardiovascular-related causes (p=0.017). This not only improves patient quality of life but also contributes to substantial cost savings for the healthcare system.
Expert and Industry Perspectives
Commenting on the significance of the findings, Dr. David D’Alessandro, Director of Heart Transplantation and Ventricular Assist Devices at Massachusetts General Hospital, emphasized the clinical implications of the study.
“Our research indicates that 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,” said Dr. D’Alessandro. “These findings provide robust support for changing the standard of care in donor heart preservation.”
Lisa Anderson, Ph.D., President of Paragonix Technologies, echoed the importance of these results and reaffirmed the company’s mission.
“These landmark findings represent monumental progress in heart transplantation technology and research,” said Anderson. “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. 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.”
Widespread Adoption and Global Impact
Paragonix Technologies has rapidly expanded the use of its SherpaPak System, which is now utilized in over 130 heart transplant programs worldwide. The company’s focus on advancing organ preservation aligns with the broader goals of transplant medicine: increasing the availability of donor organs, reducing complications, and improving long-term patient survival.
By offering a standardized, clinically validated alternative to ice-based preservation, Paragonix is helping to set new benchmarks in transplant care. The SherpaPak’s ability to maintain optimal preservation conditions during transport is not only improving individual outcomes but also reshaping the future of organ transplantation at a systemic level.
