Paragonix SherpaPak Cardiac Transport System Heart Transplant and Improved 1-Year Survival

A study found that patients who receive a heart transplant with Paragonix SherpaPak Cardiac Transport System (SHRP) tended to have improved 1-year survival compared with patients who received conventional transplant methods. These findings were published in The Journal of Heart and Lung Transplantation.

Data for this study were sourced from the Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN; ClinicalTrials.gov identifier: NCT04141605). The GUARDIAN database is a retrospective, mulit-institution registry which collects data from 11 heart transplant centers in the United States.

According to Dr Andreas Zuckermann, the EU Principal GUARDIAN Investigator, Director of Cardiac Transplantation, and Associate Professor of Surgery Medical University of Vienna, “The lack of research into preservation methods during transport for organ transplant surgery, specifically heart transplant, led me and a group of similar minded investigators to come together in the creation of the GUARDIAN-Heart Registry in 2019. Utilizing the Paragonix SherpaPak in direct comparison to the standard of care ice transport method, we could see from early results a trend to a reduction of primary graft dysfunction and some positive effects in post-transplant outcomes, utilizing advanced organ preservation with the SherpaPak. With each additional analysis we conduct, including the truly remarkable results, presented by Dr. Marzia Leacche at ISHLT 2022, highlighting not only statistically reductions in Severe PGD, and need for Post-Transplant Mechanically Circulatory Support, but an 8.7% increase in 1-year Survival, the evidence continues to mount pointing towards a significant positive clinical impact utilizing advanced organ preservation. ”

For this study, 1-year survival outcomes were evaluated among patients (N=383) who received SHRP or conventional transplant between 2015 and 2021. Patients received a heart transplant using SHRP (n=227) or conventional methods (n=156). The patient cohorts were well balanced, except that fewer patients in the SHRP cohort received implantable left ventricular assist device (35.2% vs 55.1%; P <.001), more patients received pretransplant temporary intra-aortic balloon pump (29.6% vs 13.0%; P <.001) and pre-transplant extracorporeal membrane oxygenation (17.2% vs 7.8%; P =.01), they had longer distances to the donor organ (mean, 463 vs 274 miles; P <.001), and longer ischemic times (mean, 217 vs 195 min; P <.001).

The SHRP cohort tended to have increased 30-day (97.8% vs 95.5%; P =.22) and 1-year (91.1% vs 86.0%; P =.21) survival.

In addition, SHRP associated with significantly reduced severe primary graft dysfunction (5.3% vs 13.0%; P =.01) and a trend for reduced placement of extracorporeal membrane oxygenation post-transplant (8.8% vs 14.7%; P =.07).

The major limitation of this study was the retrospective design.

This study found that despite preoperative risk factors, heart transplant with SHRP associated with numerically reduced mortality up to 1 year after transplant compared with patients who received transplant using conventional methods. These trends were observed even though patients who received SHRP implants had more known risk factors, such as more acute support.

“The potential impact of this research on clinical outcomes and patient’s lives cannot be understated. The GUARDIAN-Heart 1-year Survival Analysis we presented…at the ISHLT 2022 Annual Meeting showed a clear trend to increased 1-year survival for heart transplants utilizing the Paragonix SherpaPak, and is just 1 of many clinical analyses we are researching in the ongoing study,” said Dr Marzia Leacche, Richard DeVos Endowed Chair for Heart Transplant and MCS, Surgical Director, at Spectrum Health, MI. “With over 1100 enrolled heart transplant patients, this one-of-a-kind registry has provided exceptional insight into how transplant centers can effectively improve organ preservation methods to the benefit of all patients.”

Reference

Leacche M, Philpott J, Pham S, et al. US multi-center analysis of the global utilization and registry database for improved heart preservation (GUARDIAN) registry: 1-Year transplant survival analysis. J Heart Lung Tranplant. Published online April 7, 2022. doi:10.1016/j.healun.2022.01.067