First clinical experience with the novel cold storage SherpaPak™ system for donor heart transportation

Background: The current gold standard for donor heart preservation is a three-bag-technique and storage in a cooler filled with slush ice. This technique can cause freezing injury with protein denaturation. We report our early experience with a single-use disposable device (SherpaPak (TM), Paragonix Technologies, MA, USA) specifically designed for sterile permanent temperature-controlled transportation of donor hearts. Methods: In this case control study with 2:1 matching we identified 21 patients after heart transplantation depending on type of organ transport (standard three-bag-technique vs. SherpaPak (TM)). The outcome after donor heart storage in the SherpaPak (TM) was compared with donor heart transportation with the standard technique. Results: Since July 2018 seven patients (5 males; mean age 50.3 +/- 13.2-years) underwent heart transplantation with the SherpaPak (TM) system. Cold ischemic time was longer in the SherpaPak (TM) group (207.7 +/- 23.3 vs. 181.6 +/- 21.9, P=0.027). SherpaPak (TM) kept the organ temperature at 5.1 +/- 0.8 degrees C, with an average outside temperature of 21.4 +/- 3.6 degrees C. Among all 21 transplanted patients four developed fatal early graft failure (28.6% vs. 21.4%, P=0.432). Over the first hours we noticed no difference in hemodynamic parameters, CK-MB levels or vasoactive-inotropic score. During first follow-up we noticed slightly better right heart function in the Sherpa.Pak (TM) group (TAPSE 17.83 +/- 2.71 vs. 14.52 +/- 2.61 mm, P=0.020). We identified no positive blood cultures in the SherpaPak (TM) group within the first 30 days after heart transplantation. Conclusions: The SherpaPak (TM) provides a constant temperature during transportation with permanent monitoring, never dropping below 4 degrees C. Organs transported with this novel device showed a normal perioperative function.