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

Abstract

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™, 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™). The outcome after donor heart storage in the SherpaPak™ was compared with donor heart transportation with the standard technique. Results: Since July 2018 seven patients (5 males; mean age 50.3±13.2years) underwent heart transplantation with the SherpaPak™ system. Cold ischemic time was longer in the SherpaPak™ group (207.7±23.3 vs. 181.6±21.9, P=0.027). SherpaPak™ kept the organ temperature at 5.1±0.8 ℃, with an average outside temperature of 21.4±3.6 ℃.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 SherpaPak™ group (TAPSE 17.83±2.71 vs. 14.52±2.61 mm, P=0.020). We identified no positive blood cultures in the SherpaPak™ group within the first 30 days after heart transplantation. Conclusions:The SherpaPak™ provides a constant temperature during transportation with permanent monitoring, never dropping below 4 ℃.Organs transported with this novel device showed a normal perioperative function.

Controlled temperatures in cold preservation provides safe heart transplantation results

“…However, a critical report from a consensus conference on PGD after cardiac transplantation considers the inotropic score as one of the criteria of moderate PGD if the inotropic score is higher than 10 4 . In one study reported on Sherpa showed a baseline VIS of 44 in the ICU 1 . Our mean baseline VIS was 10.2.…”

“…PGD leads to significant perioperative morbidity and mortality, and it causes 40% of deaths in the first 30 days after cardiac transplantation 1,7 . PGD was reported at a rate of 7.4%, in a previous study including 10.000 patients 8 .…”

“…Cold static storage of donor hearts is still the conventional method worldwide. However, there is a risk of cold ischemic injury that may cause irreversible myocardial cell damage 1 . The SherpaPak™ system (Paragonix Technologies) provides stable temperatures between 4°C and 8°C, which avoids freezing and subsequent irreversible myocardial cell damage 1 …”

An innovative cold storage system for donor heart transportation—lessons learned from the first experience in Switzerland

“…The SherpaPak™ CTS with its CoolSafe™ technology aims to resolve these problems by maintaining a controlled preservation temperature between 4 ℃ and 8 ℃. Previous studies reporting clinical usage of this system have shown that throughout transportation, organ temperature can be maintained within an optimal narrow range (7)(8)(9). Even under extreme temperature conditions (−8 ℃ and 31 ℃), temperature in the inner container can be kept in the desired range of 4-8 ℃ (6).…”

“…Larger prospective trials comparing the traditional three-bag-technique with the SherpaPak™ CTS are missing. The only case-control study to date indicated that transplants preserved with SherpaPak™ CTS showed normal perioperative function (7). It even found better right ventricular function in patients in the SherpaPak™ group, suggesting that this might be the result of less hypothermic injury.…”