부산대학교 도서관

Summary of Objectives Standard heart preservation, before transplantation, consists of ischemic static cold storage (SCS) of the heart. The morbidity and mortality risk increases with an extension of the allograft ischemic time. Pre-clinical studies have demonstrated that a new preservation technology of donor hearts, using an ex-vivo non-ischemic heart preservation system (NIHP), can be safely applied for up to 24 hours in pigs. However, until now this state-of-the-art technique has never been applied on humans. The overall aim is to compare the new preservation method (NIHP) with the until now standard ischemic SCS preservation method, in adult heart transplantation. (ClinicalTrials.gov Identifier: NCT03150147) Methods Six patients have been transplanted with the NIHP method and 25 contemporary control patients have been transplanted with the standard SCS method. All patients are adult, ≥18 years old. Date of the last transplant was September 26, 2018. The NIHP system consists of an automatic pressure and flow-controlled perfusion, a gas exchange system, and a heater-cooler unit. The system is filled with a perfusate medium, comprising an hyperoncotic cardioplegic nutrition solution supplemented with hormones and erythrocytes. The heart is submerged in the solution and the medium is circulated in the preservation system through the coronary arteries of the cardioplegic heart, at a temperature of 8°C (Figure 1). Endpoints The primary end-point is defined as the combination of graft failure (patient death or re-transplantation), PGD, need for extracorporeal mechanical support, or ACR ≥ grade 2R within 30-days post transplantation. The secondary end-points are Ischemia and reperfusion injury (cTnI and CK-MB) at 0, 6, and 12 hours post transplant, ACR ≥ grade 2R, cardiac allograft vasculopathy, and graft failure within 12-months post-transplantation. Preliminary results shows a significant decrease in cTnI and CK-MB in the NIHP group compared with SCS group. Further results will be presented after complete 30-day follow up. [ABSTRACT FROM AUTHOR]