Mid-term follow-up of non-ischemic heart preservation in heart transplantation

Abstract

Background

Ex-vivo perfusion of donor hearts is gaining importance in minimizing ischemia-reperfusion injury during heart transplantation. The Non-Ischemic Heart Preservation (NIHP) device, developed in 2016, has shown promising results in pilot studies. This study aims to compare the mid-term follow-up outcomes of NIHP with traditional Static Cold Storage (SCS) in heart transplantation.

Methods

This hybrid cohort study included 47 patients. The primary outcome was event-free survival at one year, defined as survival free of severe primary graft dysfunction (PGD), extracorporeal membrane oxygenation (ECMO) use within 7 days, acute cellular rejection (ACR ≥ 2R), and death. Secondary outcomes included graft function, incidence of adverse events at one year, and overall survival.

Results

At 1 year, event-free survival was observed in 12 of 15 patients (80%) in the NIHP group and 23 of 32 patients (72%) in the SCS group. No patients in the NIHP group developed severe PGD, compared to three patients in the SCS group. ACR ≥ 2R occurred in 2/15 (13%) of NIHP patients and 5/32 (16%) of SCS patients. Overall survival at 5 years was 14/15 (93%) for NIHP and 24/32 (75%) for SCS. Immediate graft function and markers of ischemia-reperfusion injury favored the NIHP group, with lower CK-MB and lactate levels post-transplantation. Adverse events were comparable between groups, although the NIHP group had fewer severe complications.

Conclusions

The NIHP system demonstrated outcomes comparable to SCS in heart transplantation, with improved graft function and reduced markers of ischemia-reperfusion injury. Further research is required to confirm these findings.