Early Clinical Experience with a Phase Change Material-Based Temperature-Controlled Cold-Chain System for Donor Heart Preservation

Abstract Background Temperature fluctuations during conventional ice-box static cold storage may contribute to donor heart injury. We evaluated a phase change material (PCM)-based temperature-controlled cold-chain container (VIXELL) in consecutive adult heart transplantations. Methods In a single center, 12 consecutive orthotopic heart transplantations (May-Nov 2025) used VIXELL to maintain 2-8 C during ground transport with continuous temperature recording. Severe primary graft dysfunction (PGD) was assessed using International Society for Heart and Lung Transplantation criteria. Results In-transit temperatures remained within 2–8°C in cases reflecting shorter and longer transport durations within the cohort without freezing or excessive warming. Cold ischemic time was 116.8 ± 59.6 min, and early graft function markers were favorable (peak lactate 6.3 ± 2.8 mmol/L; lactate normalization 13.8 ± 3.7 h). No severe PGD occurred. Conclusions PCM-based temperature control was feasible and provided stable hypothermia during donor heart transport. Larger comparative studies are warranted.