Extension of Cold Static Donor Lung Preservation at 10°C

Abstract

BACKGROUND: Lung transplantation is performed on a 24/7 schedule to minimize organ ischemic time. Recent preclinical studies demonstrated superior graft preservation at 10°C compared with storage in an ice cooler (gold standard). METHODS: In this prospective, multicenter, nonrandomized clinical trial, we studied transplants from donors with overnight cross-clamp times (6:00 p.m. to 4:00 a.m.) that had an earliest allowed starting time of 6:00 a.m. Lungs meeting criteria for transplantation were retrieved, transported, and immediately transferred to a 10°C temperature-controlled incubator until implantation; 70 patients and 140 matched controls were included in this study. RESULTS: Total preservation times for lungs in the study group were 12 hours, 28 minutes (interquartile range, 10 hours, 14 minutes to 14 hours, 12 minutes) and 14 hours, 9 minutes (interquartile range, 12 hours, 3 minutes to 15 hours, 45 minutes) for the first and second lung implanted, respectively. Primary graft dysfunction grade 3 at 72 hours (primary outcome) was 5.7% in the study group versus 9.3% in matched controls (difference, −3.6; 95% confidence interval [CI], −10.5 to 5.3). No meaningful differences were observed in the need for postoperative extracorporeal membrane oxygenation (5.7 vs. 9.3%), median intensive care unit stay (5 vs. 5 days), or median hospital stay (25 vs. 30 days) between the two groups. One-year Kaplan–Meier survival was similar between the two groups (94 vs. 87%; hazard ratio, 0.65; 95% CI, 0.26 to 1.6). CONCLUSIONS: Extension of cold static preservation times at 10°C appears to be safe and has the potential to improve transplantation logistics and performance. (Funded by the UHN Foundation; Clinicaltrials.gov number, NCT04616365).