Extension of Cold Static Donor Lung Preservation at 10°C

Abstract

BackgroundLung 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).MethodsIn 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.ResultsTotal 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).ConclusionsExtension 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).