The NOVEL Study. A Multi-Center Clinical Trial Studying the Safety of Ex Vivo Lung Perfusion

PURPOSE: lung transplantation continues to be a life saving therapy for patients with end stage lung disease. In a donor restrictive environment and with only 22% of donor lungs currently being transplanted ex vivo lung perfusion can increase donor use and transplantation preserving safety and good outcomes METHODS: the NOVEL study is a prospective, multi-center, controlled clinical trial. Seventeen US lung transplant centers evaluated the safety of screening donors initially considered unacceptable for transplant with normothermic ex vivo lung perfusion (EVLP). RESULTS: from 2011 to 2017 seventeen lung transplant centers evaluated 216 donors with EVLP. 110 were transplanted for a 50.9% conversion rate. Early and long-term outcomes were compared to 116 control patients that underwent transplantation using standard criteria lungs. The primary endpoints for this study were Primary Graft Dysfunction (PGD) grade 3 at 72 hours and 1-year survival. The rate of PGD grade 3 at 72 hrs. was non-inferior between the ELVP and Control group (8.9% vs 9.5%, p 0.12). The 1-year survival for the EVLP group was 93.2% vs. 96.5% for the Control group, p 0.84. Secondary endpoints such as ICU length of stay, 9.9 vs 9.8 days, hospital length of stay, 23.9 vs 28.5 days, duration of mechanical ventilation, 7.0 vs 5.7 days, were also not significantly different between the EVLP and Control groups. Median FEV 1 was also no different between the EVLP and Control groups 12 months post transplant 65 vs 70 %. CONCLUSION: data from this multi-center, controlled clinical trial demonstrates that the use of ex vivo lung perfusion to screen for viable grafts within the unused donor pool is safe and provides equal short and long therm outcomes to standard criteria donor lungs.