Normothermic Ex Vivo Lung Perfusion (Novel) as an Assessment of Extended Criteria Donor Lungs: A Prospective Multi-Center Clinical Trial

Abstract

Purpose: Ex vivo lung perfusion (EVLP) allows re-evaluation of extended criteria/marginal donor lungs. This can increase the number of lung transplants. However, the long-term outcomes of transplanting EVLP-screened lungs in a multicenter setting are unknown. We proposed to evaluate the short- and long-term outcomes of EVLP performed at multiple centers. Methods: This is a prospective, nonrandomized clinical trial. Seventeen lung transplant centers in the United States. Adult patients with end-stage pulmonary disease requiring lung transplant from May 2011 to December 2017 were eligible. Lung allografts initially deemed extended criteria/marginal (n=216) were placed on EVLP and re-evaluated prior to transplant. Patients received either standard donors (n=116) or lungs screened with EVLP (n=110). Results: Half of the lung grafts (110/216, 50.9%) placed on EVLP were transplanted. The incidence of primary graft dysfunction 24 hours post-transplant was higher in the EVLP group (25.5% vs 10.3%, p=0.003), but was not significantly different 48 hours (EVLP: 15.5%, control: 9.5%, p=0.49) and 72 hours (13.6% vs 6.9%, p=0.34) post-transplant. Survival was not significantly different between the 2 groups 1 year (n=226, EVLP: 86%, control: 94%, p=0.06), 3 years (n=226, EVLP: 68%, control: 76%, p=0.16, Figure), or 5 years (n=159, EVLP: 59%, control: 65%, p=0.68) post-transplant. There were also no differences in pulmonary function, the incidence of chronic lung allograft dysfunction or quality of life measures post-transplant. Conclusion: In this multicenter study, recipients of lungs that were re-evaluated on EVLP and deemed suitable for transplant had similar outcomes as a recipients of a standard lung transplants. EVLP offers the opportunity to screen donated lungs initially considered high risk and can safely increase the availability of transplantable lungs without compromising outcomes

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