Establishing a Nursing-Led Ex-Vivo Lung Perfusion Program: A Primer.

Purpose Since the Food and Drug Administration's approval in 2014 of the XVIVO Perfusion System (XPS) and STEEN Solution as a Humanitarian Device Exemption (HDE), for the purpose of procuring marginal lungs to be transplantable, the University of Texas Southwestern (UTSW) Medical Center in Dallas, Texas, has solely utilized Cardiovascular Intensive Care Unit (CVICU) Registered Nurses (RNs) as lung perfusionists in the development of our unique Ex-Vivo Lung perfusion (EVLP) program model. Of the twenty-six XVIVO sites in the United States, we are the only RN-led team. Methods Our EVLP program centers on RNs with specializations in extracorporeal membrane oxygenation (ECMO). We have a set criteria for selection of specialist EVLP RNs. Once a RN meets criteria, training commences and involves runs utilizing the EVLP machine. Continuing education is required by all team members, including wet labs and monthly quality meetings. The EVLP team developed standardized step-by-step flashcards detailing each step of the EVLP process in order to decrease variations. Following extensive training, nursing personnel are credentialed and continue to work on both EVLP perfusion for lung transplantation and for research studies, like the XVIVO NOVEL Lung Trial and the current Mallinckrodt Study involving gNO via EVLP. Results Our team has worked on six cases with the intention for lung transplant. Four lungs showed progressive improvement in key parameters during EVLP perfusion. Of the four lungs that showed improvement, three were successfully transplanted and one withdrew consent. The two that did not move toward transplantation showed worsening in key parameters observed during perfusion. Since inclusion into the Mallinckrodt Study, our team has perfused research lungs. Along with our successes, our team has encountered challenges as well. Some of the challenges include establishing evidence-based practices and protocols, ensuring adequate supplies, on-boarding and training new staff. Conclusion We successfully established a novel EVLP model utilizing nurse specialists. Our EVLP nurse specialist team model has consistently produced successful outcomes. Much like the transition from perfusion led ECMO models to nurse specialist ECMO models throughout the country, we feel our novel model for EVLP is sustainable and will set a new standard in this arena. [ABSTRACT FROM AUTHOR]