Long-term outcomes of the international EXPAND trial of Organ Care System (OCS) Lung preservation for lung transplantation

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Summary Background Portable ex vivo lung perfusion and ventilation with the Organ Care System (OCS) Lung system is a safe, effective method for preserving extended criteria donor (ECD) organs before transplant. Although this technology is increasingly used in the United States, no published data describe its effects on long-term graft function and patient outcomes. This study assessed long-term clinical outcomes after transplantation of ECD lungs that were preserved, recruited, and assessed with the OCS Lung. Methods The EXPAND Lung Trial was a prospective, single-arm, multicenter, international trial conducted between January 2014 and July 2016; 5-year follow-up data were collected until December 2021. Double-lung donors were included who met any of four ECD criteria: age ≥55 years, PaO2/FiO2 ≤300 mmHg, expected ischemic time >6 h, and donation after circulatory death (DCD). Transplant recipients' overall survival and 5-year incidence of bronchiolitis obliterans syndrome (BOS) were compared between the EXPAND cohort (n = 79) and a control cohort from the same centers within the same time period, who received donor lungs preserved with ice but not OCS (n = 644). This study is registered with ClinicalTrials.gov (NCT04194398). Findings Overall survival was similar between the EXPAND and control cohorts; 5-year overall survival was 68.1% versus 66.5%, respectively (P = 0.795). The risk factors associated with overall survival were the degree of urgency for lung transplant and recipient age; 5-year survival was much greater for patients designated as non-urgent than for patients designated as urgent (73% versus 41%, P = 0.021). 5-Year BOS3-free survival was 60.4% for the EXPAND cohort and 63.7% for the control cohort (P = 0.599). Overall survival, development of BOS3, and development of any grade of BOS did not differ between the EXPAND and control cohorts. Interpretation Among patients who underwent lung transplantation with ECD lungs, the use of OCS Lung resulted in excellent long-term clinical outcomes. This study's findings support the use of OCS Lung to expand the donor pool and provide a foundation for future studies comparing lung-preservation strategies. Funding This study was funded by TransMedics.

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