Impact of OCS Lung Portable EVLP on Pulmonary Function and Bronchiolitis Obliterans in Standard Lung Transplant Recipients - Prospective Evidence from the OCS Lung INSPIRE Trial Patients

To-date, EVLP clinical utility has been limited to only evaluating its impact on expansion of the lung utilization from extended criteria donors. The OCS Lung INSPIRE international randomized trial is the only large prospective clinical evidence available for OCS Lung EVLP use in routine donor lungs. The OCS Lung INSPIRE trial prospectively collected long-term pulmonary function data and the clinical diagnosis of BOS from trial patients for up-to 2 years to assess the clinical impact of portable EVLP on the potential development of BOS in routine lung transplant recipients. INSPIRE Trial compared preservation of donor lungs using OCS-Lung perfusion device (OCS) to Cold flush and storage (Control). Donor Inclusion Criteria: age <65, normal gas exchange at time of final acceptance of donor lung, and no active primary pulmonary disease. Recipient Inclusion Criteria: age ≥ 18 years old; registered male or female primary double lung transplant candidate; & signed written informed consent for the trial. Donor Exclusion Criteria: positive serology; presence of moderate to severe traumatic lung injury; & presence of confirmed active pneumonia. Recipient Exclusion Criteria: prior solid organ or bone marrow transplant; single lung recipient; chronic use of renal dialysis or diagnosed of chronic renal dysfunction; and multi-organ transplant recipient. All patients will be followed up for 2 years post-transplantation. Endpoints: In addition to short and long term survival and PGD endpoints, the OCS Lung INSPIRE Trial prospectively collected pulmonary function tests results and incidence of clinical diagnosis of BOS for up-to 2 years post double lung transplantation.