Long-Term Results of the OCS Lung Expand International Trial Using Organ Care System Lung Perfusion System (OCS) in Extended-Criteria Donor (ECD) and Donation After Circulatory Death (DCD) Donor Lungs

Abstract

Purpose To evaluate short and long-term clinical outcomes after lung transplantation of ECD and DCD lungs that were preserved, recruited and assessed using the OCS Lung System. Methods OCS Lung EXPAND targeted double lungs donors with one or more risk factors: age ≥55, PaO2/FiO2 (PF) ≤ 300 mmHg, expected ischemic time > 6 hours, or DCD donors. Lungs were perfused and ventilated on OCS from procurement until time of transplantation. Lungs were transplanted after OCS perfusion if: PF > 300mmHg, vascular resistance, pulmonary artery pressures or peak airway pressures were within 20% of starting values. Patients were followed for 4 years post-transplant and assessed for incidence of BOS and survival. To benchmark the outcomes, we assessed the relative risk for the development of BOS grade 3 between the EXPAND patients and patients in the control arm of the INSPIRE trial who were transplanted with standard-criteria donor (SCD) lungs using ice preservation without OCS perfusion (N=184). Results 79 out of 91 eligible donor lungs were transplanted in the EXPAND Trial for a utilization rate of 87%. Donor inclusion risk factors for the transplanted patients were as follows: 39% age ≥55, 33% DCD, 32% expected ischemic time > 6 hours, 25% PF ≤ 300 mmHg, and 27% with multiple categories. The incidence of BOS Grade 3 is summarized in the table below. Overall graft survival at 4 years was 87.6% for EXPAND vs. 84.9% for the INSPIRE Control cohort. Patient survival at 4 years was 72.0% for EXPAND vs. 71.9% for the INSPIRE Control cohort. Conclusion OCS Lung resulted in a high utilization rate for ECD and DCD donor lungs for transplantation with similar or better long-term post-transplant clinical outcomes compared to SCD lung transplants preserved on ice. These results provide strong clinical evidence supporting the use of the OCS Lung System in extended-criteria donor lungs to increase donor lung utilization for transplantation. To evaluate short and long-term clinical outcomes after lung transplantation of ECD and DCD lungs that were preserved, recruited and assessed using the OCS Lung System. OCS Lung EXPAND targeted double lungs donors with one or more risk factors: age ≥55, PaO2/FiO2 (PF) ≤ 300 mmHg, expected ischemic time > 6 hours, or DCD donors. Lungs were perfused and ventilated on OCS from procurement until time of transplantation. Lungs were transplanted after OCS perfusion if: PF > 300mmHg, vascular resistance, pulmonary artery pressures or peak airway pressures were within 20% of starting values. Patients were followed for 4 years post-transplant and assessed for incidence of BOS and survival. To benchmark the outcomes, we assessed the relative risk for the development of BOS grade 3 between the EXPAND patients and patients in the control arm of the INSPIRE trial who were transplanted with standard-criteria donor (SCD) lungs using ice preservation without OCS perfusion (N=184). 79 out of 91 eligible donor lungs were transplanted in the EXPAND Trial for a utilization rate of 87%. Donor inclusion risk factors for the transplanted patients were as follows: 39% age ≥55, 33% DCD, 32% expected ischemic time > 6 hours, 25% PF ≤ 300 mmHg, and 27% with multiple categories. The incidence of BOS Grade 3 is summarized in the table below. Overall graft survival at 4 years was 87.6% for EXPAND vs. 84.9% for the INSPIRE Control cohort. Patient survival at 4 years was 72.0% for EXPAND vs. 71.9% for the INSPIRE Control cohort. OCS Lung resulted in a high utilization rate for ECD and DCD donor lungs for transplantation with similar or better long-term post-transplant clinical outcomes compared to SCD lung transplants preserved on ice. These results provide strong clinical evidence supporting the use of the OCS Lung System in extended-criteria donor lungs to increase donor lung utilization for transplantation.