First Report of the Organ Care System (OCS) Thoracic Organ Perfusion (TOP) Post-Approval Registry

Purpose: The TOP Registry is a multi-center, all-inclusive observational registry that was established to collect perfusion parameters and post-transplant clinical outcomes for lung transplants performed with donor lungs perfused and assessed on the OCS Lung system in the commercial setting. Methods: Registry outcomes were categorized into three groups according to the prespecified analysis populations: Standard criteria donor (SCD), extended criteria donor (ECD), and Other which included retransplants, multi-organ transplants and single lung recipients. All data were prospectively collected and verified in the Registry database. Results: At time of submission, 318 patients were transplanted using the OCS Lung system. Complete data on 262 OCS recipients was available for analysis. Of these, 70 (26.7%) were SCD, 137 (52.3%) were ECD, and 55 (20.9%) were Other. Donor and recipient characteristics and risk factors were similar between the groups. Kaplan-Meier survival analysis through 1-year post-transplant showed 85.7% for SCD, 82% for ECD, and 80% for Other (p=0.654) Figure 1. Cox regression analysis demonstrated that recipients’ LAS score at transplantation was a significant independent predictor for mortality (p=0.012) Figure 2. Conclusion: This initial report of the TOP Registry shows that the OCS Lung system has been used predominantly in ECD lungs but also in a variety of other scenarios including SCD, multiorgan, retransplants, and single lung transplants. Outcomes in all scenarios were comparable to contemporary lung transplantation in the US with survival determined primarily by the recipient\u27s degree of illness rather than the characteristics of the donor

Impact of OCS Lung Warm Perfusion Times on Post-Transplant Survival - Real-World Experience from Thoracic Organ Perfusion (TOP) Registry

Purpose: The TOP registry is a multi-center, all-inclusive observational registry that was established to collect perfusion parameters and post-transplant clinical outcomes for lung transplants performed with donor lungs perfused and assessed on the OCS Lung system. The current report establishes the association between OCS Lung warm perfusion time and post-transplant survival in the initial TOP Registry cohort. Methods: We evaluated the impact of OCS Lung perfusion time on post-transplant survival in the TOP Registry patient cohort to discern any clinical correlation. We defined 3 clinically relevant time points to analyze. Group A: ≤6 hours of OCS perfusion, Group B: 6-12 hours of OCS perfusion, and Group C: \u3e12 hours of OCS perfusion. Results: Data from 262 OCS lung transplant recipients in the registry were available for analysis. Of these, 70 were standard criteria lungs, 137 were extended criteria including DCD lungs, and 55 were characterized as “other” including single lung, retransplants and multi-organ transplants. There were 129 patients in Group A, 117 patients in Group B, and 12 patients in Group C. The 1-year survival, probability was 83.7% in Group A, 82% in Group B, and 87.5% in Group C Log-rank (p= 0.793 - Figure 1). Conclusion: OCS Lung system perfusion times were associated with good post-transplant survival even when extended beyond 12 hours. This finding has two important clinical implications: (1) the OCS Lung can be utilized to transport and preserve donor lungs from outside the recipients’ standard acceptance radius; and (2) the OCS Lung can be used to perfuse the donor lungs overnight to better manage transplant procedure logistics