Abstract
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.
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.
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.
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's degree of illness rather than the characteristics of the donor.