(620) First Report of the Transmedics Organ Care System Heart Perfusion Registry. A Multi-Institutional Outcomes Analysis

PurposeExtracorporeal organ perfusion promises to substantially increase the use of donor organs. The TransMedics Organ Care System Heart (OCS) has received FDA approval for use in expanded criteria donation after brain death (DBD) and donation after circulatory death (DCD). The OHP Heart Registry aims to document post-approval practices and outcomes.MethodsWe examined a contemporary observational multi-center registry of transplant recipients of OCS instrumented donor hearts (OCS group) and standard cold storage DBD hearts (Control group) transplanted at the same centers over the same period of time. Data sources were the OHP Registry and the US UNOS database.ResultsBetween September 2021 and September 2022, 636 patients received heart transplant at 28 centers that use OCS. Of these, 412 donor hearts underwent standard cold storage, and 224 of 236 hearts instrumented on OCS were transplanted The utilization rate of OCS instrumented hearts was 94.9% and 35.2% of all transplants at centers using OCS resulted from donor organs perfused on OCS. At submission, data on 150 OCS (60 DBD, 90 DCD), and 285 DBD Control group patients are available in the OHP Registry. Baseline and transplant characteristics are shown in Table 1ABC. Donor-recipient hospital distance was longer in OCS groups compared to Control and higher proportion of OCS DBD (48%) and OCS DCD patients (70%) were transplanted in Status 3-6 compared to Control (31%). Table 1D shows the incidence of primary graft dysfunction (PGD). Survival at 6 months after transplant in OCS groups was similar to Control - Figure 1.ConclusionOne third of transplants at OHP Registry participating centers resulted from OCS perfused donor hearts. OCS perfused hearts were more commonly allocated to lower urgency status patients, indicating improved access to transplantation with OCS. Despite a numerically greater incidence of PGD among OCS DCD vs OCS DBD, survival at 6 months was similar among these patients compared to standard DBD cold storage. Extracorporeal organ perfusion promises to substantially increase the use of donor organs. The TransMedics Organ Care System Heart (OCS) has received FDA approval for use in expanded criteria donation after brain death (DBD) and donation after circulatory death (DCD). The OHP Heart Registry aims to document post-approval practices and outcomes. We examined a contemporary observational multi-center registry of transplant recipients of OCS instrumented donor hearts (OCS group) and standard cold storage DBD hearts (Control group) transplanted at the same centers over the same period of time. Data sources were the OHP Registry and the US UNOS database. Between September 2021 and September 2022, 636 patients received heart transplant at 28 centers that use OCS. Of these, 412 donor hearts underwent standard cold storage, and 224 of 236 hearts instrumented on OCS were transplanted The utilization rate of OCS instrumented hearts was 94.9% and 35.2% of all transplants at centers using OCS resulted from donor organs perfused on OCS. At submission, data on 150 OCS (60 DBD, 90 DCD), and 285 DBD Control group patients are available in the OHP Registry. Baseline and transplant characteristics are shown in Table 1ABC. Donor-recipient hospital distance was longer in OCS groups compared to Control and higher proportion of OCS DBD (48%) and OCS DCD patients (70%) were transplanted in Status 3-6 compared to Control (31%). Table 1D shows the incidence of primary graft dysfunction (PGD). Survival at 6 months after transplant in OCS groups was similar to Control - Figure 1. One third of transplants at OHP Registry participating centers resulted from OCS perfused donor hearts. OCS perfused hearts were more commonly allocated to lower urgency status patients, indicating improved access to transplantation with OCS. Despite a numerically greater incidence of PGD among OCS DCD vs OCS DBD, survival at 6 months was similar among these patients compared to standard DBD cold storage.