Abstract
<h3>Purpose</h3> Organ Care System (OCS, Transmedics Inc) is the first clinically available system for ex-vivo normothermic heart perfusion. OHP Registry is a prospective real-world registry of Donation after Brain Death (DBD) or Donation after Circulatory Death (DCD) heart transplantation in hearts perfused and assessed on OCS Heart. OHP Registry will collect OCS ex-vivo perfusion & assessment parameters and post-transplant short & long-term clinical outcomes of heart transplant recipients in the U.S. <h3>Methods</h3> All adult heart transplant recipients of DBD or DCD heart allografts perfused and assessed on OCS Heart technology will be included, along with data on hearts perfused and assessed on OCS Heart but not transplanted. OCS Heart perfusion and assessment parameters will be prospectively collected. All recipients will be followed up to 5 years post-transplant. Patient and graft survival will be compared to a UNOS/SRTR cohort of heart transplant recipients of cold stored donor hearts transplanted at the same OHP Registry centers over the same period of time. <h3>Results</h3> Endpoints: Patient and graft survival at 1, 2, 3, 4, 5 years post-transplantation. Incidence of moderate or severe heart primary graft dysfunction (left or right ventricle) defined according to ISHLT 2014 consensus definitions. OCS Heart utilization rate defined as the number of hearts transplanted by OCS perfusion and assessment, divided by the total number of hearts perfused and assessed on the OCS Heart System. <h3>Conclusion</h3> We anticipate analyses of OHP Registry will provide important data that will inform clinical care. We plan to present regular updates at future ISHLT Annual Meetings.
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