Evidence Based Evaluation and Acceptance of Donor Hearts for Transplantation
Condition: Heart Transplantation
Study type: Observational [Patient Registry]

Summary: 
      The proposed research will provide evidence-based strategies for the evaluation and
      acceptance of donor hearts for transplantation. This is relevant to public health because
      judicious expansion of donor hearts used for transplantation will make this life-saving
      procedure available to a larger number of patients living with end-stage heart disease.
    

Detailed description: 
      The demand for donor hearts for transplantation far outstrips the supply; however, only one
      in three available cardiac grafts are used for transplantation. There are many reasons for
      graft non-use, but previous studies have failed to demonstrate consistent associations
      between donor characteristics, donor cardiac function, and adverse recipient outcomes. Thus,
      there is a critical need to standardize how cardiac allografts are evaluated and accepted for
      transplantation. The investigators long-term goal is to safely expand the use of available
      cardiac allografts without adversely affecting transplant recipient outcomes. The
      investigators propose to carefully characterize the current population of cardiac organ
      donors, particularly with regards to allograft function; to examine how decisions are made
      regarding graft acceptance for transplantation; and to systematically evaluate associations
      between donor characteristics and recipient outcomes. The investigators central hypothesis is
      that acceptable allografts for heart transplantation are being unnecessarily discarded, and
      the establishment of an evidence-based process for cardiac donor evaluation and acceptance
      will increase graft utilization rates while maintaining excellent clinical outcomes. In
      response to this need, the investigators propose a collaborative study with seven organ
      procurement organizations representing geographically diverse regions of the United States,
      to address the following specific aims: (1) To identify clinical correlates of graft function
      in potential donors being evaluated for heart transplantation. An existing online donor
      research database will be expanded for standardized collection of data on detailed donor
      characteristics, especially as pertains to cardiac allograft function. The investigators will
      perform expert core review of donor echocardiograms, including serial echocardiograms in
      donors with cardiac allograft dysfunction. Serial electrocardiograms and cardiac biomarkers
      (Troponin I and B-type natriuretic peptide) will also be studied; (2) To prospectively study
      reasons for cardiac allograft non-utilization for heart transplantation. Real-time data will
      be collected on specific reasons for allograft non-acceptance for transplantation in order to
      study graft acceptance practices and variation in graft utilization nationwide; and (3) To
      prospectively study associations between donor characteristics and recipient outcomes after
      heart transplantation. Data will be collected on recipient post-transplant length of
      hospitalization and survival to identify associations between donor predictors and recipient
      outcomes. This proposal is innovative because it focuses on an entirely different approach to
      donor-based research, thereby surmounting the limitations of prior investigations. Completion
      of the proposed study will have a positive impact by defining how to optimize the evaluation
      and use of available grafts for heart transplantation, thereby safely expanding the donor
      pool and increasing the number of heart transplants performed nationwide.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Brain dead donors for heart transplant