Heart EXPAND Continued Access Protocol

Inclusion Criteria (DONOR):

At least one of the following:

* Expected total cross-clamp time of ≥ 4 hours
* Expected total cross-clamp time of ≥ 2 hours PLUS one or more of the following risk factors Donor age 45-55 years, inclusive, with no coronary catheterization data; or Donor age ≥ 55 years; or Left ventricular septal or posterior wall thickness of \>12 mm, but ≤ 16 mm; or Reported down time of ≥ 20 min, with stable hemodynamics at time of final assessment; or Left heart ejection fraction (EF) ≥ 40%, but ≤ 50% at time of acceptance of offer; or Donor angiogram with luminal irregularities with no significant CAD (≤ 50%); or History of carbon monoxide poisoning with good cardiac function at time of donor assessment; or Social history of alcoholism with good cardiac function at time of donor assessment; or History of diabetes without significant CAD (≤ 50%) on angiogram.

Exclusion

* CAD with \> 50% stenosis on angiogram, or
* Cardiogenic shock or myocardial infarction, or
* EF consistently \< 40%, or
* Significant valve disease except for competent bicuspid aortic valve.

Eligibility Criteria (RECIPIENT)

* Registered primary heart transplant candidate
* Age \>18 years old
* Written informed consent. Exclusion
* Prior solid organ or bone marrow transplant
* Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal insufficiency requiring dialysis
* Multi-organ transplant.