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.