Heart EXPAND Continued Access Protocol

Inclusion Criteria

• •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.