Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation (PROCEEDII)

• Incidence of all cardiac graft-related serious adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
• Incidence of biopsy proven ISHLT grade 2R or 3R acute rejection on any of the surveillance endomyocardial biopsies or clinically symptomatic rejection requiring augmentation of immunosuppressive therapy during the 30 day follow up [ Time Frame: 30 day ] [ Designated as safety issue: No ]
• Length of ICU stay [ Time Frame: 30 day ] [ Designated as safety issue: No ]

The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were transplanted with donated hearts using the Organ Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused beating state. The study also compares the number of rejection episodes, heart related adverse events, ICU time, and ventilation time between the two groups. The study is considered a success if survival in the OCS group was not inferior to the ice group.

• Device: Organ Care System
  The Organ Care System (OCS) is a portable organ perfusion and monitoring system intended to preserve a donated heart in a near normal physiologic beating state during transport for eventual transplantation into a recipient. The OCS maintains organ viability by providing a controlled environment that simulates near-normal physiological conditions, continuously perfusing the donated heart with warm, oxygenated blood, supplemented with the Solution Set. The blood is collected from the donor and continuously circulated to the organ in a closed circuit along with the Solution. The OCS preserves and monitors the organ's perfusion and metabolic state after explantation from a donor and connection to the device, during transportation to the recipient site, and until disconnection from the device.
  Other Name: OCS
• Device: Cold Cardioplegia Solution
  This is the standard of care solutions used to arrest and preserve the donated heart during transport until arrival at recipient hospital

• Experimental: Organ Care System
  Intervention: Device: Organ Care System
• Active Comparator: Cold cardioplegia solution
  Intervention: Device: Cold Cardioplegia Solution

Inclusion Criteria:

Recipient Day of Transplant

• Registered male or female primary heart transplant candidate
• ≥18 years old
• Signed, written informed consent document and authorization to use and disclose protected health information

Donor Hearts

• <60 years old
• Mean systolic blood pressure >60 mmHg at the time of final heart assessment
• Satisfactory echocardiography assessment defined as:
• Ejection fraction >40%
• Absence of severe segmental wall motion abnormalities
• Absence of left ventricular hypertrophy (inter ventricular septum and posterior wall thickness <1.3 cm)
• Absence of valve abnormalities (trace to mild valvular regurgitation is acceptable)

Exclusion Criteria:

Recipient Day of Transplant

• >4 previous sternotomies
• Chronic renal failure as defined by chronic serum creatinine >3.0 mg/dL for more than 2 weeks and/or requiring hemodialysis (except for hemodialysis or hemofiltration for fluid overload)
• Ventilator dependence at the time of transplant
• Use of a ventricular assist device for > 30 days and the presence of any of the following: sepsis, intracranial hemorrhage or heparin induced thrombocytopenia
• Panel reactive antibodies > 40% with a positive prospective cross match and/or virtual cross match
• Use of an investigational drug or device, other than OCS, during the study.
• Simultaneous transplant of non-heart allograft, except for concurrent kidney transplant

Donor Hearts

• Abnormal coronary angiogram defined as >50% stenosis, requiring coronary bypass
• Donor-to-recipient body weight ratio of <0.6

• Inotrope support at time of final heart assessment including, but not limited to:

  • Dopamine >10 ug/kg/min
  • Dobutamine > 10 ug/kg/min
  • Milrinone >0.3 ug/kg/min
  • Epinephrine > 0.03 ug/kg/min
  • Norepinephrine > 0.03 ug/kg/min
  • Any bolus dose of the above prior to explants that would result in exceeding the above stated criteria
• Presence of any exclusion criterion based on the standard practice of the investigational site

• University of California, Los Angeles
• Columbia University
• The Cleveland Clinic
• Massachusetts General Hospital
• Newark Beth Israel Medical Center
• Cedars-Sinai Medical Center
• Groupe Hospitalier Pitie-Salpetriere
• Papworth Hospital
• Azienda Ospedaliera S. Maria della Misericordia