Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation

Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.

These lungs will be brought to the study transplant center to be re-assessed by the transplant team. The lungs will be physiologically assessed during ex vivo perfusion with Steen Solution. Perfusion of these lungs will be performed using Steen solution with the addition of methylprednisolone, heparin and antibiotics. With respect to the decision of lung utilization those organs with a delta pO2 (Δ pO2 = Pulmonary vein pO2 - pulmonary artery pO2) during ex vivo perfusion assessment > 350mmHg, good lung compliance, and a favorable opinion of the transplant surgeon will be considered transplantable. Lungs will be excluded for transplantation: if the Δ pO2 is less than 350mmHg or if they demonstrate >10% deterioration in any of the following functional parameters: pulmonary vascular resistance (PVR), dynamic compliance or airway pressures. Lungs will also be excluded if they are deemed unsuitable based on the clinical judgment of the lung transplant surgeon.

Inclusion criteria

for donor lung:

• Recipient to undergo a single or bilateral Lung Transplantation
• Last donor PaO2/FiO2 ≤ 300mmHg
• Poor oxygenation and/or poor lung compliance is the primary reason for unsuitability
• Absence of pneumonia, persistent purulent secretion on bronchoscopy or significant mechanical trauma

Exclusion criteria

• Infection
• Aspiration
• Significant mechanical lung injury - contusion
• Infectious diseases : HIV, Hepatitis B and C, HTLV & Syphilis
• Malignancy