Breathing lung transplantation with the Organ Care System (OCS) Lung: lessons learned and future implications

Abstract

End stage lung diseaseChronic lung disease is the fourth leading cause of death in the United States and is a major health burden worldwide (1). Lung transplant is a treatment option for patients with cystic fibrosis, chronic obstructive pulmonary disease (COPD), interstitial lung disease, pulmonary hypertension and other chronic lung diseases. There are approximately 4,500 lung transplants performed annually world-wide and the number continues to grow (2). Yet there are significant limitations with transplant. One of the biggest challenges is the critical organ shortage. Patients have a 15-30% chance of dying on the waiting list depending on their diagnosis and urgency (3). Currently, only 20% of organ offers are transplanted. Thus, 80% of lungs are discarded. Another challenge is primary graft dysfunction (PGD) which is described below. Finally, the quality of the organ at the time of transplant can contribute to chronic lung allograft dysfunction (CLAD), which occurs in 50% of patients by five years after transplant. PGDUp to 30% of transplanted lungs will develop PGD. PGD is graded from zero to three, with three being the worst category of graft dysfunction. PGD is associated with a high rate of mortality in the hospital and following discharge (4).An important donor risk factor for development of PGD is cigarette smoking. Other risk factors may include aspiration, chest trauma, lung contusions, undersized donors relative to recipient, and heavy alcohol use (5). Recipient risk factors for PGD include pre-transplant lung diseases other than COPD or cystic fibrosis, obesity and pulmonary hypertension. Importantly, prolonged cold ischemic time is associated with PGD. Ex vivo lung perfusion (EVLP)EVLP describes a concept of perfusing and ventilating a donor lung outside of the donor and recipient. Breathing lung transplantation is a form of EVLP. The Organ Care

Pushing the boundaries of innovation: the potential of ex vivo organ perfusion from an interdisciplinary point of view

“…Clinical safety and non-inferiority compared to SCS have been proven in the INSPIRE trial ( 5 ). Moreover, the OCS Lung™ has been evaluated for split lung preservation and ex vivo surgery ( 31 ). FDA approval has been granted for both standard criteria donor and ECD lung preservation, thereby including both DBD and DCD organs.…”

Ex Vivo Lung Perfusion: Current Achievements and Future Directions

“…It is noted in up to 30% of transplanted lungs and is independently associated with a higher risk of mortality. 22 A series of secondary messenger cascades during procurement result in the downstream formation of reactive oxygen species, endothelial dysfunction leading to increased vascular permeability, and the production of inflammatory cytokines. 23 Attempts to minimize the impact of IRI on graft function have been targeted at the innate immune system and reduction of oxidative stress.…”

Decreasing blood wastage during ex vivo lung perfusion recovery through utilization of thermal control technology

“…The OCS Lung is currently the only United States Food and Drug Administration-approved, portable, normothermic lung perfusion system used to recover standard and expanded criteria donor lungs. [6][7][8] Current EVLP systems use a variety of perfusates. 9,10 OCS Lung uses packed red blood cells (pRBC) diluted in OCS Lung solution.…”

“…The Organ Care System (OCS) (TransMedics) is one type of revolutionary EVLP technology that can expand the organ retrieval range. The OCS Lung is currently the only United States Food and Drug Administration‐approved, portable, normothermic lung perfusion system used to recover standard and expanded criteria donor lungs 6–8 …”

“…The OCS Lung is currently the only United States Food and Drug Administration‐approved, portable, normothermic lung perfusion system used to recover standard and expanded criteria donor lungs. 6 , 7 , 8 …”