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Portable normothermic ex-vivo lung perfusion, ventilation, and functional assessment with the Organ Care System on donor lung use for transplantation from extended-criteria donors (EXPAND): A single-arm, pivotal trial

The Lancet Respiratory Medicine Oct 31, 2019

Loor G, Warnecke G, Villavicencio MA, et al. - Researchers undertook this single-arm, pivotal trial named as the EXPAND trial in eight institutions across the USA, Germany, and Belgium, to assess the effectiveness of normothermic portable Organ Care System (OCS) Lung perfusion and ventilation on donor lung use from extended-criteria donors and donors following circulatory death. This study included adult bilateral lung transplant recipients and transplantation of lungs was done if they demonstrated stability of OCS Lung variables, partial pressure of arterial oxygen:fractional concentration of oxygen inspired air more than 300 mm Hg, and they were accepted by the transplanting surgeon. A composite of patient survival at day 30 after transplant and lack of The International Society for Heart & Lung Tranplantation primary-graft dysfunction grade 3 within 72 h following transplantation, with a prespecified objective performance goal of 65%, was considered as the primary efficacy endpoint. Although the objective primary endpoint was missed, a 87% donor lung use for transplantation resulted from the portable OCS Lung, with excellent clinical results. This novel technology allowed successful transplantation of many lungs that were declined by other transplant centres, indicating its potential to raise the number of lung transplants done worldwide.
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