Initial Successful Clinical Transplantation Using Negative Pressure Ventilation Ex-Situ Lung Perfusion with Extended Criteria Donor Lungs

Abstract

Ex-situ lung perfusion has been shown to allow for the safe evaluation and reconditioning of extended criteria donor (ECD) lungs. Negative pressure ventilation ex-situ lung perfusion (NPV-ESLP) has been shown, preclinically, to develop less ventilator-induced lung injury than positive pressure ventilation (PPV). We report the first clinical experience utilizing NPV-ESLP for the assessment, preservation, and transplantation of ECD lungs. Twelve patients were transplanted using extended criteria donor lungs. Following standard procurement of ECD lungs the organs underwent assessment and reconditioning using the NPV-ESLP device prior to implantation. Lungs were perfused with Steen solution and red blood cell concentrate. Donor and recipient characteristics including PGD scores at 0, 24, 48, and 72 hours, time to extubation, length of ICU and hospital stay, requirements for extracorporeal membrane oxygenation, and graft and patient survival. Nine out of twelve of the donors involved donation after neurologic determination of death (NDD), while the other three were donation after circulatory determination of death (DCD). The average pre-procurement donor P:F ratio was 234 ± 38 mmHg. Among the nine NDD donors, the average pre-procurement donor P:F ratio was 174 ± 24 mmHg. The average final P:F ratio on the NPV-ESLP device was 540 ± 28 mmHg. The mean duration of ESLP was 182 ± 11 mins. The average recipient P:F ratio at 72 hours post-op was 407 ± 69 mmHg. No patients had a Primary Graft Dysfunction (PGD) Score of 3 at 72 hours and none required post-operative extracorporeal membrane oxygenation. All grafts and patients survived to 30 days and recovered to discharge from hospital. NPV-ESLP demonstrates safe preservation, evaluation, and successful clinical transplantation of extended criteria donor lungs. Further validation of this initial cohort is ongoing and will require large scale pivotal clinical trials to determine overall efficacy.