Clinical transplantation using negative pressure ventilation ex situ lung perfusion with extended criteria donor lungs

Abstract

Lung transplantation remains the best treatment option for end-stage lung disease; however, is limited by a shortage of donor grafts. Ex situ lung perfusion, also known as ex vivo lung perfusion, has been shown to allow for the safe evaluation and reconditioning of extended criteria donor lungs, increasing donor utilization. Negative pressure ventilation ex situ lung perfusion has been shown, preclinically, to result in less ventilator-induced lung injury than positive pressure ventilation. Here we demonstrate that, in a single-arm interventional study (ClinicalTrials.gov number NCT03293043) of 12 extended criteria donor human lungs, negative pressure ventilation ex situ lung perfusion allows for preservation and evaluation of donor lungs with all grafts and patients surviving to 30 days and recovered to discharge from hospital. This trial also demonstrates that ex situ lung perfusion is safe and feasible with no patients demonstrating primary graft dysfunction scores grade 3 at 72 h or requiring post-operative extracorporeal membrane oxygenation.

Conflict of interest statement

Dr. Jayan Nagendran and Dr. Darren H. Freed are Co-Founders of TEVOSOL Inc. None of the remaining authors have any relationships with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.

Figures

Fig. 1. NPV-ESLP demonstrated stable hemodynamic parameters over the course of perfusion.

Dynamic compliance (Cdyn) (a), pulmonary artery pressure (PAP) (b), transpulmonary pressure (PL) (c), and pulmonary vascular resistance (PVR) (d) over time. Results are expressed as mean ± SE (nT1 = 12, nT2 = 12, nT3 = 5).