A Randomized, Multicenter, Blinded Study Assessing the Effects of Gaseous Nitric Oxide in an Ex Vivo System of Human Lungs

M. G. Hartwig¹, J. A. Klapper¹, N. Poola², A. Banga³, P. G. Sanchez⁴, J. S. Murala³, J. L. Potenziano²

¹Duke University Medical Center, Durham, NC, ²Mallinckrodt Pharmaceuticals, Bedminster, NJ, ³University of Texas Southwestern Medical Center, Dallas, TX, ⁴University of Pittsburgh Medical Center, Pittsburgh, PA

Meeting: 2021 American Transplant Congress

Abstract number: 97

Keywords: Donors, marginal, Lung transplantation, N/A, Nitric oxide

Topic: Clinical Science » Lung » Lung: All Topics

Session Information

Session Name: How to Expect the Unexpected- Incorporating Predictors into Lung Transplant Decision Making

Session Type: Rapid Fire Oral Abstract

Date: Saturday, June 5, 2021

Session Time: 6:00pm-7:00pm

Presentation Time: 6:30pm-6:35pm

Location: Virtual

*Purpose: The effects of nitric oxide (NO) on donor lungs during ex vivo lung perfusion (EVLP) have not been studied. We assessed whether the novel use of gaseous NO (gNO) in discarded human lungs improved lung health during EVLP.

*Methods: This randomized, blinded, parallel, 2-arm, proof-of-concept study compared gNO delivered via the membrane oxygenator on the XVIVO Perfusion System (XPS) (gNO + P) versus the perfusate alone (P). An additional group of lungs were administered inhaled NO (iNO) via the ventilator circuit in open-label fashion (iNO V + P). Enrolled lungs were procured from brain-dead donors that were not suitable for transplantation with or without EVLP. Primary endpoints included a novel grading system for assessing the health of EVLP lungs and total time on EVLP (duration: minimum, 6 hours; maximum, 12 hours). Secondary and exploratory endpoints included clinical assessment of lung suitability for transplantation, left atrium partial pressure of oxygen, change in lung weight, and relevant biomarkers. A Mann-Whitney test was used for between-group comparisons.

*Results: A total of 20 bilateral donor lungs (blinded study, n=16; open-label study, n=4) from 3 study centers were enrolled. Overall, lung mean and median grading system scores were generally the same or higher (indicating a better lung health) in the gNO + P group (median score range [min, max], 0-3.5 [0, 7]) versus the P alone group (median score range [min, max], 0-2.0 [0, 5]; P>0.12 for all between-group comparisons). In the open-label study, median scores were generally lower in the lungs in the iNO V + P group compared with the gNO + P group. Median (min, max) EVLP time was longer for lungs in the gNO + P group compared with the P alone group (12.4 [8.6, 12.6] vs 10.6 [6.0, 12.4] hours, respectively; P=0.01). In the open-label study, median (min, max) EVLP perfusion time was 12.4 (8.7, 13.0) hours in the iNO V + P group versus 12.4 (8.6, 12.6) hours in the gNO + P group (P=0.81).

*Conclusions: Among lungs deemed unacceptable for transplantation, the addition of gNO to the perfusate was associated with longer stability during EVLP on the XPS system. Our results support further investigation of gNO use during EVLP.

To cite this abstract in AMA style:

Hartwig MG, Klapper JA, Poola N, Banga A, Sanchez PG, Murala JS, Potenziano JL. A Randomized, Multicenter, Blinded Study Assessing the Effects of Gaseous Nitric Oxide in an Ex Vivo System of Human Lungs [abstract]. Am J Transplant. 2021; 21 (suppl 3). https://atcmeetingabstracts.com/abstract/a-randomized-multicenter-blinded-study-assessing-the-effects-of-gaseous-nitric-oxide-in-an-ex-vivo-system-of-human-lungs/. Accessed May 16, 2025.

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