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Review
. 2025 Apr 30;17(4):1832-1843.
doi: 10.21037/jtd-2024-2069. Epub 2025 Apr 27.

North American expert consensus on the clinical role of ex vivo lung perfusion (EVLP) with acellular perfusate

Matthew Bacchetta  1 , Christian A Bermudez  2 , Ankit Bharat  3 , A Whitney Brown  4 , Marie M Budev  5 , Marcelo Cypel  6 , Caitlin T Demarest  7 , Daniel F Dilling  8 , Bartley P Griffith  9 , John C Haney  10 , Shaf Keshavjee  6 , Zachary N Kon  11 , Tiago N Machuca  12 , Jorge M Mallea  13 , Si M Pham  11 , Thomas K Waddell  6 , Bryan A Whitson  14 , Kenneth R McCurry  15
Affiliations
Review

North American expert consensus on the clinical role of ex vivo lung perfusion (EVLP) with acellular perfusate

Matthew Bacchetta et al. J Thorac Dis. .

Abstract

Background: Ex vivo lung perfusion (EVLP) of donor lungs not otherwise acceptable for transplantation can provide outcomes similar to standard-criteria lung transplantation and has been reported to increase transplant volume by approximately 20% in some transplant centers. Evidence to support decisions about use of EVLP is limited, so expert opinion can be a useful decision aid. This study developed expert consensus recommendations for EVLP with acellular perfusate using a modified Delphi method.

Methods: A panel of 18 physicians with expertise in lung transplantation and EVLP who practice in North America completed three surveys on EVLP: Survey 1 used open-ended questions; Survey 2 used primarily Likert-scale questions; and Survey 3 repeated Survey 2 while providing panelists with the Survey 2 results. A follow-up meeting after Survey 3 probed open questions.

Results: The primary goal for EVLP is expanding the number of donor lungs available for transplant. Lungs that are acceptable after EVLP are equivalent to lungs that met standard criteria initially. Lungs with unclear or marginal quality should be placed on EVLP for evaluation, including lungs received from third party organizations with incomplete or concerning information. Decisions on whether to put lungs on EVLP require nuanced clinical judgement and should consider compliance and deflation, the ratio of PaO2 to fraction of inspired oxygen (P/F ratio), peak inspiratory pressure (PIP), edema on imaging, and bronchoscopy, with additional parameters considered as appropriate if lung quality is unclear. EVLP lungs are appropriate for transplant if all relevant parameters are acceptable and may be appropriate if some parameters are borderline depending on clinical judgment. Decisions about transplanting EVLP lungs should consider radiography, delta PO2, overall movement, STEEN Solution™ loss, bronchoscopy, peak airway pressure, and palpation, along with other parameters as appropriate. Key open areas for research include evidence-based criteria for lung selection and assessment, the role of biomarkers, and enhanced techniques and perfusion solutions. In addition, the role of EVLP is unclear in lungs with pulmonary emboli and lungs procured with normothermic regional perfusion (NRP), as is the maximal duration of cold ischemia time (CIT).

Conclusions: Decisions about EVLP require nuanced consideration of numerous parameters. Expert opinion from this study may help optimize use of EVLP.

Keywords: Lung transplant; acellular perfusate; donor lung evaluation; ex vivo lung perfusion (EVLP).

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Conflict of interest statement

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2024-2069/coif). B.A.W. serves as an unpaid editorial board member of Journal of Thoracic Disease from August 2023 to July 2025. All authors report that the study was sponsored and supported by Lung Bioengineering, Inc. M.B. has received grants from the National Institutes of Health, Congressionally Directed Medical Research Programs, and Cystic Fibrosis Foundation; is a board member for Xylyx Bio, Inc. and the Chief Medical Officer (unpaid, no intellectual property, patents, nor stock) for ART, Inc.; and holds several issued or pending patents related to EVLP and transplantation. C.A.B. has received consulting fees for serving on medical advisory boards for Abbot and Abiomed. A.W.B. has received grants from and is a part-time employee of the Cystic Fibrosis Foundation, received consulting fee from Lung Bioengineering, Inc., and has served as a volunteer on the OPTN Lung Transplantation Committee Region 2 and the OPTN Lung Exception Review Board. M.M.B. has participated on an advisory board for Lung Bioengineering, Inc. and Transmedics, Inc., and has held leadership roles as the UNOS Lung Committee Chair and on the UNOS Multiorgan Committee and UNOS Placement Efficiency Taskforce. M.C. has acted as a consultant for Lung Bioengineering, Inc., Incyte, and Avivo, and is the Chief Scientific Officer for and a shareholder in Traferox Technologies Inc. S.K. is the Chief Medical Officer for Traferox Technologies Inc., a consultant for United Therapeutics Corp., Lung Bioengineering, Inc., CareDx, Abbott, and CSL Behring, and holds pending or issued patents on EVLP technologies and lung diagnostic biomarkers. Z.N.K. is the Chief Executive Officer of ProCure On-Demand, Inc. He holds stock in ProCure On-Demand, Inc. and notes that Lung Bioengineering, Inc. is a minority investor. J.M.M. has consulted for Lung Bioengineering, Inc. (payments made to the Mayo Clinic, his employer). T.K.W.’s institution has received research grants and royalties or licenses from United Therapeutics Corp. He has received consulting fees from Lung Bioengineering, Inc., and has several patents related to EVLP. He is a founder of Traferox Technologies, Inc., and holds stock and stock options in the company. B.A.W. has received grants from the National Institutes of Health and participated on the Clinical Events Committee for Transmedics Inc. K.R.M. has received royalties related to intellectual property from XVIVO; received lecture honoraria from Lung Bioengineering Inc. and XVIVO; and received support for attending meetings from XVIVO; holds pending or issued patents related to lung evaluation and EVLP; has a volunteer leadership role on the UNOS/OPTN Board of Directors; and has stock or stock options in TransMedics, Inc. The authors have no other conflicts of interest to declare.

Figures

Figure 1
Figure 1
Panelists’ categorization of selected parameters as always, sometimes, or never considered in decisions about putting lungs on EVLP. CIT1, cold ischemia time 1; DBD, donation after brain death; DCD, donation after cardiocirculatory death; EVLP, ex vivo lung perfusion; P/F ratio, the ratio of PaO2 to fraction of inspired oxygen.
Figure 2
Figure 2
Recommended approach to decision making for putting donated lung(s) on EVLP, based on areas of agreement among expert panel members. CIT1, cold ischemia time 1; DBD, donation after brain death; DCD, donation after cardiocirculatory death; EVLP, ex vivo lung perfusion; P/F ratio, the ratio of PaO2 to fraction of inspired oxygen; PIP, peak inspiratory pressure; WIT, warm ischemia time.
Figure 3
Figure 3
Panelists’ categorization of selected parameters as always, sometimes, or never considered in decisions about transplanting lungs on EVLP. EVLP, ex vivo lung perfusion; PVR, pulmonary vascular resistance; LA, left atrial; CIT2, cold ischemia time 2.
Figure 4
Figure 4
Panelists’ categorization of the maximum acceptable CIT1 and CIT2 times for standard and 10 ℃ storage conditions. CIT1, cold ischemia time 1; CIT2, cold ischemia time 2.
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