Long-term outcomes of the international EXPAND trial of Organ Care System (OCS) Lung preservation for lung transplantationResearch in context

Summary: Background: Portable ex vivo lung perfusion and ventilation with the Organ Care System (OCS) Lung system is a safe, effective method for preserving extended criteria donor (ECD) organs before transplant. Although this technology is increasingly used in the United States, no published data...

Full description

Saved in:
Bibliographic Details
Main Authors: Gabriel Loor, Gregor Warnecke, Mauricio A. Villavicencio, Michael A. Smith, Xiang Zhou, Jasleen Kukreja, Abbas Ardehali, Matthew G. Hartwig, Mani Ali Daneshmand, Marshall I. Hertz, Stephen J. Huddleston, Axel Haverich, Joren C. Madsen, Arne Neyrinck, Dirk Van Raemdonck
Format: Article
Language:English
Published: Elsevier 2025-07-01
Series:EClinicalMedicine
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2589537025002664
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1849429735683129344
author Gabriel Loor
Gregor Warnecke
Mauricio A. Villavicencio
Michael A. Smith
Xiang Zhou
Jasleen Kukreja
Abbas Ardehali
Matthew G. Hartwig
Mani Ali Daneshmand
Marshall I. Hertz
Stephen J. Huddleston
Axel Haverich
Joren C. Madsen
Arne Neyrinck
Dirk Van Raemdonck
author_facet Gabriel Loor
Gregor Warnecke
Mauricio A. Villavicencio
Michael A. Smith
Xiang Zhou
Jasleen Kukreja
Abbas Ardehali
Matthew G. Hartwig
Mani Ali Daneshmand
Marshall I. Hertz
Stephen J. Huddleston
Axel Haverich
Joren C. Madsen
Arne Neyrinck
Dirk Van Raemdonck
author_sort Gabriel Loor
collection DOAJ
description Summary: Background: Portable ex vivo lung perfusion and ventilation with the Organ Care System (OCS) Lung system is a safe, effective method for preserving extended criteria donor (ECD) organs before transplant. Although this technology is increasingly used in the United States, no published data describe its effects on long-term graft function and patient outcomes. This study assessed long-term clinical outcomes after transplantation of ECD lungs that were preserved, recruited, and assessed with the OCS Lung. Methods: The EXPAND Lung Trial was a prospective, single-arm, multicenter, international trial conducted between January 2014 and July 2016; 5-year follow-up data were collected until December 2021. Double-lung donors were included who met any of four ECD criteria: age ≥55 years, PaO2/FiO2 ≤300 mmHg, expected ischemic time >6 h, and donation after circulatory death (DCD). Transplant recipients’ overall survival and 5-year incidence of bronchiolitis obliterans syndrome (BOS) were compared between the EXPAND cohort (n = 79) and a control cohort from the same centers within the same time period, who received donor lungs preserved with ice but not OCS (n = 644). This study is registered with ClinicalTrials.gov (NCT04194398). Findings: Overall survival was similar between the EXPAND and control cohorts; 5-year overall survival was 68.1% versus 66.5%, respectively (P = 0.795). The risk factors associated with overall survival were the degree of urgency for lung transplant and recipient age; 5-year survival was much greater for patients designated as non-urgent than for patients designated as urgent (73% versus 41%, P = 0.021). 5-Year BOS3-free survival was 60.4% for the EXPAND cohort and 63.7% for the control cohort (P = 0.599). Overall survival, development of BOS3, and development of any grade of BOS did not differ between the EXPAND and control cohorts. Interpretation: Among patients who underwent lung transplantation with ECD lungs, the use of OCS Lung resulted in excellent long-term clinical outcomes. This study's findings support the use of OCS Lung to expand the donor pool and provide a foundation for future studies comparing lung-preservation strategies. Funding: This study was funded by TransMedics.
format Article
id doaj-art-c4fd693575954a628422ebff066945b9
institution Kabale University
issn 2589-5370
language English
publishDate 2025-07-01
publisher Elsevier
record_format Article
series EClinicalMedicine
spelling doaj-art-c4fd693575954a628422ebff066945b92025-08-20T03:28:14ZengElsevierEClinicalMedicine2589-53702025-07-018510333410.1016/j.eclinm.2025.103334Long-term outcomes of the international EXPAND trial of Organ Care System (OCS) Lung preservation for lung transplantationResearch in contextGabriel Loor0Gregor Warnecke1Mauricio A. Villavicencio2Michael A. Smith3Xiang Zhou4Jasleen Kukreja5Abbas Ardehali6Matthew G. Hartwig7Mani Ali Daneshmand8Marshall I. Hertz9Stephen J. Huddleston10Axel Haverich11Joren C. Madsen12Arne Neyrinck13Dirk Van Raemdonck14Division of Cardiothoracic Surgery, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, USA; Department of Cardiovascular Surgery, The Texas Heart Institute, Houston, TX, USA; Corresponding author. Baylor St. Luke's Medical Center, 6770 Bertner Avenue, Suite C-355K, Houston, TX, 77030, USA.Department of Cardiac Surgery, University Schleswig-Holstein (UKSH) Campus Kiel, Kiel, GermanyDepartment of Cardiovascular Surgery, Mayo Clinic, Rochester, MN, USADepartment of General Thoracic Surgery, St. Joseph's Medical Center, Phoenix, AZ, USATransMedics Inc, Andover, MA, USADivision of Cardiothoracic Surgery, University of California San Francisco, San Francisco, CA, USADivision of Cardiothoracic Surgery, Department of Surgery, Ronald Reagan University of California, Los Angeles Medical Center, Los Angeles, CA, USADivision of Cardiovascular and Thoracic Surgery, Duke University Medical Center, Durham, NC, USADivision of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, GA, USADepartment of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota, Minneapolis, MN, USADivision of Cardiothoracic Surgery, University of Minnesota, Minneapolis, MN, USADepartment of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, GermanyMassachusetts General Transplant Center and Department of Cardiac Surgery, Massachusetts General Hospital, Boston, MA, USADepartment of Anaesthesiology, University Hospitals Leuven, BelgiumDepartment of Thoracic Surgery, University Hospitals Leuven, Leuven, BelgiumSummary: Background: Portable ex vivo lung perfusion and ventilation with the Organ Care System (OCS) Lung system is a safe, effective method for preserving extended criteria donor (ECD) organs before transplant. Although this technology is increasingly used in the United States, no published data describe its effects on long-term graft function and patient outcomes. This study assessed long-term clinical outcomes after transplantation of ECD lungs that were preserved, recruited, and assessed with the OCS Lung. Methods: The EXPAND Lung Trial was a prospective, single-arm, multicenter, international trial conducted between January 2014 and July 2016; 5-year follow-up data were collected until December 2021. Double-lung donors were included who met any of four ECD criteria: age ≥55 years, PaO2/FiO2 ≤300 mmHg, expected ischemic time >6 h, and donation after circulatory death (DCD). Transplant recipients’ overall survival and 5-year incidence of bronchiolitis obliterans syndrome (BOS) were compared between the EXPAND cohort (n = 79) and a control cohort from the same centers within the same time period, who received donor lungs preserved with ice but not OCS (n = 644). This study is registered with ClinicalTrials.gov (NCT04194398). Findings: Overall survival was similar between the EXPAND and control cohorts; 5-year overall survival was 68.1% versus 66.5%, respectively (P = 0.795). The risk factors associated with overall survival were the degree of urgency for lung transplant and recipient age; 5-year survival was much greater for patients designated as non-urgent than for patients designated as urgent (73% versus 41%, P = 0.021). 5-Year BOS3-free survival was 60.4% for the EXPAND cohort and 63.7% for the control cohort (P = 0.599). Overall survival, development of BOS3, and development of any grade of BOS did not differ between the EXPAND and control cohorts. Interpretation: Among patients who underwent lung transplantation with ECD lungs, the use of OCS Lung resulted in excellent long-term clinical outcomes. This study's findings support the use of OCS Lung to expand the donor pool and provide a foundation for future studies comparing lung-preservation strategies. Funding: This study was funded by TransMedics.http://www.sciencedirect.com/science/article/pii/S2589537025002664Ex vivo lung perfusionLung transplantationBronchiolitis obliterans syndromeChronic lung allograft dysfunctionPrimary graft dysfunctionDonation after circulatory death
spellingShingle Gabriel Loor
Gregor Warnecke
Mauricio A. Villavicencio
Michael A. Smith
Xiang Zhou
Jasleen Kukreja
Abbas Ardehali
Matthew G. Hartwig
Mani Ali Daneshmand
Marshall I. Hertz
Stephen J. Huddleston
Axel Haverich
Joren C. Madsen
Arne Neyrinck
Dirk Van Raemdonck
Long-term outcomes of the international EXPAND trial of Organ Care System (OCS) Lung preservation for lung transplantationResearch in context
EClinicalMedicine
Ex vivo lung perfusion
Lung transplantation
Bronchiolitis obliterans syndrome
Chronic lung allograft dysfunction
Primary graft dysfunction
Donation after circulatory death
title Long-term outcomes of the international EXPAND trial of Organ Care System (OCS) Lung preservation for lung transplantationResearch in context
title_full Long-term outcomes of the international EXPAND trial of Organ Care System (OCS) Lung preservation for lung transplantationResearch in context
title_fullStr Long-term outcomes of the international EXPAND trial of Organ Care System (OCS) Lung preservation for lung transplantationResearch in context
title_full_unstemmed Long-term outcomes of the international EXPAND trial of Organ Care System (OCS) Lung preservation for lung transplantationResearch in context
title_short Long-term outcomes of the international EXPAND trial of Organ Care System (OCS) Lung preservation for lung transplantationResearch in context
title_sort long term outcomes of the international expand trial of organ care system ocs lung preservation for lung transplantationresearch in context
topic Ex vivo lung perfusion
Lung transplantation
Bronchiolitis obliterans syndrome
Chronic lung allograft dysfunction
Primary graft dysfunction
Donation after circulatory death
url http://www.sciencedirect.com/science/article/pii/S2589537025002664
work_keys_str_mv AT gabrielloor longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext
AT gregorwarnecke longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext
AT mauricioavillavicencio longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext
AT michaelasmith longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext
AT xiangzhou longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext
AT jasleenkukreja longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext
AT abbasardehali longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext
AT matthewghartwig longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext
AT manialidaneshmand longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext
AT marshallihertz longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext
AT stephenjhuddleston longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext
AT axelhaverich longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext
AT jorencmadsen longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext
AT arneneyrinck longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext
AT dirkvanraemdonck longtermoutcomesoftheinternationalexpandtrialoforgancaresystemocslungpreservationforlungtransplantationresearchincontext