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Does preimplantation short-term reconditioning of kidney grafts using oxygenated hypothermic machine perfusion for at least 2 hours after an initial period of static cold storage lead to an improvement of 1-year graft survival in kidneys retrieved from expanded criteria donors?
In this randomized clinical trial of 305 kidneys, 1-year graft survival was equal between kidneys that were machine perfused following static cold storage and kidneys that remained on static cold storage prior to implantation without oxygenated hypothermic machine perfusion.
These findings suggest that the use of oxygenated hypothermic machine perfusion prior to implantation and following a period of static cold storage does not improve graft survival or kidney function in kidneys retrieved from donors who are brain dead meeting the expanded donor criteria.
Continuous hypothermic machine perfusion during organ preservation has a beneficial effect on graft function and survival in kidney transplant when compared with static cold storage (SCS).
To compare the effect of short-term oxygenated hypothermic machine perfusion preservation (end-HMPo2) after SCS vs SCS alone on 1-year graft survival in expanded criteria donor kidneys from donors who are brain dead.
Design, Setting, and Participants
In a prospective, randomized, multicenter trial, kidneys from expanded criteria donors were randomized to either SCS alone or SCS followed by end-HMPo2 prior to implantation with a minimum machine perfusion time of 120 minutes. Kidneys were randomized between January 2015 and May 2018, and analysis began May 2019. Analysis was intention to treat.
On randomization and before implantation, deceased donor kidneys were either kept on SCS or placed on HMPo2.
Main Outcome and Measures
Primary end point was 1-year graft survival, with delayed graft function, primary nonfunction, acute rejection, estimated glomerular filtration rate, and patient survival as secondary end points.
Centers in 5 European countries randomized 305 kidneys (median [range] donor age, 64 [50-84] years), of which 262 kidneys (127 [48.5%] in the end-HMPo2 group vs 135 [51.5%] in the SCS group) were successfully transplanted. Median (range) cold ischemia time was 13.2 (5.1-28.7) hours in the end-HMPo2 group and 12.9 (4-29.2) hours in the SCS group; median (range) duration in the end-HMPo2 group was 4.7 (0.8-17.1) hours. One-year graft survival was 92.1% (n = 117) in the end-HMPo2 group vs 93.3% (n = 126) in the SCS group (95% CI, −7.5 to 5.1; P = .71). The secondary end point analysis showed no significant between-group differences for delayed graft function, primary nonfunction, estimated glomerular filtration rate, and acute rejection.
Conclusions and Relevance
Reconditioning of expanded criteria donor kidneys from donors who are brain dead using end-HMPo2 after SCS does not improve graft survival or function compared with SCS alone. This study is underpowered owing to the high overall graft survival rate, limiting interpretation.
isrctn.org Identifier: ISRCTN63852508
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Corresponding Author: Peri Husen, MD, Department of General, Visceral and Transplantation Surgery, University Hospital Essen, Hufelandstr 55, 45122 Essen, Germany (email@example.com).
Accepted for Publication: January 19, 2021.
Published Online: April 21, 2021. doi:10.1001/jamasurg.2021.0949
Author Contributions: Drs Husen, Paul, and Ploeg had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Ploeg and Paul contributed equally.
Concept and design: Husen, Jochmans, Knight, Ablorsu, Pratschke, Mathe, Leuvenink, Minor, Ploeg.
Acquisition, analysis, or interpretation of data: Husen, Boffa, Jochmans, Krikke, Davies, Mazilescu, Brat, Knight, Wettstein, Cseprekal, Banga, Bellini, Szabo, Darius, Quiroga, Mourad, Pratschke, Papalois, Mathe, Pirenne, Ploeg, Paul.
Drafting of the manuscript: Husen, Davies, Mazilescu, Cseprekal, Ablorsu, Darius, Mathe, Leuvenink, Ploeg, Paul.
Critical revision of the manuscript for important intellectual content: Husen, Boffa, Jochmans, Krikke, Brat, Knight, Wettstein, Banga, Bellini, Szabo, Darius, Quiroga, Mourad, Pratschke, Papalois, Mathe, Minor, Pirenne, Ploeg, Paul.
Statistical analysis: Husen, Davies.
Obtained funding: Husen, Ploeg.
Administrative, technical, or material support: Husen, Boffa, Mazilescu, Brat, Knight, Wettstein, Cseprekal, Banga, Bellini, Szabo, Ablorsu, Darius, Quiroga, Mourad, Pratschke, Papalois, Mathe, Minor, Ploeg, Paul.
Supervision: Husen, Jochmans, Knight, Darius, Quiroga, Pratschke, Papalois, Mathe, Leuvenink, Ploeg, Paul.
Conflict of Interest Disclosures: Dr Husen reports grants from European Union 7th Framework Programme during the conduct of the study. Dr Boffa reports other support from Astellas Pharma outside the submitted work. Dr Jochmans reports grants from European Union 7th Framework Programme during the conduct of the study and other support from European Society for Organ Transplantation and European Association for the Study of the Liver outside the submitted work. Dr Knight reports personal fees from OrganOx for clinical trial design outside the submitted work. Dr Leuvenink reports grants from European Union 7th Framework Programme during the conduct of the study. Dr Minor reports grants from the European Union during the conduct of the study. No other disclosures were reported.
Funding/Support: The trial was funded by the European Union 7th Framework Programme (Theme Health.2012.1.4-1, grant agreement 305934). Perfusion devices and disposables were obtained from Organ Assist. MedAssist provided logistical support in terms of delivery and collection of devices, disposables, and samples.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Contributions: This trial was conducted by the members of the Consortium for Organ Preservation in Europe. We thank the European Commission for their funding through the Seventh Framework Programme. We also thank Timothy Boland (trial management); Ally Bradley (trial management); Virginia Chiocchia, MSc (statistical analysis); Katherine Corr (trial management) (Nuffield Department of Surgical Sciences, University of Oxford, UK); H. Sijbrand Hofker, MD (local trial coordination) (Department of Surgery, University Medical Center Groningen, the Netherlands); Undine Gerlach, MD (local trial coordination) (Department of Surgery, Charité, Berlin, Germany); Halil Karadag, MD (sample collection) (Department of General, Visceral and Transplantation Surgery, University Hospital Essen, Germany); Martin Kuizenga (assistance in machine preservation) (OrganAssist, the Netherlands); Rajeev Kumar, PhD (database management); Margaux Laspeyres, MA (trial management) (Nuffield Department of Surgical Sciences, University of Oxford, UK); Sarah Mertens (data collection and local coordination) (Transplant Research Group, Laboratory of Abdominal Transplantation, Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium); Bhumika Patel (biobank management) (Nuffield Department of Surgical Sciences, University of Oxford, UK); and Marianne Thijssen-Grooten (logistics support) (MedAssist, the Netherlands) for their support. We are indebted to the members of the data monitoring committee: Christopher J. E. Watson, MD (chair) (University of Cambridge, UK); Josep M Grinyó, MD (University of Barcelona, Spain); Gabriel C Oniscu, MD (Royal Infirmary of Edinburgh, UK); and Susan Charman, BSc, Dip Ed, MSc (London, UK), as well as to all our patients, the donors and their families. These individuals were not compensated.
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