Peri Husen1, Catherine Boffa2, Ina Jochmans3,4, Christina Krikke5, Lucy Davies2, Laura Mazilescu1, Aukje Brat5, Simon Knight2, Daniel Wettstein6, Orsolya Cseprekal6,7, Neal Banga8, Maria Irene Bellini9, Laszlo Szabo10, Elijah Ablorsu10, Tom Darius11, Isabel Quiroga12, Michel Mourad11, Johann Pratschke13, Vassilios Papalois14, Zoltan Mathe6,15, Henri G D Leuvenink5, Thomas Minor1, Jacques Pirenne3,4, Rutger J Ploeg2, Andreas Paul1. 1. Department of General, Visceral and Transplantation Surgery, University Hospital Essen, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany. 2. Nuffield Department of Surgical Sciences, University of Oxford, United Kingdom. 3. Transplant Research Group, Laboratory of Abdominal Transplantation, Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium. 4. Abdominal Transplant Surgery, University Hospitals Leuven, Leuven, Belgium. 5. Department of Surgery, University Medical Center Groningen, the Netherlands. 6. Department of Transplantation and Surgery, Semmelweis University, Budapest, Hungary. 7. International Nephrology Research and Training Center (INRTC), Budapest, Hungary. 8. Department of General Surgery, Royal Free Hospital, London, United Kingdom. 9. Renal Transplant Unit, Belfast City Hospital, Belfast, United Kingdom. 10. Nephrology and Transplant Directorate, University Hospital of Wales, Cardiff, United Kingdom. 11. Surgery and Abdominal Transplant Unit, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium. 12. Oxford University Hospitals, NHS Foundation Trust, Oxford, United Kingdom. 13. Department of Surgery, Charité, Berlin, Germany. 14. Department of Surgery, Imperial College London, London, United Kingdom. 15. Department of Transplantation and Surgery, Medical University of Vienna, Vienna, Austria.
Abstract
Importance: 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). Objective: 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. Interventions: 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. Results: 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. Trial Registration: isrctn.org Identifier: ISRCTN63852508.
Importance: 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). Objective: 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. Interventions: 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. Results: 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. Trial Registration: isrctn.org Identifier: ISRCTN63852508.
Authors: Ruta Zulpaite; Povilas Miknevicius; Bettina Leber; Kestutis Strupas; Philipp Stiegler; Peter Schemmer Journal: Front Med (Lausanne) Date: 2021-12-24
Authors: Laura I Mazilescu; Peter Urbanellis; Moritz J Kaths; Sujani Ganesh; Toru Goto; Yuki Noguchi; Rohan John; Ana Konvalinka; Istvan Mucsi; Anand Ghanekar; Darius J Bagli; Julie Turgeon; Annie Karakeusian Rimbaud; Marie-Josée Hébert; Mélanie Dieudé; Isabelle Alleys; Etienne Dore; Eric Boilard; Herman S Overkleeft; Lianne I Willems; Lisa A Robinson; Markus Selzner Journal: Transplant Direct Date: 2021-09-07
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