Original Title: Donación en asistolia controlada y no controlada con perfusión regional normotérmica o hipotérmica basada en oxigenación de membrana extracorpórea para trasplantes renales y hepáticos

Authors' objectives: General objectives • To assess the effectiveness and safety/morbidity associated with CDC with normothermic abdominal perfusion (NAP) or hypothermic abdominal perfusion (HAP) with extracorporeal membrane oxygenation (ECMO) and with donation after brain death (DBD) for kidney and liver transplants • To assess the effectiveness and safety/morbidity of the different methods of in situ preservation/removal of the graft (NAP or HAP with ECMO, super rapid recovery or double balloon technique) used in DCD for kidney and liver transplants. Specific objectives • To compare the effectiveness and safety/morbidity associated with controlled DCD (cDCD) using NAP or HAP with ECMO with those associated with DBD for liver transplants. • To compare the effectiveness and safety/morbidity associated with uncontrolled DCD (uDCD) using NAP or HAP with ECMO with those associated with DBD for liver transplants. • To compare the effectiveness and safety/morbidity of the different methods of in situ preservation/removal of the graft (NAP or HAP with ECMO, super rapid recovery or double balloon technique) used in cDCD for liver transplants. • To compare the effectiveness and safety/morbidity of the different methods of in situ preservation/removal of the graft (NAP or HAP with ECMO, super rapid recovery or double balloon technique) used in uDCD for liver transplants. • To compare the effectiveness and safety/morbidity associated with cDCD using NAP or HAP with ECMO with those associated with DBD for kidney transplants. • To compare the effectiveness and safety/morbidity associated with uDCD using NAP or HAP with ECMO with those associated with DBD for kidney transplants. • To compare the effectiveness and safety/morbidity of the different methods of in situ preservation/removal of the graft (NAP or HAP with ECMO, super rapid recovery or double balloon technique) used in cDCD for kidney transplants. • To compare the effectiveness and safety/morbidity of the different methods of in situ preservation/removal of the graft (NAP or HAP with ECMO, super rapid recovery or double balloon technique) used in uDCD for kidney transplants.

Authors' results and conclusions: The evidence to answer the research questions established in the objectives was obtained from 13 studies. In particular, the evidence concerning the effectiveness and safety/morbidity associated with DCD using NAP or HAP with ECMO for liver and kidney transplants came from seven comparative retrospective studies, four nonrandomised controlled intervention studies, one case-control study and one prospective study. CONCLUSIONS The conclusions set out below are based on low or very low quality scientific evidence, meaning that should studies be published with better bias control and larger sample sizes it is possible that the results would be different to those outlined in this report. For that reason, the data available and conclusions based thereon should be interpreted with caution. Liver transplants: No significant differences in effectiveness, morbidity or safety have been demonstrated between cDCD with NAP with ECMO and DBD. In the case of uDCD, the evidence indicates a trend to greater survival of grafts and patients in follow-up at 1 and 2 years with DBD than NAP with ECMO, though not all data indicate a statistically significant difference. No differences were identified regarding the rates of complications. No studies comparing the effectiveness and safety/morbidity of the different methods of in situ preservation/extraction of the graft (NAP or HAP with ECMO or with double balloon) used in the cDCD nor in uDCD for liver transplants have been found. Kidney transplants: cDCD with ECMO under normothermic conditions vs DBD: No significant differences in effectiveness, morbidity or safety have been demonstrated between cDCD with ECMO under normothermic conditions and DBD. uDCD with ECMO vs DBD: Graft survival: Data referring to graft survival come from a single study that indicates that the graft survival rate was significantly lower in the uDCD group with ECMO compared to the group with standard criteria, but not in the group with extended criteria. However, these results should be interpreted with caution given that they come from a single study with low bias control. Regarding patient survival, the evidence available does not show significant differences at 12 months of follow-up either overall or in subgroups, considering cases in which normothermia was maintained or stratifying by age. In long-term follow-up (for 24 months or more), recipient survival rate was significantly higher following uDCD with ECMO than DBD with donors of 60 years of age or more. This difference with DBD was not significant when donors in DBD were younger than 60 years of age or in the case of uDCD with ECMO under normothermic conditions. Delayed graft function (DGF), the results concerning safety and morbidity indicate a significantly lower rate in the recipients of kidneys from DBD than uDCD with ECMO. The difference was not significant under normothermic conditions. The overall likelihood of primary non-function (PNF), the overall likelihood of primary non-function (PNF) was significantly lower in kidney transplants from DBD than those from uDCD with ECMO; again, the difference was not significant under normothermic conditions. On the other hand, a significant difference was shown in the number of episodes of acute rejection in kidney transplants, in favour of grafts from uDCD with ECMO over those from DBD, though once again the difference was not significant under normothermic conditions. cDCD through ECMO versus cDCD with other techniques: For renal transplants, only studies comparing cDCD with ECMO versus cDCD with super-rapid surgery have been found. This comparison has not shown significant differences in graft survival. Regarding patient survival, the data indicate better outcomes at 12 and 36 months following cDCD with ECMO under hypothermic conditions than cDCD with super rapid recovery, but the statistical significance of these differences is not stated. Regarding safety and morbidity, better outcomes were found in terms of DGF, PNF and acute rejection rate following cDCD under normothermic conditions with ECMO than cDCD with super rapid recovery, though no data are available on the statistical significance of this difference uDCD through ECMO versus cDCD with other techniques: For renal transplants, only results comparing uDCD with ECMO versus uDCD by perfusion in situ have been found. The graft survival rates were higher for uDCD with ECMO, both in normothermia and in hypothermia, compared to uDCD by in situ perfusion both after 12 months of follow-up and after 24 months of follow-up, but this difference was not statistically significant. No statistically significant differences were found in the survival of the transplant patients or in PNF in the two study groups. Regarding DGF results, the difference between uDCD with ECMO versus uDCD by in situ perfusion was not statistically significant, except in normothermic conditions.

Authors' methods: A systematic review of the available scientific evidence has been conducted to assess and compare the effectiveness and safety/morbidity associated with the various options set out in the objectives, seeking to provide objective information to support decision making concerning medical care as well as public health policies.

Project Status: Completed

Year Published: 2019

URL for published report: https://www.euskadi.eus/web01-a2aznscp/es/k75aWebPublicacionesWar/k75aObtenerPublicacionDigitalServlet?R01HNoPortal=true&N_LIBR=052383&N_EDIC=0001&C_IDIOM=es&FORMATO=.pdf

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>