KOR

e-Article

The effectiveness and cost-effectiveness of methods of storing donated kidneys from deceased donors: a systematic review and economic model
Document Type
article
Source
Health Technology Assessment, Vol 13, Iss 38 (2009)
Subject
cold-ischaemic-time
delayed-graft-function
immediate-graft-function
primary-non-function
renal-replacement-therapy
Medical technology
R855-855.5
Language
English
ISSN
1366-5278
2046-4924
Abstract
Objective: To review the evidence for the effectiveness and cost-effectiveness of storing kidneys from deceased donors prior to transplantation, using cold static storage solutions or pulsatile hypothermic machine perfusion. Data sources: Electronic databases were searched in January 2008 and updated in May 2008 for systematic reviews and/or meta-analyses, randomised controlled trials (RCTs), other study designs and ongoing research. Sources included: Cochrane Library, MEDLINE, EMBASE, CINAHL, ISI Web of Knowledge, DARE, NRR, ReFeR, Current Controlled Trials, and (NHS) HTA. Bibliographies of articles were searched for further relevant studies, and the Food and Drugs Administration (FDA) and European Regulatory Agency Medical Device Safety Service websites were searched. Only English language papers were sought. Review methods: The perfusion machines identified were the LifePort Kidney Transporter® (Organ Recovery Systems) and the RM3 Renal Preservation System® (Waters Medical Systems). The cold storage solutions reviewed were: University of Wisconsin, ViaSpan™; Marshall’s hypertonic citrate, Soltran™; and Genzyme, Celsior™. Each intervention was compared with the others as data permitted. The population was recipients of kidneys from deceased donors. The main outcomes were measures of graft survival, patient survival, delayed graft function (DGF), primary non-function (PNF), discard rates of non-viable kidneys, health-related quality of life and cost-effectiveness. Where data permitted the results of studies were pooled using meta-analysis. A Markov (state transition) model was developed to simulate the main post-transplantation outcomes of kidney graft recipients. Results: Eleven studies were included: three full journal published RCTs, two ongoing RCTs [European Machine Preservation Trial (MPT) and UK Pulsatile Perfusion in Asystolic donor Renal Transplantation (PPART) study], one cohort study, three full journal published retrospective record reviews and two retrospective record reviews published as posters or abstracts only. For LifePort versus ViaSpan, no significant differences were found for DGF, PNF, acute rejection, duration of DGF, creatinine clearance or toxicity, patient survival or graft survival at 6 months, but graft survival was better at 12 months post transplant with machine perfusion (LifePort = 98%, ViaSpan = 94%, p