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Meta-Analysis
. 2024 Jul 9;7(7):CD011671.
doi: 10.1002/14651858.CD011671.pub3.

Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation

Samuel J Tingle  1 , Emily R Thompson  2 , Rodrigo S Figueiredo  3 , John Ag Moir  4 , Michael Goodfellow  5 , David Talbot  6 , Colin H Wilson  2
Affiliations
Meta-Analysis

Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation

Samuel J Tingle et al. Cochrane Database Syst Rev. .

Abstract

Background: Kidney transplantation is the optimal treatment for kidney failure. Donation, transport and transplant of kidney grafts leads to significant ischaemia reperfusion injury. Static cold storage (SCS), whereby the kidney is stored on ice after removal from the donor until the time of implantation, represents the simplest preservation method. However, technology is now available to perfuse or "pump" the kidney during the transport phase ("continuous") or at the recipient centre ("end-ischaemic"). This can be done at a variety of temperatures and using different perfusates. The effectiveness of these treatments manifests as improved kidney function post-transplant.

Objectives: To compare machine perfusion (MP) technologies (hypothermic machine perfusion (HMP) and (sub) normothermic machine perfusion (NMP)) with each other and with standard SCS.

Search methods: We contacted the information specialist and searched the Cochrane Kidney and Transplant Register of Studies until 15 June 2024 using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov.

Selection criteria: All randomised controlled trials (RCTs) and quasi-RCTs comparing machine perfusion techniques with each other or versus SCS for deceased donor kidney transplantation were eligible for inclusion. All donor types were included (donor after circulatory death (DCD) and brainstem death (DBD), standard and extended/expanded criteria donors). Both paired and unpaired studies were eligible for inclusion.

Data collection and analysis: The results of the literature search were screened, and a standard data extraction form was used to collect data. Both of these steps were performed by two independent authors. Dichotomous outcome results were expressed as risk ratios (RR) with 95% confidence intervals (CI). Survival analyses (time-to-event) were performed with the generic inverse variance meta-analysis of hazard ratios (HR). Continuous scales of measurement were expressed as a mean difference (MD). Random effects models were used for data analysis. The primary outcome was the incidence of delayed graft function (DGF). Secondary outcomes included graft survival, incidence of primary non-function (PNF), DGF duration, economic implications, graft function, patient survival and incidence of acute rejection. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Main results: Twenty-two studies (4007 participants) were included. The risk of bias was generally low across all studies and bias domains. The majority of the evidence compared non-oxygenated HMP with standard SCS (19 studies). The use of non-oxygenated HMP reduces the rate of DGF compared to SCS (16 studies, 3078 participants: RR 0.78, 95% CI 0.69 to 0.88; P < 0.0001; I2 = 31%; high certainty evidence). Subgroup analysis revealed that continuous (from donor hospital to implanting centre) HMP reduces DGF (high certainty evidence). In contrast, this benefit over SCS was not seen when non-oxygenated HMP was not performed continuously (low certainty evidence). Non-oxygenated HMP reduces DGF in both DCD and DBD settings in studies performed in the 'modern era' and when cold ischaemia times (CIT) were short. The number of perfusions required to prevent one episode of DGF was 7.69 and 12.5 in DCD and DBD grafts, respectively. Continuous non-oxygenated HMP versus SCS also improves one-year graft survival (3 studies, 1056 participants: HR 0.46, 0.29 to 0.75; P = 0.002; I2 = 0%; high certainty evidence). Assessing graft survival at maximal follow-up confirmed a benefit of continuous non-oxygenated HMP over SCS (4 studies, 1124 participants (follow-up 1 to 10 years): HR 0.55, 95% CI 0.40 to 0.77; P = 0.0005; I2 = 0%; high certainty evidence). This effect was not seen in studies where HMP was not continuous. The effect of non-oxygenated HMP on our other outcomes (PNF, incidence of acute rejection, patient survival, hospital stay, long-term graft function, duration of DGF) remains uncertain. Studies performing economic analyses suggest that HMP is either cost-saving (USA and European settings) or cost-effective (Brazil). One study investigated continuous oxygenated HMP versus non-oxygenated HMP (low risk of bias in all domains); the simple addition of oxygen during continuous HMP leads to additional benefits over non-oxygenated HMP in DCD donors (> 50 years), including further improvements in graft survival, improved one-year kidney function, and reduced acute rejection. One large, high-quality study investigated end-ischaemic oxygenated HMP versus SCS and found end-ischaemic oxygenated HMP (median machine perfusion time 4.6 hours) demonstrated no benefit compared to SCS. The impact of longer periods of end-ischaemic HMP is unknown. One study investigated NMP versus SCS (low risk of bias in all domains). One hour of end ischaemic NMP did not improve DGF compared with SCS alone. An indirect comparison revealed that continuous non-oxygenated HMP (the most studied intervention) was associated with improved graft survival compared with end-ischaemic NMP (indirect HR 0.31, 95% CI 0.11 to 0.92; P = 0.03). No studies investigated normothermic regional perfusion (NRP) or included any donors undergoing NRP.

Authors' conclusions: Continuous non-oxygenated HMP is superior to SCS in deceased donor kidney transplantation, reducing DGF, improving graft survival and proving cost-effective. This is true for both DBD and DCD kidneys, both short and long CITs, and remains true in the modern era (studies performed after 2008). In DCD donors (> 50 years), the simple addition of oxygen to continuous HMP further improves graft survival, kidney function and acute rejection rate compared to non-oxygenated HMP. Timing of HMP is important, and benefits have not been demonstrated with short periods (median 4.6 hours) of end-ischaemic HMP. End-ischaemic NMP (one hour) does not confer meaningful benefits over SCS alone and is inferior to continuous HMP in an indirect comparison of graft survival. Further studies assessing NMP for viability assessment and therapeutic delivery are warranted and in progress.

Trial registration: ClinicalTrials.gov NCT02525510 NCT04744389 NCT01170910 NCT04569682 NCT04181710 NCT04882254 NCT02621281 NCT05031052 NCT05743751.

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Conflict of interest statement

  1. Samuel J Tingle: No relevant interests were disclosed

  2. Emily R Thompson: No relevant interests were disclosed

  3. Rodrigo S Figueiredo: No relevant interests were disclosed

  4. John AG Moir: No relevant interests were disclosed

  5. Michael Goodfellow: No relevant interests were disclosed

  6. David Talbot: No relevant interests were disclosed

  7. Colin H Wilson: No relevant interests were disclosed

Figures

1
1
Options for machine perfusion timing in the tranplant pathway. ARC: assessment and recovery centre; HMP: hypothermic machine perfusion; NMP: normothermic machine perfusion
2
2
Flow chart showing review update study selection
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
5
5
Funnel plot of comparison: 1 Hypothermic machine perfusion versus static cold storage, outcome: 1.1 Delayed graft function.
6
6
Funnel plot of comparison: 1 Hypothermic machine perfusion versus static cold storage, outcome: 1.5 Primary non‐function.
1.1
1.1. Analysis
Comparison 1: Non‐oxygenated hypothermic machine perfusion (HMP) versus static cold storage (SCS), Outcome 1: Delayed graft function
1.2
1.2. Analysis
Comparison 1: Non‐oxygenated hypothermic machine perfusion (HMP) versus static cold storage (SCS), Outcome 2: Delayed graft function: type of donor
1.3
1.3. Analysis
Comparison 1: Non‐oxygenated hypothermic machine perfusion (HMP) versus static cold storage (SCS), Outcome 3: Delayed graft function: era of study
1.4
1.4. Analysis
Comparison 1: Non‐oxygenated hypothermic machine perfusion (HMP) versus static cold storage (SCS), Outcome 4: Delayed graft function: preservation times
1.5
1.5. Analysis
Comparison 1: Non‐oxygenated hypothermic machine perfusion (HMP) versus static cold storage (SCS), Outcome 5: Graft survival (12 month follow‐up)
1.6
1.6. Analysis
Comparison 1: Non‐oxygenated hypothermic machine perfusion (HMP) versus static cold storage (SCS), Outcome 6: Graft survival (at maximum follow‐up)
1.7
1.7. Analysis
Comparison 1: Non‐oxygenated hypothermic machine perfusion (HMP) versus static cold storage (SCS), Outcome 7: Primary non‐function
1.8
1.8. Analysis
Comparison 1: Non‐oxygenated hypothermic machine perfusion (HMP) versus static cold storage (SCS), Outcome 8: Duration of delayed graft function
1.9
1.9. Analysis
Comparison 1: Non‐oxygenated hypothermic machine perfusion (HMP) versus static cold storage (SCS), Outcome 9: Patient survival (12 month follow up, time‐to‐event)
1.10
1.10. Analysis
Comparison 1: Non‐oxygenated hypothermic machine perfusion (HMP) versus static cold storage (SCS), Outcome 10: Patient survival (12‐month follow up, dichotomous)
1.11
1.11. Analysis
Comparison 1: Non‐oxygenated hypothermic machine perfusion (HMP) versus static cold storage (SCS), Outcome 11: Acute rejection in the first year
See this image and copyright information in PMC

Update of

References

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References to studies excluded from this review

Alijani 1987 {published data only}
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Polyak 2002 {published data only}
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References to studies awaiting assessment

NCT01170910 {published data only}
    1. NCT01170910. Pulsatile perfusion preservation in kidney transplantation from expanded criteria donors (IMPULSION). www.clinicaltrials.gov/ct2/show/NCT01170910 (first received 27 July 2010).
NCT04569682 {published data only}
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OxyOp2 2023 {published data only}
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References to ongoing studies

APOLLO 2021 {published data only}
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NCT02621281 {published data only}
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NCT05031052 {published data only}
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NCT05743751 {published data only}
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References to other published versions of this review

Figueiredo 2015
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Tingle 2019
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Associated data