Lung transplantation from donation after cardiocirculatory death: a systematic review and meta-analysis

Krutsinger, Dustin C.; Reed, Robert M.; Blevins, Amy; Puri, Varun; Oliveira, Nilto C. De; Zych, Bartłomiej; Bölükbas, Servet; Raemdonck, Dirk Van; Snell, Gregory I; Eberlein, Michael

doi:10.1016/j.healun.2014.11.009

Cited by 125 publications

(91 citation statements)

References 40 publications

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“…41 Evidence has emerged that, when lungs from these donors are transplanted, outcomes in recipients are comparable to those achieved with lungs from donation after brain death (DBD) donors. 42 However, only a fraction of the UK DCD donors, currently about 5%, have their lungs used for standard transplantation. 41 Frequently, there are insufficient data available to be able to objectively assess the function of the lungs from DCD donors, or there is a prolonged warm ischaemic phase after withdrawal of life support that renders the lungs unusable for standard transplantation.…”

Section: Study Rationale and Designmentioning

confidence: 99%

“…Seven of the protocol violations (all minor) were in standard transplant patients, whereas 10 (five major and five minor) were in EVLP transplant patients. 42 SAEs, four of these events (9.5%) arising in four patients were judged to be possibly causally related to study procedures; all of these serious adverse reactions were initially considered by the site PI to be possibly unexpected AEs. However, after review by the chief investigator, it was decided that all were in fact events that could be expected to occur after lung transplantation, such as PGD or infection.…”

Section: Compliancementioning

confidence: 99%

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An observational study of Donor Ex Vivo Lung Perfusion in UK lung transplantation: DEVELOP-UK

Fisher

Andreasson

Chrysos

et al. 2016

Health Technol Assess

110

115

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BackgroundMany patients awaiting lung transplantation die before a donor organ becomes available. Ex vivo lung perfusion (EVLP) allows initially unusable donor lungs to be assessed and reconditioned for clinical use.ObjectiveThe objective of the Donor Ex Vivo Lung Perfusion in UK lung transplantation study was to evaluate the clinical effectiveness and cost-effectiveness of EVLP in increasing UK lung transplant activity.DesignA multicentre, unblinded, non-randomised, non-inferiority observational study to compare transplant outcomes between EVLP-assessed and standard donor lungs.SettingMulticentre study involving all five UK officially designated NHS adult lung transplant centres.ParticipantsPatients aged ≥ 18 years with advanced lung disease accepted onto the lung transplant waiting list.InterventionThe study intervention was EVLP assessment of donor lungs before determining suitability for transplantation.Main outcome measuresThe primary outcome measure was survival during the first 12 months following lung transplantation. Secondary outcome measures were patient-centred outcomes that are influenced by the effectiveness of lung transplantation and that contribute to the health-care costs.ResultsLungs from 53 donors unsuitable for standard transplant were assessed with EVLP, of which 18 (34%) were subsequently transplanted. A total of 184 participants received standard donor lungs. Owing to the early closure of the study, a non-inferiority analysis was not conducted. The Kaplan–Meier estimate of survival at 12 months was 0.67 [95% confidence interval (CI) 0.40 to 0.83] for the EVLP arm and 0.80 (95% CI 0.74 to 0.85) for the standard arm. The hazard ratio for overall 12-month survival in the EVLP arm relative to the standard arm was 1.96 (95% CI 0.83 to 4.67). Patients in the EVLP arm required ventilation for a longer period and stayed longer in an intensive therapy unit (ITU) than patients in the standard arm, but duration of overall hospital stay was similar in both groups. There was a higher rate of very early grade 3 primary graft dysfunction (PGD) in the EVLP arm, but rates of PGD did not differ between groups after 72 hours. The requirement for extracorporeal membrane oxygenation (ECMO) support was higher in the EVLP arm (7/18, 38.8%) than in the standard arm (6/184, 3.2%). There were no major differences in rates of chest radiograph abnormalities, infection, lung function or rejection by 12 months. The cost of EVLP transplants is approximately £35,000 higher than the cost of standard transplants, as a result of the cost of the EVLP procedure, and the increased ECMO use and ITU stay. Predictors of cost were quality of life on joining the waiting list, type of transplant and number of lungs transplanted. An exploratory model comparing a NHS lung transplant service that includes EVLP and standard lung transplants with one including only standard lung transplants resulted in an incremental cost-effectiveness ratio of £73,000. Interviews showed that patients had a good understanding of the need for, and the processes of, EVLP. If EVLP can increase the number of usable donor lungs and reduce waiting, it is likely to be acceptable to those waiting for lung transplantation. Study limitations include small numbers in the EVLP arm, limiting analysis to descriptive statistics and the EVLP protocol change during the study.ConclusionsOverall, one-third of donor lungs subjected to EVLP were deemed suitable for transplant. Estimated survival over 12 months was lower than in the standard group, but the data were also consistent with no difference in survival between groups. Patients receiving these additional transplants experience a higher rate of early graft injury and need for unplanned ECMO support, at increased cost. The small number of participants in the EVLP arm because of early study termination limits the robustness of these conclusions. The reason for the increased PGD rates, high ECMO requirement and possible differences in lung injury between EVLP protocols needs evaluation.Trial registrationCurrent Controlled Trials ISRCTN44922411.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 85. See the NIHR Journals Library website for further project information.

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Section: Study Rationale and Designmentioning

confidence: 99%

Section: Compliancementioning

confidence: 99%

An observational study of Donor Ex Vivo Lung Perfusion in UK lung transplantation: DEVELOP-UK

Fisher

Andreasson

Chrysos

et al. 2016

Health Technol Assess

110

115

View full text Add to dashboard Cite

show abstract

“…Tolerable WIT, defined as the time between cardiac arrest and cold flush, is around 30 minutes (5,7,(10)(11)(12)17,(19)(20)(21)(22)(23)(24)(25)(26)28,59,60,63,64). However, based on experimental data WIT of 60 minutes is tolerable (1,7).…”

Section: Donor Selection Criteria Cdcd Donorsmentioning

confidence: 99%

“…The use of lungs from donation after cardiocirculatory death (DCD) donors is one of the options to avoid organ shortage in LTx (3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16). The number of lung transplants performed from DCD donors is increasing.…”

Section: Introductionmentioning

confidence: 99%

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Donors after cardiocirculatory death and lung transplantation

İnci

2017

J. Thorac. Dis.

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Abstract:The number of patients actively awaiting lung transplantation (LTx) is more than the number of suitable donor lungs. The percentage of lung retrieval rate is lower when compared to other solid organs.The use of lungs from donation after cardiocirculatory death (DCD) donors is one of the options to avoid organ shortage in LTx. After extensive experimental research, clinical application of DCD donation is becoming wider. The results from most of the centers show at least equal survival rate compared to donors from brain death. This review paper will summarize experimental background and clinical experience from DCD donors.

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Improvised vs Commercial Tourniquets

Levy

Goolsby

Eastman

2017

JAMA

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eTable 2 and eFigure 2 show that BMI is not a predictor of disease-free survival or overall survival outcomes. eFigure 2 shows that the 95% CIs for both BMI subgroups cross 0 and thus are not statistically significant. Of the 4 checklist components for assessing the credibility of subgroup results, 1 only 1 is satisfied (marginal significant interaction), suggesting little additional (internal or external) evidence that the differential effect is real. The correlation between BMI and outcome (disease-free survival and overall survival) is small and further subdividing BMI into 4 strata would not only create groups with few events but could lead to accusations of data trawling.Randomized clinical trials generally provide unconfounded, unbiased, and consistent estimates of treatment effect and the randomization should balance both measured and unmeasured baseline variables (biomarkers, hormone replacement therapy use, etc), irrespective of their inclusion in multivariable models, and any (significant) imbalances would simply be type I errors.Although analyses adjusted for the proposed baseline factors are useful in identifying prognostic factors, inclusion of these factors in a model would not materially alter the estimates of treatment effect (only their variances). In this study, baseline hormone therapy use and smoking status were not collected and their effect could thus not be assessed.

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Lung transplantation from donation after cardiocirculatory death: a systematic review and meta-analysis

Cited by 125 publications

References 40 publications

An observational study of Donor Ex Vivo Lung Perfusion in UK lung transplantation: DEVELOP-UK

An observational study of Donor Ex Vivo Lung Perfusion in UK lung transplantation: DEVELOP-UK

Donors after cardiocirculatory death and lung transplantation

Improvised vs Commercial Tourniquets

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