Evaluation, selection, and follow-up of live kidney donors: a review of current practice in French renal transplant centres

Martine Gabolde1,, Christian Hervé1 and Anne-Marie Moulin2

1 Laboratoire d'Éthique médicale et de Santé publique, Faculté de Médecine Necker, Université Paris V and 2 CNRS, Institut de Recherche pour le Développement (IRD), Paris, France



   Abstract
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 References
 
Background. A resurgence of interest in the concept of live-donor renal transplantation has prompted a closer look at methods of live donor evaluation, selection, and follow-up. The aim of this study was to describe these methods in all 46 French renal transplant centres.

Methods. Questionnaires were sent to all chief renal physicians.

Results. The survey was completed by 78% of centres, which accounted for 95% of all live-donor renal transplants carried out in France in 1995 and 1996. There was a substantial variation in all three steps of live-donor management. For example, we observed variations in the screening for specific short- or long-term risk factors (especially cardiovascular or thrombotic risk factors and diabetes). In addition the exclusion criteria differed, especially the cut-off age for donation, which ranged from 45 to 75 years. The composition of teams evaluating and selecting potential donors and the role of the potential donors in the decision-making process varied greatly among centres. Finally, we observed less variation in the methods of donor follow-up.

Conclusions. The current survey revealed a marked disparity in the management of live donors in France. It raises the question of whether these practices should be codified into a set of guidelines for live-donor transplantation.

Keywords: clinical guidelines; evaluation; kidney transplantation; live donor; selection; survey



   Introduction
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 References
 
Although the use of live kidney donors was of great importance in the early history of renal transplantation, it declined rapidly in France with the policy of promoting the use of cadaveric donor kidneys. Cadaveric renal transplantation has therefore become the preferred method for treating end-stage renal failure [1].

Nevertheless, because of the scarcity of cadaveric organs there has been a recent resurgence of interest in live-donor transplantation in France [2], an interest reinforced by the good or even excellent outcome observed in live transplantation [3] and by several studies suggesting that both short- and long-term risks for kidney donors can be minimized by rigorous evaluation and selection of potential donors [4,5].

This increased interest in live donors has been reflected in France between 1993 and 1998 by an increase of 78% in the use of live donors. However, this still accounts for only 3.9% of all renal transplants performed in 1998 [1]. Live donor transplantation is subject to legislation in France. The bioethics laws authorize organ donation only by a competent adult, and for the benefit of his or her parent, sibling or child; donation between spouses is restricted to emergency situations [6,7].

Despite this increasing activity, there are scant data on kidney donation medical procedures in France. Therefore the aim of this study was to investigate how French renal transplant centres evaluate, select or exclude, and follow up live kidney donors, and to compare these data with existing guidelines and practices elsewhere.



   Subjects and methods
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 References
 
A general survey of live-donor renal transplantation was performed between January and September of 1998. An anonymized questionnaire consisting of 46 questions relating to the evaluation, selection and follow-up of live kidney donors was sent to chief renal physicians at the 46 authorised French renal transplant centres.

Responses to the various questions were described either by means or by percentages of responding centres. Responses were analysed according to two parameters: centre size (large centres performing an average of more than 30 transplants a year, vs small centres), and whether or not centres were used to perform live-donor transplantation (centres used to live-donor transplantation were defined as those performing an average of more than four live-donor transplants per year).

Data were processed using Epi Info software (version 6) produced by the Division of Surveillance and Epidemiology, CDC, Atlanta, USA. Qualitative variables were described using Chi-square analysis, and quantitative variables were expressed as means and standard deviation. Comparisons were performed using analysis of variance or non-parametric tests. Differences were considered significant at P<0.05.



   Results
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 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 References
 
Survey responses and centre demographics
Of the 46 centres to which questionnaires were sent, 36 chief renal physicians replied to questions concerning the evaluation, selection, and follow-up of live donors (i.e. a response rate of 78.2%). This response was from 17 large and 19 small centres. Eight centres performed an average of more than four live donor transplants per year, and 28 performed four or less per year. In 1995 and 1996, each of these 36 centres carried out an average of 37±23 cadaveric transplants (total 1324) and 1.6±2.3 live-donor transplants per year (total 56), which corresponded to 83.8 and 93.5% of the total number of cadaveric and live-donor transplants respectively, performed annually during the same period by all 46 French transplant centres.

Evaluation of potential donors
General evaluation
The list of investigations routinely performed as part of the evaluation of potential donors is shown in Table 1Go. The cardiovascular work-up was supplemented in 63% of centres by systematic echocardiography. Twenty-four-hour ambulatory blood-pressure monitoring, Doppler ultrasound of neck and lower-limb vessels, and cardiovascular stress test were routinely performed in respectively 23, 20 and 18% of centres. In 60–71% of centres these investigations were performed only when clinically indicated. Screening for thrombotic risk factors such as a deficiency of antithrombin III, protein C, protein S, or resistance to activated protein C was systematically performed respectively in 14, 28, 17 and 17% of centres. Thirteen per cent of centres performed an oral glucose tolerance test on all potential donors, and 19% performed a systematic assay of glycosylated haemoglobin. Tumour markers were routinely assayed in 19% of centres; 68% of centres performed a pregnancy test on all female potential donors; radiology of the sinuses and lung function tests were performed in less than one-quarter of all centres.


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Table 1. Investigations routinely performed as part of the general evaluation of potential donors

 

Renal assessment
The investigations performed for assessing renal tract anatomy and renal function are shown in Table 2Go.


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Table 2. Investigations systematically performed for renal anatomy and renal function assessment

 

Specialized consultations
As part of the evaluation process, potential donors underwent systematic psychological review in a little more than one-half of the centres (53%), usually by a psychiatrist (76% of cases). The social situation of potential donors was systematically evaluated by a social worker in 38% of centres, whereas 35% of centres never made use of such an assessment. A minority of centres (13%) consulted a nephrologist working independently of the transplant team to evaluate the suitability of the potential donor, while 17% requested consultation only if particular difficulties arose, and 70% never requested it at all. Potential donors consulted an anaesthetist in all centres; consultations in cardiology, gynaecology, stomatology, and phlebology were sought as a matter of course in 50, 37, 27 and 4% of centres respectively.

Selection/exclusion of potential donors
Uro-nephrological exclusion criteria
In more than 80% of centres, a creatinine clearance of less than 80 ml/min/1.73 m2 or more was a contra-indication to kidney donation, but six centres applied less strict criteria (Figure 1Go). In 97% of centres, proteinuria of between 300 and 1000 mg/day excluded a potential donor. In three centres decision criteria were based on confirmation of persistent ongoing proteinuria, on abnormal urinary protein immunoelectropheresis, or even on the outcome of a renal biopsy. Persistent microscopic haematuria was a contra-indication to donation in 82% of centres, whereas others adopted a case-specific approach with confirmation, when necessary, of the renal origin of the haematuria by renal biopsy. The exclusion frequency of potential donors in relation to other uro-nephrological criteria is summarised in Table 3Go.



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Fig. 1. Frequency of exclusion of potential donors based on creatinine clearance. All clearances are expressed per 1.73 m2.

 

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Table 3. Frequency of exclusion of potential donors based on uro-nephrological criteria

 

General and medical exclusion criteria
More than 80% of centres applied a cut-off age for kidney donation, which ranged from 45 to 75 years, with a mean age limit of 58 years (Figure 2Go). Hypertension was an exclusion criterion in 94% of centres, and the precise policies are described in Table 4Go. Other medical or psychosocial exclusion criteria applied to potential donors are presented in Table 5Go.



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Fig. 2. Cut-off age for kidney donation (years).

 

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Table 4. Frequency of exclusion of potential donors based on blood pressure

 

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Table 5. Frequency of exclusion of potential donors based on various medical or psychosocial criteria

 

Methods for selection or exclusion of potential donors
The decision to select or exclude a potential donor was generally taken by the members of the team caring for the recipient (78% of all centres). Less commonly (19%), this responsibility was assumed jointly by the recipient team and an independent third party, usually the donor's physician, who acted as his advocate. One centre delegated this responsibility to a team that was independent of those caring for the recipient.

Special situations
When evaluation of potential donors revealed an increased short- or long-term medical risk in the event of nephrectomy, 46% of centres excluded these donors, 43% involved the donors in the decision-making process, 7% allowed the donors to decide after having fully informed them of the risks entailed, and 3% made the decision on the donors’ behalf.

The risk that recurrence of the recipient's renal disease might affect the graft and cause its failure was estimated by 20% of centres to be an absolute contra-indication and by 47% to be a relative contra-indication to the use of a live donor (focal segmental glomerulosclerosis was often cited as a contra-indication, but not IgA nephropathy); 11% stated that this situation did not prohibit transplant with a live donor and 22% did not specify whether they had a specific policy for this criterion.

Follow-up of live donors
Most centres (86%) recommended lifetime annual review. Two-thirds assumed this responsibility themselves, whereas the others examined donors once or twice before referring them to their personal physicians. Four teams recommended follow-up for 1–5 years only, so that donor status would not be perceived as pathological. The work-up included routine tests (blood pressure measurement, serum creatinine, and screening for proteinuria) but was more in-depth at times. Psychological follow-up was rare: occasionally performed in 44% of centres or never in 48%. It was systematically arranged in only 7% of centres.



   Discussion
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 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 References
 
The 78% response rate to this survey and the fact that responding centres had performed 93.5% of all live-donor renal transplants indicate that the survey was properly representative.

The very low proportion of transplants carried out with a live-donor organ (4%) reflects the mixed feelings of French transplant teams towards this practice: a recent survey indicated that only 17% of chief renal physicians preferred live donors, 57% favoured the use of cadaveric organs, and one-quarter expressed no clear preference [8]. However, the percentage of live-donor transplants was lower than expected, suggesting a discrepancy between the theoretical acceptance of the concept of live-donor transplants and the actual use of live donors. This kind of divergence has been reported previously, even in medical cultures that appear to favour the live-donor concept [4,9].

The evaluation of potential donors varied from one centre to the next. While kidney donation is associated with a 0.03–0.06% mortality rate [10,11] and a 0.23–2.5% major complication rate [10,12], most surgeons agree that there is a need for a relatively comprehensive and systematic evaluation. However, there is great diversity in the more sophisticated evaluations used by centres for screening specific peri-operative or long-term risk factors. For example, although deep-vein thrombosis represents a major peri-operative complication [12], and nephrectomy may increase the risk of developing nephropathy, especially in the case of diabetes [13], screening for thrombotic risk factors and diabetes is carried out using widely differing methods. The medical suitability of potential donors is usually assessed by several individuals (nephrologist, surgeon, anaesthetist, in particular), but reliance on expert opinion outside the transplant team (psychologist, social worker or independent nephrologist) occurs relatively rarely; small centres consult independent nephrologists more often than large centres.

The same diversity was found with the donor exclusion criteria, which probably reflected the different weight given by health professionals to the impact of various medical, psychological, or social risks. The cut-off age for donation varied from 45 to 75, with small centres favouring younger donors than large centres (54.6±8 years vs 60.6±4.6 years; P=0.045). The decision process used for selecting or excluding a potential donor also varied from centre to centre; small centres usually made this decision in consultation with an independent physician acting as an advocate for the donor, while large centres less commonly relied on outside advice (P=0.038). When the work-up suggested that there would be increased medical risk for the donor in the event of nephrectomy, the attitudes of the centres tended to polarize towards either ‘paternalist’ or ‘autonomist’ stances: one-half of the centres found no place at all for the potential donor in the decision-making process, whereas the other half assigned the donor a sometimes crucial role.

More consistency was shown in the follow-up of live donors. It was carried out on a lifetime basis by 86% of centres and entailed the same routine investigations. These data should prove valuable for providing long-term prognosis information of kidney donors. We also observed that psychological follow-up was almost never a component systematically performed. This policy was adopted by some centres so that donors would be less likely to perceive their status as abnormal.

A similar inter-centre variability in donor treatment has been found in other surveys, notably in the United States [10], Europe [14], and the United Kingdom and Ireland [15]. Comparing data provided by American centres [10] with the present survey on practices in French centres, the latter tended to perform more medical tests and apply stricter exclusion criteria at the time of donor selection. In France a general trend towards laxness in large centres in terms of donor exclusion criteria was not observed (except for the age criterion), as was described in American centres. Similarly, there were no differences in the French centres as regards whether or not they were used to perform live donor transplants.

In conclusion, this survey found a marked disparity in live-donor evaluation, selection, and follow-up practices, which is the case for many diagnostic and therapeutic medical procedures. This disparity raises the currently important issue of whether it would be appropriate to codify these practices and adopt guidelines in this field. Such a desire was expressed by many of the professionals in the survey, and has been voiced in a number of French [16] and international [10,15] publications. Indeed the concept of guidelines in this practice is not original, and was put forward in American proposals on live-donor selection in 1996 [17], and more recently in a British publication [18], which provided a comprehensive framework for live renal transplantation. Should national guidelines be adopted to provide consistency in these practices, several issues need to be addressed, including information of the potential donor, type and timing of all systematic investigations, a listing of donor exclusion criteria, intervention of an independent third party, and methods of donor follow-up.



   Acknowledgments
 
We would like to thank all the physicians involved in this survey who very kindly replied to the questions. The work was supported by the ‘Etablissement Français des Greffes’ (French National Institute for Transplantation).



   Notes
 
Correspondence and offprint requests to: Martine Gabolde, Service de Pédiatrie générale, CHU de Bicêtre, 78 rue du Général Leclerc, F-94275 Le Kremlin Bicêtre Cedex, France. Email: martine.gabolde{at}bet.ap\|[hyphen]\|hop\|[hyphen]\|paris.fr Back



   References
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 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 References
 

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Received for publication: 4.11.00
Revision received 17. 4.01.