Search

The critical pathway of deceased donation provides a systematic approach to the organ donation process, considering both donation after cardiac death than donation after brain death. The pathway provides a tool for assessing the potential of deceased donation and for the prospective identification and referral of possible deceased donors.

Points essentiels Les regles anterieures de repartition des greffes laissaient une large place a la priorite locale, et la gestion finale a l’equipe, induisant de grandes disparites inter-regionales. Une etude prospective des deces et des retraits de liste d’attente pour aggravation de la maladie initiale (2003–2005) a permis de valider sur les donnees francaises l’utilisation du score MELD (Model for End-stage Liver Disease), qui permet de predire la survie spontanee des cirrhotiques a 3 mois, et qui est utilise aux Etats-Unis pour l’attribution des greffons hepatiques depuis 2002. La reflexion de l’Agence de biomedecine et des equipes de transplantation hepatique a conduit a mettre en place un score d’attribution des greffons hepatiques, a compter du 6 mars 2007. Ce score Foie tient compte du score MELD pour les cirrhoses, de la duree d’attente et du stade TNM pour les cancers, d’un score specifique pour les maladies metaboliques non cirrhotiques ainsi que pour les retransplantations electives, ainsi que d’aspects logistiques comme la distance entre le lieu de prelevement et celui de greffe. Un premier bilan a 5 mois indique que le score Foie permet de diminuer les deces et les retraits de liste pour aggravation, de diminuer le nombre de greffes « prematurees », d’accelerer l’acces a la greffe des malades les plus graves. Plusieurs questions restent en suspens : le score MELD et le score Foie peuvent etre ameliores, la variabilite du MELD liee aux methodes de dosage doit faire l’objet d’une normalisation entre laboratoires.

Resume En depit de l’augmentation significative de l’activite de prelevement et de greffe observee ces huit dernieres annees en France, la penurie s’accentue et les besoins en greffons demeurent tres superieurs a l’offre. Depuis 1968 et jusqu’a present, le prelevement a ete limite aux donneurs a cœur battant en etat de mort cerebrale. Les resultats de la greffe de reins, preleves sur donneurs a cœur arrete, se sont nettement ameliores et sont desormais comparables a ceux de la greffe renale a partir des donneurs en mort encephalique et cela grâce a une selection plus stricte des donneurs et des receveurs, le respect des delais d’ischemie chaude et froide et plusieurs innovations therapeutiques importantes. Le prelevement d’organes sur donneurs a cœur arrete a donc ete reconsidere sous l’angle de la faisabilite, des resultats et de leurs consequences ethiques et juridiques, dans le cadre exclusif d’un protocole medical edicte par l’agence de la biomedecine et d’une convention engageant le centre hospitalier pilote a respecter les termes du protocole. En regard des experiences etrangeres, ce programme est susceptible de diminuer la penurie d’organes qui penalise les nombreux patients en attente de transplantation.

En 2006, 4 400 malades, dont 4 % d’enfants, ont beneficie d’une greffe d’organe en France. Cette activite est regulee par l’Agence de la biomedecine, creee en 2005, et qui a repris l’ensemble des activites de l’Etablissement francais des Greffes en matiere de prelevement et de greffe. Elle a pour missions, entre autres, de gerer la liste nationale des personnes en attente de greffe et le registre national des refus de prelevement, de coordonner les prelevements d’organes, de repartir et attribuer les greffons et d’evaluer les resultats. En France comme ailleurs, l’offre de greffons reste inferieure aux besoins meme si l’activite de prelevement et de greffe continue d’augmenter significativement.

OBJECTIVE: To evaluate changes in the balance between supply and demand for corneal grafts over the last 15 years in France in the light of the measures implemented and the 2005 national and regional audit. Materials and methods: Corneal transplantation activities were estimated, mainly from a national prospective survey of ophthalmologists (1991-1994), annual surveys of ophthalmologists (1995-2000), tissue banks (1996-2005), and the national waiting list for surgery (since 2000). RESULTS: In 2005, the main indicators available were consistent with a stabilization in the number of candidates added to the waiting list every year (4606 in 2005), accompanied by a large increase in the number of grafts procured (9264 in 2005). There was also a substantial increase in quality testing of these grafts, leading to a high rate of rejection (49.5% of the procured grafts). In addition, the number of grafts exported decreased to a very low level (213 in 2005). The percentage of malades registered on the waiting list who received grafts in the same year also increased (68.5% in 2005). Once the waiting list had been updated, 3016 malades remained on the list at the beginning of July 2006. The gap between supply and demand for corneal transplantation has therefore narrowed. Two actions made particularly large contributions to these changes: the creation in 2000 of 120 full-time staff positions in hospital coordination teams, which has had a major impact on procurement rates; and the organization of the tissue bank sector, making it possible to guarantee the quality and distribution of grafts. CONCLUSION: Corneal procurement and transplantation activities seem to have reached equilibrium in France. A reliable estimation of demand, particularly at the regional level, has led the French agency in charge of tissue transplantation to modify the functioning of the national corneal transplant waiting list, with tissue banks now allowed access to declare transfers and the temporary registration of malades on the list to limit stagnation.

BACKGROUND: The routes of transmission of human herpes virus 8 (HHV-8) remain unclear. In particular, HHV-8 transmission by blood components and organ transplantation is still debated and raises public health issues. The objective of this study was to determine the prevalence of anti-HHV-8 in selected populations of persons or patients with or without risk factors for the transmission of viral infections, in order to determine the routes of HHV-8 transmission. STUDY DESIGN AND METHODS: A total of 1431 persons or patients at low or high risk of sexually, blood-, or graft-transmitted viral infections were tested by means of a standardized immunofluorescence serologic assay detecting anti-HHV-8. RESULTS: The persons or patients could be classified into three distinct groups according to anti-HHV-8 prevalence: a low prevalence group (0.0% to 5.0%), including healthy blood donors, healthy pregnant women, multiply transfused patients with thalassemia major, and IV drug users; an intermediate prevalence group (5.0% to 20.0%), including organ donors, kidney transplant recipients, and multiply transfused patients with sickle cell disease; a high prevalence group (>20.0%), including HIV-negative persons at high risk of sexually-transmitted viral infections, and HIV-infected homosexual men and heterosexuals. CONCLUSION: The sexual route appears to be the main route of HHV-8 transmission; bloodborne transmission of HHV-8, if it exists, is rare. In contrast, organ transplantation recipients might be exposed to HHV-8 transmission by the transplanted organ, which raises the issue of systematic screening of organ donors.

Thousands of patients throughout Europe undergo organ generally remain within Europe. However, it must be noted transplantation each year. This raises two questions from a that, in the field of organ transplantation, few organs are European perspective. The first regards the possible impact actually exchanged. This is mainly due to the general of the European construction on procurement and transorgan shortage. At the same time, patients living in areas plantation and the second, probably more unusual, regards with low procurement rates (such as southern Italy during the possible influence of procurement and grafts on the the 1980s) often seek transplantation in large numbers in European construction. other countries, such as France or Belgium. Our intention is to show that, contrary to common As far as regulation is concerned, there is currently no expectations, transplantation may be more useful to Europe European law or directive on the subject, nor does a than Europe is useful for transplantation. European body in charge of procurement and graft coordination and exchanges exist. However, despite the lack of common regulations, a European dimension of procure1. Is there a European dimension to transplantation? ment and transplantation is likely to develop in the near future, as demonstrated by the following examples: From an epidemiological point of view, common trends can be identified in most European countries with regard to • Grafts are specifically mentioned in article 152 (ex cerebral death prevalence and morbidity related to diseases article 129) of the Amsterdam treaty, thus offering many leading to transplantation indications. opportunities for developing measures at the European While facing similar problems, the various health care level. This point broadens the European field of compesystems have developed different responses. These differtence in health, traditionally restricted to preventive ences are most noticeable in policies regarding regional policies, and needs to be emphasized; planning, the establishment of hospital programs related to • In the related field of tissue banking, the European procurement and transplantation, and the number of teams Ethics Group in Science and New Technologies to the performing these activities. The mix between public and European Commission recently adopted an opinion on private sector participation also varies from one country to ethical aspects, focusing on the need for common high the next, as does the type of procurement organization. standards in safety and ethics. Clearly, this also has Procurement may be the responsibility of a national public implications for organ transplantation. agency, as in France, Spain, Portugal, and the United Kingdom, or of a private body operating nationally, as in Switzerland, or it may be the responsibility of several 2. What can Europe do for transplantation? countries at a European level, such as Eurotransplant, which includes Germany, Austria, Belgium, Luxembourg, Three main areas need to be addressed: ethics, graft and the Netherlands. availability, and safety. In terms of exchanges, patients, organs, tissues, and cells As far as ethical issues are concerned, harmonization efforts at the European level are likely to promote a high *Tel.: 133-44-67-5599; fax: 133-44-67-5555. 1 level of ethical standards. Some countries, such as France, A work from the Etablissement Francais des Greffes, 5, Rue Lacuee, 75012 Paris, France. by passing the so-called ‘Bioethics’ laws of July 23, 1994

The critical pathway of deceased donation provides a systematic approach to the organ donation process, considering both donation after cardiac death than donation after brain death. The pathway provides a tool for assessing the potential of deceased donation and for the prospective identification and referral of possible deceased donors.

The French Biomedecine Agency evaluated the outcomes of liver transplantation in France. The one-year graft failure rate in each transplant center was compared with the national rate, after adjusting for recipient, donor and transplant characteristics. All patients transplanted from 1998 to 2002 were included, except when a live donor was used. The validity and completeness of the data were first reviewed by the transplantation centers, and the quality of the database was audited by an independent contractor. The objectives, methodology and results of univariate analysis were discussed with the medical staff in each transplant center before the final analysis. The final statistical analysis used a multivariate logistic regression model including all predictive factors of the one-year graft failure rate. The adjusted failure rate was estimated for each transplant center and compared with the 99% confidence interval of the national failure rate. Twenty-four centres and 3625 transplantations were included. The national failure rate was 19%. Nineteen predictive factors were included in multivariate analysis of the one-year graft failure rate. Two centres were outside the 99% confidence interval of the national failure rate: one was significantly lower and one significantly higher. This study will be repeated each year in order to follow trends in the adjusted one-year failure rates in the different centers. The 3-year graft failure rate will also be studied in the same way. The Biomedecine Agency hopes that this work will encourage transplant centers to improve their quality of care.

Previous rules of allocation of livers for transplantation were based mainly on local priorities, with final management left to the local team. This created substantial regional disparities. A prospective survey of waiting list deaths and dropouts due to aggravation of liver disease (2003-2005) validated the MELD (Model for End-stage Liver Disease) score on French data. A new allocation score (Liver Score) for liver transplants, based on specific variables for each liver disease, was introduced in March 2007. An initial evaluation, based on the first 5 months of practice, clearly shows that the Liver Score reduces the rates of deaths, dropouts, and futile transplantations; it also accelerates access to transplantation for the sickest patients. Several points remain unresolved: both the MELD and Liver scores may be improved. The variability of the MELD score related to different laboratory assay methods requires harmonization between laboratories.

Despite a significant increase in procurement and transplantation activities observed in France in the last eight years, the shortage in grafts is on the rise and demand keeps being much higher than supply. Since 1968 and until now, procurement was limited to heart beating brain donors. The results of kidneys transplanted from non-heart-beating donors have significantly improved and are nowadays comparable to those of kidney transplantations from brain death donors, thanks to a more accurate selection of donors and recipients, to better respect of preventing cold and warm ischemia times and to several major therapeutic innovations. Procurement on non-heart-beating donors are therefore being reconsidered under considerations of feasibility, results and ethical and legal consequences, under a specific medical protocol issued by the agency of biomedicine with the pilot hospital center agreement to comply with the protocol. Referring to foreign experiences, this program is likely to decrease the organ shortage, which is jeopardizing the treatment of a large number of patients awaiting transplantation.

BACKGROUND: In France, foreign patients, whether resident or not in France, can register on the national waiting list under certain conditions. We compared waiting time to kidney transplantation, the level of HLA matching and graft cold ischemia time between foreign patients and French patients living in mainland France or in French overseas territories (FOT). METHODS: We performed a retrospective cohort survey using the nationwide registry. Between 1996 and 2003, 18,595 patients were registered on the French waiting list. Of these, 9.9% were of non-French nationality (0.7% Greek, 1.4% Italian, 1.5% other European, 3.7% North African, 1.8% sub-Saharan African and 0.9% other), and 3.8% were French nationals living in FOT. RESULTS: Median waiting time differed significantly between groups, from 13.8 months for mainland French patients to 39.5 months for sub-Saharan African patients. After adjustment for other factors significantly linked to waiting time, French residents of FOT (RR=0.83; P

The IAEA aimed at developing complete Standards for Tissue Banks, including all steps of the activity, and being applicable in all parts of the world. The IAEA draft International Standards for Tissue Banks are presented.

PURPOSE: To determine the frequency of corneal regraft (CR) and to identify risk factors associated with CR for all primary diagnoses, secondary endothelial failure (SEF), and keratoconus. METHODS: This survey included 8904 eyes registered on the French national waiting list that underwent keratoplasty between 2000 and 2002. RESULTS: The frequency of CR was 14.0% for all diagnoses, 16.9% among SEF patients, and 8.3% among keratoconus patients. For all diagnoses, the following factors were found to be independently associated with a significantly increased risk of CR (P < 0.05): primary diagnosis (stromal dystrophy, herpes simplex keratitis, SEF, trauma, and keratoconus with Fuchs dystrophy as reference), vascularization in more than 2 quadrants, planned recipient diameter over 8.5 mm, immunologic disorders, previous lens surgery (aphakic, pseudophakic anterior or posterior chamber intraocular lens), previous surgery for glaucoma or trauma, being grafted in 2001 or in 2002. For SEF patients, the risk factors were younger age, vascularization in more than 2 quadrants, planned recipient diameter over 8.5 mm, immunologic disorders, previous surgery for glaucoma or trauma, associated cataract or dry eye, and graft year. For keratoconus patients, the risk factors for CR were older age, vascularization in more than 2 quadrants, immunologic disorders, and previous lens surgery. CONCLUSION: The frequency of CR increased in France over the 2000-2002 time period. Patients presenting the above risk factors should be followed up closely to limit the loss of the first graft.

PURPOSE To study the progress of cornea donation and transplantation in France. METHODS A questionnaire was sent, every year since 1994, to all the heads of ophthalmology departments in public and private hospitals. RESULTS Response rates of almost 100% were obtained each year. In 1997, 153 hospitals carried out cornea harvesting or transplantation. The number of cornea donations decreased sharply between 1991 (3,774) and 1993 (2,383). Donations then increased slowly to reach 3,591 in 1997 [60 per million population (pmp)]. Cornea-transplantation activity followed the same pattern, decreasing from 3,843 transplants in 1991 to 3,210 (54 pmp) in 1997. In 1997, 73% of cornea transplants took place in 90 public hospitals, and only 27% took place in 28 private hospitals. The number of imported corneas has increased, particularly in 1997, in which 764 corneas were imported (24% of the corneas transplanted). Ninety-two percent of imported corneas were grafted in private hospitals. The estimate of the number of patients registered on local waiting lists increased to 8,303 at the end of 1997. There was a weak correlation between the number of corneas transplanted and the number of patients on local waiting lists by hospital (r = 0.65; p < 0.0001). CONCLUSION The rate of corneal grafts in France is similar to that in other European countries, but the number of patients on waiting lists is high. Careful thought and effort should be applied to increasing the level of corneal donation and harvesting and reducing waiting lists in France to levels similar to those in other European countries.

✓ Since 1985, the authors have been using madreporic coral fragments (genera Porites) as a bone graft substitute. Of the 167 coral grafts implanted, 150 were coral “corks” used to obliterate burr holes (diameter 10 mm), five were large implants (length 20 to 40 mm) to repair skull defects, and 12 were coral blocks to reconstruct the floor of the anterior cranial fossa. Previous experimental studies suggested that coral grafts would be well tolerated and become partially reossified as the calcific skeleton was resorbed. The authors describe their experience and detail the main biological properties of these materials, which appear to be very promising for use in cranial reconstructive surgery.