Agence de la Biomedecine

Saint-Denis-d'Oléron, France

Agence de la Biomedecine

Saint-Denis-d'Oléron, France

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Cancer prognosis has considerably improved over recent decades and increasing numbers of young adults live with the long-term consequences of their treatment. Their quality of life is often serious compromised by the inability to conceive a child. As such the recent and rapidly evolving practice of fertility preservation needs to become a standard option in cancer care. Embryos, oocytes, spermatozoa, and germinal tissue can be cryopreserved without damage until such time that the patient, freed from their illness can envisage starting a family. Fertility can be persevered prior to initiation of gonadotoxic treatments by different methods. Some options, in particular in prepubescent boys (and even in adolescents and young adults), though a high research priority and a source of great hope, remain highly experimental. Since the available options combine both validated and experimental methods, it is necessary that care teams are multidisciplinary and that they discuss these choices with the patient and (for children) their family. Even though some patients, through choice or otherwise, are not candidates for Fertility Preservation, their decision, taken in the light of complete, correct and understandable information about the available options, must be respected in accordance with their rights to determine their own reproductive future. The current situation in France needs improvement and multidisciplinary structures are forming where cancer specialists work closely with specialists in reproductive medicine and biology to provide rapid and coordinated patient care. The national cancer institute (INCA) with the Agence de la biomédecine have co-published a report that brings the knowledge of all involved in the care of these patients up to date and makes a series of propositions to improve the situation and notably to guarantee equitable access to quality care for all concerned persons. The principal areas of improvement are: - Equitably improve cancer patients' access to fertility preservation across the country through the regional planning and establishment of multidisciplinary teams, supported by targeted funding and the authorisation of centres. - Publish and disseminate professional guidelines and verify that they are taken into account during multidisciplinary decision making. - Systematically inform patients and their families about the consequences of cancer therapy on reproductive function. - Set up longitudinal cohorts of patients. - Promote research into how to prevent or reduce the risk of the attenuation of fertility and into how to restore it. © 2013 Springer-Verlag France.


Caillard S.,Strasbourg Universitary Hospital | Lamy F.X.,Agence de la Biomedecine | Quelen C.,Agence de la Biomedecine | Dantal J.,Nantes Universitary Hospital | And 4 more authors.
American Journal of Transplantation | Year: 2012

A registry of posttransplant lymphoproliferative disorders (PTLD) was set up for the entire population of adult kidney transplant recipients in France. Cases of PTLD were prospectively enrolled between January 1, 1998, and December 31, 2007. Ten-year cumulative incidence was analyzed in patients transplanted after January 1, 1989. PTLD risk factors were analyzed in patients transplanted after January 1, 1998 by Cox analysis. Cumulative incidence was 1% after 5 years, 2.1% after 10 years. Multivariate analysis showed that PTLD was significantly associated with: older age of the recipient 47-60 years and >60 years (vs. 33-46 years, adjusted hazard ratio (AHR) = 1.87, CI = 1.22-2.86 and AHR = 2.80, CI = 1.73-4.55, respectively, p < 0.0001), simultaneous kidney-pancreas transplantation (AHR = 2.52, CI = 1.27-5.01 p = 0.008), year of transplant 1998-1999 and 2000-2001 (vs. 2006-2007, AHR = 3.36, CI = 1.64-6.87 and AHR = 3.08, CI = 1.55-6.15, respectively, p = 0.003), EBV mismatch (HR = 5.31, CI = 3.36-8.39, p < 0.001), 5 or 6 HLA mismatches (vs. 0-4, AHR = 1.54, CI = 1.12-2.12, p = 0.008), and induction therapy (AHR = 1.42, CI = 1-2.02, p = 0.05). Analyses of subgroups of PTLD provided new information about PTLD risk factors for early, late, EBV positive and negative, polymorphic, monomorphic, graft and cerebral lymphomas. This nationwide study highlights the increased risk of PTLD as long as 10 years after transplantation and the role of cofactors in modifying PTLD risk, particularly in specific PTLD subgroups. The French Registry of posttransplant lymphoproliferative disorders occurring after kidney transplantation in adults is presented. © copyright 2011 The American Society of Transplantation and the American Society of Transplant Surgeons.


Lafarge M.,University Paris Diderot | Mordant P.,Hopital Bichat | Thabut G.,University Paris Diderot | Brouchet L.,Hopital Larrey | And 9 more authors.
Journal of Heart and Lung Transplantation | Year: 2013

Background Extracorporeal membrane oxygenation (ECMO) is increasingly used as a bridge to lung transplantation (LTx). However, data concerning this approach remain limited. Methods We retrospectively reviewed the medical records of all patients in France who received ECMO as a bridge to LTx from 2007 to 2011. Post-transplant survival and associated factors were assessed by the Kaplan-Meier method and the Cox model. Results Included were 36 patients from 11 centers. Indications for LTx were cystic fibrosis (CF) in 20 (56%), pulmonary fibrosis (PF) in 11 (30%), and other diagnoses in 5 (14%). ECMO was venovenous for 27 patients (75%) and venoarterial for 9 (25%). Mean follow-up was 17 months. Bridging to LTx was achieved in 30 patients (83%); however, only 27 patients (75%) survived the LTx procedure, and 20 (56%) were discharged from hospital. From ECMO initiation, 2-year survival rates were 50.4% overall, 71.0% for CF patients, 27.3% for PF patients, and 20.0% for other patients (p < 0.001). From LTx, 2-year survival rates were 60.5% overall, 71.0% for CF patients, 42.9% for PF patients, and 33.0% for other patients (p = 0.04). Conclusions Our study confirms that the use of ECMO as a bridge to LTx in France could provide a medium-term survival benefit for LTx recipients with critical conditions. Survival differed by underlying respiratory disease. Larger studies are needed to further define the optimal use of ECMO. © 2013 International Society for Heart and Lung Transplantation.


Antoine C.,Agence de la Biomedecine
Reanimation | Year: 2013

Extended-criteria donors are increasing due to aging of the donor population, changes in causes of death, and medical progresses in the field of transplantation, allowing to transplant grafts from older and/or with vascular co-morbidities donors. The use of grafts from such donors is evidence-based and beneficial for recipients with respect of certain conditions including maintenance of donors as well as evaluation of viability, conservation, and allocation of the organs. Scoring systems allow the detection of grafts at significant risk of failure, for which diagnostic tools will be developed in order to better assess their quality and function. This policy should lead to the implementation of all strategies to optimize graft function but also allow, when appropriate, the recognition of grafts that present the risk of poor or no functional status, to be discarded from transplantation. © SRLF et Springer-Verlag France 2012.


Mellerio H.,French Institute of Health and Medical Research | Alberti C.,French Institute of Health and Medical Research | Alberti C.,University Paris Diderot | Labeguerie M.,French Institute of Health and Medical Research | And 5 more authors.
Transplantation | Year: 2014

BACKGROUND: Little is known about the socioprofessional situation of adult-aged kidney-transplanted children. This nationwide French cohort study documented the socioprofessional outcomes of adults who underwent kidney transplantation before age 16 years between 1985 and 2002. METHODS: Of 890 patients, 624 were eligible for a questionnaire and 374 completed it (response rate=60%; men=193 and women=181). The data were compared with the French general population using an indirect standardization matched for gender, age, and period. RESULTS: The median ages were 27.1 years at survey time and 12.3 years at first transplantation. Of the participants, 31.1% lived with a partner (vs. 52.2%; P<0.01) and 35.7% lived with their parents (vs. 21.0%; P<0.01). When standardized for parental educational level, fewer participants had a high-level degree (≥3-year university level) and fewer women had a baccalaureate degree. Professional occupations were similar to the French general population, but unemployment was higher (18.5% vs. 10.4%; P<0.01). Independent predictive factors for poor socioprofessional outcome were primary disease severity (onset in infancy or hereditary disease), the presence of comorbidities or sensorial disabilities, low educational level of the patient or his parents, female gender, and being on dialysis after graft failure. CONCLUSIONS: Transplanted children, particularly girls and patients with low parental educational levels, require optimized educational, psychologic, and social support to reach the educational level of their peers. This support should be maintained during adulthood to help them integrate into the working population and build a family.©2013 Lippincott Williams & Wilkins.


Letur H.,Institute Mutualiste Montsouris | Merlet F.,Agence de la Biomedecine
Gynecologie Obstetrique Fertilite | Year: 2012

In France, medically assisted procreation (MAP) activities and gamete donation are strictly regulated by the bioethics law. The main ethical principles applied to the donation-no remuneration, anonymity, and the requirement for free and informed consent-aim to protect donors. In the same spirit, since MAP with oocytes donation is recognized as a healthcare activity, receiving couples benefit from exemption from co-payments by the health insurance system. Thus, it is widely accessible to couples presenting medical infertility requiring oocytes from a donor, but availability is insufficient to cover needs. This shortage in supply results in moving the demand abroad where this particular MAP is exercised at varying levels of supervision. © 2012 Elsevier Masson SAS. All rights reserved.


Antoine C.,Agence de la biomedecine | Mourey F.,Agence de la biomedecine | Prada-Bordenave E.,Directrice generale
Annales Francaises d'Anesthesie et de Reanimation | Year: 2014

On the basis of the literature and results presented at the 6th International Conference, donation after cardio-circulatory death provides a significant, practical, additional high quality source of transplantable organs. The vast majority of DCD are 'controlled' Maastricht category III donors. In 2010, the parliamentary information mission on the revision of the bioethics laws invited the Intensive Care Societies to debate and to make recommendations to implement controlled donation after circulatory death. They came to the conclusion that such retrieval is possible in France and insisted on the medical criteria that frame it: the writing of the medical procedures, the ethical aspects and the delay. The major recommendations of the ethics committees were firstly, The WLST decision is independent of the possibility of organ donation; secondly, the strict respect of "The dead donor and organ transplantation rule" and the updated national guidance for the WLST; thirdly, the drafting of a nationally agreed protocol defining the mandatory conditions to determine death and to perform procurement and transplantation. Organ donation after WLST will be authorised only in pilot centres with a locally agreed WLST policy including external second opinion and written transcript of the WLST decision, experienced intensive care staff, a local organ procurement coordination team familiar with DBD and DCD protocols and only in hospitals authorised for organ procurement. It is important to have an optimal and standardized national guidance to limit the known risk factors of graft failure (donor and recipient choice, warm and cold ischemia time), to increase acceptance by medical community and civil society and to improve results and allow more powerful analysis. © 2013.


Organ transplants are not accessible to everyone. Less than a third of the people on the waiting list are able to benefit from one each year in France. Donor organs are rare. Everyone who has expressed a wish to donate their organs should, unless there is a medical contraindication, have the reassurance that this wish will be fulfilled. It is the moral responsibility of everyone, particularly caregivers, to respect their commitment. © 2014 Elsevier Masson SAS.


Royere D.,Agence de la Biomedecine
European Journal of Public Health | Year: 2016

Background: French state health insurance has funded trisomy 21 prenatal screening for all pregnant women since decades. First-trimester combined screening was introduced nationally and funded in 2010. Objective: To evaluate the impact of the introduction, of a national policy of prenatal trisomy 21 first-trimester screening on the reduction of invasive prenatal diagnostic procedures. Methods: The results of all prenatal trisomy 21 screening and invasive diagnostic procedures were collected for the whole country over the period 2009-12. The screen-positive rates (risk cut-off 1: 250, including isolated nuchal translucency ≥ 3.5 mm), positive predictive values and percentage of cases diagnosed prenatally were calculated. Results: Over the study period the number of women undergoing serum screening (including first- and second-trimester screening tests) increased from 678 803 to 689 651 (83 to 85% of deliveries, P < 0.0001). By 2012, first-trimester combined screening accounted for 70% of all trisomy 21 screening. The screen-positive rate decreased from 9.5 to 4.8% (P < 0.001) resulting in a 37 478 (47%) drop (P < 0.001) in the number of invasive diagnostic procedures. The positive predictive value of screening increased from 2.6 to 6.1% from 2009 to 2012 (P < 0.001), due to the higher positive predictive value of first-trimester over second-trimester screening (9.1 vs. 1.8% over the period 2010-12, P < 0.001). The percentage of prenatally diagnosed cases remained high at around 80% between 2010 and 2012. Conclusions: The policy shift from second-trimester to first-trimester trisomy 21 screening allowed to reduce the number of invasive tests. The number of antenatal trisomy 21 diagnoses increased (+2.7%) over the study period. © 2015 The Author. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.


Development of the transplantation of organs and tissues are not linked solely to the feats of surgery and biology. Without quality of the organization for the donation and the organ removal, nothing would be possible. Figurehead of this organization: the coordinator nurse for donation and the organ procurement. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

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