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Background The well-documented benefits of physical activity (PA) are still poorly characterized in long-term kidney transplant outcome. This study analyzed the impact over a 10-year follow-up of PA on graft function in Italian kidney transplant recipients (KTRs). Methods Since 2002, the Italian Transplant-Information-System collected donor and recipient baseline and transplant-related parameters in KTRs. In 2015, ‘penchant for PA’ (PA ≥ 30-min, 5 times/week) was added. Stable patients aged ≥18 years at the time of first-transplantation were eligible. KTRs with at least 10-year follow-up were also analyzed. Mixed-effect regression models were used to compare eGFR changes over time in active versus non-active patients. Results PA information was available for 6,055 KTRs (active 51.6%, non-active 48.4%). Lower penchant for PA was found in overweight and obese patients (OR = 0.84; OR = 0.48, respectively), in those with longer dialysis vintage (OR = 0.98 every year of dialysis), and older age at transplant. Male subjects showed greater penchant for PA (OR = 1.25). A slower decline of eGFR over time was observed in active KTRs compared to non-active, and this finding was confirmed in the subgroup with at least 10-year follow-up (n = 2,060). After applying the propensity score matching to reduce confounding factors, mixed-effect regression models corroborated such better long-term trend of graft function preservation in active KTRs. Conclusions Penchant for PA is more frequent among male and younger KTRs. Moreover, in our group of Italian KTRs, active patients revealed higher eGFR values and preserved kidney function over time, up to 10-years of follow-up.

The complex multi-criteria optimisation problems arising in Kidney Exchange Programmes have received considerable attention both in practice and in the scientific literature. Whereas theoretical advancements are well reviewed and synthesised, this is not the case for practice. We present a synthesis of models and methods applied in present European Kidney Exchange Programmes, which is based on detailed descriptions we created for this purpose. Most descriptions address national programmes, yet we also present findings on emerging cross-national programmes. The synthesis provides a systematic and detailed description of the models and methods the programmes use, revealing important commonalities as well as considerable variation among them. Rather than distilling a single best practice from these results, we find that the variation in models and methods arises because of variation in country characteristics, policies, and ethics. The synthesised state of the art may benefit future national and cross-national initiatives and direct future theoretical contributions within and across the boundaries of the Operations Research discipline.

BACKGROUND Muscle weakness, incorrect body water distribution and reduced exercise tolerance are the main characteristics found in renal transplant recipients after surgical treatment. Regular physical supervised exercise programs, at moderate intensity, have been promoted to contrast these aspects, while few data are available for long-term unsupervised mixed exercise plans. Bioelectrical impedance vector analysis (BIVA) provides a semi-quantitative evaluation of body cell mass and body water. This study aims to approach the role of the BIVA analysis in the follow-up of Renal Transplant Group (RTG) and analyze the impact of unsupervised exercise program. METHODS Thirteen male RTG and ten healthy subjects, adherent to a tailored exercise program, at moderate intensity and prescribed in an unsupervised way, have been followed up for one year. Every six months all the subjects have been submitted to the ergometric test, echocardiographic exam and an analysis of body composition by bioimpedance. They were compared to a healthy control group (HG). RESULTS A significant reduction of the BMI was observed at the end of the study in the RTG group (T0 24.8±3.2, T12 24.2±3.2 kg/m2; P

Background: Despite the benefits of physical activity on cardiovascular risk in kidney transplant recipients (KTRs), the long-term effects of exercise have been poorly investigated. This is a three-year observational study comparing graft function and cardiovascular risk factors in active KTRs (AKTRs) vs. sedentary KTRs (SKTRs). Methods: KTRs with stable renal function were assigned to active or sedentary group in relation to the level of daily physical activity based on World Health Organization (WHO) recommendations (&lt, 150 or &gt, 150 minutes/week, respectively). Complete blood count, renal function indices, lipid profile, blood pressure and anthropometric measures were collected yearly for an observation period of three years. The comparisons between the two groups were performed by repeated measures analyses of covariance (ANCOVAs), with age as a covariate. Results: Fifty-four subjects were included in the study. Thirty of them were identified as AKTRs (M/F 26/4, aged 45 &plusmn, 12 years) and 24 as SKTRs (M/F 18/6, aged 51 &plusmn, 14 years). Baseline characteristics were similar between the groups except body mass index (BMI) that was significantly higher in SKTRs (p = 0.043). Furthermore, over the three-year observation period, BMI decreased in AKTRs and increased in SKTRs (p = 0.006). Graft function was stable in AKTRs, while it showed a decline over time in SKTRs, as indicated by the rise in serum creatinine levels (p = 0.006) and lower eGFR (p = 0.050). Proteinuria, glucose and uric acid levels displayed a decrease in AKTRs and an increase in SKTRs during the three-year period (p = 0.015, p = 0.004 and p = 0.013, respectively). Finally, concerning lipid profiles, AKTRs had a significant reduction over time of triglycerides levels, which conversely showed a clinically relevant increase in SKTRs (p = 0.014). Conclusions: Our findings indicate that regular weekly exercise training may counteract the increased cardiovascular risks and also prevent graft function decline in KTRs.

The 759 cases of brain death declaration (BDD [Italian law, 6 hours of observation time]) that occurred in 190 Italian intensive care units (ICUs) between May and September 2012 were studied to quantify carbapenem-resistant gram-negative bacteria (CR-GN) isolated in organ donors, to evaluate adherence to national screening guidelines, and to identify risk factors for CR-GN isolation. Mandatory blood, bronchoalveolar lavage, and urine cultures were performed on the BDD day in 99% of used donors. Because results were rarely made available before transplant, >20% of transplants were performed before obtaining any microbiological information, and organs from 15 of 22 CR-GN cases were used. Two (lung-liver) of the 37 recipients died, likely because of donor-derived early CR-GN sepsis. ICU stay >3 days (odds ratio [OR] = 7.49, P = .004), fever (OR = 3.11, P = .04), age

Background The donation rate (DR) per million population is not ideal for an efficiency comparison of national deceased organ donation programs. The DR does not account for variabilities in the potential for deceased donation which mainly depends on fatalities from causes leading to brain death. In this study, the donation activity was put into relation to the mortality from selected causes. Based on that metric, this study assesses the efficiency of different donation programs. Methods This is a retrospective analysis of 2001 to 2015 deceased organ donation and mortality registry data. Included are 27 Council of Europe countries, as well as the United States. A donor conversion index (DCI) was calculated for assessing donation program efficiency over time and in international comparisons. Results According to the DCI and of the countries included in the study, Spain, France, and the United States had the most efficient donation programs in 2015. Even though mortality from the selected causes decreased in most countries during the study period, differences in international comparisons persist. This indicates that the potential for deceased organ donation and its conversion into actual donation is far from being similar internationally. Conclusions Compared with the DR, the DCI takes into account the potential for deceased organ donation, and therefore is a more accurate metric of performance. National donation programs could optimize performance by identifying the areas where most potential is lost, and by implementing measures to tackle these issues.

Background In 2011, the European Directorate for the Quality of Medicines & Healthcare of the Council of Europe launched a 3-year collaborative project to address the organ shortage and improve access to transplant health services in Council of Europe member states in the Black Sea area (Armenia, Azerbaijan, Bulgaria, Georgia, Moldova, Romania, Turkey, Ukraine, and the Russian Federation) through the development of safe and ethical donation and transplantation programs. Objective Support the development of donation and transplantation programs through close interstate cooperation between national health organizations and relevant stakeholders. Methodology Several work packages (WP) were established: WP1, project coordination (European Directorate for the Quality of Medicines & Healthcare); WP2, development and implementation of an effective legislative and financial framework (Czech Republic and France); WP3, establishment of National Transplant Authorities (Italy and Portugal); and WP4, clinical practices (DTI Foundation). Data collection, surveys, and expert visits allowed for the collection of first-hand information from each participant country at national, regional, and hospital levels. Results Data analysis showed the positive impact of the project represented by a tendency to increase the total donation rates (per million people) in the participant countries (2011 vs 2013): Azerbaijan, +7.3; Armenia, −0.7; Georgia, +3.3; Bulgaria, +0.9; Moldova, +2.5; Ukraine:, +0.8; Romania, +2.3; and Turkey, +2.7. Conclusions Increases in total donation rates are the result of a number of initiatives in the Black Sea area, including the stepwise implementation of legislative, organizational and institutional country-specific recommendations tailored by the CoE, efforts of the respective Ministries of Health in each country and synergism with other European projects in the region. These countries should invest further in implementing the recommendations that emerged from this project to improve their organ donation and transplantation programs and progress toward self-sufficiency.

The Italian National Transplant Centre (CNT) is coordinating with the Italian National Blood Centre (CNS) the Joint Action ‘VISTART' (EU Grant Agreement n. 676969), which has received funding from the European Union's Health Programme (2014-2020). CNT is also the leader of the Joint Action's Work Package 10 aimed at providing technical support and guidance to European tissue- and cell-competent authorities and to tissue establishments across the European Union in the implementation of the Single European Code (SEC). A consortium of three organizations, built by CNT, the International Council for Commonality in Blood Banking Automation (ICCBBA) and Artman Technologies under the European Commission funded service contract ‘Eurocet128' (www.eurocet128.eu), already built the European Tissue Establishment and Tissue and Cell Product Compendia between 2011 and 2014 in order to provide European Member States with a tool which would grant traceability of tissues and cells at human transplant purpose across the European Union. The two compendia are available on an online platform hosted and managed by the European Commission.

Onco-nephrology is an emerging field in medicine. Patients with cancer may suffer from kidney diseases because of the cancer itself and cancer-related therapy. It is critical for nephrologists to be knowledgeable of cancer biology and therapy in order to be fully integrated in the multidisciplinary team and optimally manage patients with cancer and kidney diseases. In a recent international meeting, the key issues in this challenging clinical interface were addressed, including many unresolved basic science questions, such as the high tumor incidence in kidney transplant recipients. To this end, 70 highly qualified faculty members were gathered from all over the world to discuss these issues in 8 plenary sessions, including 5 keynote lectures. In addition, 48 young nephrologists and oncologists were invited to present their original observations that were highlighted in 2 large poster sessions.

Facial transplantation is a complex technique that involves a number of risks. However, although it is not a lifesaving transplant, for individuals in dramatic conditions due to severe facial disfigurements, it constitutes the only possibility of recovering an acceptable quality of life. For this reason, even from an ethical point of view, it is considered an important therapeutic resource, provided it is conducted in rigorously-controlled conditions.

Background Following the positive experience of the national project “A transplant...and now it’s time for sport,” the Transplant Reference Center of the Emilia-Romagna Region has pursued the promotion of pre- and post-transplant physical exercise by developing a network. Methods The path involved the transplant centers and operative units (UU.OO) who wanted to target transplant and waiting list patients, who are clinically stable, to perform personalized exercise through a program (supervised or not) prescribed by a specialist in sports medicine. With the collaboration of the Collective Prevention and Public Health Service, the network was established, consisting of the sports medicine centers and the gyms that promote health for adapted physical activity (PS-AMA). To implement the network, training courses for all the professionals involved (doctors, nurses, exercise specialists) and operational meetings in the transplant centers-nephrology units with patients’ associations have been organized. Results To date, there are 14 transplant centers and UU.OO, 9 sports medicine centers, and 45 PS-AMA involved in this network. Seven training courses were organized with the participation of 193 health professionals. Since January 2016, there have been 65 transplanted patients and 5 patients on the waiting list who practice the prescribed exercise. Of these, 45 carry out supervised exercise in PS-AMA; 25 perform autonomous exercise. Each patient is monitored every 6 months. No problems related to the exercise performance were recorded. Conclusions The development of a network of professionals and associations is the key element to raise awareness of physical activity among transplanted and waiting-for-transplant patients, reducing the pathologies associated with a sedentary lifestyle.

In order to bridge the gap between available organs and patients needing transplants, donor selection criteria for donors are increasingly being extended; the possibility of using organs from nonstandard risk donors has been introduced in many countries. This clearly poses considerable ethical issues that should be analyzed and taken into consideration by the competent bodies and institutions. In this article, we illustrate the Italian situation regarding the possibility of using organs from anti-hepatitis C virus (HCV) and HCV RNA-positive donors (anti-HCV+ve) in negative recipients (healthy subjects who have never come into contact with the hepatitis C virus) in light of the availability of new direct-acting antiviral drugs (DAAs) for hepatitis C treatment. We discuss the motivations behind the both favorable opinions of the Ethics Committee of the Italian National Institute of Health (Istituto Superiore di Sanita) and the Italian National Bioethics Committee (Comitato Nazionale per la Bioetica) discussing the main implications from an ethical point of view.

Background One of the main activities connected with transplantation is the rapid and timely transportation of patients, medical teams, and human organs from donation to transplantation centers under the compliance of national guidelines and principles of quality, performance, and safety. High-speed transportation on a railway network is becoming relevant both in terms of performance and extensiveness of the service. Methods and Objectives Our study explores the feasibility of adopting a high-speed rail network for the transportation of those organs with large cold ischemia time and those less influenced by transportation-related perturbations (ie, temperature, speed, vibrations), assessing savings and relative performance improvement. In this study, only kidneys have been considered; the transplantation database has been integrated with the national high-speed railway network and timetables. A function is implemented that allocates to air transportations those records with 1 of the 2 ends situated on islands, remote regions, and abroad, while rail transportation is preferred where constraints on capacity and compliance with cold ischemia time are met. Road transportation is still feasible for those records involving 2 adjacent regions and for intraregional transportation. Results The opportunity of integrated road-rail transportation in place of air or all-road transportation allows users to lower generalized costs and reduce driven distance for personnel and vehicles allocated to a regional transplantation center’s fleet and staff. Savings in fleet and staff usage can serve to improve the performances at the local level. Conclusions The knowledge and analysis of transportation alternatives for human organs with less stringent safety and preservation criteria allow a more efficient allocation of resources both at the local and national level—without compromising quality and reliability of the system.

To implement split liver transplantation (SLT) a mandatory-split policy has been adopted in Italy since August 2015: donors aged 18-50years at standard risk are offered for SLT, resulting in a left-lateral segment (LLS) graft for children and an extended-right graft (ERG) for adults. We aim to analyze the impact of the new mandatory-split policy on liver transplantation (LT)-waiting list and SLT outcomes, compared to old allocation policy. Between August 2015 and December 2016 out of 413 potentially “splittable” donors, 252 (61%) were proposed for SLT, of whom 53 (21%) donors were accepted for SLT whereas 101 (40.1%) were excluded because of donor characteristics and 98 (38.9%) for absence of suitable pediatric recipients. The SLT rate augmented from 6% to 8.4%. Children undergoing SLT increased from 49.3% to 65.8% (P=.009) and the pediatric LT-waiting list time dropped (229 [10-2121] vs 80 [12-2503] days [P=.045]). The pediatric (4.5% vs 2.5% [P=.398]) and adult (9.7% to 5.2% [P20kg (HR=5.113, P=.048) in LLS, and ischemic time >8hours (HR=2.475, P=.048) in ERG were identified as predictors of graft failure. A national mandatory-split policy maximizes the SLT donor resources, whose selection criteria can be safely expanded, providing favorable impact on the pediatric LT-waiting list and priority for adult sick LT candidates.

Background and aims Despite the excellent long-term outcomes in liver transplant (LT) recipients, several medical complications related to lifestyle still represent an issue. This study examined the effects of a 12-month supervised aerobic and strength training program on the aerobic capacity, muscle strength, metabolic profile, liver function, and quality of life of a cohort of LT recipients. Methods LT recipients with stable liver function were assigned to interventional exercise (group A) or usual care (group B). Aerobic capacity, muscle strength, metabolic profile, liver and kidney function, and health-related quality of life were assessed at baseline and after 6 and 12 months. Group A attended supervised training sessions 3 times per week for 12 months. Group B received general recommendations about home-based exercise. Results Forty patients from 6 Italian LT centers were randomized. Twenty-nine (72.5%, men-to-women ratio 23:6, mean age, 52 ± 8 years) LT recipients completed the study. Baseline characteristics were similar between groups except for body mass index and time from LT. No episode of acute rejection nor increase of transaminases occurred. Maximum workload and body mass index increased in both groups over time, but fasting glucose significantly decreased in group A (94.0 ± 15.0 mg/dL vs 90.0 ± 17.0 mg/dL; P = .037) and increased in controls (95.0 ± 24.0 mg/dL vs 102.0 ± 34.0 mg/dL, P = .04). Upper limb muscle strength increased only in supervised LT recipients. Vitality and general and mental health domains significantly improved after physical exercise. Conclusions Supervised combined training was safe and effective in increasing aerobic capacity, muscle strength, and quality of life and in improving glucose metabolism in stable LT recipients.

Guidelines for donor selection have changed to expand the donor pool, considering potential donors affected by a neoplasm. Aim of this retrospective study is to look at the use of organs from donors with a current or history of neoplasm within the Italian Transplant Network. Data, collected and validated by Italian National Health Institute for the time interval 2006–2015, have been reviewed retrospectively by mean of multivariable pivot tables. Donors with neoplasia represented about 5% of all donors, resulting in about 4% of all transplants. Donors presented a benign neoplasm in 29.08% of cases, a malignancy with variable risk of transmission in 69.75% while in 1.34% the nature of neoplasm could not be assessed. Considering all procedures, rate of transmission of a malignancy was 0.03% (10 cases) of all 29858 transplants of the time interval. Notably, cases of transmission were not from donors of this pool, but from donors that, according to our protocols, had no elements of suspect at time of donation. As recipient safety is always the priority and as guidelines have set exclusion criteria for donors with some specific types of malignancy, these results show that use of this type of donors is safe and improve organ pool. Furthermore represent basis for improvement and standardization of donor assessment protocols suggesting that efforts in data collection systems, to produce complete and homogeneous data, are mandatory.

BACKGROUND Techniques for banking cord blood units (CBUs) as source for hematopoietic stem cell transplantation have been developed over the past 20 years, aimed to improve laboratory efficiency without altering the biologic properties of the graft. A large-scale, registry-based assessment of the impact of the banking variables on the clinical outcome is currently missing. STUDY DESIGN AND METHODS A total of 677 single cord blood transplants (CBTs) carried out for acute leukemia in complete remission in centers affiliated with the European Society for Blood and Marrow Transplantation were selected. An extensive set of data concerning CBU banking were collected and correlations with clinical outcome were assessed. Clinical endpoints were transplant-related mortality, engraftment, and graft-versus-host disease (GVHD). RESULTS The median time between collection and CBT was 4.1 years (range, 0.2-16.3 years). Volume reduction (VR) of CBUs before freezing was performed in 59.2% of available reports; in half of these the frozen volume was less than 30 mL. Cumulative incidences of neutrophil engraftment on Day 60, 100-day acute GVHD (II-IV), and 4-year chronic GVHD were 87, 29, and 21 ± 2%. The cumulative incidence of nonrelapse mortality (NRM) at 100 days and 4-year NRM were, respectively, 16 ± 2 and 30 ± 2%. Neither the variables related to banking procedures nor the interval between collection and CBT influenced the clinical outcome. CONCLUSION These findings indicate a satisfactory validation of the techniques associated with CBU VR across the banks. Cell viability assessment varied among the banks, suggesting that efforts to improve the standardization of CBU quality controls are needed.

In Italy, the 2018 West Nile virus transmission season started early with a high number of cases reported. One-Health surveillance, within the Italian West Nile national preparedness and response plan, detected viral circulation 9 days before symptom-onset of the first confirmed human case; triggering timely implementation of blood and transplant safety measures. This is an example of how functional coordination allows health authorities to use early warning triggers from surveillance systems to implement preventive measures. ispartof: EUROSURVEILLANCE vol:23 issue:32 pages:2-6 ispartof: location:Sweden status: published

Comparison is made between the proposals put forward by the "New Charter for Health Care Workers" in the matter of organ transplants and other models of bioethics. The personalist approach adopted by the New Charter is illustrated and the proposals contained in it are finally placed alongside the reference ethical principles underlying the Italian transplant network: they are found to be fully in agreement.

AIM To evaluate the effect of a 12-mo supervised aerobic and resistance training, on renal function and exercise capacity compared to usual care recommendations. METHODS Ninety-nine kidney transplant recipients (KTRs) were assigned to interventional exercise (Group A; n = 52) and a usual care cohort (Group B; n = 47). Blood and urine chemistry, exercise capacity, muscular strength, anthropometric measures and health-related quality of life (HRQoL) were assessed at baseline, and after 6 and 12 mo. Group A underwent a supervised training three times per week for 12 mo. Group B received only general recommendations about home-based physical activities. RESULTS Eighty-five KTRs completed the study (Group A, n = 44; Group B, n = 41). After 12 mo, renal function remained stable in both groups. Group A significantly increased maximum workload (+13 W, P = 0.0003), V’O2 peak (+3.1 mL/kg per minute, P = 0.0099), muscular strength in plantar flexor (+12 kg, P = 0.0368), height in the countermovement jump (+1.9 cm, P = 0.0293) and decreased in Body Mass Index (-0.5 kg/m2, P = 0.0013). HRQoL significantly improved in physical function (P = 0.0019), physical-role limitations (P = 0.0321) and social functioning scales (P = 0.0346). No improvements were found in Group B. CONCLUSION Twelve-month of supervised aerobic and resistance training improves the physiological variables related to physical fitness and cardiovascular risks without consequences on renal function. Recommendations alone are not sufficient to induce changes in exercise capacity of KTRs. Our study is an example of collaborative working between transplant centres, sports medicine and exercise facilities.

The purpose of this study was to assess the safety and the clinical outcome associated with organ transplantation from increased infectious risk donors (IRD). We retrospectively identified all adult deceased IRD referred to the Nord Italia Transplant program coordinating center from November 2006 to November 2011. All potential donors were screened for social risk factors that may increase the risk of donor-derived infection with human immunodeficiency (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). All recipients were followed monthly for the first 6 months post-transplant. A total of 86 potential IRD were identified during the study period. Three hundred and seventy-nine organs from IRD were offered to the transplant centers, but only 185 (48.8%) were used for transplantation. Organs from IRD were transplanted into 174 recipients. The complete follow-up data were available for 152 of 174 (87.3%) recipients. During a mean follow-up of 11.7 months (median 12; range 2.4-12), no transmission of HIV, HBV, or syphilis was documented by serology and nucleic acid testing (NAT) testing. Two patients transplanted with organs from HCV-RNA-positive donors, as expected, developed post-transplant HCV infection. In conclusion, the use of organs from IRD was associated with a safe increase in the transplant procedures in our country.

Purpose: To describe cycling performance in a well-trained male a decade after Cardiac Transplantation (CTX). Case report: The patient was diagnosed with arrhythmo- genic right ventricular cardiomyopathy at 14 years of age and underwent CTX at 35 years. Exercise training began 3 weeks after CTX, and progressively increased in volume and intensity. Ten years after CTX he participated in twelve one-day cycling races over an eight-month period. Maximal cardiopulmonary exercise test was performed before the study. One race was monitored using a power meter. Results: VO2peak (47.2 mL/kg/min), maximal HR (161 bpm), and oxygen pulse (18.8 mL/bpm) were 113%, 92%, and 118% of age-predicted values respectively. HR, W, and relative VO2 at the ventilatory threshold and at the respira- tory compensation point were 128 bpm, 120 W, and 75% VO2peak, and 142 bpm, 155 W, and 86% VO2peak respec- tively. Cycling economy was ~80 W per liters per O2/min. The race was completed in 7 hours and 56 minutes, at an average of 141 bpm and 162 W, remaining between moder- ate-to-high intensity (4 h 2 min), and above high-to-severe intensity (2 h 19 min). Conclusion: Long-term aerobic training may result in a re- markable cycling performance a decade after CTX, likely because of cardiovascular adaptations.

The Effect of Differing Kidney Disease Treatment Modalities and Organ Donation and Transplantation Practices on Health Expenditure and Patient Outcomes (EDITH) aims to obtain information on long-term kidney transplant outcomes, long-term health outcomes of living kidney donors and detailed outcomes and costs related to the different treatment modalities of end-stage kidney disease. Nine partners from seven European Union countries will participate in this project.

Traceability of cells during IVF is a fundamental aspect of treatment, and involves witnessing protocols. Failure mode and effects analysis (FMEA) is a method of identifying real or potential breakdowns in processes, and allows strategies to mitigate risks to be developed. To examine the risks associated with witnessing protocols, an FMEA was carried out in a busy IVF centre, before and after implementation of an electronic witnessing system (EWS). A multidisciplinary team was formed and moderated by human factors specialists. Possible causes of failures, and their potential effects, were identified and risk priority number (RPN) for each failure calculated. A second FMEA analysis was carried out after implementation of an EWS. The IVF team identified seven main process phases, 19 associated process steps and 32 possible failure modes. The highest RPN was 30, confirming the relatively low risk that mismatches may occur in IVF when a manual witnessing system is used. The introduction of the EWS allowed a reduction in the moderate-risk failure mode by two-thirds (highest RPN = 10). In our experience, FMEA is effective in supporting multidisciplinary IVF groups to understand the witnessing process, identifying critical steps and planning changes in practice to enable safety to be enhanced.

Background and Aims In patients with hepatitis C virus (HCV), recurrence of infection after liver transplant (LT) is universal and associated with worst survival. We present the results of an Italian cohort to compare the 3-year outcome of HCV-Ab-positive and HCV-Ab-negative LT recipients and to assess the potential interaction between HCV-Ab sero-status and other risk factors for LT failure. Methods The study is a multicentre cohort including a sample of liver transplant centres. Participant's information was collected at the local level. The best functional form of variables was decided according to the objective methods based on information theory. Association between transplant failure and potential risk factors was assessed in univariate and multivariate Poisson regression model with random intercept. Results Between June 2007 and May 2009, 1164 LT recipients were enrolled in 16 Italian transplant centres, of them 275 (23.63%) experienced LT failure. Incidence rates of LT failure was 0.32 and 0.23 per 1000 person-days in HCV-Ab-positive and HCV-Ab-negative recipients respectively (P = 0.003). Inferential models according to Akaike information criterion indicated that donor–recipient age difference and donor–recipient sex matching were more informative to predict LT failure than the age and the sex as separate variables. Multivariate analysis provided evidence that HCV-Ab sero-status, time after LT, donor–recipient age difference, donor–recipient sex matching and recipient's MELD score were significantly associated with LT failure. Moreover, the effect of HCV-Ab sero-status on LT failure was modified by the simultaneous action of time after LT and donor–recipient age difference. No interaction was found between recipient's HCV-Ab sero-status and either recipient's MELD or donor–recipient sex matching. Conclusion In view of the imminent introduction of new anti-HCV therapies, our study provides information to assess which LT recipients should be prioritized for receiving these highly effective, but expensive, new treatments. This is particularly relevant for those clinical settings where healthcare prioritization is endorsed by national authorities.

The aim of the study was to investigate the effects of sport activity on health-related quality of life (HRQoL) of solid organ transplant recipients participating in sports competitions. A group of 168 sportive transplanted patients (STP), a group of 97 nonsportive transplanted patients (NSTP), and a group of 152 sportive healthy controls (SHC) were compared on the eight scales of the SF-36 questionnaire. STP and NSTP reported significantly lower scores than SHC on the physical functioning scale. STP did not differ from SHC in the Role-Physical, General Health, and Vitality scales, while NSTP reported significantly lower scores. STP obtained higher scores than NSTP and SHC on Mental Health. Among STP, the effect of quantity of sport activity was significant on General Health and Role Emotional, with more sport activity associated with higher HRQoL. Organ failure and post-transplant therapies may have negative consequences on HRQoL. Sports activities and participation in sports competitions can reduce this impact, improving general and psychological functioning of solid organ transplant recipients.

From the ISHLT Transplant Registry, Dallas, Texas; University of Utah School of Medicine, Salt Lake City, Utah; Brigham and Women’s Hospital Heart and Vascular Center, Harvard University, Boston, Massachusetts; Hospital Universitario A Coruna, La Coruna, Spain; Hospital 12 de Octubre, Madrid, Spain; Agence de la biomedecine, Saint-Denis, France; Niguarda-Ca’ Granda Hospital, Milan, Italy; St. Vincent’s Hospital, Sydney, New South Wales, Australia; Freeman Hospital, Newcastle upon Tyne, United Kingdom; Centro Nazionale Trapianti, Roma, Italy; Duke University, Durham, North Carolina; The Johns Hopkins Hospital, Baltimore, Maryland; National Health Service Blood and Transplant, Bristol, United Kingdom; and the Wythenshawe Hospital, Manchester, United Kingdom.

Narrative medicine allows professionals from all fields of medical sciences to understand the patient's total experience of illness, and meet his/her needs in an empathetic environment. Narrative medicine helps spread holistic knowledge of a multitude of complex clinical conditions, including transplantation.To underline the role of narrative medicine in women who become pregnant after a liver transplant by using their narrations of this very special experience.We describe our study with narration and listening to the stories of three women expecting their first child after a liver transplant, by analysing the structure and role of narration in the context of relationships between patients and caregivers. The narrations were transcribed verbatim with the main plot analysed in order to address all the aspects of this rare clinical condition and the transition to parenthood.The women narrated this experience in three phases: transplantation, pregnancy and delivery, and post-partum. They described all phases of pregnancy as stressful but satisfying, whereas the fact of becoming a mother was perceived as a victory both as a woman and as a transplant patient.Our results suggest that narrative medicine represents a significant professional tool for caring for transplant patients during pregnancy.

Organ transplantation, e.g., of the heart, liver, or kidney, is nowadays a routine strategy to counteract several lethal human pathologies. From literature data and from data obtained in Italy, a striking scenario appears well evident: women are more often donors than recipients. On the other hand, recipients of organs are mainly males, probably reflecting a gender bias in the incidence of transplant-related pathologies. The impact of sex mismatch on transplant outcome remains debated, even though donor-recipient sex mismatch, due to biological matters, appears undesirable in female recipients. In our opinion, the analysis of how sex and gender can interact and affect grafting success could represent a mandatory task for the management of organ transplantation.

Background. High levels of preformed anti-HLA antibodies dramatically diminish renal transplant outcomes.Most desensitization programmes guarantee good intermediate outcomes but quite disappointing long-term prognosis. The search for a fully compatible kidney increases time on the waiting list. Methods. In February 2011, a nationwide hyperimmune programme (NHP) was begun in Italy: all available kidneys are primarily proposed to highly sensitized patients with a panel reactive antibody above 80%. In this manuscript, we evaluate the outcome of paediatric patients transplanted with this approach. Results. Twenty-one patients were transplanted. Complete data are available for 20 patients. Mean age at transplantation was 14.5 years [standard deviation (SD) 6 5.5)]. Mean time on the waiting list was 29.3 months (SD 6 27.5). Median follow-up was 29.2 months (range: 11.2-59.3). The average number of HLA mismatches in these patients was 2.3 versus 3.7 in 48 standard patients transplanted in the same period (P < 0.001). Only one graft was lost. Two cases of humoral rejection occurred and were successfully treated. No cellular rejection was reported. Median creatinine clearance was 84, 88, 77 and 77 mL/min/1.73 m2 respectively 1, 6, 12 and 24 months after transplant. Conclusions. Transplantation of sensitized patients avoiding prohibited antigens is feasible, at least in a selected cohort of patients. In order to be able to further improve this approach, which in our opinion is very successful, it would be necessary to expand the donor pool, possibly increasing the number of countries participating in the programme. In this series, time on the waiting list did not increase significantly. This allocation policy should ideally lead to an outcome comparable to that expected in standard patients, which is particularly desirable in young patients who have the longest life expectancy. Since long-term results of desensitization programmes are not (yet) convincing, we suggest that these programmes should be reserved for selected cases where compatible organs cannot be found within a reasonable time span.

The National Blood Centre, the National Transplant Centre, and the Bioethics Unit of the Istituto Superiore di Sanità have compared the information leaflets and forms regarding the collection of informed consent used by each of the 18 biobanks that comprise the Italian network. With a view to harmonize the provision of information to couples and the collection of informed consent within the Italian Cord Blood Network, the 3 organizations have prepared a standard information leaflet and informed consent form to be used for the collection, storage, and allogeneic use of cord blood. The proposed model can be a useful tool for the development of specific informed consent forms for cord blood banking that comprises the minimum information necessary to meet ethical and regulatory requirements also in other countries.

The aim of the present study was to describe the current situation of donation after circulatory death (DCD) in the Council of Europe, through a dedicated survey. Of 27 participating countries, only 10 confirmed any DCD activity, the highest one being described in Belgium, the Netherlands and the United Kingdom (mainly controlled) and France and Spain (mainly uncontrolled). During 2000-2009, as DCD increased, donation after brain death (DBD) decreased about 20% in the three countries with a predominant controlled DCD activity, while DBD had increased in the majority of European countries. The number of organs recovered and transplanted per DCD increased along time, although it remained substantially lower compared with DBD. During 2000-2008, 5004 organs were transplanted from DCD (4261 kidneys, 505 livers, 157 lungs and 81 pancreas). Short-term outcomes of 2343 kidney recipients from controlled versus 649 from uncontrolled DCD were analyzed: primary non function occurred in 5% vs. 6.4% (P = NS) and delayed graft function in 50.2% vs. 75.7% (P

BACKGROUND: In Italy, the law does not permit the setting up of private banks to preserve cord blood (CB) stem cells for personal use. However, since 2007 the right to export and preserve them in private laboratories located outside Italy has existed, and an increasing number of women are requesting this collection of umbilical CB at delivery to enable storage of stem cells for autologous use. STUDY DESIGN AND METHODS: Since private banks recruit clients mainly via the Internet, we examined the content of 24 Italian-language websites that offer stem cells storage (from CB or amniotic fluid), to assess what information is available. RESULTS: We found that the majority of private banks give no clear information about the procedures of collection, processing, and banking of CB units and that the standards offered by private CB banks strongly differ in terms of exclusion or acceptance criteria from the public banks. These factors may well influence the overall quality of the CB units stored in private CB banks. Of note, during the period 2007 to 2009, the number collected for autologous use did not create a downward trend on the number of units stored in public CB banks for allogeneic use. CONCLUSION: CB is a valuable community resource but expectant parents should be better informed as to the quality variables necessary for its storage, both by institutions and by professionals. Currently, most of the advertising is insufficient to justify the expense and the hopes pinned on autologous use of CB stem cells.

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.

Summary Background: In the last years, there have been increasing concerns about the safety and traceability of human tissues and cells in Europe. In order to regulate this part of medical practice, the European Commission issued 3 directives between 2004 and 2006 and endorsed EUROCET to support member states in fulfilling some of their obligations. Methods: EUROCET created a connection with the European Union (EU) Competent Authorities (CAs) and set up a website where lists of the CAs, the authorized Tissue Establishments (TEs) and the activity data are published and updated. Moreover, EUROCET is involved within the Vigilance and Surveillance of Substances of Human Origin (SOHO V&S) project, aiming to support the EU member states in the establishment of vigilance and surveillance systems for tissues and cells. EUROCET is also working with EU stakeholders to develop a common coding system concerning donation and products. Results: There are 33 countries in EUROCET and 57 CAs. 3,974 TEs are recorded: 1,108 for tissues, 1,480 for haematopoietic progenitor cells and 1,386 for assisted reproduction. On the website, it is possible to find the 2010 activity data report. Conclusion: Based on its cooperation with the CAs, EUROCET represents them in the European network. Nowadays, the EU member states can rely on a web portal and database in order to put the tissue and cell directives into practice.

Techniques for banking cord blood units (CBUs) as source for hematopoietic stem cell transplantation have been developed over the past 20 years, aimed to improve laboratory efficiency without altering the biologic properties of the graft. A large-scale, registry-based assessment of the impact of the banking variables on the clinical outcome is currently missing.A total of 677 single cord blood transplants (CBTs) carried out for acute leukemia in complete remission in centers affiliated with the European Society for Blood and Marrow Transplantation were selected. An extensive set of data concerning CBU banking were collected and correlations with clinical outcome were assessed. Clinical endpoints were transplant-related mortality, engraftment, and graft-versus-host disease (GVHD).The median time between collection and CBT was 4.1 years (range, 0.2-16.3 years). Volume reduction (VR) of CBUs before freezing was performed in 59.2% of available reports; in half of these the frozen volume was less than 30 mL. Cumulative incidences of neutrophil engraftment on Day 60, 100-day acute GVHD (II-IV), and 4-year chronic GVHD were 87, 29, and 21 ± 2%. The cumulative incidence of nonrelapse mortality (NRM) at 100 days and 4-year NRM were, respectively, 16 ± 2 and 30 ± 2%. Neither the variables related to banking procedures nor the interval between collection and CBT influenced the clinical outcome.These findings indicate a satisfactory validation of the techniques associated with CBU VR across the banks. Cell viability assessment varied among the banks, suggesting that efforts to improve the standardization of CBU quality controls are needed.