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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.

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.

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.

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.

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.

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 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.

Objective To analyze the graft outcome after liver transplantation in Italy in the years 1995 to 2000. Methods We performed a longitudinal study with follow-up at 3 months, 1 year, 3 years, and 5 years on 1987 liver grafts. The effect of several variables on graft survival was also analyzed. Results Several variables affect graft survival: Donor and recipient older age, gender mismatching, prolonged cold ischemia time, acute hepatic necrosis, and retransplantation are reported to significantly affect liver graft survival. Donors older than 60 years show a relative risk of 1.59 (95% CI, 1.23–2.05) compared with donors with an age between 19 and 60 years; recipients older than 50 years show a relative risk of 1.29 (95% CI, 1.04–1.60) compared with recipients aged 19 to 50 years. A cold ischemia time of 12 hours or longer doubled the risk of failure (relative risk = 2.01, 95% CI, 1.36–2.96) compared with a cold ischemia time of less than 6 hours. Conclusions The results show that the overall quality of liver transplantation in Italy is satisfying and comparable to the outcome reported by international registries. Follow-up studies on large numbers of liver transplants are useful to define predictors of outcome, and subsequently modify the criteria for organ allocation.

Purpose National registry data are often a suitable basis for examination of transplant outcomes. Using data supplied by the Italian National Transplant Registry, established in 1995, we performed the first nationwide analysis of this kind. Methods A retrospective analysis of 4893 recipients of cadaveric kidneys transplanted in all Italian centers from 1995 through 2000 was done to study 5-year graft survival. The association between some donor and recipient variables and outcomes in renal transplantation was analyzed. Graft survival was 93% at 3 months, 89% at 1 year, 82% at 3 years, and 80% at 5 years after transplantation. Results A significant association between graft survival and donor age (old vs young, relative risk [RR] = 1.62, 95% CI 1.27–2.06) and recipient age (old vs young, RR = 1.25, 95% CI 1.02–1.53). Graft survival was also associated with cold ischemia time (24–36 hours, RR=1.39, 95% CI 1.05–1.85 and >36 hours, RR=1.94, 95% CI 1.32–2.86 vs 0–24 hours) and donor/recipient sex mismatch (female/male vs male/male, RR=1.50, 95% CI 1.17–1.93). Conclusion The quality of kidney transplantation in Italy is satisfactory and is comparable to that in other developed countries. Furthermore, our experience confirms that both donor and recipient factors are major determinants of renal allograft function.

Evaluation of outcomes is a major step in quality assessment of any health process. In the transplant field, the evaluation of outcome is extremely important for both patients' growing demand for health and for the joint commitment the transplant process requires. In this study, the outcome of 12,647 transplants, carried out between 1995 and 2000 were analysed. Graft survival at 5 years was 79% for kidney, 67% for liver, 72% for heart and 38% for lung. Patient survival was 92% for kidney, 76% for liver, 72% for heart and 38% for lung. In comparison to other international case records [Collaborative Transplant Study (CTS) and The United Network for Organ Sharing (UNOS)], results are similar or even better for all transplant programmes. As a whole, survival after solid organ transplant in Italy ranks among the best for both donations and transplantation. The quality of transplants carried out is above European standards. Nevertheless, the growing health needs of patients require improvement in both the procurement process and in the use of available organs.

Background Bacterial infections remain a challenge to solid organ transplantation. Due to the alarming spread of carbapenem-resistant gram negative bacteria, these organisms have been frequently recognized as cause of severe infections in solid organ transplant recipients. Methods and Findings Between 15 May and 30 September 2012 we enrolled 887 solid organ transplant recipients in Italy with the aim to describe the epidemiology of gram negative bacteria spreading, to explore potential risk factors and to assess the effect of early isolation of gram negative bacteria on recipients’ mortality during the first 90 days after transplantation. During the study period 185 clinical isolates of gram negative bacteria were reported, for an incidence of 2.39 per 1000 recipient-days. Positive cultures for gram negative bacteria occurred early after transplantation (median time 26 days; incidence rate 4.33, 1.67 and 1.14 per 1,000 recipient-days in the first, second and third month after SOT, respectively). Forty-nine of these clinical isolates were due to carbapenem-resistant gram negative bacteria (26.5%; incidence 0.63 per 1000 recipient-days). Carbapenems resistance was particularly frequent among Klebsiella spp. isolates (49.1%). Recipients with longer hospital stay and those who received either heart or lung graft were at the highest risk of testing positive for any gram negative bacteria. Moreover recipients with longer hospital stay, lung recipients and those admitted to hospital for more than 48h before transplantation had the highest probability to have culture(s) positive for carbapenem-resistant gram negative bacteria. Forty-four organ recipients died (0.57 per 1000 recipient-days) during the study period. Recipients with at least one positive culture for carbapenem-resistant gram negative bacteria had a 10.23-fold higher mortality rate than those who did not. Conclusion The isolation of gram-negative bacteria is most frequent among recipient with hospital stays >48 hours prior to transplant and in those receiving either heart or lung transplants. Carbapenem-resistant gram negative isolates are associated with significant mortality.

Context The high demand for organs for transplantation necessitates enhancement of organ procurement activity worldwide. Objective To detect critical areas in the organ donation process and to assess whether careful monitoring of deaths in each intensive care unit could improve rates of identification of brain death. Design Records of patients who died in intensive care units in the Emilia-Romagna region between July 1, 1998 and June 30, 2000 were reviewed through the Donor Action program. Results Of the 2469 patients who died during the period studied, 1010 (40.9%) had severe brain damage, as indicated by a score of 3 on the Glasgow coma scale. A total of 857 patients with severe brain damage who had spent more than 6 hours in the intensive care unit (34.7% of all deaths) were considered as potential donors. Signs of brain death were observed in 383 (44.7%) of the 857 patients who died. Rates of identification of brain death increased from 36% to 55% during the study period. Conclusion Considering that the characteristics of the study population had not changed, we believe that the Donor Action program was an important factor leading to the observed improvement in identification of brain death.

Organ and tissue donation and transplantation have a role in public health programs as organizational projects designed by public health departments to increase the quality and number of donations and transplantations. These programs serve as communication projects to inform public opinion on cerebral death, organ and tissue shortages, procurement and allocation rules, and the quality of life of transplanted patients. The health department of Emilia-Romagna created a regional law and a multimedia communication program for these purposes, resulting in a 95% increase of cadaver donor in 4 years. In 1995, regional activity reached the European mean level and afterwards surpassed it. In 1997, the bone bank was activated, followed in 1998 by the heart valve and vascular segment bank. The regional health department now considers transplant activities a primary goal; human and professional relations between intensive care units and the transplant reference center are considered crucial; cooperation among health departments, medical teams involved in organ procurement and transplant activities has been fostered, and the local coordination network has been active and efficient. The public information campaign has proven important in providing information both to professionals and citizens.

Background/Aims: The role of physical activity in transplanted patients is often underestimated. We discuss the Italian National Transplant Centre experience, which started in 2008 studying transplanted patients involved in sports activities. The study was then developed through a model of cooperation between surgeons, sports physicians and exercise specialists. Methods: A multicentre study was realized in 120 transplanted patients of which 60 treated with supervised physical activity (three sessions/week of aerobic and strengthening exercises) and 60 controls. We present the results of the first 26 patients (16 males, 10 females; 47.8±10.0 years; 21 kidney, 5 liver transplanted; time from transplant 2.3±1.4 years) who completed 12 months of supervised physical activity. Results: Data showed an increase of peak aerobic power (t=4.535; PConclusion: These preliminary results confirm the positive effects of supervised physical exercise. It can be considered as an input to promote other detailed exercise protocols.

Background: To generate a robust predictive model of Early (3 months) Graft Loss after liver transplantation, we used a Bayesian approach to combine evidence from a prospective European cohort (Liver-Match) and the United Network for Organ Sharing registry. Methods: Liver-Match included 1480 consecutive primary liver transplants performed from 2007 to 2009 and the United Network for Organ Sharing a time-matched series of 9740 transplants. There were 173 and 706 Early Graft Loss, respectively. Multivariate analysis identified as significant predictors of Early Graft Loss: donor age, donation after cardiac death, cold ischaemia time, donor body mass index and height, recipient creatinine, bilirubin, disease aetiology, prior upper abdominal surgery and portal thrombosis. Results: A Bayesian Cox model was fitted to Liver-Match data using the United Network for Organ Sharing findings as prior information, allowing to generate an Early Graft Loss-Donor Risk Index and an Early Graft Loss-Recipient Risk Index. A Donor-Recipient Allocation Model, obtained by adding Early Graft Loss-Donor Risk Index to Early Graft Loss-Recipient Risk Index, was then validated in a distinct United Network for Organ Sharing (year 2010) cohort including 2964 transplants. Donor-Recipient Allocation Model updating using the independent Turin Transplant Centre dataset, allowed to predict Early Graft Loss with good accuracy (c-statistic: 0.76). Conclusion: Donor-Recipient Allocation Model allows a reliable donor and recipient-based Early Graft Loss prediction. The Bayesian approach permits to adapt the original Donor-Recipient Allocation Model by incorporating evidence from other cohorts, resulting in significantly improved predictive capability. © 2013 Editrice Gastroenterologica Italiana S.r.l.

In Italy, a West Nile virus (WNV) surveillance plan was firstly implemented in 2008 and 2009 in two affected regions and, since 2010, according to a national plan, a WNV neuroinvasive disease (WNND) surveillance has to be carried out each year during the period 15 June–30 November, in those regions where WNV circulation has been demonstrated among humans, animals or vectors. Moreover, since WNV can be transmitted to humans even by blood transfusions and organ transplants obtained from infected donors, the national surveillance integrates the blood transfusions and organs transplant surveillances too. The paper describes the results of this integrated human surveillance in Italy in 2012. Overall, in 2012, 28 autochthonous confirmed cases of WNND were reported, 14 blood donations were found WNV positive by Nucleic Acid Amplification Test and no solid organ donors tested positive for WNV. Moreover, 17 cases of WNV fever were confirmed in Veneto region. When comparing the number of WNND cases reported to the surveillance system in previous 4 years (43 cases during the period 2008–2011), with those reported in 2012 an important increase was observed in 2012. The geographic distribution of human cases was consistent with the WNV circulation among animals and vectors. Moreover, the implementation of preventive measures for WNV transmission through blood components allowed the detection of blood donors positive for WNV, avoiding the further spread of the disease. Since surveillance strategies and preventive measures are based on the integration among human, animal and vector control activities, the Italian experience could be considered a good example of collaboration among different sectors of public health in a “one health” perspective.

a b s t r a c t Liver transplantation has indeed evolved from an experimental procedure in the early 1980s to the most effective treatment for patients with advanced liver cirrhosis and for selected patients with hepatocellular carcinoma and fulminant hepatic failure. In this new scenario, the transplant hepatologist plays a crucial clinical role, with essential duties and skills to manage the complexities encountered in waitlisted patients or transplant recipients. The clinical tasks of the transplant hepatologist include the management of patients with end-stage liver disease who are candidates for liver transplantation and/or on the waiting list, as well as the care of transplant recipients, in both the in- and outpatient setting. Starting in 2013, the Italian Association of the Study of the Liver, with the endorsement of the National Transplant Centre, will be offering a formal certification process for transplant hepatologists, implemented in accordance to Union Europeenne des Medecins Specialistes-European Board of Transplant Medicine procedures. The Special Article outlines the requirements for board certification of the Italian Association for the Study of the Liver transplant hepatologist.

Introduction Evaluation of kidney transplant candidates is based on strict exclusion of major pathologies, such as neoplastic disease. The aim of this study is to evaluate epidemiological and clinical impact of tumor disease in an Italian renal transplant waiting list and to propose a screening schedule for neoplastic detection. Materials and methods We retrospectively observed data of patients enrolled on the Emilia-Romagna kidney transplant waiting list between 1st August 2008 and 31st December 2010, evaluating the different causes of getting out from the list, the histologic type and incidence of cancer and the correlation between cancer onset and clinical features. The ratio of observed to expected cancer numbers (standardized incidence ratio, SIR), was estimated. Results We observed 2345 patients; 1297 got out from the waiting list; 57 of them (4,4%) got out because the onset of tumor. The overall incidence rate of cancer was 1354.8 (x 100000 person-year) (1045.9 person-year in patients awaiting for first transplant(FT), 1851.5 person-year in patients awaiting for second transplant(ST)). The overall prevalence of cancer was 2,43% (2.2% in FT, 3.4% in ST) with a SIR of 1.8; In our population the prevalence of cancers related to ESKD was 52.6% with a SIR of 15.8. Conclusion Kidney transplant waiting list patients present a higher incidence and prevalence of cancer compared to general population; it could be important to evaluate them for ESKD related malignancies because of their high incidence.

West Nile virus (WNV) is currently circulating in several European countries and, over recent decades, concomitantly with enhanced surveillance studies and improved diagnostic capabilities, an increase in the geographical distribution and in the number of cases in Europe has been documented. In Italy in 2011, 14 human cases of WNV neuroinvasive infections due to lineage 1 strains were registered in several Italian regions. Here we report WNV partial sequences obtained from serum samples of two patients living in different regions of Italy (Veneto and Sardinia). Phylogenetic analysis, performed on a fragment (566 nt) of the envelope gene, showed that WNV strains circulating in Italy in 2011 belong to lineage 1a, but are different from lineage 1a strains isolated in 2008–2009.The data reported here are consistent with the hypothesis of multiple recent introductions of WNV lineage 1a strains into Italy.

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.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.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.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.

BACKGROUND: The Liver Match is an observational cohort study that prospectively enrolled liver transplantations performed at 20 out of 21 Italian Transplant Centres between June 2007 and May 2009. Aim of the study is to investigate the impact of donor/recipient matching on outcomes. In this report we describe the study methodology and provide a cross-sectional description of donor and recipient characteristics and of graft allocation. METHODS: Adult primary transplants performed with deceased heart-beating donors were included. Relevant information on donors and recipients, organ procurement and allocation were prospectively entered in an ad hoc database within the National Transplant Centre web-based Network. Data were blindly analysed by an independent Biostatistical Board. RESULTS: The study enrolled 1530 donor/recipient matches. Median donor age was 56 years. Female donors (n = 681, median 58, range 12-92 years) were older than males (n = 849, median 53, range 2-97 years, p < 0.0001). Donors older than 60 years were 42.2%, including 4.2% octogenarians. Brain death was due to non-traumatic causes in 1126 (73.6%) cases. Half of the donor population was overweight, 10.1% was obese and 7.6% diabetic. Hepatitis B core antibody (HBcAb) was present in 245 (16.0%) donors. The median Donor Risk Index (DRI) was 1.57 (>1.7 in 35.8%). The median cold ischaemia time was 7.3h (≥ 10 in 10.6%). Median age of recipients was 54 years, and 77.7% were males. Hepatocellular carcinoma (HCC) was the most frequent indication overall (44.4%), being a coindication in roughly 1/3 of cases, followed by viral cirrhosis without HCC (28.2%) and alcoholic cirrhosis without HCC (10.2%). Hepatitis C virus infection (with or without HCC) was the most frequent etiologic factor (45.9% of the whole population and 71.4% of viral-related cirrhosis), yet hepatitis B virus infection accounted for 28.6% of viral-related cirrhosis, and HBcAb positivity was found in 49.7% of recipients. The median Model for End Stage Liver Disease (MELD) at transplant was 12 in patients with HCC and 18 in those without. Multivariate analysis showed a slight but significant inverse association between DRI and MELD at transplant. CONCLUSIONS: The deceased donor population in Italy has a high-risk profile compared to other countries, mainly due to older donor age. Almost half of the grafts are transplanted in recipients with HCC. Higher risk donors tend to be preferentially allocated to recipients with HCC, who are usually less ill and older. No other relevant allocation strategy is currently adopted at national level.

Transplantation is an accepted treatment today for many people suffering from organ failure. More and more patients are referred for transplant surgery, and the waiting lists are growing longer because not enough organs and tissues are donated for transplantation. This has led to several potentially viable alternatives being considered, including bio-artificial support devices, the transplantation of mature cells or stem/progenitor cells and the potential transplantation of xenogenic organs and cells [Burra P, Samuel D, Wendon J, Pietrangelo A, Gupta S. Strategies for liver support: from stem cells to xenotransplantation. J Hepatol 2004;41:1050–9]. Numerous investigators around the world are engaged in these investigations and the pace of discovery has begun to accelerate in recent years. To take stock of the achievements of recent years, the AISF sponsored a Single-Topic Conference, held in Padua on 26–27 May, 2006, with the participation of many leading investigators from various parts of Italy and Europe. This present paper summarizes the content of the Conference. Different issues were analysed, from the biology of stem cells to the possible use of gene therapy. The speakers were clinicians and scientists interested in diseases not only of the liver but also of other organs such as the kidney or heart. The fact that numerous specialties were represented helped the audience to understand the stem cell research area from different standpoints, and what research has achieved so far.

A population-based cohort study of recipients of organs from donors with a recognized history or active cancer has been conducted by linking the Italian National Registry of Transplanted Patients and the National Registry of Donors with Neoplasia Risk. Between 2002 and 2004, 8,198 solid organ transplants have been performed in Italy, 108 of them with organs from 59 cadaveric donors with various risk of neoplasia. There were two reported cases of nonmelanoma skin cancer during the follow up of the transplanted patients, which lasted 27.6+/-11.3 months (234 patient-years). In our study, recipients of organs from donors with various degree of neoplasia risk are exposed to a low risk of cancer transmission.

Limited access to scarce resources, such as organs for transplantation, has increasingly prompted the use of elderly donors, with a consequent growth of possible risk factors linked to their particular features. Acceptable organ quality must therefore be guaranteed, without exposing recipients to unacceptable risks. For this reason, a set of guidelines for assessing donor suitability has been drawn up. This document standardizes the operative steps in the donor evaluation process and provides precise instructions for center staff. A pool of experts is available round the clock to offer advice on doubtful clinical cases. Such measures have allowed more effective use of available donors for transplantation.

Alessandro Nanni Costa, J. M. Simon i Castellvi, Antonio G. Spagnolo, Nunziata Comoretto, Jean Laffitte, Hakan Gabel, Francis L. Delmonico, Ferdinand Muehlbacher, Walter Schaupp, Alexandra K. Glazier, Valter D. Garcia, Mario Abbud-Filho, Jose O. Medina-Pestana, Mariangela Gritta Grainer, Pier Paolo Donadio, Anna Guermani, Riccardo Bosco, Francesco Giordano, Blanca Martinez Lopez de Arroyabe, Marco Brunetti, Marti Manyalich, Gloria Paez, Ricardo Valero, Rafael Matesanz, Elisabeth Coll, Beatriz Dominguez-Gil, Beatriz Mahillo, Eduardo Martin Escobar, Gregorio Garrido, and Felix Cantarovich

The role of hospital staff in the organ procurement process is crucial. Nevertheless, there is little literature about their attitudes toward donation. The Donor Action Hospital Attitude Survey (HAS) comprises a series of questions to assess hospital staff's attitudes, beliefs, and knowledge on organ donation and transplantation. Further analysis of the data will help identify any weak areas in the staff viewpoint and information, highlight potential needs for more education on specific issues, and establish a baseline to monitor future improvements. We used the Donor Action HAS in the Emilia-Romagna region, Italy. The aim of this paper is to assess and better understand the personnel's viewpoint in the 12 main hospitals of the region. The survey was carried out among hospital staff involved in organ donation. 1576 responses were collected (52 % of distributed questionnaires), of which 1024 came from nurses, 475 from physicians, and 77 from other backgrounds. Questions were subdivided into categories, and for every point an overall mark (maximum 3/3) was calculated. Results: 1. Involvement in donation process during the past year: 1.24 /3, 2. Attitudes to organ donation (OD): 2.51 /3, 3. Skills / Self-confidence in donation practices: 1.36 /3, 4. Satisfaction with local transplant coordinator (TC) services: 2.31 /3. The attitude towards organ donation was positive, 1386 respondents support organ donation. A high percentage (93.6 % of respondents) is of the opinion that transplantation helps save other people's lives. Most uncertainty arises on the question whether donation helps families with grief. It is remarkable that only 53 % of those prepared to donate organs have informed the family of their wish. Many respondents do not feel comfortable performing key tasks close to donation. Major difficulties were observed in explaining to a family the concept of brain death (0.98 /3). Knowledge on the concept of brain-death was one of the most requested subjects for improvement. Emilia-Romagna is the region with one of the highest donation rates in Italy (29.9 pmp in 2000). Nevertheless, more profound knowledge of the local situation could help further improve donation.

The increasing demand for organs for transplantation entails a consensual need for enhancement of organ procurement activity. As organ donors reside mainly in hospital intensive care units (ICUs), the Donor Action programme is aimed at identifying critical areas in ICUs, in order to improve the first step of organ donation. The purpose of this paper is to analyse the problem of identification of potential donors by means of a chart revision of patients who died in 14 ICUs in the Emilia-Romagna region between 1 July 1998 and 31 December 2000. All deaths and patients with severe brain insult (score on Glasgow Coma Scale (GCS) = 3/15) were assessed by the local transplant coordinators together with a professional at the Transplant Reference Centre. Brain death diagnoses and potential donor referrals were therefore assessed in the study period, which was subdivided into five semesters. Of the 3,056 deaths reported in 30 months, 1,248 were due to severe brain damage (GCS score = 3). Brain death diagnosis (BD) was performed in 509 patients (40.8%). Although we applied the same parameters over the whole length of the study, we observed a significant increase in BDs (from 87 in the first semester to 125 in the last, 30.5% to 53.0% of the patients with GCS 3 ( P=0.003, chi(2) for trend=16.072), in spite of a slight decrease in the total number of deaths and in the total number of patients with GCS score = 3 (from 649 to 587, and from 44% to 41%, respectively). Study population characteristics could have contrasted with rather than facilitated our results: age and gender did not change significantly, whilst cause of death showed a significant reduction in trauma and an increase in cerebrovascular incidents over the whole length of the study. We can conclude that the more careful assessment of patients dying in ICUs, by the Donor Action programme, significantly contributed to the improvement of BDs observed in the study period. Therefore, Donor Action seems to be an efficient quality control programme to improve identification of potential donors, the first stage of organ procurement.

Background & Aims: The appropriate allocation of grafts from HBcAb positive donors in liver transplantation is crucial, yet a consensus is still lacking. Methods: We evaluated this issue within Liver Match, a prospective observational Italian study. Data from 1437 consecutive, first transplants performed in 2007-2009 using grafts from deceased heart beating donors were analyzed (median follow-up: 1040 days). Of these, 219 (15.2%) were HBcAb positive. Sixty-six HBcAb positive grafts were allocated to HBsAg positive and 153 to HBsAg negative recipients. Results: 329 graft losses occurred (22.9%): 66 (30.1%) among 219 recipients of HBcAb positive grafts, and 263 (21.6%) among 1218 recipients of HBcAb negative grafts. Graft survival was lower in recipients of HBcAb positive compared to HBcAb negative donors, with unadjusted 3-year graft survival of 0.69 (s.e. 0.032) and 0.77 (0.013), respectively (log-rank, p = 0.0047). After stratifying for recipient HBsAg status, this difference was only observed among HBsAg negative recipients (log rank, p = 0.0007), 3-year graft survival being excellent (0.88, s.e. 0.020) among HBsAg positive recipients, regardless of the HBcAb donor status (log rank, p = 0.4478). Graft loss due to de novo HBV hepatitis occurred only in one patient. At Cox regression, hazard ratios for graft loss were: MELD (1.30 per 10 units, p = 0.0002), donor HBcAb positivity (1.56, p = 0.0015), recipient HBsAg positivity (0.43, p