Search

The Italian experience in the organization of transplantation procedures could represent a relevant example of an internal development at a national level, combined with a strengthening of international collaborations. These results can be attributed first to the creation of the Italian National Transplant Centre (Centro Nazionale Trapianti [CNT]), and then to an ongoing European process that is leading to a greater awareness of the importance of closer collaboration between the organizations already existing and operating in the field of transplantation. This article summarizes the role and the most significant achievements of the CNT., (Copyright © 2011. Published by Elsevier Inc.)

The National Program for Emergency Heart Transplantation (NP) was implemented in 2005 is managed at the national level by the Italian National Transplant Center. Patients admitted to the NP must be undergoing one of the following treatments: short-term Ventricular Assist Device (VAD); complicated medium or long-term VAD; complicated Total Artificial Heart; or mechanical ventilation associated with an Intra-Aortic Balloon Pump and Continuous Inotrope Therapy (intravenously). The aim of this study was to evaluate the NP experience from January 1, 2008, to December 31, 2009. We analyzed the number of requests (both fulfilled and not fulfilled), the timeliness of organ availability as well as graft and recipient survivals at 1 year. During the study period, 108 patients were admitted to the NP. The most frequent causes of admission were dilated cardiomyopathies (42.7%) and congenital cardiomyopathies (28.7%). Overall, whereas 12 subjects improved 65 patients underwent heart transplantation (60.2%) and 43 did not undergo surgery (39.8%) because of 31 succumbing before a heart became available. The median waiting time for heart transplantation was 3 days (range = 0.1-22), compared with median waiting time for elective heart transplantation (EHT) of 2.47 years. Graft and recipient survivals were 76.0 ± 1.06 compared with superior graft and recipient survivals for EHT during the same period (87.1 ± 2.0). However, implementation of NP has guaranteed heart availability at a short median time, thus allowing equitable management of this procedure., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Patients scheduled for orthotopic liver transplantation (OLT) may have coexisting diseases and more likely receive grafts of poorer quality than in the past. Perioperative mortality and morbidity are usually due to a combination of factors related to the patient, graft, surgery, anesthesia, and intensive care management. Anesthesia and intensive care are the areas with the highest frequency and severity of errors. Error and accident risks are always present in this context where a human component is unavoidable. The matter of medical errors is becoming noteworthy worldwide. Nevertheless, data concerning medical errors during OLT are not available in Italy. There are only hypothetical evaluations. The number of adverse events may be high, but so far no specific programs have been developed to increase patient safety. To improve patient safety, anesthesia and intensive care units must use a proactive approach dedicated to an OLT program. We have presented herein a prevention policy to detect errors before they happen through incident reporting, anonymous and voluntary reports of adverse events or near misses, operating room checklists (patient, drugs, devices, equipment), improved training, safer facilities, equipment function, and adequate drug supplies for an OLT program., (Copyright 2010 Elsevier Inc. All rights reserved.)

Brain death (BD) is not a stable, objective condition; in fact, it strongly depends on early intensive treatment before death, brain stem reflex testing, and intensive care unit (ICU) physician attitudes. Consequently, unpredictable "silent" BDs due to inadequate treatment or omitted declaration may affect potential organ donations. Several lines of evidence suggest that 55% to 65% of all deaths among patients with acute cerebral lesions (DACL) in the ICU may become brain deaths. Since DACL are easily measurable, deviations from the expected ratio of declarations will disclose "silent" BDs. Results from the National Registry of DACL in ICU settings have confirmed that BD declarations are consistently fewer than the number expected in Italy, particularly in regions where organ donation rates are low. Only 43% of the 10,304 referred DACL were potential donors in a 2-year period. Thus, around 1000 BDs per year are missing in Italy. Significant clinical factors for lost BDs may be older age and timing of death. As DACL represent the global donation potentiality (possible donors), we suggest the use of a new indicator-DACL in ICU per million population-and careful analyses of differences in DACL per million people among regions. In conclusion, since striking deviations from the expected ratio between BD declarations and deaths with an acute cerebral lesion exist in some regions, targeted training and support to ICUs should be planned. As adequate neurointensive treatment can improve outcomes and reduce "silent" BDs, more organ donors may exist where patients with acute cerebral lesion are better treated., (Copyright 2010 Elsevier Inc. All rights reserved.)

Informed consent is of paramount importance in any field of surgery, both from the ethical and the legal points of view. Concerning organ transplantation, potential recipients are fully informed before entering the waiting list. However, according to Italian law, they have to sign another informed consent form before entering the operating room. In our opinion, not only should recipients be informed of the quality of the donor and of the particular organ(s) they are going to receive, but also before entering the waiting list they should accept or refuse the future possibility of receiving an organ from a so-called marginal or extended criteria donor (ECD) and/or a non-heart-beating donor (NHBD).

Background: We describe the results of the application of the Italian donor cancer screening protocol to all the 7608 candidate multiorgan donors presented in Italy in 2002-2005., Methods: All suspect findings raised in the two presurgical and surgical phases of the protocol were investigated by extemporary pathologic evaluation. Donors were classified as standard risk (no transmissible risk); nonstandard risk (low-risk of transmission, eligibility restricted to certified clinical emergencies pending informed consent); and unacceptable risk (unconditional exclusion because of high-risk pathologies)., Results: The protocol was successfully implemented for all 7608 candidates. In addition to 8 (0.1%) independent exclusions, clinical suspicion of cancer was raised for 337 (4.6%) donors. According to pathological examination 198 donors (2.6%) were judged at unacceptable risk of tumor transmission; 80 (1%) were included in the "standard risk". Used standard risk and nonstandard risk donors provided a total of 241 organs in 231 recipients. Although no suspect was raised after implementation of the protocol, a malignant tumor was discovered after organ transplantation in 14 (0.2%) donors. All the recipients transplanted with organs from ascertained nonstandard risk donors or from neoplastic donors who donated by accident have been carefully followed. At the time of most recent follow-up no donor/recipient tumor transmission has been reported., Conclusions: Implementation of the multiorgan cancer screening protocol is feasible at a national level in Italy. In view of the increasing demand for organs our protocol provides a useful tool for rationalization of the use of organs from neoplastic marginal donors.

The Italian Gate to Europe (IGE) was established in April 2005 to supply a single national coordinating center for the exchange of organs and patients with the rest of Europe. When an organ is offered from Italy, the IGE ascribes it to the first foreign organization that accepts it on a first-come, first-served basis. In the case of offers from abroad, the IGE allocates the organ to one of the three Italian Interregional Centres in rotation. On the basis of international agreements, the IGE also manages the transfer of foreign patients to Italian transplant centers. The first 15 months of activity have been compared with the previous period of the same length. The IGE managed 353 contacts. 53 organs were transplanted in Italy versus 19 in the previous period. Seven foreign patients received liver transplantations in Italy. The increase in imported organs could be a function of IGE creation, since it allowed a reduced response time to offers and guaranteed the participation of all Italian centers in the program of international exchanges with a subsequent increase in the pool of recipients and equitable distribution of transplanted organs. The drop in the number of exported organs was a probable a consequence of increased acceptance criteria of Italian centers. The mentioned international agreements have allowed us to better meet the health care needs of foreign citizens who live in countries with low per-million-population donation rates with no detriment to the probability of Italian citizens being transplanted.

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.

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.

Background: As part of the increased need for transparency and disclosure of information in health care, the Italian Minister of Health has commissioned the Superior Institute of Health to study health outcomes for several procedures, among which is solid organ transplants. We herein report the results of a quality evaluation of solid organ transplants and on the relationship between hospital volume of activity and outcomes, using the data routinely collected by the National Transplant Center during the period 2000 to 2002., Methods: We collected and analyzed all the information on solid organ transplants between 2000 and 2002, along with clinical information before and after transplant. Multivariate survival analysis was performed to adjust the follow-up data for the complexity of the cases. Correlation graphs are presented that assess the association between the number of transplants and the adjusted 1-year survival of both the organ and the patient., Results: One-year survival was 92.4% for kidney, 77.8% for liver, and 83.9% for heart. Patient survival was 97.0%, 84.1%, and 83.9%, respectively. A negative correlation was observed between the number of transplants performed by each center and 1-year survival of the organ., Conclusions: Our study indicated that survival after organ transplants in Italy is good and that hospital quality, indirectly measured through survival, overlaps that observed in other Western countries.

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.

Background: Only half of the patients waiting for a heart transplant undergo surgery, whereas several patients continue to die while on the waiting list. Donor organ availability still represents a major problem with respect to reducing the length of the cardiac transplant waiting list. One option to improve donor availability is the use of so called "marginal donors." The aims of the present study are to analyze the short-mid term survival of cardiac transplanted patients in Italy, and investigate the effect of donor age on prognosis., Methods: A prospective cohort study including all adult patients who underwent heart transplantations in Italy was used to analyze the main factors contributing to organ survival., Results: From 1995-2002, 2,504 adult subjects underwent a cardiac transplant, and were followed up for a period of 540.9 days. Overall, 1-year graft survival was 83.1%. Organs from donors older than 55 years had a lower survival than organs from younger donors. By multivariate analysis, both donor's and recipient's age seem to be important determinants of graft survival. A more sophisticated analysis shows that the trend of the risk of graft failure according to donor's age is not linear, with a peak at age 47.3 years, and differs according to sex., Conclusions: Results from the present analysis suggest that the association between heart transplant survival and donor's age is not a linear one, but follows a complex mathematical model, with influences of sex, at least in our sample.

Background: Italian transplantation systems have dramatically improved in the last decade. Kidney transplantations are now strictly monitored and excellent results has been achieved in terms of quality and the ability to reduce waiting times for receiving transplantation., Methods: The Italian organizational retrieval and transplant system is articulated on four levels: local, regional, inter-regional and national. The Italian Transplant Information System (SIT) was set up in 2000 in accordance with Law 91/99. Patient data on the waiting lists and follow-up of transplanted patients are routinely collected., Results: A total of 4406 kidney transplants have been carried out in the 40 Italian kidney transplant centers in 2001-2003. The survival analysis was conducted for the 2000-2002 in 4222 cases. Overall 1-yr survival was 92.4% for the graft and 97% for the patients. After adjusting for variables independently associated with the outcome at multivariate analysis (for example, the case-mix), patient and graft survival at 1 yr was 98.1% and 93.8%, respectively. No remarkable differences in 1-yr graft survival were observed between the 40 Italian kidney transplant centers. At multivariate analysis, variables independently associated with graft failure were donor age, degree of HLA mismatch and recipient case-mix. Analysis of the waiting list showed approximately 6500 patients waiting for kidney transplantation. The mean waiting time was 3.04 yrs, with a mortality rate of 1.18% per year., Conclusions: Kidney transplantation activity in Italy has produced excellent results in terms of quality and number of transplants per year. However, the number of patients on the waiting list and the waiting time call for further action to increase the number of available organs.

The current project sought to collect detailed information on the Italian donation system and in particular on the organization and functioning of the local coordinating centers. The final objective was to provide local and regional institutions with the information required to improve the system. While improving the knowledge of current Italian donation system, the project had constructive purposes. Our intention was to analyze how the national system is working, what the coordinating centers are actually doing, how they are organized, to what extent existing rules are obeyed, and what are the main limits of the system. This analysis sought to lead to the development of a set of proposals that can be summarized in two categories: (1) "intrinsic" actions, that is, those established and implemented at the hospital level; and (2) supporting "extrinsic" actions, that is, those identified by the National Transplant Centre and addressed to the regional and interregional coordinating networks. Finally, the analysis of the application of the existing rules should lead to the development of practice guidelines such that each center conforms to the existing regulations established by European directives.

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.

We have initiated regular molecular monitoring based on nested RT-PCR detection of circulating tumor cells for monitoring recipients of organs from cancer-affected donors in Italy (in the context of a "Donation Safety and Donated Organ Quality" project organized by the Centro Nazionale Trapianti). Five patients are being monitored. For two patients who each received a kidney from a single donor with prostate adenocarcinoma, RT-PCR was performed using PSA mRNA. For three recipients of organs (two livers and one kidney) from donors with renal cell carcinoma, RT-PCR was performed using cytokeratine 18 and 19 mRNA. Blood samples from five healthy subjects were used as negative controls. After a median monitoring time of 26 months (range 8 to 32), none of the regular 3-month assays has tested positive. This pilot study suggests that detection of circulating tumor cells by nested RT-PCR may provide a feasible molecular monitoring, which might assist decision making regarding other forms of clinical surveillance., (Copyright 2004 Elsevier Inc.)

Italy was lacking standardised procedures for donor safety evaluation. We developed practice guidelines, while a panel of experts coordinated by the National Transplant Centre, is available 24 hours a day to support decisions in difficult cases. The guidelines identify five levels of risk and give recommendations for the utilization of donors with HBV and HCV infections as well as for malignancies with negligible or very low risk of transmission. In conclusion we aim to standardize the process of donor evaluation across Italy, to increase the pool of utilised donors and to reduce the risk of communicable disease transmission.