Post-COVID-19 Lung Transplantation Italian Pivotal Protocol: Some Ethical Considerations.

SARS­CoV­2 mostly affects the respiratory system with clinical patterns ranging from the common cold to fatal pneumonia. During the first wave of the COVID-19 pandemic, owing to the high number of patients who were infected with SARS­CoV­2 and subsequently recovered, it has been shown that some patients with post-COVID-19 terminal respiratory failure need lung transplantation for survival. There is increasing evidence coming from worldwide observations that this procedure can be performed successfully in post-COVID-19 patients. However, owing to the scarcity of organs, there is a need to define the safety and efficacy of lung transplant for post-COVID-19 patients as compared to patients waiting for a lung transplant for other pre-existing conditions, in order to ensure that sound ethical criteria are applied in organ allocation. The Milan's Policlinic Lung Transplant Surgery Unit, with the revision of the National Second Opinion for Infectious Diseases and the contribution of the Italian Lung Transplant Centres and the Italian National Transplant Centre, set up a pivotal observational protocol for the lung transplant of patients infected and successively turned negative for SARS­CoV­2, albeit with lung consequences such as acute respiratory distress syndrome or some chronic interstitial lung disease. The protocol was revised and approved by the Italian National Institute of Health Ethics Committee. Description of the protocol and some ethical considerations are reported in this article.

Analysis of the Trend Over Time of High-Urgency Liver Transplantation Requests in Italy in the 4-Year Period 2014-2017.

BACKGROUND: The national protocol for the handling of high-urgency (HU) liver organ procurement for transplant is administered by the Italian National Transplant Center. In recent years, we have witnessed a change in requests to access the program. We have therefore evaluated their temporal trend, the need to change the access criteria, the percentage of transplants performed, the time of request satisfaction, and the follow-up. METHODS: We analyzed all the liver requests for the HU program received during the 4-year period of 2014 to 2017 for adult recipients (≥18 years of age): all the variables linked to the recipient or to the donor and the organ transplants are registered in the Informative Transplant System as established by the law 91/99. In addition, intention to treat (ITT) survival rates were compared among 4 different groups: (1) patients on standard waiting lists vs (2) patients on urgency waiting lists, and (3) patients with a history of transplant in urgency vs (4) patients with a history of transplant not in urgency. RESULTS: Out of the 370 requests included in the study, 291 (78.7%) were satisfied with liver transplantation. Seventy-nine requests (21.3%) have not been processed, but if we consider only the real failures, this percentage falls to 13.1% and the percentage of satisfied requests rises to 86.9%. The average waiting period for liver transplantation (LT) is 1.7 days and most requests (74%) are met in less than 24 hours, if we consider the hours between the registration of the request and the donor reporting . The percentage of late retransplantations is 2.1%. The clinical indication for HU-LT that appears to improve over time is hepatic artery thrombosis (82.5%). The overall 1-year patient survival is 68.3%. The overall 1-year graft survival, performed on all the patients, is 89% and all the indications for HU-LT appear to go well over time with an average survival rate greater than 85%. CONCLUSIONS: The indications for HU-LT are changing according to the changes in the hepatologic field in recent years. The centralized management of requests has proven to be successful in optimizing responses. Urgent LT is confirmed to be lifesaving in its timeliness.

Network Model for Optimal Aircraft Location for Human Organ Transportation Activities.

BACKGROUND: The efficiency of transport phases is a key factor in successful organ transplant operations. Reliability, safety, and punctuality must be in compliance with the European Union and national frameworks and be consistent with economic, quantitative, and level-of-service parameters. In this study we investigated the optimal numbers and locations of aircraft in the Italian territory by comparing performance indexes related to different time intervals and service design scenarios. METHODS: An integer linear programming model is described as an optimal service solution for covering the demand for extraregional organ transport by air between June 2015 and May 2016. Restrictions on aircraft utilization and actual length of the missions in cases of incompatible activities are the relevant input data of the model. RESULTS: Based on mission durations and their origin and destination, the model returns the optimal number and location of aircraft in various scenarios. The performance parameters required by law and the need to guarantee the service from/to the whole territory, together with the transplant figures performed and transplant center locations, have been taken into account to determine the most efficient spatial and numerical allocation. CONCLUSION: The efficient design of an urgency-based service such as the transportation of organs for transplant purposes is not an easy task. Nevertheless, knowledge of the logistic chain and continuous monitoring and update of data and performance parameters can allow for collection of useful information to guarantee a high-performing service.

Transport of Human Organs in Italy: Location, Time, and Performances.

INTRODUCTION: The outcome of transplantation activities depends on a variety of unpredictable factors. Up-to-date criteria on organ allocation foresee an efficient transport chain along with compliant performance parameters. METHODS AND OBJECTIVES: The Centro Nazionale Trapianti and the Department of Civil, Chemical, Environmental, and Materials Engineering of the University of Bologna (respectively, CNT and DICAM) have been updating a national database of organ transplantation activities to investigate performance parameters and the main causes of disruption. RESULTS: Between June 2015 and July 2016, 617 of 1061 organs have been shipped by air (making for 486 flight events), of which 407 were accompanied by medical equipment. Origin/destination and distance matrixes have been drawn for both road and air transport. Each airport node is ranked based on the n° of organs ingoing/outgoing and each route link on its frequency. Performance parameters such as average speed, distance covered, and time have been computed and compared with each organ's cold ischemia time (CIT). Average distance frontiers are rather homogeneous, but much effort is necessary to reduce the number of events performed with approximately 90% or more of CIT spent. CONCLUSIONS: The monitoring of organ transplantation activities' performance is a standalone action within Europe to support strategic policies to optimize the system. Thus, a clearer awareness on performances and issues related to organ transport has been made possible: analyses show that the higher uncertainty associated with total time of displacement by air is due to the steps which take place by road (length and paths must be optimized) and lung transports generally perform weaker than heart transports due to longer average distances travelled and smaller average speeds, often resulting in a total displacement time greater than 90% of CIT.

Analysis of the Organ Offers Received From European Union Countries Before and After the Introduction of a Dedicated Information Technology Portal: The COORENOR/FOEDUS Portal.

INTRODUCTION: To optimize the use of nontransplantable organs in their own territory, the European Commission, as part of a project led by Italy, has promoted the use of an information technology (IT) portal, the COORENOR portal, developed by the Czech Republic in 2012, which evolved to become FOEDUS in 2015. METHODS: To evaluate the impact of the portal on our reality, we analyzed the number and type of offers received and organs imported in the previous 48 months (period A) as well as the 48 months after the introduction of the portal (period B). We also examined the origin and the offer mode. RESULTS: The offers received were 404 and 753, respectively, in the two periods, with 315 (41.8%) organs received through the portal. The organs transplanted were 53 and 64, respectively, in the two periods; 20 (31.2%) were sent through the portal. The most commonly offered organs are lungs (36.7% and 29.3% of offers in periods A and B, respectively). The most transplanted organ is the liver (59.4% and 45% of transplants in periods A and B, respectively). The use of the portal has gradually increased, growing from 16.4% of the offer mode in 2012 to 84.7% in 2016. CONCLUSIONS: The increase of offers related to the increase of donations and the attitude to the sharing of resources has determined an increase of 19.2% of total transplants, especially for certain types such as pediatric transplants. The portal, ensuring speed and simultaneity of offer, real time sharing of information and transparency of allocation, is also used for trade in the International Partnership Agreements. Therefore, transplants have been conditioned by the existing agreements with Greece, Malta, and the countries of the South Transplant Alliance.

Hepatitis C Virus Positive Patients on the Waiting List for Liver Transplantation: Turnover and Characteristics of the Population on the Eve of the Therapeutic Revolution With Direct-Acting Antivirals.

INTRODUCTION: Antivirals direct acting (DAA) for hepatitis C virus (HCV) have brought a revolution in the field of transplantation. It is likely to think that in the future patients on the waiting list for liver transplantation (LT) will no longer be registered for HCV-related cirrhosis but for liver disease from other causes. On the eve of this change, we show a snapshot of the Italian waiting list for LT. METHODS: From October 1, 2012 to September 30, 2013, we estimated the total number of patients on the liver waiting list as intention to treat (ITT), the number of incident cases, and the delistings, particularly in the HCV positive (HCV+) population. Gender, median age, etiology and prognosis of liver disease, presence of hepatocellular carcinoma (HCC), reason for delisting, mean waiting time for LT, and rate of death on waiting list were evaluated. RESULTS: In the time period, there were 517 new patients who were HCV+ (median age, 53 years): 255 (49.3%) mono-infected with HCV, 236 (45.7%) co-infected with HCV and hepatitis B virus (HBV), 11 (2.1%) co-infected with HCV and human immunodeficiency virus (HIV), and 15 (2.9%) co-infected with HCV, HBV, and HIV. The median model for end-stage liver disease (MELD) score at listing was 17 and HCC was present in 206 (39.8%) cases. HCV+ patients delisted were 442 (61.9%), 355 (80.3%) for LT. The mean waiting time to transplantation was 1.9 months; the percentage of death was 7.6%. CONCLUSIONS: This snapshot of the waiting list for LT in the year before the advent of DAA drugs will allow us to assess whether and how they will change the waiting list for LT when we start to look at the impact of new therapies on the waiting list.

Optimizing the Use of Available Lungs.

BACKGROUND: Organ transplantation, the treatment of choice in organ failure, is penalized by the lack of organs. Because the increase in the number of donors is not proportional throughout the different age groups, there is no increase in lung transplantations. The aim of this work was to analyze the use of available lungs and evaluate strategies that may help increase transplantations. METHODS: We analyzed the activity of lung transplantation in 2015, divided into various allocation programs. We also examined the surplus organs, in particular, their origin, their destination, their offer's outcome, the characteristics of the donor and the proposed organ, and the reasons for rejection. RESULTS: In 2015, 112 lung transplantations were performed: 66 (68.9%) with regional organs, 46 (41.1%) with extraregional organs; 21 (45.6%) of these were allocated as emergencies/return, and 25 (54.4%) as surplus (19 in the North macroarea, 6 in the South macroarea). The number of surplus lungs was 148: 67 from the North macroarea, 71 from the South macroarea, and 10 from abroad. No organ procured in the North macroarea was transplanted in the South macroarea, whereas 6 lungs coming from the South macroarea were transplanted in the North. CONCLUSIONS: The acceptance criteria are not the same in different transplant centers and they include not only clinical parameters, but also ischemia time and composition of the waiting list at the time of the offer, quality and accessibility of the intensive care units where the donor is located, and organizational reasons. Offering organs which can not be transplanted within the region to other centers, without clinical foreclosures is a system that increases transplant activities by maximizing the available resources.

Liver Allocation in Urgent MELD Score ≥30: The Italian Experience.

INTRODUCTION: Patients with an urgent MELD score ≥30 are managed by the Italian Operative National Transplant Center on the basis of a division of Italy into 2 main areas, the northern macro area (NMA) and the southern macro area (SMA). The object of this study was to evaluate the possibility and the need to transform the MELD score ≥30 macro area-based program into a nationwide one. PATIENTS AND METHODS: When a region reports the presence of a patient with a MELD score ≥30, the same macro area-compatible donors, in the absence of urgent national and 1B status, are offered primarily to this recipient. RESULTS: From August 2014 to August 2015, 132 requests for patients with urgent MELD score ≥30, 98 from the NMA and 34 from the SMA, were handled. The average waiting list in the NMA was significantly different from that of the SMA (2.74 ± 2.29 vs 4.5 ± 3.98, P < .05). A total of 73.7% of the received requests (n = 97) were satisfied: the NMA met 80.4% of the requests (n = 77), whereas the SMA met 55.5% (n = 20). A total of 35 requests (26.5%), 21 from the NMA (60%) and 14 (40%) from the SMA, were not met. The average waiting time of these recipients for a liver was significantly different between the NMA and the SMA (3.14 ± 3.21 vs 5.78 ± 4.59; P < .05). CONCLUSIONS: The MELD score is a priority allocation, and the longer the waiting time to transplantation for these recipients, the more their mortality increases. Given the differences in waiting times between the NMA and SMA, we should start thinking about transforming the macro area program into a national one.

Transportation of Organs by Air: Safety, Quality, and Sustainability Criteria.

INTRODUCTION: The outcomes of organ transplantation activities are greatly affected by the ability to haul organs and medical teams quickly and safely. Organ allocation and usage criteria have greatly improved over time, whereas the same result has not been achieved so far from the transport point of view. Safety and the highest level of service and efficiency must be reached to grant transplant recipients the healthiest outcome. OBJECTIVES: The Italian National Transplant Centre (CNT), in partnership with the regions and the University of Bologna, has promoted a thorough analysis of all stages of organ transportation logistics chains to produce homogeneous and shared guidelines throughout the national territory, capable of ensuring safety, reliability, and sustainability at the highest levels. METHODS: The mapping of all 44 transplant centers and the pertaining airport network has been implemented. An analysis of technical requirements among organ shipping agents at both national and international level has been promoted. A national campaign of real-time monitoring of organ transport activities at all stages of the supply chain has been implemented. Parameters investigated have been hospital and region of both origin and destination, number and type of organs involved, transport type (with or without medical team), stations of arrival and departure, and shipping agents, as well as actual times of activities involved. RESULTS: National guidelines have been issued to select organ storage units and shipping agents on the basis of evaluation of efficiency, reliability, and equipment with reference to organ type and ischemia time. Guidelines provide EU-level standards on technical equipment of aircrafts, professional requirements of shipping agencies and cabin crew, and requirements on service provision, including pricing criteria. CONCLUSIONS: The introduction in the Italian legislation of guidelines issuing minimum requirements on topics such as the medical team, packaging, labeling, safety and integrity, identification, real-time monitoring of temperature, and traceability of the organ during the logistics chain is deemed a valid response to the necessity of improving safety, reliability, and sustainability of organ transplantation activities in Italy.

Solid Organ Transplantation in HIV+ Recipients: Italian Experience.

INTRODUCTION: According to current estimates, there are about 540,000 patients who are infected with HIV in Western Europe, of which about 3100 are potential candidates for organ transplantation. In Italy, there are currently 85 HIV patients on the transplant list. METHODS: Organ transplantation activity in HIV recipients from 2002 to December 2014 was assessed from the database provided by the Transplant Center of Modena until the year 2011. For the years 2012 to 2014, data are from the Transplant Information System (SIT). The follow-up data have been extracted from the function "Quality" of the SIT. RESULTS: The transplant centers on Italian territory that meet the requirements according to national protocol are in total 29: 11 for the liver, 9 for the kidney including 1 pediatric, 3 for the heart, 3 for the lungs, and for 3 for the combined kidney-pancreas. Since 2002, 257 organ transplantations were carried out, including 185 liver, 59 kidney, 5 combined liver-kidney, 5 combined kidney-pancreas, 2 heart, and 1 double lung. The first cause of death is represented by co-hepatitis C virus infection, in particular in 26 liver recipients (37%) and in 3 kidney recipients (20%). CONCLUSIONS: The analysis showed that transplantation activity in HIV is on the rise, especially in the last 2 years, with an outcome similar to that reported in the literature.

Urgent lung transplantation national program: the Italian experience.

INTRODUCTION: An urgent lung transplantation national program in Italy was developed over the past three years. Indispensable conditions that were included in the program were invasive respiratory support and/or extracorporeal vascular device (DECAP excluded). The aim of this study was to test the effectiveness of the program. MATERIALS AND METHODS: We analyzed urgent lung requests received between 2009 and 2011 taking into account primary pathology, request outcome, average waiting time, and organ origin. Taking as reference the same period of time, we also examined the ordinary waiting list, waiting list mortality, and number of transplantations performed and we have compared them with another three-year period prior to the activation of the program. RESULTS: The total number of urgent requests was 43. Primary pathologies with the highest incidence proportion were cystic fibrosis (40%) and idiopathic pulmonary fibrosis (26.6%). A total of 34 requests (79%) were successfully dealt with and 9 of them were suspended because of worsening conditions. The average waiting time was 17.9 days. During the same period of time 340 lung transplantations were performed and there were 499, 524, and 564 wait-listed patients in 2009, 2010, and 2011, respectively. The mortality rate was 21.3%. Over the previous three-year period 295 transplantations were performed and there were 457, 476, and 464 wait-listed patients in 2006, 2007, and 2008, respectively. Also the mortality rate was 25.3%. DISCUSSION: Urgent lung transplantations can provide patients in an imminent life-threatening situation with adequate care without affecting the mortality rate of patients on the ordinary waiting list.

Patients on liver transplantation waiting list with Model for End-Stage Liver Disease score ≥ 30: experience in the Organizzazione Centro Sud Trapianti macro area.

INTRODUCTION: From 2011 a program was developed for liver transplant recipients with Model for End-Stage Liver Disease (MELD) score ≥30. We examined its effectiveness and impact on the other subjects on the waiting list. MATERIALS AND METHODS: We analyzed requests received between January 2011 and May 2012 for the primary pathology, the outcome, the average waiting time, and the origin of the organ. We examined the ordinary waiting list for mortality rates and numbers of transplantations over this period (group A) versus a comparable preceding period (group B). RESULTS: There were 38 requests for 33 patients. Their primary pathologies were cirrhosis associated with viral infection (n = 15), delayed graft failure (DGF; n = 5), biliary cirrhosis (n = 4), hepatocellular carcinoma (HCC; n = 3 including 2 with cirrhosis), cryptogenic cirrhosis (n = 3), postalcoholic cirrhosis (n = 2), metabolic disease (n = 2), and iatrogenic disease (n = 1). Of the requests, 25 were successfully dealt with, whereas 5 requests were temporarily suspended and 2 were permanently suspended because of better or worse patient conditions. There were 6 deceased patients. Transplanted organs came from the inter-regional area in 64% of cases. The average waiting time was 5.9 days. Within group A were a 311 transplantations among 723 waiting list patients on with a 13.7% mortality rate. Within group B were 305 transplantations among 871 wait-listed patients with a 14% mortality rate. DISCUSSION: The liver transplantation program for recipients with MELD scores ≥ 30 allowed recipients in critical condition to receive grafts without altering substantially the opportunities for recipients on the elective waiting list.

Urgent liver, heart, and lung transplantation programs in Italy: activities and evaluation of outcomes.

The Italian national transplantation network has set up programs for liver, heart, and lung transplantation in urgent conditions. The aim of this study was to analyze the capability of these programs to meeting needs and their quality. In period between 2008 and 2011, the total number of urgent transplant requests was analyzed by organ, reason, and outcome, namely waiting time, graft origin, and number of transplantations with their one- and three-year graft survivals. There were urgent requests for 312 livers, 268 hearts, and 43 lungs totted among which 72%, 63%, and 79% were met, respectively. Actuarial graft survival rates at one and three years were 62% and 61% for liver and 73.1% and 70.5% for heart transplantations, respectively. The rate of satisfied requests and the graft outcomes showed that the national urgency programs meet the healthcare needs of patients with a short life expectancy, achieving good quality donor-recipient match.

Research for optimization in organ donation in a macro-area after federal reform of the Italian health system.

Law number 91, dated April 1, 1999, established an organizational model for the activities of donation, retrieval, and transplantation of organs consisting of 4 levels: national, interregional, regional, and local. After 12 years this organizational project, called the "National Transplant Network," has reached an excellent level of effectiveness and efficiency. Since 2001 regional administrative districts have been entrusted increasingly with responsibilities concerning health. In 2008 health federalism was approved and in 2010 the federal health fiscal system entered in force. In a country with a federal organization, where regional districts are completely autonomous, is there a reason to still have a national transplant center and 3 interregional transplantation centers? We have developed a hypothesis on the function of Interregional Transplant Centers (CIR). The risk of federalism is the fragmentation of the National Healthcare System. To adequately meet the needs of citizens, smaller regions should sign agreements with larger regions regarding transplantation programs that require a large pool of donors whereas they could retain management of patients during the presurgery and postsurgery phases. The CIR should be committed to increase organ donation, to establish shared protocols and procedures, to disseminate knowledge, and to ensure equal access to health care. In conclusion, the adoption of health and fiscal federalism provides an opportunity to build healthcare systems to optimize resources. The network model should be kept but it is necessary to overcome localism and create positive federalism.

Living organ donation, a therapeutic possibility, is still poorly used in Italy: a national analysis.

Validity of living donor kidney transplantation is universally accepted. In contrast, after enthusiastic adoption in the 1990s, living donor liver transplantation has decreased in recent years. The aim of the present study was to evaluate retrospectively the current use of this form of donation in Italy by comparing liver and kidney cadaveric and living donations from 2002 to 2010. The number of liver transplantations from living donors has decreased from 34 in 2002 (3.9% of total) to 13 in 2010 (1.3% of total). In contrast, kidney transplantation from living donors increased from 126 (7.9% of total) to 186 (11% of total). We observed that living donations for kidney transplantation are still underused, especially with unrelated donors. Living donor liver transplantation has decreased in recent years; this procedure should be reserved to centers with particular expertise. It would be appropriate to implement programs to increase the attention of health professionals and the general population and to integrate living donations into programs of deceased organ donation.

Strategies to increase heart transplantation in centre-sud transplant organization.

The 21 heart transplantations in Centre-Sud Transplant Organization (OCST) is a stable number despite increasing donations, especially among subjects aged 50 to 60 years. The aim of the present study was to evaluate the possibility to increase the usage of marginal hearts through dipyridamole ecostress. From 2008 to 2010 we analyzed OCST donors at 74 donation sites for echocardiography (31 yes versus 43 no) and heart utilization: (1) principal sites (n > 13) versus (2) minor sites (n < 13). Among 2145 signaled donors, there were 900 (42%) effective donors, including 816 (38%) utilized organs from 387 subjects of age <50 years; 189, 50 to 60 years and 240, >60 years with 217 (90%); 24 (10%), and 3 (1%) utilized hearts respectively to the analyzed sites, the utilized donors with echocardiography were 373: 259 (69.4%) versus 114 (30.5%) from those without such a service. Utilized donors between 50 and 60 years came from principal sites (n = 50), minor sites (n = 7) or those without an echocardiagram (n = 16). Utilized heart donors in each type of site were eight, one, and six, respectively. We believe that it may be possible to increase the total number of heart transplantations using dipyridamole stress-test echocardiography at the sites with major retrieval activity to increase heart transplantation among donors in the age range of 50 to 60 years.

Italy-Greece cooperation for transplantation of medically urgent Greek patients: is it an effective, efficient model?

INTRODUCTION: In 2005 the Italian National Transplant Centre (CNT) signed a cooperation agreement with the Hellenic Transplant Organization (HTO) fostering the transfer and transplantation of urgent Greek liver patients at Italian transplantation centers. So as to not reduce access to transplantation for Italian patients, the agreement provided compensation for organs allocated to Greek transplant recipients. The aim of this study was to analyze the flow of patients from Greece to Italy and the number of received livers to consider the possibility to extend this kind of agreement to other countries, so that this should not penalize Italian recipients. MATERIALS AND METHODS: The agreement provides the possibility for Greek patients affected by acute disease to be transferred to Italian transplantation centers participating in the agreement. Until 2008 livers transplanted into Greek recipients were returned through a preferential offer of surplus Greek organs, whereas from 2009 an obligation of payback was introduced. RESULTS: During the reviewed period requests for transfer, transferred patients, and number of patients who later underwent transplantation in Italy were 56, 26, and 23, respectively. Livers offered by the Greek organization that were accepted, transferred, and transplanted in Italy have been 82, 50, and 44, respectively. DISCUSSION AND CONCLUSIONS: According to our analysis, the cooperation has had as positive impact for both Greece, which has difficulties transplanting urgent recipient because of the low number of donors, and for Italy, which is not penalized by the use of an organ in a Greek recipients, but is also rewarded for helpfulness.

The use of neoplastic donors to increase the donor pool.

The aim of the study was to evaluate the experience of the Centre-Sud Transplant Organization (OCST) area using cadaveric donor with neoplastic diseases to evaluate the possibility of transmission to recipients. From January 1, 2003, to December 31, 2010, the neoplastic risk has been reported to be 5.4% (377/4654 referred donors). In 2003, the number of donors with a tumor and their mean age were respectively: 60 (10.3%) and 59.6 ± 19.9; 2004: 33 (5.2%) and 61.4 ± 15.9; 2005: 32 (6%) and 62.8 ± 15.5; 2006: 46 (7%) and 60.7 ± 19.1; 2007: 51 (7%) and 58.9 ± 16; in 2008: 58 (7%) and 59.7 ± 19.6; 2009: 47 (7%) and 57 ± 26; 2010: 49 (7%) and 64 ± 16. The organ most affected by tumor has been the central nervous system (18%). The tumor was diagnosed before in 325 (86%) cases, versus during organ retrieval in 48 (12.7%) donor operations but before, which four cases (1%) occured after transplantation. According to the histological types and grades, 28 evaluated donors (8.2%) were suitable for transplantation. The histological types were: thyroid carcinoma (n = 3); prostate carcinoma (n = 8), renal clear cell carcinoma (n = 7), oncocytoma (n = 1), meningiomas (n = 2), dermofibrosarcoma (n = 1); verrucous carcinoma of the vulva (n = 1), colon adenocarcinoma (n = 1), grade II astrocytoma (n = 1), adrenal gland tumor (n = 1), gastric GIST (n = 1), oligodendroglioma (n = 1). Forty-five organs were retrieved (22 livers, 19 kidneys, 3 hearts, and 1 pancreas) and transplanted into 44 recipients with 1 liver-kidney combined transplantation. Four recipients died due to causes not related to the tumor. No donor-transmitted tumor was detected among the recipients. Donation is absolutely not indicated in cases of tumors with high metastatic potential and high grades. Performing an accurate evaluation of the donor, taking into account the histological grade, currently can allow, organ retrieval and transplantation with an acceptable risk.

Risk management systems for health care and safety development on transplantation: a review and a proposal.

UNLABELLED: Starting from the report on medical errors published in 1999 by the US Institute of Medicine, a number of different approaches to risk management have been developed for maximum risk reduction in health care activities. The health care authorities in many countries have focused attention on patient safety, employing action research programs that are based on quite different principles. MATERIALS AND METHODS: We performed a systematic Medline research of the literature since 1999. The following key words were used, also combining boolean operators and medical subheading terms: "adverse event," "risk management," "error," and "governance." Studies published in the last 5 years were particularly classified in various groups: risk management in health care systems; safety in specific hospital activities; and health care institutions' official documents. Methods of action researches have been analysed and their characteristics compared. Their suitability for safety development in donation, retrieval, and transplantation processes were discussed in the reality of the Italian transplant network. DISCUSSION: Some action researches and studies were dedicated to entire national healthcare systems, whereas others focused on specific risks. Many research programs have undergone critical review in the literature. Retrospective analysis has centered on so-called sentinel events to particularly analyze only a minor portion of the organizational phenomena, which can be the origin of an adverse event, an incident, or an error. Sentinel events give useful information if they are studied in highly engineered and standardized organizations like laboratories or tissue establishments, but they show several limits in the analysis of organ donation, retrieval, and transplantation processes, which are characterized by prevailing human factors, with high intrinsic risk and variability. Thus, they are poorly effective to deliver sure elements to base safety management improvement programs, especially regarding multidisciplinary systems with high complexity. CONCLUSION: In organ transplantation, the possibility to increase safety seems greater using proactive research, mainly centred on organizational processes together with retrospective analyses but not limited to sentinel event reports.

Exchange of organs and patients with foreign nations during the first 15 months of activity of the Italian gate to Europe.

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.