L. Rizzato

A population-based study of cancer incidence in solid organ transplants from donors at various risk of neoplasia

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.

The Italian Multiorgan Donor Cancer Screening Protocol: 2002–2005 Experience

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.

Solid organ transplantation: the Italian experience in the international context.

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.

Emergency heart transplantation outcome: the Italian experience.

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.

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.

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.

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.

A Network Model for the 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.

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 offers 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.