Sante Venettoni

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.

Analysis of the complex effect of donor's age on survival of subjects who underwent heart transplantation.

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.

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.

Legal Aspects of Organ Transplantation in Italy

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).