The Safety of Donor




© Springer International Publishing Switzerland 2015
Antonio Daniele Pinna and Giorgio Ercolani (eds.)Abdominal Solid Organ Transplantation10.1007/978-3-319-16997-2_4


4. The Safety of Donor



Antonia D’Errico , Deborah Malvi1 and Francesco Vasuri1


(1)
“F. Addarii” Institute of Oncology and Transplant Pathology, S. Orsola Malpighi Hospital, Bologna University, Bologna, 40138, Italy

 



 

Antonia D’Errico



Safety during organ recruitment means donor safety and organ safety. Efforts to advance transplant safety are ongoing and include improvements to screening tests and checks to detect any kind of donor disease and ensure good graft function after transplantation.

Organ transplantation is the best life-saving treatment for end-stage organ failure. The current organ donor shortage has led to a progressive increase in patients on the waiting lists. Moreover, a long time on the waiting list may result in patients deteriorating or dying before receiving a transplant. In view of this, many transplant centres worldwide have extended their criteria for organ acceptance. Nowadays the donor pool includes older donors, unstable donors, donors with positive viral serology and donors with a history of cancer and in some cases with cancer [1].


4.1 Donor Safety: Transmissible Diseases



4.1.1 Infectious Disease


While reports of infections after tissue transplantation are rare, the true rate of transmission is unknown, although it is estimated in <1 % of solid organ recipients. The risk of infectious transmission has been correlated to microbiological screening, which can vary with national and regional regulations and with the availability and performance of microbiological assays used for potential donors.

Viral, bacterial, parasitic, prion and fungal infections can be transmitted by organs, tissues and cells. Infectious transmissions have often been recognised as clusters of infections among recipients of organs from a common donor. These include Mycobacterium tuberculosis, Candida and Aspergillus species, herpes simplex virus and human herpesvirus 8, lymphocytic choriomeningitis virus, rabies virus, HIV and HCV.

Each infectious disease identified in a donor must be treated before organ recruitment: common infections cured before organ donation do not preclude organ transplant. The use of organs from donors with active or suspected infection reflects the urgency of transplantation, the availability of other organs and the recipient’s informed consent.

The common screening tests are HBV serology, HIV, HCV, Toxoplasma, CMV, EBV panel, herpes simplex virus, varicella-zoster virus antibodies and nontreponemal and treponemal testing. Variations in national guidelines are mainly related to available resources and technologies in the different countries.

General exclusion criteria are rabies, active tuberculosis, HIV or HTLV infection, West Nile virus infection and uncontrolled sepsis. Increased-risk donors include all individuals with uncontrolled sexual behaviour, drug abusers, donors previously treated with human-derived clotting factor concentrates and the prison population. These donors can be considered in a “window period” with very low antibody titres and have to be tested by highly sensitive and specific microbiological assays, such as viral nucleic acid tests [25].


4.1.2 Neoplastic Diseases


The transmission of malignancies is a well-recognised complication of transplantation from donors with and without a history of cancer. The employment of older donors has increased the risk of inadvertent cancer transmission. Donor-transmitted tumours are those that existed in the donor at the time of transplantation. Donor-derived tumours are de novo tumours that develop in transplanted donor cells. Donor-transmitted tumours could be prevented by meticulous donor evaluation.

During the last 10 years, there has been a progressive decrease in the transmission of malignancies, due to the stringent application of guidelines during organ procurement and removal. In 2002 the OPTN/UNOS estimated the risk of cancer transmission to be 0.01 % [6]. In the UK, among 39,765 graft recipients, Desai et al. [7] reported a donor-transmitted cancer in 15 patients (0.05 %) from 13 donors. In no case was cancer detected at the time of transplantation.

Each donor should be investigated for smoking or other cancer related risk factors. If a history of cancer is reported, it is necessary to know the histological diagnosis and the type of tumour, its grading and staging, and the donor’s treatment and follow-up. If the donor is a childbearing woman who died from intracranial haemorrhage or had a history of uterine bleeding, all tests to exclude choriocarcinoma must be performed. All donors with intracranial haemorrhage without evidence of arterial hypertension or aneurysms must be evaluated for possible brain metastasis; in some cases, an intraoperative brain biopsy may be required. A meticulous check of the donor’s skin can reveal scars or skin lesions suspect for melanoma or a previous melanoma.

Italian guidelines (www.​trapianti.​salute.​gov.​it), the Council of Europe [5], Nalesnik et al. [8], and the UK Advisory Committee on the Safety of Blood, Tissues and Organs have defined risk categories for donor tumour transmission. A suggested approach to donor utilisation has been given for each category, recognising the emergent circumstances and clinical urgency. A careful evaluation of the donor before and during organ recruitment is always recommended: [5] palpation of the abdominal organs and lungs, immediate frozen sections of any suspected lesions and preoperative echography of the liver and the kidneys must be performed [9].

The risk profile in the different experiences can be summarised as no significant risk (standard risk), minimal risk, low to intermediate risk, high risk and unacceptable risk. Definition of a risk profile in neoplastic donors is the basis of a careful screening system designed to minimise or remove the risk of cancer transmission from the transplantation process.


4.2 Solid Organ Tumours and Risk Assessment


Skin basal cell carcinomas and in situ epithelial carcinomas of many organs may be generally accepted as no-risk tumours. The only exception is high-grade in situ carcinoma of the breast, because this tumour can be understaged, particularly during organ procurement as frozen section may fail to detect foci of microinvasive carcinoma.

Renal cancer is the most common tumour detected during organ removal. Many literature reports suggest that I–II/IV Fuhrman grade renal cell carcinoma up to 4 cm (pT1a) shows a very low risk of cancer transmission [5].

In 2005 Buell et al. [10] reported to the Penn Tumour Registry that of 14 known cases of intentional transplant of kidneys with excised tumour (mean diameter 2.0 cm), there was no cancer transmission in the recipients at a mean of 69 months (range 14–200 months).

Transmission of kidney carcinoma has been described, although in some cases it was due to the use of organs from donors with high-stage tumours or an organ containing a tumour [11, 12]. In other cases, an incomplete histological report or the lack of molecular tests failed to demonstrate donor-recipient neoplastic transmission [13, 14].

The diagnosis of renal carcinoma during organ recruitment needs a team of pathologists with expertise in the field of kidney tumour pathology. The differential diagnosis between oncocytoma and chromophobe carcinoma can be extremely difficult on frozen section; oncocytoma is a benign kidney tumour, while chromophobe carcinoma can metastasize. Donors with kidney tumours more than 4 cm in size are generally not accepted for organ donation [5].


Thyroid Tumours

Some very early types of thyroid carcinoma, such as encapsulated papillary or micropapillary carcinoma, may be considered a standard risk.


Prostate Cancer

The incidence of prostate cancer increases with age, and the use of older donors includes an increased risk of identifying this cancer during organ recruitment. PSA evaluation does not have a pivotal role because its values can be modified by ischaemia and manual procedures during catheterism.

There is no consensus on the procedure to follow for donors with prostate cancer. Some countries consider donors with prostate cancer an unacceptable risk for donation, whereas others (e.g. Italy [15]) consider donors with small intraprostatic low-grade (Gleason score ≤6) tumours a standard risk, while those with intraprostatic tumours with a Gleason score 7 are considered nonstandard risk. Histological examination of the entire prostate with tumour grading is time-consuming, and results may not be available before transplantation. A careful individual risk-benefit assessment must be undertaken. Donors with extraprostatic tumour extension or prostate cancer-related metastatic disease should be unequivocally excluded from the donation process.

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Oct 6, 2016 | Posted by in GASTROENTEROLOGY | Comments Off on The Safety of Donor

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