Increased utilization of organs from IRDs in a safe and ethical manner may lead to an increase in number of transplants in Canada coupled with decreased wait-list times and mortality. Risk exists for all donors and includes the (undefined) risk of false-negative testing (both serology and NAT). Based on a review of residual risk assessments as well as Canadian wait list mortality data, the following recommendations were agreed on by group consensus:
* Transplant physicians and surgeons should consider the utilization of organs from IRDs.
* This should be performed in conjunction with NAT testing for HCV and HIV, and hepatitis B surface antigen or NAT for HBV. Some development work is required to ensure that NAT is available across all jurisdictions in Canada (strong recommendation, moderate quality evidence).
* All potential recipients should be made aware of the option to consider accepting organs from IRDs and that declining such an offer will not impact their waiting time for a standard risk (non-IRD) organ.
Appropriate informed consent from potential recipients should be obtained. It is suggested that a standardized informed consent process be used (see informed consent section; a potential standardized informed consent template is provided in Table 5). A recommendation was made that information also be provided in an elective manner at the time each potential recipient has consented to be placed on an organ donor wait list.
* Decisions around utilization or nonutilization may take into account the timing of increased risk behavior, the WP for the specific test used, and the status of the recipient as well as other recipient-specific circumstances.
* Recipients of organs from IRDs should undergo follow-up posttransplant testing for HCV, HIV, and HBV. NAT for HIV and HCV is necessary because transplant patients may not seroconvert (1). A recommended algorithm is provided in Table 6 (strong recommendation, low-quality evidence).
Adequate informed consent for potential recipients of organs from IRDs is essential. Contextualizing the risk in a clear and understandable perspective is important. The information provided to patients should be accurate and nonleading. Risk estimates from Tables 3 and 4 are based on Canadian data and may provide useful guidance when explaining risk to potential recipients. The following are important aspects of the informed consent process:
* The discussion should be at the time of listing and again at the time of offer. The discussion should take place with the physician although other members of the team may also be involved. Although a patient may decline this option at the time of listing, this could be reassessed throughout the waiting period and the time of offer because clinical and other circumstances may change.
* A standardized informed consent process is useful, and a recommended template is provided. This may be modified as needed for center-specific practices. A separate standardized informed consent template may be needed for kidney versus non-kidney recipients given the availability of dialysis for support of end-stage renal failure patients. There is evidence to suggest that centers using a standardized informed consent process have higher utilization of organs from IRDs (38) (strong recommendation, moderate quality evidence).
Documentation of the informed consent process is essential. Institutional requirements may vary as to the format of documentation in the medical record and should be followed.
If organs from IRDs are used, posttransplant testing of recipients is recommended for early detection of potential transmissions (strong recommendation, low-quality evidence). Because delayed seroconversion may occur, posttransplant screening with NAT for HIV and HCV is recommended along with NAT or hepatitis B surface antigen testing for HBV (1). A potential proposed algorithm for testing is shown in Table 6. Other testing algorithms may also be reasonable (see PHS guidelines, reference 7) but should include NAT for HIV and HCV.
A central database for collection of data related to used and non-used deceased organ donors would provide valuable information and is currently planned as part of the Canadian National Transplant Research Program. This should be tied to recipient data including clinical and laboratory outcomes and documentation of transmission events. In addition, uniform availability of NAT testing across Canada is an important issue that needs to be addressed because this may limit the ability of some Canadian centers to use organs from IRDs. Ultimately, a Canadian registry of wait-listed patients, who would be willing to consider an offer from more risk donor, may assist with efforts to optimize utilization.
Optimal utilization of deceased donor organs from IRDs should be performed in a safe and ethical manner. This includes appropriate testing of donors and rigorous informed consent of potential recipients. Transplant programs may consider discussing their protocols with hospital senior leadership before finalizing policy. Overall, a more standardized approach across Canada should lead to optimized utilization practices and a significant increase in the number of organ transplants.
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*Working group participants in alphabetical order: Blydt-Hansen, Tom, University of Manitoba; Boyarsky, Brian, Johns Hopkins School of Medicine; Chow, Eric, Johns Hopkins School of Medicine; Cockfield, Sandra, University of Alberta; Cole, Ed, University Health Network; Cypel, Marcelo, University Health Network; Gill, John, University of British Columbia, Goldberg, Aviva, University of Manitoba; Goulet, Marie, Health Canada;Hartell, David, Canadian National Transplant Research Program; Humar, Atul, University Health Network; Husain, Shahid, University Health Network; Keshavjee, Shaf, University Health Network; Kiberd, Bryce, Dalhousie University; Kim, Joe, University Health Network; Knoll, Greg, Ottawa Hospital Research Institute; Kramer, Andreas, Southern Alberta Organ and Tissue Donation Program; Kucirka, Lauren, Johns Hopkins School of Medicine; Kumar, Deepali, University Health Network; Kutsogiannis, Jim, Alberta HOPE; Lien, Dale, University of Alberta; Nagendran, Jayan, University of Alberta; Nickerson, Peter, University of; Manitoba; Paraskevas, Steven, McGill University; Renner, Eberhard, University Health Network; Segev, Dorry, John Hopkins School of Medicine; Singer, Lianne, University Health Network; Trpkovski, Julie, Trillium Gift of Life; West, Lori, University of Alberta/Canadian National; Transplant Research Program;Wright, Linda, University of Toronto; Young, Kim, Canadian Blood Services.