The Canadian Transplant Registry (CTR) identifies transplant opportunities across Canada for heart transplant candidates who are highly sensitized to Human Lymphocyte Antigens (HLA) and/or designated as medically urgent (i.e., designated as medical status 4).
Although these policies have been approved they are not considered active until implemented through the CTR IPOS Heart Project.
Recipient Eligibility: This policy describes the eligibility requirements for potential transplant recipients to participate in the Inter-provincial Sharing: Heart program.
Allocation: Matching and Ranking: This policy outlines the rules used to identify and rank highly sensitized patients (HSP) and medical status 4 patients who are potential matches to an available donor heart.
Requirement to Offer: This policy describes the procedure with respect to offering donor hearts under the Inter-provincial Sharing: Heart program.
Exports & Imports: This policy describes the process for tracking the number of hearts shared between provinces under the Inter-provincial Sharing: Heart program.
This map provides an overview of the allocation end to end process.
This map depicts how the Canadian Transplant Registry determines the HSH Allocation recipient rankings for waitlisted medical status 4, and non urgent status highly sensitized patients.
This map outlines the rules, and possible scenarios, for calculating days at current medical status (DCMS).
This document outlines the processes used to identify and rank medically urgent patients and highly sensitized (cPRA equal to or greater than 80%) who are potential matches to an available donor heart, the offer management process, and the "recusal" process, to exempt a specific recipient from the high-status heart allocation for interprovincial organ sharing when deemed medically appropriate by the transplant team.
To support physicians through the transition, this document highlights upcoming changes, updates, and/or new processes that could impact clinical workflow when a heart is being allocated for high status recipients.
Why did the Canadian Cardiac Transplant Network and the Canadian Blood Services-led Heart Transplant Advisory Committee (HTAC) work to develop national sharing policies?
Since 2013, highly sensitized kidney patients have benefited from the opportunities provided them through the Canadian Transplant Registry (CTR) and the inter-provincial sharing of kidneys. Canadian Blood Services clinical advisory committees have recommended that other transplant groups, including highly sensitized and/or medically urgent heart transplant candidates, are patient populations that would benefit from enhanced allocation, HLA matching capabilities, and interprovincial sharing to improve quality matches.
A more efficient platform to operationalize interprovincial sharing policies for medically urgent and highly sensitized heart patients would increase the number of organ matches, shorten the organ offering and allocation process (to minutes instead of hours), improve organ utilization and support improved tracking of outcomes and impacts on this patient population.
When were the national policies approved?
The national policies were signed off by all Provinces as of February 2018 and were approved by Provincial Funding Authorities by February 2019.
Who were they reviewed and approved by?
The national policies were reviewed and approved by the Canadian Cardiac Transplant Network, Donation and Transplantation Expert Advisory Committee, Organ Donation and Transplantation Expert Advisory Committee, and National HLA Advisory Committee.
If they have been approved, do we now allocate hearts according to these national policies?
The clinical community have transitioned to following these policies for heart allocation. As such, all Organ Donor Organizations (ODOs) are encouraged to also start reviewing their local SOPs in regards to the allocation and ranking outlined in policy CTR10.002 and CTR10.003.
Can the virtual crossmatch (vXM) function activated in the CTR in October 2019 be used to make offers?
No. Heart sharing is currently in a hybrid period where the vXM tool in the CTR has been introduced to identify vXM negative highly sensitized patients to allow more efficient allocation of hearts. However, the CTR is not currently used for sending offers. This will occur once the IPOS program goes live.
Does an open offer equate to using local allocation rules?
If no medically urgent or highly sensitized patients are listed in the high-status allocation list, the offer can then be made to locally listed patients. If there are no locally listed patients, the offer can be made to a patient listed on the National Organ Waitlist.
Is there a process to report issues or cases that delineate from the allocation policy to discuss and inform change if needed?
Report issues and concerns to email@example.com. Significant issues can be brought forward to Canadian Cardiac Transplant Network Annual General Meeting for discussion at their annual review.
Where can I find a copy of the most recent policies?
Is the table included in policy CTR10.002 a ranking table?
The table included in policy CTR10.002 is intended to be used as a tie breaking system and comes into play when there is more than one matched potential recipient. The table is for status 4 and highly sensitized only, and not meant to inform local allocation rules.
How will the system calculate the days at current medical status when breaking ties?
The CTR will use the entered medical status date and subtract it from the current date at which the allocation is being run to determine the days at current medical status.
A guideline document has been developed in discussion with the Heart Transplant Advisory Committee that informs how the changes in patient’s medical status over time should be considered when entering the medical status date in the CTR. This document can be found here. Canadian Blood Services customer support can be reached at 1-855-287-2889 to help determine the medical status change date/time that should be entered.
Will all highly sensitized patients (> 80% cPRA) still be designated as status 4S?
No. Any highly sensitized patient with a ≥ 80% cPRA will be considered highly sensitized in addition to their hemodynamic/medical status. Sensitized patients within the CTR will be given a “highly sensitized” flag that will display as “YES”.
Why was status “4S” replaced by “Highly Sensitized”?
The highly sensitized flag (displayed as “YES” in the CTR) was introduced to allow for the hemodynamic status of highly sensitized patients to also be visible and utilized in the prioritization of patients for organ allocation.
What if I receive a request from a physician in my jurisdiction to not include a highly sensitized heart patient that is currently included in the national heart sharing allocation process?
If it is in the best interest of the patient, a physician may express the need to recuse a highly sensitized patient from national sharing. If such a request is received, the “High Status Heart Allocation Recusal Notification Process” should be followed. Please refer to the High Status Heart Allocation Offer Management, Notification, and Recusal Process that can be found here.
Can the recusal process be used for both high sensitized and medically urgent (Status 4) recipients?
No. This process can only be used for highly sensitized patients. If a physician expresses the need to recuse a medically urgent (status 4) recipient from national sharing, the notes section in the CTR should be used.
When the new implementation of highly sensitized heart recipients occurs, will a highly sensitized status 4 then out rank status 4?
The matching and ranking policy (CTR 10.002) confirms that status 4 and Highly-Sensitized 4 patients are treated as hemodynamically equivalent and their cPRA does not factor into ranking.
Does the #4 ranking attribute in the table in policy CTR10.002 mean pediatric recipients would receive priority over adult recipient with regards to status?
The ranking attributes listed after “medically urgent (status 4)” are tie breakers for “Highly Sensitized” patients with medical statuses of 1 to 3.5 (not medically urgent). For example, a lower hemodynamic status pediatric recipient would be prioritized higher than an adult patient with the same cPRA and a lower hemodynamic status, all things being equal. For further clarification please refer to the policy communique dated February 22, 2021.
Do the ranking attributes and/or tie breakers outlined in Policy CTR10.002 also apply for pediatric patients?
Yes. Pediatric patients would be ranked in the allocation list per the diagram referenced in the February 22, 2021 communique.
When a high-status heart offer is being made, will the CTR send notifications to the ODOs with potential medically urgent recipients listed?
Yes. An allocation notification will be sent to the ODO for all potential recipients included on the allocation list once an offer is made to the #1 ranked recipient. Please refer to the High Status Heart Allocation Offer Management, Notification, and Recusal Process that can be found here.
Should the offering ODO let the ODO of the potential medically urgent recipients listed know of the offer by phone call?
Yes. The donor ODO should call the ODO of the #1 ranked recipient and to all other ODO’s with medically urgent matched recipients listed on the allocation list; indicating their rank on the current heart offer in play.
When a heart offer is in play for the local program and a high-status recipient is listed, at what point would it be too late to re-run the allocation?
Once a heart offer has been made and verbally accepted, the list is considered frozen and the allocation list should not be re-run.
What happens if an offer is made a couple of days before retrieval of the organ can take place?
Once the offer has been made and accepted, as stated above the list is considered frozen. However, it is still incumbent on the offering ODO to monitor the situation and if the organ becomes unviable to ship, programs should be reverting to local allocation practices.
What happens if a newly urgent patient is listed in the time before an offer is accpeted? Should the allocation be re-run?
Yes, prior to an offer being accepted. Once an offer is accepted, the allocation list is considered frozen and re-run is no longer required.
If the offer has been accepted, and there are circumstances that make either the donor or recipient ODO change their decision, then the offer acceptance must be cancelled both in the CTR and via phone call. When the acceptance on an offer is cancelled the list is considered “un-frozen” and allocation must resume. Making use of the “preview allocation” function is highly recommended to see if any new status 4 recipients alters the current allocation results. If so, the allocation needs to be re-run. If not, allocation can proceed per the current allocation list.
What are the parameters considered by the matching algorithm in the CTR when generating the high-status heart allocation list?
The CTR matching algorithm will consider eligibility for acceptance of ABO Incompatible Donors, Minimum Donor Weight, and Maximum Donor Weight. The CTR has available fields where the above can be inputted.
If there are other program-specified comments in the CTR regarding parameters for donor acceptance, these are not considered for the purposes of IPOS. Programs have the option to recuse individual recipients from IPOS as per the processes outline in High Status Heart Allocation Offer Management, Notification, and Recusal Process that can be found here.
How long does the receiving ODO have to accept an offer?
The receiving ODO has 120 minutes to accept the offer. The acceptance can be conditional pending further donor assessment. The acceptance can be given verbally followed by recording the decision in the CTR. Once this has been communicated to the donor ODO, the list is frozen as noted above.
How firm is the 120-minute rule?
The 120-minute rule is intended to be adhered to as much as possible. However, there is recognition of practical and logistical issues that could make adherence challenging. The rule is meant as a guideline to avoid a situation when an offer has been made, only to find out no work is done by the receiving centre during that 120-minute window to determine a final decision. ODOs and transplant programs are required to maintain consistent communication during the offer process to ensure the allocation is moving forward expediently.
What is Canadian Blood Services’ role in Canada’s organ and tissue donation and transplantation system?
Canadian Blood Services works with the Organ and Tissue Donation and Transplantation community to support interprovincial organ sharing and national system performance. We do this through engagement with stakeholders, leading practices, professional education, public awareness and data analysis and reporting.