The New Kidney Allocation in Ontario, First Year Look Back Jeff Zaltzman Director Transplant St. Mikes CMO Transplant TGLN Co- Chair Kidney-Pancreas working group Objectives ① Discuss rational and principles for new Kidney allocation in Ontario ② Review outcomes after the first year of implementation My conflicts I am the director of a transplant program in Toronto I work at Trillium Gift of Life Network Why change ? • Expert Panel Report-access issues • Auditor General report-access issues • Ontario was only OPO region in: Canada, USA, Euro-txp, UK, with multiple kidney and pancreas lists • In Ontario all other organs: lungs, heart, livers were on a single list • The previous system was out-dated, and difficult to manage …….and for over 40% of the cases we reviewed, the highest-priority patient did not receive the organ and no reason was documented. ….. 90% of kidney recipients received a kidney within four years in one Ontario region, compared to about nine years in two other Ontario regions. Average wait-time for kidney by region and age (includes on Hold) 2010-11 2500 2000 1500 1000 500 0 19-55 >55 Average Waiting Time (days) Ottawa 1636 1526 Hamilton 1522 1557 Kingston 1499 1073 London 910 805 Toronto 2179 1948 Regional Average 1781 1626 Why change?:Better outcomes • New technology with regard to matching. Can allocate based on acceptable mismatch, known DSAs o Better short and long-term outcomes o Obviate need to cross DSA barriers • Be consistent with what we were doing with National Kidney Paired Donation and with Highly Sensitized Program • Some improvement in access to kidneys • • Waiting times sensitized Why was this the right time? • HLA technology • Ontario’s organ donor #s are now best in the country • The growth in organ donation has occurred in the regions where it had to grow! : GTA and HAMILTON • Easy to accommodate CBS National Highly Sensitized Registry for recipients with cPRA >95% Ontario 2014. 265 Deceased donors, including 76 300 (28%) DCD. A record for both! 250 200 DCD 150 NDD 100 50 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Pop: 13,500,000 RPM=19.6 Deceased Organ Donor Trends Canada 2001-2014 600 500 400 BC Praries 300 Ontario Total Ont NDD Quebec 200 ATL CANADA 100 0 Trends in deceased donor rate per million by province 30 25 Canada BC AB SK MB ON QU NS NB NL 20 15 10 5 0 2010 2011 2012 2013 2014 TGLN 2001-2014: Which donor regions saw the most growth ? • TGLN 2001-2005- 141 donors per year • TGLN 2006-2008- 182 donors per year • TGLN 2009-2012- 223 donors per year • TGLN 2013-2014- 245 donors per year TGLN 2001-2014: Which donor regions saw the most growth (last 12 years) ? London, Hamilton, GTA, Kingston, Ottawa ? • • • • • London-5% Hamilton-120% GTA -65% Kingston- 15% Ottawa-10% Problems with old allocation system Based on priorities, but no weighting applied Multiple lists, difficult to administer and allocate Required negative cross-match for allocation HLA labs for each of the 5 regions, but no access between regions. Thus kidneys moved between regions to recipients without knowing “matching” ⑤ Transplanted across DSA barriers ⑥ Belief that donors belonged to the transplant program ⑦ Unequal access in terms of wait-times and sensitized recipients ① ② ③ ④ Old Allocation vs New allocation Old February 12, 2014 Don’t Share Kidneys share 1 kidney Nationally and/or provincially Sensitized patients in Ottawa have access to ~13 million (highly sensitized~34 million) Sensitized patients in Ottawa have access to 1 million potential donors Allocation based on crossmatch Allocation based on dichotomous variables (PRA>80% or 20-79%) Transplant with donor antibody present (DSA) Allocation done virtually Allocation will be continuous(point system based on cPRA and wait-time) Eliminate transplant against DSA What is virtual cross match? • 1) Know all HLA antibodies of recipients on wait-list at the molecular level • 2) Donor antigens known at time Potential donor, if the recipient does not have any Donor Specific Antibodies (DSA) ie : if recipient has antibodies against HLA : Dr11*0401, then donor who expresses this antigen will not be a match. Sensitized patients: Ontario and Canada • All recipients have a cPRA (0-100%) • Patients across Ontario will have access to donors throughout the province. • A recipient receives points based on the following: POINTS = 0.1 every 30 days wait from start of RRT + 4 x (%cPRA)/100 -Example patient has been on on dialysis 600 days and cPRA 0f 50% 0.1x 600/30 + 4 (50/100) = 4 points All patients with cPRA of 95% or greater now registered on CBS National HSP. Eligible for kidneys from anywhere in Canada ( based on virtual xmatch) Donor region will have maximum export #, and will not export any more kidneys until below export threshold New kidney allocation for Ontario • Use same priorities as in past , but assign weighting • All recipients have know DSAs in system • Allocate based on acceptable mismatching • Goal : improve access to sensitized patients and improve transplant outcomes, improve, but not eradicate wait-time discrepancies between programs • Also able to apply changes to deal with blood group wait-time discrepancies ie: A2 to B recip. Principles of kidney Allocation Keep 1, Share 1 • 1) “Old” donor regions remain • 2) First kidney stays in local donor region • 3) Second kidney offered first to National HSP, then to next highest priority patient in Ontario KIDNEY ALLOCATION IN ONATRIO Principles: All Ontario recipients whave high quality cPRA, HLA and acceptable antigen mm entered into TGLN data base Organ offers will made after negative virtual cross match with donor 2 separate allocations SCD and ECD (regardless of NDD or DCD) First kidney stays in traditional transplant region, and second allocated to provincial or National HSP wait-list. However allocation rules remain the same for both. If only one kidney, than its allocated to transplant/donor region. All SCDs (<35) will be considered for pediatric recipients, for adults will use age matching criteria as currently applied. ALL ECD allocated to ECD recips (criteria set) PRIORTIES of ALLOCATION (SCD, both NDD,DCD) Starting point is virtual negative cross-match with donor: 1) OVERRIDING PRIORITY=Medical high priority 2) HIGH PRIORITY: -Pediatric -Multiorgan -KP 3) MEDIUM PRIORITY: Age matching ;<35 year old donor to <55 year old recipient Once donor recipients are allocated into the 1 of the 3 categories, use total points to determine further allocation using the following: Total Points= 0.1 point/month waiting + (0-4 points) for sensitization- 4x cPRA/100 SAME PRIORITIES FOR ECD, but no pediatric consideration, (Would still allocate ECD to overriding priority recipients) 3 goals 1) Improve access for Ontario kidney wait-list patients -organ redistribution - referral redistribution 2)Improve outcomes -avoid transplanting against donor specific antibodies 3) Minimal effect on transplant Program activity Try to balance these, but be aware of impact to program activity High priorities sensitization Waiting time -Depending on weighting of these, the flow of kidneys could increase or decrease -If we tried to equalize wait-time, then could compromise program activity!!!- Improve access, and mitigate transplant program volume effects Reallocation of patient referrals GTA has~50% of dialysis population but 63% of kidney wait-list (675/1075) o This will help to mitigate some access re wait-times, but not completely o Will offset concern re program transplant #s o Remains patient focused, as can be done without causing patients to travel further, and in most cases less travel than current system. Transplant referral by LIHN. Goal: Shift referrals from GTA to London by way of Hamilton Transplant OLD center LIHN referral Dialysis New Population LIHN (%) referral Dialysis Populatio n (%) change 13% of dialysis on list London 1,2, (14) 1017 (11) 1,2,3, 14 1530 (16.6) +513 (+45%) +67 Hamilton 3,4, 1407 (15) 4, 6 1806(19.6) +399 (+22%) +52 Toronto 5,6,7,8,9, 5459 (60) 12, 13, 14 5,7,8,9,12, 4547 (49) 13,14 -912 (-17%) -119 Kingston 10 374 (4) 10 374 (4) 0 0 Ottawa 11 934 (10) 11 934(10) 0 0 Ontario ALL LIHNs 9191 9191 0 0 Dialysis #s by LIHN from 2007 OLD REFERRAL London Hamilton Toronto Kingston Ottawa NEW REFERRAL -Referral base -Population -historical barriers -Program viability -Access (referrals, listing, transplant) -Blood group equity -wait-time equity -PRA equity -Donor rates -Trust -National HSR -Outcomes (measuring) -Financial . FIRST YEAR RESULTS Feb 12, 2014 -Feb 11,2015 ONTARIO: FIRST YEAR RESULTS Reasons for Decline of Local Kidney Region London Toronto Kidneys Number (%) of available local kidneys available for February that local program chose to use but 12th, 2014 – not February 12th, 2015 Reason for Decline local allocation were transplanted elsewhere No Suitable Recipient (N=7) VXM and DCD (N=1) 40 10 (25%) Medically Unsuitable (N=2) No Suitable Recipient (N=2) Medically Unsuitable (N=2) 112 7 (6%) Not suitable in recipient OR (N=3) Ottawa 15 0 (0%) Kingston 11 5 (46%) Hamilton 51 9 (18%) \ -No Suitable Recipient (N=4) Size (N=1) No Suitable Recipient (N=4) Medically Unsuitable (N=4) Resources (N=1) 4 year mean # 60.7 86.8 76.8 60.5 39.0 9.8 7.2 cPRA and Virtual Cross Match 35 Trillium Gift of Life Network cPRA of Kidney and Kidney/Pancreas Patients on the Wait List and Txped 100% 90% 22% 255 8% 25 6% 20 7% 80% % of Patients 70% 60% 6% 68 12% 134 50% 13% 146 40% 8% 96 30% 15% 176 0% 7% 24 8% 26 7% 24 23% 268 8% 91 13% 148 13% 148 13% 53 58% 16% 179 14% 154 9% 29 30% 324 12% 10% 34 17% 59 21% 84 14% 57 26% 107 13% 51 12% 131 18% 196 5% 59 50 11% 44 ≥95 18% 81-94 51-80 74 21-50 12% 22% 145 74 12% 136 29% 341 7% 87 9% 97 14% 152 9% 104 191 20% 10% 22 26% 293 8% 32 5% 21 15% 50 1-20 0 19% 13% 154 79 11% 133 15% Unknown 63 26% 87 2% 25% 298 7 2% 24 24% 98 1% 6 2012 Wait List 2011/12 Tx 2013 Wait List 2012/13 Tx 2014 Wait List 2013/14 Tx 2015 Wait List 2014/15 Tx Pre-Transplant Crossmatch Results for Kidney Only Patients February 12th to February 11th, 2015 Pre-Transplant Crossmatches for Kidney Recipients Total Number of donors that pre-transplant crossmatches were performed Number of unique donor-recipient crossmatches performed Negative (T-Cell) Negative (B-Cell) Positive T-Cell HLA-Ab Non-HLA Ab (includes 1 unknown with no clinical significance) Auto Unknown Positive B-Cell HLA-Ab Non-HLA Ab (includes 2 unknown with no clinical significance) Auto 3 37 7 n (%) 267 656 638 (97%) 642 (98%) 18 0 10 6 2 14 0 14 0 Allocation Points for Kidney Only Transplant Patients by ABO, Site ABO A AB B O 3 38 8 N Mean SD Median Min-Max N Mean SD Median Min-Max N Mean SD Median Min-Max N Mean SD Median Min-Max HSC KGH 7 4 3.1 8.8 2.8 4.4 3.3 7.2 0 - 8.1 4.8 - 15.1 1 2 2.3 9.6 0 4.9 2.3 6.2 2.3 - 2.3 6.2 - 13.1 3 0 2.4 0 1.9 0 1.7 0 1.1 - 4.6 0-0 6 5 3.9 7.1 1.9 5.1 3.9 6.7 0.3 - 5.9 2.5 - 15.7 LHSC 31 5.5 4.1 5.4 0 - 20.1 2 14.7 20.8 0 0 - 29.4 8 4.8 3.2 3.6 2 - 11.5 17 7 4.1 5.6 2.5 - 16.9 SJHH 39 6.9 3.7 6.2 1.2 - 16.1 6 3.7 1.4 3.4 2.3 - 6.2 6 11.4 8.3 10.3 2.7 - 25.2 21 7.3 3.8 6.9 0 - 18.6 SMH 31 7.1 5.6 4.6 0.3 - 26.8 5 7.5 1.7 7.1 5.8 - 10.4 20 11.3 3.4 11.4 4.3 - 16.1 24 11.1 2.1 10.6 7.7 - 15.2 TGH 45 5.9 3.4 5.3 0 - 17.8 9 4.7 2.5 5.2 1.6 - 9.9 15 10.5 4.7 10.2 4.9 - 19.2 20 10.5 2.6 10.9 6.2 - 14.6 TOH 24 8 7.4 4.1 0 - 30.3 5 6.9 4.6 4.6 3.5 - 14.5 4 9.9 8.3 6.5 2.8 - 21.9 19 8.9 4.1 8.2 0 - 16.7 ALL 181 6.5 4.7 5.3 0 - 30.3 30 6.3 5.5 5.2 0 - 29.4 56 9.6 5.4 9.8 1.1 - 25.2 112 8.7 3.9 8.6 0 - 18.6 Kidney Only Transplant Wait Times by ABO Median 8000 Mean 7000 Number of Days 6000 5000 4000 3000 2000 1000 0 A AB B O Total Count Mean 181 30 56 112 379 1557.8 1377.6 2387.3 1999.6 1796.7 SD 1256.8 1379.8 1494.3 1031.3 1286.1 Median 1247.0 1028.0 2295.0 1949.0 1467.0 Min-Max 3 - 9093 177 - 7631 58 - 6372 1 - 4409 1 - 9093 Ontario Blood group donors/Recipients 50 45 40 35 % 30 DONORS 25 RECIPIENTS 20 SMH RECIPIENTS 15 10 5 0 A B AB O Some help for blood group B recipients • 10% of blood group A donors are A2 (lower antigen expression) • Can Use A2 donors safely for B recipients when antiA titres are1:8 or less • Programs will identify B recipients with Anti-A Ab of 1:8 or less • These B recipients now prioritized to receive A2 donor kidneys Summary 1) 2) 3) 4) 5) Virtual Cross match system is working well More sensitized recipients getting transplanted Previous models predicted flow of kidneys No “Risk’ to transplant program activity Equal access across regions may take 5 years to achieve 6) Access based on blood type is still an issue Acknowledgements THANKS TO: • Members of Kidney Pancreas working group of TGLN • Transplant hospitals and all supporting staff • Referral centers • ORN • MOHLTC Discussion
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