Committee on Issues in Organ Donor Intervention Research. Presented by: Richard D. Hasz Vice President, Clinical Services

Transcription

1 Committee on Issues in Organ Donor Intervention Research Presented by: Richard D. Hasz Vice President, Clinical Services

2 Living Organ Donors 5,527 U.S. National Trends in Organ Donation Living vs. Deceased Organ Donors 2016 * * Deceased Organ Donors 9,884 12,000 10,000 8,000 6,000 4,000 2,000 9,079 8,017 8,085 8,596 7,989 8,022 8,126 8,143 6,622 6,631 7,150 7,593 8,268 7,943 6,828 6,895 6,731 5,985 6,561 7,004 6,023 4,569 5,048 6,315 6,218 6,609 5,867 5,989 5,4795,793 5,824 5,990 5,363 5,418 6,080 6,190 6,457 5,819 3,804 4,067 5,957 5,527 3,496 9,884 Waiting List Deaths 2,036 0 Living Donors Deceased Donors Source: Based on OPTN data as projected through Count based upon candidates.

3 NUMBER OF DECEASED DONORS U.S. Experience Deceased Organ Donors By Donor Type SCD ECD DCD 10,000 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1, Source: Based on OPTN data through December 31, YEAR

4 U.S. Deceased Organ Donors By Cause of Death CVA Only ,000 3,500 3,336 3,355 3,308 3,206 3,178 3,049 3,000 2,612 2,631 2,635 2,767 3,127 2,932 2,833 2,761 2,782 2,671 2,500 2,000 1,500 1, Source: Based on OPTN data as through December 31, 2015.

5 U.S. Deceased Organ Donors By Cause of Death Trauma Only ,500 3,000 2,500 2,520 2,545 2,610 2,617 2,794 2,908 3,058 3,026 2,793 2,670 2,720 2,685 2,628 2,681 2,646 2,709 2,000 1,500 1, Source: Based on OPTN data through December 31, 2015.

6 U.S. Deceased Organ Donors By Cause of Death Anoxia Only ,000 3,500 3,429 3,000 2,500 2,278 2,436 2,599 2,900 2,000 1,500 1, ,024 1,147 1,348 1,489 1,732 1,893 1, Source: Based on OPTN data through December 31, 2015.

7 Organ Donors by Cause of Death Trend GLDP /08 3/08 5/08 7/08 9/08 11/08 1/09 3/09 5/09 7/09 9/09 11/09 1/10 3/10 5/10 7/10 9/10 11/10 1/11 3/11 5/11 7/11 9/11 11/11 1/12 3/12 5/12 7/12 9/12 11/12 1/13 3/13 5/13 7/13 9/13 11/13 1/14 3/14 5/14 7/14 9/14 11/14 1/15 3/15 5/15 7/15 9/15 11/15 1/16 3/16 5/16 7/16 # Organ Donors (Previous 12 Months) Month / Year Anoxia Cerebrovascular/Stroke Head Trauma Other Causes of Death Excluded

8 1/08 3/08 5/08 7/08 9/08 11/08 1/09 3/09 5/09 7/09 9/09 11/09 1/10 3/10 5/10 7/10 9/10 11/10 1/11 3/11 5/11 7/11 9/11 11/11 1/12 3/12 5/12 7/12 9/12 11/12 1/13 3/13 5/13 7/13 9/13 11/13 1/14 3/14 5/14 7/14 9/14 11/14 1/15 3/15 5/15 7/15 9/15 11/15 1/16 3/16 5/16 7/16 Organ Donors - Cardiovascular Deaths (Previous 12 Months) GLDP Anoxic Organ Donors w/ Cardiovascular Mechanism of Death Trend Month / Year

9 1/08 3/08 5/08 7/08 9/08 11/08 1/09 3/09 5/09 7/09 9/09 11/09 1/10 3/10 5/10 7/10 9/10 11/10 1/11 3/11 5/11 7/11 9/11 11/11 1/12 3/12 5/12 7/12 9/12 11/12 1/13 3/13 5/13 7/13 9/13 11/13 1/14 3/14 5/14 7/14 9/14 11/14 1/15 3/15 5/15 7/15 9/15 11/15 1/16 3/16 5/16 7/16 Organ Donors Drug Overdose Deaths (Previous 12 Months) GLDP Anoxic Organ Donors w/drug Overdose 120 Mechanism of Death Trend Month / Year

10 Deceased Donor Kidneys Recovered in the U.S. 1/1/ /31/2016 3,500 3,000 2,500 2,000 1,500 1, ,627 1,578 1,500 1,668 2,084 2,211 2,368 Discarded 2,630 2,608 2,763 2,641 2,646 2,763 2,734 2,888 3,157 3, Discarded

11 58 OPO Donation Service Areas in the U.S. 321 million people 9,080 Deceased Donors (2015) 5,988 Living Donors (2015) 30,973 Transplants (2015) OPO Data Population Bases from 1.3 Million to 19.8 Million Deceased Donors Recovered ranged from 40 to 483 Donors Donors per million (DPM) ranged from 17.0 to 44.0; U.S. Average 29.4

12 Organ Procurement Organization Interpretive Guidance (a) (d) May 23, (a)- While an OPO may have more than 1 board, the OPO must have an advisory board that has both the authority described in paragraph (b) of this section and the following membership: (a)1-Members who represent hospital administrators, either intensive care or emergency room personnel, tissue banks, and voluntary health associations in the OPO s DSA (a)2- Individuals who represent the public residing in the OPO s DSA (a)3- A physician with knowledge, experience, or skill in the field of human histocompatibility or an individual with a doctorate degree in biological science and with knowledge, experience or skills in the field of human histocompatibility (a)4-A neurosurgeon or other physician with knowledge or skills in the neurosciences (a)5- A transplant surgeon representing each transplant hospital in the service area with which to OPO has arrangements to coordinate its activities. The transplant surgeon must have practicing privileges and perform transplants in the transplant hospital represented (a)6- An organ donor family member

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14 OPOs PUBLIC TRUST Donor Hospitals Transplant Centers

15 YEAR U.S. Organ Donor Experience DBD & DCD Donors (projected through year end 2016) Total Deceased Organ Donors = 119,542 BD (n=106,137) DCDs (n=13,405) ,187 6,000 6,757 7,062 7,036 7,069 7,002 7,102 7,140 7, ,304 7,294 7, ,195 7,585 (6,457) (6,190) 1,206 1,107 1, , ,494 (8,143) (8,126) (7,943) (8,022) (7,989) (8,085) 642 (8,017) (7,593) 564 (7,150) (9,884) 1,689 (9,079) (8,596) (8,268) 0 2,000 4,000 6,000 8,000 10,000 NUMBER OF ORGAN DONORS

16 Transplant recipients may be participating in clinical studies designed to improve transplant outcomes. If the gifts cannot be used for transplantation or therapy, I authorize their use for research and/or education purposes. Yes No Management of the donor may include research measures designed to study ways of improving organ transplant outcomes.

17 GTEx Pilot Project Participants Three biospecimen source sites to collect tissues; GLDP, LifeNet of Virginia, Drexel University College of Medicine. A laboratory data analysis center A coordinating center, led by the National Cancer Institute's Cancer Human Biobank (cahub) Specimens shipped to cahub A portion of each sent to the laboratory, data analysis center, and coordinating center for molecular analysis.

18 Ideal Process for Organ Donation Education (General Public / Healthcare Professionals) Detection/Declaration of Death/Referral to OPO Donor Evaluation by OPO Coordinator Family Approach/Consent Clinical Donor Management Matching/Allocation Surgical Recovery/Preservation/T ransportation Transplantation Case Follow-Up

19 The care of the potential donor is essentially the simultaneous care of multiple recipients. Source: Wood et al. Care of the Potential Organ Donor. N Engl J Med 2004; 351:

20 Aggressive Care Plan From the moment brain death is declared, the emphasis shifts from saving the patient s life, to maintaining the family s option to donate by optimizing end-organ function for possible transplantation. Acid Base Abnormalities Oliguria Oxygenation Excessive Urinary Output Hypothermia Impaired Gas Exchange Hypotension DIC Electrolyte Imbalances Hormonal Changes

21 Observed Organs Transplanted per 100 Donors U.S. SRTR Adjusted OPO OTPD Model 325 1/1/ /31/2015 OTPD Significantly Higher Than Expected OTPD as Expected OTPD Significantly Lower Than Expected Source: SRTR Expected Organs Transplanted per 100 Donors

22 Organ Allocation Pre-Recovery Intra-Operative Post-Recovery

23 OPO Begins Organ Offer Process OPO sends an electronic notification to a selected range of potential recipients. The primary contact for each transplant center will receive a voice and text notification. OPO sends out electronic notifications on the match results page. Prominent display of donor blood type. The candidate with the primary offer is highlighted.

24 1/08 3/08 5/08 7/08 9/08 11/08 1/09 3/09 5/09 7/09 9/09 11/09 1/10 3/10 5/10 7/10 9/10 11/10 1/11 3/11 5/11 7/11 9/11 11/11 1/12 3/12 5/12 7/12 9/12 11/12 1/13 3/13 5/13 7/13 9/13 11/13 1/14 3/14 5/14 7/14 9/14 11/14 1/15 3/15 5/15 7/15 9/15 11/15 1/16 3/16 5/16 7/16 # High Risk Organ Donors / # Organ Donors (Previous 12 Months) 40% 35% 30% 25% 20% 15% 10% 5% 0% % High Risk Organ Donor Trend GLDP Rolling 12 month avg Month / Year

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26 Summary Donor Pool and Utilization Challenge Require DIR to increase transplants Guidance for Donor Hospital Policies Central Oversight to Assist Researchers & OPOs Organ Allocation Dynamics