Innovation in Organ Donation. Darren Malinoski, MD, FACS Professor of Surgery Oregon Health & Science University

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1 Innovation in Organ Donation Darren Malinoski, MD, FACS Professor of Surgery Oregon Health & Science University

2 Disclosure Darren Malinoski, MD Grant funding: NIH Laura and John Arnold Foundation Outside relevant work: Honoraria / travel multiple Organ Procurement Organizations (OPOs)

3 Innovation in Organ Donation Improvement versus Innovation Tweaks versus Transformation? Science of Donor Management Donor Management Goals Mild Hypothermia RCT

4 BACKGROUND Need for greater quality and quantity of organs available for transplantation National average of three organs transplanted per donor (OTPD) Inconsistent donor management practices Lack of scientific foundation Paucity of RCTs Risk adjustment models lack robust donor critical care data

5 BACKGROUND Checklists have demonstrated utility in several arenas Standardized critical care endpoints Donor Management Goals (DMGs)

6 OTPD and DMGs: Current state in 2007

7 BACKGROUND UNOS Region 5 DMGs Initially utilizing published recommendations, clinical experience, and expert opinions, representatives from 8 OPOs created a DMG Bundle Meeting the bundle = achieving any 7 of the 9 DMGs Critical Care Endpoint DMG 1. Mean Arterial Pressure mmhg 2. Central Venous Pressure 4 12 mmhg 3. Ejection Fraction (EF) > 50% 4. Vasopressor use 1 and low dose 5. Arterial Blood Gas ph PaO2:FiO2 (P:F) > 300 on PEEP = 5 7. Serum Na < 155 meq/l 8. Blood Glucose < 180 mg/dl 9. Urine Output > 0.5 cc/kg/hr

8 DMGs Assessing the Impact Phase 1 Phase 2 Phase 3 Phase 4 (The Web Portal) Design Retrospective Prospective Prospective Prospective # of DMGs in Bundle Dates 2007 Time points collected 10 9 Modified 9 Modified 9 Prior to organ recovery (OR) July 2008 July 2010 At authorization hrs into case Prior to OR August 2010 February 2012 At referral At authorization hrs into case Prior to OR March Current At referral At start of case At initial allocation Prior to OR Number of donors 320 SCDs 914 DBDs 1684 donors >10,000 donors

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13 UNOS Region 5 DMG Web Portal Launched March 2012 supported by UBS Linked to UNet Forced field entry Generates reports Graft outcome data *Fields for study data - 16 OPOs from 7 UNOS Regions have joined and there are >10,000 donors as of February 2018

14 DMG Registry Web Portal Recent Enhancements: OPO EMR Import Utility Customizable, Interactive Reports OPO-specific identifiable donor summary report Aggregate de-identified Tableau report for comparing your own data to the rest of the country Ongoing Research Activity Stanford Donor Heart Study - PI Kiran Khush De-identified data set available to the public

15 DMG Registry Web Portal OPO Uses: Hospital development Real time clinical care Staff performance / case reviews Data reporting BHAG recruit enough OPOs to inform the SRTR OPO and Transplant Center O:E metrics in the PSRs

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19 Therapeutic Hypothermia in Deceased Organ Donors and Kidney Graft Function: A Randomized Controlled Trial From The UNOS Region 5 Donor Management Goals Workgroup DMG Web Portal and Collaborative Regional Workgroup served as foundational elements of HRSA grant Dr. Niemann and CTDN prior RCTs Expanded to 2 OPOs in California Randomized to C vs C DSMB stopped early for efficacy after ~50% of enrollment target met

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22 Communication and Vetting Process in the Absence of National Guidance Full IRB Review at UCSF 2 determinations OPO Research Oversight Bodies OPO Organ-specific committees Select Donor Hospitals UNOS Region 5 Business Meeting / Research Cmte Donor Families research authorization required National UNOS communication and public comment DonorNet Donor Highlights *DSMB donor physiology and graft outcome data tracked using the DMG Web Portal

23 The Transformation Continues Letters to the editor ClinicalTrials.Gov Role of Machine Perfusion* HRSA and the Alliance Donor Management Research Consensus Conference Donor Intervention Research Expert Panel Public Citizen complaint National Academy of Sciences (IOM)

24 Donor Management Research Initiative (DMRI) Laura and John Arnold Foundation Funding To produce new evidence-based standards of care by expanding a national, web-based donor management portal and conducting rigorous randomized controlled trials to test donor interventions that maximize the quantity and quality of life-saving organs each donor is able to give.

25 Donor Management Research Initiative (DMRI) Pragmatic Multi-site Randomized Controlled Trial of Hypothermia and Machine Perfusion

26 Acknowledgements Donors, families, OPOs Claus Niemann, MD Mitch Sally, MD Kiran Khush, MD Research residents/fellows Madhukar Patel Allen Kong Matthew Bloom Shariq Raza Dodie De La Cruz JR Zatarain Tahnee Groat Megan Crutchfield Sam Underwood Joie Eckert UNOS Chrystal Oley, Chris Marsh, Alex Garza HRSA / Division of Transplantation Laura and John Arnold Foundation