1. Breathing Lung- What can it do for lung numbers? Region 7 Education Meeting 2/13/14 Dr. Gail Frankle DHN, RN, CPTC Sr. Director Transplant Services, University of Minnesota Health Linette Meyer, RN, BSN, CPTC Manager of Organ Preservation Services, LifeSource

2. To Many Lungs Un-transplanted University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center. High PGD In First Year Post Transplant

3. University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center. Normothermic preservation Normal temperature, breathing, circulating Addresses PGD Addresses utilization

4. XVIVO lung perfusion University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.

5. Organ Care System University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.

6. Collaboration sets the stage OPO & transplant center relationships Engaged leadership Commitment to common visions and goals Envisioning and Problem solving

7. Implementation Plan Agility, Thoughtfulness, Comprehensive Approach University of Minnesota Health Communication Transmedics Leadership Advisement LifeSource Process Development – Transportation – Staff training and readiness – Donor Hospital Processes

8. Transportation Dry Run Engagement of University of Minnesota Health – Leadership – Physicians LifeSource Team Transportation Vendors – Towncars – Ambulance – Aircraft – Jet vs. Charter

9. Equipment and Preparation Increased Perfadex Requirements Machine prime Machine flush PRBC’s brought from MNUM No pressure bags in administration Addition of NTG to 1 st liter

10. OR Dynamics Seamless process at donor hospital BD versus DCD variables Donor Evaluation Room Dynamics: Power source! Back table instrumentation

11. Monitoring and Trial Data Serial ABG’s Availability of hard copy documentation Learning Curve

12. Lung placement on device Backtable Flush and preparation Possible patch graft preparation Increased time in OR for lung teams Packaging and Labeling Dynamics Required Tissue Typing /chart

13. Experiential Learning

14. First Case Experience 11.07.2013 Device arrival in Minnesota 11.11.2013 Transportation Dry Run 11.13.13 First Donation Case Experience

15. Functionality For Preservation, Recruitment & TransportFor Assessment of Lung Function

16. Clinical trials University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.

17. UM experience - Inspire University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center. 21 patients 11 Ice 10 OCS

18. UM experience University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.

19. UM experience University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.

20. More than preservation – ex vivo assessment University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.

21. UM experience - Expand University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center. 3 successful transplants – 100% survival – 100% freedom from PGD 3 3 procurements not meeting criteria

22. Lung Over the years University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.

23. Finances University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center. OCS costs billed as part the Organ Acquisition Cost Center Commercial Payors Trx Agreement CMS DRG & Cost Report Reimbursement $ Transplant Center CMS Trx. Patient OCS™ Lung CMS Trx. Patient OCS™ Lung OCS Charged at $45K/Procedure on Cost Report (OACC) CMS CMS Reimburses $45K OCS Cost PLUS Indirect Cost (~20%)

24. Future directions in research – organ recovery Is the story finished? University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center. Donation after cardiac death Recovery of marginal lungs

25. Continued Growth Education and training Local and import cases Expansion into second protocol: INSPIREEXPAND Age: > 18 and < 65 years Bilateral lung Transplant PaO2 /FiO2 > 300 mmHg Randomizes to cold storage or OCS at acceptance Ages: 18 to 75 years Bilateral lung transplant One of the following: PaO2/FiO2 < 300 mmHg Ischemia time > 6 hours DCD Donor Age > 55 years old

26. Outcomes “This expands the outreach of where we can go, it is exciting to take more runs and be able to evaluate suitability. Our experience is that we are transplanting people quicker before they become debilitated and all of our recipients are doing so well” Dr. (Dorothy) Gail Frankle RN, DHA, CPTC Senior Director, Solid Organ Transplant Services UMMC-Solid Organ Transplantation “The OCS essentially gave us a chance to see how the lungs would do in the standard physiologic warm environment. Interesting since we would otherwise not know without OCS. ” Gabriel Loor, MDOCS Assistant Professor Division of Cardiothoracic Surgery University of Minnesota Heart Care

27. Dr. Gail Frankle DHN, RN, CPTC Sr. Director Transplant Services, University of Minnesota Health dfrankl1@fairview.org Linette Meyer, RN, BSN, CPTC Manager of Organ Preservation Services, LifeSource lmeyer@life-source.org