Breathing Lung What can it do for lung

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, Life. Source

To Many Lungs Un-transplanted Utilized 20% Annually Wasted 80% High PGD In First Year Post Transplant University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.

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

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

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

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

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

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

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

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

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

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

Experiential Learning

First Case Experience • 11. 07. 2013 Device arrival in Minnesota • 11. 2013 Transportation Dry Run • 11. 13 First Donation Case Experience

Functionality For Preservation, Recruitment & Transport For Assessment of Lung Function

Clinical trials INSPIRE International Trial • Standard Donor Lungs • Randomized 1: 1 OCS to SOC EXPAND International Trial • Expanded Criteria & DCD • Single Arm with OPG University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.

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

UM experience Freedom from PGD 3 120 100 80 60 40 20 0 ICE University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center. OCS

UM experience Mortality within 3 months 100 80 60 40 20 0 ICE University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center. OCS

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.

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

Lung Over the years 60 52 50 40 40 30 31 29 27 20 20 24 22 10 0 5 2007 2008 2009 2010 2011 University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center. 2012 2013 2014 2015

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

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

Continued Growth • Education and training • Local and import cases • Expansion into second protocol: INSPIRE • Age: > 18 and < 65 years • Bilateral lung Transplant • Pa. O 2 /Fi. O 2 > 300 mm. Hg EXPAND • Ages: 18 to 75 years • Bilateral lung transplant • One of the following: • Pa. O 2/Fi. O 2 < 300 mm. Hg • Randomizes to cold storage or OCS • Ischemia time > 6 hours at acceptance • DCD • Donor Age > 55 years old

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, MD Assistant Professor Division of Cardiothoracic Surgery University of Minnesota Heart Care

Dr. Gail Frankle DHN, RN, CPTC Sr. Director Transplant Services, University of Minnesota Health dfrankl 1@fairview. org Linette Meyer, RN, BSN, CPTC Manager of Organ Preservation Services, Life. Source lmeyer@life-source. org