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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, CPTCManager of Organ Preservation Services, LifeSource
To Many Lungs Un-transplanted
University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.
Utilized20%
An-nually Waste
d80%
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 Normal temperature, breathing,
circulatingAddresses PGDAddresses utilization
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 PlanAgility, Thoughtfulness, Comprehensive Approach
• University of Minnesota Health Communication• Transmedics Leadership Advisement• LifeSource Process Development– Transportation– Staff training and readiness– Donor Hospital Processes
Transportation Dry Run• Engagement of University of Minnesota Health– Leadership– Physicians
• LifeSource Team• Transportation Vendors– Towncars– Ambulance– Aircraft – Jet vs. Charter
Equipment and Preparation
Increased Perfadex RequirementsMachine primeMachine flush
PRBC’s brought from MNUMNo pressure bags in administrationAddition of NTG to 1st liter
OR Dynamics
Seamless process at donor hospitalBD versus DCD variablesDonor EvaluationRoom Dynamics: Power source!Back table instrumentation
Monitoring and Trial DataSerial ABG’sAvailability of hard copy documentationLearning Curve
Lung placement on device
Backtable Flush and preparationPossible patch graft preparationIncreased time in OR for lung teams Packaging and Labeling DynamicsRequired Tissue Typing /chart
Experiential Learning
First Case Experience• 11.07.2013 Device arrival in Minnesota• 11.11.2013 Transportation Dry Run• 11.13.13 First Donation Case Experience
Functionality
For Preservation, Recruitment & Transport For Assessment of Lung Function
Clinical trials
University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.
INSPIRE International Trial
• Standard Donor Lungs• Randomized 1:1 OCS to SOC
EXPAND International Trial
• Expanded Criteria & DCD• Single Arm with OPG
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
UM experience
University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.
ICE OCS0
20406080
100120
Freedom from PGD 3
UM experience
University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.
ICE OCS0
20406080
100
Mortality within 3 months
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
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
Lung Over the years
2007 2008 2009 2010 2011 2012 2013 2014 20150
10
20
30
40
50
60
3127
2024 22
29
40
52
5
University of Minnesota Health brand represents a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.
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
OCS Charged at $45K/Procedure on Cost
Report (OACC)
CMSCMS Reimburses $45K OCS Cost PLUS Indirect
Cost (~20%)
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 deathRecovery of marginal lungs
Continued Growth• Education and training• Local and import cases• Expansion into second protocol:
INSPIRE EXPAND
• 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
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 ServicesUMMC-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 SurgeryUniversity of Minnesota Heart Care
Dr. Gail Frankle DHN, RN, CPTC Sr. Director Transplant Services, University of
Minnesota [email protected]
Linette Meyer, RN, BSN, CPTCManager of Organ Preservation Services,
