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 Healthdfrankl1@fairview.org

Linette Meyer, RN, BSN, CPTCManager of Organ Preservation Services,

LifeSourcelmeyer@life-source.org