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Lung Allocation Score


Marcelo Cypel, MD MSc
Assistant Professor of Surgery
Staff Surgeon
Division of Thoracic
University of Toronto
University Health Network
Marcelo.cypel@uhn.ca
Outline


• Principles and Rationale of UNOS LAS

• How it is calculated and who benefits the most

• Overview of lung allocation systems
LAS rationale

“ Waiting in line for medical services is common practice but
  when life is at stake, triage is a generally accepted way to
  apportion medical care”

“Surgery for a ruptured aneurysm “bumps” an electively
 scheduled operation. Indeed, a heart transplant bumps an
 elective coronary bypass. But who should get the heart?
1) The patient who has waited the longest time?
2) Or the one who cannot wait any longer?
3) What if the patient is so sick that recovery from surgery is
   unlikely or compromised?
4) What if one patient is more likely to survive than another?”


                              Egan, chest 2005
Pre-LAS system (seniority list system)


• Excessive wait list mortality

• Pulmonary fibrosis and cystic fibrosis (CF),
  compared with COPD

• Transplant benefit questionable as patients
  able to wait longer were the ones receiving
  organs
LAS principles



•To allocate lungs solely on the basis of risk of
death without a transplant would lead to large
numbers of lung transplants being performed in
critically ill individuals who would proceed to die
despite receiving a transplant”

•The LAS is calculated for each patient as a
function of waitlist survival probability without a
transplant and the transplant benefit”.
LAS principle




 Chest,2005 128:407–415
Variable for Calculation of LAS


• FEV1
• Systolic PA
• Supplemental O2
• Age
• Body Mass Index
• Insulin-Dependent DM
• NYHA
• 6 min-walk distance
• Ventilator use
• Creatinine
• PCWP
• PcO2
• Diagnosis
Higher LAS for IPF and CF




  COPD     PAH          CF             IPF

     Yussen, AJT 2010; 10, 1047-1068
Median Time on Wait List




    Yussen, AJT 2010; 10, 1047-1068
LAS = Decreased wait list mortality




           Yussen, AJT 2010; 10, 1047-1068
% Recipients in ICU pre-Tx




      Yussen, AJT 2010; 10, 1047-1068
Impact on LAS on number of transplants for
        different recipient diagnosis




            Yussen, AJT 2010; 10, 1047-1068
1 year survival after LTx




   Yussen, AJT 2010; 10, 1047-1068
Wait list and post-Tx mortality




           Yussen, AJT 2010; 10, 1047-1068
14
Conclusion I

• The number of active waiting list patients; the
  waiting times for LTx; and the death rate on wait
  list have decreased.

• One year survival did not change pre and post-
  LAS era.

• Long term outcomes have still to be determined

• Refinement of predictive model is ongoing :
  addition of bilirubin, and ECMO as variables
In search of the ideal allocation system

     • Equity – fair, impartial

     • Justice – based on societal values

     • Beneficence – patients experience more benefit
       than harm

     • Utility – maximize the value to society/transplant
       recipients as a group

     • Transparent


      Egan, Am J Transplant 2003; 3: 366--372
16
Themes underpinning attributes for community
               preferences for organ allocation




Community Preferences for the Allocation of Solid Organs for Transplantation:
A Systematic Review.
                                                                                6
Tong, Allison et el; Transplantation 2010; 89(7):796-805
Before allocation – the listing decision!

     • Similar process around the world

     • ISHLT guidelines are just that – actual
       practice varies

     • Expected post-transplant outcomes may
       heavily influence listing decisions

     • Program tolerance for risk – affected by
       many variables, not explicit


18
Novalung
  Pumpless Mode – Femoral Artery to
Femoral Vein (extra-corporeal ventilation)
Factors that may implicitly affect listing
  decisions

• Size of program – ability to dilute bad outcomes

• Program relationships with hospital, payers, regulatory
  authorities, referring physicians

• Resources available to manage complicated recipients

• Collective experience of the program – especially recent
  similar cases

• Who is at the candidacy review meeting

• Allocation system itself – patients unlikely to get transplant
  are not listed
Before listing – the referral decision!

     • Not all patients are equally likely to be referred

     • Geography – eg. in Canada – Telemedicine helps

     • Referring physician beliefs about transplant,
       willingness to assist with post-transplant care

     • Patient social support, finances, insurance coverage

     • Disadvantaged groups in every country




21
Types of allocation systems

     US LAS
        1. Geography
        2. Medical urgency
        3. Post-transplant survival

     “Rest of World”
        1. Geography- to a variable extent
        2. Clinical judgment includes urgency and
            outcomes; urgency predominates
        3. May incorporate values – restrict to residents,
            preference to organ donors (Israel)



22
Israeli allocation system




     Lavee et al, Lancet 2010;375:1131-33
23
How do allocation systems
stack up?                   US      Others

                            ++      + to +++

                            No      ?

                            No      +/-

                            Non-US +/-
                            restricted
                            ++      +/-

                            +       ++

                            +++     + to +++




                                               6
Comparing Allocation Systems

     US LAS                                 “Rest of world”
     • Pros                                 • Pros
         • Transparent                          • Allows for clinical judgment
         • Explicit balance of urgency          • May consider donor factors
            and utility                         • May consider quality of life
     • Cons                                 • Cons
         • Predictive value of LAS model        • Geographic restrictions may
           – is clinical judgment better?         limit utility
         • No consideration of donor            • Opaque “black box”
           factors                              • Considerations not explicit,
         • No consideration of quality of         may be subjective
           life
         • Geographic restrictions limit
           utility



25
Limitations of all lung allocation systems


     • Single vs. bilateral transplantation – balance
       between individual benefit and collective
       utility, policies and practices inconsistent

     • How to deal with quality of life?

     • Geographical issues not resolved




26
Towards an ideal allocation system - ideas


     • Start with improving access to referral and maximizing
       utilization of donor lungs

     • Improve consistency of listing process – how?

     • Use survival model scores as an aid to allocation rather
       than a means?

     • Model quality-adjusted survival benefit?

     • Document candidates considered and allocation criteria
       used for later review and audit?


27
Summary

• LAS has decreased wait list mortality without significant adverse
  impact on post transplant outcomes

• Differential access to donor lungs begins well before allocation

• No system is perfect

• All allocation systems involve tradeoffs

• Recognition of tradeoffs and biases is essential in developing
  improved systems which maximize benefit of donor lungs



28
Marcelo Cypel  - Canada - Tuesday 29 - Intrathoracic Transplantation New perspectives

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Marcelo Cypel - Canada - Tuesday 29 - Intrathoracic Transplantation New perspectives

  • 1. Lung Allocation Score Marcelo Cypel, MD MSc Assistant Professor of Surgery Staff Surgeon Division of Thoracic University of Toronto University Health Network Marcelo.cypel@uhn.ca
  • 2. Outline • Principles and Rationale of UNOS LAS • How it is calculated and who benefits the most • Overview of lung allocation systems
  • 3. LAS rationale “ Waiting in line for medical services is common practice but when life is at stake, triage is a generally accepted way to apportion medical care” “Surgery for a ruptured aneurysm “bumps” an electively scheduled operation. Indeed, a heart transplant bumps an elective coronary bypass. But who should get the heart? 1) The patient who has waited the longest time? 2) Or the one who cannot wait any longer? 3) What if the patient is so sick that recovery from surgery is unlikely or compromised? 4) What if one patient is more likely to survive than another?” Egan, chest 2005
  • 4. Pre-LAS system (seniority list system) • Excessive wait list mortality • Pulmonary fibrosis and cystic fibrosis (CF), compared with COPD • Transplant benefit questionable as patients able to wait longer were the ones receiving organs
  • 5. LAS principles •To allocate lungs solely on the basis of risk of death without a transplant would lead to large numbers of lung transplants being performed in critically ill individuals who would proceed to die despite receiving a transplant” •The LAS is calculated for each patient as a function of waitlist survival probability without a transplant and the transplant benefit”.
  • 6. LAS principle Chest,2005 128:407–415
  • 7. Variable for Calculation of LAS • FEV1 • Systolic PA • Supplemental O2 • Age • Body Mass Index • Insulin-Dependent DM • NYHA • 6 min-walk distance • Ventilator use • Creatinine • PCWP • PcO2 • Diagnosis
  • 8. Higher LAS for IPF and CF COPD PAH CF IPF Yussen, AJT 2010; 10, 1047-1068
  • 9. Median Time on Wait List Yussen, AJT 2010; 10, 1047-1068
  • 10. LAS = Decreased wait list mortality Yussen, AJT 2010; 10, 1047-1068
  • 11. % Recipients in ICU pre-Tx Yussen, AJT 2010; 10, 1047-1068
  • 12. Impact on LAS on number of transplants for different recipient diagnosis Yussen, AJT 2010; 10, 1047-1068
  • 13. 1 year survival after LTx Yussen, AJT 2010; 10, 1047-1068
  • 14. Wait list and post-Tx mortality Yussen, AJT 2010; 10, 1047-1068 14
  • 15. Conclusion I • The number of active waiting list patients; the waiting times for LTx; and the death rate on wait list have decreased. • One year survival did not change pre and post- LAS era. • Long term outcomes have still to be determined • Refinement of predictive model is ongoing : addition of bilirubin, and ECMO as variables
  • 16. In search of the ideal allocation system • Equity – fair, impartial • Justice – based on societal values • Beneficence – patients experience more benefit than harm • Utility – maximize the value to society/transplant recipients as a group • Transparent Egan, Am J Transplant 2003; 3: 366--372 16
  • 17. Themes underpinning attributes for community preferences for organ allocation Community Preferences for the Allocation of Solid Organs for Transplantation: A Systematic Review. 6 Tong, Allison et el; Transplantation 2010; 89(7):796-805
  • 18. Before allocation – the listing decision! • Similar process around the world • ISHLT guidelines are just that – actual practice varies • Expected post-transplant outcomes may heavily influence listing decisions • Program tolerance for risk – affected by many variables, not explicit 18
  • 19. Novalung Pumpless Mode – Femoral Artery to Femoral Vein (extra-corporeal ventilation)
  • 20. Factors that may implicitly affect listing decisions • Size of program – ability to dilute bad outcomes • Program relationships with hospital, payers, regulatory authorities, referring physicians • Resources available to manage complicated recipients • Collective experience of the program – especially recent similar cases • Who is at the candidacy review meeting • Allocation system itself – patients unlikely to get transplant are not listed
  • 21. Before listing – the referral decision! • Not all patients are equally likely to be referred • Geography – eg. in Canada – Telemedicine helps • Referring physician beliefs about transplant, willingness to assist with post-transplant care • Patient social support, finances, insurance coverage • Disadvantaged groups in every country 21
  • 22. Types of allocation systems US LAS 1. Geography 2. Medical urgency 3. Post-transplant survival “Rest of World” 1. Geography- to a variable extent 2. Clinical judgment includes urgency and outcomes; urgency predominates 3. May incorporate values – restrict to residents, preference to organ donors (Israel) 22
  • 23. Israeli allocation system Lavee et al, Lancet 2010;375:1131-33 23
  • 24. How do allocation systems stack up? US Others ++ + to +++ No ? No +/- Non-US +/- restricted ++ +/- + ++ +++ + to +++ 6
  • 25. Comparing Allocation Systems US LAS “Rest of world” • Pros • Pros • Transparent • Allows for clinical judgment • Explicit balance of urgency • May consider donor factors and utility • May consider quality of life • Cons • Cons • Predictive value of LAS model • Geographic restrictions may – is clinical judgment better? limit utility • No consideration of donor • Opaque “black box” factors • Considerations not explicit, • No consideration of quality of may be subjective life • Geographic restrictions limit utility 25
  • 26. Limitations of all lung allocation systems • Single vs. bilateral transplantation – balance between individual benefit and collective utility, policies and practices inconsistent • How to deal with quality of life? • Geographical issues not resolved 26
  • 27. Towards an ideal allocation system - ideas • Start with improving access to referral and maximizing utilization of donor lungs • Improve consistency of listing process – how? • Use survival model scores as an aid to allocation rather than a means? • Model quality-adjusted survival benefit? • Document candidates considered and allocation criteria used for later review and audit? 27
  • 28. Summary • LAS has decreased wait list mortality without significant adverse impact on post transplant outcomes • Differential access to donor lungs begins well before allocation • No system is perfect • All allocation systems involve tradeoffs • Recognition of tradeoffs and biases is essential in developing improved systems which maximize benefit of donor lungs 28