improving organ utilization to increase access to kidney ... · fig 6.2 usrds 2018 adr ed. 11 ......

1

Sumit Mohan, MD, MPH, FASN Associate Professor of Medicine & Epidemiology Columbia University Irving Medical Center, New York

Improving organ utilization to increase access

to kidney transplantation

3

• In the event of my death, I agree to the donation of my organs.

Yes

No

• I would want an organ transplant to save my life.

Yes

No

Landry DW. Kidney Int. 2006 Mar;69(6):957-9.

4

ESRD Prevalence

[VALUE]

[VALUE]

[VALUE]

[VALUE]

0

100

200

300

400

500

600

700

800

1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014

Tho

usa

nd

s HemodialysisPeritoneal dialysisTransplantAll ESRD

USRDS ADR 2018

6

ESRD Medicare costs by modality

[VALUE]

[VALUE]

[VALUE]

0

10

20

30

40

50

60

70

80

90

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

PP

PY

Exp

end

itu

re ($

, in

th

ou

san

ds)

HemodialysisPeritoneal DialysisTransplantation

Average Medicare

USRDS ADR 2017 Table 9.8

7

Transplant is the preferred option All cause mortality among Medicare beneficiaries

0

100

200

300

400

8

5 year survival rates for ESRD by modality

35 36 38 40 [VALUE]

35 36 37 39 40 37 42 46 47 50 66 69 70 72 75

75 78 82 84

[VALUE]

0

20

40

60

80

100

2000 2002 2004 2006 2008

Dialysis Hemodialysis Peritoneal Dialysis Deceased Donor Transplant Living Donor Transplant2016 USRDS ADR Table 6.1

9

Healthy People 2020 Goals Increase transplantation within 3 years of starting dialysis to 20.1% for patients under 70

Increase pre-emptive transplantation for patients under 70

Fig 6.8 USRDS 2018 ADR

Unadjusted incidence of ESRD 2011 -

2015

10

Proportion of ESRD patients waitlisted

[VALUE]

[VALUE]

[VALUE]

12

13

14

15

16

17

18

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Fig 6.2 USRDS 2018 ADR

% d

ialy

sis

pa

tie

nts

wa

itlis

ted

11

Growth in the need… and the waitlist

[VALUE]

[VALUE]

[VALUE]

0

20

40

60

80

100

120

140

1995 1998 2001 2004 2007 2010 2013 2016

Tho

usa

nd

s

Waitlist Additions

Incidence of ESRD

USRDS 2016 ADR

UNOS Data Sept 2017

Number of patients NOT being waitlisted

13

??

Transplant

Waitlist

Evaluation

Referral

Education

End Stage Renal Disease

Transplant outcomes

No

Public

Data

available

500K

patients

~95K patients

Current focus of transplant center

metrics

14

Kidney Transplant trends

0

4

8

12

16

20

1998 2000 2002 2004 2006 2008 2010 2012 2014

Tho

usa

nd

s

Deceased donor

Living donor

Total

USRDS ADR 2018

Transplant Center Medicare

Conditions of Participation

Performance is evaluated based on estimates of outcomes for 1 year kidney and patient outcomes using models that have a c statistic for 0.6 – 0.7

15

Graft failure rates after kidney transplant

0%

4%

8%

12%

16%

1989 1991 1993 1995 1997 1999 2001 2003 2005 2007

16

Regulatory Criteria for Transplant center flag

• Uses Bayesian modeling

– There is more than a 75% probability that that program’s hazard ratio is greater than 1.20.

– There is more than a 10% probability that the program’s hazard ratio is greater than 2.5

• Need to meet either one of these criteria

1. The program experiences more than 3 events more than expected based on national experience (O-E > 3) 2. The program experiences more than 50% 85% more events than expected based on national experience

(O/E > 1.85) 3. The one-sided P value of the statistical hypothesis test that O = E is less than 0.05 (one-sided P < 0.05). • All criteria need to be met

MP

SC

CM

S SR

TR

• Published on SRTR’s public website

• Patient survival 1 year outcomes are designated as “statistically higher” or “statistically lower” compared to expected risk-adjusted outcomes

• Based on a 2-tailed t-test (two-sided P ≤ 0.05)

17

Schold J CJASN 2014, 9 (10) 1773-1780

Transplant

center tiers

18

Kidney Donor Profile Index (KDPI)

• Cumulative percentage score

• Measure of expected outcome

• Derived from estimates of the relative risk of allograft failure in an adult recipient.

• Scaled using kidneys procured in the preceding calendar year

1. Age

2. Height

3. Weight

4. Ethnicity

5. Serum creatinine

6. Hypertension

7. Diabetes

8. HCV status

9. Cause of death

10. Donation after circulatory death

The Kidney Donor Risk Index (KDRI) is an estimate of the relative risk of post-transplant kidney graft

failure (in an average, adult recipient) from a particular deceased donor compared to the median (50th

percentile) donor

19

KD

PI 1

, 97

%

KD

PI 1

, 95

%

KD

PI 1

, 91

%

KD

PI 1

, 83

%

KD

PI 1

0, 9

7%

KD

PI 1

0, 9

0%

KD

PI 1

0, 9

0%

KD

PI 1

0, 8

3%

KD

PI 5

0, 9

5%

KD

PI 5

0, 9

0%

KD

PI 5

0, 8

7%

KD

PI 5

0, 8

1%

KD

PI 9

0, 8

8%

KD

PI 9

0, 8

2%

KD

PI 9

0, 7

6%

KD

PI 9

0, 6

4%

KD

PI 9

9, 8

3%

KD

PI 9

9, 7

6%

KD

PI 9

9, 7

2%

KD

PI 9

9, 6

1%

[VALUE]

66%

57%

[VALUE]

40%

60%

80%

100%

1 year 2 years 3 years 5 years

KDPI 1

KDPI 10

KDPI 50

KDPI 90

KDPI 99

Hemodialysis

https://www.usrds.org/2017/view/v2_05.aspx

Comparing Graft survival rates with dialysis survival rates

Donor reference population: All deceased kidney donors recovered for transplant in 2016.

Based on OPTN data including primary, adult, deceased donor, kidney alone transplants, as

of April 20, 2018.

Regulatory Threshold

20

12

06

11

32

11

18

11

82

15

02

16

48

17

08

19

66

18

70

21

04

19

86

19

14

19

38

19

06

20

50

23

12

32

0

32

7

29

8

35

2 4

25

41

5

49

6 5

21

56

5 5

08

52

4

58

4

61

1

62

5

64

2 6

60

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

0

500

1000

1500

2000

2500

3000

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Pro

po

rtio

n o

f K

idn

ey D

isca

rds

(%)

Kid

ney

Dis

card

s (N

)

Year

UnilateralBilateral% Discarded

The number of discards is increasing – and continues to do so after the introduction of the new allocation system

Mohan S et al. Kidney Int. 2018

Discard data calculated using data from 2000 through 2015

21

Discard rate by UNOS Region

23.3

21.5 20.7

20.0 19.8 18.5 18.2 18.2 18.0

16.3

13.3

10

15

20

25

2 7 10 11 5 3 4 9 1 8 6

% k

idn

eys

dis

card

ed

UNOS Region

King et al. 2019 In review

22

Policy changes and the discard rate

?

20%

Stewart et al. Transplantation 2017

23


24

Range of organ quality transplanted and discarded


25

Excellent quality kidneys from deceased donors are frequently being discarded


Better Worse

Most common reasons cited for discard are donor characteristics and biopsy findings

Discard data calculated using data from 2000 through 2015

26

Survival advantage of a high KDPI kidney

Massie et al. Am J Transplant 2014

27

Survival benefits of marginal kidneys

Ojo et al. JASN 2001

Marginal Donor 1 or more of: • Donor age >55 yr • Donor HTN >10 yr • Donor DM > 10 yr • DCD • Cold ischemia >36 hrs

28

Prevalence of Diabetes in the US is rising rapidly

6.9

7.4

7.5

7.9

7.9

8.7

9.3

10

.4

11

11

.9

12

.8

13

.5

14

.2

15

.1

16

.1

16

.9

17

.7

18

.65

20

.49

20

.97

20

.6

21

.2

22

.2

21

.9

23

.2

0

5

10

15

20

25

1991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015

Ad

ult

s w

ith

Dia

be

tes

(mill

ion

s)

https://gis.cdc.gov/grasp/diabetes/DiabetesAtlas.html

29

Diabetic donor kidney utilization is poor

49

82

11

5

14

1

16

2

17

0

20

3

20

5

22

0

26

4

32

8

44

6

48

8

56

4

[VA

LUE]

12

4

16

4

24

7

21

6

28

0

28

3

28

9

31

2

38

1

48

6

40

0

53

4

71

1

69

1

[VA

LUE]

0

100

200

300

400

500

600

700

800

1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Transplanted

Discarded

Mohan et al. Am J Transplant 2013

30

Reversal of diabetic nephropathy with extended normoglycemia

Fioretto et al. N Engl J Med 1998

31

Excellent outcomes with kidneys from diabetic donors

Mohan S et al. Am J Transplant 2012

32


33

Reperfusion biopsies are predictive of post transplant outcomes

Mohan et al. JASN 2017

34

Overnight pathology evaluation of procurement biopsies are non-discriminatory

Azancot et al. Kidney Int 2014

35

Husain et al. CJASN 2018

Procurement biopsies are error prone and should not be used to evaluate organ quality

36

Unilateral discards occur across the spectrum of organ quality despite excellent outcomes from the partner kidney from the same donor

Better Worse

Discard data calculated using data from 2000 through 2015 Husain et al CJASN 2018

37

Excellent outcomes with unilateral kidney transplants

Husain et al CJASN 2018

38

[VALUE]

16.3% 16.9% 17.4% 18.8% 18.4% 16.2% 1

1.09

1.13

[VALUE]

[VALUE]

1.25

[VALUE]

1.05 1.04

[VALUE]

1.19 1.18

[VALUE]

1

1.1

1.2

1.3

Monday Tuesday Wednesday Thursday Friday Saturday Sunday

10%

12%

14%

16%

18%

20%

Od

ds

of

dis

card

Day of Procurement

Perc

enta

ge d

isca

rded

Percentage discarded

OR of discard

aOR of discard

Mohan et al. Kidney Int. 2016

Kidneys procured over the weekend are more likely to be discarded

Higher quality kidneys discarded on the weekend Discard data calculated using data from 2000 through 2013

39

Kidneys are harder to place on the weekends

King et al. CJASN 2019

40

Not everyone performs transplants on the weekend…


41

Odds of discard of kidneys is highest in UNOS regions with the lowest transplant rates

Mohan et al. Transplantation. 2014 Mohan et al. Kidney Int. 2018

0.031 – 0.055

0.056 – 0.071

0.072 – 0.089

0.090 – 0.133

Annualized Transplant Rates Adjusted Odds of Discard

Better

Worse Odds of discard calculated using data from 2000 through 2015 Annualized transplantation rates calculated from 2000 through 2010

42

Odds of discard of kidneys is highest in UNOS regions with the highest ESRD incidence


Adjusted Odds of Discard

Better

Worse Odds of discard calculated using data from 2000 through 2015 Annualized transplantation rates calculated from 2000 through 2010

Unadjusted incidence of ESRD 2011 -

2015

43

Patients prioritize waitlist over posttransplant outcomes for selecting a center

11% 9%

15%

11%

15%

40%

15% 16%

12% 14%

18%

26%

0%

10%

20%

30%

40%

Patient Experience PracticalConsiderations

Transplant CenterExperience

Transplant CenterReputation

Transplant CenterOutcomes

Time on the Waitlist

Pe

rcen

t

CKD patients

Transplant recipients

Husain SA et al. Am J Transplant. 2018 Only published national survey identifying patient centered criteria on selecting a transplant center Over 500 respondents for survey conducted in 2017

44

Education resources used by patients to understand transplant

10%

15%

21% 23% 24%

29%

48%

0%

10%

20%

30%

40%

50%

SRTR Other Social Worker None NKF UNOS Nephrologist

Husain et al. Am J Transplant 2018 website website

45

Dialysis staff awareness of the kidney allocation system

84%

73%

53%

47%

39%

0%

20%

40%

60%

80%

100%

Medical Directors Social Workers FacilityAdministrators

Nurse Managers Other Staff

Patzer et al. Am J Nephrol. 2018

53%

46

Increasing number of deceased patients remain on the waitlist and continue to receive offers underscoring communication failures with patients and dialysis centers

627 740 767 778

14%

16% 17%

[VALUE]

0%

4%

8%

12%

16%

20%

0

200

400

600

800

1000

2012 2013 2014 2015

% k

idn

eys

off

ered

to

a d

ece

ase

d p

atie

nt

Dec

eas

ed

Can

did

ate

s re

ceiv

ing

off

ers

Number of deceased candidates offered at least one kidney

% of kidneys that were offered to at least one deceased candidate

Median of 4 post-death offers (range 1‐385, IQR 2‐12). Most (60.4%) offers to deceased candidates occurred >1 month after candidate death

Mohan et al. Am J Transplant. 2018

47

Thank you

50

Volatility in 5 tier ratings for transplant centers

Schold et al. Am J Transplant 2018

improving organ utilization to increase access to kidney ... · fig 6.2 usrds 2018 adr ed. 11 ......

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