OPTN

HEART ALLOCATION SYSTEMDATA UPDATE

Based on OPTN data as of July 16, 2010Based on OPTN data as of July 16, 2010

Fall 2010 Regional Meetings

OPTN

Heart Allocation Policy Modified on July 12, 2006

Allocation for adult donors:• Local Status 1A• Local Status 1B• Zone A Status 1A• Zone A Status 1B• Local Status 2• Zone B Status 1A• Zone B Status 1B• Zone A Status 2• Etc.

Allocation for pediatric donors*:• Local + Zone A Status 1A ped. cand.• Local Status 1A adult cand. • Local + Zone A Status 1B ped. cand.• Local Status 1B adult cand.• Zone A Status 1A adult cand.• Zone A Status 1B adult cand.• Local Status 2 ped. cand.• Local Status 2 adult cand.• Zone B Status 1A ped. cand.• Zone B Status 1A adult cand.• Zone B Status 1B ped. cand.• Zone B Status 1B adult cand.• Zone A Status 2 ped. cand.• Zone A Status 2 adult cand.• Etc.

* Modifications to Policy 3.7 for pediatric donors were implemented on May 6, 2009.

OPTN

HEART CANDIDATE STATUS DISTRIBUTION

0

500

1000

1500

2000

2500

3000

35007/

5/20

06

9/5/

2006

11/5

/200

6

1/5/

2007

3/5/

2007

5/5/

2007

7/5/

2007

9/5/

2007

11/5

/200

7

1/5/

2008

3/5/

2008

5/5/

2008

7/5/

2008

9/5/

2008

11/5

/200

8

1/5/

2009

3/5/

2009

5/5/

2009

7/5/

2009

9/5/

2009

11/5

/200

9

1/5/

2010

3/5/

2010

5/5/

2010

7/5/

2010

Snapshot date

Nu

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Status 1A Status 1B Status 2 Status 7

•On 7/12/06 there were 2896 candidates (1307 active)•On 7/14/10 there were 3146 candidates (2099 active)

OPTN

DEATHS PER 100 PATIENT-YEARS ON THE WAITING LIST: Stratified by Age Group

Combining Active Statuses with Corresponding Status 7 Groups

Candidate Age Group

Status

Waiting era: 7/12/03-7/11/06 Waiting era: 7/12/06-1/11/10

# patients

ever waiting

# of deaths

*

Patient years (PY) at

risk

Deaths/

100 PY

# patients ever

waiting

# of deaths*

Patient years (PY)

at risk

Deaths/

100 PY

Adult

1A 3307 355 294.1 120.7 5011 375 577.7 64.9

1B 4574 440 1231.6 35.7 6707 429 2015.4 21.3

2 6430 475 7044.5 6.7 6146 386 5833.3 6.6

ALL COMBINED

10201 1306 8713.7 15.0 11780 1235 8550.3 14.4

Pediatric

1A 1088 209 171.1 122.2 1521 213 282.2 75.5

1B 397 17 118.5 14.3 506 16 162.2 9.9

2 553 31 459.7 6.7 521 14 463.5 3.0

ALL COMBINED

1603 258 811.1 31.8 2001 244 954.3 25.6

NOTE: Caution should be used in drawing conclusions based on death rates due to differences in patient populations.

* Deaths include those reported to the OPTN or to SSDMF while on waiting list or within 7 days of non-transplant removal.

OPTN

TRANSPLANTS BY ERA AND STATUS: BY AGE GROUP

1,901 1,885 1,817 1,793 1,931

323 321 331 371368

0

500

1000

1500

2000

2500

7/12/05-7/11/06 7/12/06-7/11/07 7/12/07-7/11/08 7/12/08-7/11/09 7/12/09-7/11/10

Nu

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pla

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Transplant date

Adults Pediatrics

2224 2206 2148 21652299

OPTN

TRANSPLANTS BY ERA AND STATUS: ALL AGES COMBINED

40 47 53 56 59

3538

36 36 33

2515 11 8 8

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

7/12/05-7/11/06 7/12/06-7/11/07 7/12/07-7/11/08 7/12/08-7/11/09 7/12/09-5/11/10 (Partial Year)

Pe

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f he

art

tra

ns

pla

nts

Transplant date

Status 1A Status 1B Status 2

OPTN

TRANSPLANTS BY ERA AND STATUS: ADULTS ONLY

35 42 47 50 54

3941

41 41 38

2616 12 9 8

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

7/12/05-7/11/06 7/12/06-7/11/07 7/12/07-7/11/08 7/12/08-7/11/09 7/12/09-5/11/10 (Partial Year)

Pe

rce

nt o

f he

art

tra

ns

pla

nts

Transplant date

Status 1A Status 1B Status 2

OPTN

TRANSPLANTS BY ERA AND STATUS: PEDIATRICS ONLY

71 75 82 84 85

1216

11 10 717 10 7 6 7

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

7/12/05-7/11/06 7/12/06-7/11/07 7/12/07-7/11/08 7/12/08-7/11/09 7/12/09-5/11/10 (Partial Year)

Pe

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Transplant date

Status 1A Status 1B Status 2

OPTN

HEART TRANSPLANTS PERFORMED BY REGIONBetween 7/12/03-5/11/06 and 7/12/06-5/11/10

050

100150200250300350400450500550600650700750800850900950

100010501100

1 2 3 4 5 6 7 8 9 10 11

Region

Nu

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Era 1 Era 2

OPTN

PERCENTAGE OF STATUS 2 HEART TRANSPLANTS PERFORMED AT EACH CENTER

0

10

20

30

40

50

60

70

80

90

100

0 10 20 30 40 50 60 70 80 90 100

% Status 2 Transplants in DSA: 7/12/03-5/11/06

% S

tatu

s 2

Tra

nsp

lan

ts i

n D

SA

:

7/12

/07-

5/11

/10

Higher % of Status 2 transplants in current era than in prior era

Lower % of Status 2 transplants in current era than in prior era

r2 = 0.19

OPTN

TRANSPLANTS BY ERA AND ZONE: ADULTS VS. PEDIATRICS

6452 52 57 57

30 23 25 18 20

3142 42 37 37

41 52 52 61 61

5 6 6 6 5

24 20 20 18 183 3 2 3 1

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

7/12/05-7/11/06

7/12/06-7/11/07

7/12/07-7/11/08

7/12/08-7/11/09

7/12/09-5/11/10 (Partial

Year)

7/12/05-7/11/06

7/12/06-7/11/07

7/12/07-7/11/08

7/12/08-7/11/09

7/12/09-5/11/10 (Partial

Year)

Per

cen

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f h

eart

tra

nsp

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ts

Zone D

Zone C

Zone B

Zone A

Local

Adults Pediatrics

OPTN

SURVIVAL WITHIN 2 YEARS:Adult recipients: All statuses combined

80

85

90

95

100

0 60 120 180 240 300 360 420 480 540 600 660 720

Time (days)

Su

rviv

al (

%)

Pre-Policy: 7/12/04-5/11/06 (N=3272) Post-Policy: 7/12/06-5/11/08 (N=3375)

p = 0.90

NOTE: Scale of survival axis has been expanded.

OPTN

SURVIVAL WITHIN 2 YEARS:Pediatric recipients: All statuses combined

75

80

85

90

95

100

0 60 120 180 240 300 360 420 480 540 600 660 720

Time (days)

Su

rviv

al (

%)

Pre-Policy: 7/12/04-5/11/06 (N=559) Post-Policy: 7/12/06-5/11/08 (N=583)

p = 0.17

NOTE: Scale of survival axis has been expanded.

OPTN

SUMMARY – WAITING LIST There has been an increase in the

number of active waiting list registrations and urgent waiting list registrations

Waiting list mortality in Status 1A and Status 1B appears to have decreased

OPTN

SUMMARY – TRANSPLANT

The number of transplants has remained essentially flat over the past 3 years.

The distribution of status at transplant has changed: ↑ Status 1A and ↓ Status 2.

There is no significant change in post-transplant survival within 2 years for adults or pediatrics, overall or by status at transplant.

OPTN

LUNG ALLOCATION SCORE SYSTEMDATA UPDATE

Fall 2010 Regional Meetings

Based on OPTN data as of July 23, 2010Based on OPTN data as of July 23, 2010

OPTN

LUNG ALLOCATION SCORE STATUSFor All Registrations

0

500

1000

1500

2000

2500

3000

3500

40005/

4/05

(N

=38

65)

7/13

/200

5 (N=

3708

)

9/21

/200

5 (N=

3542

)

11/3

0/20

05

(N=34

18)

2/8/

2006

(N

=329

3)

4/19

/200

6 (N=

3241

)

6/28

/200

6 (N=

3135

)

9/6/

2006

(N

=308

5)

11/1

5/20

06

(N=30

44)

1/24

/200

7 (N=

3014

)

4/4/

2007

(N

=296

1)

6/13

/200

7 (N=

2876

)

8/22

/200

7 (N=

2549

)

10/3

1/20

07

(N=24

38)

1/9/

2008

(N

=233

8)

3/19

/200

8 (N=

2254

)

5/28

/200

8 (N=

2225

)

8/6/

2008

(N

=222

7)

10/1

5/20

08

(N=22

39)

12/2

4/20

08

(N=21

41)

3/4/

2009

(N

=209

3)

5/13

/200

9 (N=

2054

)

7/22

/200

9 (N=

1999

)

9/30

/200

9 (N=

1990

)

12/9

/200

9 (N=

1958

)

2/17

/201

0 (N=

1963

)

4/28

/201

0 (N=

1951

)

7/7/

2010

(N

=186

2)

<12 Years Old Inactive, 12+ Years LAS = 0 LAS > 0L

un

g a

nd

Hea

rt-L

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egis

trat

ion

s

NOTE: As of November 2, 2005, candidates with a zero LAS have been screened from match runs.

N=3865

N=1865

OPTN

ACTIVE LUNG AND HEART-LUNG REGISTRATIONS (12+) WITH NON-ZERO SCORE

On July 23, 2010, by Region and Age Group (1)

1 6 3 3 7 1 2 1 2 210 728 24 19

514 12

421

7

29

133

182

115

161

41

106

48

30

188

71

0

20

40

60

80

100

120

140

160

180

200

220

1 (N=40) 2 (N=146) 3 (N=213) 4 (N=142) 5 (N=187) 6 (N=47) 7 (N=122) 8 (N=61) 9 (N=34) 10 (N=211) 11 (N=80)

Region

12-17 Years 18-34 Years 35+ Years

Nu

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Reg

istr

atio

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OPTN

ACTIVE LUNG AND HEART-LUNG REGISTRATIONS (12+) WITH NON-ZERO SCORE

On July 23, 2010, by Region and Age Group (2)

1 6 3 3 7 1 2 1 2 210 728 24 19

514 12

421

71

27

37

1940

6

30

11

7

28

1123

75

93

71

68

25

65

29

17

129

575

31

52

25

53

10

11

8

6

31

3

0

20

40

60

80

100

120

140

160

180

200

220

1 (N=40) 2 (N=146) 3 (N=213) 4 (N=142) 5 (N=187) 6 (N=47) 7 (N=122) 8 (N=61) 9 (N=34) 10 (N=211) 11 (N=80)

Region

12-17 Years 18-34 Years 35-49 Years 50-64 Years 65+ Years

Nu

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Reg

istr

atio

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OPTN

CALCULATED LAS AT TIME OF LISTING FOR LUNG AND HEART-LUNG REGISTRATIONS (12+)

Excluding 0 LAS

4 4 3 2 2

5245

4237 37

22

2324

25 26

1416 20

22 19

35 5 5 6

5 7 8 9 11

0

20

40

60

80

100

5/4/05-5/3/06 5/4/06-5/3/07 5/4/07-5/3/08 5/4/08-5/3/09 5/4/09-5/3/10

Listing Date

20-<30 30-<35 35-<40 40-<50 50-<60 60+

% o

f L

un

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nd

Hea

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un

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Reg

istr

atio

ns

OPTN

DEATHS PER 100 PATIENT YEARS: LU candidates ever waiting (12+ years at time of listing)

Diagnosis grouping

Ever listed: 5/4/00-11/3/04 (pre-LAS) Ever listed: 5/4/05-11/3/09 (post-LAS)

Patients ever

waiting during

era

Deaths in

period

Patient-years in status (PY)

Death/ 100 PY

Patients ever

waiting during

era

Deaths in

period

Patient-years in status (PY)

Death/ 100 PY

A 5099 701 7408.5 9.5 4219 309 4760.8 6.5

B 1108 251 2353.0 10.7 881 142 1465.1 9.7

C 1626 368 2351.6 15.6 1481 205 1569.9 13.1

D 3360 894 3946.5 22.7 4858 697 3159.3 22.1

ALL 11123 2239 16118 13.9 11307 1353 10956 12.3

NOTE: Caution should be used in drawing conclusions based on death rates due to differences in patient populations and the small number of deaths in some groups.

* Deaths include those reported to the OPTN or to SSDMF while on waiting list or < 7 days of non-transplant removal

OPTN

TRANSPLANTS

OPTN

DECEASED DONOR LUNG AND HEART-LUNG TRANSPLANTS: 5/4/04-5/3/10

1259

1484 14491511

1574

1694

0

200

400

600

800

1000

1200

1400

1600

1800

5/4/04-5/3/05 5/4/05-5/3/06 5/4/06-5/3/07 5/4/07-5/3/08 5/4/08-5/3/09 5/4/09-5/3/10

Era

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OPTN

DECEASED DONOR LUNG AND HEART-LUNG TRANSPLANTS: 5/4/04-5/3/10

By Diagnosis Grouping

52

37 34 35 32 30

14

1515 13

13 12

2843 47 48 51 52

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

5/4/2004-5/3/2005(N=1259)

5/4/2005-5/3/2006(N=1484)

5/4/2006-5/3/2007(N=1449)

5/4/2007-5/3/2008(N=1511)

5/4/2008-5/3/2009(N=1574)

5/4/2009-5/3/2010(N=1694)

% o

f T

ran

sp

lan

ts

A B C D

OPTN

DISTRIBUTION OF LAS AT TRANSPLANT BY REGION: 5/4/2005-5/3/2010

31 27 30 29 33 29 3432

35

1929 34

25 33 22 2728

22

2826

28

21

24 23

2423

2422

2125

2025

20

28

24 25

20 1624 22 17 22

16 17 16

3121 18

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

AL

L (

N=

76

96

)

1 (

N=

19

7)

2 (

N=

13

47

)

3 (

N=

86

1)

4 (

N=

71

9)

5 (

N=

11

17

)

6 (

N=

24

4)

7 (

N=

71

2)

8 (

N=

55

7)

9 (

N=

29

2)

10

(N

=8

59

)

11

(N

=7

91

)

20-<30 30-<35 35-<40 40-<50 50+LAS:

REGION

OPTN

POST-TRANSPLANT SURVIVAL WITHIN 2 YEARSWITHOUT CONFIDENCE LIMITS

For Recipients 12+ Years

50

55

60

65

70

75

80

85

90

95

100

0 60 120 180 240 300 360 420 480 540 600 660 720

Days

Su

rviv

al

(%)

Pre-LAS: 5/4/04-5/3/05 (N=1189)Post-LAS Era 1: 5/4/05-5/3/06 (N=1415)Post-LAS Era 2: 5/4/06-5/3/07 (N=1389)Post-LAS Era 3: 5/4/07-5/3/08 (N=1467)

At 730 days the survival rate for the pre-LAS era was 73.8% and for the three post-LAS eras was 74.7%, 72.2% and 72.8%.

p = 0.49

OPTN

SUMMARY – WAITING LIST The total number of WL candidates is substantially

lower than prior to the implementation of LAS.

The number of active candidates 12+ years has increased during the most recent two years.

The distribution of LAS at listing has shifted towards higher scores in the years since implementation

The waiting list mortality is lower overall in the post-policy era compared to the pre-policy era. This same pattern was seen within all diagnosis groups.

OPTN

SUMMARY – TRANSPLANT The percentage of lungs transplanted has increased

from pre- to post-LAS. There was a huge increase in the number of

transplants from pre-LAS to post-LAS. There was also a large increase in transplants during the most recent complete year.

There has been a substantial shift in the distribution of diagnosis from pre-LAS (>50% group A) to post-LAS (>50% group D).

Post-transplant survival is comparable pre- and post-LAS, overall and by diagnosis grouping.