# Presentation: 901516

## Modifications to Heart Allocation Policy

- Implemented July 12, 2006
- Changed the allocation order for medically urgent (Status 1A and 1B) patients
- Policy Change:

- Local  Status 1A
- Local Status 1B
- Local Status 2
- Zone A Status 1A
- Zone A Status 1B
- Zone A Status 2
- Zone B Status 1A
- Zone B Status 1B
- Etc.

- 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.

## Background

- Goals of the Policy:
- Reduce waiting list mortality for urgent patients by increasing priority of urgent Status 1A and 1B candidates
- This presentation will review changes during the first 12 months following the policy implementation

## Composition of Heart Waiting List by Medical Urgency7/5/2006 – 9/19/2007

- Based on OPTN data as of  September 21, 2007

**Notes:**

There appears to be a small decline in the size of the total waiting list from approximately 2900 to 2650 candidates.  The number of active candidates is essentially the same, approximately 1300.

## Number of Active Heart Candidates on the Waiting List by Week and Region7/5/2006 – 9/19/2007

- Based on OPTN data as of  September 21, 2007

**Notes:**
There haven’t been many changes in active waiting list candidates within each region since the policy was implemented.

## Heart Transplants by recipient age group7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007

- Based on OPTN data as of  September 21, 2007

**Notes:**
The total number of transplants performed during the two eras is nearly identical – 2224 in the pre-policy period, and 2205 in the post-policy period.  When looking at the distribution of the number of transplants by age groups across the time periods there are not any major changes seen since the policy was implemented.

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007

- Based on OPTN data as of  September 21, 2007

**Notes:**
During the post-policy period, there have been more Status 1A and Status 1B transplants; and fewer Status 2 transplants – just as expected.

## Heart Transplants by Geographic Location7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007

- Based on OPTN data as of  September 21, 2007

**Notes:**
Also as expected, there has been a shift to more Zone A transplants and fewer local transplants since the policy was implemented.

## Heart Transplants by Geographic Location and Medical Urgency Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007

- Based on OPTN data as of  September 21, 2007

**Notes:**
We can examine the changes between status and location a little more closely in this slide.  The bars are divided into 3 groups.  The first represents Status 1A; the second Status 1B; and the third in Status 2.  All of the percentages in the three “post” bars add up to 100% and represent the percentage of transplants in the post-policy era, same for the the “Pre” bars – the combined 3 bars add up to 100%.  Pink represents local; blue Zone A; and yellow all other locations.  The biggest changes are observed in the Status 1A  - an increase in the percentage of Zone A transplants from the pre to post eras (15.5% to 24.3%), and a decrease in the percentage of Status 2 local transplants from the pre to post eras (17.4% to 7.9%).  There was not much change in the other categories.

## Heart Transplants by Region7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007

- Based on OPTN data as of  September 21, 2007

**Notes:**
There have been some changes in the numbers and percentages of transplants performed by region between the two eras, with increases ranging from approximately 22% and decreases ranging down to almost 22%.  But since these results reflect a relatively short time period, these may be chance occurrences or may be reflective of changing distributions of status in these regions.

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 1

- Based on OPTN data as of  September  21, 2007

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 2

- Based on OPTN data as of  September  21, 2007

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 3

- Based on OPTN data as of  September  21, 2007

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 4

- Based on OPTN data as of  September  21, 2007

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 5

- Based on OPTN data as of  September  21, 2007

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 6

- Based on OPTN data as of  September  21, 2007

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 7

- Based on OPTN data as of  September  21, 2007

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 8

- Based on OPTN data as of  September  21, 2007

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 9

- Based on OPTN data as of  September 21, 2007

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 10

- Based on OPTN data as of  September  21, 2007

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 11

- Based on OPTN data as of  September  21, 2007

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 1

- Based on OPTN data as of  September 21, 2007

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 2

- Based on OPTN data as of  September 21, 2007

- 10

- 44

- 36

- 57

- 48

- 18

- 79

- 58

- 124

- 120

**NJTO**

**PADV**

**PATF**

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 3

- Based on OPTN data as of  September 21, 2007

- 27

- 20

- 30

- 28

- 26

- 26

- 69

- 67

-  57

-  49

**FLMP**

**FLUF**

**FLWC**

**GALL**

**LAOP**

**MSOP**

**PRLL**

- 45

- 46

- 22

- 17

-  4

-  6

- 13

- 12

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 4

- Based on OPTN data as of  September 21, 2007

- 23

- 32

- 77

- 77

- 25

- 15

- 86

- 83

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 5

- Based on OPTN data as of  September 21, 2007

- 53

-  1

- 92

- 93

-  4

- 53

- 175

- 162

- 16

- 13

- 40

- 28

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 6

- Based on OPTN data as of  September 21, 2007

-  1

- 31

-  22

-  23

-  1

- 41

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 7

- Based on OPTN data as of  September 21, 2007

- 77

- 39

- 65

- 63

- 40

- 90

- 18

- 19

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 8

- Based on OPTN data as of  September 21, 2007

- 30

- 50

-  6

-  9

- 59

- 33

- 14

- 19

- 40

- 47

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 9

- Based on OPTN data as of  September 21, 2007

-  10

- 147

-  17

-  11

-  3

- 126

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 10

- Based on OPTN data as of  September 21, 2007

- 32

- 75

- 71

-  35

- 64

- 38

- 14

- 19

- 20

- 22

## Heart Transplants by Status7/12/2005-7/11/2006 vs. 7/12/2006-7/11/2007Region 11

- Based on OPTN data as of  September 21, 2007

- 26

- 19

- 20

- 23

- 62

- 22

- 20

-  54

- 34

- 26

- 13

-  13

- 57

- 37

## Preliminary Results for Death Per 100 Years on the Waiting List: All Statuses Combined11/12/2005-7/11/2006 vs. 7/12/2006-3/11/2007

- Based on OPTN data as of  July 6, 2007

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

**Notes:**
Preliminary results for death rates per 100 patient-years on the waiting list are shown for all candidates on this slide.  Extreme caution should be used in making conclusions when comparing results between eras or between statuses due to possible differences in patient populations.   But, these results do seem to indicate a decrease in waiting list mortality for all age groups.

To account for any lag in reporting or underreporting for mortality, the OPTN data were supplemented with the Social Security Death Master File (SSDMF.)  If the death occurred after removal but within 7 days, the time period between removal and death was assumed to have been spent in the same status as the patient was in at the time of removal.

Because patients may enter Status 7 for a variety of reasons (including “too well” to “too sick”), the time and deaths in Status 7 were stratified by the status immediately prior to Status 7.

If a patient had multiple registrations on a particular day, the most urgent status was used in calculating the death rates.  

## Preliminary Results for Death Per 100 Years on the Waiting List: All Ages Combined11/12/2005-7/11/2006 vs. 7/12/2006-3/11/2007

- Based on OPTN data as of  July 6, 2007

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

**Notes:**
Preliminary results for death rates per 100 patient-years on the waiting list are shown for all candidates on this slide.  Extreme caution should be used in making conclusions when comparing results between eras or between statuses due to possible differences in patient populations.   But, these results do seem to indicate a decrease in waiting list mortality for all Status groups.

To account for any lag in reporting or underreporting for mortality, the OPTN data were supplemented with the Social Security Death Master File (SSDMF.)  If the death occurred after removal but within 7 days, the time period between removal and death was assumed to have been spent in the same status as the patient was in at the time of removal.

Because patients may enter Status 7 for a variety of reasons (including “too well” to “too sick”), the time and deaths in Status 7 were stratified by the status immediately prior to Status 7.

If a patient had multiple registrations on a particular day, the most urgent status was used in calculating the death rates.  

## Summary

- Small decline in size of total waiting list candidates
- No change in the number of heart transplants comparing pre- and post-policy periods
- Substantial change in distribution of transplants by location and status
- More Status 1A and Status 1B transplants and fewer Status 2 transplants
- Fewer local transplants and more Zone A transplants
- Preliminary data suggest a decrease in waiting list mortality rates
- Thoracic Committee and Heart Allocation Task Force monitoring impact of policy changes.

## Modifications to Kidney Allocation Policy – Pediatric Priority for Donors < 35 years

- Implemented on September 28, 2005
- Priority for allocation of kidneys from donors less than 35 years to pediatric candidates listed prior to age 18 locally, regionally, then nationally.

## Background

- Goal to get “good” kidneys to children quickly with minimal impact on adult candidates
- This presentation will review results of the first 18 months following policy implementation

## Deceased Donor Kidney TransplantsBy Donor Age and Recipient Age3/28/04 – 9/27/05 vs. 9/28/05 – 3/27/07 

**Age 11-17**

**Notes:**
This slide shows donor and recipient age distributions for deceased donor kidney transplants performed during the pre- (3/28/04-9/27/05) and post-policy (9/28/05-3/27/05) periods:
The number and percentage of pediatric recipients from deceased donors under age 35 increased in all age categories. The number and percentage increased from 67 (80%) to 104 (98%) for the 0–5 year age group, 80 (83%) to 128 (96%) for the 6-10 year age group, and 288 (74%) to 601 (98%) for the 11-17 year age group. Only 18 children received a transplant from a donor > 35 since the policy was implemented, compared to 138 during the pre-policy period.  
The percentage of adult transplants from donors less than age 35 showed a slight decrease from 42% to 38%. 

## Deceased Donor Kidney Transplants, 3/28/04 – 3/27/07By Time Period, Donor Age and Recipient Age 

**Age 0-5**

**Age 18+**

**Age 11-17**

**Age 6-10**

**Notes:**
This slide shows donor and recipient age distributions for deceased donor kidney transplants performed during the pre- (3/28/04-9/27/05) and post-policy (9/28/05-3/27/05) periods:
The number and percentage of pediatric recipients from deceased donors under age 35 increased in all age categories. The number and percentage increased from 67 (80%) to 104 (98%) for the 0–5 year age group, 80 (83%) to 128 (96%) for the 6-10 year age group, and 288 (74%) to 601 (98%) for the 11-17 year age group. Only 18 children received a transplant from a donor > 35 since the policy was implemented, compared to 138 during the pre-policy period.  
The percentage of adult transplants from donors less than age 35 showed a slight decrease from 42% to 38%. 

## Kidney Transplants, 3/28/04 – 3/27/07By Period, Donor Type and Recipient Age 

**Age 0-5**

**Age 18+**

**Age 11-17**

**Age 6-10**

**Notes:**
 This slide shows transplants by donor type, recipient age, and time period:
After the policy implementation, the number and percentage of deceased donor transplants in every pediatric age category increased, whereas the number and percentage of living donor transplants have decreased

## Waiting List Removals during 3/28/04 – 3/27/06By Time Period and Age at Listing 

**Age 0-17**

**Age 18+**

**Notes:**
This slide shows the distribution of removals from the waiting list by age group and time period.
During the pre-policy period, 58% of removals for pediatric candidates were due to deceased donor transplant, and this percentage increased to 71% after the policy implementation.  
During the same time period, the percentage of pediatric candidates removed for living donor transplant decreased from 28% to17%.

## Percent Transplanted Within 12 MonthsWL Additions during 9/28/04 – 8/27/06By Policy Period and Age at Listing 

**Notes:**
This looks at the percentage of candidates transplanted within 12 months after listing for the one year prior and following the policy implementation.  Overall, for children, the percentage transplanted within 12 months has increased from 42.8% to 51.9%.  When looking by age group, most of that change has come from the 11-17 age group which has increased from 39.5% to 53.7%.  There has been a small increase in the percent transplanted among 6-10 year old candidates, but it appears that it is still difficult to transplant the very youngest candidates.  There has been no change for adults.

## Kidney Transplants, 3/28/04 – 3/27/07By Period, DR HLA MM Level and Recipient Age 

**Age 0-17**

**Age 18+**

**Notes:**
The percentage of transplants in pediatrics with 0-1 HLA-DR mismatches also decreased, while the percent with 2 HLA-DR mismatches increased.

## Pediatric Kidney Waiting List Candidates at Month End for Jan 2005 – May 2007 

**Notes:**
This slide shows the number and percentage of registrations on the waiting list at the end of each month from January 31, 2005 through May 31, 2007.  

The number of active pediatric registrations has decreased from by 28% from 589 on September 30, 2005 to 427 on May 31, 2007; whereas the number of inactive registrations has increased by 48% from 227 to 337.

## Pediatric Additions during the Month and Active Pediatric Candidates Waiting at Month End, Jan 2005 – May 2007 

**Notes:**
No of active candidates on the ki WL decrease while additions to the ki WL remains almost stable.

## Kaplan-Meier Graft Survival by Policy PeriodPediatric Recipients of DD Kidney Transplantsduring 9/28/04-9/27/06 

**P-value = 0.21**

**Notes:**
This slide shows the Kaplan-Meier graft survival rates within 12 month of transplants for transplants performed during 12 months before and 12 months after the policy implementation. Despite the higher percentage of transplants with higher HLA mismatch level after the policy was implemented, the graft  survival rates did not seem to be adversely affected. 

## Kaplan-Meier Patient Survival by Policy PeriodPediatric Recipients of DD Kidney Transplantsduring 9/28/04-9/27/06 

**P-value = 0.76**

**Notes:**
This slide shows the Kaplan-Meier patient survival rates within 12 month of transplants for transplants performed during 12 months before and 12 months after the policy implementation. Despite the higher percentage of transplants with higher HLA mismatch level after the policy was implemented, the patient survival rates did not seem to be adversely affected. 

## Summary

- Preliminary results show that the number and percentage of pediatric kidney transplants from deceased donors less than age 35 has increased since the policy change, and fewer pediatric candidates are waiting for a transplant.
- Deceased donor transplantation appears to be occurring more rapidly among pediatric recipients.
- The number of living donor pediatric kidney transplants appears to have decreased, and this will be closely monitored.

## Summary

- The number and percent of less well HLA matched transplants increased after the policy implementation.
- Graft and patient survival for transplants performed during the 12 months before the policy and 12 months after the policy implementation were not significantly different.
- Pediatric and Kidney Committees monitoring impact of the policy change.