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					HEART TRANSPLANTATION

                      Pediatric Recipients




    ISHLT                                2011
J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                                                                           Number of Centers Reporting




                                                                           10
                                                                                20
                                                                                30
                                                                                40
                                                                                     50
                                                                                          60
                                                                                               70
                                                                                                    80
                                                                                                    90
                                                                                                         100
                                                                                                               110
                                                                                                                     120




                                                                       0
                                                                19
                                                                  8
                                                                19 2
                                                                  8
                                                                19 3
                                                                  8
                                                                19 4
                                                                  8
                                                                19 5
                                                                  8




                                                        ISHLT
                                                                19 6
                                                                  8
                                                                19 7
                                                                  8
                                                                19 8
                                                                  8
                                                                19 9
                                                                  9
                                                                19 0
                                                                  9
                                                                19 1
                                                                  9
                                                                19 2
                                                                  9
                                                                19 3
                                                                  9
                                                                19 4
                                                                  9




                                                        2011
                                                                19 5
                                                                  9
                                                                19 6




J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                                                                  9
                                                                19 7
                                                                  9
                                                                19 8
                                                                  9
                                                                20 9
                                                                  0
                                                                20 0
                                                                  0
                                                                20 1
                                                                  0
                                                                20 2
                                                                  0
                                                                20 3
                                                                  0
                                                                20 4
                                                                  0
                                                                20 5
                                                                  0
                                                                20 6
                                                                                                                           PEDIATRIC HEART TRANSPLANTS




                                                                  0
                                                                                                                           NUMBER OF CENTERS REPORTING




                                                                20 7
                                                                  0
                                                                20 8
                                                                  09
                                    NUMBER OF CENTERS REPORTING
                                    PEDIATRIC HEART TRANSPLANTS
                              120
                              110
Number of Centers Reporting




                                        Other
                              100       North America
                              90        Europe
                              80
                              70
                              60
                              50
                              40
                              30
                              20
                              10
                               0
                              19 2
                              19 3
                              19 4
                              19 5
                              19 6
                              19 7
                              19 8
                              19 9
                              19 0
                              19 1
                              19 2
                              19 3
                              19 4
                              19 5
                              19 6
                              19 7
                              19 8
                              20 9
                              20 0
                              20 1
                              20 2
                              20 3
                              20 4
                              20 5
                              20 6
                              20 7
                              20 8
                                09
                                8
                                8
                                8
                                8
                                8
                                8
                                8
                                8
                                9
                                9
                                9
                                9
                                9
                                9
                                9
                                9
                                9
                                9
                                0
                                0
                                0
                                0
                                0
                                0
                                0
                                0
                                0
                              19




                                     ISHLT                               2011
                                J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                    AVERAGE CENTER VOLUME AND PERCENTAGE
                       OF TRANSPLANTS BY CENTER VOLUME
      Pediatric Heart Transplants: January 1, 1997 - June 30, 2010
                    160                                                                                              56




                                                                                                                          Percentage of transplants
                    140                                                                                              49
Number of centers




                    120                                                                                              42

                    100                                                                                              35

                     80                                                                                              28
                                            145
                                  132
                     60                                                                                              21

                     40                                                                                              14

                     20                                                                                              7
                                                               19            16                         17
                     0                                                                          9                    0
                                      1-4/yr                        5-9/yr                       10-19/yr
                                        Average number of heart transplants per year
                      Number of centers 1997-2000                                 Number of centers 2001-June 2010
                      Percentage of transplants 1997-2000                         Percentage of transplants 2001-June 2010


                              ISHLT                                 2011
                          J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                          PEDIATRIC HEART TRANSPLANTS:
AVERAGE CENTER VOLUME DISTRIBUTION BY LOCATION
                              Transplants between January 2000 and June 2010

                                      1-4/year               5-9/year       10-19/year
                   100%
% of Transplants




                   80%


                   60%


                   40%


                   20%


                     0%
                                    Europe                  North America            Other



                       ISHLT                                2011
                   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                             DISTRIBUTION OF TRANSPLANTS
                                  BY CENTER VOLUME
Pediatric Heart Transplants: January 1, 1997 - June 30, 2010
                   50
                                                      1997-2000           2001-June 2010

                   40
% of transplants




                   30

                                                                                                          46.5
                   20
                             36.3
                                           31.5              29.5                          29.2
                   10                                                     22.0


                   0
                                    1-4                             5-9                           10-19
                                          Average number of heart transplants per year
                        ISHLT                                2011
                    J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
AGE DISTRIBUTION OF PEDIATRIC HEART
  RECIPIENTS (Transplants: January 1996 - June 2010)
                        1600
                        1500
                        1400
                        1300
Number of Transplants




                        1200
                        1100
                        1000
                         900
                         800
                         700
                         600
                         500
                         400
                         300
                         200
                         100
                           0
                               0    1     2    3    4    5    6    7    8    9   10 11   12   13 14   15   16   17
                                                             Recipient Age (Years)
                               ISHLT                              2011
                         J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                                  AGE DISTRIBUTION OF
                               PEDIATRIC HEART RECIPIENTS
                                                  By Year of Transplant
                        600
                        550            11-17 Years
                        500
Number of Transplants




                                       1-10 Years
                        450
                                       <1 Year
                        400
                        350
                        300
                        250
                        200
                        150
                        100
                         50
                          0
                        19 2
                        19 3
                        19 4
                        19 5
                        19 6
                        19 7
                        19 8
                        19 9
                        19 0
                        19 1
                        19 2
                        19 3
                        19 4
                        19 5
                        19 6
                        19 7
                        19 8
                        20 9
                        20 0
                        20 1
                        20 2
                        20 3
                        20 4
                        20 5
                        20 6
                        20 7
                        20 8
                          09
                          8
                          8
                          8
                          8
                          8
                          8
                          8
                          8
                          9
                          9
                          9
                          9
                          9
                          9
                          9
                          9
                          9
                          9
                          0
                          0
                          0
                          0
                          0
                          0
                          0
                          0
                          0
                        19




                                                                                 NOTE: This figure includes only the heart transplants that are
                                                                                 reported to the ISHLT Transplant Registry. As such, this should not
                                                                                 be construed as evidence that the number of hearts transplanted
                                                                                 worldwide has increased and/or decreased in recent years.
                              ISHLT                               2011
                         J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                          PEDIATRIC HEART TRANSPLANTS:
                                AGE DISTRIBUTION BY LOCATION
                              Transplants between January 2000 and June 2010

                                    <1 years            1-10 years         11-17 years
                   100%
% of Transplants




                   80%


                   60%


                   40%


                   20%


                    0%
                                   Europe                 North America            Other



                       ISHLT                                2011
                   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                           AGE DISTRIBUTION FOR DONORS OF
                             PEDIATRIC HEART RECIPIENTS
                                            (Transplants: January 1996 - June 2010)
                        1100
                        1000
                        900
Number of Transplants




                        800
                        700
                        600
                        500
                        400
                        300
                        200
                        100
                          0
                               0    1   2    3   4   5    6   7    8    9   10 11   12   13   14   15   16   17 18- 26- 31+
                                                                                                                25 30

                                                                  Donor Age (Years)

                                   ISHLT                            2011
                           J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                      PEDIATRIC HEART TRANSPLANTS:
                    DONOR AGE DISTRIBUTION BY LOCATION
                         Transplants between January 2000 and June 2010

                               <1        1-10         11-17           18-34   35-49           50-64
               100%


                80%
% of Donors




                60%


                40%


                20%


                 0%
                                Europe                  North America                 Other



                  ISHLT                                2011
              J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                             DISTRIBUTION OF TRANSPLANTS
                              by Donor/Recipient Weight Ratio
Pediatric Heart Transplants: January 1, 1995 - June 30, 2010
                   50
                   45                                                       1995-2002      2003-June 2010
                   40
                   35
% of transplants




                   30
                   25
                   20
                   15
                   10
                   5
                   0
                           <0.75        0.75-<1.0        1.0-<1.5       1.5-<2.0    2.0-<2.5      2.5+
                                                 Donor/Recipient Weight Ratio
                        ISHLT                                2011
                    J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
          DIAGNOSIS IN PEDIATRIC HEART
       TRANSPLANT RECIPIENTS (Age: < 1 Year)
                                                                                35%
                                                            Myopathy
             18%

                                                            Congenital
      1%                                                                   1%
                                                            Other          2%
      2%                                    79%
                                                            ReTX                                 62%

                         1988-1995                                               1/1996-6/2010
             100
% of Cases




             75
             50                      Myopathy           Congenital
             25
              0
               86
               87
               88
               89
               90
               91
               92
               93
               94
               95
               96
               97
               98
               99
               00
               01
               02
               03
               04
               05
               06
               07
               08
               09
               10
             19
             19
             19
             19
             19
             19
             19
             19
             19
             19
             19
             19
             19
             19
             20
             20
             20
             20
             20
             20
             20
             20
             20
             20
             20
                       ISHLT                                2011
                   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
    DIAGNOSIS IN PEDIATRIC HEART
TRANSPLANT RECIPIENTS (Age: 1-10 Years)
              4%
                                                          Myopathy          5%
                                          53%                                                     56%
             2%
                                                                           3%
                                                          Congenital

                                                          Other

              41%                                         ReTX              37%

                        1988-1995                                                 1/1996-6/2010
             100
% of Cases




                                      Myopathy           Congenital
             75
             50
             25
              0
               86
               87
               88
               89
               90
               91
               92
               93
               94
               95
               96
               97
               98
               99
               00
               01
               02
               03
               04
               05
               06
               07
               08
               09
               10
             19
             19
             19
             19
             19
             19
             19
             19
             19
             19
             19
             19
             19
             19
             20
             20
             20
             20
             20
             20
             20
             20
             20
             20
             20
                       ISHLT                                2011
                   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
    DIAGNOSIS IN PEDIATRIC HEART
TRANSPLANT RECIPIENTS (Age: 11-17 Years)
                                                          Myopathy
                                                                                                        25%
                                            27%
                                                          Congenital

             67%                                          Other                 65%                      3%
                                           3%                                                           8%
                                          3%              ReTX
                         1988-1995                                                      1/1996-6/2010
             100
% of Cases




                                                     Myopathy              Congenital
              75
              50
              25
               0
                86
                87
                88
                89
                90
                91
                92
                93
                94
                95
                96
                97
                98
                99
                00
                01
                02
                03
                04
                05
                06
                07
                08
                09
                10
              19
              19
              19
              19
              19
              19
              19
              19
              19
              19
              19
              19
              19
              19
              20
              20
              20
              20
              20
              20
              20
              20
              20
              20
              20
                       ISHLT                                2011
                   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                            PEDIATRIC HEART TRANSPLANTS:
                            DIAGNOSIS DISTRIBUTION BY LOCATION
                                Transplants between January 2000 and June 2010
                   100%

                                                                                     Other
                   80%
% of Transplants




                                                                                     Re-TX/Graft
                                                                                     Failure
                   60%                                                               Malignancy

                                                                                     Coronary Artery
                   40%                                                               Disease
                                                                                     Congenital

                   20%                                                               Cardiomyopathy



                    0%
                                Europe            North America              Other



                          ISHLT                               2011
                     J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                                  PEDIATRIC HEART RECIPIENTS
                 % of Patients Bridged with Mechanical Circulatory
                          Support* (Transplants: 7/2004 – 6/2010)
                30


                       23.0
% of Patients




                20




                10                  9.2
                                                                                                  7.3
                                                                         4.8

                                                 0.4         0.1                0.1      1.0
                 0
                     Any Device    LVAD        RVAD          TAH     LVAD+RVAD Unknown VAD+ECMO   ECMO
                                                                              Type (VAD
                                                                                or TAH)

                         ISHLT                                2011              * LVAD, RVAD, TAH, ECMO
                     J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
               PEDIATRIC HEART TRANSPLANTATION
               Kaplan-Meier Survival (Transplants: 1/1982-6/2009)
               100
                                                <1 Year (N = 2,226)            1-10 Years (N = 3,247)
                90                              11-17 Years (N = 3,357)        Overall (N = 8,830)
                80

                70
Survival (%)




                60
                         0-<1 vs. 1-10: p < 0.0007;
                50       0-<1 vs. 11-17: p=0.5977;
                40       1-10 vs. 11-17: p=0.0005.

                30

                20

                10       Half-life <1: 18.4 Years; 1-10: 16.4 Years; 11-17: 12.0 Years

                 0
                     0     1   2   3    4   5     6   7   8    9    10 11 12 13 14 15 16 17 18 19 20
                                                                   Years
                         ISHLT                                2011
                J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                PEDIATRIC HEART TRANSPLANTATION
                                Conditional Kaplan-Meier Survival
                                              (Transplants: 1/1982-6/2009)
               100
                                                            Half-life: <1: na; 1-10: 19.3 Years; 11-17: 16.0 Years
               90

               80
Survival (%)




               70
                         0-<1 vs. 1-10: p = 0.0023;
               60        0-<1 vs. 11-17: p < 0.0001;
                         1-10 vs. 11-17: p < 0.0001.
               50

               40               <1 Year     (N = 1,553)        1-10 Years (N = 2,536)
                                11-17 Years (N =2,692)         Overall     (N = 6,781)
               30
                     0      1   2    3   4    5    6   7   8     9    10 11 12 13 14 15 16 17 18 19 20
                                                                     Years
                           ISHLT                                2011
                     J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
               PEDIATRIC HEART TRANSPLANTATION
                    Kaplan-Meier Survival by Era
                                           (Transplants: 1/1982-6/2009)

               100                                      1982-1989 (N=913)            1990-1994 (N=1,902)
                                                        1995-1999 (N=1,907)          2000-2004 (N=2,005)
                                                        2005-6/2009 (N=2,103)
                80
Survival (%)




                60


                40       Half-life 1982-1989: 12.0 years; 1990-1994: 12.9 years;
                         1995-1999: n.c.; 2000-2004: n.c.; 2005-6/2009: n.c.

                20        P-values for era comparisons
                          All p-values significant at p = 0.001 except comparison of 82-89 vs.
                          90-94, 95-99 vs. 00-04 and 00-04 vs. 05-6/09
                0
                     0    1   2    3   4    5   6   7     8    9     10 11 12 13 14 15 16 17 18 19 20
                                                                   Years

                         ISHLT                                2011
                J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
               PEDIATRIC HEART TRANSPLANTATION
                      Conditional Kaplan-Meier Survival for Recent Era
                                            (Transplants: 1/1999-6/2009)
               100



                90

                            0-<1 vs. 1-10: p = 0.1153
Survival (%)




                80          0-<1 vs. 11-17: p < 0.0001;
                            1-10 vs. 11-17: p < 0.0001

                70



                60
                            <1 Year     (N = 783)             1-10 Years (N =1,374)
                            11-17 Years (N = 1,397)           Overall    (N = 3,554)
                50
                     0            1             2             3              4         5   6   7
                                                                  Years
                         ISHLT                                2011
                     J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
  PEDIATRIC HEART TRANSPLANTATION
Kaplan-Meier Survival by Era (Transplants: 1/1982-6/2009)
                                                        Age: < 1 Year
                100
                                                               1982-1989 (N=189)            1990-1994 (N=590)
                                                               1995-1999 (N=479)            2000-2004 (N=456)
                80                                             2005-6/2009 (N=512)
 Survival (%)




                60


                40        Half-life 1982-1989: 12.2 years; 1990-1994: 11.4 years;
                          1995-1999: n.c. ; 2000-2004: n.c.; 2005-6/2009: n.c.

                20        P-values for era comparisons
                          All p-values significant at p = 0.001 except comparison of 82-89 vs. 90-
                          94, 95-99 vs. 00-04, 95-99 vs. 05-6/09 and 00-04 vs. 05-6/09
                 0
                      0      1     2    3     4     5    6     7     8        9   10   11   12   13   14   15   16
                                                                   Years

                           ISHLT                               2011
                      J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
  PEDIATRIC HEART TRANSPLANTATION
Kaplan-Meier Survival by Era (Transplants: 1/1982-6/2009)
                                                        Age: 1-10 Years
                100                                      1982-1989 (N = 286)            1990-1994 (N=670)
                                                         1995-1999 (N=738)              2000-2004 (N=752)
                                                         2005-6/2009 (N=801)
                80
 Survival (%)




                60


                40        P-values for era comparisons
                          All p-values significant at p = 0.05 except for 00-05 vs.
                          05-6/09
                20
                          Half-life 1982-1989: 11.2; 1990-1994: 14.1; 1995-1999: n.c.; 2000-2004: n.c.;
                          2005-6/2009: n.c.
                 0
                      0      1     2    3     4     5     6    7     8        9   10   11   12   13   14    15   16
                                                                   Years
                            ISHLT                              2011
                      J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
  PEDIATRIC HEART TRANSPLANTATION
Kaplan-Meier Survival by Era (Transplants: 1/1982-6/2009)
                                                   Age: 11-17 Years
                100                                     1982-1989 (N=438)              1990-1994 (N=642)
                                                        1995-1999 (N=690)              2000-2004 (N=797)
                                                        2005-6/2009 (N=790)
                80
 Survival (%)




                60


                40
                          Half-life 1982-1989: 12.0; 1990-1994: 12.9; 1995-1999:
                          10.3; 2000-2004: n.c.; 2005-6/2009: n.c.
                20        P-values for era comparisons
                          No p-values significant at p = 0.05 except 82-89 vs. 05-6/09: p < 0.0001
                          and 90-94 vs. 05-6/09: p=0.0187
                 0
                      0     1    2   3    4    5    6   7    8   9   10 11 12 13 14 15 16 17 18 19
                                                                 Years
                          ISHLT                             2011
                  J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
               PEDIATRIC HEART TRANSPLANTATION
                 Kaplan-Meier Survival by Diagnosis
                                   Age: < 1 Year (Transplants: 1/1996-6/2009)
               100
                                                                                 p-value < 0.0001

               80
Survival (%)




               60


               40


               20
                             Congenital (N=838)         Cardiomyopathy (N=447)

                0
                     0         1        2        3         4        5        6    7       8         9   10
                                                                 Years

                         ISHLT                                 2011
                     J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
               PEDIATRIC HEART TRANSPLANTATION
                 Kaplan-Meier Survival by Diagnosis
                              Age: 1 - 10 Years                (Transplants: 1/1996-6/2009)
               100


               80
Survival (%)




               60
                          Congenital vs. Cardiomyopathy: p < 0.0001
                          Congenital vs. Retransplant: p = 0.0170
               40
                          Cardiomyopathy vs. Retransplant: p < 0.0001


               20
                              Congenital (N=777)                   Cardiomyopathy (N=1,164)
                              Retransplant (N=110)
                0
                     0         1        2        3         4        5        6    7       8   9   10
                                                                 Years

                         ISHLT                                 2011
                     J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
               PEDIATRIC HEART TRANSPLANTATION
                 Kaplan-Meier Survival by Diagnosis
                             Age: 11 - 17 Years                (Transplants: 1/1996-6/2009)
               100


               80
Survival (%)




               60
                          No p-values significant at p = 0.05 except
                          Cardiomyopathy vs. Retransplant: p=0.0007
               40


               20
                              Congenital (N=527)                   Cardiomyopathy (N=1,344)
                              Retransplant (N=164)
                0
                     0         1        2        3         4        5        6    7       8   9   10
                                                                 Years

                         ISHLT                                 2011
                     J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
               PEDIATRIC HEART TRANSPLANTATION
                Kaplan-Meier Patient vs. Graft Survival
                                              (Transplants: 1/1999-6/2009)
                     Average Center Volume: 1-4 Transplants per Year
               100


               80
Survival (%)




               60
                           p = 0.2081

               40


               20
                                   Patient (N=1,460)                Graft (N=1,460)
                0
                     0         1        2        3        4         5        6        7   8   9   10
                                                                 Years

                         ISHLT                                2011
                     J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
               PEDIATRIC HEART TRANSPLANTATION
                Kaplan-Meier Patient vs. Graft Survival
                                              (Transplants: 1/1999-6/2009)
                     Average Center Volume: 5-9 Transplants per Year
               100


               80
Survival (%)




               60
                           p = 0.0839
               40


               20
                                    Patient (N=985)                  Graft (N=985)
                0
                     0          1         2           3        4           5         6   7   8   9
                                                                   Years

                         ISHLT                                2011
                     J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
               PEDIATRIC HEART TRANSPLANTATION
                Kaplan-Meier Patient vs. Graft Survival
                                              (Transplants: 1/1999-6/2009)
                 Average Center Volume: 10-19 Transplants per Year
               100


               80
Survival (%)




               60
                           p = 0.0181

               40


               20
                                   Patient (N=2,041)                Graft (N=2,041)
                0
                     0         1        2        3        4         5        6        7   8   9   10
                                                                 Years

                         ISHLT                                2011
                     J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
                    Risk Factors For 1 Year Mortality
                                                                Relative             95% Confidence
VARIABLE                                                    N              P-value
                                                                 Risk                   Interval
ECMO, age = 0                                           131      2.83      <0.0001     2.05 -3.91

On dialysis                                             109      2.01      0.0002      1.40 -2.89

Congenital diagnosis                                   1650      1.97      <0.0001     1.56 -2.49

ECMO, age >0                                            173      1.95      0.0004      1.35 -2.82

Retransplant                                            244      1.74      0.0057      1.17 -2.57

On ventilator                                           777      1.50      0.0004      1.20 -1.88

Male donor/female recip vs. male donor/male recip      1022      1.42      0.0045      1.11 -1.80

PRA > 10%                                               369      1.41      0.0.127     1.08 -1.85
Donor cause of death = cerebrovascular/stroke vs.
                                                        387      1.41       0.021      1.05 -1.88
head trauma
Prior sternotomy                                        991      1.26      0.0442      1.01 -1.59

Infection requiring IV drug therapy (with 2wk/TX)       628      1.25      0.0447      1.00 -1.56
Donor cause of death = anoxia vs. head trauma           968      0.77      0.0266      0.62 -0.97
                                          N=3,998
         ISHLT                                2011                 Reference diagnosis = cardiomyopathy
    J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
  PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
 Borderline Significant Risk Factors For 1 Year Mortality


                                                                                 95%
                                                         Relative
VARIABLE                                          N                 P-value   Confidence
                                                          Risk
                                                                               Interval

Transplant year 1999/2000 vs. 2003/2004          542         1.34    0.084    0.96 -1.86




                                          N=3,998
         ISHLT                                2011
     J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS                                     (1/1997-6/2009)
                   Risk Factors for 1 Year Mortality



                     Continuous Factors (see figures)
  Creatinine                                    Ischemia time

  Pediatric transplant volume (borderline)




                                        N=3,998
       ISHLT                                2011
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
                                                   Risk Factors for 1 Year Mortality
                                                      Pre-Transplant Creatinine
                                          3
     Relative Risk of 1 Year Mortality




                                         2.5
                                          2
                                         1.5
                                          1
                                         0.5
                                                                            p = 0.0007
                                          0
                                               0              0.5               1           1.5
                                                     Recipient serum creatinine (mg/dl)
                                         ISHLT                      2011
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                                  N=3,998
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
                                                 Risk Factors for 1 Year Mortality
                                                         Ischemia Time
                                       2.5
   Relative Risk of 1 Year Mortality




                                        2


                                       1.5

                                        1


                                       0.5
                                                 p = 0.0146
                                        0
                                             2          3             4         5         6

                                                        Ischemia time (hours)
                                        ISHLT                  2011
            J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                    N=3,998
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
                                                Risk Factors for 1 Year Mortality
                                             Center Volume of Pediatric Transplants
                                       2.5
   Relative Risk of 1 Year Mortality




                                        2

                                       1.5


                                        1

                                       0.5
                                                 p = 0.096
                                        0
                                             0          5               10             15        20
                                                      Center volume (cases per year)

                                        ISHLT                    2011
          J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                             N=3,998
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
           Factors Not Significant for 1 Year Mortality
Recipient Factors:
Age, gender, IV inotropes, sternotomy, history of
malignancy, hospitalized, diabetes

Donor Factors:
Age, gender, clinical infection, history of diabetes

Transplant Factors:
CMV mismatch, HLA mismatch




        ISHLT                                2011
    J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
 PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
              Age = <1 Years
                    Risk Factors For 1 Year Mortality
                                                               Relative
VARIABLE                                                                P-value 95% Confidence
                                                       N        Risk               Interval
ECMO, diagnosis = congenital                           84       2.92     <.0001        1.91 -4.46

ECMO, diagnosis other than congenital                  47       2.52     0.0091        1.26 -5.05

On dialysis                                            30       2.28     0.0037        1.31 -3.98

PRA > 10%                                              80        1.8      0.022        1.09 -2.99

On ventilator                                         383        1.7     0.0014        1.23 -2.34

Prior sternotomy                                      196       1.49     0.0443        1.01 -2.19

Diagnosis = cardiomyopathy                            334        0.6     0.0496        0.36 -1.00




                                            N=1,064
              ISHLT                             2011               Reference diagnosis = congenital
                                                                   without PGE or ECMO
       J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
  PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
               Age = <1 Years
 Borderline Significant Risk Factors For 1 Year Mortality

                                                                                 95%
                                                         Relative
VARIABLE                                          N                 P-value   Confidence
                                                          Risk
                                                                               Interval

Donor cause of death =
                                                 47          1.74   0.0574    0.98 -3.08
cerebrovascular/stroke vs. head trauma

Transplant Year: 1997-1998 vs. 2003-2004         170         1.56   0.0806    0.95 -2.57

Infection requiring IV drug therapy (with
2wk/TX)                                          279         1.32   0.0886    0.96 -1.8




                                          N=1,064
         ISHLT                                2011
     J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS                                     (1/1997-6/2009)
                               Age = <1 Years
                  Risk Factors for 1 Year Mortality


                     Continuous Factors (see figures)
  Ischemia time                          Pediatric transplant volume

  Creatinine




                                       N=1,064
      ISHLT                                2011
  J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
   Risk Factors for 1 Year Mortality in Age = <1 Years
                     Ischemia Time
                                          2.5
      Relative Risk of 1 Year Mortality




                                           2

                                          1.5

                                           1

                                          0.5
                                                    p = 0.0091
                                           0
                                                2           3           4           5         6

                                                            Ischemia time (hours)

                             ISHLT                               2011
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                                N=1,064
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
   Risk Factors for 1 Year Mortality in Age = <1 Years
               Pre-Transplant Creatinine
                                           3
      Relative Risk of 1 Year Mortality



                                          2.5
                                           2
                                          1.5
                                           1
                                          0.5
                                                                                 p = 0.0025
                                           0
                                                0      0.2      0.4       0.6      0.8        1
                                                    Recipient serum creatinine (mg/dl)
                             ISHLT                              2011
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                                 N=1,064
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
   Risk Factors for 1 Year Mortality in Age = <1 Years
        Center Volume for Pediatric Transplants
                                           2
      Relative Risk of 1 Year Mortality




                                          1.5

                                           1

                                          0.5
                                                    p = 0.0361
                                           0
                                                0    2     4     6    8     10   12   14   16    18   20
                                                         Center Volume (cases per year)

                             ISHLT                                   2011
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                                        N=1,064
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
            Age = 1-10 Years
                   Risk Factors For 1 Year Mortality

                                                             Relative              95% Confidence
VARIABLE                                            N                    P-value
                                                              Risk                    Interval

Diagnosis = congenital                             601        2.07       <.0001       1.46 -2.92

Transfusions prior to transplant                   423        1.72       0.0033         1.2 -2.46

Female recipient                                   768        1.39       0.0455       1.01 -1.91

Donor cause of death = anoxia vs. head trauma      364        0.58        0.011       0.38 -0.88




                                          N=1,536
          ISHLT                               2011                      Reference diagnosis = cardiomyopathy
     J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS                                  (1/1997-6/2009)
                             Age = 1-10 Years
                  Risk Factors for 1 Year Mortality


                     Continuous Factors (see figures)
  Creatinine                                     Bilirubin

  Donor height




                                       N=1,536
      ISHLT                                2011
  J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
  Risk Factors for 1 Year Mortality in Age = 1-10 Years
               Pre-Transplant Creatinine
     Relative Risk of 1 Year Mortality

                                         4

                                         3

                                         2

                                         1

                                                                                   p < 0.0001
                                         0
                                             0.2    0.4     0.6          0.8   1        1.2     1.4
                                                   Recipient serum creatinine (mg/dl)

                                         ISHLT                    2011
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                                  N=1,536
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
  Risk Factors for 1 Year Mortality in Age = 1-10 Years
                      Donor Height
                                           3
      Relative Risk of 1 Year Mortality


                                                               p < 0.0001
                                          2.5

                                           2

                                          1.5

                                           1

                                          0.5

                                           0
                                                70   80   90      100    110   120   130   140   150

                                                                 Height (cm)

                             ISHLT                                2011
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                                   N=1,536
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
  Risk Factors for 1 Year Mortality in Age = 1-10 Years
                   Recipient Bilirubin
                                          2.5
      Relative Risk of 1 Year Mortality


                                                    p = 0.0166
                                           2

                                          1.5

                                           1

                                          0.5

                                           0
                                                0     0.5    1      1.5    2    2.5   3    3.5   4

                                                                 Bilirubin (mg/dL)

                             ISHLT                                  2011
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                                  N=1,536
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
            Age = 11-17 Years
                  Risk Factors For 1 Year Mortality

                                                                                       95%
                                                             Relative     P-
VARIABLE                                          N                                 Confidence
                                                              Risk       value
                                                                                     Interval
ECMO                                             49           2.96      0.0006       1.59 -5.53

Diagnosis = other than myopathy,
                                                 41           2.72       0.022       1.16 -6.40
congenital, or retransplant

Diagnosis = retransplant                        138           2.34      0.0018       1.37 -3.98

Diagnosis = congenital                          359           2.09      0.0004       1.40 -3.14

On dialysis prior to transplant                  44           2.08      0.0408       1.03 -4.21



                                          N=1,398
         ISHLT                                2011                   Reference diagnosis = cardiomyopathy
     J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
  PEDIATRIC HEART TRANSPLANTS (1/1997-6/2009)
              Age = 11-17 Years
  Borderline Significant Risk Factors For 1 Year Mortality
                                                                                     95%
                                                               Relative
VARIABLE                                                  N             P-value   Confidence
                                                                Risk
                                                                                   Interval

Transplant Year: 2001-2002 vs. 2003-2004                 221    1.72    0.0787    0.94 -3.13

PRA > 10%                                                119    1.58     0.072    0.96 -2.60

Donor cause of death = cerebrovascular/stroke
                                                         202    1.55     0.053    0.99 -2.42
vs. head trauma

Donor cause of death = anoxia vs. head trauma            187    0.55    0.0792    0.29 -1.07




                                           N=1,398
          ISHLT                                2011
      J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS                               (1/1997-6/2009)
                            Age = 11-17 Years
                  Risk Factors for 1 Year Mortality


                     Continuous Factors (see figures)
  Ischemia time




                                       N=1,398
      ISHLT                                2011
  J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS                                                             (1/1997-6/2009)
  Risk Factors for 1 Year Mortality in Age = 11-17 Years
                      Ischemia Time
                                          2.5
      Relative Risk of 1 Year Mortality




                                           2

                                          1.5

                                           1

                                          0.5
                                                    p = 0.0039
                                           0
                                                2           3           4           5             6

                                                            Ischemia time (hours)

                             ISHLT                               2011
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                                 N=1,398
 PEDIATRIC HEART TRANSPLANTS (1/997-6/2005)
                   Risk Factors For 5 Year Mortality
                                                           Relative         95% Confidence
VARIABLE                                          N                 P-value
                                                            Risk               Interval
ECMO, age = 0                                    69         2.78    <.0001      1.92 -4.02

Diagnosis = retransplant                        154         2.12    <.0001      1.56 -2.89

On dialysis                                      64         1.64    0.0146      1.10 -2.43

Diagnosis = congenital                          1061        1.53    <.0001      1.26 -1.85

PRA > 10%                                       258         1.52    0.0003      1.21 -1.91

On ventilator                                   490         1.30    0.0147      1.05 -1.60

Female recipient                                1115        1.26    0.004       1.08 -1.48




                                        N=2,529
       ISHLT                                2011                   Reference diagnosis = cardiomyopathy
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
  PEDIATRIC HEART TRANSPLANTS (1/997-6/2005)
Borderline Significant Risk Factors For 5 Year Mortality


                                                                                    95%
                                                            Relative
VARIABLE                                          N                    P-value   Confidence
                                                             Risk
                                                                                  Interval

Donor clinical infection                         451         0.82      0.0741    0.66 -1.02




                                         N=2,529
         ISHLT                               2011
    J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS                                        (1/997-6/2005)
                  Risk Factors for 5 Year Mortality



                     Continuous Factors (see figures)
  Pediatric transplant volume
                                                 Ischemia time (borderline)
  (borderline)




                                       N=2,529
      ISHLT                                2011
  J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS (1/997-6/2005)
                                              Risk Factors for 5 Year Mortality
                                           Center Volume for Pediatric Transplants
                                          2.5
      Relative Risk of 5 Year Mortality




                                           2

                                          1.5

                                           1

                                          0.5
                                                    p = 0.061
                                           0
                                                0    2     4    6    8     10   12   14   16    18   20
                                                         Center Volume (cases per year)

                             ISHLT                                  2011
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                                       N=2,529
PEDIATRIC HEART TRANSPLANTS                                                             (1/997-6/2005)
                                                   Risk Factors for 5 Year Mortality
                                                           Ischemia Time
                                         2.5
     Relative Risk of 5 Year Mortality




                                          2

                                         1.5

                                          1

                                         0.5
                                                    p = 0.054
                                          0
                                               2            3           4           5            6

                                                            Ischemia time (hours)

                            ISHLT                                2011
  J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                                 N=2,529
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2000)
                Risk Factors For 10 Year Mortality
                                                            Relative     P-     95% Confidence
VARIABLE                                          N
                                                             Risk       value      Interval

Diagnosis = retransplant                         52          2.33      <.0001       1.53 -3.55

Infection requiring IV drug therapy
                                                 117         1.42      0.0253       1.04 -1.92
(within 2 weeks prior to transplant)




                                                                    Reference diagnosis = cardiomyopathy

        ISHLT                                2011                            N=933
    J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2000)
Borderline Significant Risk Factors For 10 Year Mortality


                                                       Relative               95% Confidence
  VARIABLE                                     N                   P-value
                                                        Risk                     Interval

  ECMO, age = 0                                17           2.01    0.0506         1.00 -4.06


  Diagnosis = not myopathy, congenital
                                               33           1.64     0.07          0.96 -2.80
  or retransplant


  Diagnosis = congenital                      415           1.23    0.0936         0.97 -1.57




                                                                   Reference diagnosis = cardiomyopathy

        ISHLT                                2011                            N=933
    J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS                                         (1/1997-6/2000)
                  Risk Factors for 10 Year Mortality



                       Continuous Factors (see figures)
  Height ratio                                     Recipient weight (borderline)

  Donor BSA (borderline)




       ISHLT                                2011                 N=933
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2000)
                                                    Risk Factors for 10 Year Mortality
                                                            Recipient Weight
                                          3.5
     Relative Risk of 10 Year Mortality



                                           3
                                          2.5
                                           2
                                          1.5
                                           1
                                          0.5
                                                                                        p = 0.095
                                           0
                                                0     10   20     30 40 50 60 70          80   90 100
                                                                Recipient weight (kg)

                                          ISHLT                      2011                 N=933
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2000)
                                                   Risk Factors for 10 Year Mortality
                                                              Donor BSA
                                            2
      Relative Risk of 10 Year Mortality




                                           1.5

                                            1

                                           0.5
                                                                                          p = 0.0841
                                            0
                                                 0.4   0.6   0.8      1    1.2      1.4      1.6       1.8
                                                                   Donor BSA (m2)
                              ISHLT                                2011
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                                      N=933
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2000)
                                                  Risk Factors for 10 Year Mortality
                                                 Donor Height/Recipient Height Ratio
                                           2.5
      Relative Risk of 10 Year Mortality



                                                                            p = 0.0057
                                            2

                                           1.5

                                            1

                                           0.5

                                            0
                                                 0.9     1       1.1      1.2      1.3     1.4
                                                                 Height ratio
                              ISHLT                             2011               N=933
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS (1/1997-6/2000)
          Factors Not Significant for 10 Year Mortality

Recipient Factors:
PRA, diabetes, hospitalized, PGE, VAD, bilirubin,
creatinine

Donor Factors:
Cause of death, age, clinical infection

Transplant Factors:
Ischemia time, CMV mismatch



        ISHLT                                2011
    J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS (1/1992-6/1995)
                Risk Factors For 15 Year Mortality
                                                            Relative     P-     95% Confidence
VARIABLE                                          N
                                                             Risk       value      Interval

Diagnosis = retransplant                         35          2.45      0.0062       1.29 -4.67


Diagnosis = congenital                           546         1.56      0.0071       1.13 -2.16




                                                                    Reference diagnosis = cardiomyopathy

        ISHLT                                2011                            N=1105
    J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS                                  (1/1992-6/1995)
                  Risk Factors for 15 Year Mortality



                        Continuous Factors (see figure)
  Center volume




       ISHLT                                2011           N=1105
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS (1/1992-6/1995)
                                              Risk Factors for 15 Year Mortality
                                           Center Volume for Pediatric Transplants
                                           2
     Relative Risk of 15 Year Mortality




                                          1.5
                                                                              p < 0.0001
                                           1

                                          0.5

                                           0
                                                0        5          10         15          20
                                                    Center Volume (cases per year)

                                          ISHLT               2011               N=1105
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PEDIATRIC HEART TRANSPLANTS (1/1992-6/1995)
          Factors Not Significant for 15 Year Mortality

Recipient Factors:
Age, height, weight, gender

Donor Factors:
Cause of death, age, height, weight, gender

Transplant Factors:
Ischemia time, HLA mismatch




        ISHLT                                2011
    J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
            PEDIATRIC HEART RECIPIENTS
                 Cross-Sectional Analysis
          Functional Status of Surviving Recipients
                        (Follow-ups: April 1994 - June 2010)
100%



80%


60%



40%


20%

              No Activity Limitations    Performs with Some Assistance   Requires Total Assistance

 0%
               1 Year (N = 2,177)              3 Years (N = 1,783)           5 Year (N = 1,432)


           ISHLT                                2011
       J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
            PEDIATRIC HEART RECIPIENTS
       Functional Status of Surviving Recipients
                        (Follow-ups: April 1994 - June 2010)
                                   Age: <1 Year
100%


80%


60%


40%


20%

            No Activity Limitations     Performs with Some Assistance   Requires Total Assistance

 0%
              1 Year (N = 547)                  3 Year (N = 526)            5 Year (N = 477)


           ISHLT                                2011
       J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
            PEDIATRIC HEART RECIPIENTS
       Functional Status of Surviving Recipients
                         (Follow-ups: April 1994 - June 2010)
                                   Age: 1-10 Years
100%


80%


60%


40%


20%

               No Activity Limitations   Performs with Some Assistance   Requires Total Assistance

 0%
              1 Year (N = 830)                  3 Year (N = 662)             5 Year (N = 523)


           ISHLT                                2011
       J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
            PEDIATRIC HEART RECIPIENTS
       Functional Status of Surviving Recipients
                        (Follow-ups: April 1994 - June 2010)
                                 Age: 11-17 Years
100%


80%


60%


40%


20%

               No Activity Limitations   Performs with Some Assistance   Requires Total Assistance

 0%
              1 Year (N = 800)                 3 Year (N = 595)              5 Year (N = 432)


           ISHLT                                2011
       J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
         PEDIATRIC HEART RECIPIENTS
       Functional Status of Surviving Recipients
                   (Follow-ups: March 2005 - June 2010)
                           US Recipients Only
100%
                                                                       Not Applicable (patient <
                                                                       1 year old)
                                                                       10%

80%                                                                    20%

                                                                       30%

60%                                                                    40%

                                                                       50%

                                                                       60%
40%
                                                                       70%

                                                                       80%
20%
                                                                       90%

                                                                       100%

 0%
        1 Year (N = 1,409)   2 Years (N = 1,242) 3 Years (N = 1,136)

        ISHLT                               2011
   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
            PEDIATRIC HEART RECIPIENTS
Rehospitalization Post-transplant of Surviving Recipients
                        (Follow-ups: April 1994 - June 2010)
100%


80%


60%



40%
           No Hospitalization                             Hospitalized, Not Rejection/Not Infection
           Hospitalized, Rejection                        Hospitalized, Infection Only
20%
           Hospitalized, Rejection + Infection


 0%
            1 Year (N = 4,161)               3 Years (N =3,274)             5 Years (N = 2,598)



           ISHLT                                 2011
       J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                           PEDIATRIC HEART RECIPIENTS
                                      Induction Immunosuppression
                                  (Transplants: January 2001 - June 2010)
                60

                50


                40
% of Patients




                30

                20


                10

                 0
                     Any Induction (N = Polyclonal ALG/ATG              OKT3 (N = 55)         IL-2R Antagonist (N
                           1,738)           (N = 1,163)                                              = 576)



                     ISHLT                               2011                 Analysis is limited to patients who were alive
                                                                              at the time of the discharge
                J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                         PEDIATRIC HEART RECIPIENTS
Induction Immunosuppression (Transplants: January 2001 - June 2010)
                   70
                                                                                              2001
                   60                                                                         2002
                                                                                              2003
                                                                                              2004
                   50                                                                         2005
                                                                                              2006
   % of Patients




                                                                                              2007
                   40                                                                         2008
                                                                                              2009
                                                                                              2010
                   30

                   20

                   10

                    0
                              Any Induction            Polyclonal ALG/ATG         IL-2R Antagonist
                                                                             Test of increasing trend over time:
                                                                             Any induction p < 0.0001
                                                                             Polyclonal p < 0.0001
                        ISHLT                               2011             IL2 p < 0.0001
                                                                            Analysis is limited to patients who were
                   J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132    alive at the time of the discharge
                     PEDIATRIC HEART TRANSPLANTATION
                           Kaplan-Meier Survival by Induction Group
          (Transplants: January 2000 – June 2009) Conditional on Survival to 14 Days
               100
                                                  No comparisons are statistically significant.

               90
Survival (%)




               80



               70
                                   No induction (N = 1,377)
                                   Polyclonal induction (N = 1,072)
               60
                                   IL-2R antagonist (N = 449)

               50
                     0        1           2           3           4         5           6         7   8

                                                                Years
                         ISHLT                            2011
                 J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                     PEDIATRIC HEART TRANSPLANTATION
               Kaplan-Meier Survival by Induction Group and Treated Rejection Between
                             Transplant Discharge and 1-Year Follow-up
                             (1-Year Follow-ups: July 2004 - June 2009)
                                  Conditional on Survival to 1 Year
               100



                90
Survival (%)




                80
                         No pair-wise comparisons of survival by induction are statistically
                         significant within either rejection grouping

                70               No induction/No rejection (N = 379)
                                 Polyclonal induction/No rejection (N = 356)
                                 IL-2R antagonist/No rejection (N = 162)
                60               No induction/Treated Rejection (N = 129)
                                 Polyclonal induction/Treated Rejection (N = 142)
                                 IL-2R antagonist/Treated Rejection (N = 65)
                50
                     0                     1                    2                     3                             4                            5
                                                                       Years        Treated rejection = Recipient was reported to (1) have at least
                                                                                    one acute rejection episode that was treated with an anti-
                         ISHLT                                      2011
                                                                                    rejection agent; or (2) have been hospitalized for rejection.
                                                                                    No rejection = Recipient had (i) no acute rejection episodes
                                                                                    and (ii) was reported either as not hospitalized for rejection or
                 J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132              did not receive anti-rejection agents.
                     PEDIATRIC HEART TRANSPLANTATION
 Kaplan-Meier Survival by Induction Group (Transplants: January 2000 – June 2009)
                                            Conditional on Survival to 14 Days
                                                        Age: < 1 Year
               100



               90
Survival (%)




               80

                         No comparisons are statistically significant.
               70


                                          No induction (N = 305)
               60                         Polyclonal induction (N = 369)
                                          IL-2R antagonist (N = 64)

               50
                     0                1                2              3    4     5   6
                                                                   Years
                         ISHLT                               2011
                J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                           PEDIATRIC HEART TRANSPLANTATION
Kaplan-Meier Survival by Induction Group (Transplants: January 2000 – June 2009)
                                       Conditional on Survival to 14 Days
                                                Age: 1-10 Years
               100



               90
Survival (%)




               80

                          No comparisons are statistically significant.
               70



               60             No induction (N = 551)
                              Polyclonal induction (N = 377)
                              IL-2R antagonist (N = 180)
               50
                     0             1               2              3       4   5   6
                                                               Years

                         ISHLT                           2011
                J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                          PEDIATRIC HEART TRANSPLANTATION
Kaplan-Meier Survival by Induction Group (Transplants: January 2000 – June 2009)
                                       Conditional on Survival to 14 Days
                                               Age: 11-17 Years
               100



               90
Survival (%)




               80

                          No comparisons are statistically significant.
               70


                              No induction (N =521)
               60
                              Polyclonal induction (N = 326)
                              IL-2R antagonist (N = 205)
               50
                     0             1               2              3       4   5   6
                                                               Years

                         ISHLT                             2011
                 J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                        PEDIATRIC HEART RECIPIENTS
                      Maintenance Immunosuppression at Time of Follow-up
                             (Follow-ups: January 2001 - June 2010)
                100
                                  Year 1 (N = 2,579)                  Year 5 (N = 1,644)
                 80
% of Patients




                 60


                 40


                 20


                  0
                      Cyclosporine    Tacrolimus       Sirolimus          MMF     Azathioprine        Prednisone
                                      NOTE: Different patients are analyzed in Year 1 and Year 5

                      ISHLT                                2011                     Analysis is limited to patients who
                                                                                    were alive at the time of the follow-up
                  J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                            PEDIATRIC HEART RECIPIENTS
                         Maintenance Immunosuppression at Time of Follow-up
                                 for Same Patients at Each Time Point
                                (Follow-ups: January 2001 - June 2010)
                100%

                                                             None
                80%
                                                             Other
% of Patients




                                                             Tacrolimus
                60%
                                                             Tacrolimus + MMF

                                                             Tacrolimus + AZA
                40%
                                                             Cyclosporine

                                                             Cyclosporine + MMF
                20%
                                                             Cyclosporine + AZA


                 0%
                                     Year 1 (N = 984)                             Year 5 (N = 984)


                       ISHLT                              2011                     Analysis is limited to patients who
                                                                                   were alive at the time of the follow-up
                 J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                            PEDIATRIC HEART RECIPIENTS
  Maintenance Immunosuppression Drug Combinations at Time of Follow-up
                 (Follow-ups: January 2001 - June 2010)
                100%

                                                                                     None
                80%
                                                                                     Other

                                                                                     Tacrolimus
% of Patients




                60%
                                                                                     Tacrolimus + MMF

                                                                                     Tacrolimus + AZA
                40%
                                                                                     Cyclosporine

                                                                                     Cyclosporine + MMF
                20%
                                                                                     Cyclosporine + AZA

                 0%
                           Year 1 (N = 2,579)             Year 5 (N = 1,644)
                                 NOTE: Different patients are analyzed in Year 1 and Year 5
                       ISHLT                              2011                    Analysis is limited to patients who
                                                                                  were alive at the time of the follow-up
                 J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
               PEDIATRIC HEART TRANSPLANTATION
                     Kaplan-Meier Survival Based on Prednisone Use
Conditional on Survival to 1 Year (Transplants: April 1994 - June 2009)
               100


                90
Survival (%)




                80
                          p < 0.0001

                70
                            Prednisone use at discharge and 1 year (N = 2,274)

                60          No Prednisone at discharge or at 1 year (N = 578)
                            Prednisone at discharge/not at 1 year (N = 534)
                50
                     0       1         2      3        4          5     6   7    8   9   10
                                                             Years

                         ISHLT                             2011
                J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
               PEDIATRIC HEART TRANSPLANTATION
Kaplan-Meier Survival Based on Prednisone Use for a Recent Era
          Conditional on Survival to 1 Year (Transplants: January 1998 – June 2009)

               100


                90
Survival (%)




                80


                70
                             Prednisone use at discharge and 1 year (N = 1,810)       p = 0.0045

                60           No Prednisone at discharge or at 1 year (N = 460)

                             Prednisone at discharge/not at 1 year (N = 447)
                50
                     0       1        2        3        4          5      6       7    8       9   10
                                                              Years

                         ISHLT                              2011
                 J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                       PEDIATRIC HEART TRANSPLANTATION
Kaplan-Meier Survival Stratified by Tacrolimus vs. Cyclosporine Use at Discharge
                    (Transplants: January 1998 - June 2009)
                       Conditional on Survival to 14 Days
                 100
                                                                                  p = 0.3357
                  90
  Survival (%)




                  80


                  70
                             Tacrolimus use at discharge (N = 1,711)
                  60
                             Cyclosporine use at discharge (N = 1,550)

                  50
                       0      1        2        3        4          5     6   7    8      9    10
                                                               Years

                           ISHLT                             2011
                  J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                     PEDIATRIC HEART TRANSPLANTATION
                 Kaplan-Meier Survival Stratified by Tacrolimus vs. Cyclosporine Use
               Conditional on Survival to 1 Year (Transplants: January 1998 - June 2009)

               100
                                                                                           p = 0.1130
                90
Survival (%)




                80


                70
                            Cyclosporine use at discharge and 1 year (N = 949)
                            Tacrolimus use at discharge and 1 year (N = 1,298)
                60
                            Cyclosporine use at discharge/Tacrolimus at 1 year (N = 285)
                            Tacrolimus use at discharge/Cyclosporine at 1 year (N = 33)
                50
                     0       1        2         3        4          5        6        7      8          9   10
                                                               Years

                         ISHLT                               2011
                 J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
            PEDIATRIC HEART TRANSPLANTATION
Kaplan-Meier Survival Based on Treated Rejection within 1st Year
Conditional on survival to 1 year (1-Year Follow-ups: April 2004 - June 2009)
                100


                 90
 Survival (%)




                 80
                          p = 0.0378

                 70


                 60
                                 Free from Rejection during 1 year (N = 725)
                                 Treated Rejection within 1st Year (N = 362)
                 50
                      0                1                2                 3                        4                        5
                                                                         Treated rejection = Recipient was reported to (1) have at
                                                              Years      least one acute rejection episode that was treated with an
                                                                         anti-rejection agent; or (2) have been hospitalized for
                                                                         rejection.
                          ISHLT                             2011         No rejection = Recipient had (i) no acute rejection
                                                                         episodes and (ii) was reported either as not hospitalized
                 J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132   for rejection or did not receive anti-rejection agents.
            PEDIATRIC HEART TRANSPLANTATION
Kaplan-Meier Survival Based on Treated Rejection within 1st Year
                                 Stratified by Calcineurin Use at Discharge
Conditional on survival to 1 year (1-Year Follow-ups: April 2004 - June 2009)
                100


                 90
 Survival (%)




                      Free from Rejection: CyA vs. TAC p = 0.5676
                 80
                      Treated Rejection: CyA vs. TAC p = 0.0758
                      CyA: Rejection vs. no rejection p = 0.9100
                      TAC: Rejection vs. no rejection p = 0.0199
                 70
                                       CyA: Free from Rejection during 1 year (N = 198)
                                       CyA: Treated Rejection within 1st Year (N = 126)
                 60
                                       TAC: Free from Rejection during 1 year (N = 485)
                                       TAC: Treated Rejection within 1st Year (N = 200)
                 50
                      0                   1                    2                3                        4                         5
                                                                               Treated rejection = Recipient was reported to (1) have at
                                                                      Years    least one acute rejection episode that was treated with an
                                                                               anti-rejection agent; or (2) have been hospitalized for
                                                                               rejection.
                          ISHLT                                     2011       No rejection = Recipient had (i) no acute rejection
                                                                               episodes and (ii) was reported either as not hospitalized
                 J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132         for rejection or did not receive anti-rejection agents.
            PEDIATRIC HEART TRANSPLANTATION
Kaplan-Meier Survival Based on Treated Rejection within 1st Year
                  Stratified by Calcineurin Use at Discharge: Age = 0-10 Years
Conditional on survival to 1 year (1-Year Follow-ups: April 2004 - June 2009)
                100


                 90
 Survival (%)




                 80       Free from Rejection: CyA vs. TAC p = 0.6566
                          Rejection: CyA vs. TAC p = 0.2169
                          CyA: Rejection vs. no rejection p = 0.9871
                          TAC: Rejection vs. no rejection p = 0.0231
                 70
                                         CyA: Free from Rejection during 1 year (N = 138)
                                         CyA: Treated Rejection within 1st Year (N = 83)
                 60
                                         TAC: Free from Rejection during 1 year (N = 308)
                                         TAC: Treated Rejection within 1st Year (N = 109)
                 50
                      0                     1                    2                 3                           4                            5
                                                                        Years    Treated rejection = Recipient was reported to (1) have at least
                                                                                 one acute rejection episode that was treated with an anti-
                                                                                 rejection agent; or (2) have been hospitalized for rejection.

                          ISHLT                                      2011        No rejection = Recipient had (i) no acute rejection episodes
                                                                                 and (ii) was reported either as not hospitalized for rejection or
                                                                                 did not receive anti-rejection agents.
                 J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
            PEDIATRIC HEART TRANSPLANTATION
Kaplan-Meier Survival Based on Treated Rejection within 1st Year
                 Stratified by Calcineurin Use at Discharge: Age = 11-17 Years
Conditional on survival to 1 year (1-Year Follow-ups: April 2004 - July 2009)
                100


                 90
 Survival (%)




                          Free from Rejection: CyA vs. TAC p = 0.2758
                 80
                          Rejection: CyA vs. TAC p = 0.2358
                          CyA: Rejection vs. no rejection p = 0.7317
                          TAC: Rejection vs. no rejection p = 0.4045
                 70
                                        CyA: Free from Rejection during 1st Year (N = 60)
                                        CyA: Treated Rejection within 1st Year (N =43)
                 60
                                        TAC: Free from Rejection during 1st Year (N = 177)
                                        TAC: Treated Rejection within 1st Year (N = 91)
                 50
                      0                          1                        2                          3                               4
                                                                                 Treated rejection = Recipient was reported to (1) have at
                                                                        Years    least one acute rejection episode that was treated with an
                                                                                 anti-rejection agent; or (2) have been hospitalized for
                                                                                 rejection.
                          ISHLT                                    2011          No rejection = Recipient had (i) no acute rejection
                                                                                 episodes and (ii) was reported either as not hospitalized
                 J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132           for rejection or did not receive anti-rejection agents.
                                       PERCENTAGE OF PEDIATRIC HEART TRANSPLANT
RECIPIENTS EXPERIENCING ACUTE REJECTION BETWEEN TRANSPLANT
                 DISCHARGE AND 1-YEAR FOLLOW-UP
       Stratified by Induction (Follow-ups: July 2004 - June 2010)
 % experiencing acute rejection within 1 year




                                                   70
                                                                No induction Used, Treatment                  No induction Used, No Treatment

                                                   60           Induction Used (no OKT3), Treatment           Induction Used (no OKT3), No Treatment


                                                   50

                                                   40

                                                   30

                                                   20

                                                   10

                                                     0
                                                             Overall                <1           1-10       10-17                  Female             Male
                                                                                                        Treated rejection = Recipient was reported to (1) have at least
                                                No comparisons are statistically significant at 0.05.   one acute rejection episode that was treated with an anti-
                                                                                                        rejection agent; or (2) have been hospitalized for rejection.
                                                                                                        No rejection = Recipient had (i) no acute rejection episodes and
                                                                                                        (ii) was reported either as not hospitalized for rejection or did not
                                                         ISHLT                                  2011    receive anti-rejection agents.

                                                                                                                                Analysis is limited to patients who
                                                    J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                       were alive at the time of the follow-up
 PERCENTAGE OF PEDIATRIC HEART TRANSPLANT RECIPIENTS
EXPERIENCING ACUTE REJECTION BETWEEN TRANSPLANT DISCHARGE
                          AND 1-YEAR FOLLOW-UP
   Stratified by Type of Induction (Follow-ups: July 2004 - June 2010)
    70         No induction, Treatment       No induction, No Treatment
 % experiencing acute rejection within 1 year




                                                                 Polyclonal, Treatment                      Polyclonal, No Treatment
                                                                 IL-2R antagonist, Treatment                ILR antagonist, No Treatment
                                                   60

                                                   50

                                                   40

                                                   30

                                                   20

                                                   10

                                                    0
                                                             Overall              <1           1-10     10-17                  Female              Male

                                                                                                        Treated rejection = Recipient was reported to (1) have at least
                                                No comparisons are statistically significant at 0.05.   one acute rejection episode that was treated with an anti-
                                                                                                        rejection agent; or (2) have been hospitalized for rejection.
                                                                                                        No rejection = Recipient had (i) no acute rejection episodes
                                                                                                        and (ii) was reported either as not hospitalized for rejection or

                                                         ISHLT                                  2011
                                                                                                        did not receive anti-rejection agents.

                                                                                                                              Analysis is limited to patients who
                                                    J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132                     were alive at the time of the follow-up
                            PERCENTAGE OF PEDIATRIC HEART TRANSPLANT RECIPIENTS
                EXPERIENCING ACUTE REJECTION BETWEEN TRANSPLANT DISCHARGE
                                   AND 1-YEAR FOLLOW-UP
                 Stratified by Maintenance Immunosuppression and Induction (Follow-ups: July 2004 - June 2010)
                                                     CyA + No induction, Treatment                             CyA + No induction, No Treatment
% experiencing acute rejection within




                                        70           CyA + Induction (no OKT3), Treatment                      CyA + Induction (no OKT3), No Treatment
                                                     TAC + No induction, Treatment                             TAC + No induction, No Treatment
                                                     TAC + Induction (no OKT3), Treatment                      TAC + Induction (no OKT3), No Treatment
                                        60
                                        50
               1 year




                                        40
                                        30
                                        20
                                        10
                                         0
                               Overall                 <1                 1-10               10-17
        No CyA + no induction vs. CyA + induction and TAC + no induction vs. TAC + induction comparisons are
        statistically significant at 0.05

        All other comparisons are statistically significant at 0.05 except <1: CyA + induction vs. TAC + no
        induction vs. and <1: CyA + induction vs. TAC + induction
                                             Analysis is limited to patients who were alive at the time   Treated rejection = Recipient was reported to (1) have at least
                                             of the follow-up                                             one acute rejection episode that was treated with an anti-
                                                                                                          rejection agent; or (2) have been hospitalized for rejection.
                                                                                                          No rejection = Recipient had (i) no acute rejection episodes
                                               ISHLT                                              2011    and (ii) was reported either as not hospitalized for rejection or
                                                                                                          did not receive anti-rejection agents.

                                        J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                    PERCENTAGE OF PEDIATRIC HEART TRANSPLANT
    RECIPIENTS EXPERIENCING ACUTE REJECTION BETWEEN TRANSPLANT
                  DISCHARGE AND 1-YEAR FOLLOW-UP
                       Stratified by Maintenance Immunosuppression (Follow-ups: July 2004 - June 2010)
                                                             Cyclosporine + MMF, Treatment                         Cyclosporine + MMF, No Treatment
      % experiencing acute rejection within



                                                             Cyclosporine + AZA, Treatment                         Cyclosporine + AZA, No Treatment
                                                70           Tacrolimus + MMF, Treatment                           Tacrolimus + MMF, No Treatment
                                                             Tacrolimus + AZA, Treatment                           Tacrolimus + AZA, No Treatment
                                                60
                                                50
                     1 year




                                                40
                                                30
                                                20
                                                10
                                                  0
                                                                 Overall                                   <1                   1-10                      10-17
Overall: all comparisons were statistically significant at 0.05 except CyA+MMF vs. CyA+AZA and TAC+MMF vs. TAC+AZA.
<1: CyA + MMF vs. TAC + MMF (p =0.0037).
1-10: CyA + MMF vs. TAC + MMF (p = 0.0017); CyA + AZA vs. TAC + MMF (p=0.0036).
11-17: all comparisons were statistically significant at 0.05 except CyA +MMF vs. CyA +AZA TAC + MMF vs. TAC + AZA.
                                                                                                                Treated rejection = Recipient was reported to (1) have at least
                                              Analysis is limited to patients who were alive at the time        one acute rejection episode that was treated with an anti-
                                              of the follow-up                                                  rejection agent; or (2) have been hospitalized for rejection.
                                                                                                                No rejection = Recipient had (i) no acute rejection episodes
                                                 ISHLT                                               2011
                                                                                                                and (ii) was reported either as not hospitalized for rejection or
                                                                                                                did not receive anti-rejection agents.

                                      J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
PERCENTAGE OF PEDIATRIC HEART TRANSPLANT RECIPIENTS
EXPERIENCING ACUTE REJECTION BETWEEN TRANSPLANT DISCHARGE
                   AND 1-YEAR FOLLOW-UP
                                                              Stratified by Calcineurin Inhibitor Use at Discharge
                                                                        (Follow-ups: July 2004 - June 2010)
% experiencing acute rejection within 1 year




                                                             Cyclosporine, Treatment               Cyclosporine, No Treatment
                                               60            Tacrolimus, Treatment                 Tacrolimus, No Treatment

                                               50

                                               40

                                               30

                                               20

                                               10

                                                0
                                                             Overall                      <1                   1-10                  10-17
                                                    Overall: CyA vs. TAC (p < 0.0001)
                                                    <1: CyA vs. TAC (p = 0.0247)                       Treated rejection = Recipient was reported to (1) have at least
                                                                                                       one acute rejection episode that was treated with an anti-
                                                    1-10: CyA vs. TAC (p = 0.0001)                     rejection agent; or (2) have been hospitalized for rejection.
                                                    11-17: CyA vs. TAC (p < 0.0001)
                                                                                                       No rejection = Recipient had (i) no acute rejection episodes

                                                    ISHLT                               2011
                                                                                                       and (ii) was reported either as not hospitalized for rejection or
                                                                                                       did not receive anti-rejection agents.

                                                                                                                Analysis is limited to patients who were alive at the
                                               J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132            time of the follow-up
                     FREEDOM FROM CORONARY ARTERY VASCULOPATHY
                     For Pediatric Heart Recipients (Follow-ups: April 1994 - June 2010)

                     100



                     90
% Freedom from CAV




                     80



                     70



                     60



                     50
                           0    1       2       3        4       5       6     7   8   9   10   11
                                                                  Years
                               ISHLT                            2011
                       J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
 FREEDOM FROM CORONARY ARTERY VASCULOPATHY
For Pediatric Heart Recipients (Follow-ups: April 1994 - June 2010)
                                                    Stratified by Induction
                      100



                      90
 % Freedom from CAV




                      80
                                p = 0.2243

                      70


                      60               Induction (N = 1,682)

                                       No Induction (N = 1,976)

                      50
                            0      1         2       3         4        5       6   7   8   9   10
                                                                     Years
                                ISHLT                              2011
                        J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
        FREEDOM FROM CORONARY ARTERY VASCULOPATHY
        For Pediatric Heart Recipients (Follow-ups: 1999 - June 2010)
                                        Stratified by Tacrolimus vs. Cyclosporine Use
                                                Conditional on Survival to 1 Year
                     100
% Freedom from CAV




                     90


                     80
                                p = 0.7862

                     70
                                   Cyclosporine use at discharge and 1 year (N = 897)
                                   Tacrolimus use at discharge and 1 year (N = 1,165)
                     60
                                   Cyclosporine use at discharge/Tacrolimus at 1 year (N = 270)
                                   Tacrolimus use at discharge/Cyclosporine at 1 year (N = 31)
                     50
                           0        1         2         3         4            5   6         7    8   9
                                                                  Years

                               ISHLT                            2011
                       J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
 FREEDOM FROM CORONARY ARTERY VASCULOPATHY
For Pediatric Heart Recipients (Follow-ups: April 1994 - June 2010)
                                                  Stratified by Age Group
                      100
 % Freedom from CAV




                       90



                       80
                                        p < 0.0001

                       70

                                       <1 Year (N = 968)
                       60              1-10 Years (N = 1,377)
                                       11-17 Years (N = 1,329)

                       50
                            0     1         2        3        4          5     6   7   8   9   10
                                                                    Years
                                ISHLT                             2011
                       J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
FREEDOM FROM CORONARY ARTERY VASCULOPATHY
  For Pediatric Heart Recipients (Follow-ups: 1999-June 2010)
                                                 Stratified by Age Group
                     100



                     90
% Freedom from CAV




                     80
                                        p < 0.0001

                     70
                                        <1 Year (N = 722)
                                        1-10 Years (N = 1,077)
                     60
                                        11-17 Years (N = 1,046)


                     50
                           0        1           2           3          4      5   6   7   8
                                                                    Years
                               ISHLT                            2011
                      J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
 FREEDOM FROM CORONARY ARTERY VASCULOPATHY
For Pediatric Heart Recipients (Follow-ups: April 1994 - June 2010)
                                                   Stratified by Ischemia Time
                      100


                      90
 % Freedom from CAV




                      80
                                          p = 0.0017

                      70


                                        0-<2 hours (N=376)
                      60
                                        2-<4 hours (N=1,878)
                                        4+ hours (N=1,158)
                      50
                            0       1          2         3          4           5   6   7   8   9
                                                                        Years

                                ISHLT                            2011
                        J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
  FREEDOM FROM CORONARY ARTERY VASCULOPATHY
                 For Pediatric Heart Recipients (Follow-ups: January 1999 - June 2010)
                             Stratified by Ischemia Time for Recent Era
                     100


                     90
% Freedom from CAV




                     80
                                       p = 0.0022

                     70


                                   0-<2 hours (N=261)
                     60
                                   2-<4 hours (N=1,443)
                                   4+ hours    (N=900)
                     50
                           0       1           2          3           4       5   6   7   8
                                                                   Years

                               ISHLT                           2011
                      J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
 FREEDOM FROM CORONARY ARTERY VASCULOPATHY
For Pediatric Heart Recipients (Follow-ups: April 1994 - June 2010)
                                    Stratified by Ischemia Time and Recipient Age
                      100



                      90
 % Freedom from CAV




                      80
                                0-10 years: p = 0.0093;
                                11-17 years: p = 0.1662

                      70
                                         0-<2 hours/0-10 years (N=217)
                                         2+ hours/0-10 years    (N=1,958)
                      60
                                         0-<2 hours/11-17 years (N=159)
                                         2+ hours/11-17 years   (N=1,078)
                      50
                            0        1         2          3       4             5   6   7   8   9
                                                                      Years
                                ISHLT                            2011
                        J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
  GRAFT SURVIVAL FOLLOWING REPORT OF CORONARY
              ARTERY VASCULOPATHY
                           For Pediatric Heart Recipients (Follow-ups: April 1994 - June 2010)
                                                Stratified by Age Group
                                   100
Survival since Report of CAV (%)




                                   90                                                           <1 Year    (N = 98)
                                                                                                1-10 Years (N = 174)
                                   80
                                                                                                11-17 Years (N = 226)
                                   70

                                   60

                                   50

                                   40

                                   30

                                   20
                                                     p = 0.5233
                                   10

                                    0
                                         0              1                 2                 3                4          5
                                                              Time since Report of CAV (Years)
                                             ISHLT                            2011
                                    J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
FREEDOM FROM SEVERE RENAL DYSFUNCTION*
        For Pediatric Heart Recipients (Follow-ups: April 1994 - June 2010)

                    100



                        90
% Freedom from Severe
   Renal Dysfunction




                        80
                                 * Severe renal dysfunction = Creatinine > 2.5
                                 mg/dl (221 μmol/L), dialysis or renal transplant
                        70



                        60



                        50
                             0        1       2       3       4       5         6   7   8   9   10   11
                                                                       Years
                                 ISHLT                             2011
                        J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
FREEDOM FROM SEVERE RENAL DYSFUNCTION*
                        For Pediatric Heart Recipients (Follow-ups: 1999 - June 2010)
                                         Stratified by Tacrolimus vs. Cyclosporine Use
                                                 Conditional on Survival to 1 Year
                        100
% Freedom from Severe




                         90
   Renal Dysfunction




                                  p = 0.2590
                         80
                                  * Severe renal dysfunction = Creatinine > 2.5 mg/dl (221
                                  μmol/L), dialysis or renal transplant
                         70
                                        Cyclosporine use at discharge and 1 year (N = 934)
                                        Tacrolimus use at discharge and 1 year (N = 1,279)
                         60
                                        Cyclosporine use at discharge/Tacrolimus at 1 year (N = 276)
                                        Tacrolimus use at discharge/Cyclosporine at 1 year (N = 32)

                         50
                              0           1         2          3          4          5        6        7   8
                                                                        Years
                              ISHLT                                2011
                         J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
  FREEDOM FROM RENAL REPLACEMENT THERAPY*
         For Pediatric Heart Recipients (Follow-ups: April 1994 - June 2010)

                   100



                       90
% Freedom from Renal
Replacemetn Therapy




                       80
                                * Renal replacement therapy = dialysis or renal transplant

                       70



                       60



                       50
                            0        1       2       3      4       5          6    7        8   9   10   11
                                                                     Years
                                ISHLT                            2011
                       J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
MALIGNANCY POST-HEART TRANSPLANTATION FOR PEDIATRICS
Cumulative Prevalence in Survivors (Follow-ups: April 1994 - June 2010)

 Malignancy/Type                                 1-Year             5-Year            10-Year
                                                Survivors          Survivors         Survivors
 No Malignancy                                 4,026 (98.2%)      1,717 (95.1%)      488 (92.2%)

 Malignancy (all types combined)                 72 (1.8%)          89 (4.9%)         41 (7.8%)

 Malignancy                       Lymph                      67                 84           38
       Type                                                   4                  5                4
                                    Other
                                     Skin                     0                  1                1

                  Type Not Reported                           1                  0                0



                    NOTE: Multiple types may be reported; sum of types
                    may be greater than total number with malignancy.

        ISHLT                                2011
    J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                                      FREEDOM FROM MALIGNANCY
                   For Pediatric Heart Recipients (Follow-ups: April 1994 - June 2010)

                            100
% Freedom from Malignancy




                            95




                            90



                            85

                                           All malignancy              Lymph          Skin            Other


                            80
                                  0    1      2       3     4      5       6      7   8      9   10       11   12   13
                                                                           Years

                                      ISHLT                             2011
                              J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                                      FREEDOM FROM MALIGNANCY
              For Pediatric Heart Recipients (Follow-ups: April 1994 - June 2010)
                                              Stratified by Tacrolimus vs. Cyclosporine Use
                                                      Conditional on Survival to 1 Year
                            100
                                                                                                         p = 0.0061
% Freedom from Malignancy




                            95


                            90


                            85


                            80
                                               Cyclosporine use at discharge and 1 year (N = 915)
                                               Tacrolimus use at discharge and 1 year (N = 1,192)
                            75
                                               Cyclosporine use at discharge/Tacrolimus at 1 year (N = 273)
                                               Tacrolimus use at discharge/Cyclosporine at 1 year (N = 31)
                            70
                                  0       1          2         3         4            5      6          7        8    9
                                                                             Years
                                      ISHLT                            2011
                              J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                                     FREEDOM FROM LYMPHOMA
             For Pediatric Heart Recipients (Follow-ups: April 1994 - June 2010)
                                   Stratified by Induction
                          100
% Freedom from Lymphoma




                          95

                                           p = 0.8355

                          90



                          85
                                                  Induction (N = 1,727)
                                                  No Induction (N = 1,885)
                          80
                                0     1       2         3      4       5       6    7   8   9   10   11
                                                                    Years

                                    ISHLT                            2011
                            J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
      PEDIATRIC HEART RECIPIENTS
        Incidence of Hypertension between 1 and 3 Years
              (Transplants: April 1993 - June 2007)

     Maintenance                   % HTN reported between 1 and
Immunosuppression at                         3 years
 discharge and 1 year                                                  P-value
                                     For Patients       For Patients
                                       on drug          not on drug
Azathioprine                              20.0             25.3        0.0415
Cyclosporine                              22.1             22.0        0.9823
MMF                                       24.8             22.3        0.3428
Prednisone                                29.0             12.8        <0.0001
Rapamycin                                 38.5             22.1        0.1784
Tacrolimus                                24.4             21.2        0.1997



    ISHLT                                2011
J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
      PEDIATRIC HEART RECIPIENTS
Incidence of Hypertension between 3 and 5 Years
                 (Transplants: April 1993 - June 2005)

     Maintenance                   % HTN reported between 3 and
Immunosuppression at                         5 years
 discharge and 1 year                                                  P-value
                                     For Patients       For Patients
                                       on drug          not on drug
Azathioprine                              13.8             20.8        0.0339
Cyclosporine                              16.1             19.3        0.3655
MMF                                       19.9             15.9        0.2579
Prednisone                                21.4              7.2        <.0001
Rapamycin                                 25.0             17.3        0.5340
Tacrolimus                                17.9             16.2        0.6212



    ISHLT                                2011
J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
           PEDIATRIC HEART RECIPIENTS
Relationship of Rejection and Coronary Artery Vasculopathy
            (Follow-ups: July 2004 – June 2010)


        Rejection            Reported CAV between 1st and 3rd years
        During 1st                      post-transplant
          Year
                                   Yes                   No     All
            Yes                    13                    239     252
                                  5.2%                  94.8%   100%
             No                    17                    387     404
                                  4.2%                  95.8%   100%



                                        p = 0.5707

    ISHLT                                2011
J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
      KAPLAN-MEIER SURVIVAL RATES FOR PEDIATRIC HEART
   RETRANSPLANTS STRATIFIED BY INTER-TRANSPLANT INTERVAL
             Re-transplants: January 1994 - June 2009
                             <1 Year (N=54)                1-<3 Years (N=39)                 3-<5 Years (N=50)
                             5+ Years (N=166)              Primary TX (N=6,054)
                100
                                                                              Comparison of survival for
                                                                              re-transplant groups: p = 0.0019
                90
Surrvival (%)




                80

                70

                60

                50

                40
                       0       0.5       1       1.5       2       2.5         3       3.5          4         4.5          5

                                        Time (years) since most recent transplant

                           ISHLT                               2011
                                                                                    Only patients who were less than 18 years
                                                                                    old at the time of re-transplant are included.
                      J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                             PEDIATRIC HEART RE-TRANSPLANTS
                                                            By Transplant Year
                                        Re-transplants: January 1994 – December 2009
                        40

                        35
Number of transplants




                        30

                        25

                        20

                        15

                        10

                         5

                         0
                           94

                                  95

                                         96

                                                97

                                                       98

                                                              99

                                                                     00

                                                                            01

                                                                                   02

                                                                                          03

                                                                                                 04

                                                                                                        05

                                                                                                               06

                                                                                                                      07

                                                                                                                             08

                                                                                                                                    09
                         19

                                19

                                       19

                                              19

                                                     19

                                                            19

                                                                   20

                                                                          20

                                                                                 20

                                                                                        20

                                                                                               20

                                                                                                      20

                                                                                                             20

                                                                                                                    20

                                                                                                                           20

                                                                                                                                  20
                                                                      Year of re-transplant
                                 ISHLT                                      2011                  Only patients who were less than 18 years
                                                                                                  old at the time of re-transplant are included.
                             J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                       PEDIATRIC HEART RE-TRANSPLANTS
                                                  By Inter-transplant Interval
                                          Re-transplants: January 1994 - June 2010
                      50

                                     0-10 Years         11-17 Years
% of Re-Transplants




                      40


                      30


                      20


                      10


                       0
                              <1 month           1-<12           12-<36           36-<60         60+ months Not reported
                                                months           months           months
                                          Time Between Previous and Current Transplant

                                ISHLT                                   2011     Only patients who were less than 18 years old at
                                                                                 the time of re-transplant are included. Analysis is
                           J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132 based on the age at the time of re-transplant
          PEDIATRIC HEART TRANSPLANT RECIPIENTS:
                  Cause of Death (Deaths: January 1992 - June 2010)
 CAUSE OF DEATH        0-30 Days     31 Days - 1       >1 Year - 3       >3 Years - 5     >5 Years - 10    >10 Years
                       (N = 508)    Year (N = 479)   Years (N = 363)   Years (N = 271)   Years (N = 424)   (N = 264)
CORONARY ARTERY
                       5 (1.0%)       35 (7.3%)        71 (19.6%)        74 (27.3%)        113 (26.7%)     62 (23.5%)
VASCULOPATHY
ACUTE REJECTION        49 (9.6%)     112 (23.4%)       80 (22.0%)        35 (12.9%)        47 (11.1%)      15 (5.7%)
LYMPHOMA               1 (0.2%)       9 (1.9%)          13 (3.6%)         10 (3.7%)         36 (8.5%)      21 (8.0%)
MALIGNANCY, OTHER                     4 (0.8%)          4 (1.1%)          4 (1.5%)          12 (2.8%)      19 (7.2%)

CMV                    1 (0.2%)       12 (2.5%)         1 (0.3%)                                            1 (0.4%)

INFECTION, NON-CMV    60 (11.8%)     72 (15.0%)         28 (7.7%)         13 (4.8%)         19 (4.5%)      24 (9.1%)

PRIMARY FAILURE       111 (21.9%)     24 (5.0%)         12 (3.3%)         18 (6.6%)         23 (5.4%)       8 (3.0%)
GRAFT FAILURE         106 (20.9%)    56 (11.7%)        76 (20.9%)        67 (24.7%)        98 (23.1%)      59 (22.3%)

TECHNICAL              29 (5.7%)      4 (0.8%)          4 (1.1%)          3 (1.1%)          5 (1.2%)        6 (2.3%)

OTHER                  24 (4.7%)      30 (6.3%)         32 (8.8%)         23 (8.5%)         37 (8.7%)      18 (6.8%)

MULTIPLE ORGAN
                      51 (10.0%)     62 (12.9%)         12 (3.3%)         8 (3.0%)          14 (3.3%)      16 (6.1%)
FAILURE
RENAL FAILURE          1 (0.2%)       7 (1.5%)          1 (0.3%)          1 (0.4%)          2 (0.5%)        6 (2.3%)
PULMONARY              31 (6.1%)      35 (7.3%)         18 (5.0%)         11 (4.1%)         10 (2.4%)       5 (1.9%)

CEREBROVASCULAR        39 (7.7%)      17 (3.5%)         11 (3.0%)         4 (1.5%)          8 (1.9%)        4 (1.5%)




            ISHLT                                    2011
        J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
          PEDIATRIC HEART TRANSPLANT RECIPIENTS:
                       Cause of Death (Deaths: January 1998 - June 2010)
 CAUSE OF DEATH        0-30 Days     31 Days - 1      >1 Year - 3       >3 Years - 5     >5 Years - 10    >10 Years
                       (N = 259)   Year (N = 299)   Years (N = 239)   Years (N = 197)   Years (N = 358)   (N =257)
CAV                    2 (0.8%)      17 (5.7%)        39 (16.3%)        48 (24.4%)        92 (25.7%)      60 (23.3%)

ACUTE REJECTION       26 (10.0%)     56 (18.7%)       44 (18.4%)        27 (13.7%)        38 (10.6%)      15 (5.8%)
LYMPHOMA                              6 (2.0%)         8 (3.3%)          8 (4.1%)          30 (8.4%)      21 (8.2%)
MALIGNANCY,
                                      1 (0.3%)         3 (1.3%)          2 (1.0%)          10 (2.8%)      18 (7.0%)
OTHER
CMV                                   8 (2.7%)         1 (0.4%)                                            1 (0.4%)

INFECTION, NON-
                      32 (12.4%)     39 (13.0%)        19 (7.9%)         8 (4.1%)          15 (4.2%)      22 (8.6%)
CMV
PRIMARY FAILURE       54 (20.8%)     10 (3.3%)         6 (2.5%)          9 (4.6%)          15 (4.2%)       8 (3.1%)
GRAFT FAILURE         39 (15.1%)     35 (11.7%)       59 (24.7%)        58 (29.4%)        90 (25.1%)      57 (22.2%)

TECHNICAL             15 (5.8%)       1 (0.3%)         3 (1.3%)          1 (0.5%)          5 (1.4%)        6 (2.3%)

OTHER                 19 (7.3%)      25 (8.4%)        27 (11.3%)         16 (8.1%)         33 (9.2%)      18 (7.0%)

MULTIPLE ORGAN
                      33 (12.7%)     49 (16.4%)        11 (4.6%)         7 (3.6%)          12 (3.4%)      16 (6.2%)
FAILURE
RENAL FAILURE                         7 (2.3%)         1 (0.4%)          1 (0.5%)          2 (0.6%)        6 (2.3%)
PULMONARY             13 (5.0%)      32 (10.7%)        13 (5.4%)         9 (4.6%)          9 (2.5%)        5 (1.9%)

CEREBROVASCULAR       26 (10.0%)     13 (4.3%)         5 (2.1%)          3 (1.5%)          7 (2.0%)        4 (1.6%)



            ISHLT                                   2011
        J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
                              PEDIATRIC HEART TRANSPLANT RECIPIENTS:
                              Relative Incidence of Leading Causes of Death
                                                 (Deaths: January 1998 - June 2010)
                       40
                                    CAV       Acute Rejection      Infection (non-CMV)    Primary Failure   Graft Failure
Percentage of Deaths




                       30



                       20



                       10



                       0
                              0-30 Days (N 31 Days – 1          >1 Year – 3    >3 Years – 5 >5 Years – 10 >10 Years (N
                                 = 259)     Year (N =           Years (N =      Years (N =   Years (N =      = 257)
                                               299)                239)            197)         358 )



                                ISHLT                                2011
                            J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132

				
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