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SURGICAL OPTIONS FOR THE TREATMENT OF HEART FAILURE - PART 6 potx

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Adult heart retransplanlatton !-year survival by interval from first transplantation.. Figure 10 presents 5-year actuarial survival rates for those retransplantations done within and bey

Trang 1

96 J-D: Hosenpud et at

\A%

17.3%

7,2% 50.4%

61-<1 Ys 1-5 Years i45Years

•CongBnital BOlhet •Myopathy OReTK

Figure 6 Pediatric heart transplantation indications by age Rett = Retransplantation

cardiomyopatliy and patisnts with coronarv' lulery disease Figures 5 and 6 present tlie indications for pedia.tnc heart tra.nspIantation (age < 16 years), first a.s overall uidications, indications by yeai- for the two major indications, and finally indications by age of Ihc recipient Congenital heait disea-se is the most common indication for transplantation in the pediatric population and has been since 1989, As anticipated, congenital heart disease makes up close to 75% of the transplan^iations in the less than 1 year age group, 3'et less

than 30% m the older aged children

Figure 7 presents tie actuarial suri'ival rate after heart transplantation over a

13^yeai-penod 'Die overall 1-ycar siu-^ival rate for heart transplantation is 79% The patient V2 lite (time to 50% sim'ival) is 8.7 years and m those surviving tlie firet year, the patient V2 He is

11.4 years The falloff in sur\'ival is almost a straight luie firom year 1 through 14 witli a constant mortality rate of 4% per year

The next series of figiu'es represent actumal sur>;ival rates for yeai" of transplantation, recipient age, and retransplantation Figure 8 demonstjates 5-year actuarial son-ival rates over the past ] 7 yeai's broken down m ,3-ycar time blocks There was a substantial increase

in more recent patients, compared with those who underwent transplantation fi^oin 1980 to

1985 There is a marginal but statisticahy significant fuitlier increase in survival rates comparmg tic last 5 years of the 1980s with patients who imdeweiit transplantation from

Haif-lif8=8,7 yrs Ccnd, tialf-llfe=11,4yre

7 8 8 10 11 12 13 14 Years Post Transplantation

Hgnre 7 Total heart transplantation actuarial survival

Trang 2

100

90

80

70

60

50

40

•'^'Sj-1980-1985 Ha)f4ife=5.3 yrs 1986-1990 ttalfnife=8.8yrs 1991-1997 Half-life=9.4yrs

" " - 5 J J I » i m j j j „

i80-85vs 86-90: p=<,0001

• ' - " * ' "• p=<.OI)Of

p=<.0001 i80-85vs 91-97:

86-90 «s 91-97:

0 5 10 15 20 25 30 35 40 45 50 55 60

Months Post Transplantation

• 1980-1985 » 1986-1990 » 1991-1997 N=2,207 N=-,2,80! N=2:,97-;

Figure 8 Aduh hean transplantation actuarial f-annval by era

Monttis Post Transplantation

• <45 Years u 4S-54 Years -+ 55-64 Years •» >=65 Years

N = m i 9 5 N-12 769 N=12.J86 N=1 291

Figure f Adult heart transplantation actuarial survival by age

0 6 12 18 24 30 36 42 48 54 60

ivionths Post Transplantation + Retransplant < 9 MO » Retransplant > 9 MO o Overall Retransplants

N=484 N=415 N=899

Trang 3

98 J.D Hosenpudetal

3? 100

03

>

d

-:

rn

r

ID

TO

k_

to

0)

>

an

tjO

40

20

3^ 7-12 13-24 25-36 37-48 4a«) 61-84 85+

Inter-transplart interval (months)

Figure 11 Adult heart retransplanlatton !-year survival by interval from first transplantation

1991 onward Figure 9 demonstrates actuarial survival rates broken down by recipient age group There is a statistically significant decrease in survival for each increase in decade

of life, with a clinically significant decrease in those patients over age 65 years The actuarial survival rate for adult retransplantation is displayed in Figures 10 and 11 Figure

10 presents 5-year actuarial survival rates for those retransplantations done within and beyond 9 months after the initial transplantation Figure 11 presents the average (± 95% confidence intervals) 1 -year survival rate depending on the interval between first and second transplantation As can be seen, there is a progressive increase in survival rates with increased time between operations Those patients who underwent transplantation after 2 years have 1-year survival rates of approximately 70%, still lower than priman transplantation

Tables I and 11 show multivariate logistic regression analyses for adult cardiac allogratt recipients perfonned on all patients in the Registry having complete data In this analysis, the end points are 1 - and 5-years survival rates As has been previously shown in prior Registry reports, the vast majority of risk factors known to affect 1 -year mortality persist at the 5-year time point as a result of their profound effects early on Recipient factors that have a statistically significant negative impact include prior transplantation, requiring a venU-icular assist device or ventilator support before transplantation, and increasing age Recipient factors that have a positive impact include diagnosis of either coronan artery disease or cardiomyopathy and ABO blood group A Center factors that

are negative include low volume, and donor factors include increasing ischemic time, donor sex, iuid age In this report (as with last year's report) donor and recipient age, as well as ischemic time, were analyzed as a)ntinuous variables and dcTnonstrate a highly statisticalh significant increasing risk with increasing values

Figure 12 demonstrates survival rates after pediatnc heart transplantation overall and IS broken down by age groups The older age pediatric group has sur\ival rates nearly identical to the adult population, whereas those with the worst outcome are less than 1 year of age Patients 1 to 5 years of age have intermediate survival rates

Trang 4

Registry -oflnt 'I Soc for Heart <S Lung Tmnsplaniation: 15''^ Official Report '98 9 9

T a i l e 1 Risk factors, for I-year mortality aftcsr adult heart transplantation

Negative recipient factors

Ventilator 2.66

Repeat T x 2.33

VAD IA<J

Ctrvol" :9TX/YR 1.3

Female, donor 1.2'!^

Positive reeipiettt factors

AEO.iypsA -0,9

CAD 0.79

CM 0.71

Isctieiiiic time linear

lschefnic'time:(0} QJS

Ischeniictlme (2)'' 0.93

Ischemic time (4)- 1.1 S

rseliemic time (6)' 1 .43

rscliemic4'i!ae:(.S) 1 7S

Recip age (linear)

Recip age 20 0.S5

KecipageSO' O.XS:

Recip.agc.40 0.8?:

Reeip.-age 50 1

Recip age 50 1,19

Recip age 70 1,5'

Donor age (linear)

Donor age JO- 0\t9

'Donor age \10

.0,9.9-Donor age 4.0' 1.18

Donor age 50 1 48:

Donor age'6Q 1.99

,2.20-3.2!

1,80-3.01 1.23-1,SO 1 15-1.47 1.11-1,33 0,83.0:9S fl.8-8-0.93 0.:60-0.83 0.67-0.83:

0.90-0.-95 1.09-1.22 1.25-1.64 1.43-2.22 0.'69-1.06:

0.76-0.94 0.85-0.93 LOW.OO 1.11-1.27

•1.26-1,?<)•

0.84-0:95 0.99-1,00 1 14-1.22 1.34-1.64 159-2.48

0 0001

0 01^01

onooi

0 0001

0 OOOI OOl

0 005 (.IHIiIl

0 CIIJOI

<a.ooo;l

•<0.0001

T%^Jransplantation'^ VAB, V^asmlar

CM, •cnrdiomyffpaihy^ Recip, mapient device; Ctr viA,.Gmter volsira^,.CAD, comnnry-artery dh^me

l<1 vs6 15 p='f»00!

1 18 i 4 30 3o 42 4'J

Months Post Trahsplantalion, -•••<1Yea.r -u 1-5 Tears.- ©:.S 15Yea« »-Overall

N-=1.01-0- N=71-8 N = ! , 2 » l<J=3.,1319

Figure 12 Pediatric heart (rampkmtalkm 'actuarial 'mtvivai by age

Trang 5

1 0 0 J D Hosenpud et al

Table 2 Risk factors for 5 year mortality after adult heart transplantation

Variable

Repeal Tx

Ventilator

Ctr vol 9 Tx,yr

Female donor

Ischemic time (linear)

Ischemic lime (0)

Ischemic time (2)

Ischemic time (4)

Ischemic time (6)

Ischemic time (8)

Recip age (linear)

Recip age 20

Recip age 30

Recip age 40

Recip age 50

Recip age 60

Recip age 70

Donor age (linear)

Donor age 20

Donor age 30

Donor age 40

Donor age 50

Donor age 60

l>onor age 60

Odds ratio

3.08 1.78 1.29 1.15 0.77 0.94 1.13 1.37 1.66 1.21 0.99 0.93

1 1.22 1.71 0.89 0.99 1.19 1.53 2.21 2.21

95% Confidence interval p Value

2.34-4.05 1.40-2,27 1.14-1.47

1 04-1.28 0.68-0.88 0.91-0.97 1.06-1.21 1.17-1.60 1.29-2.13 0.97-1.51 0.89-1.10 0.89-0.97 1.00-1.00 1.10-1.31 1.40-2.09 0.83-0.94 0.99-1,00 1.14-1.25 1.34-1.76 1.57-2.82 1.78-2.75

0.0001

• 0.0001 0.0001 0.006 0.0001

0.0001

0.0001

Tx Transplanlatwn Ctr vol center volume Recip, recipient ' 9.536

Tables III and IV demonstrate the multivariate logistic regression analysis of risk at 1 and

5 years for pediatric heart transplantation Similar to the adult population, repeat transplantation, ventricular assist device, and ventilator mechanical support carry the greatest risks Other risk factors include very young age, congenital heart disease, low center volume, and donor age Interestingly, recipient age risk m the pediatric population

is also linear, but in this ca.se, the risk is inversely correlated to age At 5 years, recipient age is no longer a nsk factor, but recipient se.x (female) becomes one

In this year's report, morbidity' data at both 1 and 3 years are presented The data set for these analyses include worldwide data from 1994 onward ( U S data only for employment status) Figures 13 and 14 demonstrate the acti\ity levels and employment status of paticiits 1 iind 3 years after transplantation Most of the patients are considered to have no limitations in function, yet less than 40% are working (does not include those retired)

Figure 15 demonstrates the percent of patients requiring hospitalization alter the initial transplantation, with approximately 18% still requiring a hospitalization between the second and third years after tran.splantation

Figures 16 to 18 outline incidences of other morbid conditions in the first 3 years after tran.splantation, including drug-treated hypertension, renal dysfunction, drug-treated

Trang 6

Registry of bit 1 Soafor Heart A Lung Transplantation: 15'" Official Report '98 101

Table 3 Risk factors for 1 year mortality in pediatric heart transplantation

Variable Odds ratio 95% Confidence interval p Value

Retransplmt

lABP/VAD

Ventilator

Congenital

Ctr vol <9 Tx,'>T

Becip age (linear)

Recip age 0

Recip age 3

Recip age 6

Recip age 12

Recip age 17

Donor age (quadratic)

Donor age 0

Donor age 10

Donor age 20

Donor age 30

Donor age 40

Donor age 50

2.55 2.54 1.5

1.41

1.36 1.39 1.2 1.03 0.75 0.58

1.08

1 1.07

1.33

1.89

3.11

1.44-4.51 1.17-5.51 1.24-2.0C 1.10-2.80 1.08-1.71

1.21-1.61 1.11-1.29 1.01-1.04 0.67-0.85 0.46-0.73 1.03-1.13 1.00-1.00 1.02-1.12 1.10-1.60 1.24-2.87 0.87-7.86

<0.0001 0.02 0.0003 0.006 0.009

<0.0001

0.003

lAWjMraaomc balloon pump; VAD, vmcular assist device-, Ctr vol, cenler volume; Tx, transplantation; Recip, recipient

II = 20113,

T a b l e 4, Risk factors for 5 year mortality after pediatric heart transplantation

Variable Odds ratio 95% Confidence interval p Value

Retranisplant

Ventilator

Diagnosis-cong

Female recipient

Donor age (quadratic)

Donor age 0

Donor age 10

Donor age 20

Donor age 30

Donor age 40

Donor age 50

3.21 1.47 1.36 1.31 1.08

1

1.08 1.34 1,95 3,28

1.40-7.35 1.08-2.01 1.03-1.79 1.00-1.71

1.01-1.15 1.00-1.00 1.01-1.15 1.04-1.7.1 1.10-3.45 1.19-9.0S

0.006 0.02 0.03 0.05 0.03

, congemtal; n~ i 063

93.5%

1.4%

8.5%

O.B%

5 8%

1 Year Followup 3 Year Follovjup

• No Activity Limitations nPerforms witli Assistance •Total Assistance

Trang 7

102 / D Ilosenpud et al

47.1 39J ^ - ' A

1 Year Followup 3 Year Followup

•Working Full Time S Working Part Time a Not Working HI Retired

Figure 14 Heart transplant recipient work status

5-i

:::•:• •

1 Year Followup

mi'/-• 7 1 %

4.8%

"if:

;::iE"

• • • : : : • • • • : : • } ? : : :

3 Year Followup

• No Hospitalization • H o s p , NoiRei ,'Not liifect T H o s p , Rejection

• Hosp, Infection • H o s p , Rej +Infect

Figure 15 Rehospifabzation after heart transplantation

HTN

No

33.7%

Yes

66.3%

No

29.7»/

Yes

70.3%

Renal

Dysfyni o°*

• N o Rsnai •ZJysfunclion IHHenal Dysf iliJCreatnine >?.5mg/dl • C n r o n i c Datv'sss

Figure 16 Hyperten-iiot: and renal dysjunction after heart transplantation HTN hypertension

Trang 8

Hyperiipder

Ni

64.1

D i a b e t e s

«

^"J

" ^ • ^ M "

-s , 1 ^ | P

Yes 45.6%

16 SK

r

F i g u r e 17 Hyperlipidemia and diabetes after heart transptantation

Malignancif

No

96.3»,-,

1 Year Foilowu,

^ ^ ^

No J I I M

92 4¥- IIIIIIJ^^

3 Year Foitowup i l l l l l P '

licA ?.(.•••

1 !1

Yes

3 7 % 0 ! • ••=; -••

2 5 ••••• •

Lynip'l NotRe-pora ' 5.0%

1 Ves

FigMi-e 18 Malignancy after heart transplantation

^WVear 1 llYiSar 3

^^^_

1

• ;

:i4.9%

1-1 51-1.7%

-\ -\ -\

r//

Trang 9

104 J.D Ilosenpiid et at

M u i t i o • , •••••• •••••••• ••' ^^*^^'

Other.Cardiac

31 Days-1 Year

•• • • •.•• -• • ; a r d i a c

CAl

Lymphom Malig, C

-1+ Year

Figure 20 Heart transplantation cause of death by time after tramplantation

CMV, Cytomegalovirus, CAV, cardiac allograft myopathy

hyperlipidemia, drag-treated diabetes, and malignancy Figure 19 demonstrates the inaiBtenance itninimosuppression in the population An increasing number of patients are being treated willi tacrolimus or mycophcnolatc mofetil, and more than 75% of patients arc still on corticosteroids at 3 years after transplantation

Figure 20 demonstrates the causes of death after heart transplantation (both adult and pediatnc) at three different time points with the entire data set Early after transplantation, nonspecific graft failure accounts for the largest proportion of deaths In the mtennediate penod, there is an approximately equal representation by aeute rejection and infection Late after transplantation the most common causes of death are cardiac allograft vasculopathy, malipancy, and, interestingly, acute rejection The other categoiy is made up of listed diagnoses not fitting into die more common categories

>

Figure 21 Heart-lung transplantation volumes and donor age hyyear

Trang 10

Registryof Int'lSoc for Heart & Lung Transplantation: 15'^' Official Report '98 105

50

S

'a

£ 30

H 20

^^ O

^ 10

0

>1 1-5 6-10 11-17 18-34 35-49 50-64

Age

Figure 22 Age distribution of heart-lung transplant recipients

Heart-Lung Tranplantatioii

Figure 21 shows tlie number of heart-lung trasnplantations reported to the registrv' from

1982 to 1997 and the average donor age over this period The number of heart-lung transplantations peaked in 1989 and has dechned thereafter Similar to heart, transplantation, donor age has continued to ri.se Figure 22 demonstrates the age distribution for heart-lung transplantation, with clustering between 18 and 49 years

Figure 23 demonstrates the indications for heart-lung Iran.splantation in the adull population The three most common indications are pulmonar}' hypertension, congenital heart disease, and cystic fibrosis

The 11-year actuanal survival rate for heart-keg transplantation is demonstrated m Figure 24 The 1 -year siir\'ival rate is approxmiately 60%, whereas tlie 11 -year survival rate

IS 21% The survival Vi life for the entire curve is 2.6 years because of the high first-year mortality rate The conditional Yi life for those sun-iving the first year is more than 8.4

years Tables V and VI demonstrate the multivariate logistic regression analysis of

lital 27,7%

PPH 25,9'

,1A 2,3%

ipp 2.' nnphysema 3,8%

ReTx 2.8"/

X., 15.6%

Misc 19.2%

Figure 23 Heart-lung transplant indications PPH, Primary pulmonary hypertension; AI,4, alpha,, antitrypsin: C¥ cystic fibrosis, MeTx, reinmsplantation, IPF, idiopathic pulmonary fibrosis

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