J Heart Lung Transplant 2004; 23: 1027-1034 Continuous Patient Characteristics at Hospital Admission...

J Heart Lung Transplant 2004; 23: 1027-1034

Continuous Patient Characteristics at Hospital Admission

Measurement Mean Minimum Maximum Std. Error

Age at admission 50.27 10 79 0.68

Weight (kg) at admission

81.79 7 165.7 0.93

BSA at admission 1.96 1.28 2.57 0.01

Table I

BSA, body surface area


Primary Device Implant

LVAD (alone) 339

Pulsatile flow, chronic device 303

Continuous flow, chronic device 27

Not specified 9

LVAD + RVAD 74

LVAD: Pulsatile flow, chronic device 69

LVAD: Continuous flow, chronic device 1

LVAD: Not specified 4

RVAD: Pulsatile flow, chronic device 44

RVAD: Pulsatile flow, temporary device 21

RVAD: Continuous flow, temporary device 8

RVAD: Not specified 1

Total 413

Table III


Intention to Treat

Category # of patients

% of all patients

Bridge to transplant 312 75.5%

Bridge to recovery 24 5.8%

Destination Therapy, Advanced age 19 4.6%

Destination Therapy, Co-morbidity 12 2.9%

Destination Therapy, Fixed Pulmonary Hypertension 3 0.7%

Destination Therapy, Contraindication to Transplant 1 0.2%

Not specified 7 1.7%

Table IV


Major Causes of Death

Cause n % of 105

Multiple organ failure 28 27%

Hemorrhage 17 16%

Cardiovascular 11 10%

Stroke 10 10%

Infection 7 7%

Other 23 22%

Unspecified 9 9%

Total 105 100%

Table VI


Risk Factors for Death after Device ImplantRisk Factor Relative Risk P-value

EARLY PHASE OF HAZARD

Blood type: AB 4.7 .004

Diagnosis other than Cardiomyopathy 3.5 .001

BUN at implant 1.9 (20 vs 120) .04

Concurrent placement of RVAD 7.4 <.0001

CONSTANT PHASE OF HAZARD

Older age 2.7 (30 vs 60) .02

Gender: female 2.8 .002

*Patients are censored at transplant

BUN, Blood Urea Nitrogen

Table VII


Death before transplant

Transplant Explant-recovery

Reason for Implant

n n % n % n %

Bridge to transplant

312 79 25% 145 46% 8 6%

Bridge to recovery

24 7 29% 2 8% 8 66%

Destination 35 10 29% 2 6% 0 -

Other 7 2 29% 0 - 2 29%

Unknown 35 7 20% 15 43% 0 -

Total 413 105 25% 164 40% 18 4%

Table VIII ISHLT/MCSD RegistryJanuary 2002 – May 2004, n=413


Summary of Post-Implantation Patient-related Events

Event # of Patients % of all Patients

Infection 134 32.5%

Bleeding 115 27.8%

Arrhythmia 100 24.2%

Renal dysfunction 85 20.6%

Respiratory dysfunction 66 16.0%

Neurological dysfunction 58 14.0%

Right ventricular dysfunction 44 10.7%

Hepatic dysfunction 30 7.2%

Cardiac tamponade 22 5.3%

Thrombotic vascular complication 18 4.4%

Hematoma 10 2.4%

Pleural effusion 9 2.2%

Internal organ compromise 5 1.2%

Pacemaker implanted 2 0.5%

Table IX


Device Malfunction

Event # of EventsController 16

Pump/pump drive unit 7

Conduit/graft inflow 5

Conduit/graft outflow 2

Valve/valved conduit inflow 2

Battery 1

Implanted battery 1

Percutaneous lead/drive line 1

Other 19

Total 54

Table X


0

10

20

30

40

50

60

70

80

90

100

0 1 2 3 4 5 6 7 8 9 10 11 120.00

0.05

0.10

0.15

0.20

0.25

ISHLT/MCSD Analysis: Jan 2002 – May 2004n=413, 105 deaths

Per

cen

t S

urv

ival

Months after Device Implant

De

ath

s / Mo

nth

Event: Death after Implant *

* censored at transplant

Hazard

Months % Survival1 84 %3 76 %6 68 %12 55 %

(279)

(140)

(78)(33)

Figure 1


0

10

20

30

40

50

60

70

80

90

100

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

p < .0001

Per

cen

t Su

rviv

al


LVAD only (n=339)

LVAD + RVAD at the same operation (n=74)

ISHLT/MCSD Analysis: Jan 2002 – May 2004n=413, 105 deaths

Primary Device Implant:

Event: Death after Implant

Figure 2


0

10

20

30

40

50

60

70

80

90

100

0 10 20 30 40 50 60 70 80 90 100 110 120

ISHLT/MCSD Analysis: Jan 2002 – May 2004n=413

BUN at Implant

Pre

dic

ted

% M

ort

alit

y a

t 3

mo

nth

s

LVAD + RVADat the same operation

LVAD (alone)

Primary Device Implant:

Figure 3


0

10

20

30

40

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60

70

80

90

100

0 1 2 3 4 5 6 7 8 9 10 11 120.00

0.05

0.10

0.15

0.20

0.25

Per

cen

t fr

eed

om

fro

m E

xpla

nt

(du

e to

rec

ove

ry)


Exp

lant d

ue to

recovery / M

on

th ISHLT/MCSD Analysis: Jan 2002 – May 2004

n=413, 18 Explants due to recovery

Event: Device Explant due to Recovery

Hazard

(285)(150)

(81)(21)

Figure 4


0

10

20

30

40

50

60

70

80

90

100

0 1 2 3 4 5 6 7 8 9 10 11 120.00

0.05

0.10

0.15

0.20

0.25

Per

cen

t fr

eed

om

fro

m T

ran

spla

nta

tio

n


Tra

ns

plan

ts / M

on

th ISHLT/MCSD Analysis: Jan 2002 – May 2004

n=413, 164 transplants

Event: Transplantation

Hazard

Months % Freedom1 90 %3 67 %6 43 %12 22 %

(279)

(140)

(72)

(18)

Figure 5


Instantaneous Event Rates:

0.00

0.05

0.10

0.15

0.20

0.25

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

Ev

ents

/ M

on

th


Death *

Transplantation

Explant due to recovery

* Censored at transplant

ISHLT/MCSD Analysis: Jan 2002 – May 2004n=413, Death, Transplant, Recovery

Figure 6


0

10

20

30

40

50

60

70

80

90

100

0 1 2 3 4 5 6 7 8 9 10 11 12Months after Device Implant

Pro

po

rtio

n o

f P

atie

nts

MCSD Study: Jan 2002 – May 2004Competing Outcomes Analysis (n=339)

Primary Implant: LVAD only

Alive (Still waiting)

Death (before transplant)

Explanted (recovery)

Transplanted

30 %

44 %

23 %

3 %11 %

59 %

26 %

4 %

Figure 7


MCSD Study: Jan 2002 – May 2004Competing Outcomes Analysis (n=74)

Primary Implant: LVAD + RVAD at the same operation

0

10

20

30

40

50

60

70

80

90

100

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


Pro

po

rtio

n o

f P

atie

nts

Alive (Still waiting)

Death (before transplant)

Explanted (recovery)

Transplanted

14 %

33 %

43 %

10 %3 %

36 %

48 %

13 %

Figure 8


0.0

0.5

1.0

1.5

2.0

0 1 2 3 4 5 6 7 8 9 10 11 12Months after Device Implant

Cu

mu

lati

ve E

ven

ts p

er P

atie

nt


Bleeding events (n=282)

Infection events (n=304)

Thromboembolism (n=59)

Figure 9


0

10

20

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40

50

60

70

80

90

100

0 1 2 3 4 5 6 7 8 9 10 11 120.00

0.05

0.10

0.15

0.20

0.25


Per

cen

t F

reed

om

fro

m D

evic

e M

alfu

nct

ion


Months % Freedom1 95 %3 89 %6 79 %12 60 % Hazard

De

vic

e A

dve

rse

Ev

en

ts /

Mo

nth

(285)(132)

(70)

(30)

Figure 10

J Heart Lung Transplant 2004; 23: 1027-1034 Continuous Patient Characteristics at Hospital Admission...

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Transcript of J Heart Lung Transplant 2004; 23: 1027-1034 Continuous Patient Characteristics at Hospital Admission...