ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 178 Deaths

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655

178 Deaths

* censored at transplant

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

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urv

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Months after Device Implant

De

ath

s / Mo

nth

Event: Death after Implant *

Months % Survival1 83 %3 74 %6 67 %12 50 %

(423)

(224)(137)

(32)

Hazard

ISHLT 2005

J Heart Lung Transplant 2005;24:1182-1187


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10 20 30 40 50 60 70 80Pre

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% M

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alit

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t 6

mo

nth

s

Age (years) at Device Implant

Primary Device Implant:

LVAD alone(left ventricular failure)

LVAD + RVADat the same operation(biventricular failure)

ISHLT 2005


ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 (n=655)

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Cu

mu

lati

ve E

ven

ts p

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100

Pa

tie

nts


Bleeding Episodes (n=396)

Infection Episodes (n=668)

Thromboembolism Episodes (n=86)

75

175

18

ISHLT 2005



66 Patients with Major Device Malfunction

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ice

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dverse E

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on

th

Event: Death after Implant *

* censored at transplant

Months % Survival1 95 %3 92 %6 84 %12 66 %

(410)(212)

(122)

(38)

Hazard

ISHLT 2005



Alive (Still waiting)

Death (before transplant)

Explanted (recovery)

Transplanted

33 %

51 %

10 %

6 %7 %

74 %

13 %

6 %Pr

opor

tion o

f Pati

ents

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0.9

1.0

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




Transplanted

27 %

39 %

33 %

.4 %10 %

50 %

37 %

2 %

Prop

ortio

n of P

atien

ts

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ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 Bridge to Transplant

Age > = 50 (n=292) Age < 30 (n=52)

ISHLT 2005


ISHLT/MCSD Analysis: Jan 2002 – Dec 2004

Intent to Treat: Bridge to Recovery (n=35)

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Pro

po

rtio

n o

f P

atie

nts Alive

(Still waiting)



Transplanted17 % 12 %

27 %

45 %

5 %

12 %

37 %

45 %

ISHLT 2005


ISHLT/MCSD Analysis: Jan 2002 – Dec 2004

Intent to Treat: Destination Therapy (n=78)

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po

rtio

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f P

atie

nts

Alive

Death

Explanted (recovery)Transplanted

65 %

2 %

33 %

0 %

34 %

11 %

55 %

0 %

ISHLT 2005




Death


48 %

52 %

0 %

26 %

74 %

0 %Pr

opor

tion o

f Pati

ents

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Death


83 %

13 %

0 %

41 %

39 %

0 %

Transplanted4 %

20 %Prop

ortio

n of P

atien

ts

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

ISHLT/MCSD Analysis: Jan 2002 – Dec 2004Destination Therapy

Age < 65 (n=37) Age >= 65 (n=41)

ISHLT 2005


* Type of VAD not specified in 16 patients

Primary Device Implant n

LVAD (alone) 542* Pulsatile flow, chronic device 487 Continuous flow, chronic device 39

LVAD + RVAD Combinations 100

TAH Pulsatile flow, chronic device 13

Total 655


ISHLT 2005


Intention to Treat n % of 655

Bridge to transplant 513 78.3%

Bridge to recovery 35 5.3%

Destination Therapy 78 11.9%

Not specified 29 4.4%

Total 655 100%


ISHLT 2005


Major Causes of Death n % of 178

Multiple organ failure 62 34.8%

Hemorrhage 27 15.2%

Cardiovascular 22 12.4%

Stroke 18 10.1%

Infection 14 7.9%

Pulmonary 9 5.1%

Other 24 13.5%

Unspecified 2 1.1%

Total 178 100%


ISHLT 2005


ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655Risk factors for death* after device implant

Risk Factor Relative Risk P-value

EARLY PHASE OF HAZARD

Concurrent placement of RVAD 4.89 <.0001

Age (older) 3.13 <.0001

Female 2.53 .0003

Platelet count (lower) 2.13 .02

WBC count (higher) 2.01 .008

Blood type A 1.89 .008

CONSTANT PHASE OF HAZARD

Diabetes 2.01 .01

Ventilator (pre-implant) 1.84 .03

Creatinine (higher) 1.64 .05

*Patients are censored at time of transplant.

ISHLT 2005


ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655Summary of Post-Implantation Patient-related Events

Event # of Patients % of all PatientsInfection 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%

ISHLT 2005



Major Device Malfunctions n

Controller 31 Pump/pump drive unit 14Pump thrombosis 13Pump inflow 11 Percutaneous lead/drive line 4Pump outflow 4Cannula dislodgement 1 Power base electrical malfunction 1 Pump stoppage 1Other 3

Total Events 83

66 Patients with 83 major device malfunctions

ISHLT 2005


ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655Intent to Treat: Bridge to Recovery

* Type of VAD not specified in 4 patients


LVAD (alone) 21* Pulsatile flow, chronic device 16 Continuous flow, chronic device 1


Total 35

ISHLT 2005


Indications for Destination Therapy n % of 78

Advanced age 38 48.7%

Co-morbidity 28 35.9%

Fixed pulmonary hypertension 8 10.3%

Contraindication to immunotherapy 2 2.6%

Patient refuses transplant 2 2.6%

Total 78 100%


ISHLT 2005


ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655Intent to Treat: Destination Therapy


LVAD (alone) 74 Pulsatile flow, chronic device 71 Continuous flow, chronic device 3


TAH Pulsatile flow, chronic device 1

Total 78

ISHLT 2005


ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655 178 Deaths

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