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ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655
178 Deaths
* censored at transplant
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 S
urv
ival
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
ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655
0
10
20
30
40
50
60
70
80
90
100
10 20 30 40 50 60 70 80Pre
dic
ted
% M
ort
alit
y a
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
J Heart Lung Transplant 2005;24:1182-1187
ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 (n=655)
0
50
100
150
200
250
300
0 1 2 3 4 5 6 7 8 9 10 11 12
Cu
mu
lati
ve E
ven
ts p
er
100
Pa
tie
nts
Months after Device Implant
Bleeding Episodes (n=396)
Infection Episodes (n=668)
Thromboembolism Episodes (n=86)
75
175
18
ISHLT 2005
J Heart Lung Transplant 2005;24:1182-1187
ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655
66 Patients with Major Device Malfunction
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 F
reed
om
fro
m
Maj
or
Dev
ice
Mal
fun
ctio
n
Months after Device Implant
Majo
r Device A
dverse E
vent / M
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
J Heart Lung Transplant 2005;24:1182-1187
Months after Device Implant
Alive (Still waiting)
Death (before transplant)
Explanted (recovery)
Transplanted
33 %
51 %
10 %
6 %7 %
74 %
13 %
6 %Pr
opor
tion o
f Pati
ents
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
0 1 2 3 4 5 6 7 8 9 10 11 12Months after Device Implant
Alive (Still waiting)
Death (before transplant)
Explanted (recovery)
Transplanted
27 %
39 %
33 %
.4 %10 %
50 %
37 %
2 %
Prop
ortio
n of P
atien
ts
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
0 1 2 3 4 5 6 7 8 9 10 11 12
ISHLT/MCSD Analysis: Jan 2002 – Dec 2004 Bridge to Transplant
Age > = 50 (n=292) Age < 30 (n=52)
ISHLT 2005
J Heart Lung Transplant 2005;24:1182-1187
ISHLT/MCSD Analysis: Jan 2002 – Dec 2004
Intent to Treat: Bridge to Recovery (n=35)
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
0 1 2 3 4 5 6 7 8 9 10 11 12
Months after Device Implant
Pro
po
rtio
n o
f P
atie
nts Alive
(Still waiting)
Death (before transplant)
Explanted (recovery)
Transplanted17 % 12 %
27 %
45 %
5 %
12 %
37 %
45 %
ISHLT 2005
J Heart Lung Transplant 2005;24:1182-1187
ISHLT/MCSD Analysis: Jan 2002 – Dec 2004
Intent to Treat: Destination Therapy (n=78)
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
0 1 2 3 4 5 6 7 8 9 10 11 12
Months after Device Implant
Pro
po
rtio
n o
f P
atie
nts
Alive
Death
Explanted (recovery)Transplanted
65 %
2 %
33 %
0 %
34 %
11 %
55 %
0 %
ISHLT 2005
J Heart Lung Transplant 2005;24:1182-1187
Months after Device Implant
Alive (Still waiting)
Death
Explanted (recovery)
48 %
52 %
0 %
26 %
74 %
0 %Pr
opor
tion o
f Pati
ents
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
0 1 2 3 4 5 6 7 8 9 10 11 12
Months after Device Implant
Alive (Still waiting)
Death
Explanted (recovery)
83 %
13 %
0 %
41 %
39 %
0 %
Transplanted4 %
20 %Prop
ortio
n of P
atien
ts
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
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
J Heart Lung Transplant 2005;24:1182-1187
* 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/MCSD Analysis: Jan 2002 – Dec 2004, n=655
ISHLT 2005
J Heart Lung Transplant 2005;24:1182-1187
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/MCSD Analysis: Jan 2002 – Dec 2004, n=655
ISHLT 2005
J Heart Lung Transplant 2005;24:1182-1187
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/MCSD Analysis: Jan 2002 – Dec 2004, n=655
ISHLT 2005
J Heart Lung Transplant 2005;24:1182-1187
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
J Heart Lung Transplant 2005;24:1182-1187
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
J Heart Lung Transplant 2005;24:1182-1187
ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655
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
J Heart Lung Transplant 2005;24:1182-1187
ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655Intent to Treat: Bridge to Recovery
* Type of VAD not specified in 4 patients
Primary Device Implant n
LVAD (alone) 21* Pulsatile flow, chronic device 16 Continuous flow, chronic device 1
LVAD + RVAD Combinations 14
Total 35
ISHLT 2005
J Heart Lung Transplant 2005;24:1182-1187
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/MCSD Analysis: Jan 2002 – Dec 2004, n=655
ISHLT 2005
J Heart Lung Transplant 2005;24:1182-1187
ISHLT/MCSD Analysis: Jan 2002 – Dec 2004, n=655Intent to Treat: Destination Therapy
Primary Device Implant n
LVAD (alone) 74 Pulsatile flow, chronic device 71 Continuous flow, chronic device 3
LVAD + RVAD Combinations 3
TAH Pulsatile flow, chronic device 1
Total 78
ISHLT 2005
J Heart Lung Transplant 2005;24:1182-1187