Cost-Effectiveness of Left Ventricular Assist Devices (LVADs) as Permanent Implants for End-Stage Heart Failure David Samson Blue Cross and Blue Shield Association Technology Evaluation Center, University at Albany Thanks to: Alan M. Garber Stanford University Gillian Sanders Duke University Naomi Aronson Blue Cross and Blue Shield Association Technology Evaluation Center Copyright 2004 Blue Cross Blue Shield Association
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Cost-Effectiveness of Left Ventricular Assist Devices (LVADs) as Permanent Implants for End-Stage Heart Failure David Samson Blue Cross and Blue Shield.
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Cost-Effectiveness of Left Ventricular Assist Devices (LVADs) as Permanent Implants for End-Stage Heart Failure
David Samson Blue Cross and Blue Shield Association
Technology Evaluation Center, University at Albany
Thanks to: Alan M. Garber Stanford University
Gillian Sanders Duke University
Naomi Aronson Blue Cross and Blue Shield Association Technology Evaluation Center
Copyright 2004 Blue Cross Blue Shield Association
Copyright 2004 Blue Cross Blue Shield Association
Rose et al.NEJM, 2001;345:1435
REMATCH Trial
REMATCH: destination therapy, in contrast to bridge to transplant
129 patients with NYHA Class IV end-stage heart failure,
contraindications for heart transplantation, randomized to LVAD or
optimal medical management (OMM)
Median survival: LVAD - 408 d, OMM - 150 d ( 8.5 mo, p=0.001)
Rate of all serious adverse events per patient-yr:
LVAD - 6.45, OMM - 2.75, rate ratio (95% CI): 2.35 (1.86 - 2.95) Copyright 2004 Blue Cross Blue Shield Association
REMATCH Trial
Copyright 2004 Blue Cross Blue Shield Association
0.0
0.2
0.4
0.6
0.8
1.0
months from randomization
Su
rviv
al
0 6 12 18 24 30
LVAS, n=OMM, n=
6861
4128
3316
154
73
REMATCH, all cause mortalityFeb. 2002 update
LVASOMM
CDRH-FDA, CSDAP,03/04/02
REMATCH Trial
• 1 yr median NYHA Class: LVAD - II, OMM - IV (p<0.001)
• 1 yr mean SF-36 PF: LVAD - 46, OMM - 21 (p=0.01)
Copyright 2004 Blue Cross Blue Shield Association
Class I: No limitation on physical activity (sx > ordinary activity)
Class II: Slight limitation on physical activity (sx ordinary activity)
Class III: Marked limitation on physical activity (sx < ordinary activity)
Class IV: Inability to carry on physical activity (sx at rest)
REMATCH Trial
Copyright 2004 Blue Cross Blue Shield Association
Thoratec,FDA, CSDAP,03/04/02
Month
LVAD% NYHA
I/II
OMM% NYHA
I/II
0 0 0
1 54 0
3 68 3
6 80 9
9 82 0
12 71 0
18 44 0
24 71 33
Structural Components of CEA
• Time horizon, perspective: Lifetime (3 years), payor