Cost-Effectiveness of Surgical Aortic
Valve Replacement versus Transcatheter
Aortic Valve Replacement
Using Registry Data
Christopher U. Meduri, MD
Matthew R. Reynolds, Philippe Généreux, Andrew
N. Rassi, David A. Burke and Jeffrey J. Popma
American College of Cardiology
Annual Scientific Sessions
March 11th, 2013
Background
• PARTNER Cohort A is the only randomized-control trial
evaluating TAVR vs. SAVR in high-risk patients.
• The 12-Month cost-effectiveness analysis in the PARTNER
Cohort A study (TAVR vs. SAVR) showed:
 Transfemoral (TF)-TAVR vs. SAVR: ∆ QALYs = + 0.06;
∆ Cost = - $2,210
 Transapical (TA)-TAVR vs. SAVR: ∆ QALYs = - 0.07;
∆ Cost = + $9,595.
•
Detailed cost-effective analysis
extensively evaluated in “real
undergoing TAVR and SAVR.
Reynolds MR, Cohen DJ JACC 2012
has not been
world” patients
Objectives
• To determine the cost-effectiveness of TAVR compared with
high-risk isolated SAVR outside of RCTs.
• To explore potential differences in the cost-effectiveness of
TF-TAVR and TA-TAVR compared with isolated SAVR.
• To identify the influence of varying rates of procedural
complications on the cost-effectiveness of TF-TAVR, TATAVR and SAVR.
Methods
• Markov decision analytic model (TreeAge Pro software) with
Monte Carlo simulations.
• Model informed with:
 Outcome Probabilities: Derived from meta-analysis of 20
TAVR Registries and 8 isolated SAVR Registries.
 Costs: Utilized PARTNER A CEA and current literature
review of costs of complications.
 Quality of Life: Utilized PARTNER A CEA and current
literature review of QoL related to complications.
• All cost and benefits discounted at 3%.
• Probabilities and utilities in Beta-distributions.
• Lifetime model with mortality after year 1 from adjusted US lifetables based on changes in mortality from year 1 to 2 in TAVR
registry.
Markov Model
30-Day
1-Year
Annual
Well
Die
Alive
Alive
TAVR
Major Stroke
Die
Die
Minor Stroke
Symptomatic
Severe Aortic
Stenosis
New Dialysis
SAVR
(Clone of TAVR)
Vascular
Complication
New PPM
Registry Data Meta-Analysis
Variable
(# Studies)
TAVR-All
(20)
TF-TAVR
(7)
TA-TAVR
(5)
Isolated
SAVR (8)
Patients (#)
15,691
10,311
3,097
2,046
Age (Years)
82.0
81.7
81.5
78.5
Female (%)
50.7
54.4
48.0
51.3
Mean Logistic
EuroSCORE
21.3
21.0
22.7
21.5
Mean STS Score
11.8
14.2
13.2
12.2
NYHA III-IV (%)
86.8
81.1
81.3
65.0
Registry Data Meta-Analysis
Variables
30-Day Mortality
TAVR
(%)
7.6
1-Year Mortality
TF-TAVR (%) TA-TAVR (%) SAVR (%)
5.9
9.5
9.4
18.2
15.8
23.7
18.4
30-Day to 1-Year Mortality
10.6
9.9
14.2
9.0
Major Stroke
2.5
2.1
2.5
3.8
Minor Stroke
1.1
1.5
2.2
2.5
Vascular Complication
12.3
13.8
2.5*
2.5
New Dialysis
1.7
1.7
1.7
4.0
Pacemaker
16.2
19.0
8.9
7.7
*Vascular Complications for Cardiac Surgery were not available from registry data so a vascular complication rate was
imputed from TA-TAVR.
Costs
Access
In Hospital ($)
•
Annual ($)
TAVR
SAVR
TAVR
SAVR
TAVR
SAVR
TF
61,162
59,687
10,687
14,000
5,558
5,558
TA
74,421
61,395
18,098
24,963
5,558
5,558
Major Stroke
Minor Stroke
Vascular Complications
Dialysis
Pacemaker
•
•
Hospital to 12
months ($)
In Hospital ($)
14,155
8,658
10,037
5,616
13,845
Annual ($)
14,561
2,924
300
30,365
76
In hospital, hospital to 12 months and annual cost derived from median costs from PARTNER A CEA.
Each upfront cost provided for in hospital/30d cost. After that patients given annual cost x11/12 for first year, then full cost
annually.
Annual TAVR/SAVR Annual Cost (after year 1) made the same, based on average of median outpatient cost in year one for
TF/SAVR arm of PARTNER A.
Utilities
One-Month
Variable
Well
Major Stroke
Minor Stroke
Dialysis
One-Year
Variable
All TAVR
0.74
0.237
0.525
0.518
All TAVR
Transfemoral
TAVR
0.74
0.237
0.525
0.518
Transapical
TAVR
0.68
0.213
0.483
0.476
Isolated
SAVR
0.68
0.213
0.483
0.476
Transapical
TAVR
0.73
Isolated
SAVR
0.74
Well
0.75
Transfemoral
TAVR
0.75
Major Stroke
0.24
0.24
0.234
0.237
Minor Stroke
0.533
0.533
0.518
0.525
Dialysis
0.525
0.525
0.511
0.518
• All Well Utilities based on results of PARTNER A CEA.
• Utilties for Major Stroke (0.32), Minor Stroke (0.71) and Hemodialysis (0.70) were mutliplied times Well utilities to inform our model.
• Disutilities were assigned for New Pacemaker (3 days) and Vascular Complication (1 week).
Transfemoral TAVR v. SAVR
.
More Effective,
More Cost
Less Effective,
More Cost
∆ Cost = - $1110
∆ QALYs = + 0.36
ICER = dominant
Less Effective,
Less Cost
% <$50,000 per
QALY = 92.8%
More Effective,
Less Cost
Sensitivity Analysis:
Transfemoral Cohort
Variable
30-Day Mortality
Rate TAVR
Major Stroke
Rate TAVR
Vascular
Complications
Rate TAVR
New Pacemaker
Rate TAVR
Threshold to
Meta-Analysis
Exceed ICER
Rate
>$50,000
Mortality increase
5.9%
to 13.3%
Major stroke rate
increased to 8.1%
No Effect
2.5%
13.8%
No Effect
19%
Transapical TAVR v. SAVR
Less Effective,
More Cost
% <$50,000 per
QALY = 11.2%
More Effective,
More Cost
∆ Cost = + $2995
∆ QALYs = - 0.22
ICER = dominated
Less Effective,
Less Cost
More Effective,
Less Cost
Sensitivity Analysis:
Transapical Cohort
Variable
Threshold to
Reduce
ICER < $50,000
Meta-Analysis
Rate and Costs
30-Day Mortality
Rate TAVR
Mortality
reduced to 2.6%
9.5 %
In-Hospital Cost
TAVR
Cost of
Hospitalization
Reduced by
$14,041
$74,421
The Learning Curve of Transapical?
Partner A Transapical Continued Access Registry
Outcome
TA-Partner A
TA-Continued
Access
SAVR (Current
Registry)
30d mortality
8.7
8.2
9.4
1 yr mortality
29.1
23.6
18.4
30d-1yr
22.1
10.9
9
Stroke
7
2
3.8
Variable
Patients (#)
Age (Years)
Female (%)
Mean Logistic EuroSCORE
Mean STS Score
NYHA III-IV (%)
TA-Partner A CA
822
84.7
53.4
28.4
12.2
94.8
*Partner A Transapical Continued Access Registry excluded from our meta-analysis because it is not published.
Dewey T STS 2012
TA TAVR Using PARTNER A Continued Access
Transapical Data
Less Effective,
More Cost
% <$50,000 per
QALY = 36.1%
More Effective,
More Cost
∆ Cost = + $4437
∆ QALYs = + 0.02
Less Effective,
Less Cost
More Effective,
Less Cost
Limitations
• This is a non-randomized analysis from registry data,
and as such it is possible that both identified and
unidentified confounders may have influenced the
outcomes.
• Costs and quality of life were not directly obtained
and instead outcome and cost data were derived
from PARTNER A CEA and literature review.
• Comparison of TA to SAVR outcomes in this
observational study is limited by unmeasured
confounding related to choice of access route.
• The actual rate of complications, apart from death,
beyond 30 days is not available in observational
databases for these cohorts.
Summary
• In this analysis of “real world” high-risk registries,
transfemoral TAVR is an economically dominant
strategy compared with isolated SAVR
• This Markov model supports the PARTNER A CEA,
though the magnitude is greater in the real world
than seen in RCTs.
• Sensitivity analyses suggest that with significantly
increased rates of major stroke (up to 8%), vascular
complications or pacemaker implantation,
transfemoral TAVR remains preferred.
Summary
• In contrast, SAVR is economically preferrable to
transapical TAVR in high-risk patients.
• However, accounting for the “learning curve”
demonstrated in the PARTNER A Transapical
Continued Access Registry, transapical TAVR
become an economically more acceptable option
for high risk patients.
Conclusions
• Markov modeling is an effective tool to evaluate
the cost-effectiveness of TAVR in high risk
patients reported in real world clinical registries.
Acknowledgements
Jeff Popma, M.D.
Matt Reynolds, M.D., M.Sc.
Philippe Généreux, M.D.
David Cohen, M.D., M.Sc.
Myriam Hunink, M.D., PhD
Brian Potter, M.D.
Duane Pinto, M.D, MPH
David Burke, M.D.
Andrew Rassi, M.D.
To contact author:
[email protected]
Backup Slides
Base Case Summary
For All Patients:
• TAVR provided 5.28 QALYs and Cost $108,660
• SAVR provided 5.07 QALYs and Cost $111,036
TAVR is an economically DOMINANT
strategy compared with SAVR:
• Improvement of 0.21 QALYs
• Cost Savings of $2,376
Transfemoral TAVR Using PARTNER A Stroke Rate
.
Less Effective,
More Cost
More Effective,
More Cost
∆ Cost = + $3227
∆ QALYs = + 0.20
Less Effective,
Less Cost
More Effective,
Less Cost
Vascular Complication Rate (%)
2-Way Sensitivity Analysis for Stroke
and Vascular Complications
50
40
Favors SAVR
Favors TAVR
30
20
10
0
3
6
9
Stroke Rate (%)
12
15