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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

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slide1

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
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 has not been extensively evaluated in “real world” patients undergoing TAVR and SAVR.

Reynolds MR, Cohen DJ JACC 2012

objectives
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, TA-TAVR and SAVR.
methods
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 life-tables based on changes in mortality from year 1 to 2 in TAVR registry.
markov model
Markov Model

30-Day

1-Year

Annual

registry data meta analysis1
Registry Data Meta-Analysis

*Vascular Complications for Cardiac Surgery were not available from registry data so a vascular complication rate was imputed from TA-TAVR.

costs
Costs
  • 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
Utilities

One-Month

One-Year

  • 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
Transfemoral TAVR v. SAVR

More Effective, More Cost

Less Effective, More Cost

∆ Cost = - $1110

∆ QALYs = + 0.36

ICER = dominant

% <$50,000 per QALY = 92.8%

More Effective, Less Cost

Less Effective, Less Cost

transapical tavr v savr
Transapical TAVR v. SAVR

% <$50,000 per QALY = 11.2%

More Effective, More Cost

Less Effective, More Cost

∆ Cost = + $2995

∆ QALYs = - 0.22

ICER = dominated

More Effective, Less Cost

Less Effective, Less Cost

the learning curve of transapical
The Learning Curve of Transapical?

Partner A Transapical Continued Access Registry

*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
TA TAVR Using PARTNER A Continued Access Transapical Data

% <$50,000 per QALY = 36.1%

More Effective, More Cost

Less Effective, More Cost

∆ Cost = + $4437

∆ QALYs = + 0.02

More Effective, Less Cost

Less Effective, Less Cost

limitations
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
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.
summary1
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
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
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.

slide21

To contact author:

cmeduri@bidmc.harvard.edu

base case summary
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
Transfemoral TAVR Using PARTNER A Stroke Rate

More Effective, More Cost

Less Effective, More Cost

∆ Cost = + $3227

∆ QALYs = + 0.20

More Effective, Less Cost

Less Effective, Less Cost

2 way sensitivity analysis for stroke and vascular complications
2-Way Sensitivity Analysis for Stroke and Vascular Complications

50

40

Favors SAVR

Favors TAVR

30

Vascular Complication Rate (%)

20

10

0

3

6

9

12

15

Stroke Rate (%)