1. Michael Mack, M.D. Dallas, TX February 21, 2010
Determining the Surgical Risk Stratification in Aortic Stenosis: STS, EuroSCORE, and “Frailty” Assessments
Michael Mack, M.D.
Dallas, TX
February 21, 2010

2. Michael J. Mack, MD DISCLOSURES Consulting Fees
Edwards Lifesciences LLC, MAQUET GmbH & Co. KG, Medtronic CardioVascular, Inc.
I intend to reference unlabeled/ unapproved uses of drugs or devices in my presentation.
I intend to reference Percutaneous Heart valves.

3. Aortic Valve Surgery Predictive Risk Algorithms
STS
EuroSCORE (additive)
EuroSCORE (logistic)
Ambler (UK)
Northern New England
New York State
Providence Health System

4. Do any of these algorithms accurately predict risk in patients undergoing TAVI ?

5. > 20 33% 12.5% <10 7.3% 7.5% 10-20 13.7% 12.6% LES Mean LES
30day/ Hosp Mortality
<10
7.3%
7.5%
10-20
13.7%
12.6%
> 20
33%
12.5%

8. STS LES >90th Percentile 13.3% (8.38-46.8) 50.87 (33.47-93.32)
Observed
18.75%
15.63%
O/E Ratio
1.41
0.31
N= 638

9. LES 8.46% 13.9% 28.5% All LES 10-20 LES >20 n 652 130 52 Observed
Mortality
2.5%
4.6%
3.9%
LES
8.46%
13.9%
28.5%
STS
4.4%
6.5%
10.1%

13. European Journal of Cardio-thoracic Surgery 37 (2010) 255—260

14. European Journal of Cardio-thoracic Surgery 37 (2010) 255—260

15. Conclusions: EuroSCORE appears to be an invalid model in absolute and relative risk prediction for isolated AVR

16. “Hence, why is the logistic EuroSCORE, which by all
accounts gives the highest values and is the furthest away from observed rates, used almost exclusively by the groups performing PAVI, when it has been conclusively proven to be inaccurate, unreliable and difficult to validate for all groups of patients?”
Manuel Antunes

17. Logistic Euroscore in Surgical AVR
LES Predicted
Observed
DiGiammarco
379
9.4%
5.2%
German Society
6,305
7.3%
3.9%
Kalavrouziotis
1,421
3.2%
LES over predicts AVR mortality by 1.5-2X

18. Logistic Euroscore in High Risk (LES >20) Surgical AVR
LES Predicted
Observed
Leontyev 33
12.5
Brown
23.6
5.8
Dewey
50.8
15.6
Wendt
28.5
3.9
Kalavrouziotis
38.7%
11.4%
LES over predicts mortality in high risk AVR by 3-7X

19. Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database
Started in 1986 in response to HCFA (CMS) public reporting of non risk adjusted outcomes of cardiac surgery
Outcomes from 1,000 centers
90% of all cardiac surgery providers in U.S.
3.6 million procedures
Warehoused and managed by DCRI

20. Society of Thoracic Surgeons Adult Cardiac Surgery Database
NQF endorsed
Audited
Predicts Mortality and 8 other endpoints
Data shared with 5 major payors
Public reporting in 2010
Linkage to SS Death Masterfile and CMS
Harmonization with ACC Database

21. STS Aortic Valve Risk Algorithm
Valves only
N= 67,292 Aortic Valve Operations
60% Development Sample/40% Validation
24 covariates for mortality
C-index for mortality

22. EuroSCORE Risk Algorithm
Developed in Europe
All cardiac operations
Additive
14,871 patients in 128 centers in 8 countries between Sept and November 1995
Logistic-LES
14,799 patients in published 2003

23. Risk Algorithms LES STS Population Analyzed 1995 2002-2006 Place
Europe
(8 countries) US
Number Operations
14,799
67,292
Type of Operations
All cardiac
Aortic Valve only
Covariates for Aortic Valve Mortality 12 24

24. Risk Factors Not Included in Algorithms
Data not collected or too few patients with variables to validate
Liver disease
Porcelain aorta
Frailty
Radiation
Dementia/Parkinson’s

25. LES
OBSERVED
STS

26. What Does This Mean? LES- the TAVI is better than expected
STS- the TAVI is worse than predicted
Neither apply since these are different patients (inoperable) and the algorithms aren’t accurate at the extreme risk
LES
STS
OBSERVED

27. 2 Females > 85 years, STS>10 One operable, one NOT !

28. Age Gender Functional Ability Co-Morbidities Bathing Diabetes Walking
Lung Disease
CHF
Active Tobacco Use
BMI
Functional Ability
Functional Ability
Bathing
Walking
Managing Finances
Pushing Large Objects

30. Score
4 Year Mortality
0-5
<4%
6-9
15%
10-13
42%
>14
64%

31. Summary
Both STS and LES are fairly accurate for predictive value in low risk patients
STS is more accurate especially in high risk:
Larger database- 67K vs. 14K
More specific – AVR only vs.all cardiac
More variables collected- 24 vs.12
More current- by 10 years
US population
LES should not be used for predicting risk
If used needs to be with a “recalibration coefficient” of

32. Logistic Euroscore should no longer be used for predicting risk or evaluating outcomes in TAVI patients!
The evidence of inaccuracy in high risk AVR patients is overwhelming
It gives a false sense that outcomes of TAVI are better than they are
There is no valid excuse not to use STS risk algorithm
Most accurate
Online user friendly
Free

33. National Disease-based Registry of Valvular Heart Disease Linkage of:
Response to RFA-HS ARRA-AHRQ Recovery Act 2009 Limited Competition PROSPECT Studies Building New Clinical Infrastructure for Comparative Effectiveness Research February 16, 2010
National Disease-based Registry of Valvular Heart Disease
Linkage of:
STS Adult Cardiac Database
ACCF NCDR Database
Social Security Death Masterfile
Medicare Parts A and B Claims Database
Direct Comparison of Clinical Outcomes of:
Medical Therapy
TAVI
Surgery

34. The FDA GOT THIS ONE RIGHT 6 YEARS AGO