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

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.

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

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

> 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%

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

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%

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

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

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

“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

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

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

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

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

STS Aortic Valve Risk Algorithm Valves only- 2002-2006 N= 67,292 Aortic Valve Operations 60% Development Sample/40% Validation 24 covariates for mortality C-index 0.799 for mortality

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 1995- published 2003

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

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

LES OBSERVED STS

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

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

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

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

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 0.3-0.5

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

National Disease-based Registry of Valvular Heart Disease Linkage of: Response to RFA-HS-10-005 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

The FDA GOT THIS ONE RIGHT 6 YEARS AGO