Patients the Surgeon Should Refer for TAVR Michael J. Reardon, M.D. Professor of Cardiothoracic Surgery Methodist DeBakey Heart & Vascular Center

Conflict of Interest Consultant to Medtronic CoreValve Trial Steering committee member SurTAVI Trial National PI

All patients with symptomatic severe AS? Who gets aortic valve replacement now? All patients with symptomatic severe AS?

Severe Symptomatic Aortic Stenosis Percent of Cardiology Patients Treated Under-treatment especially prevalent among patients managed by Primary Care physicians No AVR AVR Iung BBouma B J et al. Heart 1999;82:143-148 et al European Heart Journal 2003;24:1231-1243 (*includes both Aortic Stenosis and Mitral Regurgitation patients) Pellikka, Sarano et al Circulation 2005 Charlson E et al. J Heart Valve Dis2006;15:312-321

All patients with symptomatic severe AS PROM 0% 100% All patients with symptomatic severe AS Risk Anatomy Clinical Senerio Age Co-morbidities

Subject Assessment: Eyeball Test Patient A vs. Patient B Same STS Score Photos courtesy of Michael J. Mack, MD

Currently being referred for surgery Currently not being referred for surgery

CoreValve Extreme Risk 4% 8.3% Extreme Risk but benefits from TAVR Extreme Risk and will not benefit from TAVR 10% 25% Partner IIA SurTAVI Partner B CoreValve Extreme Risk Partner A CoreValve High Risk

Partner B Partner A One year TAVI Medical Rx All stroke/TIA 10.6% 4.5% Major stroke 7.8% 3.9% Partner A One Year TAVI AVR All stroke/TIA 8.3% 4.3%

“In judging futility, physicians must distinguish between an effect, which is limited to some part of the patient's body, and a benefit, which appreciably improves the person as a whole. Treatment that fails to provide the latter, whether or not it achieves the former, is "futile".” Schneiderman, LJ et al. Ann Intern Med 1990

4% 8.3% Benefit No Benefit

4% 8.3% Benefit No Benefit

4% 8.3% Benefit No Benefit

years to life, not life to years.” Cohort C Cohort B Porcelain Aorta Hostile Chest RIMA/LIMA Anatomy Severe COPD Liver Cirrhosis Dementia Severe Frailty “We've added years to life, not life to years.” George Carlin 2001

Beyond Frailty  Need for an Better Index Disability: ADL IADLs Difficulty or dependency in daily living Frailty Impairment in multiple systems that leads to a decline in homeostatic reserve and resiliency Charlson Co-Morbidities Two or more medical conditions

ESRD- dialysis CIRCULATION 2002;105:1336-1341

Partner B Partner A One year TAVI Medical Rx All stroke/TIA 10.6% 4.5% Major stroke 7.8% 3.9% Partner A One Year TAVI AVR All stroke/TIA 8.3% 4.3%

Fine line between utility and futility … How can society afford TAVR in the very elderly? How can we prevent inappropriate use and abuse? Lower boundary Upper boundary Fine line between utility and futility …

Age and comorbidity RISK 5 4 3 2 1 Age 70 75 80 85 90 Equal Logistic EuroSCORE distribution in different age groups, suggesting younger age groups have more co-morbidity RISK

4% 8.3% Benefit No Benefit

Commercial Product 4% 8.3% Benefit No Benefit

Study Patients 4% 8.3% Benefit No Benefit

Stroke Para Valvular Leak Valve Durability

Who should the surgeon refer for TAVR? The extreme risk patient that the surgeon believes will benefit High Risk and Intermediate Risk patients in the context of a clinical trial

Thank You