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

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

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

4. 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:
et al European Heart Journal 2003;24: (*includes both Aortic Stenosis and Mitral Regurgitation patients)
Pellikka, Sarano et al Circulation 2005
Charlson E et al. J Heart Valve Dis2006;15:

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

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

7. Currently being referred
for surgery
Currently not being
referred for surgery

8. CoreValve Extreme Risk4%
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

9. 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%

10. “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

11. 4%
8.3%
Benefit
No Benefit

12. 4%
8.3%
Benefit
No Benefit

13. 4%
8.3%
Benefit
No Benefit

14. 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

15. 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

16. ESRD- dialysis
CIRCULATION 2002;105:

17. 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%

18. 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 …

19. Age and comorbidity RISK5 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

20. 4%
8.3%
Benefit
No Benefit

21. Commercial Product 4%
8.3%
Benefit
No Benefit

22. Study Patients 4%
8.3%
Benefit
No Benefit

23. Stroke
Para Valvular Leak
Valve Durability

24. 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

25. Thank You