Aortic Stenosis Steven F. Bolling, M.D. Professor of Cardiac Surgery University of Michigan

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1 Aortic Stenosis Steven F. Bolling, M.D. Professor of Cardiac Surgery University of Michigan

2 Aortic Surgery

3 Aortic Stenosis

4 EB CT - Ca++ everywhere!

5 Surgery for Aortic Stenosis 100,000 USA + 100,000 OUS High-risk patients 25% Non operable candidates 30%

6 Geometry of Heart Failure Risk of Late Death following myocardial infarction Survival vs. ESVI Buckberg et al. Congestive heart failure: Treat the disease, not the symptom Return to normalcy J. Thorac. Cardiovasc. Surg. 2001;121:

7 Geometry of Heart Failure LV dilation in AS is progressive Risk of death = LV size & volume : - predicts mortality > LVEF

8 Surgery for Heart Failure AS Patients followed to death Severe LV dysfunction Low transvalvular gradient role of Dobutamine echo?

9 100 AVR with low EF Survival P< %±3% Survival (%) Nl EF 50% MedEF 35%-50% 50% Low EF <35% 56%±5% 5% 41%±9% Years 56±4% 41±5% 21±9% 45%±3% 34%±6% Chaliki et al: Circ 2002

10 Surgery for Heart Failure AS 157 patients (68 AVR; 89 med) AVA < 0.75 cm2 LVEF < 35% Mean AV gradient < 30 mmhg Pereira JJ et. al. Survival after aortic valve replacement for severe aortic stenosis with low transvalvular gradients and severe left ventricular dysfunction. JACC 2002;39:

11 Surgery for Heart Failure AS All Patients Propensity-matched Patients Pereira JJ et. al. Survival after aortic valve replacement for severe aortic stenosis with low transvalvular gradients and severe left ventricular dysfunction. JACC 2002;39:

12 Surgery for Heart Failure AS Dobutamine echo Group I (respond) Group II (non) (n=32) n=24 Δ LVEF.12 ( ).03 ( ) Δ CI% 49 (42-74) 24 (18-37) Δ AVA% 17 (8-29) 5 (-3 8) Δ MPG% 38 (31-45) 20 (14-30) Monin et al. Aortic stenosis with severe left ventricular dysfunction and low transvalvular pressure gradients: Risk stratification by low-dose dobutamine echocardiography JACC 2001;37:

13 Surgery for Heart Failure AS Monin et al. Aortic stenosis with severe left ventricular dysfunction and low transvalvular pressure gradients: Risk stratification by low-dose dobutamine echocardiography JACC 2001;37:

14 70 60 Ejection Fraction 58±7% 56±10% 50 35±14% EF % ±6% LV systolic and diastolic dimensions also get better.geometry is improved! 20 P< Pre-op Post-op LoEF (EF <35%) Pre-op Post-op Nl EF (EF 50%)

15 AVR and Low EF Acceptable mortality and morbidity Long-term survival without CHF Improvement in EF Never too late in AS? Valve problem makes heart bad!

16 AVR : 2011 Ross Prima or Freestyle

17 Ross procedure sorry NO!

18

19 State of the Art

20 What you want to drive 2011!

21 Current Valves Tissue valves : better Improved hemodynamics Improved durability Proven 20 years of data Addition of anti-ca Improved ease of implant

22 Shift in Valve Prostheses : Mechanical Tissue 100% U.S. 100% Rest of World Percent of Total Valves 80% 60% 40% Mechanical Tissue Percent of Total Valves 80% 60% 40% Mechanical Tissue 20% 20% 0% %

23 Aortic Surgery and CHF Critical AS : % Underoperated Other approaches : Far end of bell curve increased catchment

24 Minimally Invasive Surgical Approaches High risk surgical candidates without adequate femoral access Trans Apical Beating Heart Surgery Circ 2006;114:

25 Aortic Suture-less Drop in Valves

26 Percutaneous Valves Fantastic advance Entire future -??!

27 TAVI for Aortic Stenosis 50% patient adoption by 2014

28 TAVI B - inoperable Control TAVR Difference in In-Trial Life Expectancy = 0.49 years Based on data available as of 28SEP2010

29 Projected Survival Life Expectancy (undiscounted) TAVR: 3.11 years Control: 1.23 years Difference: 1.88 years

30 TAVI A HIGH RISK 699 pts STS 12%.

31 TAVI A High Risk for Aortic Stenosis.

32 TAVI for Aortic Stenosis # 2 reason won t : FDA.

33 Longevity? - Crush loaded!

34 5000 implants pavr - K-M (12-Mo)) 1.00 Survival Distribution Function Post-procedure Days Time to death until 360 jours after procedure (Days) Legend: Product-Limit Estimate Curve Censored Observations Time to death until 360 days after procedure One-Year Total All Mortality Rate = 28.4%

35 AVR for all EF 30 % mortality low 5-10 years!! 100 P< %±3% Survival (%) Nl EF 50% MedEF 35%-50% 50% Low EF <35% 56%±5% 5% 41%±9% Years 56±4% 41±5% 21±9% 45%±3% 34%±6% Chaliki et al: Circ 2002

36 TAVI for Aortic Stenosis # 1 reason won t : $$$$.

37 Cost-Effectiveness of TAVR $100,000 per LY ΔCost = $79,837 Δ LE = 1.59 years ICER = $50,212/LYG $50,000 per LY

38 $$$ Analyses Incremental Costs (TAVR Control) Incremental Life Years (TAVR Control) ICER ($/LY) Base Case $79, ,212 QALYs $79, ,889* QALYs assuming no QOL improvement $79, ,163* Exclude non-cv costs $53, ,860 Study device = $20,000 $69, ,642 Study device = $40,000 $90, ,782 Exclude BAV costs $82, ,964 * $/QALY

39 Aortic Surgery 2011 Find AS Fix AS! any way you can!

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