1. Aortic Stenosis -The Unmet Need Simon Ray University Hospitals of South Manchester ACI 2009

2. NO CONFLICT OF INTEREST TO DECLARE ACI 2009

3. Unmet Need – Lack of Data No epidemiological data for the prevalence of valve disease in the UK No UK data on the number of patients with known symptomatic aortic stenosis not referred for surgery No UK data on the number of patients referred for surgery but not operated ACI 2009

4. Unmet Need – US Data Prevalence of moderate to severe aortic valve disease in the US population > 75 years 2.8% English population > 75 years about 3.9M About 110K individuals in England >75 years with moderate to severe AS About 1200 AVR performed annually >75years About 1.1% of affected population operated annually ACI 2009

5. Unmet Need – Euro Heart Euro Heart Survey –About 1/3 older or comorbid patients not referred for surgery For age >75 ‘surgical rejects’ alone: –600 TAVI candidates per year in England Assume some switch of ‘high risk’ > 75 patients to TAVI: –10%; 720 per year –20%; 840 per year ACI 2009

6. Unmet Need – SCTS Data SCTS data for high risk surgery in the UK –About 1500 per year over 80 or Euroscore > 10 –Mortality about 10% Assume 1/3 not referred and suitable for TAVI: –750 TAVI for UK Assume some switch of ‘high risk’ to TAVI –10%; 900 TAVI per year for the UK –20%; 1050 TAVI per year for the UK ACI 2009

7. Possible Demand Relatively conservative estimates: –About 1000 TAVI per annum for the UK –About 900 for England and Wales –About 16/million population Does not take into account the impact of possible trials of lower risk patients ACI 2009