Aortic Stenosis -The Unmet Need

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

8. ACI 2009