1. Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis David H. Adams et al (U.S. CoreValve Clinical Investigators) Journal Club November 20 th Scott C Laura

2. TAVR with a Self-Expanding Prosthesis Objective – Comparison of TAVR with self expanding bioprosthesis with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery

3. TAVR with a Self-Expanding Prosthesis Background (Dismal prognosis after symptom onset) – Often affects elderly, a population often with increased surgical risk – TAVR improves survival compared with medical therapy for those with increased surgical risk – TAVR similar to Surgical with respect to survival (high risk pop) albeit higher frequency of neurological events

4. TAVR with a Self-Expanding Prosthesis Methods – Multicenter, Randomized, non-inferiority trial – Medtronic Funded, developed protocols, selected 45 clinical sites throughout US, monitored/managed all source data and statistical analyses – Analyses for primary and secondary endpoints validated by Harvard Clinical Research Institute

5. TAVR with a Self-Expanding Prosthesis Inclusion – Severe AS and NYHA class II or higher: Aortic valve area of ≤0.8cm 2 or AV area index ≤0.5cm 2 /m 2 AND Mean AV gradient ≥ 40mmHg or peak aortic jet velocity ≥ 4 m/s. – Two cardiac surgeons and one interventional cardiologist estimated risk of death w/I 30days of surgery was ≥ 15% or risk of death or irreversible complications w/I 30days ≤ 50%

6. TAVR with a Self-Expanding Prosthesis Population 900 eligible patients, 871 patients enrolled, 795 randomized 394 TAVR -> 390 completed 401 Surgical -> 357 completed

8. TAVR with a Self-Expanding Prosthesis Results – Primary End Point: rate of death from any cause at 1 year TAVR 14.2% and surgical group 19.1% representing an ARR of 4.9% P<0.001 for noninferiority, P = 0.04 for superiority)

11. TAVR with a Self-Expanding Prosthesis Secondary End Points – TAVR noninferior to Surgical Mean Aortic Valve gradient Change from baseline to one year Effective Orifice area change from baseline to one year NYHA class change from baseline to one year

14. TAVR with a Self-Expanding Prosthesis Conclusions – Survival at 1 year after TAVR superior to surgery – Suggest that the occurrence of Major Adverse Cerdiovascular and Cerebrovascular events lower in TAVR group at 1 year – No increased risk of stroke with TAVR at 1 year

15. TAVR with a Self-Expanding Prosthesis Cautions/Future – Lower surgical risk population than previous studies – Actual mortality rate at 30Ds amoung surgical patients was 4.5% (much lower than the predicted rate IE greater than 15%) – More patients declined surgery after randomization

16. A O R T I C Stenosis