1. ENDOPROTESI VALVOLATE L’opinione di F. MAISANO San Raffaele Milano

3. The PARTNER IDE Trial Co-principal Investigators: Martin B. Leon, MD Interventional Cardiology Craig Smith, MD, Cardiac Surgeon Columbia University Population: High Risk/Non-Operable Symptomatic, Critical Calcific Aortic Stenosis Two Trials: Individually Powered Cohorts (Cohorts A & B) Update SEPT 2008 No Not in Study No VS Trans apical AVR Control 1:1 Randomization Cohort A TA Powered to be Pooled with TF Yes Cohort B No ASSESSMENT: Operability Cohort A n= up to 690 pts n=350 pts Total n= 1040 ASSESSMENT: Transfemoral Access Trans femoral AVR Control VS Yes 1:1 Randomization Cohort A TF Powered Independently Primary Endpoint: All Cause Mortality (Non-inferiority) Medical Management Control ASSESSMENT: Transfemoral Access VS Trans femoral 1:1 Randomization Yes Primary Endpoint: All Cause Mortality (Superiority)

5. PARTNER EU TF Procedure Outcomes *Implant success = Successful device delivery and deployment resulting in an AVA>0.9cm² with AI <2+ Ventricular embolization (n = 1) Aortic embolization (n=1) 23 mm SAPIEN valve N=25 26 mm SAPIEN valve N=27 Implant failures n = 2 Patients Implanted n = 54 Successful Implants* n = 52 Patients Planned n = 60 Implant aborted n = 6 Vascular access (n = 3) Unsucessfull BAV (n=2) Active endocarditis (n=1) 96.3%

6. PARTNER EU TF Procedure Outcome Procedure time, minutes (Skin to skin) 134.9 ± 63.3 Deployment time, minutes (from BAV to deployment) 30.0 ± 18.0 Fluoroscopy time, minutes 28.8 ± 17.0 Contrast volume, ml 210.5 ± 127.2 Reballooning, (n) 11% (7) Closure Device, (n) 51% (30) New pacemakers, (n) 1.8% (1) Arrhythmia requiring intervention, (n) 11% (6)

7. PARTNER EU TF Kaplan Meier Survival Data Extracted: 01SEP2008 Time (months) Probabilty of daeth (%) 0 1 2 3 4 5 6 0 20 40 60 80 100 30D: 0.92 Nrisk: 54 6M: 0.9 Nrisk: 33 Freedom from death at 6M = 90% Euroscore

8. PARTNER EU TF Cause of Death (#) Causes Procedural <30 days >30 days Implant not done Myocardial Infarction 0 0 2(83, 267) 0 Sepsis 0 0 1 (198) 0 Multiple Organ Failure 0 3 (0, 10, 27) 0 0 Cardiac Arrhythmia 1 (0) not implanted 0 0 0 Unknown 0 0 1 (229) 0 Endocarditis 0 0 0 1 (15) enrolled but exited study before procedure

9. PARTNER EU TF Complications Non Hierachical Ranking Complication (n) Intraprocedural <30 days >30 Days Myocardial Infarction 1 0 2 Stroke 0 2 1 Renal Failure (Dialysis) 0 2 1 Arrhythmias requiring intervention 6 0 0 New Pacemaker 0 1 0 Cardiogenic Shock 1 0 0 Congestive Heart Failure 0 0 1 Vascular Events 8 7 2 Valve Embolization 2 0 0

10. PARTNER EU Transapical Survival Curve 58% @ 6months n=33 81% @ 30days n=57

14. THV Learning Curve Percent Successful Implant %

15. ITT All Cause Mortality Transfemoral and Early Studies 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 0 Revival Revive 3 6 12 0 9 Partner EU Months past Procedure Freedom from Death Recast I-Revive

19. The shocking news: euro-heart survey 31.8% did not undergo intervention, most frequently because of comorbidities

20. Prevalenza della patologia valvolare nell’anziano Nkomo et al , Lancet 2006

30. PARTNER EU 9 Participating Centers in 6 Countries n

32. Percorso TAVI di 22

33. Funzioni del VALVETEAM

36. A suboptimal set-up

38. savana