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1 > 1200 Patients Transfemoral (n=628) Transapical (n=457) Antegrade N=59 Retrograde N=569 TRAVERCE n=172 RECAST n = 24 REVIVE II n = 106 REVIVAL II n =40 Early First in Man irevive n = 22 REVIVE n = 4 REVIVAL I n = 7 US Compassionate n=2 REVIVAL II n = 55 Canadian Special Access n = 125 PARTNER EU n=63 PARTNER US n > 200 (>100 TF) SOURCE Registry n= 400 Canadian Special Access n =90 US Compassionate n=2 PARTNER EU n= 67 SOURCE Registry n= 86
2 Columbia University (NY) Edwards THV Feasibility Clinical Trials Transfemoral REVIVE II REVIVAL II Canada Special Access Frankfurt (Sievart) Aarhus (Andersen) Essen (Sacks) Vancouver Detroit (MI) Med City Dallas Cleveland Clinic Rouen (Cribier) Madrid San Carlos (Macaya) Gregorio Maranon (Garcia) Paris Paris Institute (Lefevre) Bichat (Vahanian)
3 REVIVE II (Europe) Centers Hôpital Charles Nicolle Rouen- F 27 St. Paul s s Hospital - Canada 13 Institut Jacques Cartier Paris - F 13 Hôpital Bichat Paris - F 12 Universitätsklinikum tsklinikum Essen - Allemagne 11 Skejby University Hospital -Danemark 9 Hospital Gregario Maranon - Espagne 8 Sankt Katharinen Hospital 8 Hospital Univer. San Carlos - Espagne 5 REVIVE II -- TOTAL 106 n
4 REVIVE II & REVIVAL II TF Patient Demographics REVIVE II (n=106) Europe REVIVAL II (n = 55) USA Age Mean ± SD 83.9 ± ± 5.2 Gender Female 54 (51.4%) 30 (54.6%)
5 REVIVE II (Europe) Co-morbidities Co-morbidities % Systemic hypertension 70.2 Angina 47.0 Pulmonary disease 29.1 Diabetes mellitus 23.8 Chronic renal disease 24.0 Peripheral vascular disease 17.6 Congestive heart failure 84.5 Myocardial infarction 15.6 Carotid disease 17.6 Prior PTCA/stent 18.4 Prior CABG 22.9 Prior stroke 22.9 Prior aortic valvuloplasty 37.1
6 REVIVE II : Contra-indication to surgery REVIVE II (n=105) Porcelain aorta 4 (3.8%) Irradiatied sternum 7 (6.6%) Severe COPD 20 (18.9%) Thorax distorsion 4 (3.8%) Surgical refusal 31 (29.2%) Logistic Euroscore: 29.9 ± 13.2% (16-43)
7 REVIVE II Procedural Success Rate 90.9%
8 REVIVE II & REVIVAL II TF Procedure Implantation Success 88 (88%) 100% in the last 25 Pts (Webb et al)
9 REVIVE II (Europe) 30-days follow-up REVIVE II (n=106) Mortality 14 (13.2%) AVR 1 (0.9%) 0% in Neurological the last compl 25 Pts 3 (2.8%) (Webb et al) Vascular complications or access problems 13 (12.3%) Pacemaker 3 (2.8%) + MI defined as elevation of CK to more than 2 times normal with elevated CKMB. 7 of these 9 patients had had CK elevation without clinical of evidence.
10 80.0 REVIVE II Mean Gradient Progression Baseline Discharge or 7 days post-procedure 3 months 1 year Mean Gradient mmhg < 10 mm Hg 45.2± ± ± ± 1.2 Pooled Pooled Pooled Pooled mm 26 mm MM n= 26 MM n= Baseline Discharge or 7 days postproc. 3 months 1 year = Core Lab Analysis
11 REVIVE II : Aortic valve area 2.0 Baseline Discharge or 7 days post-procedure 3 months 1 year Aortic Valve Area EOA MM n= 26 MM n= AVA=1.7 cm² (23-mm valve) AVA=1.9 cm² (26-mm valve) 0.56± ± ± ±0.08 Pooled Pooled Pooled Pooled Baseline Discharge or 7 days post-proc. 3 months 1 year 26 mm 23 mm = Core Lab Analysis
12 REVIVE II, REVIVAL II, Canada LV Ejection Fraction n * Assessed by Echo
13 REVIVE, REVIVAL and Canada All cause Mortality Freedom from Death Revival Canada Revive Months Post Procedure 74.7 % 73.8 % 73.0 % Number at Risk Canada REVIVE
14 Randomized Study: PARTNER US (1000 Pts, 15 Centers) High symptomatic patients with severe AS Primary endpoint: Operable Mortality? at 1 year NO YES Medical Tt + BAV THV TF ou TA RVA THV TF ou TA
15 Bioprosthesis: New generation: Bioprosthesis - New stent (Cobalt-Chromium) Increased radial strength -New valvular geometry for improved long-term function ( better stress distribution) - Bovine pericardium treated with ThermaFix anti-calcificati calcification n system New valve sizes: 18, 23, 26 y 29 mm Laser mapping which assures uniform leaflet thickness and movement
16 New Generation: Delivery system 1. RetroFlex II Catheter 2. RetroFlex III: 3 a 5 F size reduction 18F: 23 mm valve 19.5F: 26 mm valve 22F: 28 mm valve FIM: Ist semester 2008
17 Conclusion Good Good acute results are observed in a high surgical risk population One year valve performance strong Up Up to 4.5 years follow-up with the Edwards bioprosthesis, with no sign of device deterioration Learning curve evident and vascular complications can be addressed with screening and product improvements
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