An Update on the Edwards TAVR Results. Zvonimir Krajcer, MD Director, Peripheral Intervention Texas Heart Institute at St.

Transcription

1 An Update on the Edwards TAVR Results Zvonimir Krajcer, MD Director, Peripheral Intervention Texas Heart Institute at St. Luke s Hospital

2 Disclosures On the speaker s bureau for Endologix, TriVascular, Edwards, Lombard Training courses for: Endologix, Lombard, TriVascular

3 Edwards THV Program Ascendra 3 System approval SAPIEN XT Valve all access, high-risk indication approval SAPIEN 3 Valve all access, high-risk indication approval June 2015 SAPIEN Valve TF inoperable indication approval SAPIEN Valve TF& TA high-risk indication approval July 2013 June 2014 November 2011 October 2012

4 SAPIEN 3 Transcatheter Heart Valve Outer Sealing Skirt Designed to minimize paravalvular leak Frame Design 2 Frame geometry for low delivery profile Cobalt-chromium 1 3 Bovine Pericardial Tissue Enhanced Frame Geometry Large cells on outflow side for coronary access Wide Strut Angles For reduced crimp profile

5 SAPIEN 3 Valve Sizes Valve Size 20 mm 23 mm 26 mm 29 mm Native Annulus Size By TEE mm mm mm mm Native Annulus Area (CT) mm mm mm mm 2 Area-derived Diameter (CT) mm mm mm mm

6 Evolution of the Edwards Balloon-Expandable Transcatheter Valves Cribier- Edwards SAPIEN SAPIEN XT SAPIEN

7 14F or 16F esheath introducer set Low Profile Demonstrated > 50% Reduction in Major Vascular Complications* *PARTNER II Trial high-risk TF SAPIEN 3 valve cohort (VARC II) versus SAPIEN XT valve cohort (VARC I) 30-day results.

8 Edwards Commander Delivery System Dual articulation for coaxiality Added distal flex to help cross in a variety of anatomies Improved control and precise valve positioning Fine control for valve positioning Distal flex Partial flex Optimal Center Marker Zone (6 mm)

9 The PARTNER II Trial Clinical and Echocardiographic Outcomes at 30 Days with the SAPIEN 3 valve in Inoperable, High-Risk AS Patients 29 US Participating Sites Symptomatic Severe Aortic Stenosis ASSESSMENT by Heart Valve Team n = 1076 Patients Intermediate-Risk Operable* SAPIEN 3 2 Single Arm Non-Randomized Historical-Controlled Studies High-Risk Operable / Inoperable (HR) n = 583 Patients ASSESSMENT: Optimal Valve Delivery Access ASSESSMENT: Optimal Valve Delivery Access Transfemoral Transapical / Transaortic Transfemoral (TF) Transapical / Transaortic) TF TAVR SAPIEN 3 TAA TAVR SAPIEN 3 TF TAVR SAPIEN 3 TAA TAVR SAPIEN 3 Valve area < 0.8 cm 2 or valve area index < 0.5 cm 2 /m 2 and mean gradient > 40 mmhg or peak velocity > 4 m/s

10 Key Inclusion Criteria Inoperable / high-risk STS score 8 or Heart Team determination Severe aortic stenosis determined by echocardiography Valve area < 0.8 cm 2 or valve area index < 0.5 cm 2 /m 2 and mean gradient > 40 mmhg or peak velocity > 4 m/s

11 Baseline Patient Characteristics SAPIEN 3 Valve HR Patients Average STS = 8.6% (Median 8.4%) Average Age = 82.6yrs TA / TAo, 16% TF, 84% N = 583 Female 42% Male 58% 1.9% 34.3% 38.9% 24.9% 20 mm 23 mm 26 mm 29 mm

12 Procedural Factors SAPIEN 3 Valve HR (n=583) Post-Dilatation (%) 14.8 >1 Valve Implanted (%) 0.9 Valve Embolization (%) 0.2 IABP During Procedure (%) 0.5 Cardiopulmonary Bypass (%) 2.2 Conscious Sedation (%) 13 Median LOS Days (Min, Max) 5 (1, 33)

13 All-Cause Mortality at 30 Days 20% PARTNER I Trial and PARTNER II Trial Overall and TF Patients 15% Cardiovascular 1% 10% 5% 6.3% 5.2% 3.7% 4.5% 3.5% 1.6% 0% PARTNER I B (TF) PARTNER I A (All) PARTNER I A (TF) PARTNER II B (TF) PARTNER II B (TF) PARTNER II HR (TF) SAPIEN Valve SAPIEN XT Valve SAPIEN 3 Valve

14 All Strokes at 30 Days 20% PARTNER I Trial and PARTNER II Trial 15% Neurologist Evaluations (Pre- and Post) 10% 7.3% Disabling 0.8% 5% 4.4% 4.1% 4.3% 1.4% 0% PARTNER I B (TF) PARTNER I A (Overall) PARTNER II B (TF) PARTNER II B (TF) PARTNER II HR (TF) SAPIEN Valve SAPIEN XT Valve SAPIEN 3 Valve

15 NYHA Functional Class (As Treated Patients) 100% 13% 80% IV % 60% 40% 90% III II I 20% 0% SAPIEN 3 Valve HR SAPIEN 3 Valve HR Baseline 30 Days

16 Echocardiographic Findings Mean and Peak Gradients (Valve Implant) Peak Gradient - Overall 60 Mean Gradient - Overall Gradient (mmhg) Baseline 30 Days No. of Echos Overall

17 Paravalvular Leak (At 30 Days - Transfemoral Cohort) 100% 2.5% 0.0% - Severe Percent of Evaluable Echos 80% 60% 40% 20% 36.4% 61.1% 0.1% 0% 30 Day None/Trace Mild Moderate Severe

18 Moderate / Severe PVL At 30 Days Edwards SAPIEN Valves 50% PARTNER I Trial and PARTNER II Trial 40% 30% 24.2% 20% 10% 12.0% 13.2% 17.3% 2.5% 0% PARTNER I B (TF) PARTNER I A (Overall) PARTNER II B (TF) PARTNER II B (TF) PARTNER II HR (Overall) SAPIEN Valve SAPIEN XT Valve SAPIEN 3 Valve

19 Other Clinical Events at 30 Days (As Treated Patients) Events (%) SAPIEN 3 Valve HR TF (n=491) Major Vascular Comps. 5.3 Disabling Bleeding 5.5 Annular Rupture 0.0 Myocardial Infarctions 0.4 Coronary Obstruction 0.0 Acute Kidney Injury 0.8 New Permanent Pacemaker 13.2 Aortic Valve Re-intervention 0.8 Endocarditis 0.2

20 The PARTNER II Trial: SAPIEN 3 Valve HR (TF Cohort) Conclusions In high-risk and inoperable patients, the SAPIEN 3 valve demonstrated low mortality and stroke at 30 days: All-cause Mortality: 1.6% Disabling Stroke: 0.8%

21 What to Expect in the Future? Edwards THV Program SAPIEN Valve TF inoperable indication approval SAPIEN Valve TF and TA high-risk indication approval October 2012 Ascendra 3 System approval July 2013 SAPIEN Valve all access indication approval January 2014 SAPIEN XT Valve all access, high-risk indication approval June 2014 SAPIEN 3 Valve all access, high-risk indication approval June 2015 SAPIEN 3 Valve all access, Intermediate-risk indication approval November 2011

22

23 Baseline Patient Characteristics S3i Patients Average STS = 5.3% (Median 5.2%) TAo, 4% N = 1076 TA, 7% Average Age = 81.9yrs TF, 89% Female 38% Male 62% 4.1% 32.2% 43.7% 20.0% 20 mm 23 mm 26 mm 29 mm

24 Baseline Patient Characteristics Demographics Characteristic (%) S3HR (n=583) S3i (n=1076) NYHA Class III or IV Previous CABG Previous CVA Peripheral Vascular Disease Diabetes COPD - O 2 Dependent CKD - Creat. 2mg/dL Atrial Fibrillation Permanent Pacemaker Frailty

25 Procedural Factors S3HR (n=583) S3i (n=1076) Post-Dilatation (%) >1 Valve Implanted (%) Valve Embolization (%) IABP During Procedure (%) Cardiopulmonary Bypass (%) Conscious Sedation (%) Median LOS Days (Min, Max) 5 (1, 33) 4 (1, 64)

26 Mortality and Stroke: S3i At 30 Days (As Treated Patients) 100 Mortality All-Cause Cardiovascular 100 All Stroke Stroke Disabling O:E = 0.21 (STS 5.3%) % % S3i S3i

27 All-Cause Mortality at 30 Days Edwards SAPIEN Valves (As Treated Patients) 20% PARTNER I and II Trials Overall and TF Patients 15% 10% 5% 6.3% 5.2% 3.7% 4.5% 3.5% 2.2% 1.6% 1.1% 1.1% 0% P1B (TF) P1A (All) P1A (TF) P2B (TF) P2B XT (TF) S3HR (All) S3HR (TF) S3i (All) S3i (TF) SAPIEN SXT SAPIEN 3

28 All Strokes at 30 Days Edwards SAPIEN Valves 20% PARTNER I and II Trials 15% Neurologist evaluations (pre- and post) 10% 5% 6.7% 5.6% 4.1% 4.3% 1.5% 2.6% 0% P1B (TF) P1A (Overall) P2B (TF) P2B XT (TF) S3HR (Overall) S3i (Overall) SAPIEN SAPIEN XT SAPIEN 3

29 Conclusions (1) In intermediate-risk patients (S3i), SAPIEN 3 was associated with strikingly low mortality and strokes at 30 days: Mortality: 1.1% (TF 1.1%, TA/TAo 1.6%) Disabling Stroke: 1.0%

30