An Update on the Edwards TAVR Results Zvonimir Krajcer, MD Director, Peripheral Intervention Texas Heart Institute at St. Luke s Hospital
Disclosures On the speaker s bureau for Endologix, TriVascular, Edwards, Lombard Training courses for: Endologix, Lombard, TriVascular
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
SAPIEN 3 Transcatheter Heart Valve 2 3 1 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
SAPIEN 3 Valve Sizes Valve Size 20 mm 23 mm 26 mm 29 mm Native Annulus Size By TEE 16-19 mm 18-22 mm 21-25 mm 24-28 mm Native Annulus Area (CT) 273-345 mm 2 338-430 mm 2 430-546 mm 2 540-683 mm 2 Area-derived Diameter (CT) 18.6-21 mm 20.7-23.4 mm 23.4-26.4 mm 26.2-29.5 mm
Evolution of the Edwards Balloon-Expandable Transcatheter Valves Cribier- Edwards SAPIEN SAPIEN XT SAPIEN 3 2002 2006 2009 2013
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.
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)
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
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
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
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)
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) 175 344 240 271 282 491 SAPIEN Valve SAPIEN XT Valve SAPIEN 3 Valve
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) 179 344 271 282 491 SAPIEN Valve SAPIEN XT Valve SAPIEN 3 Valve
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 583 550 Baseline 30 Days
Echocardiographic Findings Mean and Peak Gradients (Valve Implant) 80 75.8 70 Peak Gradient - Overall 60 Mean Gradient - Overall Gradient (mmhg) 50 40 30 45.5 21.2 20 10 11.1 0 Baseline 30 Days No. of Echos Overall 539 506
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
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) 179 344 263 280 491 SAPIEN Valve SAPIEN XT Valve SAPIEN 3 Valve
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
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%
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
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
Baseline Patient Characteristics Demographics Characteristic (%) S3HR (n=583) S3i (n=1076) NYHA Class III or IV 90.1 72.6 Previous CABG 33.1 28.0 Previous CVA 11.0 8.9 Peripheral Vascular Disease 35.2 28.3 Diabetes 34.5 34.1 COPD - O 2 Dependent 11.7 5.0 CKD - Creat. 2mg/dL 12.0 7.5 Atrial Fibrillation 43.7 36.0 Permanent Pacemaker 16.3 13.2 Frailty 30.9 8.6
Procedural Factors S3HR (n=583) S3i (n=1076) Post-Dilatation (%) 14.8 11.3 >1 Valve Implanted (%) 0.9 0.4 Valve Embolization (%) 0.2 0.1 IABP During Procedure (%) 0.5 0.4 Cardiopulmonary Bypass (%) 1.2 0.6 Conscious Sedation (%) 13 17 Median LOS Days (Min, Max) 5 (1, 33) 4 (1, 64)
Mortality and Stroke: S3i At 30 Days (As Treated Patients) 100 Mortality All-Cause Cardiovascular 100 All Stroke Stroke Disabling 80 80 60 40 O:E = 0.21 (STS 5.3%) % % 60 40 20 20 0 1.1 0.9 S3i 0 2.6 1.0 S3i
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) 175 344 240 271 282 583 491 1072 947 SAPIEN SXT SAPIEN 3
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) 179 344 276 284 583 1076 SAPIEN SAPIEN XT SAPIEN 3
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%