Percutaneous Aortic Valves The Canadian Perspective Robert C. Welsh, MD, FRCPC Associate Professor of Medicine Director, Adult Cardiac Catheterization and Interventional Cardiology Co-director, Mazankowski Alberta Heart Institute TAVI Team Co-Chair, Vital Heart Response Co-director, U of A Chest Pain Program
Disclosures Research funding: ‐ Abiomed, Astra Zeneca, Bayer, Boeringher Ingelheim, Bristol Myers-Squibb, Eli Lilly, Johnson and Johnson, Pfiser, Portola, Regado, Roche, sanofi aventis Consultant/honorarium: ‐ Astra Zeneca, Bayer, Bristol Myers-Squibb, Eli Lilly, Medtronic, Roche, sanofi-aventis
Transcatheter Aortic Valve Implantation. A Canadian Cardiovascular Society Position Statement John Webb, Josep Rodés-Cabau, Stephen Fremes , Philippe Pibarot, Marc Ruel, Reda Ibrahim, Robert Welsh, Christopher Feindel, Samuel Lichtenstein 1. Who should undergo TAVI? 2. Screening for TAVI. 3. TAVI program principles 1. The multidisciplinary team 2. TAVI procedure room 3. TAVI training 4. TAVI procedural volumes 5. Post procedural management
PARTNER A and B - Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High Risk AVR Candidate 3105 Total Patients Screened Total = 1058 patients 2 Parallel Trials: Individually n=358 n= 700 High Risk Inoperable Powered ASSESSMENT: ASSESSMENT: Transfemoral Access Transfemoral Access High Risk TF High Risk TA 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study TAVI TAVI TAVI Standard Surgical Surgical Trans Trans Trans VS Therapy VS AVR AVR VS femoral femoral femoral (usually BAV) Primary Endpoint: All Cause Mortality (1 yr) Primary Endpoint: All Cause Mortality over length (Non-inferiority) of trial (Superiority)
Study Devices Edwards-SAPIEN THV Retroflex 1 23mm and 26mm 22F and 24F valve sizes sheath sizes
PARTNER B Key Exclusion Criteria - 1 • Aortic valve is bicuspid or non-calcified • Aortic dissection or iliac-femoral dimensions or disease which precludes safe sheath insertion • Severe LV dysfunction (LVEF < 20%) • Untreated CAD requiring revascularization • Severe AR or MR (> 3+) or prosthetic valve (any location) • Hemodynamic instability (e.g. requiring inotrope support) • Life expectancy < 12 months (or little hope for meaningful lifestyle recovery)
PARTNER B Key Exclusion Criteria - 2 • Serum Cr > 228 mmol/L or dialysis dependent • Acute MI within 1 month • Upper GI bleed within 3 months • CVA or TIA within 6 months • Any cardiac procedure, other than BAV, within 1 month or within 6 months for DES
PARTNER B - Patient Characteristics - 1 TAVI Standard Rx Characteristic P value n=179 n=179 Age - yr 83.1 ± 8.6 83.2 ± 8.3 0.95 Male sex (%) 45.8 46.9 0.92 STS Score 11.2 ± 5.8 12.1 ± 6.1 0.14 Logistic EuroSCORE 26.4 ± 17.2 30.4 ± 19.1 0.04 NYHA I or II (%) 7.8 6.1 0.68 III or IV (%) 92.2 93.9 0.68 CAD (%) 67.6 74.3 0.20 Prior MI (%) 18.6 26.4 0.10 Prior CABG (%) 37.4 45.6 0.17 Prior PCI (%) 30.5 24.8 0.31 Prior BAV (%) 16.2 24.4 0.09 CVD (%) 27.4 27.5 1.00
PARTNER B - Patient Characteristics - 2 TAVI Standard Rx Characteristic P value n= 179 n=179 PVD (%) 30.3 25.1 0.29 COPD Any (%) 41.3 52.5 0.04 O2 dependent (%) 21.2 25.7 0.38 Creatinine >2mg/dL (%) 5.6 9.6 0.23 Atrial fibrillation (%) 32.9 48.8 0.04 Perm pacemaker (%) 22.9 19.5 0.49 Pulmonary HTN (%) 42.4 43.8 0.90 Frailty (%) 18.1 28.0 0.09 Porcelain aorta (%) 19.0 11.2 0.05 Chest wall radiation (%) 8.9 8.4 1.00 Chest wall deformity (%) 8.4 5.0 0.29 Liver disease (%) 3.4 3.4 1.00
Procedural Outcomes TAVI (179 patients) • 6 (3.4%) pts did not receive TAVI 2 died before scheduled implant 2 unsuccessful transfemoral access 2 intra-procedural annulus measurement too large and procedure aborted • After randomization, median time to TAVI was 6 days (inter- quartile range 3 - 11 days) • During TAVI (first 24 hours) 2 (1.1%) deaths 3 (1.7%) major strokes 1 (0.6%) valve embolization 2 (1.1%) pts with multiple (≥ 2) valve implants • In the first 30 days, 11 (6.4%) pts receiving TAVI died
Procedural Outcomes Standard Rx (179 patients) • BAV performed in 114 (63.7%) pts ≤ 30 days and an additional 36 (20.1%) pts > 30 days after randomization (total BAV = 83.8% pts) • Despite inoperable status: 12 (6.7%) pts received AVR 5 (2.8%) received LV - desc Ao conduit + AVR 4 (2.2%) received TAVI outside US • 1-year mortality of pts receiving AVR, AVR-conduit, or TAVI (outside US): AVR - 33% AVR + conduit - 80% TAVI (outside US) - 0%
All Cause Mortality (ITT) Crossover Patients Followed HR [95% CI] = Standard Rx 100% 0.57 [0.44, 0.75] TAVR p (log rank) < 0.0001 All Cause Mortality (%) 80% 67.6% ∆ at 1 yr = 20.0% 60% 50.7% NNT = 5.0 pts 40% 43.3% 30.7% ∆ at 2 yr = 24.3% 20% NNT = 4.1 pts 0% 0 6 12 18 24 Months Numbers at Risk TAVR 179 138 124 110 83 Standard Rx 179 121 85 67 51 12
Cardiovascular Mortality (ITT) Crossover Patients Censored Standard Rx 100% HR [95% CI] = Cardiovascular Mortality (%) TAVR 0.44 [0.32, 0.60] 80% p (log rank) < 0.0001 62.4% ∆ at 1 yr = 24.1% 60% NNT = 4.1 pts 44.6% 40% 31.0% 20% ∆ at 2 yr = 31.4% 20.5% NNT = 3.2 pts 0% 0 6 12 18 24 Months Numbers at Risk TAVR 179 138 124 110 83 Standard Rx 179 121 85 62 42 13
Repeat Hospitalization (ITT) HR [95% CI] = Standard Rx 100% 0.41 [0.30, 0.58] TAVR Repeat Hospitalization (%) p (log rank) < 0.0001 80% 72.5% ∆ at 1 yr = 26.9% 53.9% 60% NNT = 3.7 pts 40% 35.0% 20% ∆ at 2 yr = 37.5% 27.0% NNT = 2.7 pts 0% 0 6 12 18 24 Months Numbers at Risk TAVR 179 115 100 89 64 Standard Rx 179 86 49 30 17 14
All Stroke (ITT) Standard Rx 100% HR [95% CI] = TAVR 2.79 [1.25, 6.22] 80% p (log rank) = 0.009 Incidence (%) 60% ∆ at 1 yr = 5.7% ∆ at 2 yr = 8.3% 40% 13.8% 20% 11.2% 5.5% 0% 5.5% 0 6 12 18 24 Months Numbers at Risk TAVR 179 128 116 105 79 Standard Rx 179 118 84 62 42 15
Mortality Stratified by Paravalvular Leak (ITT) Starting at Discharge Moderate or Severe 100% None to Mild 80% Death Incidence (%) p (log rank) = 0.891 60% 41.2% 35.3% 40% 40.5% 20% 27.2% 0% 0 6 12 18 24 Months Numbers at Risk None to Mild 147 118 107 95 72 Moderate or Severe 17 12 11 10 8 16
NYHA Class Over Time Survivors P = 0.68 P < 0.0001 P < 0.0001 P < 0.0001 Percent TAVI Standard Rx TAVI Standard Rx TAVI Standard Rx TAVI Standard Rx Treatment Baseline 30 Day 6 Month 1 Year Visit I II III IV
Cost-Effectiveness of TAVR vs. Control Lifetime Results $100,000 per LY Cost = $79,837 LE = 1.59 years ICER = $50,212/LYG $50,000 per LY Reynolds MR et al, Circulation. 2012 Feb 3. [Epub ahead of print]
TAVR vs. SAVR Transfemoral and Transapical Transapical Transfemoral
Patient Characteristics (1) Characteristic TAVR (N = 348) AVR (N = 351) p-value Age (yr) 0.07 83.6 ± 6.8 84.5 ± 6.4 Male sex - % 57.8 56.7 0.82 STS Score 11.8 ± 3.3 11.7 ± 3.5 0.61 Logistic EuroSCORE 29.3 ± 16.5 29.2 ± 15.6 0.93 NYHA II - % 5.7 6.0 III or IV - % 94.3 94.0 0.79 CAD - % 74.9 76.9 0.59 Previous MI - % 26.8 30.0 0.40 Prior CV Intervention - % 72.1 71.6 0.93 Prior CABG - % 42.6 44.2 0.70 Prior PCI - % 34.0 32.5 0.68 Prior BAV - % 13.4 10.2 0.24 Cerebrovascular disease - % 29.3 27.4 0.60
Patient Characteristics (2) Characteristic TAVR (N = 348) AVR (N = 351) p-value Peripheral vascular disease - % 43.0 41.6 0.76 COPD 43.4 0.94 Any 43.0 Oxygen dependent 9.2 7.1 0.34 Creatinine > 2mg/dL - % 11.1 7.0 0.06 Atrial fibrillation - % 40.8 42.7 0.75 Permanent pacemaker - % 20.0 21.9 0.58 Pulmonary hypertension - % 42.4 36.4 0.15 Frailty - % 15.6 17.6 0.58 Porcelain aorta - % 0.6 1.1 0.69 Chest wall radiation - % 0.9 0.9 1.00 Liver disease - % 2.0 2.6 0.80
Transcatheter vs. Surgical Aortic Valve Replacement in High Risk Patients with Severe Aortic Stenosis: Results From The PARTNER Trial Primary Endpoint: All-Cause Mortality at 1 Year HR [95% CI] = 0.5 TAVR 0.93 [0.71, 1.22] AVR P (log rank) = 0.62 0.4 26.8 0.3 0.2 24.2 0.1 0 0 6 12 18 24 No. at Risk Months TAVR 348 298 260 147 67 AVR 351 252 236 139 65 Smith CRet al, N Engl J Med. 2011 Jun 9;364(23):2187-98. Epub 2011 Jun 5.
NYHA Functional Class P = 1.00 P < 0.001 P = 0.05 P = 0.75 100 Patients Surviving, % 80 60 40 20 0 TAVR AVR TAVR AVR TAVR AVR TAVR AVR Baseline 30 Days 6 Months 1 Year I II III IV
Transcatheter vs. Surgical Aortic Valve Replacement in High Risk Patients with Severe Aortic Stenosis : Results From The PARTNER Trial All-Cause Mortality: Transfemoral (N=492) HR [95% CI] = 0.5 0.5 TAVR TAVR 0.83 [0.60, 1.15] AVR AVR P (log rank) = 0.25 0.4 0.4 26.4 0.3 0.3 0.2 0.2 22.2 0.1 0.1 0 0 0 6 12 18 24 0 6 12 18 24 No. at Risk Months TAVR 244 215 188 119 59 AVR 248 180 168 109 56 Smith CRet al, N Engl J Med. 2011 Jun 9;364(23):2187-98. Epub 2011 Jun 5.
All-Cause Mortality Transapical (N=207) HR [95% CI] = 0.5 TAVR 1.22 [0.75, 1.98] AVR P (log rank) = 0.41 0.4 29.0 0.3 27.9 0.2 0.1 0 0 6 12 18 24 No. at Risk Months TAVR 104 83 72 28 8 AVR 103 72 68 30 9
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